Bicycle Health's Presentation to the DEA

Background

Dr. Brian Clear, MD, the Chief Medical Officer at Bicycle Health, was one of a handful of experts selected to present information about the successful treatment of opioid use disorder through the practice of telemedicine at a DEA listening session held in Washington, D.C., on September 12, 2023.

Dr. Clear was one of 60 presenters selected by the DEA from more than 1,000 inquiries. Each presenter had 10 minutes, followed by questions from DEA Administrators Anne Milgram and Tom Prevoznik. The goal of the two-day sessions was to gather feedback on the issue of telehealth prescribing, specifically the prescribing of controlled substances like buprenorphine.

To their great credit, the DEA is trying to learn more about the current state of telehealth prescribing in order to improve the way it is regulated, without limiting patient access to effective treatment options.

The DEA will use the feedback from the listening session to develop a path forward for the prescribing of controlled substances through telehealth.

Opening Remarks at 9/23 DEA Listening Session from Dr. Brian Clear

I directed in-person OUD (opioid use disorder) care programs for about 5 years prior to beginning telemedicine work with the onset of the COVID PHE (public health emergency). Through the flexibilities permitted by the waivers, at Bicycle Health we have come to employ 80 addiction medicine specialist providers and we are currently treating over 11,000 patients with OUD across 32 states.

When I began this work in 2020, like most of our providers, I initially assumed that telemedicine would be limited compared to in-person care. In some ways it is, but like all effective treatment settings it also has advantages, and these have been so significant they have enabled us to expand access and improve outcomes in ways that have exceeded expectations from in-person experience.

Data on the Quality & Outcomes of Bicycle Health's Care Model:

We see a 90-day retention rate of 70%, compared to an in-person norm of about 50%.

• We are able to see and begin treatment for over 2/3 of new enrollees within 24 hours of their initial outreach.
• 19 of 20 patients who begin care with us (95%) achieve their initial effective treatment dose within 7 days,
• 80% of our patient population completes a drug screen in any given month.

These outcomes would indicate an extraordinary program in any setting, and we have achieved them broadly at scale through telemedicine. 

What Drives Skepticism of Telehealth-based OUD Care?

These results beg the question: why are so many providers like myself initially skeptical of telemedicine OUD care?

To get the answer, our research team at Bicycle Health used a qualitative research design to interview our own provider team to find out what drives initial skepticism of telehealth treatment.

We found the following common themes regarding the initial hesitance at starting telemedicine work:

• The newness of the setting as it establishes credibility
• The regulatory uncertainty surrounding the future of telehealth
• Assumptions about who patients with OUD are, which leads to doubt about telemedicine's ability to serve them well

This third hesitation comes from a common misconception. Most providers look at the typical population of an in-person OUD care program, and assume that the average person with OUD is unemployed, has few or no family obligations, has a high likelihood of being unsheltered, and has limited access to technology, much less the ability to use it reliably.

However, these assumptions are incorrect. In fact, traditional OUD in-person treatment programs only serve 10% of the population and tend to design their programs for the most severely affected. As a result, the majority of those with OUD, even if there is a nearby in-person program, often won't access that program—either due to conflicting obligations or a perception that the program isn't intended for them.

Our survey results support this. Despite initial skepticism from clinicians, after beginning telemedicine practice, our team feels effective and rewarded in their roles.

Here is what our providers observe:

• We can effectively build relationships with patients in the telemedicine setting. We even have some advantages such as the ability to see into their homes, meet their families, and see them quickly on their lunch break when they can't get off work.
• We can effectively reach rural patients and treatment-naive patients, which is especially impactful and rewarding for our team. In fact, 18.2% of our patients are rural, 67% are employed, and over 20% of new patients haven't engaged with any MOUD (medication for opioid use disorder) treatment program before.

We're reaching patients who have previously been unreached. As a result, like our patients, our providers also tend to stick with us and stick with telemedicine. We consistently see an under 1.5% quarterly provider turnover rate.

Efficacy of Telehealth-based Drug Testing

Another element of telemedicine OUD care that invites curiosity and skepticism is how drug testing is performed. The following is a summary of how our drug screening program works, along with the results of a published study on the efficacy of our program:

• We utilize a randomized at-home drug testing program that prompts patients, on average, once every 30 days to complete a urine drug screen.
• Test results are submitted through a series of timed photographs of the at-home kit, and we also utilize video-observed saliva drug screens when necessary.

We know that sample falsification rates at in-person programs range from about 5 to 18% in the literature. 

To get a sense of our own sample falsification rates, we ran a study that required a cohort of patients to submit a one-time sample by mail to a research partner, and following that submission we collected a buccal swab under direct video observation for genetic matching to the previously submitted urine sample.

Among submitted samples:

• Only 2.3% were found to contain exogenous or “spiked” buprenorphine or other evidence of adulteration.
• 0.8% were determined to be human urine from a source other than the patient.

These observations support a high rate of drug screen adherence among participants who completed the study, and full findings were published in the Journal of Substance Abuse in September.  

In the past, when we determined that a patient was struggling to use their medication as directed, following our best interventions, our only option was to refer them to an in-person program for Sublocade or Daily Observed Treatment.

Beginning in August of this year, we can now use Sublocade via telemedicine in some areas of the country, which is then administered directly by a qualified pharmacist. Sublocade is a once-per-month injected extended-release buprenorphine.

For some patients, it can solve medication adherence issues, and it is essentially impossible to divert. It is not a magic bullet; it is still very costly and access is limited, but it is a promising new resource that we have used now for several patients and look forward to continuing to scale as more pharmacies begin to offer the service. 

Alabama Airdrop

One of the potential controls the DEA is exploring is to reinstate an in-person visit requirement for OUD patients prescribed buprenorphine via telehealth. Addiction medicine experts agree this restriction would negatively impact access to care and does not convey any known benefit to care quality or safety.  We do not have to guess at this because we have a real-world example.

In July 2022, the state of Alabama enacted a law requiring that for any controlled prescription to be issued on the basis of a telemedicine encounter, the prescriber must have seen the patient in-person at least once within the preceding 12 months.

When this law was enacted, Bicycle Health had been operating in Alabama and was treating just over 500 patients via telemedicine. Our initial response was to support as many patients as possible to transition to in-person care, but only 20% of our patients were able to find an in-person program. That left about 400 who were either unresponsive to the effort or were unable or declined to find an accessible in-person provider.

To protect these 400 patients from potential relapse and other complications, we sent a team of 2 physicians and support staff to Birmingham to offer a weekend popup clinic. All patients were asked to travel to the popup clinic to see our physicians in-person and satisfy the mandate for 1 year.

In total, 162 patients were able to complete the visit. Over 200 patients did not and were lost to follow-up. Of the 162, 160 recently completed their second annual in-person visit this past July and 158 also completed an experience survey.

These are the survey results:

• 100% of patients arrived by car, none by public transit.
• Mean travel distance was 86 miles.
• 25% missed work to attend (on the weekend).
• 16% needed to find childcare to attend.

Patient sentiment:

Patients disagreed with the following statements on a 1-5 Likert scale, with a median score of 2:

• "Seeing my provider in-person improves my care or my ability to succeed in treatment."
• "I have other resources for opioid use disorder care in my community."

Analysis:

The in-person mandate selected for the most resourced and engaged patients in Alabama. While almost everyone who completed the requirement once went on to do it again a year later, it is foolish to assume that the in-person visit itself had anything to do with achieving that 98% retention rate. In fact, it created a filter which removed the most vulnerable 60% of patients from the treatment program, and their outcomes are unknown. By any measure, the reinstatement of the in-person mandate in Alabama was a disaster. 

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Summation

Telemedicine-based OUD care has been highly successful in expanding access to and improving the quality of OUD care. However, we have also seen that these improvements are as vulnerable as a person in early recovery from OUD in the face of hasty regulation.

My ask is this:

1. In designing a permanent regulatory framework, we must consider that it needs to work for the majority of patients, not just the more resourced and motivated minority. For patients, we should understand that any new barrier to access will discourage that access.
2. In regulating a requirement for a patient, no matter how seemingly small, it must already be a universal component of good OUD care or it becomes a barrier to good OUD care. A bonafide physical exam meets this standard, and so does maintaining a valid form of ID. An in-person visit doesn't.

For providers, those of us currently braving telemedicine OUD care are highly motivated and willing to accept risk and expense for public health and for the field. The majority of providers won't be as eager to sign up for new costs and risks unless there's an offsetting benefit. If special registration is the pathway chosen to enable telemedicine OUD care, it won't be successful if its net effect is a burden and expense.

My Medical Group would prefer for telemedicine OUD care to be enabled through regular rule-making, as opposed to the addition of a new special registration process. However, special registration could potentially be a net benefit to multi-state telemedicine OUD practice if it were set up in the following ways:

• Offer a single national registration pathway, rather than state-by-state registration.
• For effective OUD care, it would only need to permit the prescribing of schedule 3-5 medications that are FDA-approved for the treatment of OUD, and presumably it would not authorize any onsite medication storage or dispensing.
• It would also be reasonable, as a condition to receiving special registration, to require attesting to certain practice elements that are established as universal in good quality telemedicine OUD care: PDMP reviews; a formal medication adherence support (diversion control) policy; and a formal drug screen monitoring policy based on published standards of care endorsed by reputable professional societies.
• It would also be reasonable to require ePrescribing.

We strongly discourage including arbitrary dose, duration, or formulation requirements in any framework. I urge the DEA to design any new process to improve its ability to oversee and audit prescribing patterns and to intervene when exploitative practice is identified, and to avoid attempting to preemptively control or limit clinical practice through regulation. 

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