This chapter sets forth the definitions for this subtitle and the requirement that a program be licensed to provide community behavioral health treatment, care, or rehabilitation services. In this subtitle, the following terms have the meanings indicated. Terms Defined. “Accreditation” means the approval granted by an approved accreditation organization of a provider, or the process of obtaining the approval. “Accreditation-based license” means a license that, in accordance with COMAR 10.63.02, may be issued or received only if the provider is accredited by an approved accreditation organization. “Administration” means the Behavioral Health Administration within the Maryland Department of Health. “Administrative services organization (ASO)” means the entity under contract with the Department to provide administrative services for the public behavioral health system. “Agreement to cooperate” means a written agreement between the program and a core service agency, local addictions authority, or local behavioral health authority that provides for coordination and cooperation in carrying out behavioral health activities in a given jurisdiction. “American Society of Addiction Medicine (ASAM) Criteria” means an instrument designed to indicate placement guidelines for admission, continued stay, and discharge of individuals with a substance-related disorder. “Approval” means the authorization issued on behalf of the former Maryland Mental Hygiene Administration to mental health providers to receive State funding for their services. “Approved accreditation organization” means an entity approved by the Secretary or the Secretary’s designee, under Health-General Article, §19-2302, Annotated Code of Maryland. “Assessment” means the process of ascertaining the treatment needs of an individual seeking behavioral health services. “Behavioral health program” means: A substance-related disorders program; A mental health disorders program; An addictive disorder program; or A program that consists of a combination of disorder programs listed above. “Board” means the executive authority and policy-making group that oversees the operation of a behavioral health program. “Case resolution conference” means an informal proceeding that may take place before an evidentiary hearing to determine if there are grounds for settlement of a contested case. “Certification” means, unless otherwise specifically stated, the approval issued by the former Maryland Alcohol and Drug Abuse Administration authorizing substance use disorder treatment programs to operate in Maryland. “Community-based” means the setting of a program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland. “Completed application” means that: All questions on the application form are answered; All necessary documents are included; and The application form has been signed by the applicant. “Consultant” means a professional who: Is not a salaried employee of the program; Provides advice in the professional’s area of expertise; and Is a contractor if paid, and a volunteer if not paid. “Core service agency (CSA)” means the designated county or multicounty authority that is responsible for planning, managing, and monitoring publicly funded mental health services. Correctional Facility. “Correctional facility” means an institution overseen by the State or one of the 24 subdivisions where individuals are incarcerated. “Correctional facility” includes a: Jail; Detention center; Prison; or Correctional halfway house. “Critical incident” means any of the following: Death of a program participant; Life threatening injury to a program participant; Non-consensual sexual activity, as prohibited in COMAR 10.01.18; Any sexual activity between a staff member and a program participant; Unexpected evacuation of a building under circumstances that threaten the life, health or safety of participants; Diversion of medication from the stock of a program providing opioid treatment services; or Any injury related to an opioid medication dispensed by a program providing opioid treatment services. “Deficiency” means a failure to meet an accreditation standard, or a relevant federal, State, or local ordinance, law, regulation, or building code, as applicable. “Deemed status” means the procedure, pursuant to COMAR 10.21.16.10 or COMAR 10.47.04.05E under which programs with accreditation from an approved accreditation organization are permitted to operate in Maryland. “Demonstration project” means an experimental project that, if deemed successful, will be considered for future adoption. “Department” means the Maryland Department of Health. “Designated approval unit” means the office within the Department that is designated by the Secretary to: Evaluate applications for licenses to provide behavioral health and other health-related services in Maryland; Issue licenses to provide the services; Investigate allegations of deficient services; and Impose sanctions for deficiencies in service. “Directed plan of correction” means the program’s plan of correction, as defined in this subtitle that is mandated by the Department. “Discharge” means the release of a participant from a program. “Drug” means: A controlled dangerous substance that is regulated under the Maryland Controlled Dangerous Substances Act, Criminal Law Article, §§5-101 — 5-1101, Annotated Code of Maryland; A prescription medication; or A chemical substance when used for unintended and harmful purposes. “Exempt provider” means a provider that, under Health-General Article, §7.5-401, Annotated Code of Maryland, is not required to be licensed by the Secretary to provide services in Maryland. “Family” means an individual’s immediate relatives or significant others. “Family provided support services” means a set of non-clinical activities provided by family members of individuals with mental health or substance-related and addictive disorders to support individuals with the disorders or their families. Group Home. “Group home” means a residential program as defined in Health-General Article, §10-514, Annotated Code of Maryland. “Group home” does not include: A foster home that is the domicile of the foster parent; A facility that is owned or leased to the State or any public agency; A facility that is regulated by the Department of Juvenile Services or the Developmental Disabilities Administration; or Organized wholly or partially to make a profit. “Guardian” has the meaning stated in Estates and Trusts Article, §13-101, Annotated Code of Maryland. “Jurisdiction” means Baltimore City or one of the 23 counties in Maryland. “License” means the approval issued by the Secretary or designee that permits a behavioral health provider to operate in Maryland. “Local addictions authority (LAA)” means the designated county or multicounty authority that is responsible for planning, managing, and monitoring publicly funded substance-related and addictive disorder services. “Local behavioral health authority (LBHA)” means the designated county or multicounty authority that is responsible for planning, managing, and monitoring publicly funded mental health, substance-related, and addictive disorder services. “Maintenance” means medically supervised continuation of the administration of methadone or other drugs approved by the Administration. “Medical director” means a physician who oversees the medical practice of a program. “Multidisciplinary” means a mix of representatives from at least three different mental health professions licensed in accordance with the Health Occupations Article, one of whom shall be: A psychiatrist; An advanced practice registered nurse-psychiatric mental health; or A certified registered nurse practitioner-psychiatric mental health. “Non-accreditation-based license” means a license that may be issued or received without the provider being accredited by an approved accreditation organization. “Office of Health Care Quality (OHCQ)” means the Office of Health Care Quality of the Maryland Department of Health. “Patient” means an individual receiving care and treatment in a community behavioral health program. “Peer support services” means a set of non-clinical activities provided by individuals in recovery from mental health or substance-related and addictive disorders who use their personal, lived experiences and training to support other individuals with mental health or substance-related and addictive disorders. “Physician” means an individual who is licensed and legally authorized to practice medicine: Under Health Occupations Article, §14-101, Annotated Code of Maryland; or In the state where the service is given. “Pilot project” means an experimental project that, if deemed successful, will be adopted as a permanent policy or program. “Plan of correction” means the program’s proposed response to findings of deficiency identified by the Department’s designated approval unit or the Department. “Program” means an organization that provides or seeks a license to provide community-based behavioral health services. “Program director” means the individual who has over-all responsibility for the day-to-day activities of the program, including staff, records, policies, and procedures. “Provider” means a program that is approved, certified or licensed to provide community-based behavioral health services. “Psychiatrist” means a physician who: Is licensed by the Maryland Board of Physicians; and Is either: Certified in psychiatry by the American Board of Psychiatry and Neurology; or Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in psychiatry. “Recovery residence” means a service that provides alcohol-free and illicit drug-free housing to individuals with substance-related disorders or addictive disorders or co-occurring mental health and substance-related disorders or addictive disorders, and that does not include clinical treatment services. “Referral” means a contact made by an individual, or on behalf of an individual, for behavioral health or other services. “Residence” means a housing unit leased or owned by a licensed residential rehabilitation program. “Resident” means an individual who resides in a community-based residential behavioral health program. “Secretary” means the Secretary of Health or the Secretary’s designee. “Treatment” means professionally rendered therapeutic interventions provided to an individual to address behavioral health disorders. “Variance” means an alternate method of meeting the intent of a regulation under this subtitle as approved by the Administration. “Waiver” means the exemption from compliance with a regulation under this subtitle. “Withdrawal management” means direct or indirect services for an individual manifesting the symptoms that occur on cessation or reduction of use of a substance or medication, by: Monitoring the amount of alcohol and other toxic agents in the body of the individual; Managing withdrawal symptoms; and Motivating an individual to participate in the appropriate substance-related disorder programs. “Working day” means any day except Saturday, Sunday, or other day on which State offices are closed. Except as provided in Regulation .04 of this chapter, an individual or entity shall have a valid and current license issued by the Department under this subtitle in order to provide community-based behavioral health services in Maryland. A license issued under this subtitle may not be transferred. In accordance with Health-General Article, §7.5-401, Annotated Code of Maryland, the following providers are exempt from the requirements of, and are not required to be licensed under, this subtitle: Except as provided in §B of this regulation: A health professional, in either a solo practice or group practice, who is licensed under the Health Occupations Article; and Is providing services in accordance with the requirements of the appropriate professional board; Alcoholics Anonymous; Narcotics Anonymous; Recovery residences; Peer support services; Family-provided support services; An employees’ assistance program of a business entity; Outpatient behavioral health treatment and rehabilitation services provided in regulated space of a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland, if the hospital is accredited by an approved accreditation organization under the accreditation organization’s behavioral health standards; and A therapeutic group home authorized under: Health-General Article, §§10-920 — 10-923, Annotated Code of Maryland; COMAR 10.21.07; and COMAR 14.31.05 — 14.31.07; Notwithstanding the provisions of §A of this regulation, a provider shall have a valid and current license under this subtitle in order to provide the following services: DUI education programs as described in COMAR 10.63.05.05; and Substance-related disorder programs as described in COMAR 10.63.03.11 — .14. The Department may exempt a program from the requirements of this subtitle: If the program: Is a pilot project; Is a federal or State demonstration project; or Does not fall within any of the program descriptions set out in: COMAR 10.63.03; COMAR 10.63.04; or COMAR 10.63.05; and If the program demonstrates to the satisfaction of the Department that it is subject to: Contractual provisions; Conditions of grant award; or Other requirements that are comparable to the regulations in this subtitle. A program licensed under this subtitle to provide community-based behavioral health services in Maryland shall comply with the requirements listed in this regulation. Post-Licensing Inspections. The Department or its designees may make announced or unannounced visits to inspect a program to investigate a complaint. The Department or its designees may inspect and copy records, including, but not limited to: Financial records; Treatment records; and Service records. Criminal Background Investigation. To be licensed in accordance with this chapter, a program shall have and follow a written policy that complies with §C(2) of this regulation regarding the criminal history of the program’s employees, contractors, and volunteers. At a minimum, the program’s policy shall require that, when deciding whether the criminal history of an individual applying for employment, whether paid or volunteer, and a contractor disqualifies the individual from the employment, the program consider: The age at which the individual committed the crime; The circumstances surrounding the crime; Any punishment imposed for the crime, including any subsequent court actions regarding that punishment; The length of time that has passed since the crime; Subsequent work history; Employment and character references; and Other evidence that demonstrates whether the employee, contractor, or volunteer poses a threat to the health or safety of a program participant, program staff, or a member of the public. The program may not hire an individual as an employee, contractor, or volunteer if the program does not receive and consider the criminal history record information required under this regulation. An individual may not be hired as an employee, contractor, or volunteer: For a program serving participants younger than 18 years old, if the individual has been convicted at any time of child abuse or child sexual abuse; or For a program serving participants 18 years old or older, if the individual has been convicted at any time of abuse or neglect of a vulnerable adult. The criminal background investigation policy may be stricter than that required by this regulation, as appropriate, to protect program participants. A program shall: Document the programs’: Review of criminal history records of potential employees, contractors, and volunteers; Decision regarding the impact of the criminal history on the employability of each applicant for employment and on each employee, contractor, and volunteer; and Implementation of the policy required by §C(1) of this regulation; and Maintain the documentation required by this regulation for 3 years after the individual either is not hired or leaves employment with the program. Applicable Laws. A program licensed in accordance with this chapter shall comply with all applicable federal and State laws and regulations, including the following: The Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, and regulations implementing the statute, as amended; Federal Regulations on Confidentiality of Alcohol and Drug Abuse Patient Records, 42 CFR Part 2, as amended; State confidentiality statutes, including: Health-General Article, §4-301, et seq., Annotated Code of Maryland, as amended; and General Provisions Article, §4-101, et seq., as amended; Current applicable State confidentiality regulations; The Americans With Disabilities Act, 42 U.S.C. §12101, et seq.; and The federal Fair Housing Act, 42 U.S.C. §3604. Agreement to Cooperate. Before applying for licensure, a program shall enter into an agreement to cooperate with the CSA, LAA, or LBHA that operates in the relevant county or Baltimore City. The agreement to cooperate shall provide for coordination and cooperation between the parties in carrying out behavioral health activities in the jurisdiction, including but not limited to facilitating: A complaint investigation; and The transition of services if: The program closes; or A program discontinues a service. The agreement to cooperate may not include a provision that authorizes the CSA, LAA, or LBHA to prohibit a program from offering services at any location. Opioid Treatment Services—Non-Discrimination. A program may not exclude or discriminate against an individual on the basis of the individual receiving opioid treatment services. Critical Incident Reports. A licensed program shall report all critical incidents to the Department, or its designee, within 5 calendar days following the program receiving knowledge of the incident, on the form required by the Department. 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 .02 amended effective February 27, 2017 (44:4 Md. R. 255) Regulation .04 amended effective February 27, 2017 (44:4 Md. R. 255) Regulation .05E amended effective February 27, 2017 (44:4 Md. R. 255) This chapter identifies those programs that are required to be accredited in order to receive a license to provide community-based behavioral health services. The following programs shall require an accreditation-based license under this chapter: Group Homes for Adults with Mental Illness programs; Integrated Behavioral Health programs; Intensive Outpatient Treatment Level 2.1 programs; Mobile Treatment Services (MTS) programs; Outpatient Mental Health Center (OMHC) programs; Outpatient Treatment Level 1 programs; Partial Hospitalization Treatment Level 2.5 programs; Psychiatric Day Treatment Program (PDTP) programs; Psychiatric Rehabilitation Program for Adults (PRP-A) programs; Psychiatric Rehabilitation Program for Minors (PRP-M) programs; Residential Crisis Services (RCS) programs; Residential: Low Intensity Level 3.1 programs; Residential: Medium Intensity Level 3.3 programs; Residential: High Intensity Level 3.5 programs; Residential: Intensive Level 3.7 programs; Residential Rehabilitation Program (RRP) programs; Respite Care Services (RPCS) programs; Supported Employment Program (SEP) programs; Mobile Crisis Team programs; and Behavioral Health Crisis Stabilization Center (BHCSC) programs. Of the licensed community-based behavioral health services programs listed in §A of this regulation, the following may provide the services identified in §C of this regulation, so long as the program’s license specifically authorizes the service: Integrated Behavioral Health programs; Intensive Outpatient Treatment Level 2.1 programs; Outpatient Treatment Level 1 programs; Partial Hospitalization Treatment Level 2.5 programs; Residential: Low Intensity Level 3.1 programs; Residential: Medium intensity Level 3.3 programs; Residential: High intensity Level 3.5 programs; and Residential: Intensive Level 3.7 programs. Programs listed in §B of this regulation and licensed to provide community-based behavioral health services may provide the following services so long as the program’s license specifically authorizes the service: Withdrawal Management Service; and Opioid Treatment Service. In addition to complying with the requirements for licensed community-based behavioral health programs specified in COMAR 10.63.01.05, a program with an accreditation-based license to provide community-based behavioral health services in Maryland shall comply with this regulation. A program with an accreditation-based license shall comply with the requirements and meet the standards of the accreditation organization by which it is accredited. The Department or its designee may enforce any requirement or standard of the accreditation organization by which a program is accredited. In addition to the post-licensing inspections provided for in COMAR 10.63.01.05B, a program with an accreditation-based license shall be subject to inspection by the Department or its designees in cases in which significant concerns have been raised regarding operation of the program or the organization that accredited the program, in order to: Determine compliance with a requirement under its accreditation; Follow-up on any problem identified by the accreditation organization that accredited the program; or Validate the findings of the accreditation organization that accredited the program. A licensed halfway house and group home shall ensure that its sites comply with Health-General Article, §§8-406 and 10-518, Annotated Code of Maryland, as follows: A small halfway house or private group home is considered conclusively a single-family dwelling for purposes of zoning, and may be located in all residential zones; A large halfway house or private group home is considered conclusively a multi-family dwelling for purposes of zoning and may be located in zones of similar density; and A halfway house or a private group home may not be made subject to any special exception, conditional use permit, or procedure that differs from that required for a single-family dwelling or a multi-family dwelling of similar density in the same zone. Health-General Article, §§7.5-204, 8-402, 8-404, 10-901, and 10-1402, Annotated Code of Maryland Effective date: July 1, 2016 (43:10 Md. R. 585) Regulation .02A amended effective May 27, 2024 (51:10 Md. R. 526) This chapter sets forth the descriptions of and the criteria for the community behavioral health programs that are permitted to operate in Maryland, so long as they have valid and current accreditation-based licenses under this subtitle. To be licensed under this subtitle, an integrated behavioral health program shall: Meet the requirements for an: Outpatient mental health center, as outlined in Regulation .05 of this chapter; and Outpatient treatment level 1 program, as outlined in Regulation .06 of this chapter; and Have the capacity to provide, as appropriate: Mental health evaluation and treatment services to individuals with mental health diagnoses; Substance-related disorder evaluation and treatment services to individuals with a substance-related disorder; and Integrated mental health and substance-related disorder evaluation and treatment services to individuals with both a substance use disorder and a mental health diagnosis. An integrated behavioral health program may provide the following services if the program’s license specifically authorizes the services: A withdrawal management service as described in Regulation .18 of this chapter; and An opioid treatment service as described in Regulation .19 of this chapter. To be licensed under this subtitle, an intensive outpatient treatment level 2.1 program shall provide structured outpatient substance-related disorder treatment based on a comprehensive assessment, for: Individuals who meet the ASAM Criteria for level 2.1; and Adults, from 9 to 20 hours weekly, and individuals younger than 18 years old for 6 to 20 hours weekly. An intensive outpatient treatment level 2.1 program may provide the following services if the program’s license specifically authorizes the services: A withdrawal management service as described in Regulation .18 of this chapter; and An opioid treatment service as described in Regulation .19 of this chapter. In order to be licensed under this subtitle, a mobile treatment services program shall: Provide intensive, assertive outpatient mental health treatment and support services by a multidisciplinary team to an individual who is homeless or is otherwise unable or unwilling to access traditional outpatient treatment services as follows: Flexibly in a community setting considered appropriate to the individual; and On an on-call basis, 24 hours per day, 7 days a week; Be designed to enable the individual to remain in the community, thus reducing admissions to emergency rooms, inpatient facilities, or detention facilities; and Provide discharge services, including developing a transition plan and arranging to initiate authorized services before the planned discharge, in collaboration with the individual, the treatment team, family members, and significant others who are designated by the individual, the CSA, LBHA, ASO and the designated transition service providers. In order to be licensed under this subtitle, an outpatient mental health center shall: Provide regularly-scheduled outpatient mental health treatment services in a community-based setting; Provide, at a minimum, individual, group, and family therapy and medication management; Employ a medical director, who: Is a psychiatrist; Has over-all responsibility for clinical services; and Is on-site at least 20 hours per week; and Employ multidisciplinary clinical treatment staff who is authorized to provide the services under Health Occupations Article, Annotated Code of Maryland. In order to be licensed under this subtitle, an outpatient treatment level 1 program shall provide outpatient substance-related disorder treatment based on a comprehensive assessment: For individuals who: Meet the ASAM Criteria for level 1; Have a physical and emotional status that allows the individual to function in the individual’s usual environment; and For adults, require services for fewer than 9 hours weekly, or, for individuals younger than 18 years old, require services for fewer than 6 hours weekly. An outpatient treatment level 1 program may provide the following services if the program’s license specifically authorizes the services: A withdrawal management service as described in Regulation .18 of this chapter; and An opioid treatment service as described in Regulation .19 of this chapter. A partial hospitalization treatment level 2.5 program shall provide structured outpatient substance-related disorder treatment based on a comprehensive assessment for: Individuals who meet the ASAM Criteria for level 2.5; and From 20 to 35 hours weekly. A partial-hospitalization treatment-level 2.5 program may provide the following services if the program’s license specifically authorizes the services: A withdrawal management service as described in Regulation .18 of this chapter; and An opioid treatment service as described in Regulation .19 of this chapter. In order to be licensed under this subtitle, a psychiatric day treatment program (PDTP) shall: Provide short-term, intensive, day or evening mental health treatment and support services for individuals who do not require 24-hour care; Focus on the amelioration of an individual’s acute psychiatric symptoms; and Be medically supervised and staffed by a multidisciplinary treatment team that includes, at a minimum: A psychiatrist; and A registered nurse. In order to be licensed under this subtitle, a psychiatric rehabilitation program for adults (PRP-A) shall: Provide community-based comprehensive rehabilitation and recovery services and supports, including, but not limited to: Community living skills; Activities of daily living; and Family and peer support; Promote successful community integration and use of community resources; Be under the direction of a rehabilitation specialist who is: A licensed mental health professional; Certified by the Commission on Rehabilitation Counselor Certification; or Certified by the Psychiatric Rehabilitation Association; and Employ the rehabilitation specialist in §C of this regulation: At least 20 hours per week when the program serves less than 30 individuals; or 40 hours per week when the program serves 30 individuals or more. In order to be licensed under this subtitle, a psychiatric rehabilitation program for minors (PRP-M) shall provide community-based comprehensive rehabilitation services and supports designed to: Promote resiliency; and Facilitate the development or restoration of appropriate skills in an individual younger than 18 years old including but not limited to: Self-care skills; Social, peer, family, and teacher interactions; and Semi-independent living skills; and Promote successful integration into the community and the use of community resources. The program shall be under the direction of a rehabilitation specialist who has a minimum of 2 years direct care experience working with youth with a serious emotional disorder and who is: A licensed mental health professional; or Certified by the Psychiatric Rehabilitation Association and has obtained the Psychiatric Rehabilitation Association Children’s Psychiatric Rehabilitation Certificate. The PRP-M shall employ the rehabilitation specialist in §B of this regulation for: At least 20 hours per week when the program serves less than 30 individuals; or At least 40 hours per week when the program serves 30 individuals or more. In order to be licensed under this subtitle, a residential-low intensity level 3.1 program shall provide clinically-managed, low intensity, substance-related disorder treatment in large and small halfway houses, as defined in Health-General Article, §8-101, Annotated Code of Maryland, to individuals who: Meet the ASAM Criteria for level 3.1; and Are capable of self-care but are not ready to return to family or independent living. Services shall be: Provided for a minimum of 5 hours per week, and Directed toward: Preventing relapse; Applying recovery skills; and Reintegrating into the community. A residential-low intensity level 3.1 program may provide the following services if the program’s license specifically authorizes the services: A withdrawal management service as described in Regulation .18 of this chapter; and An opioid treatment service as described in Regulation .19 of this chapter. In order to be licensed under this subtitle, a residential-medium intensity level 3.3 program shall provide clinically-managed, medium intensity, substance-related disorder treatment based on a comprehensive assessment: In a structured environment in combination with medium-intensity treatment and ancillary services to support and promote recovery; From 20 to 35 hours weekly; and To individuals who: Meet the ASAM Criteria for level 3.3; Are chronic alcohol- or other drug-dependent; Do not need skilled nursing care; May have a history of multiple admissions to substance related disorder programs described in this chapter; May have physical or mental disabilities resulting from a prolonged substance-related disorder; and Have been identified as requiring a controlled environment and supportive therapy for an indefinite period of time. A residential-medium intensity level 3.3 program may provide the following services if the program’s license specifically authorizes the services: A withdrawal management service as described in Regulation .18 of this chapter; and An opioid treatment service as described in Regulation .19 of this chapter. In order to be licensed under this subtitle, a residential-high intensity level 3.5 program shall provide clinically-managed, high-intensity, substance-related disorder treatment services based on a comprehensive assessment: In a highly-structured environment, in combination with moderate- to high-intensity treatment and ancillary services to support and promote recovery; For a minimum of 36 hours of therapeutic activities a week; That are characterized by reliance on the treatment community as a therapeutic agent; and To individuals who meet the ASAM Criteria for level 3.5. A residential-high intensity level 3.5 program may provide the following services if the program’s license specifically authorizes the services: A withdrawal management service as described in Regulation .18 of this chapter; and An opioid treatment service as described in Regulation .19 of this chapter. In order to be licensed under this subtitle, a residential-intensive level 3.7 program shall provide medically-monitored, intensive substance-related disorder treatment based on a comprehensive assessment: To individuals who meet the ASAM Criteria for level 3.7; For a minimum of 36 hours of therapeutic activities a week; On a planned regimen of 24-hour evaluation, care, and treatment in a residential setting; In an Intermediate Care Facility Type C/D; and While meeting the requirements for withdrawal management services as outlined in Regulation .18 of this chapter. If the program's license specifically authorizes the service, a residential-intensive level 3.7 program may provide an opioid treatment service as described in Regulation .19 of this chapter. A residential-intensive level 3.7 program shall employ a physician, nurse practitioner, or physician assistant who: Assesses each patient in person within 24 hours of admission or earlier, if medically necessary; Assesses each patient thereafter, as medically necessary; and Is available to provide on-site monitoring of care and further evaluation on a daily basis. In order to be licensed under this subtitle, a respite care services (RPCS) program: Shall provide short-term, in home or overnight temporary services to support an individual to remain in the individual’s home: Through enhanced support or a temporary alternate living arrangement; or By temporarily freeing the caregiver from the responsibility of caring for the individual; and For individuals younger than 21 years old, may offer overnight respite in an appropriately licensed program or therapeutic foster care home. In order to be licensed under this subtitle, a supported employment program (SEP) shall: Provide services designed to assist an individual to choose, obtain, and maintain competitive employment; and Assist an individual to obtain competitive employment in an integrated work environment that provides: Compensation of at least minimum wage; An individualized approach that establishes an hours-per-week employment goal to maximize an individual’s vocational potential; and Additional supports, as needed, delivered where appropriate. A substance-related disorder treatment program located in a State or local correctional facility requires a license under this chapter in order to operate. A withdrawal management service is one that: May be provided at one or more of the following ASAM levels: Level 1-WM, ambulatory withdrawal management without extended on-site monitoring; Level 2-WM, ambulatory withdrawal management with extended on-site monitoring; Level 3.2-WM, clinically-managed residential withdrawal management; or Level 3.7-WM, medically-monitored residential withdrawal management; Monitors the decreasing amount of psychoactive substances in the body; Manages the withdrawal symptoms; Motivates the individual to participate in appropriate treatment programs for alcohol or other drug dependence; Provides additional referrals as necessary; and At Level I-WM, Level 2-WM, and Level 3.7-WM, employs a physician, nurse practitioner, or physician assistant who: Obtains a comprehensive medical history and physical examination of the patient at admission; and Medically monitors each patient. An opioid treatment service is one that: Complies with the requirements of 42 CFR §8; Is under the direction of a medical director who is a physician and: Has at least 3 years of documented experience providing services to persons with substance-related disorders and opioid use disorders, including at least 1 year of experience in the treatment of opioid use disorder with opioid maintenance therapy and is board-certified in addiction medicine or addiction psychiatry; or Is certified in added qualifications in addiction psychiatry by the American Board of Psychiatry and Neurology, Inc.; Uses pharmacological interventions, including dispensing of full and partial opiate agonist treatment medications as part of treatment, support, and recovery services to an individual with an opioid addiction; Provides clinical services to each patient at a frequency based on the patient’s clinical stability level, not to exceed an overall program average of 50:1 patient-to-counselor ratio; Arranges for any opioid maintenance medication dispensed to a patient to be transported to the following service sites: Residential programs at Levels 3.3, 3.5, and 3.7, as described in Regulations .12—.14 of this chapter; Withdrawal management services at ASAM levels 3.2-WM and 3.7-WM as described in Regulation .18 of this chapter; or Residential programs at levels 3.1, when the patient, because of a developmental or physical disability, or lack of access to transportation, cannot obtain or transport the patient’s take-home opioid maintenance medication; In accordance with 21 CFR §1300, et seq., arranges transportation of opioid maintenance medication from the program sites identified in §E of this regulation or confirms the disposal of such medication when a patient leaves residential levels of care; Conducts random drug testing on each patient at least monthly, according to the provisions of COMAR 10.10.03.02; Conducts random drug testing, at a minimum, for the following substances: Benzodiazepines; Marijuana; Cocaine; Opiates; Alcohol; Methadone or buprenorphine, whichever is appropriate; and Oxycodone; Develops a taper schedule at least 21 days long with daily dosage reductions less than 5 percent of the original total dose, regardless of the patient’s ability to pay; Nonvoluntarily tapers or transfers a patient only if the: Patient’s behavior on program premises is abusive, violent, or illegal; Patient fails to pay fees and has been informed in writing and counseled as to responsibility and possible sanctions, including taper; Patient misses 3 consecutive medication days, and the program physician, after reevaluation, has determined that nonvoluntary taper is warranted; or Clinical staff documents therapeutic reasons for taper, which may include continued use of illicit drugs or an unwillingness to follow appropriate clinical interventions; Requires that a patient show evidence of the availability of locked storage before a patient may take home any dose of medication; and Provides clinical services addressing any substance-use disorders to each patient. Definition. In this regulation, the following term has the meaning indicated. Term Defined. “Program” means the site and service combination which is recognized through licensure to offer an organized system of activities performed for the benefit of persons served. In order to be licensed under this subtitle, a mobile crisis team within a mobile crisis team program shall: Meet the requirements of COMAR 10.63.01, 10.63.02, and 10.63.06 and this regulation; Provide, 24 hours per day, 7 days per week, 365 days per year, professional intervention for children or adults whose behaviors are consistent with experiencing: A mental health crisis; A substance use disorder crisis; or Both §B(2)(a) and (b) of this regulation; Meet the requirements defined in Health-General Article, Title 10, Subtitle 14, Annotated Code of Maryland; Be pre-approved by the Department or its designee to participate in the public behavioral health system to receive funding through the Department; and Respond to urgent symptoms or behaviors that are disrupting an individual’s behavioral health functioning. Mobile crisis team response may also include engaging law-enforcement where the addition of a law enforcement presence provides additional safety measures, when indicated, for all individuals involved in the mobile crisis intervention. Mobile Crisis Team Program Services. A mobile crisis team program shall provide the following services: In-person, community-based professional and peer intervention services which shall: Be age and culturally appropriate, and explained in terms understandable to the individual; Be designed to: De-escalate an individual’s behavioral health crisis; Evaluate the nature of the crisis; Stabilize the individual to the pre-crisis level of functioning; and Maintain continuity of care by coordinating access to various treatment and support services; Be deployed to the location of an individual in crisis; Address immediate dynamics that may be contributing to the crisis; Include a response initiated by a mobile crisis team within an average of 60 to 120 minutes of determining an individual is in need of crisis intervention; Use evidence-based tools to screen, assess, stabilize, and refer persons, as clinically indicated; Be provided by a mobile crisis team that is nearest to the location of the individual in crisis; and Be provided under the documented supervision of a licensed mental health professional approved by the appropriate board to supervise. Crisis Intervention Services. A mobile crisis team program shall provide medically necessary crisis intervention services, inclusive of the following: Triage and screening to determine the level of risk faced by the individual in crisis and assess the most appropriate response; An immediate assessment conducted by a licensed mental health professional to determine the services necessary to stabilize the crisis for the individual; A plan for de-escalation and resolution of the crisis, including in-person interventions for immediate de-escalation of presenting behavioral symptoms; Brief therapeutic and skill-building interventions and therapeutic counseling techniques specific to the crisis that aims to lower risks and resolve the crisis so that a higher level of care is not needed; Case management and care coordination services, which may include referrals to other services as well as follow-up contacts; Engaging peer and natural and family support when appropriate; A safety crisis plan, which shall aim to keep an individual in crisis and their environment safe and may include the distribution of opioid overdose reversal drugs, lethal means counseling, and other evidence-based interventions; Stabilization services to ensure the individual’s safety and connection to needed resources to reduce the behavioral symptoms leading to crisis; and Follow-up screening and assessment for ongoing risk when indicated by the needs of persons served, in-person, via phone, or via telehealth following the initial crisis intervention. Follow-up services, provided in-person, via phone, or via telehealth, which shall include, but are not limited to: Referral and linkage with other service providers; and Ongoing coordination to meet identified resource needs. Mobile Crisis Team Program Staffing. A mobile crisis team program shall include at least one licensed mental health professional available at all times, either via telehealth or face-to-face, who is: Licensed at the independent practice level; Eligible to oversee the staff of the team; and Eligible to complete an emergency petition. A mobile crisis team: Shall include two staff members responding in-person; Shall include a licensed mental health professional face-to-face or via telehealth; and May not include law enforcement, if present, as part of the two-person response team. Mobile Crisis Team Program Staff Training Requirements. All mobile crisis team program staff shall complete required trainings approved by the Department. A mobile crisis team program shall have a training and competency plan in place that: Is reviewed annually; Is consistent with: Accreditation requirements; and Requirements published by the Department; Defines the core competencies needed to provide reliable and high-quality care for each clinical discipline, within their scope of practice, as a staff member of a mobile crisis team; and Ensures that all staff receive competency verification following all initial and ongoing training. All mobile crisis teams shall be trained in the mobile response and stabilization services (MRSS) model. Mobile Crisis Team Program Reporting Requirements. A mobile crisis team program shall provide data on outcomes and social determinants of care to the State in the format and frequency required by the Department. A mobile crisis team program shall obtain pre-approval from the Department and LBHA or CSA to operate mobile crisis services in the PBHS to ensure services meet local community needs for behavioral health crisis services. Definition. In this regulation, the following term has the meaning indicated. Term Defined. “Program” means the site and service combination which: Is recognized through licensure to offer an organized system of activities to provide an alternative to emergency departments for behavioral health crisis care, emergency petition assessment, and avoidable inpatient or carceral engagement; and Serves as a critical access point for individuals experiencing a mental health, substance use disorder, substance use related, or combined crisis. In order to be licensed under this subtitle, a BHCSC program shall: Meet the requirements of this regulation; Meet the requirements of Health-General Article, Title 10, Annotated Code of Maryland; Meet the requirements of COMAR 10.63.01—10.63.06; and Be pre-approved by the Department or its designee to receive PBHS funding before participating in the PBHS. BHCSC Program Services. The BHCSC program shall: Provide crisis response services as outlined in Health-General Article, Title 10, Subtitle 14, Annotated Code of Maryland; Process involuntary admissions according to Health-General Article, §§10-613—10-621, Annotated Code of Maryland; Provide BHCSC services 24 hours a day, 7 days a week, 365 days a year; Initiate triage upon patient arrival and deliver this service in a manner that aligns with best practice and makes reasonable efforts to minimize time on-site at the BHCSC for law enforcement or other first responders; Use evidence-based tools to screen, assess, stabilize, and refer persons, as clinically indicated; Provide medical screening at triage for the presence of any condition of sufficient severity to require transfer to an appropriate facility for immediate medical or surgical care; Provide active acute mental health and substance use disorder crisis intervention and stabilization services in a BHCSC setting that is not in the Health Services Cost Review Commission regulated space of a hospital, for children, adolescents, and adults whose behaviors are consistent with experiencing: A mental health crisis; A substance use disorder crisis; or Both §C(7)(a) and (b) of this regulation; Provide assessment, counseling, de-escalation, and safety planning; Initiate, maintain, and prescribe psychotropic and somatic medications as appropriate, including: PRN intramuscular medication; Long-acting injectable antipsychotic medication; Medications used for withdrawal management; and Medications for Opioid Use Disorder; Provide withdrawal management services for all substances; and Maintain compliance with the model program structure and facility standards designed by the Department, as required by Health-General Article, §10-621, Annotated Code of Maryland. BHCSC Staffing Requirements. A BHCSC program shall designate a program director who is a licensed mental health professional operating at the independent level of practice who shall be responsible for the overall management and operation of the BHCSC and whose qualifications and duties are defined in the individual’s job description. The job description shall ensure that other job responsibilities will not impede the operation and administration of the BHCSC. A BHCSC program shall have a nursing manager who is a registered nurse. A BHCSC program shall continuously employ an adequate number of staff and ensure an appropriate staff composition are on-site to: Carry out the BHCSC program’s services, goals, and objectives; and Ensure the continuous provision of sufficient supervision and monitoring of individuals receiving crisis stabilization services. A BHCSC program shall employ a qualified prescriber or prescribers who are authorized to prescribe medications by the Maryland Board of Physicians or the Maryland Board of Nursing to provide general medical services and prescription of medications and treatment, and who shall: Be available 24 hours per day; Make daily rounds, including in-person reassessment, to any individual who has been emergency petitioned and remains in the BHCSC for more than 24 hours; and Be approved by the Department if the qualified prescriber is not a psychiatrist or a psychiatric nurse practitioner. A physician shall be on call at all times for the provision of those BHCSC services that may only be provided by a physician. There shall be a minimum of one registered nurse on site at all times. There shall be additional staff, including mental health professionals, on-site at all times to provide active crisis intervention to ensure BHCSC services are provided by personnel within their scope of practice and with expertise appropriate to the service recipient's needs. BHCSC Staffing Plan. A BHCSC program shall develop and maintain a written staffing plan designed to ensure sufficient coverage, discipline mix, service quality, and safety and which shall: Outline the qualifications and duties of each staff position; and Be approved by the Department at the time of licensure. A BHCSC program shall notify the Department of any changes in staffing composition, or an addition or reduction in staffing numbers that varies from the approved staffing plan by greater than 10 percent. BHCSC Program Quality Assurance and Reporting. A BHCSC program shall begin assessment and active treatment immediately upon a patient’s admission. A BHCSC program shall ensure that, within 60 minutes or less of the individual’s arrival, a registered nurse initiates an in-person nursing assessment and physical exam in collaboration with the approved physician or psychiatric nurse practitioner, and develops and implements an initial treatment plan for services in the BHCSC. A BHCSC mental health professional shall provide a crisis assessment at the earliest opportunity. For individuals in the BHCSC under an emergency petition with stays beyond 24 hours, BHCSC mental health professional staff shall perform, at a minimum, daily in-person reassessment. Crisis assessments shall be staffed with the approved physician or psychiatric nurse practitioner. An approved physician or psychiatric nurse practitioner shall review and sign off on every discharge plan for individuals receiving services in the BHCSC. An initial evaluation by an approved physician or psychiatric nurse practitioner shall be completed at the earliest reasonable opportunity, which shall be no later than 4 hours after admission, either in-person or via telehealth, and include the following: A medical evaluation; Assessment of suicide, homicide, violence, and other risk factors; and Review and authorization of the BHCSC initial crisis intervention care plans. A BHCSC program shall maintain relationships with existing community behavioral health service providers who may receive referrals from the BHCSC, which shall include written referral agreements with the following: Outpatient community behavioral health providers; Hospital psychiatric units; Residential crisis programs; Respite programs; Residential substance use treatment programs; and Providers of medications for opioid use disorders. A BHCSC program shall make documented attempts to contact and follow up with all individuals discharged to a community setting and, for individuals who received outpatient services and who initially presented or were later evaluated as a danger to self or others, follow up within 72 hours after discharge from the BHCSC. A BHCSC program shall have protocols, which may include referral agreements with other programs, that provide for admission and treatment of individuals with: Limited English proficiency; Hearing and speaking disabilities; and Physical, developmental, and intellectual disabilities. A BHCSC program shall develop and maintain written triage policies and procedures approved by the Department, including ability to accept and provide services to individuals under an emergency petition and individuals referred by 9-8-8 and other local crisis hotlines. A BHCSC program shall notify the Department and LBHA, in a form and manner determined by the Department, of the following: Initiation of diversion status for the BHCSC program; and Diversion of any individual on an emergency petition. A BHCSC program shall maintain a referral log that includes documentation and rationale for individuals not accepted for admission or transfer to the BHCSC, and make this available to the Department upon request. A BHCSC program shall develop, implement, and maintain written policies and procedures in place to ensure the safety of all individuals, regardless of age. A BHCSC program shall provide data to support quality assurance and improvement initiatives to the State in the format and frequency requested by the Department. BHCSC Program Staff Training Requirements. BHCSC program staff shall complete required trainings approved by the Department. A BHCSC program shall have a training and competency plan in place that: Is reviewed annually; Is consistent with: Accreditation requirements; and Requirements published by the Department; Defines the core competencies needed to provide reliable and high-quality care for each clinical discipline within their scope of practice as a part of the BHCSC program; and Ensures that all staff receive needed training and competency verification. Clinical Record Documentation. A BHCSC program shall maintain, either manually or electronically, adequate documentation of each contact with a participant as part of the medical record, which, at a minimum, includes: The date or dates of service within the BHCSC, including triage and discharge times; The individual’s presenting problems or reason for the BHCSC admission; A brief description of services provided, including progress notes; An official e-Signature, or a legible signature, along with the printed or typed name, and appropriate title of each individual providing services; Documentation of risk assessments; Documentation of medication evaluation and management throughout the stabilization period; Crisis assessment or assessments by the mental health professional staff; and A crisis discharge plan for each individual, which shall indicate the referrals and other activities intended to maintain stabilization. Seclusion and Restraint. A BHCSC program shall have the capacity for both seclusion and restraint. For purposes of this regulation: Seclusion has the meaning set forth in 42 CFR §482.13(e)(1)(ii); and Restraint has the meaning set forth in 42 CFR §482.13(e)(1)(i). A BHCSC program shall be compliant with State and federal seclusion and restraint regulations and laws, including 42 CFR §482.13 and Health-General Article, §10-701, Annotated Code of Maryland, and any successor laws and regulations. Application of seclusion or restraint within a BHCSC program requires: Use as a last resort, only after less restrictive interventions have been considered or tried, unless the emergency nature of the situation precludes the latter, and An order from an approved physician or other clinician permitted by law, with exceptions noted for an emergency as outlined in §I(4) of this regulation. Seclusion and restraint may be initiated by a registered nurse, if a physician or other clinician permitted by law is not present and an emergency situation warrants immediate seclusion or restraint, in which case: BHCSC staff shall obtain an order as soon as possible, but no later than within 1 hour; and A clinical assessment by a psychiatrist or psychiatric nurse practitioner shall occur within 1 hour of initiation or renewal by a registered nurse. An order for seclusion or restraint may not exceed 4 hours for adults, 2 hours for youth 9 years old or older, and 1 hour for children younger than 9 years old. Such an order does not require continuation of the seclusion or restraint for the entire time specified by the order. The seclusion or restraint shall be discontinued as soon as clinically indicated. An individual in seclusion or restraint shall be maintained on 1:1 observation the entire time the individual is secluded or restrained to protect them from harm. Restraint and seclusion shall never occur simultaneously for an individual. Environmental/Life Safety Requirements. A BHCSC program shall: Provide a comfortable, furnished admission pre-triage waiting area for individuals who voluntarily present; Provide a locked and secure dedicated drop-off admission space, designed to accommodate those individuals who have been emergency petitioned; Provide a comfortable, furnished waiting area for individuals accompanying participants in the BHCSC program; Allow for continual visual observation and monitoring of individuals being served; Ensure a safe environment of care for a participant younger than 18 years old by having a separation from adults, with appropriate staff maintaining an adequate level of supervision; Ensure that the 23-hour crisis BHCSC shall have at least one locked door seclusion room, which: Shall be a minimum of 80 square feet; Allows for continual visual observation and monitoring that allows for immediate emergency response; and Uses a locking mechanism consistent with National Fire Protection Association (NFPA) standards for the facility; and Ensure that there is at least one quiet room that is separate from the seclusion room and remains unlocked whenever in use. The Department may require the BHCSC program to add additional seclusion or quiet rooms, based on the intended capacity of the BHCSC Program. The BHCSC program facility shall be free from fire hazards and have: Adequate smoke detectors; Working and updated fire extinguishers; Fire sprinklers as required by law; A written fire evacuation plan; and A current fire inspection certification. The BHCSC program shall conduct and document an annual environmental safety review and take actions to replace items that create an unnecessary risk of self-harm with safer items designed for behavioral health settings, including, but not limited to: Anchor points; Door handles; Curtains; Hooks; and Shower rods and curtains. The BHCSC program shall comply with applicable federal, State, and local sanitation, building, fire codes, and zoning requirements. The BHCSC program shall maintain documentation of legally and accreditation required periodic evacuation drills. The BHCSC program shall have: Bathrooms; Telephones; An automated external defibrillator; and Confidential office space for treatment. BHCSC Dietary Services. BHCSC program dietary services shall be as follows: At least three meals plus an evening snack provided daily with no more than 14 hours between any two meals; Dietary services shall comply with applicable local, State, and federal laws; A BHCSC program shall have a written plan describing the organization and delivery of dietary services; and A dietitian licensed under Health Occupations Article, §5-101, Annotated Code of Maryland, shall develop and implement the dietary service plan. Infection Control — Universal Precautions. A BHCSC program shall observe universal precautions as required under COMAR 10.52.11 as applicable to health care facilities. Site Inspection. At a minimum, an annual site inspection of each BHCSC shall be conducted by the assigned LBHA. Required Management Staff. The required staff in a BHCSC program, as defined in subsection §D of this regulation and COMAR 10.63.01, and subject to the requirements for reporting of vacancies under COMAR 10.63.01.05, includes: Program director; Medical director; Nurse manager; and Mental health professionals in the event that the vacancy leads to an inability to meet the staffing requirements of the regulation. Health-General Article, §§7.5-204, 8-402, 8-404, and 10-901, and 10-1402, Annotated Code of Maryland Effective date: July 1, 2016 (43:10 Md. R. 585) Regulation .14 amended effective February 27, 2017 (44:4 Md. R. 255) Regulation .18 amended effective February 27, 2017 (44:4 Md. R. 255) Regulation .19J amended effective February 27, 2017 (44:4 Md. R. 255) Regulation .20 adopted effective May 27, 2024 (51:10 Md. R. 526) Regulation .21 adopted effective May 27, 2024 (51:10 Md. R. 526) This chapter sets forth descriptions of, criteria for, and licensing requirements for, three specific programs that provide residential community-based behavioral health services. These programs shall comply with COMAR 10.63.01—.02, 10.63.04, and 10.63.06. Residential Rehabilitation Programs shall also comply with COMAR 10.63.03.09. This chapter applies to the following programs: Group Homes for Adults with Mental Illness; Residential Crisis Services (RCS) program; and Residential Rehabilitation Program (RRP). In order to be licensed under this subtitle, a group home for adults with mental illness shall: Meet the definition in Health-General Article, §10-514 (b), (d), and (e), Annotated Code of Maryland; Provide a home-like, supportive residential environment: In a small group home, which provides services for more than 3, but not more than 8 individuals with a mental health disorder; or In a large group home for more than 8, but not more than 16 individuals with a mental health disorder; and Meet the site requirements set out in Regulation .07 of this chapter verified through an annual site inspection conducted by the CSA or LBHA. A group home for adults with mental illness may not provide services for individuals with a primary diagnosis of developmental disability, as defined in Health-General Article, §7-101, Annotated Code of Maryland. In order to be licensed under this subtitle, a residential crisis services program: Shall provide short-term mental health treatment and support services in a structured environment for individuals who require 24-hour supervision due to a psychiatric crisis; Shall be designed to: Prevent psychiatric inpatient admission; Shorten the length of inpatient stay; Effectively use general hospital emergency departments; and Provide an alternative to psychiatric inpatient admission; Shall have staff who are on-site 24 hours per day, 7 days per week, whenever an individual is on-site receiving services; For adults, shall meet the site requirements set out in Regulation .07 of this chapter verified through an annual site inspection conducted by the CSA or LBHA; and For individuals younger than 21 years old, may offer services in an appropriately licensed therapeutic program, as appropriate. In order to be licensed under this subtitle, a residential rehabilitation program (RRP) shall: Serve individuals with a mental disorder; Be operated by a licensed PRP-A; Lease or own the RRP sites; Be approved by BHA for RRP funding; Provide a home-like, supportive residential environment; Provide services for no more than 3 individuals per RRP site, unless also licensed as a group home as provided in Regulation .03 of this chapter; Promote the individual’s ability to engage and participate in appropriate community activities; Enable the individual to develop the daily living skills needed for independent functioning; Have: On-site staffing, as needed to meet the needs of the individuals served; and Staff that are available on call, 24 hours per day, 7 days per week; Meet the site requirements as set out in Regulation .07 of this chapter, verified through an annual site inspection conducted by the CSA or LBHA, as appropriate; Have a written policy regarding the development of and process for implementation of a managed intervention plan (MIP) for an individual receiving residential services who may be at risk of an unplanned discharge, which: Is developed in collaboration with the individual, treatment team members, and CSA or LBHA, as appropriate; and Includes a description of additional individualized services and supports that may be needed, and identification of temporary residential alternatives, if any; and If an MIP is executed, develop a transition plan that: Is created in collaboration with the individual, treatment team members, CSA or LBHA, as appropriate, and ASO; and Includes the elements outlined in §K(2) of this regulation. A program seeking a license under this subtitle for a residential site shall submit to the CSA or LBHA a completed application that: Is on the form required by the Administration with all required documents attached; and Includes documentation that the residence: Is owned or leased by the applicant; or Will be owned or leased by the applicant; and Is located in a building that will have continuous fire, liability, and hazard insurance coverage. A program licensed to provide community-based behavioral health residential services under this chapter shall ensure that: All areas of a residence, including storage areas: Are safe; Clean; and Free of hazards and clutter; A residence has: No housing code or zoning violations; Working smoke alarms or smoke detectors that meet local fire codes for residential dwellings; Hot and cold running water: Adequate light, heat, and ventilation; and Sufficient, appropriate, and functional furnishings, equipment, supplies, and utensils comparable to those found in the residences of nondisabled individuals; Each resident: Has the resources to purchase or has access to food; Has the resources to acquire an adequate supply of soap, towels, and toilet tissue; Who self-administers medication, has access to a secure storage area for the resident’s medications; Has access to a secure storage area for funds and valuables; Has access to transportation; Has access to a telephone in the residence; and To the extent possible, may use personal possessions and preferences in furnishing and decorating the resident’s space. The following emergency procedures are followed: Posted near the telephone are telephone numbers for the: Fire department, police, ambulance, and poison control center; and Program’s on-call staff; and An emergency evacuation procedure that is explained to and practiced by residents within 10 days after entering residence and, at a minimum, every 3 months after that; Each bedroom has: A minimum of 70 square feet for a single bedroom and a minimum of 120 square feet for a double bedroom; An interior door, except for an efficiency apartment; Closet space in or convenient to each bedroom for each individual using the bedroom; Coverings for each window, for privacy; A bed with a clean mattress and pillow for each resident using the bedroom; At least two sets of bed linens per resident; and Not more than two residents using the bedroom; Each toilet and bathing area has: A minimum of one full bathroom for every four residents; and At least one toilet, one basin, and one tub or shower connected to hot and cold water; Easy access and conveniently located, not more than one floor level from living, dining, and sleeping rooms; and Privacy for the individual using it; and The program has a written relocation plan for each site that: Specifies where residents may live temporarily if the CSA or LBHA determines that conditions in the approved residence pose an imminent risk to the health, safety, or welfare of a resident; Is approved by the CSA or LBHA, as appropriate; and Is updated annually. 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 .03 amended effective February 27, 2017 (44:4 Md. R. 255) This chapter sets forth the descriptions of, and the criteria for, community behavioral health programs that are permitted to operate in Maryland so long as they have valid and current non-accreditation-based licenses under this subtitle. The program shall also meet the requirements of COMAR 10.63.01, 10.63.05—10.63.06. To operate in Maryland, the programs described in this chapter shall have a valid and current non-accreditation-based license to provide community-based behavioral health services. This chapter applies to the following programs: Substance-Related Disorder Assessment and Referral Program; DUI Education Program; and Early Intervention Level 0.5 programs. To be licensed under this subtitle, a substance-related disorder assessment and referral program shall: Be operated by a State or local government entity; Provide a comprehensive assessment of an individual’s current status and relevant history in the following areas: Alcohol, tobacco, and other drug use (ATOD); Employment or financial support; Gambling behavior; ATOD and gambling treatment history; Mental health; Legal involvement; Family and social systems; Educational involvement; and Somatic health, including a review of medication; Diagnose behavioral health disorders; Determine type and intensity of services needed for behavioral health disorders; Refer to behavioral health services programs and other services as determined by assessment with appropriate follow-up; and Have clinical staff authorized under the Health Occupations Article to provide the service. To be licensed under this subtitle, a DUI education program shall: Provide services to individuals convicted under Transportation Article, §21-902, Annotated Code of Maryland, and ordered under Criminal Procedure Article, §6-219, to attend an education program; Provide a comprehensive assessment, unless the participant has received an assessment by a licensed or certified clinician, or licensed program within the preceding 45 days, of a participant’s current status and relevant history in the following areas: Alcohol, tobacco, and other drug use (ATOD); Employment or financial support; Gambling behavior; ATOD and gambling treatment history; Mental health; Legal involvement; Family and social systems; Educational involvement; and Somatic health, including a review of medications; If the assessment determines that referral to a treatment program or other indicated service is necessary, make the referral and notify the court of the results of the assessment; Require participants to successfully complete, at a minimum, six weekly, 2-hour sessions for a total of 12 hours; Have instructors who, at a minimum, are certified as a Certified Supervised Counselor—Alcohol and Drug, as defined by Health Occupations Article, Title 17, Annotated Code of Maryland; Teach the Administration’s curriculum or an equivalent curriculum approved by the Department, which covers: Scope of the drinking-driver problem; Drinking driver patterns and characteristics; The pharmacology of drugs and alcohol; The process of addiction to drugs and alcohol; The relationship of substance use to criminal, health, family, and other social problems; and Treatment resources; and Report to the court or probation agent, as specified by the court order. To be licensed under this subtitle, an early intervention level 0.5 program shall: Provide services to individuals: Who meet the ASAM Criteria for level .05; For whom a diagnosable substance-related disorder is not documented; and Who are, for a known reason, at risk for developing a substance-related disorder; Provide a comprehensive assessment, unless the participant has received an assessment by a licensed or certified clinician or licensed program within the preceding 45 days, of the participant’s current status and relevant history in the following areas: ATOD use; Employment or financial support; Gambling behavior; ATOD and gambling treatment history; Mental health; Legal involvement; Family and social systems; Educational involvement; and Somatic health, including a review of medications; If the assessment determines that referral to a treatment program or other service is necessary, make a referral to a treatment program or other service as indicated; and Provide alcohol and drug education services. The provisions of this regulation apply to a program with a community-based behavioral health license that does not require accreditation. Participant Rights. A program shall: Treat each participant with consideration, respect, and full recognition of the participant’s human dignity and individuality; Provide care and services that are adequate, appropriate, and in compliance with relevant State, local, and federal laws and regulations; Prohibit physical or mental abuse by the program staff; Provide an atmosphere free from discrimination; Prohibit use of any physical restraints; Ensure privacy and confidentiality; and Permit the participant to refuse to participate in any research. A program shall post in a conspicuous area and provide to each participant a statement of participants’ rights. Grievance Procedures. A program shall: Provide the participant on admission with a description of the program’s grievance policy and procedures, which shall include the: Participant’s right to grieve program decisions, including but not limited to: Discharge; and Change in status or services; Steps of the grievance process; and Levels to which the grievance may be taken; Take no retaliation against a participant who presents a grievance; and Inform each participant if revisions are made to the grievance policy and the nature and extent of the revisions. Nondiscrimination. A program may not discriminate in the provision of services on the basis of race, creed, color, age, gender, sexual orientation, gender identity, national origin, marital status, disabilities, and any other classification prohibited under State or federal law, including: Americans with Disabilities Act, 42 U.S.C §12101 et seq.; and Fair Housing Act, 42 U.S.C. §3604. 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) 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) This chapter establishes a pilot program for outpatient civil commitment (OCC) to allow for the release of individuals who are involuntarily committed for inpatient treatment under Health-General Article, §10-632, Annotated Code of Maryland, on the condition of admission to the OCC pilot program. This chapter is not intended to impose any exhaustion requirement on an individual as a prerequisite to the individual’s pursuing concurrently or in any order any legal remedy to obtain release from an inpatient facility. In this chapter, the following terms have the meanings indicated. Terms Defined. “Administration” means the Behavioral Health Administration and its agents or designees. “Administrative law judge (ALJ)” means an individual in the Office of Administrative Hearings authorized under State Government Article, §9-1604, Annotated Code of Maryland, to conduct hearings under this chapter. “Application” means the application made by the inpatient facility to the Administration, which seeks the voluntary or involuntary outpatient admission of an individual to the outpatient civil commitment pilot program. “Department” means the Maryland Department of Health. “Discharge” means the removal or withdrawal of an individual from the outpatient civil commitment pilot program and the termination of the outpatient civil commitment order. “Eligible resident” means an individual who: Has a current residence in Baltimore City or a contiguous zip code; or Is willing to establish a residence in Baltimore City or a contiguous zip code. “Federal grant program funding” means the funding awarded pursuant to the Substance Abuse Mental Health Services Administrations Assisted Outpatient Treatment Grant Program for Individuals with Serious Mental Illness, established by the Protecting Access to Medicare Act of 2014, section 224. Inpatient Facility. “Inpatient facility” means an inpatient institution that provides evaluation, care, or treatment for individuals who have mental disorders. “Inpatient facility” includes a Veterans' Administration (VA) hospital. “Involuntary inpatient facility admissions” means that an individual has been admitted to an inpatient facility by an ALJ following an involuntary admission hearing pursuant to Health-General Article, §10-632, Annotated Code of Maryland. “Involuntary outpatient admission” means the admission of an individual into the outpatient civil commitment pilot program who shall be subject to conditions imposed by the Administration and ordered by an ALJ following a hearing as described in this chapter. “Legal service provider” means the entity that the Department designates to provide representation for an individual at the proceedings described in this chapter. “Licensed certified social worker-clinical” means an individual who is licensed, certified, or otherwise legally authorized to independently provide the mental health service under Health Occupations Article, Title 19, Annotated Code of Maryland. “Licensed clinical professional counselor” means an individual who is licensed, certified, or otherwise legally authorized to independently provide the mental health service under Health Occupations Article, Title 17, Annotated Code of Maryland. “Licensed master social worker” means an individual who is licensed, certified, or otherwise legally authorized to independently provide the mental health service under Health Occupations Article, Title 19, Annotated Code of Maryland. Mental Disorder. “Mental disorder” means a behavioral or emotional illness that results from a psychiatric or neurological disorder. “Mental disorder” includes a mental illness that substantially impairs the mental or emotional functioning of an individual as to make care or treatment necessary or advisable for the welfare of the individual or for the safety of the individual or property of another. “Mental disorder” does not include mental retardation or a primary diagnosis of alcohol or drug abuse. “Office of Administrative Hearings” means the office created under State Government Article, §9-1602, Annotated Code of Maryland. “Order” means the formal written order issued by an Administrative Law Judge committing an individual into the outpatient civil commitment pilot program. “Outpatient civil commitment (OCC) pilot program” means the program established by the Behavioral Health Administration to provide community-based treatment and supports to: Individuals involuntarily ordered by an ALJ to participate in the OCC pilot program as a condition of release from inpatient admission; or Individuals who choose to participate in the OCC pilot program voluntarily after a settlement conference with the legal service provider and a representative of the inpatient facility. “Physician” means an individual licensed under Health Occupations Article, Title 14, Annotated Code of Maryland, to practice medicine in this State. “Program” means the outpatient civil commitment (OCC) pilot program. “Psychiatric nurse practitioner” means an individual licensed to practice registered nursing in this State and certified to practice as an advanced practice registered nurse/psychiatric mental health (APRN/PMH) under Health Occupations Article, Title 8, Annotated Code of Maryland. “Psychiatrist” means a physician who: Is licensed by the Maryland Board of Physicians; and Is either: Certified in psychiatry by the American Board of Psychiatry and Neurology; or Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in psychiatry. “Psychologist” means an individual who is: Licensed under Health Occupations Article, Title 18, Annotated Code of Maryland, to practice psychology; and Listed in the National Register of Health Service Providers in Psychology. “Release” means the authorization for an individual who is confined in an inpatient facility under Health-General Article, §10-632, Annotated Code of Maryland, to leave the inpatient facility on the condition of admission to the OCC pilot program. “Voluntary inpatient admission” means the admission of an individual to an inpatient facility on the basis of: A signed and endorsed formal application for voluntary admission pursuant to Health-General Article, §10-609 or 10-610, Annotated Code of Maryland; An informal request for admission pursuant to Health-General Article, §10-609, Annotated Code of Maryland; or If the voluntary admission is to a VA hospital, the procedure established by the VA hospital. “Voluntary outpatient admission” means the admission of an individual to the outpatient civil commitment pilot program described in this chapter voluntarily after a settlement conference with the legal service provider and a representative of the inpatient facility. The Department authorizes the Administration to create a program to provide community-based treatment to individuals with mental disorders who were: Admitted to an inpatient facility under Health-General Article, Title 10, Annotated Code of Maryland; and Released on condition of admission to the program pursuant to the requirements of this chapter. The program shall be funded with money received from a federal government grant to conduct an outpatient civil commitment program. The program shall be limited to eligible residents. Individuals shall be admitted to the program through voluntary outpatient admission or involuntary outpatient admission consistent with this chapter. The program and the regulations under this chapter shall end on the expiration of the federal grant program funding. To be involuntarily admitted to the program, an individual shall meet the following criteria: Have a mental disorder; Be 18 years old or older; Be an eligible resident; Have had two or more involuntary inpatient facility admissions in the preceding 12 months, including the most recent admission, before the application for admission into the program; Has a demonstrated history of refusing community treatment that has been a significant factor in contributing to the current involuntary inpatient admission; Has a treatment history and behavior that indicates the need for outpatient treatment to prevent deterioration after discharge and that is substantially likely to result in the individual becoming a danger to self or others in the community in the foreseeable future; Has been offered, and refused, the opportunity to accept voluntary outpatient admission into the program on discharge from the inpatient facility; Is substantially likely to benefit from the outpatient treatment; Would not be a danger to self or others in the community if released to the program; and For whom treatment in the program is the least restrictive alternative appropriate for the individual. Involuntary Admission. To be voluntarily admitted to the program, an individual shall meet the following criteria: Have a mental disorder; Be 18 years old or older; Be an eligible resident who has had: A combination of two voluntary or involuntary inpatient facility admissions in the preceding 12 months, including the most recent admission before the application for admission into the program; or One inpatient facility admission and three psychiatric emergency department visits in the preceding 12 months; Have a demonstrated history of refusing community treatment that has been a significant factor in contributing to the current inpatient admission; Have a treatment history and behavior that indicates the need for outpatient treatment to prevent deterioration after discharge that is substantially likely to result in the individual becoming a danger to self or others in the community in the foreseeable future; Show that they are substantially likely to benefit from the outpatient treatment; Not be a danger to self or others in the community if released to the program; Be able to demonstrate that treatment in the program is the least restrictive alternative appropriate for the individual; Participate in a settlement conference with the legal service provider and a representative of the inpatient facility; and Enter into a settlement agreement whereby the individual agrees to adhere to program recommendations including a treatment plan or support services, or both, as needed by the individual. If the individual is eligible, an immediate family member may request voluntary enrollment. The administrative head of an inpatient facility may submit an application to the Administration for admission to the program of an individual who is committed to the inpatient facility under Health-General Article, §10-632, Annotated Code of Maryland. The Administration shall provide an application form that includes the following: The statutory authority for the application; The applicant’s: Name; Address; and Telephone number; The name and address of the individual for whom the program is being requested; The criteria for admission into the program; The facts that support the applicant’s determination that the individual who is the subject of the application meets each criterion for admission to the program; and The signature and verification by a physician, psychiatrist, psychologist, psychiatric nurse practitioner, licensed certified social worker-clinical, licensed master social worker, or licensed clinical professional counselor on behalf of the inpatient facility. If the individual’s address is unknown, or the individual is homeless, the address of the inpatient facility may be used. If an application does not include the information required under §B of this regulation, the Administration may not consider the application. Within 3 business days from receiving an application for admission, the Administration shall: Determine whether the individual meets the criteria for admission to the program; Determine whether the program is appropriate to meet the individual’s needs; and Provide written notice to the individual and to the administrative head of the inpatient facility of the Administration’s decision to approve or deny the application. If the application is approved, the Administration shall oversee the development of the proposed program treatment plan. If the application is denied, the individual may not be admitted into the program. If the application for admission to the program has been approved, the inpatient facility staff shall: Schedule a hearing with the Office of Administrative Hearings; Notify the legal service provider that the hearing has been scheduled; Provide the individual with a copy of the application and proposed treatment plan; and Provide the individual with a copy of the Notice of Hearing and Rights. The parent, guardian, or next of kin of an individual approved for admission to the program: Shall be given notice of the hearing; and May offer evidence and testify at the hearing. The notice of hearing and rights shall be on the form provided by the Administration and shall include: The date, time, and place that the hearing will be held; The legal authority for and purpose of the hearing; A short statement explaining why the individual’s admission to the program is being sought; The criteria set forth in Regulation .06 of this chapter that govern whether the individual shall be admitted to the program; The individual’s right to consult with an attorney of the individual’s choice and, if the individual is unable to afford an attorney, the availability of representation at the hearing through the legal service provider; and The individual’s rights at the hearing as set forth in Regulation .09 of this chapter. Within 10 business days from the Administration’s approval of the program application, a hearing shall be held by the Office of Administrative Hearings to decide if the patient meets the program admission requirements of this chapter. The hearing may be postponed for good cause for not more than 10 business days from date of the postponed hearing. Burden of Proof. The Administration shall demonstrate by clear and convincing evidence that the individual meets each of the requirements set forth under Regulation .05 of this chapter. Rights of Parties. At a hearing, the parties have the right to: Be represented by counsel; Present witnesses; Cross-examine witnesses presented by the other party; Present documentary or other relevant evidence; Submit rebuttal evidence; and Present summation and argument. In addition, an individual has the right to: Wear the individual’s choice of clothes; and Be present or waive the right to be present, if the waiver is: Knowingly and intelligently made; and Witnessed by the individual’s counsel. Findings and Conclusions. After the evidence and testimony are presented, and following summation and argument by the parties, the ALJ shall: Consider all evidence and testimony of record; Rule on issues raised by the individual that relate to the admission of the individual into the program; Order the individual released into the program if the inpatient facility has met its burden of proof establishing that the individual meets the program admission criteria under Regulation .05 of this chapter; and State on the record the: Findings, including whether the individual waived the right to attend the hearing; Conclusions of law on any issue presented; and Right of the individual to judicial review of the decision of the ALJ under State Government Article, §10-222, Annotated Code of Maryland, and the procedure for requesting judicial review. An order shall: Specify that each of the admission criteria has been met; Order the individual to adhere to program recommendations including a treatment plan or support services, or both, as needed by the individual; and Specify the date on which the order shall expire. An order issued under this chapter shall expire at the end of the 180-day period beginning with the individual’s initial inpatient commitment under Health-General Article, §10-632, Annotated Code of Maryland. If the individual elects to participate in the program voluntarily, the individual shall participate in a settlement conference. The settlement conference shall include the individual, the legal service provider, and a representative of the inpatient facility. In order for the individual to be voluntarily admitted to the program, the individual shall sign the settlement agreement and agree to adhere to program recommendations including a treatment plan or support services, or both, as needed by the individual. Before Discharge. Before the expiration of the program order, the Administration shall ensure that a transition plan is in place which provides the outpatient services necessary to support the individual in the community. Early Discharge. The Administration may discharge an individual from the program prior to the expiration of the program order upon finding that the individual is: Not likely a danger to self or others without the order; and Compliant with the treatment plan and is likely to remain compliant in the future without the order. After Discharge. Following the discharge of a patient from the program, the Administration shall monitor the transition of the individual from the program to voluntary community services for 60 days. Nothing in this chapter prevents the admission to a hospital pursuant Health-General Article, §10-601 et seq., Annotated Code of Maryland, of an individual participating in the Program. An individual’s participation in the program does not prohibit the individual’s evaluation and involuntary admission under Health-General Article, §10-601 et seq., Annotated Code of Maryland. This chapter is effective July 1, 2017. Health-General Article, §§7.5-205 and §7.5-205.1, Annotated Code of Maryland Effective date: November 6, 2017 (44:22 Md. R. 1037) Regulation .02B amended effective September 9, 2019 (46:18 Md. R. 774); February 3, 2025 (52:2 Md. R. 67) Regulation .03A amended effective September 9, 2019 (46:18 Md. R. 774) Regulation .03C amended effective February 3, 2025 (52:2 Md. R. 67) Regulation .05 amended effective February 3, 2025 (52:2 Md. R. 67) Regulation .05B amended effective September 9, 2019 (46:18 Md. R. 774) Regulation .06B amended effective September 9, 2019 (46:18 Md. R. 774) Regulation .11 amended effective February 3, 2025 (52:2 Md. R. 67) This chapter establishes standards for the imposition of civil money penalties against an organization or program determined to be in violation of this subtitle. In this chapter, the following terms have the meanings indicated. Material and Egregious Violation “Material violation” means any course of conduct, including a single incident, that may cause a program, individual, or organization to fail to comply with any statutory, regulatory, or contractual requirement. “Material and egregious violation” includes but is not limited to: Fraudulent or other behavior which influences or may influence the payment or receipt of money or other property; Practices which affect or may affect the health or safety of any individual; or Practices which violate or may violate participant rights. The Department may impose a civil money penalty against an organization for a material violation of a State or federal law or regulation in any of its programs. The Department may additionally cite violations of accreditation standards in support of an identified violation of law or regulation. A civil money penalty may be imposed regardless of whether any other civil, criminal, or administrative action is taken against the organization or program by any State, federal, or Departmental agency for the same covered period or violation. If a violation occurs at multiple site locations of an organization, each location will constitute a separate violation. If there are multiple services at a location and the violation occurs with multiple services, each service will constitute a separate violation. If the Department determines that a material deficiency, or continuing pattern of deficiencies which together amount to a material and egregious violation, exists, the Department shall notify the organization of the deficiency or deficiencies and may: Permit the organization the opportunity to correct the deficiencies by a specified date; or Impose a civil money penalty of up to $500 per day not to exceed $15,000 in one month until compliance is achieved. If the Department permits an organization the opportunity to correct the deficiencies by a specific date, and the organization fails to comply, the Department may impose a civil penalty of up to $500 for each day of violation until the organization has submitted sufficient documentation of correction of the deficiency not to exceed $15,000 in 1 month. In determining whether a civil money penalty is to be imposed and in setting the amount of the civil money penalty, the Department shall consider each of the following: The number, nature, and seriousness of the violation or violations; The extent to which the deficiency or deficiencies are part of an ongoing pattern; The organization’s history with the Department, including any prior history of compliance or any prior actions that would indicate whether the violation is an isolated occurrence or represents a pattern of behavior; The efforts made by the organization to correct the violations and any continuation of conduct after notification of possible violations; The organization’s level of cooperation with the Department or its agents as it relates to the review of the program; The degree of risk to the health, life, or safety of individuals as a result of the violations; and Any other reasonable mitigating factors. The Department shall give consideration to the extent to which the organization’s size, operations, or financial condition: May have contributed to the violations; and May affect the organization’s ability to provide care and continue program operations after payment of a civil money penalty. If the civil money penalty is imposed under this chapter, the Department shall issue a written notice to the organization operating the program that: States the total amount of the civil money penalties being imposed; and Includes the following information: Each regulation or statute violated; The amount of each civil money penalty imposed for each violation; The manner in which the amount of the civil money penalty was calculated; and The organization’s right to request a hearing in accordance with COMAR 10.63.06; and The organization’s appeal rights. The notice shall be sent to the organization, owner, resident agent, and Board of Directors, as appropriate, by certified mail. An organization that operates or purports to operate a service or site without a license that is required pursuant to this subtitle may be assessed a civil money penalty by the Department of $1,000 per day of operation per location site or service. An organization aggrieved by the imposition of a civil money penalty may appeal the action by filing a request for a hearing in accordance with COMAR 10.63.06. If the hearing affirms the imposition of the penalty, the Secretary shall issue a final order which shall state the basis on which the order is made, the amount of the civil money penalty imposed, and the manner in which the amount of the civil money penalty was calculated. After exhaustion of all appeals, an organization shall pay a civil money penalty to the Department within 10 days after the organization receives a final order that affirms the imposition of the civil money penalty. The Department, at its discretion, may agree to accept a repayment schedule, which may include a discount for timely payments. If an organization does not pay the civil money penalty to the Department after receiving the final order or according to a negotiated repayment schedule: The balance due shall be referred to the Central Collection Unit; and The organization and its programs may be subject to licensing action. Health-General Article, §§7.5-205(b)(2)—(3), (d), 7.5-402(a)(6), Annotated Code of Maryland Effective date: April 14, 2025 (52:7 Md. R. 323)