Title 08
DEPARTMENT OF NATURAL RESOURCES

Subtitle 02 FISHERIES SERVICE

Notice of Final Action

[26-067-F]

On August 11, 2026, the Secretary of Natural Resources adopted amendments to:

(1) Regulation .01 under COMAR 08.02.03 Blue Crabs;

(2) Regulations .01, .02, .03, .08, .10, and .12 under COMAR 08.02.04 Oysters;

(3) Regulation .19 under COMAR 08.02.05 Fish;

(4) Regulations .02 and .03 under COMAR 08.02.07 Hard-Shell Clams; and

(5) Regulations .02 and .03 under COMAR 08.02.25 Gear.

This action, which was proposed for adoption in 53:13 Md. R. 590—592 (June 26, 2026), has been adopted as proposed.

Effective Date: August 31, 2026.

JOSH KURTZ
Secretary of Natural Resources

08.02.08 Shellfish—General

Authority: Natural Resources Article, §§4-206, 4-215, 4-1007, 4-1020, 4-1028, 4-1033, and 4-1035, Annotated Code of Maryland

Notice of Final Action

[26-070-F]

On August 11, 2026, the Secretary of Natural Resources adopted amendments to Regulation .09 under COMAR 08.02.08 Shellfish—General. This action, which was proposed for adoption in 53:13 Md. R. 592—593 (June 26, 2026), has been adopted as proposed.

Effective Date: August 31, 2026.

JOSH KURTZ

Secretary of Natural Resources

Title 10
MARYLAND DEPARTMENT OF HEALTH

Subtitle 44 BOARD OF DENTAL EXAMINERS

10.44.01 Dental Assistants

Authority: Health Occupations Article, §§4-205(a)(1)(iii), 4-301.1, 4-302.1, 4-304.1, 4-305.1, and 4-311.1, Annotated Code of Maryland

Notice of Final Action

[25-178-F]

On August 4, 2026, the Secretary of Health adopted the repeal of existing Regulations .01—.08 and new Regulations .01—.30 under COMAR 10.44.01 Dental Assistants. This action, which was proposed for adoption in 52:17 Md. R. 882—888 (August 22, 2025), has been adopted with the nonsubstantive changes shown below.

Effective Date: August 31, 2026.

Attorney General’s Certification

In accordance with State Government Article, §10-113, Annotated Code of Maryland, the Attorney General certifies that the following changes do not differ substantively from the proposed text. The nature of the changes and the basis for this conclusion are as follows:

Regulation .09: Nonsubstantive changes are being made at final action to replace “the effective date of this chapter” with the actual date upon which the proposal will be finalized, which was unknown at the time of initial publication. Additionally, a small typographical error is being addressed.

.09 Dental Assistants Previously Recognized as Qualified in Orthodontics.

A. Except as otherwise provided in this regulation, in order to perform the intraoral procedures of an orthodontic EFDA, a dental assistant recognized by the Board as qualified in orthodontics prior to [[the effective date of this chapter]] August 31, 2026 shall:

(1)—(4) (proposed text unchanged)

B. A dental assistant recognized by the Board as qualified in orthodontics prior to [[the effective date of this chapter]] August 31, 2026 is not required to take the Board-approved course or take the DANB orthodontic EFDA examination.

C. After initial orthodontic EFDA certification, a dental assistant recognized by the Board as qualified in orthodontics prior to [[the effective date of this chapter]] August 31, 2026 who becomes an orthodontic EFDA shall meet all of the requirements [o] of renewal in accordance with Regulation .11 of this chapter.

D. Grace Period.

(1) A dental assistant recognized by the Board as qualified in orthodontics prior to [[the effective date of this chapter]] August 31, 2026 may lawfully perform the duties of an orthodontic EFDA [[for 6 months after the effective date of this chapter]] until February 28, 2027.

(2) A dental assistant recognized by the Board as qualified in orthodontics prior to [[the effective date of this chapter]] August 31, 2026 who has not become an orthodontic EFDA [[within 6 months of the effective date of this chapter]] by February 28, 2027 may not perform the duties of either a dental assistant recognized as qualified in orthodontics or an orthodontic EFDA.

MEENA SESHAMANI, MD, PHD

Secretary of Health

Subtitle 44 BOARD OF DENTAL EXAMINERS

10.44.20 Fees

Authority: Health Occupations Article, §§4-205, 4-207, 4-304, 4-304.1, 4-309.1, 4-311.1, 4-505, and 12-102.1, Annotated Code of Maryland; Ch.469, Acts of 2006

Notice of Final Action

[25-243-F]

On August 4, 2026, the Secretary of Health adopted amendments to Regulation .02 under COMAR 10.44.20 Fees. This action, which was proposed for adoption in 52:23 Md. R. 1171—1172 (November 14, 2025), has been adopted as proposed.

Effective Date: August 31, 2026.

MEENA SESHAMANI, MD, PHD
Secretary of Health

Title 17
DEPARTMENT OF BUDGET AND MANAGEMENT

Subtitle 04 PERSONNEL SERVICES AND BENEFITS

17.04.11 Leave

Authority: State Personnel and Pensions Article, §§4-106, 9-101, and 9-1108, Annotated Code of Maryland

Notice of Final Action

[26-077-F]

On August 11, 2026, the Secretary of Budget and Management adopted amendments to Regulation .31 under COMAR 17.04.11 Leave. This action, which was proposed for adoption in 53:13 Md. R. 613—614 (June 26, 2026), has been adopted as proposed.

Effective Date: August 31, 2026.

YAAKOV JAKE WEISSMANN
Secretary

Title 21
STATE PROCUREMENT REGULATIONS

Notice of Final Action

[26-029-F]

On August 5, 2026, the Board of Public Works adopted:

(1) Amendments to Regulation .01 under COMAR 21.01.01 Authority, Policies, and Purposes;

(2) Amendments to Regulation .01 under COMAR 21.01.02 Terminology;

(3) Amendments to Regulations .01 and .01-1 under COMAR 21.01.03 Applicability;

(4) Amendments to Regulations .04 and .05 under COMAR 21.02.01 Board of Public Works;

(5) Amendments to Regulation .01 under COMAR 21.05.01 General Provisions;

(6) Amendments to Regulations .04, .07, and .16 under COMAR 21.05.02 Procurement by Competitive Sealed Bidding;

(7) Amendments to Regulation .03 under COMAR 21.05.03 Procurement by Competitive Sealed Proposals;

(8) Amendments to Regulations .01—.03 under COMAR 21.05.06 Emergency and Expedited Procurements;

(9) Amendments to Regulations .01, .03, .04, and .05 under COMAR 21.05.07 Small Procurement Regulations;

(10) Amendments to Regulation .02 under COMAR 21.05.08 Mandatory Written Solicitation Requirements;

(11) Amendments to Regulation .05 under COMAR 21.05.09 Intergovernmental Cooperative Purchasing;

(12) Amendments to Regulation .05 under COMAR 21.05.10 Construction Management at Risk;

(13) Amendments to Regulations .03 and .04 under COMAR 21.05.12 Procurement of Human, Social, Cultural, and Educational Services;

(14) Amendments to Regulations .01, .03, .05, .06, and .07, and adopt new Regulation .08 under COMAR 21.05.13 Master Contracting;

(15) The repeal of existing Regulations .01—.05 and new Regulations .01—.03 under COMAR 21.05.15 Legislative Fast-Track Procurement;

(16) Amendments to Regulations .01, .09, and .10 under COMAR 21.06.07 Bid and Contract Security/Bonds;

(17) Amendments to Regulation .05 under COMAR 21.06.09 Invoicing, Payment, and Interest on Late Payments;

(18) New Regulations .01—.05 under a new chapter, COMAR 21.06.10 Pay for Success Contracting;

(19) Amendments to Regulations .18, .19, .24, .27, and .28 under COMAR 21.07.01 Mandatory Contract Provisions—All Contracts (except as provided under COMAR 21.05.07, 21.07.02, and 21.07.03);

(20) Amendments to Regulations .05-1, .10 and .11 under COMAR 21.07.02 Mandatory Construction Contract Clauses;

(21) Amendments to Regulation .02 under COMAR 21.07.04 Prohibited Provisions;

(22) Amendments to Regulation .04 under COMAR 21.10.04 Contract Claims and Disputes;

(23) Amendments to Regulations .01 and .06 under COMAR 21.11.01 Small Business Procurements;

(24) Amendments to Regulations .01, .03, .04, .07, .08, .09, .11, .12, .13, .15, and .17 under COMAR 21.11.03 Minority Business Enterprise Policies;

(25) Amendments to Regulations .01, .06, and .07 under COMAR 21.11.05 Procurement from Maryland Correctional Enterprises, Blind Industries and Services of Maryland, and the Employment Works Program;

(26) Amendments to Regulations .08 and .11 under COMAR 21.11.07 Miscellaneous Purchasing Preferences;

(27) Amendments to Regulations .03 and .04 under COMAR 21.11.12 State Apprenticeship Training Fund;

(28) Amendments to Regulation .05 under COMAR 21.12.02 Department of Transportation and Department of General Servies; A/E Services Exceeding $200,000; and

(29) Amendments to Regulations .02, .03, and .15 under COMAR 21.13.01 Reporting Requirements.

This action, which was proposed for adoption in 53:8 Md. R. 368—387 (April 17, 2026), has been adopted with the nonsubstantive changes shown below.

Effective Date: August 31, 2026.

Attorney General’s Certification

COMAR 21.05.13.01B(7): Correction of a typographical error.

21.05.13 Master Contracting

Authority: State Finance and Procurement Article, §§12-101, 13-101, 13-102, 13-113, 13-114, and 14-303, Annotated Code of Maryland; Ch. 601, Acts of 2025

.01 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)—(6) (text unchanged)

(7) “Secondary competition award” has the meaning stated in State Finance and Procurement Article, [[§13-101(i)]] §13-101(h), Annotated Code of Maryland, and must be one of the types listed in COMAR 21.05.13.05B.

JOHN GONTRUM

Executive Secretary

Proposed Action on Regulations

Title 10
MARYLAND DEPARTMENT OF HEALTH

Subtitle 63 COMMUNITY-BASED BEHAVIORAL HEALTH PROGRAMS AND SERVICES

Notice of Proposed Action

[26-079-P-I]

The Secretary of Health proposes to:

(1) Repeal existing Regulations .01—.05 under COMAR 10.63.01 Requirements for All Licensed Programs and adopt new Regulations .01—.08 under a new chapter, COMAR 10.63.01 General Requirements for All Programs;

(2) Repeal existing Regulations .01—.04 under COMAR 10.63.02 Programs Required to Be Accredited in Order to Be Licensed to Provide Community-Based Behavioral Health Services and adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.02 Compliance and Reporting Requirements;

(3) Repeal existing Regulations .01—.21 under COMAR 10.63.03 Descriptions and Criteria for Programs and Services Required to Have an Accreditation-Based License and adopt new Regulations .01—.12 under a new chapter, COMAR 10.63.03 General Staffing Requirements;

(4) Repeal existing Regulations .01—.07 under COMAR 10.63.04 Additional Requirements for Accreditation-Based Licenses for Specific Residential Community-Based Behavioral Health Services and adopt new Regulations .01—.09 under a new chapter, COMAR 10.63.04 Documentation Requirements;

(5) Repeal existing Regulations .01—.07 under COMAR 10.63.05 Descriptions and Criteria for Programs Requiring a Non-Accreditation-Based License and adopt new Regulations .01—.07 under a new chapter, COMAR 10.63.05 Program Site Requirements;

(6) Repeal existing Regulations .01—.21 under COMAR 10.63.06 Application and Licensure Process and adopt new Regulations .01—.18 under a new chapter, COMAR 10.63.06 Licensure Process;

(7) Amend and recodify existing Regulations .02, .03, and .05 under COMAR 10.63.08 Civil Money Penalty to be Regulations .02, .03, and .05 under COMAR 10.63.38 Civil Money Penalty and recodify existing Regulations .01 and .04 under COMAR 10.63.08 Civil Money Penalty to be Regulations .01 and .04 under COMAR 10.63.38 Civil Money Penalty;

(8) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.08 DUI Education Program;

(9) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.09 Early Intervention Level 0.5 Program;

(10) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.10 Substance-Related Disorder Assessment and Referral Program;

(11) Adopt new Regulations .01—.11 under a new chapter, COMAR 10.63.11 Behavioral Health Crisis Stabilization Center (BHCSC) Program;

(12) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.12 Integrated Behavioral Health Program;

(13) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.13 Intensive Outpatient Treatment Level 2.1—Substance-Related Disorder Treatment Program;

(14) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.14 Mobile Crisis Team Program;

(15) Adopt new Regulations .01—.09 under a new chapter, COMAR 10.63.15 Mobile Treatment Services Program;

(16) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.16 Outpatient Mental Health Center (OMHC);

(17) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.17 Outpatient Treatment Level 1.0—Substance-Related Disorder Treatment Program;

(18) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.18 Level 2.5 Substance-Related Disorder Treatment Partial Hospitalization Program (PHP);

(19) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.19 Mental Health—Partial Hospitalization Program (PHP);

(20) Adopt new Regulations .01—.07 under a new chapter, COMAR 10.63.20 Psychiatric Rehabilitation Program for Adults (PRP-A);

(21) Adopt new Regulations .01—.07 under a new chapter, COMAR 10.63.21 Psychiatric Rehabilitation Program for Minors (PRP-M);

(22) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.22 Respite Care Services;

(23) Adopt new Regulations .01—.07 under a new chapter, COMAR 10.63.23 Supported Employment Program (SEP);

(24) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.24 Substance-Related Disorder Treatment Program in a Correctional Facility;

(25) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.25 Group Homes for Adults with Mental Illness;

(26) Adopt new Regulations .01—.07 under a new chapter, COMAR 10.63.26 Mental Health Residential Crisis Services Program;

(27) Adopt new Regulations .01—.08 under a new chapter, COMAR 10.63.27 Recovery Residence Program;

(28) Adopt new Regulations .01—.07 under a new chapter, COMAR 10.63.28 Substance-Related Disorder Residential Crisis Services Program;

(29) Adopt new Regulations .01—.07 under a new chapter, COMAR 10.63.29 Level 3.1 Clinically Managed Low-Intensity Residential Services Program;

(30) Adopt new Regulations .01—.07 under a new chapter, COMAR 10.63.30 Level 3.3 Clinically Managed Population-Specific High-Intensity Residential Services Program;

(31) Adopt new Regulations .01—.07 under a new chapter, COMAR 10.63.31 Level 3.5 Clinically Managed High-Intensity Residential Services Program;

(32) Adopt new Regulations .01—.07 under a new chapter, COMAR 10.63.32 Level 3.7 Medically Monitored Intensive Inpatient Services Program;

(33) Adopt new Regulations .01—.07 under a new chapter, COMAR 10.63.33 Residential Rehabilitation Program (RRP);

(34) Adopt new Regulations .01—.16 under a new chapter, COMAR 10.63.34 Therapeutic Group Homes;

(35) Adopt new Regulations .01—.09 under a new chapter, COMAR 10.63.35 Opioid Treatment Program;

(36) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.36 Withdrawal Management Service;

(37) Adopt new Regulations .01—.06 under a new chapter, COMAR 10.63.37 Mental Health Intensive Outpatient Program; and

(38) Adopt new Regulations .01—.10 under a new chapter, COMAR 10.63.39 Corrective Actions and Sanctions.

Statement of Purpose

The purpose of this action is to repeal existing regulations and adopt new regulations within COMAR 10.63 Community-Based Behavioral Health Programs and Services to align with current statutory requirements and to support improved quality of services, compliance, and a more equitable and sustainable operating environment for community-based behavioral health programs in the State.

The subtitle will be organized as follows:

(1) 10.63.01 sets forth the requirements for all organizations operating programs to provide community-based behavioral health services;

(2) 10.63.02 sets forth compliance and reporting requirements for all organizations operating programs to provide community-based behavioral health services;

(3) 10.63.03 outlines general staffing requirements;

(4) 10.63.04 identifies and sets forth documentation requirements for all organizations operating programs to provide community-based behavioral health services;

(5) 10.63.05 sets forth program site requirements for programs providing community-based behavioral health services;

(6) 10.63.06 sets forth the licensing process for all organizations licensed to provide community-based behavioral health services;

(7) 10.63.08—10.63.37 provide detailed program-specific information required for an organization to operate a specific community-based behavioral health services program; and

(8) 10.63.38 sets forth a civil money penalty for material and egregious non-compliance with federal or State law or regulation; and

(9) 10.63.39 provides the regulatory framework for corrective actions and sanctions undertaken by the Behavioral Health Administration against an organization for material and egregious non-compliance with federal or State law or regulation.

Estimate of Economic Impact

I. Summary of Economic Impact. The proposed regulations will have an economic impact for the Department. The proposed regulations update and add requirements for organizations to be licensed to provide community-based behavioral health programs and services. The proposed regulations add to the review and approval of licensure applications by the Department before licenses are issued. In this manner, the proposed regulations increase expenditures in the required staffing levels, training, and systems support needed to implement the changes to licensure requirements. The amount of these increased expenditures is indeterminable as any method used to project the effect of the proposed regulations on the current volume of licensure applications is speculative, but the Department estimates an indeterminable increase of expenditures in FY27 for the certification and oversight of recovery residences.

For organizations operating programs to provide community behavioral health services, the cost of adhering to the proposed regulations that update and clarify application requirements for licensure is indeterminable, as any costs will vary by organization, number of sites and the program type(s) they are seeking licensure for in the State. For certain program types, the proposed regulations update staffing requirements which may include changes to required staff credentials, staffing levels, site requirements, program requirements, and management requirements for licensure. The proposed regulatory package also updates and clarifies program requirements for certain program types, which may also generate regulatory burden and associated compliance costs.

Some local governments functioning as the Local Behavioral Health Authority or the Local Addiction Authority may provide substance-related disorder services, which may require the local government agencies to be accredited. The number of agencies that would need to be accredited cannot be determined as it will vary between local governments.

II. Types of Economic Impact.

Impacted Entity	Revenue (R+/R-) Expenditure (E+/E-)	Magnitude
A. On issuing agency:
Maryland Department of Health	(E+)	Indeterminable
B. On other State agencies:	NONE
C. On local governments:
Local Behavioral Health Authorities/Local Addiction Authorities	(E+)	Unquantifiable
	Benefit (+) Cost (-)	Magnitude
D. On regulated industries or trade groups:
(1) Licensed Community-Based Behavioral Health Organizations	(-)	Indeterminable
(2) Licensed Community-Based Behavioral Health Organizations	(+)	Indeterminable
(3) Administrative Service Organization	(+)	Unquantifiable
E. On other industries or trade groups:
(1) Accreditation Organizations	(-)	Indeterminable
(2) Behavioral Health Consultants	(+)	Indeterminable
(3) Community Behavioral Health Trade Groups	(+)	Indeterminable
F. Direct and indirect effects on public:
(1) Indirect Effects on Access to Care	(+)	Unquantifiable
(2) Indirect Effects on Access to Care	(-)	Unquantifiable
(3) Indirect Effects on Quality of Care	(+)	Indeterminable

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

A. The new requirements add to the review and approval of licensure applications by the Department before licenses are issued. Further, the new regulations set forth new licensure procedures for license renewals, additional site licensure, and change of location licensure. Additionally, these regulations will require the Department to begin certification and oversight for all recovery residences in the State. In this manner, the proposed regulations increase expenditures in the required staffing levels, training, and systems support needed to implement the changes to licensure requirements. The economic impact on the Maryland Department of Health for implementing these regulations is currently indeterminable.

C(1). Additional expenditures may be related to increased audit and compliance activities and any increased regulatory burden. At this time, the impact is unquantifiable.

D(1). The Department anticipates that increased program and compliance activities and increased regulatory burden may result in additional costs for organizations.

D(2). The Department anticipates that a reduction in fraud, waste, and abuse within the provider community may result in benefits for organizations as a whole, but any exact amount of benefit would be indeterminable.

D(3). The Department anticipates that a reduction in fraud, waste, and abuse within the provider community may result in a benefit for the Administrative Service Organization. At this time, the impact is unquantifiable.

E(1). The Department understands that as a result of these regulations, accreditation organizations may see less organizations operating programs providing community-based behavioral health services seeking accreditation. Any cost associated with this would be indeterminable.

E(2). The Department anticipates that Behavioral Health Consultants may have additional opportunities to assist regulated organizations with compliance with these regulations and the new licensure process. Any exact amount of benefit would be indeterminable.

E(3). The Department anticipates that Community Behavioral Health Trade Groups may see an increased need for support among association members to comply with new regulatory requirements. Any exact amount of benefit would be indeterminable.

F(1). The Department strongly believes that these new regulatory requirements will result in a higher quality of care and improved access to care for community-based behavioral health programs.

F(2). The Department appreciates that these new regulatory requirements may result in the closure of some community-based behavioral health programs over time, though any exact impact would be unquantifiable.

F(3). The Department strongly believes that these new regulatory requirements will result in better providers and better overall quality of care. Nevertheless, any exact amount of this benefit is indeterminable.

Economic Impact on Small Businesses

The proposed action has a meaningful economic impact on small businesses. An analysis of this economic impact follows:

For organizations operating community behavioral health programs, many of which are small businesses, the cost of adhering to the proposed regulations that update and clarify application requirements for accreditation-based and non-accreditation-based licenses is indeterminable, as costs will vary by organization, number of sites, and the program type(s) they are seeking licensure for in the State. For certain program types, the proposed regulations update staffing requirements which may include changes to required staff credentials, staffing levels, site requirements, program requirements, and management requirements for licensure all of which may increase operating costs, compliance costs and general regulatory burden.

Impact on Individuals with Disabilities

The proposed action has an impact on individuals with disabilities as follows:

To the extent that individuals with disabilities receive community-based behavioral health services, the Department believes that these regulations will result in better care for individuals receiving these services. Overall, the Department anticipates a positive impact and an improved quality of care.

Opportunity for Public Comment

Comments may be sent to Jordan Fisher Blotter, Director, Office of Regulation & Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 534 Baltimore, Maryland 21201, or call 410-767-0938, or email to [email protected]. Comments will be accepted through September 21, 2026. A public hearing has not been scheduled.

Editor’s Note on Incorporation by Reference

Pursuant to State Government Article, §7-207, Annotated Code of Maryland, The ASAM Criteria: Treatment Criteria for Addictive, Substance-Related, and Co-Occurring Conditions (American Society of Addiction Medicine, Third Edition, 2013) and NARR Standard 3.0 (National Association of Recovery Residences, 2018) have been declared documents generally available to the public and appropriate for incorporation by reference. For this reason, they will not be printed in the Maryland Register or the Code of Maryland Regulations (COMAR). Copies of these documents are filed in special public depositories located throughout the State. A list of these depositories was published in 53:1 Md. R. 10 (January 9, 2026), and is available online at www.dsd.maryland.gov. These documents may also be inspected at the office of the Division of State Documents, 16 Francis Street, Annapolis, Maryland 21401.

10.63.01 General Requirements for All Programs

Authority: Health-General Article, §§2-104(b), 7.5-204(a)(2), and 7.5-402, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Accreditation” means the approval granted to a program by an accreditation organization.

(2) “Accreditation-based license” means a license which requires the organization be accredited by an approved accreditation organization

(3) “Accreditation organization” means a private entity that conducts inspections and surveys of health care facilities or health care staff agencies based on nationally recognized and developed standards that is approved by the Secretary in accordance with Health-General Article, §19-2302, Annotated Code of Maryland.

(4) Addictive Disorder.

(a) “Addictive disorder” means a chronic disorder of the brain’s reward-activation system in which the individual pathologically pursues reward or relief by substance-related disorder or other behaviors, with diminished control, and the individual persists in the behavior despite adverse consequences.

(b) “Addictive disorder” includes gambling, which is the only nonsubstance-related addictive disorder recognized under State law.

(5) “Administration” means the Behavioral Health Administration within the Department that provides oversight to organizations that are licensed or certified in accordance with this subtitle.

(6) “Behavioral health services” means prevention, screening, early intervention, treatment, recovery, support, wraparound, and rehabilitation services for individuals with substance-related disorders, addictive disorders, mental disorders, or a combination of these disorders.

(7) “Business day” means any day except Saturday, Sunday, or a State holiday.

(8) “Community-based” means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(9) “Critical incident” means an event that impacts the health, safety, or welfare of a program participant or staff.

(10) “Crisis” means an event that produces mental, physical, emotional, or behavioral distress.

(11) “Department” means the Maryland Department of Health.

(12)”Drug” means:

(a) 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;

(b) A prescription medication; or

(c) A chemical substance when used for unintended and harmful purposes.

(13) “Family support services” has the meaning stated in Health-General Article, §7.5-101, Annotated Code of Maryland.

(14) “Group home” means a private group home, as defined in Health-General Article, §10-514, Annotated Code of Maryland, that provides mental health services in a residential facility.

(15) “Group practice” has the meaning stated in Health Occupations Article, §1-301, Annotated Code of Maryland.

(16) “Guardian” has the meaning stated in Estates and Trusts Article, §13-101, Annotated Code of Maryland.

(17) “Hospital” has the meaning stated in Health-General Article, §19–301, Annotated Code of Maryland.

(18) “License” means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(19) “Licensed mental health professional” means:

(a) A psychiatrist; or

(b) A practitioner authorized under Health Occupations Article, Annotated of Code of Maryland, who has specialty in the diagnosis and treatment of mental health, addictive, substance-related, or co-occurring disorders.

(20) Local Authority.

(a) “Local authority” means the designated county or multicounty authority responsible for planning, managing, and monitoring publicly funded mental health, substance-related, or addictive disorder services.

(b) “Local authority” includes the:

(i) Core service agency as defined in Health-General Article, §7.5-101(g), Annotated Code of Maryland;

(ii) Local addictions authority as defined in Health-General Article, §7.5-101(j), Annotated Code of Maryland; and

(iii) Local behavioral health authority as defined in Health-General Article, §7.5-101(k), Annotated Code of Maryland.

(21) “Medical record” has the meaning stated in Health-General Article, §4-301, Annotated Code of Maryland.

(22) “Medically necessary” means a service or benefit that is:

(a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;

(b) Consistent with current accepted standards of good medical practice;

(c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and

(d) Not primarily for the convenience of the participant, family, provider, or organization.

(23) “Mental disorder” has the meaning stated in Health-General Article, §10-101, Annotated Code of Maryland.

(24) “Organization” means an association, partnership, corporation, unincorporated group, or other legal entity licensed to operate a program to provide community-based behavioral health services.

(25) “Participant” means an individual receiving behavioral health services in a community-based program.

(26) “Peer support services” has the meaning stated in Health-General Article, §7.5-101, Annotated Code of Maryland.

(27) “Plain language” means language which is easily understandable by program participants and takes into account the various levels of education and understanding of the population.

(28) “Program” means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health-General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health-General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of (a)—(c).

(29) “Provider” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland to provide health care services.

(30) “Psychiatrist” means a physician who:

(a) Is licensed by the Maryland Board of Physicians; and

(b) Is either:

(i) Certified in psychiatry by the American Board of Psychiatry and Neurology; or

(ii) Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in psychiatry.

(31) “Public Behavioral Health System” means the system that provides medically necessary behavioral health services for Medical Assistance participants and certain other uninsured individuals.

(32) “Recovery Residence” means a service that:

(a) Provides alcohol–free and illicit–drug–free housing to individuals with substance–related disorders or addictive disorders or co–occurring mental health disorders and substance–related disorders or addictive disorders; and

(b) Does not include clinical treatment services.

(33) “Rendering provider” means the licensed, certified, or otherwise authorized provider under Health Occupations Article, Annotated Code of Maryland, who provides medically necessary services to a program participant.

(34) “Residential” means the setting of a community-based program in which program participants both reside and receive behavioral health services.

(35) “Secretary” means the Secretary of the Maryland Department of Health or their designee.

(36) “Site” means the location where the organization operates the program as detailed on the program’s license.

(37) “Substance-related disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances.

(38) “Telehealth” has the meaning stated in Health-General Article, §15–141.2, Annotated Code of Maryland.

(39) “Treatment” means professionally rendered therapeutic interventions provided to an individual to address behavioral health disorders.

(40) “Withdrawal Management” means direct or indirect services for an acutely intoxicated program participant to fulfill the physical, social, and emotional needs of a participant n individual by:

(a) Monitoring the amount of alcohol and other toxic agents in the body of the participant;

(b) Managing withdrawal symptoms; and

(c) Motivating a participant to participate in appropriate substance-related disorder programs.

.02 Incorporation by Reference.

In this subtitle, The ASAM Criteria: Treatment Criteria for Addictive, Substance-Related, and Co-Occurring Conditions (American Society of Addiction Medicine, Third Edition, 2013) is incorporated by reference.

.03 Programs Requiring License.

A. Except as provided in Regulation .04 of this chapter, an organization shall have a valid and current license issued by the Secretary in accordance with COMAR 10.63.06 to operate a program that provides community-based behavioral health services in the State and falls within the program descriptions set forth in this subtitle.

B. A license issued in accordance with COMAR 10.63.06 may not be transferred.

.04 Programs Exempt from Licensure.

A. In accordance with Health-General Article, §7.5-401, Annotated Code of Maryland, the following do not fall within the program descriptions set forth in this subtitle that require a license in accordance with COMAR 10.63.06:

(1) A health professional in either a solo or group practice, who is:

(a) Licensed under the Health Occupations Article, Annotated Code of Maryland; and

(b) Providing behavioral health services in accordance with the requirements of the appropriate professional board;

(2) Alcoholics Anonymous, Narcotics Anonymous, peer support services, family support services, or other similar organizations, if the organization holds meetings or provides support services but does not provide treatment;

(3) Employees’ assistance programs of a business or State entity;

(4) Outpatient behavioral health treatment and rehabilitation services provided in a regulated space in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland, if the services are accredited by an approved accreditation organization under its behavioral health standards; and

(5) A federally qualified health center providing primary health services in accordance with 42 U.S.C. §254b.

B. Recovery Residences.

(1) Recovery Residences are exempt from the licensure requirements set forth in Regulation .03 of this chapter.

(2) Recovery Residences shall be certified by the Maryland Certification of Recovery Residences in accordance with COMAR 10.63.27.

C. Administration Exemptions.

(1) The Administration may exempt an organization from the requirements of this subtitle if the program:

(a) Is an experimental, demonstration or pilot project or does not fall within any of the program descriptions set forth in this subtitle; and

(b) At the satisfaction of the Administration, it is proved to be subject to contractual provisions, conditions of grant award, or other requirements that are comparable to the requirements of this subtitle.

(2) For the purposes of this section, an experimental, demonstration, or pilot project means a project, irrespective of funding, that if deemed successful, may be considered and adopted as a permanent policy or program.

.05 Community-Based Behavioral Health Services Requiring Accreditation.

A. An organization seeking licensure to provide the following community-based behavioral health programs or services shall have accreditation from an accreditation organization approved by the Administration:

(1) Behavioral Health Crisis Stabilization Center (BHCSC);

(2) Group Homes for Adults with Mental Illness;

(3) Integrated Behavioral Health Program;

(4) Intensive Outpatient Treatment Level 2.1 Substance-Related Disorder Treatment Program;

(5) Mental Health—Partial Hospitalization Program (PHP);

(6) Mental Health Residential Crisis Services Program (MH-RCS);

(7) Mobile Crisis Team Program;

(8) Mobile Treatment Services Program (MTS);

(9) Opioid Treatment Program (OTP);

(10) Outpatient Mental Health Center (OMHC);

(11) Outpatient Treatment Level 1.0 Substance-Related Disorder Treatment Program;

(12) Level 2.5 Substance-Related Disorder Treatment Partial Hospitalization Program (PHP);

(13) Psychiatric Rehabilitation Program for Adults (PRP-A);

(14) Psychiatric Rehabilitation Program for Minors (PRP-M);

(15) Level 3.1 Clinically Managed Low-Intensity Residential Services Program;

(16) Level 3.3 Clinically Managed Population-Specific High-Intensity Residential Services Program;

(17) Level 3.5 Clinically Managed High-Intensity Residential Services Program;

(18) Level 3.7 Medically Monitored Intensive Inpatient Services Program;

(19) Residential Rehabilitation Program (RRP);

(20) Respite Care Services;

(21) Substance-Related Disorder Residential Crisis Services Program (SRD-RCS);

(22) Supported Employment Program (SEP); and

(23) Withdrawal Management Service (WM).

B. An organization operating a program to provide community-based behavioral health services with an accreditation-based license shall:

(1) Adhere to all requirements and standards of the accreditation organization by which it is accredited;

(2) Provide behavioral health services only to populations for which it is accredited; and

(3) Notify the Administration in writing within 5 business days of any change in accreditation status.

.06 Community-Based Behavioral Health Services Not Requiring Accreditation.

The following community-based behavioral health programs or services do not require accreditation to operate:

A. Substance-Related Disorder Assessment and Referral Program;

B. DUI Education Program;

C. Early Intervention Level 0.5 Program; and

D. Therapeutic Group Homes.

.07 Telehealth Service Requirements.

A. Scope. This regulation applies to community-based behavioral health services delivered via synchronous telehealth which are eligible for reimbursement by the Public Behavioral Health System.

B. Covered Services. In accordance with Health-General Article, §15–141.2, Annotated Code of Maryland, community-based behavioral health services delivered via telehealth shall be:

(1) Medically necessary;

(2) Held with the program participant or, for family sessions or other services which are permitted to be held without the program participant in attendance, with the family or guardian of the participant;

(3) Provided to the same extent and standard of care as services provided in person;

(4) Within a behavioral health professional’s scope of practice; and

(5) Permitted to be provided via telehealth as set forth in the chapter of this subtitle defining the program services being rendered.

C. The organization shall ensure that all rendering providers obtain the program participant’s consent to services via telehealth, unless there is an emergency that prevents obtaining consent, which shall be documented in the program participant’s medical record.

D. Medical Record Documentation. The organization shall ensure medical records for services rendered via telehealth:

(1) Are maintained in the same manner as during an in-person visit, using either electronic or paper medical records, in accordance with COMAR 10.63.04;

(2) Are retained according to the provisions of Health-General Article, §4-403, Annotated Code of Maryland; and

(3) Include program participant consent documentation as required in §C of this regulation.

E. Technical Requirements.

(1) An organization operating a program providing community-based behavioral health services through telehealth shall adopt and implement technology in a manner that supports the standard of care to deliver the required service.

(2) A service delivered through synchronous audio-visual telehealth shall, at minimum, meet the following technology requirements:

(a) Cameras at both the originating and distant sites that provide clear, synchronous video of the program participant and provider, respectively, with the ability to meet the clinical requirements of the service;

(b) Unless engaging in a telehealth session with a program participant who is deaf or hard of hearing, microphones and speakers at both the originating and distant sites, respectively, that provide clear, synchronous, two-way audio transmission;

(c) Network connectivity and bandwidth at both the originating and distant site sufficient to provide clear, synchronous two-way video and audio for the full duration of the service;

(d) Display monitor size sufficient to support diagnostic needs used in the telehealth services; and

(e) Utilization of technology that meets the standards required by State and federal laws governing the privacy and security of protected health information in accordance with the Health Insurance Portability and Accountability Act, 42. U.S.C. §§1320d—1320d-9 and implementing regulations at 45 CFR Part 160 and 164.

(3) An organization operating a program providing community-based behavioral health services through telehealth shall ensure the rendering provider is located within the United States or its territories for participation with the federal Medicaid program in accordance with 42 U.S.C. §1396(a)(80).

F. Confidentiality. An organization operating a program providing community-based behavioral health services through telehealth shall meet all confidentiality requirements in accordance with COMAR 10.63.04.

G. Limitations. An organization operating a program providing community-based behavioral health services through telehealth is subject to the following limitations on the provision of a service delivered via telehealth:

(1) A service delivered via telehealth is subject to the same program restrictions, preauthorizations, limitations, and coverage requirements that exist for services delivered in person;

(2) A service delivered via telehealth does not include:

(a) An electronic mail message between a licensed mental health professional and a program participant;

(b) A facsimile transmission between a licensed mental health professional and a program participant; or

(c) A telephone conversation, electronic mail message, or facsimile transmission between a licensed mental health professional without direct interaction with the program participant; and

(3) Any program specific limitations as set forth in the chapter of this subtitle defining the program services being rendered.

.08 Organization Grievance Policy.

A. Grievance Policy.

(1) An organization operating a community-based behavioral health program shall have a grievance policy.

(2) An organization shall provide program participants with a copy of the grievance policy when admitted.

(3) An organization’s grievance policy shall include at minimum:

(a) The right of program participants to grieve program decisions including, but not limited to, decisions concerning:

(i) Treatment;

(ii) Violations of program participant rights;

(iii) Discharge; and

(iv) Change in status or services;

(b) Instructions on how to file a grievance as described in §B of this regulation; and

(c) Procedures for the following:

(i) Review of the initial decision on the grievance by supervisory staff;

(ii) An opportunity to appeal the outcome of the initial decision to senior management; and

(iii) Explicit provisions that allow the program participant at any time to contact the appropriate local authority, the Administration, and if applicable, the accreditation organization.

B. An organization operating a program providing community-based behavioral health services shall provide program participants instructions on how to file a grievance which shall:

(1) Be in plain language;

(2) Be in a language that the program participant understands;

(3) Accommodate individuals who are unable to read print or communicate in writing;

(4) Outline the steps of the grievance process as described in §A(3)(c) of this regulation; and

(5) Contain current contact information for the appropriate local authority, the Administration, and if applicable, the accreditation organization.

C. An organization operating a program providing community-based behavioral health services may not retaliate against a program participant who presents a grievance.

D. An organization operating a program providing community-based behavioral health services shall inform each program participant in writing when revisions are made to the grievance policy and communicate to program participants the nature and extent of the changes.

10.63.02 Compliance and Reporting Requirements

Authority: Health-General Article, §§2-104(b), 7.5-204(a)(2), and 7.5-402, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Accreditation” means the approval granted to a program by an accreditation organization.

(2) “Accreditation organization” means a private entity that conducts inspections and surveys of health care facilities or health care staff agencies based on nationally recognized and developed standards that is approved by the Secretary in accordance with Health-General Article, §19-2302, Annotated Code of Maryland.

(3) Addictive Disorder.

(b) “Addictive disorder” includes gambling, which is the only nonsubstance-related addictive disorder recognized under State law.

(4) “Administration” means the Behavioral Health Administration within the Department that provides oversight to organizations that are licensed or certified in accordance with this subtitle.

(5) “Advance directive for mental health services” means a plan made by an individual under Health-General Article, §5–602.1, Annotated Code of Maryland.

(7) “Business day” means any day except Saturday, Sunday, or a State holiday.

(8) “Community-based” means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(9) “Corrective action” means specific actions undertaken by an organization to address a violation of any local, state, or federal law or regulation.

(10) “Court” has the meaning stated in Criminal Procedure Article, §10-201 and Courts and Judicial Proceedings Article, §1–101, Annotated Code of Maryland.

(11) “Critical incident” means an event that impacts the health, safety, or welfare of a program participant or staff.

(12) “Department” means the Maryland Department of Health.

(13) “Hospital” has the meaning stated in Health-General Article, §19–301, Annotated Code of Maryland.

(14) “License” means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(15) Local Authority.

(b) “Local authority” includes the:

(i) Core service agency as defined in Health-General Article, §7.5-101(g), Annotated Code of Maryland;

(ii) Local addictions authority as defined in Health-General Article, §7.5-101(j), Annotated Code of Maryland; and

(iii) Local behavioral health authority as defined in Health-General Article, §7.5-101(k), Annotated Code of Maryland.

(16) “Medically necessary” means a service or benefit that is:

(a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;

(b) Consistent with current accepted standards of good medical practice;

(c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and

(d) Not primarily for the convenience of the participant, family, provider, or organization.

(17) “Mental disorder” has the meaning stated in Health-General Article, §10-101, Annotated Code of Maryland.

(18) “Organization” means an association, partnership, corporation, unincorporated group, or any other legal entity licensed to operate a program to provide community-based behavioral health services.

(19) “Overdose” has the meaning stated in Health-General Article, §13-3601, Annotated Code of Maryland.

(20) “Participant” means an individual receiving behavioral health services in a community-based program.

(21) Plan of Care.

(a) “Plan of care” means a medically necessary care plan which is responsive to an individual’s goals, values, and preferences while considering the individual’s needs respective to their behavioral health condition.

(b) “Plan of care” includes but is not limited to:

(i) An individualized treatment plan; and

(ii) An individualized rehabilitation plan.

(22) “Program” means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health-General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health-General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of (a)—(c).

(23) “Provider” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland to provide health care services.

(24) “Public Behavioral Health System” means the system that provides medically necessary behavioral health services for Medical Assistance participants and certain other uninsured individuals.

(25) “Referral” means a contact made by an individual, or on behalf of an individual, for behavioral health or other services.

(26) “Residential” means the setting of a community-based program in which program participants both reside and receive behavioral health services.

(27) “Secretary” means the Secretary of the Maryland Department of Health or their designee.

(28) “Site” means the location where the organization operates the program as detailed on the program’s license.

(29) “Substance-related disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances.

(30) “Treatment” means professionally rendered therapeutic interventions provided to an individual to address behavioral health disorders.

.02 Compliance with State and Federal Law and Regulation.

A. An organization licensed in accordance with COMAR 10.63.06 to operate a program to provide community-based behavioral health services in the State shall comply with all applicable requirements of this subtitle.

B. An organization licensed in accordance with COMAR 10.63.06 to operate a program shall comply with all applicable federal and State laws and regulations, including, but not limited to:

(1) The Health Insurance Portability and Accountability Act, 42. U.S.C. §§1320d—1320d-9 and implementing regulations at 45 CFR Parts 160 and 164;

(2) Federal regulations on confidentiality of substance use disorder patient records, 42 CFR Part 2;

(3) State confidentiality laws, including:

(a) Health-General Article, §§4-301—4-310, Annotated Code of Maryland;

(b) General Provisions Article, §§4-101—4-601 Annotated Code of Maryland; and

(c) Current applicable State confidentiality regulations;

(4) The Americans with Disabilities Act, 42 U.S.C. §§12101—12213;

(5) The federal Fair Housing Act, 42 U.S.C. §3604;

(6) The Eliminating Kickbacks in Recovery Act, 18 U.S.C. §220;

(7) The Patient Protection and Affordable Care Act, 42 U.S.C. §18116; and

(8) Labor and Employment Article, Title 3, Annotated Code of Maryland.

.03 Corporate Compliance Requirements.

A. An organization shall document and implement a corporate compliance plan covering each program it operates.

B. Corporate Compliance Plan. An organization’s compliance plan shall:

(1) Meet the standards established by the applicable accreditation organization for its operated program or services; or

(2) For organizations without an applicable accreditation organization compliance standard, meet the standards outlined in §C of this regulation.

C. Corporate Compliance Standards. A corporate compliance plan shall include the:

(1) Implementation of policies and procedures covering compliance in key areas of the organization’s provision of behavioral health care services, including, at minimum:

(a) Billing;

(b) Coding;

(c) Confidentiality;

(d) Documentation;

(e) Ethical behavior;

(f) Preventing illegal service and referral incentives; and

(g) Contingency planning in case of a loss of key staff or capacity to serve program participants;

(2) Appointment of a corporate compliance officer;

(3) Implementation of a no-fault reporting system for compliance issues that ensures that whistleblowers are not subject to punitive actions;

(4) Documentation of a policy statement indicating a prohibition of conflicts of interest between the organization and program participants;

(5) Implementation of a strategy for risk assessment, auditing, and monitoring which includes:

(a) A documented annual review of risk areas in the organization;

(b) Succession and contingency plans for the organization; and

(c) An audit program with at least four audits a year that is focused on proper documentation, billing, and coding practices in high-risk areas;

(6) A process for documentation of the organization’s responses to critical incidents in accordance with Regulation .04 of this chapter and the development of any necessary corrective actions;

(7) Investigation of any violations of State or federal law or regulation, or organizational policy; and

(8) Organization’s procedure in the event of any violation of State or federal law or regulation, or organizational policy including the:

(a) Implementation of any necessary corrective action; and

(b) Submission of any required reports to the Administration or other applicable State, local, or federal authority.

.04 Reporting Requirements.

A. Critical Incident Reporting.

(1) An organization operating a community-based behavioral health program shall report the following critical incidents to the Administration, if known by the organization:

(a) Any death of a program participant in a residential program;

(b) Any unexpected death of a program participant in any other program;

(c) Injuries to program participants that are life-threatening or the result of interpersonal violence which;

(i) Are between a program participant and another program participant;

(ii) Are between a program participant and an individual associated with the organization including staff, volunteers, or consultants; or

(iii) Occur at the organization’s licensed program site;

(d) The following sexual activity, if it occurs while the program participant is admitted to the program:

(i) Consensual sexual activity between a current program participant and an individual associated with the organization, including staff, volunteers, and consultants; or

(ii) Non-Consensual sexual activity between a current or former program participant and an individual associated with the organization, including staff, volunteers, and consultants;

(e) Any unexpected evacuation of a program site under circumstances that threaten the life, health, or safety of program participants;

(f) Any fatal overdose of a program participant;

(g) Any non-fatal overdose of a program participant that requires treatment or transportation by emergency medical services or transportation by the program or organization to a hospital or other emergency facility;

(h) Suspected or alleged abuse, neglect, or exploitation of a program participant by an individual associated with the organization including staff, volunteers, and consultants;

(i) If diagnosed by the program, a disease or condition listed in the List of Reportable Diseases or Conditions, as set forth in COMAR 10.06.01.03 in addition to the reporting requirements of COMAR 10.06.01.04 for any program participant or staff;

(j) Any suicide attempt by a current program participant;

(k) Any credible threat by a program participant determined by the organization to represent a risk to the life, health, or safety of staff, other program participants, targeted individuals, or the general public;

(l) From a program that administers, dispenses, monitors or stores medication:

(i) Any theft of medication stored by the organization; and

(ii) Any medication error by the organization that results in a visit to an emergency department, a visit to an urgent care provider, a hospitalization, or death; and

(m) Any disappearance or elopement of one of the following program participants from a residential program site:

(i) A child;

(ii) A vulnerable adult, if the disappearance or elopement is longer than 24 hours;

(iii) An older adult, if the disappearance or elopement is longer than 24 hours; or

(iv) An adult with a behavioral health or somatic condition that, if left unattended or untreated, would become life threatening within 72 hours.

(2) An organization shall report all critical incidents to the Administration, or its designee, on the form provided by the Administration within 3 business days of the organization’s knowledge of the critical incident.

(3) An organization's failure to report a critical incident in accordance with §A(1)—(2) of this regulation may result in a civil money penalty in accordance with COMAR 10.63.38.

(4) The requirements of this section do not create any obligation of a program or organization to conduct follow up activities on discharged program participants or participants who have not maintained contact with the program.

B. Organization Financial Status Reporting.

(1) An organization shall report to the Administration changes in the financial condition of the organization that may affect its ability to operate a program to provide behavioral health services including, at minimum:

(a) Filing of bankruptcy;

(b) Any wage claim filed against the organization in accordance with Labor and Employment Article, Title 3, Subtitle 5, Annotated Code of Maryland;

(c) Notification of a tax lien levied by the State or federal government;

(d) Any foreclosure action against the organization filed in circuit court;

(e) Any of the following district court actions filed against the organization:

(i) Failure to pay rent; or

(ii) Breach of lease;

(f) Any utility shut off due to non-payment;

(g) Any legal actions brought against the organization or the organization’s owner seeking to recover greater than 20 percent of the organization’s annual budget; and

(h) Any other action which is likely to affect the organization’s ability to operate a program or is likely to result in a negative variance in the organization’s annual budget greater than 20 percent.

(2) An organization shall report all changes in its financial condition to the Administration, or its designee, on the form provided by the Administration within 3 business days of the organization’s knowledge of the change in the financial condition.

(3) An organization's failure to report a change in the financial condition in accordance with §B(1)—(2) of this regulation may result in a civil money penalty in accordance with COMAR 10.63.38.

C. Program Outcome Reporting.

(1) An organization shall provide data elements to the Administration at the frequency required by the Administration if:

(a) The program’s provided behavioral health services are funded by the federal Substance Abuse and Mental Health Services Administration and related federal funding sources; or

(b) The organization bills the Public Behavioral Health System for either:

(i) Specialty Mental Health Services in accordance with COMAR 10.09.59;

(ii) Community-based Substance Use Disorder Services in accordance with COMAR 10.09.80;

(iii) Intensive Behavioral Health Services for Children, Youth, and Families in accordance with COMAR 10.09.89; or

(iv) Mental Health Case Management: Care Coordination for Children and Youth in accordance with COMAR 10.09.90.

(2) The data elements provided to the Administration shall be in accordance with federal requirements set forth in:

(a) 42 U.S.C. §300x-9;

(b) 42 U.S.C. §300x-35;

(c) 42 U.S.C. §300x-52(a); and

(d) 42 U.S.C. §300x-53(a).

D. An organization shall report vacancies in accordance with COMAR 10.63.03.03.

.05 Prohibition on Deceptive or False Advertising.

A. An organization licensed to provide community-based behavioral health services may not engage in deceptive or false advertising practices including but not limited to using advertisements that:

(1) Contain false or misleading statements or claims;

(2) Contain false or misleading disclosure of fees and payments for services; and

(3) Imply by the organization's name or the services name that the organization is offering services for which it is not licensed to provide.

B. Organizations Advertising or Offering Housing for Program Participants. Any organization advertising or offering housing for nonresidential program participants shall comply with Real Property Code, Title 8, Annotated Code of Maryland, if the oral, implied, or written agreement constitutes a lease under Real Property Code, Title 1, Annotated Code of Maryland and any local requirements, regardless of whether housing is provided directly by the organization or program or through a referral to another organization.

.06 Rights of Program Participants.

A. An organization may not discriminate in the provision of community-based behavioral health services on the basis of race, creed, color, age, gender, sexual orientation, gender identity, national origin, marital status, disabilities, or any other classification prohibited under State or federal law in accordance with the requirements of Regulation .02 of this chapter.

B. An organization shall protect and promote the exercise of the program participant rights enumerated in §D of this regulation in all aspects of its program operations.

C. Notification of Program Participant Rights. The organization shall inform the program participant, in a language that the participant understands, of:

(1) The rights and responsibilities listed in §D of this regulation; and

(2) The Suicide and Crisis Hotline.

D. Program Participant Rights.

(1) An organization shall provide care for program participants in a manner and in an environment that maintains or enhances each participant’s dignity and respect.

(2) A program participant receiving community-based behavioral health services from an organization licensed in accordance with COMAR 10.63.06 has the right to:

(a) Be treated with consideration, respect, and full recognition of the program participant’s human dignity and individuality;

(b) Receive treatment, care, and services that are adequate, appropriate, and in compliance with relevant State, local, and federal laws and regulations;

(c) Receive treatment in accordance with their individualized plan of care or rehabilitation plan;

(d) If applicable, receive treatment in accordance with the preferences of their advance directive for mental health services in accordance with Health-General Article, §5–602.1, Annotated Code of Maryland;

(e) Consent to or refuse treatment after the possible consequences of refusing treatment are fully explained;

(f) Be free from mistreatment, neglect, and verbal, mental, emotional, sexual, and physical abuse;

(g) Contact at any time:

(i) Personal legal counsel;

(ii) The State protection and advocacy agency;

(iii) The applicable local authority;

(iv) The Administration; and

(v) The Department;

(h) Make suggestions, complaints, or present grievances on behalf of the program participant or others, to the organization, the State protection and advocacy agency, the applicable local authority, the Administration, the Department, or other individuals without threat or fear of retaliation;

(i) Receive a prompt response, through the organization’s established complaint or grievance policy, to any complaints, suggestions, or grievances the program participant may have;

(j) Except when prohibited for the health and safety of the program participant or others, keep any identification, insurance information, and public benefits documentation in their possession;

(k) Designate their own representative payee for Social Security;

(l) Authorize advocates, family, or friends to participate in care coordination or the treatment planning and discharge planning process;

(m) Contact emergency services for emergency assistance or transportation to a hospital at any time; and

(n) Not be compelled to perform work for the organization and, if the program participant chooses to perform work for the organization, is monetarily compensated by the organization for any work performed.

E. Addressing Alleged Violations of Participant Rights. An organization licensed to operate a program to provide community-based behavioral health services in accordance with COMAR 10.63.06 shall:

(1) Initiate an investigation within 3 business days into any alleged violations of program participant rights involving anyone furnishing services on behalf of the organization;

(2) Document any actions taken to prevent further violations while the alleged violation is investigated;

(3) Investigate and document all alleged violations in accordance with the organization’s written policies as outlined in §F of this regulation;

(4) Take any corrective action required by the local authority or the Administration; and

(5) Report any identified critical incidents in accordance with Regulation .04 of this chapter.

F. Policy Regarding Program Participant Rights. An organization operating a community-based behavioral health program shall have a written policy to investigate and document all alleged violations of participant rights that, at minimum, outlines:

(1) The timeline of the investigation;

(2) The procedure for private interviews with any witnesses;

(3) Any necessary safeguards to ensure that the alleged perpetrator is not involved in conducting the investigation;

(4) The procedure for the review of the program participant’s file and other relevant records;

(5) Action taken based on the organization’s written policies; and

(6) The procedure for the completion and submission of documentation relevant to the investigative process to the local authority or the Administration.

10.63.03 General Staffing Requirements

Authority: Health-General Article, §§2-104(b), 7.5-204(a)(2), and 7.5-402, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Accreditation” means the approval granted to a program by an accreditation organization.

(3) Addictive Disorder.

(b) “Addictive disorder” includes gambling, which is the only nonsubstance-related addictive disorder recognized under State law.

(4) “Administration” means the Behavioral Health Administration within the Department that provides oversight to organizations that are licensed or certified in accordance with this subtitle.

(5) Allied Health Staff.

(a) “Allied health staff” means an individual not licensed in accordance with Health Occupations Article, Annotated Code of Maryland who is used by an organization to provide support services or direct care services in the operation of a community-based behavioral health program.

(b) “Allied health staff” includes, but is not limited to:

(i) Rehabilitation workers;

(ii) Direct service staff;

(iii) Non-certified peer recovery specialists;

(iv) Community health workers;

(v) Health educators;

(vi) Counselor aides; and

(vii) Group living workers.

(6) “Assessment” means the process of ascertaining the treatment needs of an individual seeking behavioral health services.

(7) “Behavioral health services” means prevention, screening, early intervention, treatment, recovery, support, wraparound, and rehabilitation services for individuals with substance-related disorders, addictive disorders, mental disorders, or a combination of these disorders.

(8) “Business day” means any day except Saturday, Sunday, or a State holiday.

(9) “Certification” means the approval issued to a program by the Administration to provide services under this subtitle.

(10) “Clinical director” means the individual who is responsible for the therapeutic and rehabilitative aspects and direction of a program.

(11) “Clinical supervisor” means a licensed mental health professional approved by the Board of Professional Counselors and Therapists, the Board of Physicians, the Board of Social Work Examiners, or the Board of Examiners of Psychologists as a supervisor.

(12) “Community-based” means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(13) Corporate Officers.

(a) “Corporate officers” means the managing employees or other individuals responsible for the conduct of the affairs of the organization inclusive of the organization’s controlling board.

(b) “Corporate officers” includes but is not limited to the organization's:

(i) Chief Executive Officer;

(ii) Chief Financial Officer;

(iii) Chief Medical Officer;

(iv) Chief Information Officer;

(v) Corporate Compliance Officer;

(vi) Board members; and

(vii) Other senior officers of the organization.,

(14) “Court” has the meaning stated in Courts and Judicial Proceedings Article, §1–101, Annotated Code of Maryland.

(15) “Critical incident” means an event that impacts the health, safety, or welfare of a program participant or staff.

(16) “Criminal history record information” has the meaning stated in Criminal Procedure Article, §10-201, Annotated Code of Maryland.

(17) “Criminal Justice Information System” has the meaning stated in Criminal Procedure Article, §10-201, Annotated Code of Maryland.

(18) “Department” means the Maryland Department of Health.

(19) “Drug” means:

(a) 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;

(b) A prescription medication; or

(c) A chemical substance when used for unintended and harmful purposes.

(20) “Hospital” has the meaning stated in Health-General Article, §19–301, Annotated Code of Maryland.

(21) Independent Practice Level.

(a) “Independent practice level” means a behavioral health professional licensed under Health Occupations Article, Annotated Code of Maryland who is providing behavioral health services according to the requirements of the appropriate health occupations board to diagnose and treat behavioral health disorders independent of formal supervision.

(b) “Independent practice level” does not include a:

(i) Licensed graduate professional counselor;

(ii) Licensed graduate marriage and family therapist;

(iii) Licensed graduate art therapist;

(iv) Licensed graduate alcohol and drug counselor;

(v) Licensed master social worker;

(vi) Licensed certified social worker;

(vii) Registered psychology associate; or

(viii) Certified addiction counselor at any level.

(22) “License” means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(23) “Licensed mental health professional” means:

(a) A psychiatrist; or

(24) Local Authority.

(b) “Local authority” includes the:

(i) Core service agency as defined in Health-General Article, §7.5-101(g), Annotated Code of Maryland;

(ii) Local addictions authority as defined in Health-General Article, §7.5-101(j), Annotated Code of Maryland; and

(iii) Local behavioral health authority as defined in Health-General Article, §7.5-101(k), Annotated Code of Maryland.

(25) “Maryland Addiction and Behavioral-Health Certification Board” means the Board, or its successor, authorized by the Department to certify peer recovery specialists in the State.

(26) “Medical director” means an individual licensed in accordance with Health Occupations Article, Annotated Code of Maryland who oversees the operation of a community-based behavioral health program.

(27) “Mental disorder” has the meaning stated in Health-General Article, §10-101, Annotated Code of Maryland.

(28) “Organization” means an association, partnership, corporation, unincorporated group, or any other legal entity licensed to operate a program to provide community-based behavioral health services.

(29) “Participant” means an individual receiving behavioral health services in a community-based program.

(30) “Professional licensure background check” means a background check conducted into an individual's professional status, history, and credentials.

(31) “Program” means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health-General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health-General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of (a)—(c).

(32) “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.

(33) “Provider” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland to provide health care services.

(34) “Psychiatrist” means a physician who:

(a) Is licensed by the Maryland Board of Physicians; and

(b) Is either:

(i) Certified in psychiatry by the American Board of Psychiatry and Neurology; or

(ii) Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in psychiatry.

(35) “Rap Back Program” has the meaning stated in COMAR 12.15.01.03

(36) “Residential” means the setting of a community-based program in which program participants both reside and receive behavioral health services.

(37) “Secretary” means the Secretary of the Maryland Department of Health or their designee.

(38) “Site” means the location where the organization operates the program as detailed on the program’s license.

(39) “Substance-related disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances.

(40) “Telehealth” has the meaning stated in Health-General Article, §15–141.2, Annotated Code of Maryland

(41) “Treatment” means professionally rendered therapeutic interventions provided to an individual to address behavioral health disorders.

(42) “Variance” means an alternate method of meeting the intent of a regulation under this subtitle as approved by the Administration.

.02 General Staff Requirements.

A. Supervision of Staff. An organization operating a community-based behavioral health services program shall provide supervision to staff providing direct care services, including meeting all supervision requirements under Health Occupations Article, Annotated Code of Maryland.

B. Dedicated Program Staff.

(1) Dedicated program staff are individuals who are employed by an organization to perform duties at a single program site at a time.

(2) Dedicated program staff may perform the following duties at multiple program sites simultaneously via audio-visual conferencing:

(a) Supervision and training;

(b) Data and critical incident review;

(c) Policy and procedure development and review; and

(d) Case conferencing.

(3) Organizations that require dedicated program staff to perform duties at multiple program sites shall ensure that timekeeping records clearly indicate the program site at which the individual performed duties for each hour worked.

(4) For the purposes of determining if a program meets minimum staffing requirements, an organization may only count the number of hours during which the dedicated program staff performs duties at the program in question.

(5) An organization may not count the hours during which a dedicated program staff performs duties at another program site for the purposes of determining if a program meets minimum staffing requirements, regardless of:

(a) The physical proximity of the different programs;

(b) The amount of services provided by telehealth;

(c) The overlap of services provided by the different programs; or

(d) The overlap in program participants served by the different programs.

C. Organizational Level Staff. Organizational level staff are individuals who are employed by an organization that may perform duties for multiple program sites simultaneously, provided that:

(1) The programs are managed according to uniform organizational policies and procedures applicable to all programs;

(2) All program participant records may be accessed from any program site;

(3) The individual in the position responds to emergencies, in person or via remote video conference, within 1 hour of being notified;

(4) Staff at each licensed program site have direct access to the individual in the position, as needed; and

(5) On a routine basis, and as clinically required, the individual in the position provides on-site consultation at each licensed program site to ensure adequate clinical and administrative oversight.

D. Organizations who employ a single individual to perform the duties of multiple positions shall:

(1) When the individual performs both an organizational level position and a dedicated program position, consider the individual dedicated program staff for the purposes of determining minimum staffing requirements; and

(2) Meet the requirements of this chapter and any program specific descriptions set forth in this subtitle associated with each of the positions the individual fills.

.03 Vacancy Reporting Requirements.

A. An organization shall follow the requirements of §B of this regulation upon the vacancy of the following staff if employed by the organization or if a required position under this subtitle:

(1) A corporate officer;

(2) An Outpatient Mental Health Clinic’s medical director in accordance with COMAR 10.63.16;

(3) The program director in accordance with Regulation .07 of this chapter;

(4) The clinical director in accordance with Regulation .06 of this chapter;

(5) Clinical supervisors in accordance with Regulations .09 and .12 of this chapter;

(6) A Psychiatric Rehabilitation Program’s rehabilitation specialist in accordance with COMAR 10.63.20 and COMAR 10.63.21; and

(7) Any other required staff as specified within any of the program descriptions set forth in this subtitle.

B. Upon the vacancy of any staff specified in §A of this regulation, the organization shall:

(1) Immediately implement a good-faith effort to fill the vacancy;

(2) Seek a variance in accordance with COMAR 10.63.06.17, if applicable, within 40 business days of the vacancy;

(3) Notify the Administration and the appropriate local authority within 40 business days of the vacancy in the manner specified by the Administration; and

(4) Notify the Administration and the appropriate local authority immediately on the hire of the individual filling the vacancy in the manner specified by the Administration to include, at minimum, the individual’s:

(a) Name;

(b) Credentials, including a copy of any applicable licenses or certifications and a resume or curriculum vitae; and

(c) Actual start date.

C. Vacancy Reporting for Critical Positions.

(1) Notwithstanding the requirements of §B of this regulation, an organization shall immediately, but in no event longer than 48 hours, report to the Administration any vacancy that causes a significant impact to a licensed program’s operations or the health, safety, or welfare of program participants.

(2) Instances of a vacancy that may cause a significant impact to the licensed program’s operations or the health, safety, or welfare of program participants may include but is not limited to:

(a) Vacancy of the program’s medical director without an identified acting medical director; or

(b) Vacancy of the program’s sole clinician.

D. If the organization reassigns the required duties of the vacant position to a qualified existing staff member on a temporary or permanent basis and the program meets all the staffing requirements of this subtitle, the organization is not subject to the requirements of §§B(2) and B(3) of this regulation.

.04 Staff Training and Competency Plans.

A. An organization operating a community-based behavioral health services program shall develop and implement a staff training and competency plan that covers each staff member which includes, at minimum, policies and procedures related to:

(1) Onboarding;

(2) Orientation;

(3) Annual training;

(4) Performance standards; and

(5) Competency development.

B. Within 60 business days of hire, all staff shall receive training from the organization in, at minimum, the following:

(1) Role and responsibilities;

(2) Corporate compliance;

(3) Confidentiality and communication with program participants and others, including participant consent;

(4) Building caring and collaborative relationships with program participants;

(5) Setting and maintaining safe boundaries with program participants;

(6) Any other training as specified within the program descriptions set forth in this subtitle; and

(7) Any other training required by the organization’s accreditation organization.

C. Staff Training Records. An organization shall maintain all staff training in accordance with the employment records requirements under COMAR 09.32.01.06.

.05 Background Checks for All Programs.

A. Employees of community-based behavioral health programs are in a position to:

(1) Jeopardize the life or safety of program participants;

(2) Cause significant loss or damage by illegally accessing or misusing the fiscal or non-fiscal assets of the employer, including controlled substances; or

(3) Otherwise engage or participate in criminal conduct in violation of State, local, and federal law.

B. Criminal Background Checks.

(1) An organization shall, at minimum, perform a criminal background check, at the organization’s expense, for each employee and contractor:

(a) Before employment; and

(b) Every 5 years.

(2) The pre-employment criminal background check shall, at minimum, include:

(a) The individual’s criminal history record information in any state in which they have lived or worked in the past 10 years; and

(b) If their scope of work for the organization includes transporting program participants, the individual’s driving record for the past 3 years in the state in which they have a current, valid driver’s license.

(3) Any subsequent criminal background checks conducted while the individual is employed by the organization shall, at minimum, include the State, and, if the individual resides out of State, the state in which the individual resides.

(4) Any organization providing licensed behavioral health services to minors shall comply with the criminal background check requirements set forth in Family Law Article, §5-551, Annotated Code of Maryland.

(5) A criminal background check through the Criminal Justice Information System satisfies the requirements of:

(a) The initial pre-employment criminal background check; or

(b) Any subsequent criminal background checks.

(6) An organization participating in the Department of Public Safety and Correctional Services Rap Back Program is exempt from the requirements of §B(1)(b) of this regulation.

C. Professional Licensure Background Check.

(1) An organization shall perform a professional licensure background check for each employee and contractor who holds professional licensure:

(a) Before employment; and

(b) Every 2 years.

(2) Each professional licensure background check shall include the State and any state in which the individual has held professional licensure in the past 10 years.

D. Continuous Monitoring for Exclusion.

(1) Each organization shall continuously monitor the following resources to ensure they are not employing individuals who have been excluded from providing services:

(a) Maryland Medicaid’s sanctioned providers list;

(b) The Department’s Office of the Inspector General’s exclusion list; and

(c) The federal Department of Health and Human Services, Office of the Inspector General’s List of Excluded Individuals/Entities database.

(2) An organization shall, at minimum, check all employees for exclusion in the resources enumerated in §D(1) of this regulation quarterly.

E. Background Check Policy.

(1) An organization shall have a background check policy covering each program it operates regarding the criminal history and professional licensure history of employees and contractors.

(2) The background check policy, at minimum, shall:

(a) Outline the criteria to be used to determine if an individual with a criminal history can be employed by the organization, including the following considerations:

(i) The age at which the individual committed the crime;

(ii) The circumstances surrounding the crime;

(iii) Any punishment imposed for the crime, including any subsequent court actions regarding that punishment;

(iv) The length of time that has passed since the crime;

(v) Subsequent work history;

(vi) Employment and character references; and

(vii) Other evidence that demonstrates whether the employee, contractor, or volunteer poses a threat to the health or safety of program participants, program staff, or members of the public;

(b) Outline the criteria to be used to determine if an individual with a license not in good standing in the past 10 years can be employed by the organization; and

(c) Require employees and contractors to report the following:

(i) All arrests or pending criminal charges except for minor traffic violations that occur during employment; and

(ii) Any change in professional licensure or certification status.

(3) The background check policy may contain exclusionary criteria stricter than required by §F of this regulation, as appropriate, to protect program participants.

F. Exclusionary Criteria.

(1) The organization may not employ an employee or contractor if the organization does not complete the criminal background check and professional licensure check as required by §§A and B of this regulation.

(2) The organization may not employ an employee or contractor if the individual is excluded from providing services by:

(a) Maryland Medicaid;

(b) The Department’s Office of the Inspector General; or

(c) The federal Department of Health and Human Services.

(3) An organization may not employ an employee or contractor if the individual has been convicted at any time of:

(a) Child abuse;

(b) Abuse or neglect of a vulnerable adult; or

(c) Sexual abuse.

G. Documentation Requirements.

(1) An organization shall document the organization’s:

(a) Review of criminal history and professional licensure records of potential employees and contractors;

(b) Decisions regarding the impact of the criminal history or professional licensure history on the employability of each applicant for employment and on each employee and contractor; and

(c) Implementation of the policy required by §E of this regulation.

(2) An organization shall maintain the documentation required by §G(1) of this regulation for 3 years after the individual either:

(a) Is not hired; or

(b) If hired, leaves employment with the organization.

H. An organization seeking to use volunteers shall ensure current and prospective volunteers are subject to the background check requirements as described in this regulation.

.06 Clinical Director.

A. A clinical director is an organizational level staff member and may perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

B. A clinical director shall possess, at minimum, the following qualifications:

(1) Active licensure as a mental health professional at the independent practice level in accordance with the applicable Health Occupations Board under Health Occupations Article, Annotated Code of Maryland; and(2) At least 5 years of documented experience in human services, 2 years of which include providing administrative or clinical supervision.

C. A clinical director shall:

(1) Be an employee of the organization which operates the program which they direct;

(2) Be available in person at each program site enough hours to effectively direct the clinical aspects of the program in accordance with §D of this regulation; and

(3) Arrange for an appropriate clinical supervisor in accordance with Health Occupations Article, Annotated Code of Maryland.

D. A clinical director is responsible for the following functions:

(1) Leading and approving the development of clinical program policies and procedures;

(2) Providing clinical supervision and oversight of the clinical quality of the organization;

(3) Managing clinical crises; and

(4) Ensuring the organization follows appropriate discontinuation of service procedures including transition of care in accordance with COMAR 10.63.06.18.

E. A clinical director may be a clinical supervisor if authorized as a supervisor under Health Occupations Article, Annotated Code of Maryland.

.07 Program Director.

A. A program director is an organizational level staff member and may perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

B. A program director shall possess, at minimum, the following qualifications:

(1) A bachelor's degree from an accredited educational institution; and

(2) Five years of documented experience in human services, 2 years of which include providing administrative or clinical supervision.

C. The program director shall:

(1) Be an employee of the organization that operates the program which they direct; and

(2) Be available in person at each program site for enough hours to effectively direct the program in accordance with §D of this regulation.

D. The program director is responsible for the following functions:

(1) Leading and approving the development of program policies and procedures;

(2) Administrative oversight;

(3) Program supervision and oversight;

(4) Ensuring the implementation and safety of the therapeutic and treatment environment;

(5) Ensuring the organization’s program license is posted in accordance with COMAR 10.63.06.11D; and

(6) Ensuring the organization follows appropriate discontinuation of service procedures including the transition of care in accordance with COMAR 10.63.06.18.

E. The program director may delegate the responsibilities enumerated in §D of this regulation through a formal delegation agreement.

.08 Corporate Compliance Officer.

A. A corporate compliance officer is an organizational level staff member and may perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

B. A corporate compliance officer or local designee shall meet all minimum qualifications as set forth by the organization.

C. The corporate compliance officer shall:

(1) Be an employee of the organization that operates the program which they oversee; and

(2) Be available in person or via audio-visual conferencing at each program site for enough hours to effectively oversee the program in accordance with §D of this regulation or appoint a local designee to serve as the corporate compliance officer for the licensed program site.

D. The corporate compliance officer shall:

(1) Have direct access to the organization’s corporate officers;

(2) Educate the organization on necessary compliance requirements;

(3) Develop and oversee compliance with the corporate compliance plan in accordance with COMAR 10.63.02.03; and

(4) Address noncompliance within the organization and, if necessary, report noncompliance in accordance with COMAR 10.63.02.03C.

.09 Licensed Mental Health Professionals and Clinical Supervisors.

A. Licensed Mental Health Professionals.

(1) A licensed mental health professional is dedicated program staff and may not perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

(2) A licensed mental health professional shall possess active licensure in accordance with Health Occupations Article, Annotated Code of Maryland and may include the following:

(a) Psychiatrist;

(b) Licensed psychologist;

(c) Psychiatric nurse practitioner;

(d) Clinical nurse specialist in psychiatric and mental health nursing;

(e) Licensed certified social worker-clinical;

(f) Licensed clinical alcohol and drug counselor;

(g) Licensed clinical marriage and family therapist;

(h) Licensed clinical professional art therapist;

(i) Licensed clinical professional counselor; or

(j) An individual properly supervised under a formal supervision agreement who is either a:

(i) Licensed master social worker;

(ii) Licensed graduate alcohol and drug counselor;

(iii) Licensed graduate marriage and family therapist;

(iv) Licensed graduate professional art therapist;

(v) Licensed graduate professional counselor;

(vi) Licensed certified social worker; or

(vii) Registered psychology associate.

B. Clinical Supervisors.

(1) Clinical supervisors are organizational staff and may perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

(2) A clinical supervisor shall:

(a) Only provide clinical supervision if actively licensed to do so in accordance with Health Occupations Article, Annotated Code of Maryland; and

(b) If providing supervision to alcohol and drug counselors, have written approval from the Board of Professional Counselors as required by COMAR 10.58.07.13—.15.

(3) If a clinical supervisor is not an employee of the organization, the clinical supervisor shall execute the following agreements:

(a) A Business Associates Agreement between the clinical supervisor and the organization in accordance with 45 CFR §164.502; and

(b) A formal supervision agreement between the clinical supervisor and the individual they supervise.

C. Clinical Interns. An organization may use clinical interns within the scope of service limits established by State law and regulation.

D. An organization may not allow a licensed mental health professional to provide behavioral health services to program participants when the mental health professional is located outside the United States or its territories.

.10 Certified Peer Recovery Specialists.

A. Certified peer recovery specialists are dedicated program staff and may not perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

B. A certified peer recovery specialist shall possess the following minimum qualifications:

(1) A high school diploma or high school equivalency certificate; and

(2) A current certification as a peer recovery specialist from the Maryland Addiction and Behavioral-Health Professional Certification Board.

C. A certified peer recovery specialist shall adhere to all requirements of the Maryland Addiction Behavioral-Health Professional Certification Board, including at minimum:

(1) Formal training and education of the knowledge, skills, and abilities in each of the four domains identified by the Maryland Addiction and Behavioral-Health Professional Certification Board; and

(2) Adherence to the Ethics, Code of Conduct, Principles, and Service Guidelines established by the Maryland Addiction and Behavioral-Health Professional Certification Board.

D. A certified peer recovery specialist may not perform any clinical treatment services or functions unless otherwise licensed in accordance with Health Occupations Article, Annotated Code of Maryland.

.11 Allied Health Staff.

A. An organization operating a community-based behavioral health services program may use allied health staff in the operation of the program to provide:

(1) Support services;

(2) House manager services; or

(3) Direct care services which are not within the scope of practice of a licensed clinical professional in accordance with Health Occupations Article, Annotated Code of Maryland.

B. Qualifications. An organization shall have policies and procedures for the employment of allied health staff which specifies:

(1) Minimum qualifications; and

(2) Any prevailing professional standards in accordance with the program descriptions set forth in this subtitle.

C. A corporate officer may not serve as allied health staff in the course of their regular duties.

.12 Substance-Related Disorder Program Specific Staff.

A. Substance-Related Disorder Clinical Supervisors.

(1) Substance-related disorder clinical supervisors are organizational program staff and may perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

(2) A substance-related disorder clinical supervisor shall have, at minimum, the following qualifications:

(a) Be employed as a clinical supervisor before October 1, 2002, or at minimum, licensed or certified as one of the following:

(i) A licensed clinical professional counselor;

(ii) A licensed certified social worker—clinical;

(iii) A licensed alcohol and drug counselor; or

(iv) A certified associate alcohol and drug counselor; and

(b) Be approved to supervise from the Board of Professional Counselors and Therapists or the Board of Social Work Examiners as required by COMAR 10.58.07.13—.15.

(3) A community-based behavioral health program may use a certified associate alcohol and drug counselor who is approved by the Board of Professional Counselors and Therapists to supervise as a substance-related disorder clinical supervisor provided that the certified associate alcohol and drug counselor is appropriately supervised by a Board approved supervisor in accordance with COMAR 10.58.07.07.

(4) A clinical supervisor shall provide supervision of staff, in person or via audio visual teleconference, while maintaining a staff to supervisor ratio of no greater than 15 staff to 1 supervisor.

(5) A clinical supervisor may carry a caseload so long as the supervisor’s caseload does not impede the clinical supervisor’s ability to supervise.

B. Facility Coordinator.

(1) Facility coordinators for residential substance-related disorder programs are dedicated program staff and may not perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

(2) A facility coordinator shall have, at minimum, the following qualifications:

(a) A high school diploma or high school equivalency certificate; and

(b) Two years of experience as an allied health staff member in a substance-related disorder treatment program.

(3) The responsibilities of a facility coordinator include:

(a) Overseeing the daily operations of the licensed program site; and

(b) Ensuring the program site is sufficiently maintained to meet the needs of the program.

C. Substance-Related Disorder Clinical Staff.

(1) Substance-related disorder clinical staff are dedicated program staff and may not perform duties at multiple program sites simultaneously in accordance with Regulation .02 of this chapter.

(2) Substance-related disorder clinical staff shall, at minimum, be:

(a) Licensed or certified as an alcohol and drug counselor by the Board of Professional Counselors and Therapists; or

(b) Licensed, certified, or permitted under Health Occupations Article, Annotated Code of Maryland to provide substance-related disorder treatment.

(3) Substance-related disorder clinical staff are responsible for the following:

(a) Providing substance-related disorder assessment and treatment services;

(b) Documenting services accurately;

(c) Maintaining confidentiality;

(d) Ensuring services are provided in accordance with applicable supervision requirements; and

(e) Ensuring program participant rights are respected.

10.63.04 Documentation Requirements

Authority: Health-General Article, §§2-104(b), 7.5-204(a)(2), and 7.5-402, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Accreditation” means the approval granted to a program by an accreditation organization.

(3) Addictive Disorder.

(b) “Addictive disorder” includes gambling, which is the only nonsubstance-related addictive disorder recognized under State law.

(4) “Assessment” means the process of ascertaining the treatment needs of an individual seeking behavioral health services.

(5) “Behavioral health services” means prevention, screening, early intervention, treatment, recovery, support, wraparound, and rehabilitation services for individuals with substance-related disorders, addictive disorders, mental disorders, or a combination of these disorders.

(6) “Clinical supervisor” means a licensed mental health professional approved by the Board of Professional Counselors and Therapists, the Board of Physicians, the Board of Social Work Examiners, or the Board of Examiners of Psychologists as a supervisor.

(7) “Community-based” means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(8) “Contact note” means an entry that:

(a) Is made in a program participant’s medical record by a program staff member; and

(b) Describes face-to-face, written, or telephone contact with or regarding the program participant.

(9) “Crisis” means an event that produces mental, physical, emotional, or behavioral distress.

(10) “Face-to-face” means contact with a program participant that occurs in-person or via audio-visual telehealth in accordance with Health-General Article, §15–141.2, Annotated Code of Maryland.

(11) “Guardian” has the meaning stated in Estates and Trusts Article, §13-101, Annotated Code of Maryland.

(12) “Hospital” has the meaning stated in Health-General Article, §19–301, Annotated Code of Maryland.

(13) “License” means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(14) “Licensed mental health professional” means:

(a) A psychiatrist; or

(15) “Medical record” has the meaning stated in Health-General Article, §4-301, Annotated Code of Maryland.

(16) “Medically necessary” means a service or benefit that is:

(a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;

(b) Consistent with current accepted standards of good medical practice;

(c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and

(d) Not primarily for the convenience of the participant, family, provider, or organization.

(17) “Mental disorder” has the meaning stated in Health-General Article, §10-101, Annotated Code of Maryland.

(19) “Participant” means an individual receiving behavioral health services in a community-based program.

(20) “Professional licensure background check” means a background check conducted into an individual's professional status, history, and credentials.

(21) “Program” means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health-General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health-General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of (a)—(c).

(22) “Provider” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland to provide health care services.

(23) “Psychiatrist” means a physician who:

(a) Is licensed by the Maryland Board of Physicians; and

(b) Is either:

(i) Certified in psychiatry by the American Board of Psychiatry and Neurology; or

(ii) Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in psychiatry.

(24) “Referral” means a contact made by an individual, or on behalf of an individual, for behavioral health or other services.

(25) “Rendering provider” means the licensed, certified, or otherwise authorized provider under Health Occupations Article, Annotated Code of Maryland, who provides medically necessary services to a program participant.

(26) “Secretary” means the Secretary of the Maryland Department of Health or their designee.

(27) “Site” means the location where the organization operates the program as detailed on the program’s license.

(28) “Substance-related disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances.

(29) “Telehealth” has the meaning stated in Health-General Article, §15–141.2, Annotated Code of Maryland.

(30) “Treatment” means professionally rendered therapeutic interventions provided to an individual to address behavioral health disorders.

.02 Documentation Requirements..

A. Clinical Records. An organization licensed under this subtitle to operate a community-based behavioral health program shall maintain documentation of all behavioral health services provided to program participants, to include, at minimum:

(1) Any referral for service or request for admission received by the program;

(2) Demographic information for program participants;

(3) Referrals made for program participants, if applicable;

(4) Program participant receipt of policies in accordance with §B of this regulation;

(5) Release of information in accordance with §D of this regulation;

(6) Consent for services in accordance with Regulation .03 of this chapter;

(7) Comprehensive assessments in accordance with Regulation .04 of this chapter;

(8) Contact notes in accordance with Regulation .05 of this chapter;

(9) Psychiatric evaluations in accordance with Regulation .06 of this chapter;

(10) Program participant care planning in accordance with Regulation .07 of this chapter; and

(11) Discharge planning in accordance with Regulation .08 of this chapter.

B. An organization shall maintain documentation that all program participants have received copies of:

(1) The organization’s grievance policy in accordance with COMAR 10.63.01.08A(2);

(2) Any necessary billing documents; and

(3) The notice of participant rights in accordance with COMAR 10.63.01.06C.

C. Confidentiality. An organization shall maintain program medical records and confidential information:

(1) According to the requirements of COMAR 10.63.01.2B; and

(2) At the licensed program site in a location that is:

(a) Exclusively controlled by the organization; and

(b) Locked.

D. Release of Information.

(1) An organization licensed to provide community-based behavioral health services shall document requests to release program participant information in accordance with this regulation.

(2) Minimum Requirements. At minimum, the release of information shall document the following information:

(a) The program participant’s information to include relevant demographic information;

(b) The name of individual or organization into which the information is being released;

(c) The reason for the release of information;

(d) A signature block for all required signatures which may be handwritten or electronic which includes the following for the program staff:

(i) Printed name;

(ii) Signature; and

(iii) Date of signature;

(e) A statement indicating when the release will expire and that it may be revoked by the program participant at any time;

(f) Documentation of review with the program participant or their parent or guardian, that:

(i) The program may disclose, without consent, certain protected health information, including to other medical assistance programs and providers; and

(ii) An acknowledgment has been obtained from the individual of having received notice that the disclosure may occur; and

(g) The requirements of the relevant federal and State law and regulations, as to scope and limits of the confidentiality provisions.

.03 Consent for Services.

A. Before initiating services to a program participant an organization shall at minimum:

(1) Obtain written consent from the participant or the participant’s parent or guardian, if appropriate, before rendering services to the program participant; and

(2) Involve, as appropriate, the participant’s family members, and others designated by the participant in the provision of their services.

B. If the program participant agrees to consent to services but is unable or unwilling to give written consent, the program shall:

(1) Document the reason why the program participant cannot give written consent;

(2) Verify the program participant’s verbal consent to services; and

(3) Periodically attempt to obtain written consent from the program participant and document these efforts.

C. Inferred Consent for Services. If a Mobile Crisis Team program cannot obtain consent for services in accordance with §§A and B of this regulation, the program participant’s consent for Mobile Crisis Team program services may be inferred by the participant’s continued engagement with program staff.

.04 Comprehensive Assessments.

A. As applicable, an organization licensed to provide community-based behavioral health services shall conduct a comprehensive assessment in accordance with:

(1) The standards of the organization’s accreditation organization; and

(2) §B of this regulation.

B. Minimum Requirements. At minimum, the comprehensive assessment shall document the:

(1) Program participant’s:

(a) Information including relevant demographic information;

(b) Presenting problem or reason for referral;

(c) History including their:

(i) Medical history, including current medications;

(ii) Substance use history;

(iii) Family behavioral health history;

(iv) Trauma or abuse history;

(v) Legal history; and

(vi) Cultural background; and

(d) Strengths and resources;

(2) Date of assessment and the start and end times of assessment;

(3) Licensed professional’s clinical impression, as applicable;

(4) Diagnosis;

(5) Any ASAM Level of Care recommendations, if applicable; and

(6) A signature block for all required signatures which may be handwritten or electronic which include the following for all rendering providers:

(a) Printed name;

(b) Title;

(c) Signature; and

(d) Date of signature.

.05 Contact Notes.

A. An organization licensed to provide community-based behavioral health services shall document contact notes in accordance with:

(1) The standards of the organization’s accreditation organization; and

(2) §B of this regulation.

B. Minimum Requirements. At minimum each contact note shall contain:

(1) The program participant’s information including relevant demographic information;

(2) The date of service and the start and end times of the contact;

(3) The program participant’s primary behavioral health complaint or the reason for the visit or communication;

(4) A brief description of the service provided, including progress notes and any referrals for additional services;

(5) The place of service;

(6) Whether the service is by telehealth, and, if so, the location of both the licensed mental health professional and the program participant; and

(7) A signature block for all required signatures which may be handwritten or electronic which includes the following for the licensed mental health professional:

(a) Printed name;

(b) Title;

(c) Signature; and

(d) Date of signature.

.06 Psychiatric Evaluations.

A. As applicable, an organization licensed to provide community-based behavioral health services shall conduct a psychiatric evaluation, in accordance with:

(1) The standards of the organization’s accreditation organization; and

(2) §B of this regulation.

B. Minimum Requirements. At minimum, the psychiatric evaluation shall document:

(1) The program participant’s:

(a) Information including relevant demographic information;

(b) Presenting problem or reason for evaluation; and

(c) Brief medical history, including their family medical history;

(2) The date of the evaluation and the evaluation’s start and end times;

(3) Notes from the participant’s:

(a) Mental status exam;

(b) Physical examination and laboratory tests performed, if applicable; and

(c) Cognitive and behavioral tests performed, if applicable;

(4) The diagnosis; and

(5) A signature block for all required signatures which may be handwritten or electronic signatures and includes the following for the physician or practitioner:

(a) Printed name;

(b) Title;

(c) Signature; and

(d) Date of signature.

.07 Participant Individual Care Planning.

A. An organization licensed to provide community-based behavioral health services shall develop the program participant’s individual care plan:

(1) In accordance with the standards of the organization’s accreditation organization;

(2) In accordance with §B of this regulation; and

(3) In conjunction with:

(a) The program participant;

(b) The program participant’s parent or legal guardian; or

(c) Any other individual designated by the program participant as appropriate.

B. Minimum Requirements. At minimum, the participant's individual care plan shall document:

(1) The program participant’s:

(a) Information including relevant demographic information; and

(b) Clearly defined and measurable goals which allow for tracking progress;

(2) The date the care plan was completed;

(3) Any staff interventions and techniques to be implemented to assist the program participant in reaching their goals; and

(4) A signature block which meets the requirements of §C(1) of this regulation for:

(a) The program participant or the participant’s parent or guardian in accordance with §C(2) of this regulation;

(b) The staff completing the plan with the participant; and

(c) Any treating professional who collaborated on the plan including the treating prescriber, other licensed mental health professionals, rehabilitation specialists, or the clinical supervisor if applicable.

C. Signature Requirements.

(1) Signature Block. The signature block for the individual care plan which may be handwritten or electronic shall contain the signer’s:

(a) Printed name;

(b) Title, if applicable;

(c) Signature; and

(d) Date of signature.

(2) Program Participant Signature.

(a) If the program participant is unable or unwilling to sign the individual care plan, the organization shall:

(i) Verify and document the participant’s verbal agreement to the plan; and

(ii) Document the reason for the verbal agreement.

(b) If the program participant is under the age of 18, the minor’s parent or guardian shall sign the care plan unless the program documents the minor’s consent under Health-General Article, §§20-102 and 20-104, Annotated Code of Maryland.

.08 Participant Discharge Plan.

A. An organization licensed to provide community-based behavioral health services shall conduct discharge planning:

(1) In accordance with the standards of the organization’s accreditation organization;

(2) In accordance with §B of this regulation; and

(3) In collaboration with:

(a) The program participant;

(b) The participant’s parent or legal guardian; or

(c) Any other individual designated by the participant as appropriate.

B. Minimum Requirements. At a minimum the discharge plan shall document:

(1) The referral of the program participant to or scheduled appointment with a provider for the next level of care;

(2) A list of prescribed medications for the program participant, including dosage, if applicable;

(3) A list of crisis services providers; and

(4) Any additional referrals for the participant to community-based services and supports, if applicable.

.09 Organization’s Administrative Records.

A. An organization shall maintain a personnel record for all employees, contractors, volunteers and interns who provide services to program participants at a community-based behavioral health program in accordance with:

(1) The standards of the organization’s accreditation organization; and

(2) §§B—D of this regulation.

B. Personnel Records. At minimum, the personnel record for each employee, contractor, volunteer, and intern shall include the individual’s:

(1) Identifying information;

(2) Education and training history;

(3) Employment history;

(4) Documentation of criminal background check and professional licensure background check in accordance with COMAR 10.63.03.05;

(5) Job description in accordance with §C of this regulation;

(6) Documented qualifications;

(7) Documented staff training and competency plan in accordance with COMAR 10.63.03.04;

(8) Timekeeping records in accordance with §D of this regulation; and

(9) If applicable, records of any disciplinary action taken by the organization.

C. Job Description. An organization shall maintain a written job description for each position which shall include at minimum the:

(1) Job title;

(2) Duties and responsibilities of the position;

(3) Minimum knowledge, skills, and abilities required;

(4) Minimum education or experience required;

(5) Any required professional credentials; and

(6) Position’s training requirements.

D. Timekeeping.

(1) An organization shall maintain timekeeping records in accordance with COMAR 09.32.01.06.

(2) Timekeeping records shall be maintained for required staff enumerated in:

(a) COMAR 10.63.03; and

(b) Any of the program descriptions set forth in this subtitle.

(3) Individuals identified as contractors or another type of employee are not excused from timekeeping requirements.

E. Governing Body and Organizational Structure. An organization shall maintain documentation:

(1) Of the administrative framework of the governmental agency in which the organization is a component; or

(2) Describing the legal and administrative framework under which the organization was established and operates.

F. Fiscal Responsibility and Sustainability.

(1) An organization or its parent corporation shall maintain documentation of the organization’s fiscal sustainability in accordance with:

(a) The standards of the organization’s accreditation organization; and

(b) §F(2) of this regulation.

(2) Fiscal responsibility and sustainability documentation shall include, at minimum:

(a) Documentation of working capital or a line of credit that is adequate to ensure ongoing operations for at least 90 days on an ongoing basis;

(b) Documentation of a working budget showing projected revenue and expenses; and

(c) The title and qualifications of the person with the authority and responsibility for the fiscal management of the program’s services.

(3) If the organization charges program participants for program services, the written schedule of rates and charges shall be available to a program participant or their authorized representative on request.

10.63.05 Program Site Requirements

Authority: Health-General Article, §§2-104(b), 7.5-204(a)(2), and 7.5-402, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) Addictive Disorder.

(b) “Addictive disorder” includes gambling, which is the only nonsubstance-related addictive disorder recognized under State law.

(2) “Administration” means the Behavioral Health Administration within the Department that provides oversight to organizations that are licensed or certified in accordance with this subtitle.

(3) “Behavioral health services” means prevention, screening, early intervention, treatment, recovery, support, wraparound, and rehabilitation services for individuals with substance-related disorders, addictive disorders, mental disorders, or a combination of these disorders.

(4) “Community-based” means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(5) “Crisis” means an event that produces mental, physical, emotional, or behavioral distress.

(6) “Department” means the Maryland Department of Health.

(7) Dietary Services.

(a) “Dietary services” means the services provided by a community-based behavioral health program which offers comprehensive food preparation as a service to program participants.

(b) “Dietary services” does not include communal food preparation by program participants or food preparation done as a rehabilitative activity.

(8) “Dormitory style” means a sleeping arrangement which utilizes bunk beds or any sleeping space designed to sleep more than six individuals.

(9) “Dwelling” has the meaning stated in 42 U.S.C. §3602.

(10) “Guardian” has the meaning stated in Estates and Trusts Article, §13-101, Annotated Code of Maryland.

(11) “Hospital” has the meaning stated in Health-General Article, §19–301, Annotated Code of Maryland.

(12) “License” means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(13) Local Authority.

(b) “Local authority” includes the:

(i) Core service agency as defined in Health-General Article, §7.5-101(g), Annotated Code of Maryland;

(ii) Local addictions authority as defined in Health-General Article, §7.5-101(j), Annotated Code of Maryland; and

(iii) Local behavioral health authority as defined in Health-General Article, §7.5-101(k), Annotated Code of Maryland.

(14) “Mental disorder” has the meaning stated in Health-General Article, §10-101, Annotated Code of Maryland.

(15) “Organization” means an association, partnership, corporation, unincorporated group, or any other legal entity licensed to operate a program to provide community-based behavioral health services.

(16) “Participant” means an individual receiving behavioral health services in a community-based program.

(17) “Program” means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health-General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health-General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of (a)—(c).

(18) “Residential” means the setting of a community-based program in which program participants both reside and receive behavioral health services.

(19) “Site” means the location where the organization operates the program as detailed on the program’s license.

(20) “Substance-related disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances.

(21) “Treatment” means professionally rendered therapeutic interventions provided to an individual to address behavioral health disorders.

.02 General Site Requirements.

A. An organization’s licensed program site shall:

(1) Be located in the State;

(2) Comply with applicable federal, State, and local sanitation, building, fire codes, and zoning laws;

(3) Meet the accessibility requirements of §B of this regulation;

(4) Provide sufficient space for licensed services;

(5) Be appropriately furnished, well lit, adequately ventilated, easily accessible, safe, and clean;

(6) Be maintained in good repair;

(7) Be free of:

(i) Insects;

(ii)Rodents; and

(iii) Hazards, including fire hazards, which may jeopardize the health or safety of program participants;

(8) Provide:

(a) Secure storage for program participant records and confidential business information in accordance with COMAR 10.63.02.02 and 10.63.04.02C;

(b) For the safe and sanitary disposal of trash;

(c) Marked fire exits and the posting of evacuation routes;

(d) Access to restrooms for program participants receiving services on site; and

(e) Safe and secure storage of program participant medication, if applicable;

(9) Have:

(a) Adequate and functional smoke and carbon monoxide detectors, and any required alarms, that meet local fire codes;

(b) A written fire evacuation plan; and

(c) A current fire inspection certification; and

(10) Ensure within the first 30 days of employment, the provision of staff training in emergency evacuation procedures.

B. Accessibility Requirements.

(1) A community-based behavioral health program licensed or certified under this subtitle shall make all reasonable efforts to be accessible to program participants.

(2) Program accessibility shall include, at minimum:

(a) Compliance with the federal Americans with Disabilities Act, 42 U.S.C. §§12101—12213;

(b) Compliance with the federal Patient Protection and Affordable Care Act, 42 U.S.C. § 18116;

(c) The provision of translation services as necessary to meet the needs of program participants; and

(d) Making reasonable accommodations and modifications to be able to serve program participants with physical disabilities to the maximum extent possible.

(3) Programs which are not fully accessible shall refer individuals to a community-based behavioral health program which is fully accessible.

C. Dietary Services. If an organization’s licensed program prepares and provides meals on-site, the program shall:

(1) Have a written plan describing the organization and delivery of dietary services;

(2) Provide dietary services in accordance with Health-General Article, §7.5-402(e), Annotated Code of Maryland, and any program specific limitations under this subtitle; and

(3) Require a dietitian licensed under the Health Occupations Article, §5-101, Annotated Code of Maryland, to develop and implement the dietary service plan.

.03 Outpatient Program Site Requirements.

A. General Outpatient Program Site Requirements. An outpatient community-based behavioral health program site shall:

(1) Meet the general site requirements in accordance with Regulation .02 of this chapter; and

(2) Have sufficient space to provide confidential behavioral health services during approved operating hours.

B. Physical Location. An outpatient program site may not be located in a private dwelling.

C. Shared Space. If an organization uses a shared space for a program providing outpatient community-based behavioral health services, the organization shall maintain confidentiality in accordance with the requirements of COMAR 10.63.04.02C.

.04 Residential Program Site Requirements.

A. General Residential Program Site Requirements. A residential community-based behavioral health program site shall:

(1) Meet general site requirements in accordance with Regulation .02 of this chapter; and

(2) Have sufficient space to provide confidential behavioral health services during approved operating hours.

B. Physical Location. A residential site:

(1) May not have any housing, sanitation, building and occupancy, fire, or zoning code violations; and

(2) Shall have:

(a) Hot and cold running water;

(b) Adequate light, heat, and ventilation to ensure the safety of program participants;

(c) Sufficient, appropriate, and functional furnishings, equipment, supplies, and utensils comparable to those found in the residences of nondisabled individuals;

(d) Except in a residential rehabilitation program utilizing apartments or mental health permanent supported housing program, private space for administrative and counseling staff to provide services, if providing services;

(e) A dining area;

(f) A living room or common space;

(g) Space for leisure time activities; and

(h) Unless approved by the Department, a separate entrance for any other service or program operating in the same building or a separate unit entry maintained for each program within a multi-unit building.

C. Kitchen Requirements. A residential program site shall have a kitchen which shall:

(1) Have adequate space for food preparation;

(2) Accommodate all residents;

(3) Be commensurate with the size of the facility; and

(4) Have trash cans with lined containers and covers.

D. For each residential program participant, each participant shall:

(1) Have the resources to purchase or have access to food;

(2) Have the resources to acquire an adequate supply of soap, towels, and toilet tissue;

(3) If self-administering medication, have access to a secure storage area for their medications;

(4) Have access to a secure storage area for funds and valuables;

(5) Have access to transportation;

(6) Have access to a telephone in the residence; and

(7) To the extent possible, be permitted to use personal possessions and preferences in furnishing and decorating the resident’s space.

E. Bedroom Requirements.

(1) A residential program shall ensure that each bedroom has:

(a) A minimum of 70 square feet for a single bedroom and a minimum of 120 square feet for a double bedroom, and an additional 60 square feet each for additional bed in the bedroom.

(b) Except for a permitted dormitory-style arrangement as outlined in §D(2) of this regulation, a maximum of 6 program participants using the bedroom in mental health and substance-related disorder treatment or recovery programs;

(c) Except for an efficiency apartment, or permitted dormitory-style arrangement, an interior door and four walls which affix to the floor and to the ceiling;

(d) Closet space in or convenient to each bedroom for each program participant using the bedroom;

(e) Coverings for each window, for privacy;

(f) A bed for each program participant that has:

(i) A clean mattress, in good condition, with a protective cover, that matches the size of the bed frame;

(ii) A foundation to support the mattress;

(iii) A bed frame on which the foundation rests;

(iv) Bed side rails, if necessary for the safety of the program participant;

(v) A pillow; and

(vi) At least two sets of clean bed linens;

(h) Beds that are, at minimum, twin in size, not roll away beds or recliners, and at least 36 inches apart;

(i) At least two dresser drawers and an enclosed space for hanging clothes for each program participant;

(j) A mirror;

(k) Separate sleeping quarters for adolescent and adult program participants;

(l) Beds that do not block egress from a window; and

(m) At least 60 square feet of personal space per program participant.

(2) Dormitory Style Sleeping Arrangements. A residential program may not use dormitory style sleeping arrangements unless the dormitory style sleeping arrangement:

(a) Has been pre-approved by the Administration for a substance-related disorder residential crisis program;

(b) Is approved by the Administration for a Level 3.1, Level 3.3 and Level 3.5 substance-related disorder residential treatment program that is already using dormitory style sleeping arrangements on the effective date of this regulation; or

(c) Is for a Level 3.7 residential treatment program.

F. Bathrooms. A residential program shall ensure that each residence has:

(1) A minimum of one toilet and bathroom sink for every four program participants;

(2) One tub or shower, connected to hot and cold water, and a bath mat with non-slip backing or equivalent, for every six program participants;

(3) A bathroom which is easily accessed and conveniently located, not more than one floor level from living, dining, and sleeping rooms; and

(4) Privacy for the individual using the bathroom.

.05 Residential Program Site Emergency and Safety Procedures.

A. Emergency Procedure Notifications. A residential community-based behavioral health program site shall ensure that:

(1) Posted near the telephone are telephone numbers for the:

(a) Fire department, police, ambulance, and poison control center; and

(b) Program’s on-call staff;

(2) A written emergency evacuation plan is posted conspicuously and updated annually;

(3) An emergency evacuation procedure is explained to program participants within 10 days after their admission; and

(4) The emergency evacuation procedure is conducted, at minimum, every 3 months.

B. Annual Environmental Safety Review. A residential community-based behavioral health program site shall:

(1) Conduct and document an annual environmental safety review; and

(2) Based on the review conducted in accordance with §B(1) of this regulation, take actions to:

(a) Ensure that a residential site meets applicable residential safety codes; and

(b) Ensure that issues creating an unnecessary risk of self-harm are mitigated.

C. Safety Plan and Policies. A residential community-based behavioral health program site shall:

(1) Have a written safety plan and associated policies that cover at minimum:

(a) Flood risk;

(b) Fire;

(c) Active shooter and threats;

(d) Environmental hazards; and

(e) Community safety.

(2) The program shall ensure that documented monthly safety drills are conducted.

D. Relocation Plan. A residential community-based behavioral health program site shall have a written relocation plan for each site that shall:

(1) Specify where program participants may live temporarily if the local authority determines that conditions in the approved residential site pose an imminent risk to the health, safety, or welfare of a program participant or becomes uninhabitable;

(2) Be approved and updated annually by the local authority; and

(3) When executed, require notification to the local authority not later than 24 hours following the relocation of program participants.

.06 Residential Program Site Dietary Services.

A. Dietary Services. If meals are provided, a residential program site shall:

(1) Comply with applicable local, State, and federal laws;

(2) Obtain any necessary permits;

(3) Have a written plan describing the organization and delivery of dietary services; and

(4) Require a dietitian licensed under the Health Occupations Article, §5-101, Annotated Code of Maryland, to develop or review the dietary service plan.

B. A program which is exempt under Health-General §7.5-402(e), Annotated Code of Maryland, from obtaining a commercial food service license as a residential treatment program for substance-related disorders with fewer than 17 residents, shall require that staff :

(1) Ensure cleanliness and hygiene in accordance with §C of this regulation;

(2) When in a food preparation or utensil washing area, handle containers in a way that prevents contamination of:

(a) An individual’s hands;

(b) Exposed food;

(c) Clean equipment;

(d) Utensils;

(e) Linens; and

(f) Unwrapped single service or single use articles;

(3) Ensure no cross-contamination from one item to another, including, but not limited to the use of cooking implements in multiple dishes, the mixing of raw and cooked food, or handling different food items without first rewashing hands;

(4) Ensure that cooked items are:

(a) Heated to cooking temperatures recommended by the federal Food Safety and Inspection Services of the United States Department of Agriculture; and

(b) Maintained at the temperature recommended by the federal Food Safety and Inspection Services of the United States Department of Agriculture before dining and before storage; and

(5) Ensure that items being stored:

(a) Are promptly refrigerated at a temperature of no higher than 40°F;

(b) Are labeled with the date of preparation; and

(c) Are disposed of within an appropriate time.

C. Cleanliness and Hygiene.

(1) Residential programs shall ensure cleanliness and hygiene by ensuring that:

(a) Individuals involved in food preparation of food shall wash their hands and cooking surfaces frequently, including before handling food, whenever leaving the food area, or whenever any form of contamination occurs;

(b) Food is prepared, served, and stored in a clean and sanitary environment;

(c) Kitchen implements and storage receptacles are clean, clearly labeled, and hygienic;

(d) The program follows COMAR 10.15.03.14A—D with regards to employee or participant illness; and

(e) Employees involved in food preparation receive training in proper food handling and sanitation as it relates to their assigned duties.

(2) Residential program staff supporting program participants in preparing their own food shall provide ongoing training and support to participants preparing food which promote the practices outlined in this regulation, including, at minimum, annual refresher training.

.07 Residential Program Site Requirements for Facilities Serving Youth.

A. All organizations that provide residential services to youth and adolescents shall meet all requirements outlined in COMAR 10.63.05.04, as well the requirements of §§B—F of this regulation.

B. General. The organization shall ensure that:

(1) Basic life needs are met, according to the requirements of COMAR 14.31.06.10; and

(2) Communication and visiting policies, and daily routines are implemented according to the requirements of:

(a) Health-General Article, §§10-702 and 10-703, Annotated Code of Maryland; and

(b) COMAR 14.31.06.09B.

C. Supervision of Youth. The organization shall ensure that residential staff, as defined in COMAR 10.63.03, provide supervision for each program participant on the premises, as follows:

(1) During the hours of 8:00 a.m. to 10:00 p.m., at least one staff member shall be present for every 3 youth in the residence;

(2) During the hours of 10:00 p.m. to 8:00 a.m., at least one awake staff member shall be present in the residence; and

(3) At all times, at least one staff member shall be available, at the request of on-duty staff or management, to arrive at the residence within 1 hour of the request.

D. The organization shall have a policy that outlines the organization’s procedures for contacting emergency response to include emergency services, crisis response, and law enforcement.

E. Elopement.

(1) In the event of a youth or adolescent program participant elopement, the facility shall contact not later than 2 hours after the elopement:

(a) The program participant’s parent or guardian; and

(b) Law enforcement.

(2) In the event of a youth or adolescent program participant elopement, the facility shall re-assess the program participant and determine whether:

(a) The participant requires a higher level of care or security; or

(b) The participant can be safely served at the facility.

F. Facility Security.

(1) The organization shall maintain an alarm or security system to alert staff to unauthorized entry and exit into the facility.

(2) Contraband. The organization shall:

(a) Provide a copy of its contraband policy to program participants and their parent or guardian on admission; and

(b) Inform program participants of search policies to prevent contraband.

(3) The organization shall:

(a) Verify visitor identification;

(b) Maintain a sign-in log; and

(c) Screen any visitors for contraband before permitting entry.

(4) The organization shall ensure program participants and visitors are aware of the use of CCTV or other recording devices in the facility or on the facility grounds.

10.63.06 Licensure Process

Authority: Health-General Article, §§2-104(b), 7.5-204(a)(2), and 7.5-402, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Accreditation” means the approval granted to a program by an accreditation organization.

(2) “Accreditation-based license” means a license which requires the organization be accredited by an approved accreditation organization

(4) Addictive Disorder.

(b) “Addictive disorder” includes gambling, which is the only nonsubstance-related addictive disorder recognized under State law.

(5) “Administration” means the Behavioral Health Administration within the Department that provides oversight to organizations that are licensed or certified in accordance with this subtitle.

(6) “Administrative withdrawal” means the Administration's cancellation of an organization's application for licensure.

(7) “Agreement to cooperate” means a written agreement between an organization operating a program and the appropriate local authority that provides for coordination and cooperation in carrying out behavioral health activities in a given jurisdiction.

(8) “Applicant” means the legally authorized individual or entity submitting an application for licensure.

(9) “Behavioral health services” means prevention, screening, early intervention, treatment, recovery, support, wraparound, and rehabilitation services for individuals with substance-related disorders, addictive disorders, mental disorders, or a combination of these disorders.

(10) “Business day” means any day except Saturday, Sunday, or a State holiday.

(11) “Community-based” means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(12) Corporate Officers.

(a) “Corporate officers” means the managing employees or other individuals responsible for the conduct of the affairs of the organization inclusive of the organization’s controlling board.

(b) “Corporate officers” includes but is not limited to the organization's:

(i) Chief Executive Officer;

(ii) Chief Financial Officer;

(iii) Chief Medical Officer;

(iv) Chief Information Officer;

(v) Corporate Compliance Officer;

(vi) Board members; and

(vii) Other senior officers of the organization.

(13) “Corrective action” means specific actions undertaken by an organization to address a violation of any local, state, or federal law or regulation.

(14) “Crisis” means an event that produces mental, physical, emotional, or behavioral distress.

(15) “Critical incident” means an event that impacts the health, safety, or welfare of a program participant or staff.

(16) “Deficiency” means a failure to meet a licensure, or certification standard, a material accreditation standard, or a relevant federal, State, or local ordinance, law, regulation, or building code, as applicable.

(17) “Department” means the Maryland Department of Health.

(18) Dietary Services.

(a) “Dietary services” means the services provided by a community-based behavioral health program which offers comprehensive food preparation as a service to program participants.

(b) “Dietary services” does not include communal food preparation by program participants or food preparation done as a rehabilitative activity.

(19) “Discontinuation plan” means an organization's written plan which is provided to the Administration when the organization intends to discontinue program or licensed service operations.

(20) “Guardian” has the meaning stated in Estates and Trusts Article, §13-101, Annotated Code of Maryland.

(21) “Hospital” has the meaning stated in Health-General Article, §19–301, Annotated Code of Maryland.

(22) “Jurisdiction” means Baltimore City or one of the 23 counties in the State.

(23) “License” means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(24) Local Authority.

(b) “Local authority” includes the:

(i) Core service agency as defined in Health-General Article, §7.5-101(g), Annotated Code of Maryland;

(ii) Local addictions authority as defined in Health-General Article, §7.5-101(j), Annotated Code of Maryland; and

(iii) Local behavioral health authority as defined in Health-General Article, §7.5-101(k), Annotated Code of Maryland.

(25) “Mental disorder” has the meaning stated in Health-General Article, §10-101, Annotated Code of Maryland.

(26) “Organization” means an association, partnership, corporation, unincorporated group, or any other legal entity licensed to operate a program to provide community-based behavioral health services.

(27) “Participant” means an individual receiving behavioral health services in a community-based program.

(28) “Plan of correction” means an organization's written plan of corrective actions to address program deficiencies.

(29) “Program” means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health-General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health-General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of (a)—(c).

(30) “Provider” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland to provide health care services.

(31) “Resident Agent” has the meaning stated in Corporations and Associations Article, §1-101, Annotated Code of Maryland.

(32) “Residential” means the setting of a community-based program in which program participants both reside and receive behavioral health services.

(33) “Secretary” means the Secretary of the Maryland Department of Health or their designee.

(34) “Site” means the location where the organization operates the program as detailed on the program’s license.

(35) “Substance-related disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances.

(36) “Treatment” means professionally rendered therapeutic interventions provided to an individual to address behavioral health disorders

(37) “Variance” means an alternate method of meeting the intent of a regulation under this subtitle as approved by the Administration.

(38) “Zoning verification” means an official document from a local government’s permitting authority that confirms a property’s current zoning classification, permitted uses, and compliance with local laws.

.02 License Application Process.

A. An organization seeking to operate a program to provide community-based behavioral health services shall submit a completed application for licensure to the Administration or its designee in the manner specified by the Administration.

B. The application shall, at minimum, provide the following information:

(1) The services the organization intends to provide at the program site;

(2) Verification of the organization’s compliance with all applicable requirements for the program under this subtitle; and

(3) Attestation of the organization’s compliance with relevant federal, State, or local ordinances, laws, regulations, and orders governing the program.

C. The applicant shall provide the following information regarding the organization seeking licensure:

(1) A listing of all individuals or entities with an ownership stake in the organization;

(2) A listing of the names and contact information of all corporate officers of the organization;

(3) Contact information including:

(a) The name and email address of a designated point of contact;

(b) A mailing address; and

(c) The organization’s Resident Agent; and

(4) A copy of any program license or certification currently or previously held by the organization.

D. The applicant shall complete a disclosure form in the manner specified by the Administration that discloses, at minimum, the following information for individuals or entities with an ownership stake, corporate officers, key staff, or any additional individuals specified by the Administration:

(1) Any deficiencies identified by an accreditation organization that threaten the health, safety, or welfare of program participants, or that may affect its ability to operate a program to provide behavioral health services;

(2) Any suspension, revocation, or termination of a license;

(3) Any criminal convictions other than minor traffic violations within the preceding 10-year period;

(4) Any settlements with the Department's Office of the Inspector General; and

(5) Any money owed to the Department.

E. The applicant shall include with the application all documentation required in §B—D of this regulation, Regulation .03 of this chapter, and any additional program specific documentation as specified within the applicable program description set forth in this subtitle.

F. Additional Application Requirements for Organizations Requiring Accreditation.

(1) In addition to the documentation requirements set forth in §E of this regulation, an applicant applying for an accreditation-based license shall submit the following with the organization's application:

(a) The program's most recent behavioral health accreditation survey report;

(b) The final letter or certificate issuing accreditation to the organization; and

(c) The findings, reports, and program improvement plans arising from any accreditation survey or decision by any behavioral health accreditation organization during the previous 3 years.

(2) An organization currently operating a program with a plan of correction approved by an approved accreditation organization shall provide:

(a) A copy of the plan of correction; and

(b) Documentation demonstrating that the organization’s program currently complies with the plan of correction.

G. As part of the initial license application process, the Administration may request that an organization submit to an inspection of the program site before issuing a license.

.03 Documentation to Accompany License Application.

A. An applicant shall include the following documentation with their application for licensure to operate a program to provide community-based behavioral health services in the State:

(1) A copy of the agreement to cooperate between the organization and the appropriate local authority as described in Regulation .04 of this chapter;

(2) Copies of all applicable permits required by local jurisdictions and the Administration, including, at minimum:

(a) Fire permits; and

(b) Zoning verification;

(3) A copy of the organization’s current by-laws and articles of incorporation;

(4) A copy of the organization’s certificate of status from the State Department of Assessments and Taxation, verifying the organization is in good standing, issued within the current tax year of the application;

(5) A copy of the organizational chart for the organization and the program showing the supervisory structure which includes the names, roles, professional titles, and credentials of all required management staff and other required staff;

(6) Documented verification that the program site is:

(a) Owned or leased by the organization;

(b) Under the sole control of the organization; and

(c) Not prohibited from providing behavioral health services on the site;

(7) A copy of the organization’s business plan and 1-year operating budget; and

(8) A copy of the organization’s plan for continuity of operations in the event of the loss of key staff, loss of the ability to provide services for any reason, or loss of facility.

B. Any organization currently operating a community-based behavioral health program with a plan of correction approved by the Administration or local authority shall provide documentation demonstrating the organization’s compliance with the plan of correction.

C. Any organization seeking licensure for a community-based behavioral health program which provides dietary services in accordance with Health-General Article, §7.5-402(e), Annotated Code of Maryland shall provide either:

(1) A copy of its dietary service plan and commercial kitchen license for the program; or

(2) A copy of the service agreement with the dietary service provider.

D. Additional Documentation.

(1) The Administration may determine additional documentation is necessary to evaluate a license application.

(2) On request by the Administration, the organization shall provide any additional documentation requested by the Administration.

.04 Agreement with Local Authorities.

A. An organization that is applying for licensure and intends to operate a program to provide community-based behavioral health services in the State shall execute an agreement to cooperate with the applicable local authority in each jurisdiction in which they intend to provide behavioral health services before applying for a license for any program licensed under this subtitle.

B. The agreement to cooperate shall provide for coordination and cooperation between the organization and local authority in the jurisdiction that services are to be provided, including, but not limited to, facilitating:

(1) Any site visit, including but not limited to a complaint or critical incident investigation;

(2) The transition of services if the organization closes any of its program sites, or the organization plans to close or discontinue a service;

(3) Program compliance audits; and

(4) The provision of any additional documentation requested by the Administration.

C. The agreement to cooperate may not include a provision that authorizes the local authority to prohibit an organization from offering services at any location.

D. In accordance with Regulation .03A(1) of this chapter, the agreement to cooperate shall be included with the licensure application provided to the Administration.

E. The agreement to cooperate may include a provision authorizing the local authority to conduct pre-licensure inspections or review required documents before licensure.

F. An organization shall coordinate and cooperate with the applicable local authority in accordance with the terms of the agreement.

.05 Relocation Application Process.

A. An organization seeking to relocate the site of a program already licensed under this chapter to provide community-based behavioral health services shall submit a relocation licensure application to the Administration or its designee in the manner specified by the Administration.

B. The relocation licensure application shall, at minimum, provide the following information:

(1) The services the organization intends to provide at the program site;

(2) Verification of the organization’s compliance with all applicable requirements for the program under this subtitle;

(3) Attestation of the organization’s compliance with relevant federal, State, or local ordinances, laws, regulations, and orders governing the program;

(4) Contact information including:

(a) The name and email address of a designated point of contact;

(b) A mailing address; and

(c) The organization’s Resident Agent; and

(5) A copy of any program license or certification currently held by the organization.

C. The applicant shall include with the application all documentation required under §B of this regulation, Regulation .06 of this chapter, and any additional program specific documentation as specified within the applicable program description set forth in this subtitle .

D. As part of the change of location license application process, the Administration may request that an organization submit to an inspection of the program site before issuing a license.

E. If the Administration does not approve or deny a completed application for a program site relocation within 45 business days of initial review, the Administration shall issue a conditional license extension for the relocation until the Administration gives a final decision.

F. Temporary Conditional License Eligibility. To be eligible for a temporary conditional license, an organization shall submit with the application information which includes:

(1) The correction of any deficiencies identified by the Department;

(2) An adequate explanation for any reduction in square footage;

(3) That the relocation location is within a reasonable geographic area for the jurisdiction, not to exceed 10 miles; and

(4) A detailed floorplan of the new site, which shall include:

(a) Photographs of each location which shall demonstrate readiness and fitness for occupancy and show all walls of each space; and

(b) An attestation from the organization which indicates that the photographs are a true and accurate depiction of the space which is ready and available for use.

G. The Department or its designee may visit a temporary conditional licensed organization site at any time.

H. A temporary conditional license may be revoked at any time after a site visit from the Department or its designee.

I. Denial or revocation of a temporary conditional license is at the Department’s discretion and may not be appealed.

.06 Documentation to Accompany Relocation License Application.

A. Applicants for change of location licensure shall include the following documentation related to the new location with their application:

(1) Copies of all applicable permits required by local jurisdictions and the Administration, including, at a minimum:

(a) Fire permits; and

(b) Zoning verification;

(2) Documented verification that the program site is:

(a) Owned or leased by the organization;

(b) Under the sole control of the organization; and

(c) Not prohibited from providing behavioral health services on the site;

(3) A copy of the organization’s plan for continuity of operations in the event of the loss of key staff, the ability to provide services for any reason, or loss of facility; and

(4) If applying for an accreditation-based license, a copy of documentation from the accreditation organization demonstrating the new location has been accredited.

B. Any organization seeking licensure for a community based behavioral health program which provides dietary services in accordance with Health-General Article, §7.5-402(e), Annotated Code of Maryland shall provide either:

(1) A copy of its dietary service plan and commercial kitchen license for the program; or

(2) A copy of the service agreement with the dietary service provider.

C. Additional Documentation.

(1) The Administration may determine additional documentation is necessary to evaluate a change of location license application.

(2) On request by the Administration, the organization shall provide any additional documentation requested by the Administration.

.07 License Renewal Application Process.

A. An organization seeking to continue operating a program beyond the program’s current license period shall submit a new application in accordance with this regulation and Regulation .08 of this chapter.

B. The fully completed application shall be received by the Administration at least 40 business days, but no more than 120 business days, before the expiration of the organization's current license.

C. Failure to Submit a Timely Renewal Application.

(1) If the organization does not submit a new application in a timely manner, as described in §B of this regulation, the Secretary may suspend the organization’s license at the end of the current license period.

(2) If an organization’s license is suspended, the organization shall proceed with enacting an unplanned discontinuation of program operations as outlined in Regulation .18 of this chapter.

D. If the Administration does not approve or deny a completed application within 60 business days of submission, the Administration shall issue a letter of good standing extending the current license in accordance with Regulation .09 of this chapter until the Administration renders a final decision.

E. License Renewal for Organizations with Sanctions.

(1) For any organization that is subject to a plan of correction or sanctions under COMAR 10.63.38 the organization may request a temporary license extension to address any deficiencies at least 40 business days before the expiration of the organization’s current license.

(2) The Secretary may grant a temporary license extension, not to exceed 60 business days, to allow the program to perform any corrective actions to address deficiencies or sanctions.

(3) An organization operating under a temporarily extended license may submit a new license application in accordance with §A of this regulation once they have addressed all deficiencies or sanctions.

(4) The Secretary may deny a license for any organization that has:

(a) Failed to address program deficiencies which present a risk to the health, safety, or welfare of program participants; or

(b) Failed to comply with a plan of correction, directed plan of correction, or sanction in accordance with COMAR 10.63.38.

F. The effective date and duration period for the license is established in accordance with Regulation .12 of this chapter.

G. An organization’s previously issued license expires the day before the effective date of the newly issued license.

.08 Documentation to Accompany License Renewal Application.

A. Applicants for renewal shall include the documentation with their renewal application for licensure to operate a program to provide community-based behavioral health services as enumerated in Regulation .06 of this chapter, §B of this regulation, and any documentation listed in Regulation .03 of this chapter, if any of the information in those documents has changed since they were submitted with the initial application or the immediately preceding renewal application.

B. For any organization submitting a renewal application for licensure, the following documentation shall be included with the renewal application:

(1) The most recent:

(a) Fire inspection report;

(b) Organizational chart for the organization and the program showing the supervisory structure which includes the names, roles, professional titles, and credentials of all required management staff and other required staff;

(c) Lease or rental agreement, if applicable; and

(d) Accreditation documentation, if applicable;

(2) Organizational emergency preparedness plan;

(3) Zoning verification documentation, if the documentation has expired since the last application submission; and

(4) A copy of the Certificate of Approval from the local authority, which is required for the following programs:

(a) Group Home for Adults with Mental Illness under COMAR 10.63.25;

(b) Mental Health Residential Crisis Services Program under COMAR 10.63.26; and

(c) Residential Rehabilitation Program under COMAR 10.63.33.

C. Any organization currently operating a community-based behavioral health program with a plan of correction approved by the Administration or local authority shall provide documentation demonstrating the organization’s compliance with the plan of correction.

D. Any organization seeking renewal licensure for a community-based behavioral health program which provides dietary services in accordance with Health-General Article, §7.5-402(e), Annotated Code of Maryland shall provide either:

(1) A copy of its dietary service plan and commercial kitchen license for the program; or

(2) A copy of the service agreement with the dietary service provider.

E. Additional Documentation.

(1) The Administration may require the submission of reasonable and relevant additional documentation that is necessary to evaluate a renewal license application.

(2) On request by the Administration, the organization shall provide any additional documentation requested by the Administration.

.09 License Extension Request Process.

A. Purpose of License Extension. An organization may seek an extension of the current license period in the event of the organization needing additional time to complete all required processes and obtain documentation required for the program to be prepared to submit a license renewal application in accordance with Regulations .07 and .08 of this chapter.

B. An organization seeking to request an extension of the current license period shall submit a written request to the Administration in the manner specified by the Administration.

C. The fully completed license extension request shall be received by the Administration at least 40 business days, but no more than 120 business days, before the expiration of the organization's current license.

D. If the Administration does not approve or deny a completed license extension request within 60 business days of submission, the Administration shall issue a letter that includes a conditional license extension until the Administration gives a final decision on the completed license extension request.

E. The Secretary may grant a license extension request not to exceed 60 business days, to allow the program to complete all required processes and obtain documentation required for the program to be prepared to submit a license renewal application.

F. Failure to Submit a Timely Extension Request.

(1) If the organization does not submit a license extension request in a timely manner, as described in §C of this regulation, the Secretary may suspend the organization’s license at the end of the current license period.

(2) If an organization’s license is suspended, the organization shall proceed with enacting an unplanned discontinuation of program operations as outlined in Regulation .18 of this chapter

G. The effective date and duration period for the license is established in accordance with Regulation .12 of this chapter.

H. An organization’s previously issued license expires the day before the effective date of the newly issued license

.10 Documentation to Accompany a License Extension Request.

A. An organization seeking an extension of their current license to operate a community-based behavioral health program shall submit the following documentation to the Administration with their license extension request:

(1) Documentation supporting the reason for the request for an extension; and

(2) If applying for an accreditation-based license, documentation of ongoing accreditation in good standing from an approved accreditation organization.

B. Additional Documentation.

(1) The Administration may determine additional documentation is necessary to evaluate a license extension request.

(2) On request by the Administration, the organization shall provide any additional documentation requested by the Administration.

.11 Issuance of License.

A. The Administration or its designee shall:

(1) Review all completed and accurate applications for licensure submitted in accordance with Regulations .02—.10 of this chapter;

(2) Notify an applicant if the application is incomplete or missing documentation within 20 business days of initial review; and

(3) Provide a formal response to the applicant regarding licensure approval or denial:

(a) Within 120 calendar days for new programs;

(b) Within 60 business days for the renewal of an existing programs license; and

(c) Within 45 business days for relocation of a licensed site for an existing program.

B. If the Administration or its designee determines that the application meets the requirements of this subtitle to provide community-based behavioral health services, the Secretary shall issue a license to the organization to operate a program to provide community-based behavioral health services that specifies the:

(1) Programs that the applicant is licensed to provide, including the addresses of all licensed program sites;

(2) Duration of the licensure period:

(3) If applicable, the name of the accreditation organization; and

(4) Date of issue.

C. Notifications of Licensure.

(1) The Administration shall notify the applicable local authority when an organization has been issued a license to operate a program to provide community-behavioral health services.

(2) The Administration shall post a license listing on its website that describes the following for each licensed program:

(a) The name of the organization operating the program;

(b) The licensed program type;

(c) The effective dates of licensure; and

(d) Contact information:

(i) For non-residential programs, the licensed program site address; or

(ii) For residential programs, the contact address which is provided by the organization.

D. Each organization shall ensure that the license is posted in a public area at the licensed program site.

.12 Duration of License.

A. A license is effective on the date approved as it appears on the issued license and remains in effect for the duration of the license period.

B. Unless modified by the Secretary for good cause, the license period is:

(1) For an accreditation-based license, the duration of the accreditation period plus 3 months; or

(2) For all other licenses, the period established by the Administration when the license was issued, which is not to exceed 3 years.

C. The Secretary may, with notice to the organization, issue an extension or modify a license expiration date.

.13 Administrative Withdrawal.

A. This regulation applies to applications for licensure which are submitted in accordance with:

(1) Regulation .02 of this chapter—license application;

(2) Regulation .05 of this chapter—relocation application;

(3) Regulation .07 of this chapter—license renewal application; and

(4) Regulation .09 of this chapter—license extension request.

B. The Administration may withdraw an application for licensure submitted to the Administration when:

(1) The Administration cannot make a determination on the application due to incomplete information or missing required documentation;

(2) The Administration has attempted to contact the applicant using the contact information provided to complete the application or obtain the missing documentation; and

(3) The applicant has not supplied the Administration with completed information within 30 business days of notification that the application is incomplete or that additional documentation is required.

C. The Administration shall notify the organization when an application for licensure has been administratively withdrawn.

D. An applicant whose application is withdrawn in accordance with this regulation may submit a new application in accordance with Regulation .02 of this chapter.

E. An applicant whose application is withdrawn in accordance with this regulation may not submit more than two applications for the same program in 1 calendar year.

F. An administrative withdrawal of an application is not a denial and may not be appealed in accordance with COMAR 10.63.39.09.

.14 Post-Licensing Inspections.

A. The Administration or its designee may make announced or unannounced visits to inspect an organization at:

(1) A licensed program site;

(2) An administrative office; or

(3) Any other location deemed necessary for the health, safety, or welfare of program participants.

B. The Administration, or its designee, has the authority to inspect, scan, and copy business records of the organization or program, including but not limited to:

(1) Financial records;

(2) Treatment records;

(3) Service records;

(4) Staffing records; and

(5) Policies and procedures.

C. The Administration, or its designee, may inspect an organization operating a program providing behavioral health services to:

(1) Determine compliance with any accreditation standards;

(2) Follow-up on any issue identified by the organization’s accreditation organization;

(3) Validate the findings of the organization’s accreditation organization;

(4) Investigate any critical incidents; or

(5) Determine compliance with any State or federal law or regulation.

.15 Denial of License to Provide Community-Based Behavioral Health Services.

A. The Secretary may deny a license to any applicant submitted in accordance with Regulations .02—.11 of this chapter that does not sufficiently demonstrate its ability to meet the requirements of this subtitle to provide community-based behavioral health services.

B. When determining the applicant’s capacity to operate a program in accordance with the requirements of this subtitle, the Secretary shall consider, at minimum, the following:

(1) If the applicant or any of the individuals listed under Regulation .02C(1)—(2) of this chapter have:

(a) Had a previous license revoked by the Administration or other licensing authority, or has surrendered or defaulted on a license for disciplinary related reasons; or

(b) Discontinued operations of another program without complying with the requirements of Regulation .18 of this chapter;

(2) If the information the applicant disclosed in accordance with Regulation .02D of this chapter would indicate an inability of the applicant to safely operate a program;

(3) Any loss or denial of accreditation status by an accreditation organization;

(4) Any outstanding debts or financial obligations of the organization; and

(5) Any criminal convictions of the applicant or any of the individuals listed under Regulation .02C(1)—(2) of this chapter, in accordance with §D of this regulation.

C. The Secretary shall deny any application that meets one or more of the following criteria:

(1) The applicant failed to disclose information in accordance with Regulation .02D of this chapter;

(2) The applicant intentionally falsified information provided in connection with any application to the Department;

(3) A continuing course of conduct of material non-compliance with applicable statutes and regulations; or

(4) A pattern of submission of false information to the State or its designees to:

(a) Obtain medical necessity authorizations for service; or

(b) Obtain payment.

D. In making a determination about a license application from an applicant with a criminal record, the Secretary shall consider the following factors:

(1) The age at which the crime was committed;

(2) The circumstances surrounding the crime;

(3) The length of time that has passed since the crime;

(4) Subsequent work history;

(5) Employment and character references; and

(6) Other evidence that demonstrates whether the applicant poses a threat to the health, safety, or welfare of program participants.

E. If the Secretary denies licensure, the Administration shall give written notice of the denial to the applicant.

F. The notice of the denial of an application for a license shall include:

(1) The reason for the denial of licensure;

(2) The effective date of the denial; and

(3) Notice that the program has a right to a hearing in accordance with COMAR 10.63.39.

.16 License Modification.

A. An organization shall submit a written request to the Administration as a license modification, in the manner required by the Administration, before increasing the licensed capacity of individuals to be served at a licensed program site.

B. A written request for license modification shall, at minimum, include the following:

(1) An application for license modification in the manner required by the Administration;

(2) Documentation indicating that the organization has notified the appropriate local authority of the proposed license modification;

(3) Documentation indicating that the organization has notified any program participants of the proposed change; and

(4) If the program operates in accordance with an accreditation-based license, documentation indicating that the organization has notified the appropriate accreditation organization of the proposed program modification.

C. Before approval for any modification described in this regulation is granted, an organization’s program site may be inspected by the Administration or its designee.

D. Change of Location.

(1) A license modification does not include the change of location of a licensed program to a new program site.

(2) An organization seeking to relocate operations of a licensed program to a new program site shall:

(a) Initiate a discontinuation of program operations in accordance with Regulation .18 of this chapter; and

(b) Submit a relocation application in accordance with Regulations .05 and .06 of this chapter.

E. Additional Program Site.

(1) A license modification does not include the addition of a new licensed program site.

(2) An organization seeking to add a new program site shall submit an additional site licensure application in accordance with Regulations .02 and .03 of this chapter.

F. If an organization adds a program site, relocates a program site, or increases the program’s capacity above the licensed capacity at a program site without prior approval from the Administration, the Secretary may suspend the organization's license in accordance with COMAR 10.63.39.05.

.17 Variances.

A. Purpose.

(1) A variance is used by the Administration to:

(a) Support continued operations of an organization in an instance when an organization is temporarily unable to meet the requirements of this subtitle; and

(b) Ensure an organization is protected from regulatory action when an organization is out of compliance with this subtitle.

(2) A variance may not constitute a punitive measure, corrective action, or sanction issued by the Administration.

B. An organization shall request a variance from the Administration if:

(1) The organization cannot meet the requirements of any regulation under this subtitle for any program it operates; and

(2) The organization intends to request the Administration to temporarily exempt an organization from the requirements of any regulation under this subtitle.

C. An organization seeking a variance shall request the variance from the Administration within 40 business days unless the timeline for reporting the occurrence to the Administration as required by this subtitle is sooner.

D. The Administration may grant a variance to any organization operating a program providing community-based behavioral health services licensed in accordance with this chapter for any regulation under this subtitle.

E. The organization shall submit a written request for a variance in the manner determined by the Administration.

F. Granting Variances.

(1) The Administration shall review completed variance requests and determine if the intent of the regulation to which a variance is sought is met by the alternative proposed by the organization.

(2) The Administration shall respond to all variance requests with a written notice within 60 days of a complete submission to the Administration that:

(a) Provides the organization with the decision on the request for a variance, including the justification the Administration used to reach the decision;

(b) Provides the timeframe for which the variance is granted; and

(c) Is shared with the applicable local authority.

G. A variance applies to a single licensed program site and is non-transferable.

H. Failure to comply with any conditions under which the variance is granted may result in revocation of the variance.

I. The Administration may not grant a variance:

(1) That would endanger the health, safety, or welfare of program participants;

(2) For any accreditation standard; or

(3) For any State, local, or federal laws and regulations other than those governed under this subtitle.

J. Variances are granted at the Administration’s discretion and may not be appealed.

.18 Discontinuation of Program Operations.

A. Planned Discontinuation of Program Operations.

(1) An organization operating a program providing community-based behavioral health services shall notify the following no less than 60 business days before the intended discontinuation date:

(a) The Administration;

(b) The appropriate local authority; and

(c) If applicable, the State Opioid Treatment Authority.

(2) The notice provided shall include the organization’s written plan for:

(a) Discontinuation of operations, including relevant dates;

(b) Informing program participants or guardians of the planned discontinuation of services;

(c) Informing program participants or guardians of other behavioral health service options;

(d) Transitioning program participants to other behavioral health services;

(e) Storing and protecting all records after the discontinuation of operations for a period of at least 7 years; and

(f) Notifying employees, contractors, and consultants of its discontinuation of operations.

(3) Within 20 business days from receipt of the organization’s notification of intention to discontinue program or licensed service operations, the Administration shall:

(a) Notify the organization in writing whether the organization’s written discontinuation plan is acceptable; and

(b) Either:

(i) Approve final closure; or

(ii) If the organization’s plan is unacceptable, meet with the organization and the appropriate local authority within 10 business days to make a plan that protects the health, safety, and welfare of program participants.

(4) Until the Administration approves final closure, the organization shall:

(a) Provide services as appropriate;

(b) Make best efforts to refer program participants to alternative services to ensure continuation of care; and

(c) Document its efforts to refer program participants to alternative services.

(5) Upon approval by the Administration of the organization’s discontinuation plan, the organization shall implement the discontinuation plan.

(6) At all times during the discontinuation process, the organization shall cooperate with the Administration and the appropriate local authority.

B. Unplanned Discontinuation of Program Operations.

(1) An organization licensed in accordance with this chapter that experiences an unexpected discontinuation or interruption of services for more than 1 operating day at any licensed program site which dispenses medication, and more than 5 operating days at any other licensed program site, whether temporary or permanent, shall immediately, but no longer than 24 hours, inform:

(a) Program participants or their guardians via:

(i) Direct communication; and

(ii) Visible signage at the licensed program site;

(b) The Administration;

(c) The appropriate local authority; and

(d) If applicable, the State Opioid Treatment Authority.

(2) The organization, if requested by the Administration or the local authority, shall provide a proposed written emergency plan that includes:

(a) A census of program participants affected by the discontinuation of services;

(b) Types of services affected;

(c) Expected or estimated duration of closure;

(d) How services shall be provided in the interim, including any staffing changes;

(e) If applicable, the location where interim services shall be provided;

(f) If applicable, a plan to transition program participants to an alternative program or make other arrangements to ensure continuity of services for the individuals;

(g) A plan for storing and protecting all records, ensuring program participant and auditor access on request; and

(h) A plan for notification of employees, contractors, consultants, and consumers.

(3) In the event of an unplanned discontinuation of program operations, the Administration or its designee may contact program participants to discuss the discontinuation of services and ensure the continuity of care.

(4) Within 7 business days after receipt of the organization’s notification of discontinuation of program operations, the Administration shall:

(a) Notify the organization in writing whether the organization’s written discontinuation plan is acceptable; and

(b) Either:

(i) Approve final discontinuation; or

(ii) If the organization’s plan is unacceptable, meet with the organization and the appropriate local authority, to make a plan that protects the health, safety, and welfare of program participants.

(5) The organization may not discontinue program operations until the Administration approves the discontinuation plan in accordance with this regulation, unless §C(1) of this regulation is applicable.

(6) At all times during the discontinuation process, the organization shall cooperate with the Administration and the appropriate local authority.

(7) An unplanned discontinuation of program operations does not include weather-related closures for which the organization has made program participants aware of procedures for weather-related closures and is able to communicate the closures to participants via electronic methods.

C. Discontinuation of Program Operations—Without Administration Approval.

(1) If the Administration denies or does not approve an organization’s discontinuation plan within 10 business days following the meeting conducted in accordance with §A(3)(b)(ii) or §B(4)(b)(ii) of this regulation, the organization may discontinue the program.

(2) Within 7 business days of the final date of operation, the organization shall submit a final closure report notifying the Administration of the following:

(a) Date on which operations ceased;

(b) Number of participants referred to other providers to include internal referral to other program sites;

(c) Name and contact information of custodian of records; and

(d) Name and contact information of the individual responsible for inquiries regarding organization.

(3) The Administration may impose a civil monetary penalty in accordance with COMAR 10.63.38 if the program discontinuation:

(a) Is conducted in a manner that is inconsistent with health care industry standards;

(b) Causes serious physical or emotional harm to any program participant or staff; or

(c) Otherwise meets the requirement for a civil money penalty under COMAR 10.63.38.

(4) In determining whether a civil monetary penalty shall be imposed, the Administration shall consider the organization’s good faith efforts to work with the Administration and applicable local authority to come to an agreement on the program’s discontinuation plan.

D. Non-Compliance with Discontinuation Requirements.

(1) In the event of a planned discontinuation of services, if an organization fails to comply with §A or §C of this regulation, the Secretary may deny any future application for a license submitted by the organization, its corporate officers, or required staff of the organization.

(2) In the event of an unplanned discontinuation of services, if an organization fails to comply with §B of this regulation, the Secretary may deny any future application for a license submitted by the organization, its corporate officers, or required staff of the organization.

E. Initiation of Receivership. The Secretary may take action to initiate receivership of licensed program in accordance with the requirements outlined in Health-General Article, §§19-333—19-339, Annotated Code of Maryland.

10.63.08 Driving Under the Influence (DUI) Education Program

Authority: Transportation Article, §§16-212 and 16-212.1, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) Addictive Disorder.

(b) “Addictive disorder” includes gambling, which is the only nonsubstance-related addictive disorder recognized under State law.

(2) “Administration” means the Behavioral Health Administration within the Department that provides oversight to organizations that are licensed or certified in accordance with this subtitle.

(3) “Assessment” means the process of ascertaining the treatment needs of an individual seeking behavioral health services.

(4) “Behavioral health services” means prevention, screening, early intervention, treatment, recovery, support, wraparound, and rehabilitation services for individuals with substance-related disorders, addictive disorders, mental disorders, or a combination of these disorders.

(5) “Clinical supervisor” means a licensed mental health professional approved by the Board of Professional Counselors and Therapists, the Board of Physicians, the Board of Social Work Examiners, or the Board of Examiners of Psychologists as a supervisor.

(6) “Community-based” means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(7) “Court” has the meaning stated in Courts and Judicial Proceedings Article, §1-101, Annotated Code of Maryland.

(8) “Department” means the Maryland Department of Health.

(9) “Drug” means:

(a) 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;

(b) A prescription medication; or

(c) A chemical substance when used for unintended and harmful purposes.

(10) “Hospital” has the meaning stated in Health-General Article, §19–301, Annotated Code of Maryland.

(11) “License” means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(12) “Licensed mental health professional” means:

(a) A psychiatrist; or

(13) “Mental disorder” has the meaning stated in Health-General Article, §10-101, Annotated Code of Maryland.

(14) “Organization” means an association, partnership, corporation, unincorporated group, or any other legal entity licensed to operate a program to provide community-based behavioral health services.

(15) “Participant” means an individual receiving behavioral health services in a community-based program.

(16) “Program” means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health-General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health-General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of (a)—(c).

(17) “Psychiatrist” means a physician who:

(a) Is licensed by the Maryland Board of Physicians; and

(b) Is either:

(i) Certified in psychiatry by the American Board of Psychiatry and Neurology; or

(ii) Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in psychiatry.

(18) “Referral” means a contact made by an individual, or on behalf of an individual, for behavioral health or other services.

(19) “Secretary” means the Secretary of the Maryland Department of Health or their designee.

(20) “Site” means the location where the organization operates the program as detailed on the program’s license.

(21) “Substance-related disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances.

(22) “Telehealth” has the meaning stated in Health-General Article, §15–141.2, Annotated Code of Maryland

(23) “Treatment” means professionally rendered therapeutic interventions provided to an individual to address behavioral health disorders.

.02 DUI Education Program Description.

A. An organization licensed under this subtitle to provide DUI Education Program services shall be designed to provide DUI education to program participants:

(1) Convicted under Transportation Article, §21-902, Annotated Code of Maryland; and

(2) Ordered by the court to attend an education program in accordance with Criminal Procedure Article, §6-219, Annotated Code of Maryland.

B. Program participants are required to successfully complete, at minimum, six weekly, 2-hour sessions for a total of 12 hours.

.03 DUI Education Program Staff Requirements.

An organization licensed under this subtitle to provide DUI Education Program services shall employ, at minimum, a certified supervised counselor who shall:

A. Be certified as a certified supervised counselor— alcohol and drug, in accordance with Health Occupations Article, §17-404, Annotated Code of Maryland;

B. Meet the general staffing requirements in accordance with COMAR 10.63.03;

C. Meet the substance-related clinical supervisor requirements in accordance with COMAR 10.63.03.12A();

D. Provide a comprehensive assessment in accordance with Regulation .04B of this chapter to program participants; and

E. Teach the DUI curriculum approved by the Administration and the Motor Vehicle Administration.

.04 DUI Education Program Services.

A. An organization licensed under this subtitle to provide DUI Education Program services shall provide, at minimum, the following services:

(1) A comprehensive assessment in accordance with §B of this regulation;

(2) Referral services in accordance with §C of this regulation;

(3) Telehealth services in accordance with §D of this regulation; and

(4) Reporting services in accordance with §E of this regulation.

B. Comprehensive Assessment.

(1) A DUI Education Program shall provide a comprehensive assessment to the program participant that, in addition to the items required by COMAR 10.63.04.04B shall cover:

(a) The scope of drinking-driver problem;

(b) Drinking-driver patterns and characteristics;

(c) The pharmacology of substance use;

(d) The process of addiction to drugs and alcohol;

(e) The relationship of substance-use to crime, health, family, and other social problems; and

(f) Treatment resources.

(2) A comprehensive assessment is not required for a program participant if:

(a) The program participant has received an assessment by a licensed or certified clinician, or licensed program within the preceding 45 days, of a program participant's current status; and

(b) The assessment includes relevant history in the following areas:

(i) Alcohol, tobacco, and other drug use;

(ii) Employment or financial support;

(iii) Gambling behavior;

(iv) Alcohol, tobacco, and other drug use and gambling treatment history;

(v) Mental health;

(vi) Legal involvement;

(vii) Family and social systems;

(viii) Educational involvement; and

(ix) Somatic health, including a review of medications.

C. Referral Services. A DUI Education Program shall refer program participants to a treatment program or indicated services based on the comprehensive assessment conducted under §B of this regulation.

D. Telehealth Services. A DUI Education Program may provide DUI Education Program telehealth services if the DUI Education Program:

(1) Meets the requirements of:

(a) COMAR 10.63.01—.04;

(b) COMAR 10.63.06; and

(c) A DUI Education Program as outlined in this chapter; and

(2) Is licensed by the Administration to provide online DUI Education Program services.

E. Reporting Services. A DUI Education Program shall report to the court or the program participant’s probation agent as specified by the court order.

.05 DUI Education Program Licensure Process.

To be licensed as a DUI Education Program under this subtitle, an organization operating a DUI Education Program shall meet the licensing requirements in accordance with COMAR 10.63.06.

.06 DUI Education Program Site and Documentation Requirements.

A. Site Requirements. An organization licensed as a DUI Education Program under this subtitle shall:

(1) Meet the site requirements in accordance with COMAR 10.63.05;

(2) Have a mechanism to verify program participant participation and to monitor program participant progress; and

(3) Have an office located in the State that is staffed on site during the program’s stated business hours.

B. Documentation Requirements. An organization licensed as a DUI Education Program shall meet documentation requirements in accordance with COMAR 10.63.04.

10.63.09 Early Intervention Level 0.5 Program

Authority: Health-General Article, §§2-104(b), 8-401—8-405, and 19-308, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Assessment” means the process of ascertaining the treatment needs of an individual seeking behavioral health services.

(2) “Behavioral health services” means prevention, screening, early intervention, treatment, recovery, support, wraparound, and rehabilitation services for individuals with substance-related disorders, addictive disorders, mental disorders, or a combination of these disorders.

(3) “Clinical director” means the individual who is responsible for the therapeutic and rehabilitative aspects and direction of a program.

(4) “Clinical supervisor” means a licensed mental health professional approved by the Board of Professional Counselors and Therapists, the Board of Physicians, the Board of Social Work Examiners, or the Board of Examiners of Psychologists as a supervisor.

(5) “Community-based” means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(6) “Hospital” has the meaning stated in Health-General Article, §19–301, Annotated Code of Maryland.

(7) “License” means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(8) “Licensed mental health professional” means:

(a) A psychiatrist; or

(9) “Mental disorder” has the meaning stated in Health-General Article, §10-101, Annotated Code of Maryland.

(10) “Organization” means an association, partnership, corporation, unincorporated group, or any other legal entity licensed to operate a program to provide community-based behavioral health services.

(11) “Participant” means an individual receiving behavioral health services in a community-based program.

(12) “Program” means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health-General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health-General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of (a)—(c).

(13) “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.

(14) “Provider” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland to provide health care services.

(15) “Psychiatrist” means a physician who:

(a) Is licensed by the Maryland Board of Physicians; and

(b) Is either:

(i) Certified in psychiatry by the American Board of Psychiatry and Neurology; or

(ii) Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in psychiatry.

(16) “Referral” means a contact made by an individual, or on behalf of an individual, for behavioral health or other services.

(17) “Secretary” means the Secretary of the Maryland Department of Health or their designee.

(18) “Site” means the location where the organization operates the program as detailed on the program’s license.

(19) “Substance-related disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances.

(20) “Treatment” means professionally rendered therapeutic interventions provided to an individual to address behavioral health disorders.

.02 Level 0.5 Program Description.

An organization licensed under this subtitle to provide a Level 0.5 Program shall treat program participants who:

A. Are known to be at risk of developing a substance-related disorder;

B. Do not yet meet the criteria for a substance-related disorder diagnosis; and

C. Meet Level 0.5 of the ASAM Criteria Levels of Care.

.03 Level 0.5 Program Staffing Requirements.

A. An organization licensed under this subtitle to provide Level 0.5 Program services shall employ, at minimum, the staff in §§B—E of this regulation.

B. Program Director. The program director of a Level .05 Program shall meet:

(1) The general staffing requirements in accordance with COMAR 10.63.03; and

(2) The program director requirements in accordance with COMAR 10.63.03.07.

C. Clinical Director. The clinical director of a Level .05 Program shall meet:

(1) The general staffing requirements in accordance with COMAR 10.63.03; and

(2) The clinical director requirements in accordance with COMAR 10.63.03.06.

D. Licensed Clinical Supervisors.

(1) A licensed clinical supervisor of a Level .05 Program shall meet:

(a) The general staffing requirements in accordance with COMAR 10.63.03; and

(b) One of the conditions in §D(2) of this regulation.

(2) A licensed clinical supervisor shall meet either:

(a) The licensed mental health professional and clinical supervisor requirements in accordance with COMAR 10.63.03.09; or

(b) The substance-related disorder clinical supervisor requirements in accordance with COMAR 10.63.03.12.

E. Clinical Staff. Clinical staff of a Level .05 Program shall meet:

(1) The general staffing requirements in accordance with COMAR 10.63.03;

(2) The substance-related disorder clinical staff requirements in accordance with COMAR 10.63.03.12; and

(3) The staffing limitations in accordance with COMAR 10.63.03.12.

.04 Level 0.5 Program Services.

A. Program Services. Level 0.5 Program services shall include:

(1) Consent for services in accordance with COMAR 10.63.04.03;

(2) A comprehensive assessment in accordance with COMAR 10.63.04.04;

(3) Brief intervention to increase the program participant’s awareness of substance use behaviors;

(4) Psychoeducation about the risk of continued substance use; and

(5) Coordination and referral to treatment programs or resources identified by the comprehensive assessment in accordance with §§B and C of this regulation.

B. Referral Services.

(1) Level 0.5 Program referral services shall include coordination and referral to any treatment programs or resources identified by the comprehensive assessment.

(2) If the program participant’s comprehensive assessment does not identify any treatment programs or resources for referral, the Level 0.5 Program shall provide, at minimum, the services listed in §A(1)—(4) of this regulation.

C. Referral Documentation. For any referrals made by the Level 0.5 Program, program staff shall document the:

(1) Program participant’s identifying information;

(2) Date of referral;

(3) Referring program name;

(4) Receiving program or provider name;

(5) Reason for referral; and

(6) Final disposition of referral.

.05 Level 0.5 Program Licensure Process.

To be licensed as a Level 0.5 Program under this subtitle, an organization operating a Level .05 Program shall meet the licensing requirements in accordance with COMAR 10.63.06.

.06 Level 0.5 Site and Documentation Requirements.

An organization licensed as a Level 0.5 Program under this subtitle shall meet:

A. Site requirements in accordance with COMAR 10.63.05; and

B. Documentation requirements in accordance with COMAR 10.63.04.

10.63.10 Substance-Related Disorder Assessment and Referral Program

Authority: Health-General Article, §§2-104(b), 8-401—8-405, and 19-308, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) Addictive Disorder.

(b) “Addictive disorder” includes gambling, which is the only nonsubstance-related addictive disorder recognized under State law.

(2) “Assessment” means the process of ascertaining the treatment needs of an individual seeking behavioral health services.

(4) “Community-based” means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(5) “Drug” means:

(a) 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;

(b) A prescription medication; or

(c) A chemical substance when used for unintended and harmful purposes.

(6) “Hospital” has the meaning stated in Health-General Article, §19–301, Annotated Code of Maryland.

(7) “License” means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(8) “Mental disorder” has the meaning stated in Health-General Article, §10-101, Annotated Code of Maryland.

(9) “Organization” means an association, partnership, corporation, unincorporated group, or any other legal entity licensed to operate a program to provide community-based behavioral health services.

(10) “Participant” means an individual receiving behavioral health services in a community-based program.

(11) “Program” means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health-General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health-General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of (a)—(c).

(12) “Referral” means a contact made by an individual, or on behalf of an individual, for behavioral health or other services.

(13) “Secretary” means the Secretary of the Maryland Department of Health or their designee.

(14) “Site” means the location where the organization operates the program as detailed on the program’s license.

(15) “Substance-related disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances.

(16) “Treatment” means professionally rendered therapeutic interventions provided to an individual to address behavioral health disorders.

.02 Substance-Related Disorder Assessment and Referral Program Description.

A. An organization licensed under this subtitle to provide Substance-Related Disorder Assessment and Referral Program services shall be designed to provide Substance-Related Disorder Assessment and Referral Program services to program participants to determine the type and intensity of services needed by the participant for behavioral health disorders.

B. An organization licensed under this subtitle to provide Substance-Related Disorder Assessment and Referral Program services shall be operated by a State or local government entity.

.03 Substance-Related Disorder Assessment and Referral Program Staffing Requirements.

An organization licensed under this subtitle to provide Substance-Related Disorder Assessment and Referral Program services shall:

A. Meet the general staffing requirements in accordance with COMAR 10.63.03; and

B. Employ clinical staff authorized under Health Occupations Article, Annotated Code of Maryland to provide the service being rendered.

.04 Substance-Related Disorder Assessment and Referral Program Services.

A. Comprehensive Assessment.

(1) A Substance-Related Disorder Assessment and Referral Program shall provide a comprehensive assessment of the program participant’s current status in accordance with COMAR 10.63.04.04 and include a relevant history related to the following:

(a) Alcohol, tobacco, and other drug use;

(b) Employment or financial support;

(c) Gambling behavior;

(d) Alcohol, tobacco, other drug, and gambling treatment history;

(e) Mental health;

(f) Legal involvement;

(g) Family and social systems;

(h) Educational involvement; and

(i) Somatic health, including a review of medication.

(2) The Substance-Related Disorder Assessment and Referral program shall use the comprehensive assessment conducted under §A(1) of this regulation to determine the type and intensity of services needed for the program participant's behavioral health disorders.

B. Referral Services. A Substance-Related Disorder Assessment and Referral program shall:

(1) Refer the program participant to behavioral health services programs and other services as determined by the comprehensive assessment in §A(1) of this regulation; and

(2) Provide appropriate follow-up to the program participant.

.05 Substance-Related Disorder Assessment and Referral Program Licensure Process.

To be licensed as a Substance-Related Disorder Assessment and Referral Program under this subtitle, an organization operating a Substance-Related Disorder Assessment and Referral Program shall:

(1) Meet the licensing requirements in accordance with COMAR 10.63.06; and

(2) Be operated by a State or local government entity.

.06 Substance-Related Disorder Assessment and Referral Program Site and Documentation Requirements.

An organization licensed as a Substance-Related Disorder Assessment and Referral Program under this subtitle shall meet:

A. Site requirements in accordance with COMAR 10.63.05; and

B. Documentation requirements in accordance with COMAR 10.63.04.

10.63.11 Behavioral Health Crisis Stabilization Center (BHCSC) Program

Authority: Health-General Article, §§2-104(b), 7.5-204, 8-402, 8-404, 10-901, and 10-1402, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Accreditation” means the approval granted to a program by an accreditation organization.

(3) Addictive Disorder.

(b) “Addictive disorder” includes gambling, which is the only nonsubstance-related addictive disorder recognized under State law.

(4) “Administration” means the Behavioral Health Administration within the Department that provides oversight to organizations that are licensed or certified in accordance with this subtitle.

(5) “Assessment” means the process of ascertaining the treatment needs of an individual seeking behavioral health services.

(7) “Community-based” means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(8) “Crisis” means an event that produces mental, physical, emotional, or behavioral distress.

(9) “Department” means the Maryland Department of Health.

(10) Dietary Services.

(a) “Dietary services” means the services provided by a community based behavioral health program which offers comprehensive food preparation as a service to program participants.

(b) “Dietary services” does not include communal food preparation by program participants or food preparation done as a rehabilitative activity.

(11) “Emergency evaluee” has the meaning stated in Health-General Article, §10-620, Annotated Code of Maryland.

(12) “Hospital” has the meaning stated in Health-General Article, §19–301, Annotated Code of Maryland.

(13) Independent Practice Level.

(a) “Independent practice level” means a behavioral health professional licensed under Health Occupations Article, Annotated Code of Maryland who is providing behavioral health services according to the requirements of the appropriate professional board to diagnose and treat behavioral health disorders independent of formal supervision.

(b) “Independent practice level” does not include:

(i) Licensed graduate professional counselor;

(ii) Licensed graduate marriage and family therapist;

(iii) Licensed graduate art therapist;

(iv) Licensed graduate alcohol and drug counselor;

(v) Licensed master social worker;

(vi) Licensed certified social worker;

(vii) Registered psychology associate; or

(viii) Certified addiction counselors at any level.

(14) “License” means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(15) “Licensed mental health professional” means:

(a) A psychiatrist; or

(16) Local Authority.

(b) “Local authority” includes the:

(i) Core service agency as defined in Health-General Article, §7.5-101(g), Annotated Code of Maryland;

(ii) Local addictions authority as defined in Health-General Article, §7.5-101(j), Annotated Code of Maryland; and

(iii) Local behavioral health authority as defined in Health-General Article, §7.5-101(k), Annotated Code of Maryland.

(17) “Medical director” means an individual licensed in accordance with Health Occupations Article, Annotated Code of Maryland who oversees the operation of a community-based behavioral health program.

(18) “Medically necessary” means a service or benefit that is:

(a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;

(b) Consistent with current accepted standards of good medical practice;

(c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and

(d) Not primarily for the convenience of the participant, family, provider, or organization.

(19) “Medications for Opioid Use Disorder (MOUD)” means an approach to opioid use treatment that uses medications approved by the federal Food and Drug Administration as the treatment for people diagnosed with opioid use disorder.

(20) “Mental disorder” has the meaning stated in Health-General Article, §10-101, Annotated Code of Maryland.

(21) “Organization” means an association, partnership, corporation, unincorporated group, or any other legal entity licensed to operate a program to provide community-based behavioral health services.

(22) “Participant” means an individual receiving behavioral health services in a community-based program.

(23) “Program” means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health-General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health-General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of (a)—(c).

(24) “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.

(25) “Provider” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland to provide health care services.

(26) “Psychiatrist” means a physician who:

(a) Is licensed by the Maryland Board of Physicians; and

(b) Is either:

(i) Certified in psychiatry by the American Board of Psychiatry and Neurology; or

(ii) Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in psychiatry.

(27) “Public Behavioral Health System” means the system that provides medically necessary behavioral health services for Medical Assistance participants and certain other uninsured individuals.

(28) “Referral” means a contact made by an individual, or on behalf of an individual, for behavioral health or other services.

(29) “Residential” means the setting of a community-based program in which program participants both reside and receive behavioral health services.

(30) “Secretary” means the Secretary of the Maryland Department of Health or their designee.

(31) “Site” means the location where the organization operates the program as detailed on the program’s license.

(32) “Substance-related disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances.

(33) “Telehealth” has the meaning stated in Health-General Article, §15–141.2, Annotated Code of Maryland.

(34) “Treatment” means professionally rendered therapeutic interventions provided to an individual to address behavioral health disorders.

(35) “Withdrawal Management” means direct or indirect services for an acutely intoxicated program participant to fulfill the physical, social, and emotional needs of a participant by:

(a) Monitoring the amount of alcohol and other toxic agents in the body of the participant;

(b) Managing withdrawal symptoms; and

(c) Motivating a participant to participate in appropriate substance-related disorder programs.

.02 BHCSC Program Description.

An organization licensed under this subtitle as a BHCSC Program shall:

A. Serve as a critical access point for individuals experiencing a mental health, substance-related, or combined crisis; and

B. 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.

.03 BHCSC Staffing Requirements.

A. Staffing Requirements. An organization licensed under this subtitle to provide BHCSC Program services shall meet the staffing requirements of §§B and C of this regulation and Regulation .04 of this chapter.

B. BHCSC Program Director. The BHCSC program director shall:

(1) Meet the general staffing requirements in accordance with COMAR 10.63.03;

(2) Meet the program director requirements in accordance with COMAR 10.63.03.07;

(3) Be a licensed mental health professional operating at the independent practice level;

(4) Be responsible for the management and operation of the BHCSC; and

(5) Have a job description that, at minimum:

(a) Describes the required qualifications;

(b) Describes the BHCSC program director’s duties; and

(c) Ensures that the other job responsibilities of the BHCSC program director may not impede the operation and administration of the BHCSC.

C. BHCSC Nursing Manager. The BHCSC nursing manager shall:

(1) Meet the general staffing requirements in accordance with COMAR 10.63.03;

(2) Have active licensure as a registered nurse in the State in accordance with Health Occupations Article, Title 8, Subtitle 3, Annotated Code of Maryland; and

(3) Provide supervision and management of the BHCSC program’s nursing staff, as applicable.

D. Qualified Prescribers.

(1) The BHCSC qualified prescribers shall:

(a) Meet the general staffing requirements in accordance with COMAR 10.63.03;

(b) Meet one of the conditions of §D(2) of this regulation; and

(c) Provide general medical services and prescribe medication and treatment, as applicable.

(2) Be licensed in the State as either:

(a) A psychiatrist;

(b) A certified registered nurse practitioner in accordance with Health Occupations Article, §8-302.1, Annotated Code of Maryland with a specialization in the practice of psychiatric mental health (CRNP-PMH); or

(c) Another prescriber authorized under Health Occupations Article, Annotated Code of Maryland and be approved by the Administration if the individual is not a psychiatrist or a CRNP-PMH.

E. Vacancy Reporting.

(1) Requirements for reporting of vacancies under COMAR 10.63.03.03 for a BHCSC, includes the program’s:

(a) Program director;

(b) Qualified prescriber;

(c) Nurse manager; and

(d) Licensed mental health professionals if the vacancy leads to an inability to meet the staffing requirements set forth in §B of this regulation.

(2) Vacancy reporting under COMAR 10.63.03.03 shall also include any changes in the BHCSC’s staffing composition, or an addition or reduction in staffing numbers that varies from the program’s approved staffing plan by greater than 10 percent.

.04 BHCSC Program Staff Training Requirements.

A. Annual Staff Training: An organization licensed under this subtitle to provide BHCSC Program services shall:

(1) Develop and implement an annual staff training plan that, at minimum, defines staff competencies within their scope of practice; and

(2) Ensure all staff receive any training required by the Administration and any other training required by the organization’s accreditation organization.

B. BHCSC Staffing Plan. An organization licensed under this subtitle to provide BHCSC Program services shall:

(1) Develop and maintain a written staffing plan designed to ensure sufficient coverage, discipline mix, service quality, and safety and which shall:

(a) Outline the qualifications and duties of each staff position; and

(b) Be approved by the Department at the time of licensure;

(2) Continuously employ enough staff personnel and ensure an appropriate staff composition on site to:

(a) Provide BHSCS Program services; and

(b) Ensure the continuous supervision and monitoring of program participants receiving crisis stabilization services;

(3) Ensure a physician shall be on call at all times for the provision of those BHCSC services that may only be provided by a physician;

(4) Ensure that there is a minimum of one registered nurse on site at all times;

(5) Ensure there is additional staff, including licensed mental health professionals, on-site at all times to provide active crisis intervention;

(6) Ensure BHCSC services are provided by personnel within their scope of practice and with expertise appropriate to the service recipient's needs; and

(7) Ensure that at least one qualified prescriber:

(a) Is available 24 hours a day, 7 days a week;

(b) Who makes daily rounds; and

(c) Who conducts an in-person reassessment of any patient who is an emergency evaluee, and remains at the BHCSC for more than 24 hours; and

(d) If utilizing a qualified prescriber that is not a psychiatrist or certified nurse practitioner, psychiatric mental health, is approved by the Administration.

.05 BHCSC Patient Triage Services.

A BHCSC Program shall:

A. Deliver triage services in a manner that aligns with best practices;

B. Conduct screening for the presence of any condition of sufficient severity to require transfer to an appropriate facility for immediate medical or surgical care, including laboratory studies; and

C. Make reasonable efforts to minimize the time on-site at the BHCSC for law enforcement or other first responders.

.06 BHCSC Involuntary Admissions.

A BHCSC Program shall accept involuntary admissions in accordance with Health-General Article, §§10-613—10-621, Annotated Code of Maryland.

.07 Seclusion and Restraint.

A. A BHCSC Program licensed under this subtitle shall have the capacity to perform both seclusion and restraint.

B. Terms Defined. For purposes of this regulation:

(1) Seclusion has the meaning stated in 42 CFR §482.13(e)(1)(ii); and

(2) Restraint has the meaning stated in 42 CFR §482.13(e)(1)(i).

C. A BHCSC Program shall be compliant with State and federal seclusion and restraint laws and regulations, including:

(1) 42 CFR §482.13;

(2) Health-General Article, §10-701, Annotated Code of Maryland;

(3) COMAR 10.21.12;

(4) COMAR 10.21.13; and

(5) Any successor State and federal laws or regulations related to seclusion and restraint.

D. The Administration may require the BHCSC program to add additional seclusion or quiet rooms, based on the intended capacity of the BHCSC Program.

.08 BHCSC Program Services.

A BHCSC Program shall:

A. Provide the services outlined in this regulation 24 hours a day, 7 days a week, 365 days a year;

B. Provide crisis response services in accordance with Health-General Article, §§10-1401—1405, Annotated Code of Maryland;

C. Screen, assess, stabilize, and refer patients, through the utilization of evidence-based tools;

D. Provide acute mental health and substance-related disorder crisis intervention and stabilization services for children, adolescents, and adults whose behaviors are consistent with experiencing a mental health crisis, a substance-related disorder crisis, or both;

E. Provide assessment, counseling, de-escalation, and safety planning;

F. Provide for the initiation, maintenance, and prescription of psychotropic and somatic medications as appropriate, including:

(1) As needed intramuscular medication;

(2) Long-acting injectable antipsychotic medication;

(3) Medications used for withdrawal management; and

(4) Medications for opioid use disorder (MOUD); and

G. Provide Withdrawal Management services in accordance with COMAR 10.63.36.

.09 BHCSC Licensure Process.

A. To be licensed to operate a BHCSC Program, an organization:

(1) Shall:

(a) Meet the licensing requirements in accordance with COMAR 10.63.06;

(b) 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;

(c) Be pre-approved by the Department or its designee to receive Public Behavioral Health System funding before participating in the Public Behavioral Health System;

(d) Be pre-approved by the Department and local authority to operate BHCSC services in the Public Behavioral Health System to ensure services meet local community needs for behavioral health crisis services; and

(2) May not be located within the Health Services Cost Review Commission regulated space of a hospital.

B. In addition to the documents required to be submitted with a licensure application set forth in COMAR 10.63.06, a BHCSC Program shall submit to the Administration a staffing plan as outlined in Regulation .04B of this chapter.

.10 BHCSC Quality Assurance Standards.

An organization licensed as a BHCSC Program under this subtitle shall:

A. Begin assessment and active treatment immediately upon an individual's admission.

B. 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;

C. Ensure a BHCSC licensed mental health professional provides a formal crisis assessment at the earliest opportunity which shall be reviewed by the physician or certified registered nurse practitioner, psychiatric mental health (CRNP-PMH) and shared with the treatment team;

D. Ensure for individuals in the BHCSC under an emergency petition with stays beyond 24 hours, that licensed mental health professional staff perform, at minimum, daily in-person reassessments;

E. Ensure an initial evaluation by an approved physician or certified registered nurse practitioner, psychiatric mental health (CRNP-PMH) is completed at the earliest reasonable opportunity, which may not be later than 4 hours after an individual's admission, through video-telehealth or in-person, and shall include the following:

(1) A medical evaluation;

(2) Assessment of suicide, homicide, violence, and other risk factors; and

(3) Review and authorization of the BHCSC initial crisis intervention care plans;

F. Have every discharge plan for individuals receiving services in the BHCSC signed off on by an approved physician or certified registered nurse practitioner, psychiatric mental health (CRNP-PMH);

G. Maintain relationships with existing community-based behavioral health providers who may receive referrals from the BHCSC, which shall include written referral agreements with the following:

(1) Outpatient community-based behavioral health providers;

(2) Hospital psychiatric units;

(3) Residential Crisis Services Programs for mental health and substance-related disorder under COMAR 10.63.26 and COMAR 10.63.28;

(4) Respite Care Services Programs under COMAR 10.63.22;

(5) Residential substance-related disorder programs under COMAR 10.63.29—.32;

(6) Providers of medications for opioid use disorders (MOUD); and

(7) Opioid Treatment Programs under COMAR 10.63.35;

H. Make documented attempts to contact and follow up with all individuals within 72 hours after discharge from the BHCSC for:

(1) Individuals discharged to a community setting;

(2) Individuals who received outpatient services; and

(3) Individuals who initially presented or were later evaluated as a danger to self or others;

I. Have protocols, which may include referral agreements with other programs, that provide for admission and treatment of individuals with:

(1) Limited English proficiency;

(2) Hearing and speaking disabilities; and

(3) Physical, developmental, and intellectual disabilities;

J. Develop and maintain written triage policies and procedures approved by the Administration, 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;

K. Notify the Administration and local authority, in a form and manner determined by the Administration, of the following:

(1) Initiation of diversion status for the BHCSC program; and

(2) Diversion of any individual on an emergency petition;

L. 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 Administration on request;

M. Develop, implement, and maintain written policies and procedures in place to ensure the safety of all individuals, regardless of age; and

N. Provide data to support quality assurance and improvement initiatives to the State in the format and frequency requested by the Administration.

.11 BHCSC Site and Documentation Requirements.

A. An organization licensed as a BHCSC Program under this subtitle shall meet the documentation requirements in §§B—G of this regulation.

B. A BHCSC program shall meet site requirements in accordance with COMAR 10.63.05.

C. A BHCSC program shall meet documentation requirements in accordance with COMAR 10.63.04.

D. BHCSC Environmental Requirements.

(1) The BHSCSC shall:

(a) Provide a comfortable, furnished, admission pre-triage waiting area for individuals who voluntarily present;

(b) Provide a locked and secure dedicated drop-off admission space, designed to accommodate those individuals who have been emergency petitioned;

(c) Provide a comfortable, furnished, waiting area for individuals accompanying participants in the BHCSC Program;

(d) Allow for continual visual observation and monitoring of individuals being served;

(e) Ensure a safe environment of care for individuals younger than 18 years old by having a separation from adults, with appropriate staff maintaining an adequate level of supervision;

(f) Ensure that the BHCSC has at least one locked door seclusion room, which shall:

(i) Be a minimum of 80 square feet;

(ii) Allow for continual visual observation and monitoring that allows for immediate emergency response; and

(iii) Use a locking mechanism consistent with National Fire Protection Association (NFPA) standards for the facility; and

(g) Ensure that there is at least one quiet room that is separate from the seclusion room and remains unlocked whenever in use.

(2) Annual Environmental Safety Review. 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:

(a) Anchor points;

(b) Door handles;

(c) Curtains;

(d) Hooks; and

(e) Shower rods and curtains.

(3) The BHCSC program shall comply with applicable federal, State, and local sanitation, building, fire codes, and zoning requirements.

(4) The BHCSC program shall maintain documentation of all legally and accreditation required periodic evacuation drills.

(5) The BHCSC program shall have:

(a) Bathrooms;

(b) Telephones;

(c) An automated external defibrillator; and

(d) Confidential office space for treatment.

E. BHCSC Dietary Services. BHCSC program dietary services shall:

(1) Meet the dietary services requirements in accordance with COMAR 10.63.05.06.

(2) Have at least three meals plus an evening snack provided daily with no more than 14 hours between any two meals;

(3) Ensure dietary services comply with applicable local, State, and federal laws;

(4) Have a written plan describing the organization and delivery of dietary services; and

(5) Have a dietitian licensed under Health Occupations Article, §5-101, Annotated Code of Maryland, who shall develop and implement the dietary service plan.

F. BHCSC Infection Control — Universal Precautions. A BHCSC program shall observe universal precautions as required under COMAR 10.52.11 as applicable to health care facilities.

G. BHCSC Site Inspection. At minimum, an annual site inspection of each BHCSC shall be conducted by the applicable local authority.

10.63.12 Integrated Behavioral Health Program

Authority: Health-General Article, §§2-104(b), 7.5-204, 8-402, 8-404, 10-901, and 10-1402, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) Addictive Disorder.

(b) “Addictive disorder” includes gambling, which is the only nonsubstance-related addictive disorder recognized under State law.

(2) “Assessment” means the process of ascertaining the treatment needs of an individual seeking behavioral health services.

(4) “Case management” means the process of coordinating and monitoring the services provided to a program participant both within the program and in conjunction with other providers.

(5) “Community-based” means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(6) “Corrective action” means specific actions undertaken by an organization to address a violation of any local, state, or federal law or regulation.

(7) “Crisis” means an event that produces mental, physical, emotional, or behavioral distress.

(8) “Hospital” has the meaning stated in Health-General Article, §19–301, Annotated Code of Maryland.

(9) “License” means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(10) “Opioid Treatment Program” means a program that:

(a) Is licensed by the State under Health-General Article, §7.5-401, Annotated Code of Maryland;

(b) May treat program participants with opioid dependence with a medication approved by the federal Food and Drug Administration for opioid dependence;

(c) Complies with:

(i) 42 CFR Part 8;

(ii) COMAR 10.63.13; and

(iii) Requirements for the secure storage and accounting of opioid medication imposed by the federal Drug Enforcement Administration and the Department’s Office of Controlled Substances Administration; and

(d) Has been granted a certification for operation by the Department, the federal Substance Abuse and Mental Health Services Administration, and the Federal Center for Substance Abuse Treatment.

(11) “Mental disorder” has the meaning stated in Health-General Article, §10-101, Annotated Code of Maryland.

(12) “Organization” means an association, partnership, corporation, unincorporated group, or any other legal entity licensed to operate a program to provide community-based behavioral health services.

(13) “Participant” means an individual receiving behavioral health services in a community-based program.

(14) “Program” means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health-General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health-General Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of (a)—(c).

(15) “Provider” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland to provide health care services.

(16) “Psychiatrist” means a physician who:

(a) Is licensed by the Maryland Board of Physicians; and

(b) Is either:

(i) Certified in psychiatry by the American Board of Psychiatry and Neurology; or

(ii) Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in psychiatry.

(17) “Referral” means a contact made by an individual, or on behalf of an individual, for behavioral health or other services.

(18) “Residential” means the setting of a community-based program in which program participants both reside and receive behavioral health services.

(19) “Secretary” means the Secretary of the Maryland Department of Health or their designee.

(20) “Site” means the location where the organization operates the program as detailed on the program’s license.

(22) “Treatment” means professionally rendered therapeutic interventions provided to an individual to address behavioral health disorders.

(23) “Withdrawal Management” means direct or indirect services for an acutely intoxicated program participant to fulfill the physical, social, and emotional needs of a participant by:

(a) Monitoring the amount of alcohol and other toxic agents in the body of the participant;

(b) Managing withdrawal symptoms; and

(c) Motivating a participant to participate in appropriate substance-related disorder programs.

.02 Integrated Behavioral Health Program Description.

An organization licensed under this subtitle to operate an Integrated Behavioral Health Program shall:

A. Meet all requirements for an:

(1) Outpatient Mental Health Center, in accordance with COMAR 10.63.16; and

(2) Outpatient Treatment Level 1.0 - Substance-Related Disorder Treatment Program, in accordance with COMAR 10.63.17; and

B. Have the capacity to provide:

(1) Mental health evaluation and treatment services to program participants with mental health diagnoses;

(2) Substance-related disorder evaluation and treatment services to program participants with a substance-related disorder; and

(3) Integrated mental health and substance-related disorder evaluation and treatment services to program participants with both a substance-related disorder and a mental health diagnosis.

.03 Integrated Behavioral Health Program Staffing Requirements.

An organization licensed as an Integrated Behavioral Health Program shall meet :

A. The general staffing requirements in accordance with COMAR 10.63.03;

B. The Outpatient Mental Health Center staffing requirements in accordance with COMAR 10.63.16.03; and

C. The Outpatient Treatment Level 1.0 - Substance-Related Disorder Treatment Program staffing requirements in accordance with COMAR 10.63.17.03.

.04 Integrated Behavioral Health Program Services.

A. Program Services. Integrated Behavioral Health Program services include:

(1) Consent for services in accordance with COMAR 10.63.04.03;

(2) A comprehensive assessment in accordance with COMAR 10.63.04.04;

(3) An individual care plan in accordance with COMAR 10.63.04.07;

(4) Therapy services;

(5) Coordination and referral to treatment programs or resources identified by the comprehensive assessment in accordance with §B of this regulation;

(6) Case management services; and

(7) Medication services in accordance with §C of this regulation.

B. Referral Services. Integrated Behavioral Health Program referral services include:

(1) Coordinated access, as appropriate, to emergency services, including Behavioral Health Crisis Stabilization Centers (BHCSC), Mobile Crisis Team Services, Residential Crisis Services, Hospitals, and other service providers that are designated to provide crisis and emergency care and treatment; and

(2) Any referrals to treatment programs or resources as identified through the program participant’s comprehensive assessment.

C. Medication Services.

(1) An Integrated Behavioral Health Program shall provide medication services by a physician, psychiatrist, or certified registered nurse practitioner, psychiatric mental health (CRNP-PMH).

(2) Medication services provided by an Integrated Behavioral Health Program shall include:

(a) Prescription;

(b) Administration;

(c) Monitoring; and

(d) Education.

D. An Integrated Behavioral Health Program may provide the following services when the program's license specifically authorizes the services:

(1) Withdrawal Management Service in accordance with COMAR 10.63.36; and

(2) Opioid Treatment Program in accordance with COMAR 10.63.35.

.05 Integrated Behavioral Health Program Licensure Process.

To be licensed as an Integrated Behavioral Health Program under this subtitle, an organization operating an Integrated Behavioral Health Program shall meet the licensing requirements in accordance with:

(1) COMAR 10.63.06;

(2) COMAR 10.63.16; and

(3) COMAR 10.63.17.

.06 Integrated Behavioral Health Program Site and Documentation Requirements.

An organization licensed as an Integrated Behavioral Health Program under this subtitle shall meet:

A. Site requirements in accordance with COMAR 10.63.05; and

B. Documentation requirements in accordance with COMAR 10.63.04.

10.63.13 Intensive Outpatient Treatment Level 2.1—Substance-Related Disorder Treatment Program

Authority: Health-General Article, §§2-104(b), 7.5-204, 8-402, 8-404, 10-901, and 10-1402, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Administration” means the Behavioral Health Administration within the Department that provides oversight to organizations that are licensed or certified in accordance with this subtitle.

(2) “Assessment” means the process of ascertaining the treatment needs of an individual seeking behavioral health services.

(4) “Business day” means any day except Saturday, Sunday, or a State holiday.

(5) “Case management” means the process of coordinating and monitoring the services provided to a program participant both within the program and in conjunction with other providers.

(6) “Certified Recovery Residence” means a Recovery Residence that holds a certificate of compliance.

(7) “Clinical director” means the individual who is responsible for the therapeutic and rehabilitative aspects and direction of a program.

(8) “Clinical supervisor” means a licensed mental health professional approved by the Board of Professional Counselors and Therapists, the Board of Physicians, the Board of Social Work Examiners, or the Board of Examiners of Psychologists as a supervisor.

(9) “Community-based” means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(10) “Crisis” means an event that produces mental, physical, emotional, or behavioral distress.

(11) “Department” means the Maryland Department of Health.

(12) “Drug” means:

(a) 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;

(b) A prescription medication; or

(c) A chemical substance when used for unintended and harmful purposes.

(13) “Hospital” has the meaning stated in Health-General Article, §19–301, Annotated Code of Maryland.

(14) “License” means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State.

(15) “Licensed mental health professional” means:

(a) A psychiatrist; or

(16) “Medically necessary” means a service or benefit that is:

(a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;

(b) Consistent with current accepted standards of good medical practice;

(c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and

(d) Not primarily for the convenience of the participant, family, provider, or organization.

(17) “Mental disorder” has the meaning stated in Health-General Article, §10-101, Annotated Code of Maryland.

(19) “Opioid Treatment Program” means a program that:

(a) Is licensed by the State under Health-General Article, §7.5-401, Annotated Code of Maryland;

(b) May treat program participants with opioid dependence with a medication approved by the federal Food and Drug Administration for opioid dependence;

(c) Complies with:

(i) 42 CFR Part 8;

(ii) COMAR 10.63.13; and

(d) Has been granted a certification for operation by the Department, the federal Substance Abuse and Mental Health Services Administration, and the Federal Center for Substance Abuse Treatment.

(20) “Participant” means an individual receiving behavioral health services in a community-based program.

(21) “Peer support services” has the meaning stated in Health-General Article, §7.5-101, Annotated Code of Maryland.

(22) “Program” means a named set of services operated by an organization inclusive of:

(a) A substance-related disorders program as defined in Health-General Article, §7.5-101(q), Annotated Code of Maryland;

(b) A mental health program as defined in Health-General-Article, §7.5-101(m), Annotated Code of Maryland;

(c) An addictive disorders program; and

(d) A combination of (a)—(c).

(23) “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.

(24) “Provider” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland to provide health care services.

(25) “Psychiatrist” means a physician who:

(a) Is licensed by the Maryland Board of Physicians; and

(b) Is either:

(i) Certified in psychiatry by the American Board of Psychiatry and Neurology; or

(ii) Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in psychiatry.

(26) “Recovery Residence” means a service that:

(a) Provides alcohol-free and illicit-drug-free housing to individuals with substance-related disorders or addictive disorders or co-occurring mental health disorders and substance-related disorders or addictive disorders; and

(b) Does not include clinical treatment services.

(27) “Referral” means a contact made by an individual, or on behalf of an individual, for behavioral health or other services.

(28) “Residential” means the setting of a community-based program in which program participants both reside and receive behavioral health services.

(29) “Secretary” means the Secretary of the Maryland Department of Health or their designee.

(30) “Site” means the location where the organization operates the program as detailed on the program’s license.

(31) “Substance-related disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances.

(32) “Telehealth” has the meaning stated in Health-General Article, §15–141.2, Annotated Code of Maryland

(33) “Treatment” means professionally rendered therapeutic interventions provided to an individual to address behavioral health disorders.

(34) “Withdrawal Management” means direct or indirect services for an acutely intoxicated program participant to fulfill the physical, social, and emotional needs of a participant by:

(a) Monitoring the amount of alcohol and other toxic agents in the body of the participant;

(b) Managing withdrawal symptoms; and

(c) Motivating a participant to participate in appropriate substance-related disorder programs.

.02 IOP Level 2.1 Program Description.

A. An organization licensed under this subtitle to provide an Intensive Outpatient Treatment Program (IOP) Level 2.1 shall provide structured, medically necessary, and appropriate outpatient substance-related disorder treatment based on a comprehensive assessment for program participants.

B. An IOP Level 2.1 shall ensure that program participants meet the ASAM Criteria Levels of Care for IOP Level 2.1.

C. An IOP Level 2.1 shall provide structured treatment services to program participants who require treatment:

(1) From 9 to 20 hours weekly for adult intensive outpatient services; and

(2) From 6 to 20 hours weekly for adolescent intensive outpatient services, based on the adolescents' developmental and clinical needs.

.03 IOP Level 2.1 Staffing Requirements.

A. An organization licensed under this subtitle to provide IOP Level 2.1 services shall employ, at minimum, the staff in §§B—D of this regulation.

B. Program Director. The IOP Level 2.1 program director shall meet:

(1) The general staffing requirements in accordance with COMAR 10.63.03; and

(2) The program director requirements in accordance with COMAR 10.63.03.07.

C. Clinical Director. The IOP Level 2.1 clinical director shall meet:

(1) The general staffing requirements in accordance with COMAR 10.63.03; and

(2) The clinical director requirements in accordance with COMAR 10.63.03.06.

D. Licensed Clinical Supervisors.

(1) An IOP Level 2.1 licensed clinical supervisor shall meet:

(a) The general staffing requirements in accordance with COMAR 10.63.03; and

(b) One of the conditions in §D(2) of this regulation.

(2) A licensed clinical supervisor shall meet either:

(a) The licensed mental health professional and clinical supervisor requirements in accordance with COMAR 10.63.03.09; or

(b) The substance-related disorder clinical supervisor requirements in accordance with COMAR 10.63.03.12.

E. Clinical Staff. IOP Level 2.1 clinical staff shall meet:

(1) The general staffing requirements in accordance with COMAR 10.63.03;

(2) The substance-related disorder clinical staff requirements in accordance with COMAR 10.63.03.12; and

(3) The staffing limitations in accordance with §F of this regulation.

F. Staffing Limitations. A IOP Level 2.1 shall ensure that:

(1) The IOP Level 2.1 employs, at minimum, 1 clinical supervisor for every 15 licensed or certified alcohol and drug counselors and alcohol and drug trainees; and

(2) The ratio of program participants to alcohol and drug counselors may not exceed:

(a) 40 program participants to 1 full-time alcohol and drug counselor; or

(b) 40 program participants to 1 alcohol and drug trainee, operating in accordance with the disclosure and supervision requirements set by the Board of Professional Counselors and Therapists.

.04 IOP Level 2.1 Program Services.

A. Program Services. IOP Level 2.1 services include:

(1) Consent for services in accordance with COMAR 10.63.04.03;

(2) A comprehensive assessment in accordance with COMAR 10.63.04.04;

(3) An individual care plan in accordance with COMAR 10.63.04.07;

(4) Therapy services;

(5) Coordination and referral to treatment programs or resources identified by the comprehensive assessment in accordance with §B of this regulation;

(6) Case management services; and

(7) Toxicology screens conducted at least weekly for each program participant.

B. Referral Services. IOP Level 2.1 referral services include:

(2) Relationships with medical and mental health practitioners that allow for referral of program participants for telehealth consultation within 3 business days in accordance with §C of this regulation;

(3) Services through the Division of Rehabilitation Services;

(4) Vocational assistance;

(5) Legal assistance programs;

(6) Entitlements assistance programs; and

(7) Peer support services.

C. Referral Agreements and Program Cooperation.

(1) An IOP Level 2.1 shall have referral agreements with other community-based behavioral health programs for program participants with disabilities whom the program may be unable to accommodate.

(2) An IOP Level 2.1 may coordinate program participant care with other community service providers to ensure that the widest range of appropriate services are available to program participants.

(3) An IOP Level 2.1 may establish referral agreements with organizations including but not limited to:

(a) Other licensed community-based behavioral health organizations;

(b) Certified Recovery Residences;

(c) Human service agencies; or

(d) Other health care organizations.

(4) If the IOP Level 2.1 has any referral agreements, the program, on request, shall make the referral agreements available to the Administration or its designee for review.

D. An IOP Level 2.1 may provide the following services when the program’s license specifically authorizes the service:

(1) Withdrawal Management Service in accordance with COMAR 10.63.36; and

(2) Opioid Treatment Program in accordance with COMAR 10.63.35.

.05 IOP-Level 2.1 Licensure Process.

To be licensed as an IOP Level 2.1 under this subtitle, an organization operating an IOP Level 2.1 shall meet the licensing requirements in accordance with COMAR 10.63.06.

.06 IOP-Level 2.1 Site and Documentation Requirements.

An organization licensed as an IOP Level 2.1 under this subtitle shall meet:

A. Site requirements in accordance with COMAR 10.63.05; and

B. Documentation requirements in accordance with COMAR 10.63.04.

10.63.14 Mobile Crisis Team Program

Authority: Health-General Article, §§2-104(b), 7.5-204, 8-402, 8-404, 10-901, and 10-1402, Annotated Code of Maryland

.01 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Accreditation” means the approval granted to a program by an accreditation organization.

(3) Addictive Disorder.

(b) “Addictive disorder” includes gambling, which is the only nonsubstance-related addictive disorder recognized under State law.

(4) “Administration” means the Behavioral Health Administration within the Department that provides oversight to organizations that are licensed or certified in accordance with this subtitle.

(5) “Assessment” means the process of ascertaining the treatment needs of an individual seeking behavioral health services.

(7) “Case management” means the process of coordinating and monitoring the services provided to a program participant both within the program and in conjunction with other providers.

(8) “Community-based” means a setting of a behavioral health services program that is not located in a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland.

(9) “Crisis” means an event that produces mental, physical, emotional, or behavioral distress.

(10) “Department” means the Maryland Department of Health.

(11) “Drug” means:

(a) 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;

(b) A prescription medication; or

(c) A chemical substance when used for unintended and harmful purposes.

(12) “Hospital” has the meaning stated in Health-General Article, §19–301, Annotated Code of Maryland.

(13) Independent Practice Level.

(a) “Independent practice level” means a behavioral health professional licensed under Health Occupations Article, Annotated Code of Maryland who is providing behavioral health services according to the requirements of the appropriate professional board to diagnose and treat behavioral health disorders independent of formal supervision.

(b) “Independent practice level” does not include:

(i) Licensed graduate professional counselor;

(ii) Licensed graduate marriage and family therapist;

(iii) Licensed graduate art therapist;

(iv) Licensed graduate alcohol and drug counselor;

(v) Licensed master social worker;

(vi) Licensed certified social worker;

(vii) Registered psychology associate; or

(viii) Certified addiction counselors at any level.

(14) “License” means an authorization issued by the Secretary permitting an organization to operate a behavioral health program at a specific site in the State

(15) “Licensed mental health professional” means:

(a) A psychiatrist; or

(16) Local Authority.

(b) “Local authority” includes the:

(i) Core service agency as defined in Health-General Article, §7.5-101(g), Annotated Code of Maryland;

(ii) Local addictions authority as defined in Health-General Article, §7.5-101(j), Annotated Code of Maryland; and

(iii) Local behavioral health authority as defined in Health-General Article, §7.5-101(k), Annotated Code of Maryland.

(17) “Medically necessary” means a service or benefit that is:

(a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition;

(b) Consistent with current accepted standards of good medical practice;

(c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and

(d) Not primarily for the convenience of the participant, family, provider, or organization.

(18) “Mental disorder” has the meaning stated in Health-General Article, §10-101, Annotated Code of Maryland.

(19) “Organization” means an association, partnership, corporation, unincorporated group, or any other legal entity licensed to operate a program to provide community-based behavioral health services.

(20) “Overdose” has the meaning stated in Health-General Article, §13-3601, Annotated Code of Maryland.