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)