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

DBHDS Office of Regulatory Affairs
1220 Bank Street, 4th Floor South
Richmond, VA 23219

C/O Susan H. Puglisi/Regulatory Research Specialist

Dear Ms. Puglisi,

We believe there are many benefits to mobile Medication-Assisted Treatment (MAT) services for our community. As a large and diverse locality, transportation is often a barrier that prevents access to services. We are optimistic of the benefits this initiative would provide and how it could help close the gap by increasing access to those with substance use disorders (SUD), outlining some of the benefits below:

1. Increased Access to Treatment

• Addresses transportation barriers: In areas where public transportation is limited or nonexistent, many individuals struggling with opioid use disorder (OUD) may not have the means to travel to a treatment center. Mobile MAT units bring services directly to them, removing this barrier.
• Reaches remote or rural areas: Mobile MAT can serve patients in geographically isolated locations, ensuring that even those in the most remote parts of the community can access life-saving treatment.

2. Improved Health Outcomes

• Timely intervention: Bringing MAT to individuals in need can reduce the likelihood of overdose, improve retention in treatment, and support better overall health outcomes.
• Integrated care: Many mobile units provide not only medication (like methadone or buprenorphine) but also offer mental health counseling, primary care, and harm reduction services, which can holistically address the needs of people with OUD.

3. Reduced Stigma

• More privacy: In communities where there is stigma associated with seeking treatment for substance use disorder, a mobile MAT program can provide more privacy than visiting a central clinic, making individuals more comfortable accessing services.
• Community engagement: Mobile units often work in close partnership with local organizations and stakeholders, fostering community trust and reducing stigma associated with MAT and recovery.

4. Cost-Efficiency

• Lower infrastructure costs: Operating a mobile MAT unit can be more cost-effective than building new treatment centers, particularly in areas where the demand may not justify a permanent facility. It also allows services to be flexible and respond to changing community needs.

5. Flexibility and Convenience

• Convenient scheduling: Mobile units can operate on a flexible schedule, meeting individuals in various locations throughout the community on specific days and times, making it easier for patients to plan around their work or personal commitments.
• Rapid response: In times of crisis or increased demand, mobile MAT units can quickly mobilize to deliver services where they are most needed, offering a dynamic approach to care.

6. Reduction in Crime and Overdoses

• Lower opioid misuse: By expanding access to treatment, mobile MAT can help reduce the prevalence of opioid misuse, leading to fewer drug-related crimes in the community.
• Decreased overdose rates: Increasing access to MAT has been shown to lower the incidence of fatal overdoses, which is particularly important in areas without immediate access to emergency care.

7. Continuity of Care-Ongoing support:

• A mobile MAT unit can ensure that patients receive consistent care, even in areas where there is a shortage of healthcare professionals or addiction specialists. Many mobile units include follow-up services, ensuring that people stay engaged in long-term recovery.

As a resource for our jail, having the medicines delivered directly to our facility would be very helpful. Currently, we verify the prescriptions for each inmate, then must travel to the original prescribing clinic and pick up the doses at a specific time each day. The current system is ineffective for retrieving these medicines, but because we believe in MAT, knowing that it saves lives, we are willing to do whatever it takes to secure these treatments for our community.

Additionally, once an inmate still in recovery has been released, having someone come to them rather than having to set up transportation and get them to appointments would be a significant benefit. Many recently released inmates are very overwhelmed in the first 30 days, putting them at the greatest risk of overdose in the first two weeks post-release.

As outlined above, there are many benefits to access MAT more effectively. However, there must also be careful considerations for how the regulations are established. Of note, notification to Community Services Board (CSB) is essential, and establishing procedures around notification method, appropriate next steps for the CSBs and additional responsibilities identified in advance will clarify the role of all stakeholders in this important process.

Further, based on our experience and the scale at which we utilize these treatments today, it would be helpful for there to be a system to manage all requests, appointments, disbursements, ultimately collecting data for use and distribution metrics.

We look forward to further progress on this topic and offer our assistance if needed to effectively implement better access to MAT services.

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 Development Services (DBHDS) (amending 12VAC35-105-20 and adding 12VAC35-105-1830 through 12VAC35-105-1870). On behalf of the Stafford County Board of Supervisors (Board), I am writing to share our Board's comments. It is our understanding that the intent of these regulations is to explicitly incorporate this existing federal law into Virginia law. 

The Board offers the following comments:

• We believe the fast-tracking of these regulations should be stalled to allow for greater public comment, public engagement, and public education about the impact of, and the need for mobile medication assisted treatment in local communities. 

• We believe DBHDS should carefully consider its guidance for coordinating notice to local governing bodies to ensure localities have an opportunity for comment, similar to the process for DBHDS approval for providers seeking to operate a brick-and-mortar location. 

• We believe DBHDS should work with localities to identify planned service sites to ensure compliance with local zoning laws and regulations, to document compliance, and to identify any potential problems or concerns. 

• We appreciate the physical security and record-keeping measures DBHDS intends to require as part of the implementation of these regulations. The Board believes DBHDS should also consider a notification process to ensure local law enforcement and fire, rescue, and emergency services departments are aware of when mobile MAT services are provided to ensure appropriate emergency response when necessary. 

• We encourage DBHDS, in publishing its planned implementation requirements, to ensure they are published in a publicly available manner which ensures that providers and localities are aware of them prior to undertaking any planning to offer mobile services. 

The Board appreciates the conversations DBHDS has had with the Virginia Association of Counties (VACo) and offer our support for their comments. We appreciate your efforts and stand ready to assist in any way possible throughout this endeavor. 

Sincerely, 

Meg Bohmke

Chairwoman, Stafford County Board of Supervisors

Falmouth District