This chapter sets forth the processes governing application for accreditation-based and non-accreditation-based licenses to provide community-based behavioral health services, issuance and parameters of the license, and sanctioning of licensees. An applicant for a license, whether accreditation or non-accreditation-based, to provide community-based behavioral health services shall: Use the application form required by the Department; Include the following information with the application: Verification that the program complies with the program descriptions and criteria set out in this subtitle; Attestation of compliance with relevant federal, State, or local ordinances, laws, regulations, and orders governing the program; Disclosure of the following: Any revocation of a license, certificate, or approval issued within the previous 10 years from any in-State or out-of-State provider previously or currently associated with the applicant, including deficiency reports and compliance records; Whether the applicant, or a program, corporation, or provider previously or currently associated with the applicant, has surrendered or defaulted on its license, certificate, or approval for reasons related to disciplinary action, within the previous 10 years; The identity of any individual who has served as a corporate officer for the provider who has had a license, certificate or approval revoked, or has surrendered or defaulted on an approval license, certificate or approval, for reasons related to disciplinary action, within the previous 10 years; and Any criminal conviction of the applicant, or the owner, program director, or other staff of the applicant; Include the following documents with the application: A copy of the agreement to cooperate between the program and the CSA, LAA, or LBHA, as appropriate; Copies of all applicable permits required by local jurisdictions, including fire, safety, and health, for each proposed site, if the program will provide services at a site whose primary function is the delivery of behavioral health services; and All documentation supporting or demonstrating the information disclosed under §A(2)(c) of this regulation; Include any other information considered necessary and requested by the Department; and Submit the completed application to the Department’s designated approval unit, identifying: The services that the applicant would provide if licensed; and The physical sites where the services would be provided; If the application submitted under §A of this regulation is incomplete or missing any of the documentation required by this regulation, the application shall be returned to the program to provide the missing information, and processing of the application shall stop until the information is provided. In addition to the application requirements for all community-based behavioral health services licenses, the provisions of this regulation apply to all applicants for licenses to provide community-based behavioral health services, if the license is required by this subtitle to be accreditation-based. A program applying for an accreditation-based license to provide community-based behavioral health services shall submit with the program’s application: The program’s most recent behavioral health accreditation survey report; Any corrective action plans required by the behavioral health accreditation organization survey report of the program; and The final letter or certificate issuing accreditation for the program. Before determining whether a program requiring an accreditation-based license to provide community-based behavioral health services is eligible for licensure, the Department’s designated approval unit may conduct an on-site review in cases in which significant concerns have been raised regarding the operations of the program or the organization that accredited the program. In addition to the application requirements for all community-based behavioral health services licenses, the provisions of this regulation apply to all applicants for licenses to provide community-based behavioral health services, if the license is permitted by this subtitle to be non-accreditation-based. A program applying for a non-accreditation-based license to provide community-based behavioral health services shall pass an inspection by the Department, or its designee, of all of the program’s sites before issuance of the license; The on-site inspection conducted under §B of this regulation shall include: A tour of the physical plant for safety and quality and compliance with regulations and codes; Interviews with the staff to verify training and competencies; and A review of emergency and disaster preparedness systems. During the on-site inspection, the Department shall ascertain whether the physical plant: Provides sufficient space for required services; Is appropriately furnished, well lit, adequately ventilated, and easily accessible; Is maintained in good repair, safe, clean and free of insects and rodents and hazards; Provides secure storage for participant records; Provides for the safe and sanitary disposal of trash; and Provides marked fire exits and the posting of evacuation routes. If the Department’s designated approval unit determines that a program is eligible for a license to provide community-based behavioral health services, whether accreditation-based or non-accreditation-based, the Department’s designated approval unit shall issue a license to the program that specifies the: Programs that the applicant is licensed to provide, including the addresses of all sites where the services will be provided; Duration of the licensure period: Name of the accreditation organization, if applicable; and Date of issue. The duration of the license: For an accreditation-based license, shall equal the accreditation period plus 3 months; and For a non-accreditation-based license, may not exceed 3 years. The Department’s designated approval unit shall notify the following when a license has been issued for a program: The Administration; The CSA, LAA, or LBHA, as appropriate, of the jurisdiction in which the program is providing or will provide services; The Medical Assistance Program; and The ASO for MDH. The program director shall ensure that the license: For non-residential programs, is posted in clear view during the regular hours of operation; or For residential programs, is available for review during regular hours of operation. In order to be approved, an application for renewal of a license and supporting documentation shall be received by the Department or its designee at least 60 days before the expiration of the program’s current license. If the program fails to submit the application and supporting documentation within the timeframe established in §E of this regulation, the program’s license shall be suspended from the license expiration date until the issuance of a new license for the program. If the Department’s designated approval unit suspends the program’s license in accordance with §F of this regulation, the program director shall immediately take the actions described in Regulation .11D of this chapter. The Department may deny a license to provide community-based behavioral health services to: An applicant, if the Department’s designated approval unit determines that the application does not meet the licensure requirements; An applicant that has had a license or approval revoked by the Department or other licensing agency, or has surrendered or defaulted on its license or other approval for reasons related to disciplinary action, within the previous 10 years; An applicant that has an officer who has served as an officer for a provider that has had a license revoked, or has surrendered or defaulted on its license or other approval for reasons related to disciplinary action, within the previous 10 years; or Any program that discontinues operations without complying with Regulation .10 of this chapter. If the Department’s designated approval unit denies licensure to an applicant under this chapter, the Department’s designated approval unit shall give written notice of the proposed denial to the program. The notice of the proposed denial of an application for a license shall include: The facts that warrant the proposed denial of licensure; and Notice that the program has a right to a hearing in accordance with Regulation .19 of this chapter. A program may not change its program sites by adding, closing, or moving locations without prior approval from the Department’s designated approval unit. To request a change in its program sites by adding, closing, or moving locations, a licensed program shall submit to the Department’s designated approval unit: An application modification on the form required by the Department; Evidence that the program has notified the appropriate accreditation organization of the proposed program modification, if the program has an accreditation-based license; Evidence that the program has notified the appropriate CSA, LAA, or LBHA of the proposed program modification; Evidence that the program has notified the program participants of any proposed change in program site; and Copies of all applicable permits required by local jurisdictions, including fire, safety, and health, for each proposed site, if the program will provide services at a site whose primary function is the delivery of behavioral health services. To request a change in its service array, a licensed program shall submit to the Department’s designated approval unit: If applicable, evidence that the program has received accreditation for the proposed additional program type; and Evidence that the program has notified the appropriate CSA, LAA, or LBHA of the proposed program modification. Before being approved for any modification described in this regulation, the following programs shall pass an inspection of the sites by the Department or its designee: Programs with a non-accreditation-based license; and Residential sites described in COMAR 10.63.04. If the Department’s designated approval unit approves the application modification submitted under §B or C of this regulation, the existing program license shall extend to the additional program and additional site, as applicable. Waivers. The Administration may not grant waivers of: The requirements of any regulation adopted under this subtitle; or Any accreditation standard. Variances. If a program is licensed under this chapter, the Administration may grant a variance for a regulation if the Administration: 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. Any variance granted by the Administration shall: Remain in effect for as long as the program continues to comply with the conditions under which the variance is granted; or Be time-limited. The Administration may not grant a variance: That would endanger the health or safety of the individuals served; or For any accreditation standard. The Administration shall: Issue a written decision on the request for a variance, including the reason or reasons for granting or not granting the variance; Send the decision to the: Program director; CSA, LAA, or LBHA, as appropriate; and Department’s designated approval unit; and Enter the decision in the records of the Administration. The license of a program to provide community-based behavioral health services shall be valid only for the program and address for which the license is issued. If the sale or transfer of a program causes a change in ownership, the program: May not sell, assign, or transfer its license; and Shall apply for and receive a new license to operate in Maryland. If a program licensed to provide community-based behavioral health services intends to discontinue operations, the program director shall, no less than 60 calendar days before the program intends to discontinue operations, submit to the Department’s licensure unit, the Administration, and the CSA, LAA, or LBHA, as appropriate, its written plan for: Cessation of operations, including relevant dates; Informing participants in the program or their guardians of the planned discontinuation and of other behavioral health service options; Transitioning participants in the program to other behavioral health services; Storing and protecting all records; and Notifying employees, contractors, consultants, and consumers of its cessation of operations. Within 30 days after receipt of the program’s request to discontinue operations, the Department’s designated 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 CSA, LAA, or LBHA as appropriate, to make 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 designated approval unit authorizes the discontinuation. Once the Department has approved the discontinuation plan, the program shall implement the plan. At all times during the discontinuation process, the program shall cooperate with the Administration, the Department’s designated approval unit, and the CSA, LAA, or LBHA, as appropriate. If a program that is discontinuing operation does not comply with §§A—E of this regulation, the Department may deny any future application for a license that the program, or principals of the program, may submit. If a program licensed to provide community-based behavioral health services intends to discontinue a service, the program director shall provide immediate notification to the: CSA; LAA; LBHA; or OHCQ. Upon finding that a program licensed under this chapter has violated a regulation and that the public health, safety, or welfare imperatively requires emergency action, the Department may order the immediate suspension of the license of the program and the immediate cessation of the program’s operation. Following the summary suspension of the license of the program, and under State Government Article, §10-226(c)(2), Annotated Code of Maryland, the Department shall deliver a written notice to the program that includes: The facts supporting the finding that the public health, safety, or welfare imperatively require the emergency action; and Notice that the program may request a hearing under Regulation .19 of this chapter. If the program requests a hearing on the summary suspension, the Department shall provide an administrative hearing after the suspension, in accordance with Regulation .20 of this chapter. If the Department summarily suspends the license of a program, the program shall immediately: Stop providing services to individuals; and Develop and implement a written plan, approved by the Department, to: Notify individuals receiving services from the program, or the guardians of these individuals, of the suspension; Transition individuals receiving services from the program to an alternative program or make other arrangements to ensure continuity of services for the individuals; Store and protect all service and medical records, and transition the records to alternative program or to the individual; and Notify employees, contractors, consultants, and consumers of its cessation of operations. If the Department determines that a program licensed under this chapter has violated any provision of this chapter, but does not summarily suspend the program, the Department’s designated approval unit shall provide the program with a notice of deficiencies. In the notice of deficiencies, the Department’s designated approval unit shall list each failure to comply with a requirement, including identifying the requirement and the basis for the finding. Plan of Correction. The program shall submit a plan of correction to the Department’s designated approval unit within 10 working days of receipt of the notice of deficiencies, stating how and when each failure to comply shall be corrected. The Department’s designated approval unit may require that the POC be submitted sooner than 10 working days when the nature of the noncompliance warrants a more immediate response, as determined by the Department’s designated approval unit. The director of the Department’s designated approval unit may grant an extension of not more than 30 days for the submission of the POC. If the Department issues a notice of deficiencies to a program under this regulation, the program shall notify individuals receiving services from the program, or the guardians of these individuals, that the program has received a notice of deficiencies. If the Department’s designated approval unit determines that a program licensed under this chapter has violated a requirement of this chapter, the Department may revoke the license. If the Department’s designated approval unit determines that the program has violated a requirement of a sanction imposed under Regulation .14 of this chapter, the Department may revoke the license. If the Department revokes a program’s license under this regulation, the program shall notify individuals receiving services from the program, or the guardians of these individuals, of the revocation. If the Department determines that a program licensed under this chapter has violated a requirement of this subtitle, the Department’s designated approval unit may take one or more of the following actions: Prohibit the program from serving any additional individuals; Require the program to reduce the number of individuals currently receiving services; Prohibit the program from providing specific services or restricting the program to providing only specified services; Require the program, and any of its staff, to receive mandatory training in identified areas; Require the program to use the services of a consultant approved in advance by the Department; Require the establishment of an escrow account; Impose a civil money penalty, in accordance with this chapter. If the Department imposes a sanction under this regulation, the program shall notify individuals receiving services from the program, or the guardians of these individuals, of the sanction. If the Department determines that a program licensed under this chapter has violated any requirement of this chapter, the Department’s designated approval unit may impose a directed plan of correction, in addition to any intermediate sanctions imposed in accordance with this chapter. The directed plan of correction may include any one or more of the following: Mandating staffing patterns, specifying the number of personnel, personnel qualifications, or both; Imposing a temporary site monitor, whereby the Department maintains an on-going physical presence for the purpose of providing assistance and evaluating the extent of the program’s progress in correcting violations; Requiring the program to submit periodic reports of the program’s progress in correcting violations. If the Department issues a directed plan of correction to a program under this regulation, the program shall notify individuals receiving services from the program, or the guardians of these individuals, that the program has received a directed plan of correction. The Department may enter into a settlement agreement with a program licensed under this chapter that has violated a requirement of this chapter, establishing specific conditions for continued operation, including time limits for compliance. A settlement agreement is a public document and may be disseminated under the State Government Article, §§10-611—10-630, Annotated Code of Maryland. A copy of the settlement agreement shall be distributed to individuals served by the program or posted in a public location at the program’s physical site. The Secretary or designee may take action to initiate receivership of a program licensed under this chapter, pursuant to Health-General Article, §§19-333—19-339, Annotated Code of Maryland. Notwithstanding any penalty that may be imposed under the Civil False Claims Act, pursuant to Health-General Article, §2-611, Annotated Code of Maryland or other statute, the Department may impose a civil monetary penalty on a person for: Operating a community-based behavioral health services program without a license, if one is required by law or regulation; Any material and egregious violation of any provision of this subtitle; or Both. In determining whether a civil monetary penalty is to be imposed, the Department shall consider the following, among any other relevant factors: The nature, number, and seriousness of the deficiencies; The extent to which the deficiency or deficiencies are part of an ongoing pattern; The degree of risk to the health, life, or safety of the individuals receiving services from the program; The efforts made by the program, and the ability of the program, to correct the deficiency or deficiencies; and The program’s prior history of compliance or non-compliance. In determining the amount of any civil money penalty to be imposed, the Department shall consider the factors listed in §B of this regulation, among any other relevant factors. A program licensed under this chapter that is aggrieved by the proposal of the Department’s designated approval unit to take any of the following actions may appeal the Department’s decision by filing a request for an administrative hearing in accordance with Regulation .20 of this chapter: The denial of an application for a license or for renewal of a license; The summary suspension of a license, under Regulation .11 of this chapter; The denial of a request for modification of a license, under Regulation .07 of this chapter; The denial of a request to discontinue a program, under Regulation .10 of this chapter; A revocation of a license, under Regulation .13 of this chapter; The imposition of a sanction under Regulation .14, .16, or .18 of this chapter. If the program submits a request for a hearing on a proposed summary suspension, the hearing shall take place in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. If the Department’s designated approval unit proposes to take an action listed in Regulation .19 of this chapter, the Department shall deliver a written notice of the proposed action to the program director, in accordance with the provisions of COMAR 10.01.03.05. Within 10 working days after receipt of the notice of the proposed action, the program may submit to the Department, at the address identified in the notice, a written request for a hearing, with copies to the: Administration; CSA, LAA, or LBHA, as appropriate; and Director of the Department’s designated approval unit. If the program does not submit to the Department a hearing request that is postmarked within 10 working days after the date on the notice: The program’s right to a hearing is waived; and The Department’s designated approval unit may implement the proposed action. The Department may offer the program the opportunity, when possible, for an informal case resolution conference, in which to attempt to resolve all or some of the deficiencies listed in the notice. The hearing shall comply with the provisions of COMAR 10.01.03.06. Accreditation-based Licenses. The following shall apply for programs that are required by law and this chapter to be accredited to be licensed: A program may not operate on or after April 1, 2018 without a license; To be licensed on or before April 1, 2018, a program shall submit a completed and accurate application to the Department’s designated approval unit before January 1, 2018; An accreditation-based license may be issued on or after, and not before, January 1, 2017; The Department’s designated approval unit shall begin accepting applications for accreditation-based licenses on October 1, 2016; As of October 1, 2016, applications for an accreditation-based license shall include evidence that the program is accredited by an approved accreditation organization; The Department’s designated approval unit may not accept an application for initial certification or approval under COMAR Title 10, Subtitles 21 or 47 after September 30, 2016; A program with a certification or approval under COMAR Title 10, Subtitles 21 or 47: May apply for renewal of the certification or approval before January 1, 2018; If eligible for renewal, shall receive a certification or approval, valid until April 1, 2018; and May not operate under the certification or approval after March 31, 2018. A program that is certified or approved based on deemed status in accordance with COMAR 10.21.16.10 or COMAR 10.47.04.05 shall receive a license, which shall be effective during the current accreditation period; and If the Department’s designated approval unit cannot issue a license by April 1, 2018 for a program that submits a completed, accurate application for a license before January 1, 2018, the Department’s designated approval unit shall extend the expiration date of the existing approval or certification to complete the license application process. Non-Accreditation-Based Licenses. The following shall apply for programs that are not required by law and this chapter to be accredited to be licensed: A program may not operate on or after April 1, 2018 without a license; A program that is certified or approved under COMAR Title 10, Subtitles 21 or 47, may operate under those subtitles until the expiration of the term of its current certification or approval, but not after March 31, 2018; The Department’s designated approval unit may not accept an application for initial certification or approval under COMAR Title 10, Subtitles 21 or 47, after September 30, 2016; A program with a current certification or approval under COMAR Title 10, Subtitles 21 or 47: May apply for renewal of the certification or approval under COMAR Title 10, Subtitles 21 or 47, before January 1, 2018; and May not operate after March 31, 2018 without a license. To be licensed on or before April 1, 2018, a program shall submit a completed and accurate application to the Department’s designated approval unit before January 1, 2018; A license may be issued on or after, and not before, January 1, 2017; and If the Department’s designated approval unit cannot issue a license by April 1, 2018 for a program that submits a completed accurate application for licensure before January 1, 2018, the Department’s designated approval unit shall extend that expiration date of the existing approval or certification to complete the license application process. Applicability Dates of Regulations. Current chapters of regulations under COMAR 10.21 and 10.47 shall remain in effect concurrently with the regulations in this chapter until April 1, 2018. Health-General Article, §§7.5-204, 8-402, 8-404, and 10-901, Annotated Code of Maryland Effective date: July 1, 2016 (43:10 Md. R. 585) Regulation .10G adopted effective February 27, 2017 (44:4 Md. R. 255)