Brian Clear, M.D., is chief medical officer at Bicycle Health, a digital health organization that provides biopsychosocial treatment of opioid use disorder (OUD) via telehealth. He recently spoke with Healthcare Innovation about the progress the company is making reaching people who would otherwise never make it to in-person treatment.
HCI: Would tell me a little bit about your background — when you joined the company and what you'd been doing before that?
Clear: I'm a family doctor. I trained in Kentucky, with my early career in Florida. Shortly after residency, I started working with patients with opioid use disorder. Patients were coming in at a high volume with a problem that has a has a solution, but a solution that isn't being deployed very well. It stood out as a very high-need opportunity within the medical field. It had an answer that just wasn't being offered and wasn't being delivered to patients. Patients were coming into the hospital overdosing on opioids and discharged and sent to 90-day abstinence-based retreats that have a 60- or 90-day waiting period to get in the door and would cost tens of thousands of dollars. That was what I saw happening most commonly during my residency training in Kentucky. Whereas if you can provide it, we have medication that has over 90 percent success rate in terms of avoiding overdose and death for OUD as long as you can drive adherence.
HCI: Why were those medications not being offered in those settings?
Clear: A combination of stigma as well as very complex regulatory oversight. That makes it difficult to prescribe. And doctors who had the motivation to jump through those regulatory hoops and get the certifications and build their practices also faced their own stigma within the professional community. At that time, it was seen as somehow shameful to be using medical interventions to work with patients with addiction. There wasn't something to be proud of, at that time — to run a suboxone clinic. We know that was a badly mistaken mentality. It's something that's highly effective. So you need to overcome those stigmas.
HCI: You joined Bicycle Health in 2020?
Clear: Yes, that is right. I worked in in-person programs for about seven years before joining Bicycle, so I've worked in opioid treatment programs as well as office-based buprenorphine programs with integrated primary care. Right when the COVID waivers were released, which permitted telehealth-based treatment of opioid use disorder, I jumped on this opportunity to develop a telehealth-only model through Bicycle Health.
HCI: What's the origin story of the company? How did the founder see the combination of opioid use disorder treatment and telehealth working?
Clear: When founder Ankit Gupta started working on this in Redwood City, Calif., it wasn't possible to do a telehealth-only model of opioid use disorder care, but you could do a hybrid model. His background is in technology. He saw some of the same problems that I did where there was a solution for opioid use disorder that was effective but it was being delivered very, very poorly. With his tech background, he had experience building automations and efficiencies to create a good user experience. Through that lens, he was able to see some of the inefficiencies and the healthcare experience that patients were having.
HCI: So the COVID telehealth rules allowed for this great expansion where OUD treatment didn't have to be hybrid; it could just be pure telehealth? And is that what allowed for the expansion of the company?
Clear: Yes, dramatically. For context, opioid use disorder affects at least 10 million people nationwide. And we know that only 10 percent of persons who self-report that they have opioid use disorder engage in any kind of medical treatment for it at all in a given year. So 90 percent of this public health crisis is not being addressed. Opioid treatment programs historically have developed to serve the needs of this 10 percent who are already engaging in treatment. They'll leave treatment or come back to treatment, but they represent only a very small percentage of the problem. With a hybrid model that starts with patient care in person, it still serves that same 10 percent that's used to coming in in person. You don't engage anyone new or reach anyone new through a hybrid model. We found that once we started doing telehealth only, over 30 percent of all new patients coming into our program had never been in an in-person treatment program before. We were finally tapping into that invisible 90 percent that other programs don't serve. And that's just everything for trying to truly address this public health crisis.
HCI: Is there any challenge finding enough clinicians to keep up with the growth in the number of people you're getting as clients?
Clear: There is. But at the same time, we've been very effective at recruiting over the past three years. It is a rare specialty, especially to be board-certified in addiction medicine. But it's also a very desirable work environment to be able to serve patients broadly enough to actually engage yourself in opioid use disorder-focused addiction medicine full-time. If you're working in an in-person program, usually OUD-focused addiction medicine is a small percent of your practice and you're going to struggle to focus on that specialty exclusively. We can offer that through telehealth by deploying these clinicians very broadly. We've been able to recruit a team of over 80 full-time employed addiction medicine specialists at this point and we are still growing.
HCI: I understand that Bicycle Health is working on scaling up a micro-dosing program. Can you describe why that is innovative?
Clear: Historically, the process of starting treatment for opioid use disorder has included a period of two to three days of opioid withdrawal, while you're essentially clearing your system of other opioids that you were using. When you do start prescribed buprenorphine, if you still have stronger opioids in your system, buprenorphine will essentially displace those opioids from the active receptors. If that happens quickly, you'll experience a pretty nasty withdrawal reaction where you're going to feel like you've got the flu for a day or two, and it's enough to discourage a lot of patients from continuing with the treatment process. Many patients will go back to using illicit opioids. If you instead continue using other opioids and start suboxone in very small doses and gradually taper up over a week, you can avoid this withdrawal period entirely. Then you stop other existing illicit opioid use after that week-long taper period, and you're on suboxone without a withdrawal phase. It is highly effective.
As far as we know, we're not the first telemedicine program to try this approach, but we are the first telemedicine program to study it. We're wrapping up a clinical trial here probably in the next month and we'll be submitting it for publication.
We found that when offered the choice between micro-dosing and the traditional induction approach, a large majority of patients will elect for micro-dosing and we see higher success rates with micro-dosing compared to traditional induction also when we randomize. So it seems to be a more patient-friendly, equivalent outcome, relatively low risk and possible to do safely in the telemedicine setting.
HCI: Is there any chance of the payers changing their tune about paying for telehealth-only for OUD as they perceive the COVID emergency winding down?
Clear: There's always some risk, but the more we talk to payers and the more we talk to regulators, the climate is moving in the right direction. There's a lot of fear that telemedicine-based practice can lend itself to overprescribing or abuse. We've seen that play out in some other industries, but we've not seen that play out in the treatment of opioid use disorder specifically. Even DEA have acknowledged publicly there has been no increase in diversion of buprenorphine or misuse of buprenorphine since the telehealth waivers went into effect. The DEA is taking the lead on this issue.
The payers and state regulators are watching the DEA to see what they're going to do before they act locally. Just yesterday DEA released a draft solicitation for feedback from telemedicine programs and stakeholders and they'll be hosting a series of town halls in September to basically get ideas from the industry at large of how it should be regulated in a way that preserves the successes of telehealth and doesn't undermine it. This all looks extremely promising. I think the DEA honestly wants to engage in this conversation and wants to do the right thing. And we've got so many experienced, innovative minds working on this, we'll find the solution that allows us to continue this form of treatment for patients.