Definitions:

DSM is defined as the DSM-5. This is not the most recent version of the DSM; I recommend referencing the DSM-5-TR.

Under “Withdrawal Management,” long-term withdrawal management is described. However, short-term withdrawal management is not defined even though it is referenced in 12VAC35-105-990 (D). I recommend a clear definition of “short-term withdrawal management be added to the definitions.

12VAC35-105-960 (A):

The term "examination" is used inconsistently throughout this section, referring to an initial medical examination, a screening examination, and a full history and examination. However, subsequent sections reference "the examination" multiple times without specifying which type is being discussed. For instance, section B states, "when the examination is performed," and in B1, "...the narrative of the examination," without clarifying which examination is meant.

I recommend revising the language to clearly distinguish between these different types of examinations. For example, use "initial medical evaluation," "screening," or "full history and examination" as appropriate. Additionally, I suggest reviewing all mentions of "the examination" to ensure clarity about which component is being referenced.

12VAC35-105-970 (A):

Research demonstrates that virtual and telephonic counseling sessions yield outcomes comparable to in-person sessions for participants in MOUD treatment programs. To date, no evidence suggests that in-person sessions offer greater benefits than virtual or telephonic options. In fact, multiple studies show that MOUD participants report enhanced quality of life when provided virtual or telephonic counseling, citing the convenience of meeting during their lunch break, while their children sleep, or from the comfort and safety of their home. Additionally, the flexibility of these options has been shown to reduce both stress and stigma for people who use drugs.

For example, patients with 28 days of take-home medication may prefer to continue counseling weekly but should not be required to visit the clinic on non-dosing days simply to wait for a counselor. Such policies undermine the flexibility that virtual counseling provides.

As a Licensed Provider, I have heard Virginia DBHDS personnel express a preference for in-person counseling to "get eyes on them." However, all patients are required to visit the clinic at least once per month, ensuring regular face-to-face contact. This stance appears to reflect an unsupported bias rather than evidence-based practice, suggesting an inequitable treatment of those with substance use disorders compared to individuals with other mental health conditions.

DBHDS has repeatedly recognized the value of person-centered care, which has been shown to improve outcomes. Similarly, research and SAMHSA’s new guidelines endorse the benefits of virtual and telephonic counseling, emphasizing the importance of patient choice. Aligning with these best practices, MOUD participants should have the option to choose the timing and format of their counseling sessions, without being forced to attend in-person if they prefer virtual or telephonic meetings. Accordingly, I recommend you alter the language of this section as follows:

“The provider shall conduct in-person, virtual, or telephonic counseling sessions (either individual or group) at a frequency tailored to each individual based on an individualized assessment and the individual’s care plan that was completed after shared decision-making between the individual and the clinical team. At a minimum, the provider shall conduct one in-person, virtual, or telephonic counseling session per month for the first year of the individual’s treatment and quarterly during the second year.”

12VAC35-105-970 (A):

I recommend removing this section. Allowing counseling to be provided through external referrals undermines the MOUD treatment facility’s ability to effectively monitor and oversee the patient’s care. It prevents licensed medical and mental health providers from fully managing the treatment process, while also limiting the ability of the clinic and regulatory bodies (such as DBHDS and CARF) to assess the quality of counseling services.

Moreover, licensed mental health providers would be unable to train or ensure that outside counselors have the necessary expertise in treating co-occurring mental health conditions and opioid use disorder. This disconnect removes the counselor, who is often the patient’s strongest advocate, from the treatment team, leaving critical decisions to be made without their clinical input. Such an approach could set a harmful precedent, with significant risks to patient care.

12VAC35-105-990 (C):

1. There is no research support for removing the clinic’s ability to provide new patients with one take-home dose for clinic closures. I recommend reinstatement of the former language of C1 to allow one take-home dose for closures.

12VAC35-105-990 (C):

Please note that there are currently two sections titled “C.”

12VAC35-105-1020

I recommend adding a provision at the end of this paragraph to allow for immediate discharge in cases where there is a significant threat to clinic staff. For example, at one of our clinics, we recently had a patient, known to be a gang member and violent offender, caught by police selling methamphetamine in the clinic parking lot. When confronted, the patient made a direct and serious threat to a staff member. As the regulation is currently written, we would be required to contact DBHDS and request permission to discharge the patient before having the police remove them from the property, which could pose an immediate risk to the safety of staff and patients.

12VAC35-105-980  (B)

There is no evidence to support the benefit of requiring weekly drug screens for patients who test positive for illicit substances. On the contrary, these frequent screenings can heighten feelings of shame and distress, which are known to be major contributors to ongoing drug use. When patients feel shame, they are more likely to use substances as a way to cope with those distressing emotions. Increasing the frequency of drug screens may, therefore, unintentionally increase the likelihood of further substance use. I recommend removing the requirement for weekly drug screens in these cases.