Title of Regulation: 12VAC35-105. Rules and Regulations for Licensing Providers by the Department of Behavioral Health and Developmental Services (amending 12VAC35-105-925).

Statutory Authority: § 37.2-203 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: September 21, 2017.

Effective Date: October 6, 2017.

Agency Contact: Cleopatra L. Booker, Psy.D., Director, Office of Licensing, Department of Behavioral Health and Developmental Services, 1220 Bank Street, P.O. Box 1797, Richmond, VA 23218, telephone (804) 663-7271, FAX (804) 692-0066, or email cleopatra.booker@dbhds.virginia.gov.

Basis: Section 37.2-203 of the Code of Virginia authorizes the State Board of Behavioral Health and Developmental Services to adopt regulations that may be necessary to carry out the provisions of Title 37.2 and other laws of the Commonwealth administered by the Commissioner and the Department of Behavioral Health and Developmental Services (DBHDS).

Purpose: The purpose of this fast-track regulatory action is to align 12VAC35-105-925 of the licensing regulations with changes in § 37.2-406 of the Code of Virginia. Specifically, the Code of Virginia contains three exceptions to the geographic restriction on DBHDS-licensed providers of treatment for persons with opiate addiction through the use of opioid replacements that are within one-half mile of a K-12 school or licensed day care center for the treatment of opioid addiction. The history of the exemptions is:

• Chapter 845 of the 2004 Acts of Assembly, which added Planning District 8.

• Chapter 415 of the 2014 Acts of Assembly, which added Planning District 23.

• Chapter 480 of the 2016 Acts of Assembly, which added using nonmethadone opioid replacements if the opioid replacement has been approved by the U.S. Food and Drug Administration for the treatment of opioid addiction.

Rationale for Using Fast-Track Rulemaking Process: The language already exists in the Code of Virginia, thus providers must already comply with the language. No new language is proposed.

Substance: This fast-track rulemaking action updates the existing regulation to reflect these, and any future, changes to state law. The amendment deletes all language in 12VAC35-105-925 B, except the language cross-referencing § 37.2-406.

Issues: This action makes it clearer to providers what is required regarding where to locate services for DBHDS-licensed providers of treatment for persons with opiate addiction. Rather than attempting to replicate language in the Code of Virginia, which was and could become updated faster than the regulatory language, this amendment will direct providers directly to the appropriate source in the Code of Virginia.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 480 of the 2016 Acts of Assembly,¹ the State Board of Behavioral Health and Developmental Services (Board) proposes to permit treatment programs using non-methadone opioid replacements to be within a half-mile of a K-12 school or licensed day care center if the opioid replacement has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of opioid addiction.

Result of Analysis. The benefits likely exceed the costs for the proposed change.

Estimated Economic Impact. The current regulation prohibits providers of services to individuals with opioid addiction from locating within one-half mile of a public or private licensed day care center or a public or private K-12 school.² Consistent with the above-mentioned 2016 legislation, the Board proposes to allow treatment programs using non-methadone opioid replacements to be within a half-mile of a K-12 school or licensed day care center if the opioid replacement has been approved by FDA for the treatment of opioid addiction. Providing greater location flexibility may reduce costs for providers of programs that provide services to individuals who are addicted to opioids. This may enable greater resources to be directly applied toward opioid treatment services and may enable additional clinics to open.

The prohibition has existed in the first place since there has been concern that the presence of drug treatment facilities might increase crime near schools. Research has shown though that the presence of drug treatment facilities is no more associated with crime than the presence of other commercial businesses, and is less associated with crime than are convenience stores and corner stores.³ Thus the benefits of the proposed amendment likely exceed the cost.

Businesses and Entities Affected. There are 36 programs licensed by the Department of Behavioral Health and Developmental Services (DBHDS) that provide services to individuals who are addicted to opioids. Community Service Boards run 3 of the programs. The remaining 33 licensed programs are private.⁴ The proposed amendment potentially affects these programs and future programs.

Localities Particularly Affected. All localities in Planning District 8 (Northern Virginia)⁵ and cities in Planning District 23 (Hampton Roads)⁶ are already exempted from the location prohibition. Thus the proposed elimination of the location prohibition would potentially affect all Virginia localities outside of Northern Virginia that are not cities in Hampton Roads.

Projected Impact on Employment. The proposed amendment is not likely to significantly directly affect employment.

Effects on the Use and Value of Private Property. The proposed amendment would newly allow private property located within a half-mile of a K-12 school or licensed day care center to be used by programs using non-methadone opioid replacements if the opioid replacement has been approved by the FDA for the treatment of opioid addiction. Given that such programs would make up a very small portion of potential renters or purchasers of property located within a half-mile of a K-12 school or licensed day care center, the proposed amendment would in most cases not significantly affect the market value of private property.

Real Estate Development Costs. The proposed amendment does not significantly affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed amendment increases the potential locations that may be used by small private programs that provide services to individuals who are addicted to opioids. This may reduce their facility/office rental costs.

Alternative Method that Minimizes Adverse Impact. The proposed amendment does not adversely affect small businesses.

Adverse Impacts:

Businesses. The proposed amendment does not adversely affect businesses.

Localities. The proposed amendment does not adversely affect localities.

Other Entities. The proposed amendment does not adversely affect other entities.

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¹ See http://leg1.state.va.us/cgi-bin/legp504.exe?161+sum+SB556

² There are exceptions to the prohibition for programs within Planning District 8 and within cities in Planning District 23. Planning District 8 includes: a) the Counties of Arlington, Fairfax, Loudoun, and Prince William, b) the Cities of Alexandria, Fairfax, Falls Church, Manassas, and Manassas Park, and c) the Towns of Dumfries, Herndon, Leesburg, Purcellville, and Vienna. The cities within Planning District 23 are: Chesapeake, Franklin, Hampton, Poquoson, Williamsburg, Newport News, Norfolk, Portsmouth, Suffolk, and Virginia Beach.

³ See C. Debra M. Furr-Holden, Adam J. Milam, Elizabeth D. Nesoff, Renee M. Johnson, David O. Fakunle, Jacky M. Jennings, and Roland J. Thorpe, Jr. "Not in My Back Yard: A Comparative Analysis of Crime Around Publicly Funded Drug Treatment Centers, Liquor Stores, Convenience Stores, and Corner Stores in One Mid-Atlantic City," Journal of Studies on Alcohol and Drugs 2016 77:1, 17-24.

⁴ Data source: Department of Behavioral Health and Developmental Services

⁵ Planning District 8 includes: a) the Counties of Arlington, Fairfax, Loudoun, and Prince William, b) the Cities of Alexandria, Fairfax, Falls Church, Manassas, and Manassas Park, and c) the Towns of Dumfries, Herndon, Leesburg, Purcellville, and Vienna.

⁶ Cities within Planning District 23 are: Chesapeake, Franklin, Hampton, Poquoson, Williamsburg, Newport News, Norfolk, Portsmouth, Suffolk, and Virginia Beach.

Agency's Response to Economic Impact Analysis: The agency concurs with the Department of Planning and Budget's economic impact analysis.

Summary:

Chapter 480 of the 2016 Acts of Assembly authorizes the Department of Behavioral Health and Developmental Services to license programs using nonmethadone opioid replacements that are within one-half mile of a K-12 school or licensed day care center if the opioid replacement has been approved by the U.S. Food and Drug Administration for the treatment of opioid addiction. The amendments implement the changes to § 37.2-406 of the Code of Virginia enacted by Chapter 480.

Part VI
Additional Requirements for Selected Services

Article 1
Medication Assisted Treatment (Opioid Treatment Services)

12VAC35-105-925. Standards for the evaluation of new licenses for providers of services to individuals with opioid addiction.

A. Applicants requesting an initial license to provide a service for the treatment of opioid addiction through the use of methadone or any other opioid treatment medication or controlled substance shall supply information to the department that demonstrates the appropriateness of the proposed service in accordance with this section.

B. The proposed site of the service shall comply with § 37.2-406 of the Code of Virginia and, with the exception of services that are proposed to be located in Planning District 8, shall not be located within one-half mile of a public or private licensed day care center or a public or private K-12 school.

C. In jurisdictions without zoning ordinances, the department shall request that the local governing body advise it as to whether the proposed site is suitable for and compatible with use as an office and the delivery of health care services. The department shall make this request when it notifies the local governing body of a pending application.

D. Applicants shall demonstrate that the building or space to be used to provide the proposed service is suitable for the treatment of opioid addiction by submitting documentation of the following:

1. The proposed site complies with the requirements of the local building regulatory entity;

2. The proposed site complies with local zoning laws or ordinances, including any required business licenses;

3. In the absence of local zoning ordinances, the proposed site is suitable for and compatible with use as offices and the delivery of health care services;

4. In jurisdictions where there are no parking ordinances, the proposed site has sufficient off-street parking to accommodate the needs of the individuals being served and prevent the disruption of traffic flow;

5. The proposed site can accommodate individuals during periods of inclement weather;

6. The proposed site complies with the Virginia Statewide Fire Prevention Code; and

7. The applicant has a written plan to ensure security for storage of methadone at the site, which complies with regulations of the Drug Enforcement Agency (DEA), and the Virginia Board of Pharmacy.

E. Applicants shall submit information to demonstrate that there are sufficient personnel available to meet the following staffing requirements and qualifications:

1. The program director shall be licensed or certified by the applicable Virginia health regulatory board or by a nationally recognized certification board or eligible for this license or certification with relevant training, experience, or both, in the treatment of individuals with opioid addiction;

2. The medical director shall be a board-certified addictionologist or have successfully completed or will complete within one year a course of study in opiate addiction that is approved by the department;

3. A minimum of one pharmacist;

4. Nurses;

5. Counselors shall be licensed or certified by the applicable Virginia health regulatory board or by a nationally recognized certification board or eligible for this license or certification; and

6. Personnel to provide support services.

F. Applicants shall submit a description for the proposed service that includes:

1. Proposed mission, philosophy, and goals of the provider;

2. Care, treatment, and services to be provided, including a comprehensive discussion of levels of care provided and alternative treatment strategies offered;

3. Proposed hours and days of operation;

4. Plans for on-site security; and

5. A diversion control plan for dispensed medications, including policies for use of drug screens.

G. Applicants shall, in addition to the requirements of 12VAC35-105-580 C 2, provide documentation of their capability to provide the following services and support directly or by arrangement with other specified providers when such services and supports are (i) requested by an individual being served or (ii) identified as an individual need, based on the assessment conducted in accordance with 12VAC35-105-60 B and included in the individualized services plan:

1. Psychological services;

2. Social services;

3. Vocational services;

4. Educational services; and

5. Employment services.

H. Applicants shall submit documentation of contact with community services boards or behavioral health authorities in their service areas to discuss their plans for operating in the area and to develop joint agreements, as appropriate.

I. Applicants shall provide policies and procedures that each individual served to be assessed every six months by the treatment team to determine if that individual is appropriate for safe and voluntary medically supervised withdrawal, alternative therapies including other medication assisted treatments, or continued federally approved pharmacotherapy treatment for opioid addiction.

J. Applicants shall submit policies and procedures describing services they will provide to individuals who wish to discontinue opioid treatment services.

K. Applicants shall provide assurances that the service will have a community liaison responsible for developing and maintaining cooperative relationships with community organizations, other service providers, local law enforcement, local government officials, and the community at large.

L. The department shall conduct announced and unannounced reviews and complaint investigations in collaboration with the Virginia Board of Pharmacy and DEA to determine compliance with the regulations.