Substance use disorder (SUD) treatment providers who prescribe medications for opioid use disorder (MOUD) via telehealth received some good news on Wednesday.
The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) announced a final rule that allows clinicians to prescribe buprenorphine via telehealth or audio-only telehealth visits for up to six months. This rule, called the Expansion of Buprenorphine Treatment via Telemedicine Encounter, is finalized and published in the Federal Register.
While the new rule could make it easier for virtual prescribing, many providers are worried that ambiguity in the regulations would complicate the legal landscape for MOUD prescribing in the future.
The DEA also released a proposed role that would allow certain practitioners to prescribe controlled substances via telehealth as long as practitioners meet the specifications of a special registration framework. The proposed rule, Special Registrations for Telemedicine and Limited State Telemedicine Registrations, would dramatically expand the organization’s authority to regulate prescribers and telemedicine companies, according to Dr. Brian Clear, chief medical officer of Bicycle Health.
“Ultimately, I think it’s better than the existing system,” Clear said. “It eliminates the need to have practice locations and physical offices in all 50 states to treat patients nationwide. It eliminates the really exorbitant state-by-state registration fees of almost $1,000 in every state, and cuts that down to $50 per state. It’s workable. I think it creates new efficiencies and saves some money in the process, but also expands DEA’s authority. It’s just legally very complex to navigate.”
Virtual OUD treatment provider Bicycle is headquartered in Boston, Massachusetts and offers MOUD-based treatment, recovery coaching and peer support groups.
The special registration framework
If passed, the proposed rule would require providers and telehealth companies to maintain multiple DEA registration numbers. Some providers could be required to maintain up to five special registration numbers, depending on the medications prescribed and if they belong to a larger organization, along with other factors.
If the special registration framework passes, Bicycle Health would likely have to employ an expert full-time to navigate its complexities, Clear said. For smaller providers, the legal minutiae may limit telehealth prescribing.
The proposed special registration rule is the most flexible iteration of the DEA’s attempts to allow permanent telehealth controlled substance prescribing, according to Clear and Zack Gray, founder and CEO of virtual OUD treatment provider Ophelia. But the incoming Trump-Vance administration could potentially toss the entire framework and the DEA could be forced to start from scratch again.
The largely bipartisan response to the opioid crisis lends hope that the new administration would carry forward with a version of the framework, however.
“My belief is that if you follow the data and the expertise of the clinical community and major medical associations, it would be very silly to reinstate any version of the in-person visit requirement for buprenorphine,” Gray said. “Everything we know about it is that it has been highly effective, prescribed via telemedicine and saved a lot of lives. I still think that’s where we will land. I think how we get there depends on the law-making process and the timeline of bureaucratic implementation.”
New York City-based Ophelia provides virtual OUD treatment in 14 states, focusing largely on Medicaid beneficiaries.
The special registration document consists of 160 pages and invested parties across the telehealth and SUD industries were still parsing the details as of this article’s publication. The framework is in the comment period, and a significant number of comments are likely to be submitted with concerns and questions regarding the rule.
“After initial review of that language, the rule includes elements that will not be easy to operationalize, and we hope that these unworkable restrictions are changed in the final rule,” Kyle Zebley, senior vice president of public policy at the American Telemedicine Association (ATA) and executive director of ATA Action, told ATB in an email.
“Specifically, for Schedule II controlled substances, this rule looks to be unfeasible and cannot be operationalized, which would be a major setback, should this become the final rule,” Zebley continued. “Another particularly concerning requirement is that, regardless of the type of special registration, special registrants must verify the identity of the patient and conduct a nationwide Prescription Drug Monitoring Program (PDMP) check of all 50 states and any U.S. district or territory that maintains its own PDMP. While this requirement would go into effect three years after a final rule becomes effective, it raises significant concerns about feasibility.”
The buprenorphine prescribing rule
Early reactions suggest that the final rule allowing clinicians to prescribe buprenorphine via telehealth for six months without an in-person visit will be a net positive for patients with OUD – but the extent of that net good is unclear.
The much shorter, but still 64-page document, is still muddy in parts, according to Jessica Rigsby, vice president of legal and compliance at Ophelia. It’s unclear if the rule will only impact current patients, Rigsby told ATB, or if it will give providers a six-month window to continue to treat current patients.
After the sixth-month period, patients need to either see their provider in person or transfer their care to someone authorized to continue telemedicine prescribing beyond six months, Clear said.
“It’s a lot better than not having it because you can get patients started, and you’ve got a nice long window to find a way to see them in person,” Clear said. “But it’s not a permanent fix, even if you can see the patient in person because it’s limited to a single provider.”
Cross-coverage issues may arise if a clinician goes on vacation or retires, Clear said.
The final rule that allows clinicians to prescribe buprenorphine via telehealth is set to go into effect 30 days after its official publication date on Jan. 17.
While the industry largely sees the final rule as a positive, without the special registration framework patients would still be required to see a clinician in person after six months, Rigsby said.
“Without the special registration, telemedicine is only telemedicine for the clinician,” Rigsby said. “If the patient still has to go to a clinic to be seen in person or has to go see their clinician in person somewhere, then this is no longer telemedicine for the patient.”
While providers wait to see the outcome of the special registration proposal, it will be business as usual for Ophelia. COVID-era flexibilities are in place through the end of 2025, and Gray anticipates they may be extended yet again after that.
Still, the final buprenorphine rule offers a permanent short-term option, at least for new patients.
“What we’re looking at right now is a little legal certainty that is permanent, which allows for six months for new patients and continuing patients, but then a new mess that needs to be unpacked by the new administration and frankly, may never get done,” Gray said.