I am writing on behalf of the Virginia Association of Medication-Assisted Recovery Programs (VAMARP) to provide our feedback on the DRAFT Fast-Track: MOUD Amendments to Align with Federal Updates. We have identified several key suggestions that we believe will enhance the final rule. 

Firstly, we noted the inclusion of a definition for long-term withdrawal; however, the absence of a definition for short-term withdrawal may lead to confusion. To clarify the distinction between the two, we recommend adding a clear definition for short-term withdrawal. Additionally, on page 5, the document references the DSM-5; it should specify the DSM-5-TR for accuracy. 

12VAC35-105-925 

In terms of terminology, we propose substituting "physician" with "licensed medical provider" on pages 17, 19, and 20. This adjustment will better align with the Federal Final Rule, “A medical director may delegate specific responsibilities to authorized program physicians, appropriately licensed non-physician practitioners with prescriptive authority functioning under the medical director's supervision, or appropriately licensed and/or credentialed non-physician healthcare professionals providing services in the OTP, in compliance with applicable Federal and State laws. Such delegations will not eliminate the medical director's responsibility for all medical and behavioral health services provided by the OTP.” 

12VAC35-105-970  

We also suggest enhancing counseling options on page 21 by permitting the use of telephonic counseling alongside traditional face-to-face sessions, to ensure patient choice is respected. Our experience during the pandemic demonstrated significant improvements in patient outcomes and engagement with the implementation of telephonic counseling sessions. While we acknowledge concerns regarding oversight, clinics have maintained supervision measures to ensure patient safety and compliance during our use of telephonic counseling sessions.  

In section B, we recommend removing the phrase “or through referral,” as it is crucial for Opioid Treatment Programs (OTPs) to provide clinical services in-house. Allowing referrals could inadvertently create a “dose and go” model, which will increase stigma and hinder patient recovery. This model will also create additional gaps in services by potentially referring to an external counselor who does not have training in MOUD. 

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This year, the decision to allow clinics to close on Sundays has significantly benefited both patients and staff. This change has encouraged patients to work towards obtaining more take-home medication, resulting in improved overall outcomes. To sustain these benefits, we suggest the removal of section C-1 from page 22. Per the new federal rule take home medication should be “based on the clinical judgment of the treating provider, patients may be eligible for unsupervised, take-home doses of methadone upon entry into treatment.” This line is taken directly from the federal guidelines. 

In addition to Sunday closures, we advocate for moving away from restrictive timelines for take-home medications, as these promote stigma and diminish patient autonomy. Our experience during the pandemic revealed that removing these constraints led to better patient control over their recovery and allowed medical director and treatment team the flexibility to adapt care to individual needs.  

We propose following the federally approved timeline: 

(i) During the first 14 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is limited to 7 days. It remains within the OTP practitioner's discretion to determine the number of take-home doses up to 7 days, but decisions must be based on the criteria listed in paragraph (i)(2) of this section. The rationale underlying the decision to provide unsupervised doses of methadone must be documented in the patient's clinical record, consistent with paragraph (g)(2) of this section.  

(ii) From 15 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) is limited to 14 days. It remains within the OTP practitioner's discretion to determine the number of take-home doses up to 14 days, but this determination must be based on the criteria listed in paragraph (i)(2) of this section. The rationale underlying the decision to provide unsupervised doses of methadone must be documented in the patient's clinical record, consistent with paragraph (g)(2) of this section. 

(iii) From 31 days of treatment, the take-home supply (beyond that of paragraph (i)(1) of this section) provided to a patient is not to exceed 28 days. It remains within the OTP practitioner's discretion to determine the number of take-home doses up to 28 days, but this determination must be based on the criteria listed in paragraph (i)(2) of this section. The rationale underlying the decision to provide unsupervised doses of methadone must be documented in the patient's clinical record, consistent with paragraph (g)(2) of this section. 

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Over the course of the last year, across the state, we have recognized increased collaboration between correctional institutions and OTPs. To encourage these continued partnerships, we would like correctional institutions added to section C on page 23 in addition to residential treatment. 

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We recommend incorporating language that allows for the immediate discharge of patients who exhibit violent behavior or threats of violence. Maintaining these patients for a minimum of 10 days poses significant safety risks to other patients, staff, and visitors. 

12VAC35-105-980 Part B 

Lastly, while not currently included in the draft, we urge consideration of a more flexible approach to weekly drug screenings. The current regulation mandates weekly tests for patients testing illicitly, which can adversely affect recovery and perpetuate stigma, this regulation serves as a shaming tool, as it is no longer an evidence-based intervention.  
“Reducing the requirements for random toxicology testing as an important method to further reduce stigma and loss of bodily autonomy among a population that has often faced violent and punitive treatment”. This previous statement was taken verbatim from the new federal final rule.  

We also know that some substances can take considerably longer to leave an individual’s system. Allowing individual medical providers and treatment teams discretion over testing frequency would foster a more supportive recovery environment that focuses on the individuals progress toward all treatment goals. We ask this regulation to be changed to align with the federal guidelines.  

On behalf of myself and the OTPs represented by VAMARP, I appreciate your consideration of these comments. Should you have any questions or require further clarification, please do not hesitate to reach out. Thank you for your attention to these important matters. 

Sincerely, 

Nicholas Cawby 
President  
Virginia Association of Medication-Assisted Recovery Programs (VAMARP)