Ms. Susan H. Puglisi

Regulatory Research Specialist

DBHDS Office of Regulatory Affairs

1220 Bank Street, 4th Floor South

Richmond, VA 23219

Dear Ms. Puglisi:

Thank you for the opportunity to comment on the proposed regulations amending 12VAC35-105, Rules and Regulations for Licensing Providers by the Department of Behavioral Health and Developmental Services (amending 12VAC35-105-20 and adding 12VAC35-105-1830 through 12VAC35-105-1870).  We very much appreciate your time and that of your colleagues in meeting with us to discuss these proposed regulations and the Department's plan to implement them.

Based on our conversation with Department staff several weeks ago, we understand that the Department is planning to require certain safeguards of providers with respect to local governments' notice and opportunity to comment regarding planned locations for mobile medication-assisted treatment program services.

Specifically, it is our understanding that the following requirements will be imposed:

• The Department will require proof that providers have received approval from the Drug Enforcement Administration for additional site locations and that providers have informed the local governing body and the local Community Services Board of the locations where they intend to provide services.
• Providers must document the locality's response to the proposed service locations and communicate that response to the Department.  Providers will be given a standard form for a locality to use to submit any concerns or complaints to the Department.
• Providers must document that the locations where services are intended to be provided are in compliance with all local laws and regulations, to include zoning ordinances.

We believe that notice to localities and an opportunity for localities to comment, similar to the process for Department approval for providers seeking to operate a brick-and-mortar location, is important in ensuring that localities are aware of planned service sites and able to point out potential problems or concerns.  We also strongly support a requirement for providers to document compliance of mobile medication-assisted treatment program site locations with local laws and regulations, to include zoning ordinances.  We encourage the Department to formalize these planned implementation requirements by including them in the proposed regulations or otherwise documenting them in a manner that ensures that providers and localities are aware of these requirements prior to undertaking any planning to offer mobile services.

Thank you for your consideration of our perspective.

Sincerely,

Dean A. Lynch, CAE

Executive Director

Dear Susan Puglisi,

I would like to object to the proposed Fast Tracking of mobile units to be deployed for the purpose of MAT expansion.

MAT availability has increased tremendously since the new ARTS guided programs were rolled out in 2016. In the year 2018, when preferred OBATS were gaining traction, the overdose rates reversed and dipped substantially. Since then, MAT programs have soared in number-- making MAT (predominantly buprenorphine) available to the point of being virtually “over the counter.”  Overdose rates reversed course again and trended back upward .

The success in 2018 was most likely due to programs being of better quality. Patients were held more accountable in their recovery. Extrinsic motivations imposed by conscientious programs enabled  motivational interviewing techniques, a more comprehensive milieu, and better control of controlled substances. Patients became  more intrinsically motivated when a better understanding of the psychosocial impact and risks for overdose and death were gained.

When more treatment options were made available,  patients would simply choose a more permissive program and receive “pill mill” quantities of MAT without the milieu of therapies and without being held accountable. Instead of seeking recovery, patients would often seek providers allowing the easiest access to abusable, (un)controlled substances.

To allow Mobile Unit delivery of MAT without leverage for a more comprehensive program would only lead to more abuse of substances, worsening of opioid use disorders, overdose, and death.

Gene Germano MD

Medical Director and Founder

GHR Center for Addiction Treatment and Recovery

850 Tidewater Drive Suite A

Norfolk, VA 23504

Main Phone: 757-333-6992

Fax: 757-383-6399

Email: GGermanoMD@GHRCenterAddiction.com