This chapter outlines the process for application for, denial of, and disciplinary action on, the approval for a program to be eligible to receive State or federal funds for providing community mental health services. This chapter does not apply to programs approved under COMAR 10.21.07 Therapeutic Group Homes or Federally Qualified Health Centers. In this chapter, terms have the meanings indicated in COMAR 10.21.17. To be eligible for approval under this chapter, a program shall: Meet the requirements of: This chapter; COMAR 10.21.17; The chapter under this subtitle that outlines the requirements for the specific program; and Medical Assistance regulations, including, but not limited to COMAR 10.09.36, 10.09.59. and 10.09.70; and Demonstrate compliance with: Relevant federal, State, or local ordinances, laws, regulations, and orders governing the program; and The satisfactory fire, safety, and health inspection reports of the site that are required by the local jurisdiction, if a program provides services at a site whose primary function is the delivery of mental health services. Consultation. Before submitting an application, an applicant for approval of a program may request assistance from the Department's designated approval unit or the appropriate core service agency (CSA) director regarding the proper compilation of application materials and completion of the application. Lead CSA Determination. For programs providing services in multiple jurisdictions, the Administration, in collaboration with the appropriate CSAs, shall determine the lead CSA. Application. An applicant for approval of a program shall: Submit an application to the Department’s designated approval unit; Submit the application on the written or electronic form approved by the Department, with all questions answered and all required documents attached; Include in the application, at a minimum, the following information: Documentation of the applicant's program service plan, as outlined in Regulation .05 of this chapter; A written business plan that clearly demonstrates the program's ability to provide services in accordance with applicable Maryland regulations and Medicaid and Medicare funding requirements; Information to demonstrate the program's financial viability, including, but not limited to: Salary structure; Client mix; Anticipated administrative expenses; Necessary cash reserves to maintain the program during the start-up phase and a financial crisis; Identification of the individual responsible for providing the required financial information; and Other information deemed necessary by the Department; A summary of the program's demonstrated experience in the field of mental health; Prior licensing reports issued within the previous 10 years from any in-State or out-of-State entities associated with the program, including deficiency reports and compliance records from which the Department may make reasoned decisions about the qualifications of the program; Disclosure of: Any license or approval revocation within the previous 10 years by the Department or other licensing agency; Whether the program, or corporation or entity associated with the program, has surrendered or defaulted on its license or approval for reasons related to disciplinary action, within the previous 10 years; and Any corporate officer who has served as a corporate officer for a corporation or entity that has had a license revoked, or has surrendered or defaulted on its license or approval for reasons related to disciplinary action within the previous 10 years; A written quality assurance plan that addresses how the organization will ensure the health and safety of the individuals served by the program and the quality of services provided to individuals by the program; and For 26 U.S.C. §501(c)(3) organizations, a statement of how the organization intends to satisfy its charitable mission; and Forward a copy of the: Completed application to the: CSA of the jurisdiction where the program services are to be delivered; or For programs providing services in multiple jurisdictions, lead CSA identified under §B of this regulation; and Application cover letter to the Administration and all CSAs of the jurisdictions where the program plans to deliver services. Action by the CSA or Lead CSA. The CSA, or lead CSA identified under §B of this regulation, shall submit to the Department's designated approval unit: Verification that: The program agrees to collaborate with all CSAs where the program proposes to provide services, according to the provisions of COMAR 10.21.17.06; and The financial information submitted under §C of this regulation appears to demonstrate potential financial viability of the program; and Comments, if any, on the content of the application. Application Modification. A program that proposes to change its program sites by adding, closing, or moving locations shall submit an application modification, on the form required by the Department, to the Department's designated approval unit. If the Department's designated approval unit approves the application modification, the existing program approval shall extend to the additional site, as applicable. On the forms approved by the Administration as part of the application required under Regulation .04C of this chapter or COMAR 10.21.04.05B, a program shall submit a PSP that includes a description of: The range of services that the program will provide; The populations to be served, including age groups and other relevant characteristics, and the number of individuals that the program expects to serve; Program sites and hours of operation, and the method to ensure that services are accessible to the individuals served; The goals, objectives, and expected outcomes of the program; The composition of the program's governing body, board of directors, or advisory committee, whichever applies, as outlined in COMAR 10.21.17.05A; The jurisdictions where services will be provided and the number of services to be provided in each jurisdiction; and The jurisdiction where most of the program's services will be rendered. The Department's designated approval unit shall evaluate the application to determine whether the applicant adequately documents that the: Proposed program has met all approval requirements; Applicant has reviewed and is knowledgeable regarding all applicable regulations; and Program will be financially viable. Before making a determination under §A of this regulation, the Department's designated approval unit may: Request clarification of application materials; and Consult with the CSA director, or lead CSA director, and the Administration. Before determining that a program is eligible for approval under this or any other chapter of the Administration's regulations, the Department shall conduct an on-site investigation of the program and meet with the applicant. If the Department's designated approval unit determines that the program meets all approval requirements, the Secretary shall: Issue temporary approval according to the provisions of §B of this regulation; and Forward copies of the approval to the: Appropriate CSA; Administration; ASO; Medical Assistance Program; and The program's chief executive officer (CEO) and president of the advisory committee or governing body, whichever applies. Duration of Temporary Approval. The temporary approval is valid for a period of not more than 6 months unless: Before the end of 6 months, the program requests an extension due to a delay in beginning operations; and Upon the recommendation of the Department's designated approval unit, the Secretary grants an extension of not more than 6 months. If a program is granted an extension of temporary approval under §B(1)(b) of this regulation, and the program fails to begin operation during the effective date of the extension, the program's approval automatically ceases. Denial of Temporary Approval. The Department may deny temporary approval to an applicant if the Department's designated approval unit determines that the application does not meet all approval requirements. The Department may deny a license or approval to: Any corporation or entity that has had a license or approval revoked by the Department or other licensing agency, or has surrendered or defaulted on its license or approval for reasons related to disciplinary action, within the previous 10 years; and Any corporation or entity that has a corporate officer who has served as a corporate officer for a corporation or entity that has had a license revoked, or has surrendered or defaulted on its license or approval for reasons related to disciplinary action, within the previous 10 years. The Secretary may, according to the provisions of Regulation .12A of this chapter, issue an initial notice of proposed denial of temporary approval. If the Secretary takes the action in §C(1) or (2) of this regulation, the Secretary shall advise the applicant of hearing rights, as described in Regulations .12A and .16 of this chapter. Before the expiration of a temporary approval period: The Department's designated approval unit shall conduct an on-site review to determine approval status outlined in Regulation .08 of this chapter; and Following completion of the on-site review required under §D(1) of this regulation, the Secretary shall grant or propose to revoke approval according to the provisions of Regulation .08 or .12 of this chapter. Approval Without Conditions. The Secretary shall grant approval without conditions to a program if, based on an on-site review, the Department's designated approval unit determines that the program complies with the requirements for approval. Unless the program has been granted deemed status under Regulation .10 of this chapter, within not more than 3 years of the date of the program's last full on-site review, the Department's designated approval unit shall conduct a full, on-site review of the program. Based on the review conducted under §A(2) of this regulation, the Secretary shall redetermine the program's approval status according to the provisions of this chapter. Approval with Conditions. The Secretary may grant approval with conditions to a program if, based on an on-site review, the Department's designated approval unit determines that the program: Is deficient in one or more of the requirements under this chapter, COMAR 10.21.17, or the chapter under the subtitle for the specific program; Has no deficiencies that constitute a threat to health, safety, or welfare of the individuals served; Has documented that the program will collaborate with the CSA, as required under COMAR 10.21.17.06; and Has submitted an acceptable program improvement plan within the time frame established under §B(3) of this regulation. If the Secretary grants a program an approval with conditions under §B(1) of this regulation, the Secretary shall notify the program that the Department's designated approval unit may conduct a focused review under the provisions of §B(4) of this regulation. Program Improvement Plan (PIP). Within 10 working days of receipt of the list of deficiencies cited during the on-site review, the program director shall: Submit a proposed PIP that addresses the identified deficiencies to the CSA or lead CSA; and Collaborate with the CSA or lead CSA to finalize the PIP. Within 30 calendar days of receipt of the list of deficiencies cited during the on-site review, the program director shall submit: The PIP to the Department's designated approval unit; and Documentation of the collaboration with the CSA or lead CSA. Unless an extension has been granted by the Department's designated approval unit, if a program fails to submit a completed PIP within the time frames established in §B(3)(a) and (b) of this regulation, the Secretary may pursue disciplinary action under Regulation .12C of this chapter. Focused Review. For programs that have been granted approval with conditions, the Department's designated approval unit may conduct a focused review to: Reevaluate the deficiencies cited during the on-site review conducted under §B(1) of this regulation; and Review the program's progress on the PIP. Based on the focused review conducted under §B(4)(a) of this regulation, the Secretary shall redetermine the program's approval status according to the provisions of this chapter. Regular Program Review. Within 3 years of the date of the program's last full on-site review, the Department's designated approval unit shall conduct a full, on-site review of the program. Based on the review conducted under §B(5)(a) of this regulation, the Secretary shall redetermine the program's approval status according to the provisions of this chapter. Certificate of Approval. If the Department's designated approval unit determines that a program is eligible for approval, the Secretary shall issue a certificate of approval to the program director that specifies the: Chapter under which the program has been approved; Type of approval; and Beginning and expiration dates of the approval period. The Secretary shall notify the Administration, the CSA of the jurisdiction where the program provides services, the Medical Assistance Program, and the ASO of the program's approval. The program director shall ensure that the certificate of approval is available during the regular hours of operation. Sale or Transfer of Certificate of Approval. The Secretary's certificate of approval of a program, issued according to the provisions of §C(1) of this regulation, is valid only for the program to which the Secretary's certificate of approval is issued. A program may not sell, assign, or transfer a certificate of approval to another program. Extension of Approval Status. The Secretary shall maintain the program's existing approval status if, before the expiration of approval period, the: Department's designated approval unit does not complete an on-site review; or Department does not reach a decision regarding approval. Waivers. The Secretary may not waive the requirements of any regulation adopted under: This chapter; COMAR 10.21.17; or The chapter under this subtitle that outlines the requirements for a specific program. Variances. A program that is approved under Regulation .08 of this chapter may apply for a variance. When a program is approved under Regulation .08 of this chapter, the Secretary may grant a variance for a regulation if the Secretary: Receives a written request from a program on the form required by the Administration; and Finds that the intent of the regulation to which a variance is sought is met by the alternative proposed by the program. The Secretary may not grant a variance that would endanger the health or safety of the individuals served. The Secretary may grant a variance that: Remains in effect for as long as the program continues to comply with the conditions under which the variance is granted; or Is time limited. The Secretary shall: Issue a written decision, including the reason or reasons for granting or not granting the variance; Send the decision to the: Program director; CSA; and Department's designated approval unit; and Enter the decision in the records of the Department. Initial Request for Deemed Status. If a program is approved under Regulation .08 of this chapter and is accredited under relevant behavioral health care standards of the Joint Commission on the Accreditation of Health Care Organizations (JCAHO) or the Rehabilitation Accreditation Commission (CARF), the program director may request that the Secretary grant the program deemed status by submitting a written request to the Administration and the CSA at least 90 days before the expiration of the program's current approval status that includes the: Application for deemed status; Accreditation body's full report, including the program's status and any conditions placed on the program; Most recent report by the Department's designated approval unit; and Program improvement plans, if any, required by the accreditation body or the Department's designated approval unit. Request for Renewal of Deemed Status. The program may request that the Secretary renew the program's deemed status by submitting a written request to the Administration at least 60 calendar days before the expiration of the program's current deemed status that includes the: Application for deemed status renewal; Most recent accreditation body's full report, including the program's status and any conditions placed on the program; Program improvement plan, if any, required by the accreditation body; and Documentation of verification from the CSA or lead CSA, of program compliance with the conditions, if any, outlined under §D(1)(b) of this regulation. Evaluation of Request for Initial Deemed Status or Renewal of Deemed Status. Within 60 calendar days of receipt of the request under §A or B of this regulation: The Administration, in consultation with the CSA or lead CSA, and the Department's designated approval unit: Shall evaluate the request for deemed status; May meet with the program director; and May arrange for an on-site evaluation; and The Director shall recommend to the Secretary a decision regarding deemed status, based on: Comparison of the standards used by the accreditation body with the chapter under this subtitle that outlines the requirements for the specific program; and The results of an on-site evaluation, if any. Decision Regarding Deemed Status. Based on the evaluation of the request for deemed status conducted under §C of this regulation, the Secretary shall: Decide whether to: Approve deemed status; Approve deemed status with conditions, which may include evaluation by the Department's designated approval unit; or Propose to deny approval of deemed status; and Send notice of the decision to the: Department's designated approval unit; Program director; Administration; and CSA or lead CSA. Denial of Deemed Status. If the Secretary proposes to deny approval of deemed status, the Secretary shall give written notice of the proposed denial to the: Department's designated approval unit; Program director; Administration; and CSA or lead CSA. In the notice under §E(1) of this regulation, the Secretary shall include: The date that the Secretary proposes to deny approval of deemed status; and The facts that warrant the proposed denial of deemed status. Upon receipt of the notice under §E(2) of this regulation, the program director may: Withdraw the request for deemed status; and Request an on-site review for approval by the Department's designated approval unit. If the program director does not take the action under §E(3) of this regulation and if, after notice and opportunity to be heard, the Secretary denies approval of deemed status, the Director shall notify the program director that, unless the program elects not to seek approval, the Department's designated approval unit shall conduct an on-site review for the purpose of granting or denying approval under Regulation .08 or .12 of this chapter. The Department, its designees, the Administration, the Administration's ASO, CSA, and federal funding agents may: Make announced and unannounced visits to a program; and Inspect and copy all records, including, but not limited to financial, treatment, and service records. Denial of Approval. If the Secretary proposes to deny approval to an applicant under the provisions of this chapter, the Secretary shall give written notice of the proposed denial to the: Applicant; Program's CEO and president of the advisory committee or governing body, whichever applies; Administration; CSA or lead CSA; ASO; and Medical Assistance Program. In the notice under §A(1) of this regulation, the Secretary shall include: The date on which the Secretary proposes to deny approval; The facts that warrant the proposed denial of approval; Citation of the regulation or regulations upon which the proposed denial is based; and Notification: That before the denial of approval, the program may request a hearing under the provisions of Regulation .16 of this chapter; and When feasible, of a case resolution conference. Emergency Suspension of Approval. Under State Government Article, §10-226, Annotated Code of Maryland, upon findings of conditions that pose an imminent risk to the health, safety, or welfare of an individual served by a program, the Secretary may order the immediate suspension of the approval of the program and the cessation of operation. If the Secretary takes the action under §B(1) of this regulation, the Secretary shall promptly give written notice of the proposed emergency suspension to the: Program director; President of the program's advisory committee, board of directors, or governing body, whichever is applicable; Administration; CSA or lead CSA; Department's designated approval unit; ASO; and Medical Assistance Program. In the notice under §B(2) of this regulation, the Secretary shall include: The proposed effective date of the emergency suspension; When feasible, the date of a pre-deprivation hearing and a case resolution conference prior to the Department's final action; The findings under §B(1) of this regulation and the reasons that support the finding; Notification that: Following the emergency suspension, the program may request a hearing under the provisions of Regulation .16 of this chapter; and The emergency suspension may lead to revocation of the approval if the violation or violations are not corrected within the time period specified by the Department. If the Secretary suspends approval, the program director shall immediately: Notify individuals or the guardians of individuals receiving services of the suspension; Cooperate with the CSA or lead CSA and the Administration in accessing appropriate alternate services for individuals in the program; and Cease operations of the program. Disciplinary Action. The Secretary may propose to take any of the following disciplinary actions against a program: Revocation of approval; Suspension of approval; Probation with conditions; or Banning new admissions. The Secretary may propose to take one of the actions outlined in §C(1) of this regulation if the program: Is out of compliance with the requirements of: This chapter; COMAR 10.21.17; or The chapter under this subtitle that outlines the requirements for the specific program; Fails to maintain financial viability; or Obtains or attempts to obtain approval by fraud, misrepresentation, or the submission of false information to the Secretary. Except under §B of this regulation, no less than 45 calendar days in advance of the proposed action taken under this regulation, the Secretary shall send written notice of the proposed action to the: Program director; President of the program's advisory committee, board of directors, or governing body, whichever is applicable; Administration; and CSA or lead CSA. In the notice under §C(3) of this regulation, the Secretary shall include: The date on which the Secretary proposes to take action, and when feasible, the date of a case resolution conference; The facts that warrant the proposed action; Citation of the regulation or regulations upon which the proposed action is based; and Notification that, before the action, the program has the right to request a hearing under the provisions of Regulation .16 of this chapter. If, after notice and opportunity to be heard, the Secretary takes disciplinary action, the program director shall, within 10 working days: Notify individuals or the guardians of individuals receiving services of the action; and If the program ceases operations: Notify the CSA or lead CSA and the Administration of the cessation; and Cooperate with the CSA or lead CSA and the Administration in accessing appropriate alternate services for individuals in the program. If a program intends to discontinue operation, the program director shall, no less than 60 calendar days before the program intends to discontinue operation, submit to the Department's approval unit, the Administration, and the lead CSA its written plan for: Cessation of operations, including relevant dates; Transitioning individuals within its program to other mental health services; Storing and protecting all records; Notifying employees, consultants, and consumers of its cessation of operations; If a nonprofit organization, the return of funds to the State, as required; Reimbursement of employees for lost benefits, such as sick leave, vacation, and pension plan transitions; and An audited financial statement, current as of the date of the request to discontinue operations. Within 30 days of receipt of the program's request to discontinue operations, the Department's approval unit shall: Notify the program in writing whether its plan is acceptable; and If the plan is unacceptable, meet with the program and the lead CSA to formulate a plan that protects the health, safety, and welfare of the individuals served by the program and program staff. The program may not discontinue operations until the Department's approval unit authorizes this discontinuation. The program shall be responsible for delivering services to the individuals in its program until such time as the Department's approval unit approves the discontinuation. The program shall surrender its approval to provide services concurrent with the date on which it ceases operation. At all times, the program shall cooperate with the Administration, the Department's approval unit, and the lead CSA. Failure to comply with any section of this regulation may result in monetary penalties against the program's surety bond. If a program that is discontinuing operation does not comply with §§A — F of this regulation, the Secretary may deny approval to any future application that the program, or principals of the program, may submit. If a program wishes to discontinue approval, the program director shall, not less than 60 calendar days before the date the program wishes to discontinue approval: Submit to the Department's designated approval unit a letter requesting discontinuation of approval; and Notify, in writing, the: Individuals or the guardians of individuals receiving services that the program has requested discontinuation of approval, and the effective date of the discontinuation; and CSA or lead CSA, the Administration, Medical Assistance Program, and the ASO of the discontinuation of approval and the effective date of discontinuation. Within 60 calendar days from the receipt of the request for discontinuation of approval, the Secretary shall: Notify, in writing, the program director of the discontinuation of the program's approval and the effective date; and Forward a copy of the discontinuation to the Administration, Medical Assistance Program, CSA, and the ASO. When a program's decision to discontinue approval results in the discontinuation of services to any individual receiving services, the program director shall cooperate with the CSA or lead CSA and the Administration in accessing appropriate alternate services for individuals in the program. The Secretary may take action to initiate receivership under the provision of Health-General Article, §§19-333 — 19-339, Annotated Code of Maryland. If the Secretary proposes to deny approval or initiate disciplinary action, the Secretary shall give the program director written notice of the proposed action, according to the provisions outlined in Regulation .12A — C of this chapter. Within 10 working days of receipt of the notification of the action under §A of this regulation, the program director may file a written request for a hearing with the Office of Administrative Hearings, with copies to the: Administration; CSA or lead CSA; and Director of the Department's designated approval unit. If the program director does not file a request for hearing that is postmarked within 10 working days of receipt of the notification, the program waives the right to request a hearing, and the Secretary may effect the proposed action. If a timely request for hearing has been received, the Office of Administrative Hearings shall: Notify the Director and the program director of the date, time, and location of the hearing; and Hold a hearing and render a proposed decision to the Secretary in accordance with COMAR 28.02.01. After giving parties the opportunity to file exceptions and make oral arguments under the provisions of State Government Article, §10-216, Annotated Code of Maryland, the Secretary shall issue a final decision according to State Government Article, §10-221, Annotated Code of Maryland, and send notice of the decision to the: Administration; ASO; Appropriate CSA; Medical Assistance Program; and Program director. Further Appeal. A program may appeal any final decision by the Secretary by following the provisions of Health-General Article, §2-207, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. Health-General Article, §§7.5-205, 10-901, and 10-902, Annotated Code of Maryland Effective date: January 2, 1995 (21:26 Md. R. 2187) Chapter revised effective October 5, 1998 (25:20 Md. R. 1529) Regulations .01 — .12 repealed and new Regulations .01 — .16 adopted effective January 14, 2008 (35:1 Md. R. 19) Regulation .04C amended effective March 13, 2017 (44:5 Md. R. 292)