12VAC35-105-990: Section C.2

"A maximum of a five-day consecutive supply of take-home doses from 8 days of treatment to 30 days of treatment."   I would suggest/ask if this could be increased to a 6 day supply. 

I would also like to ask that 12-VAC-35-105-980 Section B, requiring weekly urine drug testing on patients who continue to use illicit drugs be eliminated. This requirement makes no sense from a medical/toxilogical standpoint, is significantly stigmitizing to our patients, requires a great deal of provider/clinician time and effort for no significant clinical return,  overrides the ability to provide more than 6 take home doses to those who continue to use illicit drugs but might benefit from additional takehomes in conflict with SAMHSA guidelines, and costs the state a lot of money in unnecessary lab fees for no clinical benefit. No other state requires drug testing this frequently. 

I would request and recommend that section D - "No individual younger than 18 years of age may be admitted to maintenance treatment unless without parent, legal guardian, or responsible adult designated by the relevant state authority consents in writing to such treatment " be reviewed and updated to better reflect federal guidance and ASAM best practices. Some adolescents do not have access to supportive parent/guardian support for treatment and best practices indicate that this should not be a barrier to access and maintain treatment.  

The overall document also is confusing in language choices, whereas majority of the updates and language appears to be directed at methadone specific treatment, the broader terminology of medications for opioid use disorder encompasses Suboxone, Naltrexone and other medications and could be misconstrued to provide tighter restrictions on treatment options in other settings. I recommend clarification of the intended target of Opioid Treatment Programs to clarify if this pertains to centers that utilize methadone or all programs that prescribe medications for opioid use disorder. 

I would take out the requirement for weekly drug screens being administered to patients who are still actively using because the new 8-point criteria does not take into account illicit drug screens. Patients are going to be able to receive take homes even with illicit use so drug testing them weekly is contradicting due to this not being something that is factored into getting the take-home medication. 

I believe when it comes to not taking into consideration the illicit substances and the danger it can cause the patient of providing take-home of methadone while testing positive for multiple benzodiazepines or other substance, the chances of potential overdose will be very high resulting an increase on overdose death rate. 

12VAC35-105-960.D This change in language that does not specify a "physical examination" and instead states an "examination" can be manipulated by the provider, it is important to specify a physical examination.  

12VAC35-105-970. The individual's progress in treatment should still be documented and evaluated.  This should be specified in the regulation.  

12VAC35-105-990. Regular attendance of counseling in accordance to an Indvidual's treatment plan should be taken into consideration of take homes, given that it has been clinically proven that counseling as a combination of MAT is the most successful for recovery.  Also, the other additions that state "absence of" how is the treatment provider determining there is an "absence of" this needs to be defined more....is it by assessment? and if so, what type of assessment? 

Requesting a 7 day maximum supply of take home medications to allow for clinics that are not open on weekends. 7, 14 and 28 day take home supplies allow the client to come in the clinic on the same day of the week. This allows room for mandatory court days, and clinic closings on the weekends. 

It is important to be able meet with patients and virtual/telehealth. This is helpful for those who work, take care of others including children. It gives them the opportunity to not feel rushed and they usually speak freely and longer when they can do telehealth. 

Also, I respectfully ask for you to remove the required weekly drug screens when patients are using illicit substances it increases the guilt and shame and is not helpful, instead harmful. 

I wanted to take a moment to highlight the many advantages of telehealth for patients, especially in terms of flexibility and reducing transportation stress associated with Medicaid.

Telehealth provides patients with the convenience of accessing healthcare services from the comfort of their own homes. This not only saves time but also alleviates the stress of arranging transportation, which can often be a challenge for many. With telehealth, patients can schedule appointments that fit their lifestyles, making it easier to prioritize their health without the added burden of travel.

Moreover, for those utilizing Medicaid, telehealth can significantly simplify access to essential services, ensuring that patients receive the care they need without the logistical hurdles.

By embracing telehealth, we are paving the way for a more accessible and efficient healthcare experience.

I advocating for the continued support and expansion of telehealth counseling services within our Virginia.

Telehealth has been important in improving access to counseling care for clients who face barriers to attend in-person appointments. Many individuals benefit significantly from the flexibility and convenience that telehealth provides, enabling them to receive timely and effective support from the comfort of their homes. Many clients experience barriers with transportation or having transportation willing to wait for the client to attend a counseling session. Some clients also have difficulty with attended the facility for counseling due to caring for families or work hours. From personal experience, telehealth sessions are frequently longer, more in-depth, and improvement in counseling attendance. 

I encourage you to consider the positive impact of telehealth and thank you for your attention to this important matter

First, I strongly advocate for the availability of both phone counseling and telehealth video counseling for patients. Many individuals face challenges that hinder their ability to attend in-person sessions, including full-time employment, parenting responsibilities, and geographic barriers, particularly for those in rural areas. Offering flexible telehealth options can significantly enhance accessibility and comfort for our patients, allowing them to engage in treatment in a manner that suits their individual circumstances.

Second, I propose a reevaluation of the requirement for weekly drug screenings for patients who test positive for illicit substances. This practice can inadvertently contribute to feelings of shame and stigma, which may hinder a patient’s willingness to seek help. A more compassionate approach could foster a supportive environment that encourages recovery and open communication.

Telehealth has yielded mixed results in my experience - for those that are compliant with telehelath counseling, it proves to be incredibly beneficial as they are more at peace and willing to talk when in the comfort of their own home. Removing telehealth as an option could decrease the amount of time a patient is willing to spend with their counselor.

Making drug screens a weekly requirement for patients that are illicit is harmful from a harm reduction standpoint. If patients are constantly being reminded of their illicit substance use, it can negatively impact their mental health. 

Please consider the impact these can have on our patients going forward!

I am an advocate for the continuing use of telehealth services provided for clients in Virginia. 

Telehealth allows the client the ability to receive mental health services from the comfort of their home. This resource allows them to have flexibility they may need due to other responsibilities such as career, environment, parental duties, and other factors that could otherwise be a barrier to receiving mental health care. Overall, telehealth counseling can improve access to care and enhance the therapeutic experience. 

As a substance abuse counselor in a very chaotic setting, many of my patients do not come in for neatly scheduled timeslots. Several of my patients have work schedules that make it very difficult to have sessions, or who are worried about their scheduled ride leaving them. There are days where a stable patient who only comes in once a month comes in at the same time as a harm-reduction patient, forcing a choice between a greater need and lesser availability. Virtual sessions provide my patients access to me during hours that work best for them, and often during times when I am more free to engage with them. (After normal in-person hours have ended and things are less chaotic.) It is true that some patients do not show up for scheduled sessions, but for me this offers another measure of stability: do they follow through on their commitments? I have another avenue to discuss things with them in such cases. In summary, the flexibility that virtual sessions offer in my setting is such that I and a number of my patients would have difficulty continuing with the counseling side of their treatment without it.

Telephonic counseling was very successful in increasing patient engagement during the pandemic. Audio visual counseling is excellent to use when patients have smart phones and wifi, but the majority of patient in my clinic do not have these luxury. Telephonic counseling mitigates the daily stress of Medicaid transportation services. When clients live with the reality based fear their ride will leave them at the clinic and they will be stranded, it is very difficult to successfully engage them in a counseling session. Telephonic counseling option does not discriminate against clients of lower socioeconomic status who rely on un predictable transportation or have the needed technology for face to face zoom counseling. Please consider this option of adding telephonic as I know other states continued to allow this option for clients after covid and remains successful in reaching people who otherwise wouldn't have easy access to their counselors.

12 VAC35-105-930

In section B, "A medication for opioid use disorder treatment program's physician  shall assess individuals...", change physician to provider to allow for sites that utilize NP or other licensed provider to complete assessment to allow greater access for the population served.

12 VAC 35-105-970

In section A, define Face-face counseling sessions to include Telehealth options audio/visual and full telephonic to be able to complete "in person" session. This allows for greater flexibility for engagement with the population served on a schedule that allows for full integration into functional society and encourage meeting persons served where they are. This will also allow for right treatment right now, when a patient is available and not limit session completion due to transportation or time constraints. 

In section B, add language to define if counseling is not completed trough referral, or verification of completion cannot be obtained, counseling must be completed at site or through telehealth services.

12 VAC 35-105-980

In section B, Toxicology screening weekly if positive for unfavorable substance needs removed/changed to toxicology screening will be at the discretion of the provider/Interdisciplinary team if unfavorable in monthly screen. This is to promote site to individualize treatment to their specific needs and allow for substances that may process slowly to be assessed for impact on sobriety.

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.