Updated Feb. 18.
The Drug Enforcement Administration (DEA) and the Department of Health and Human Services submitted an unpublished rule to the Federal Register on Feb. 14 that delays the effective date of the “Expansion of Buprenorphine Treatment via Telemedicine Encounter” final rule, from Feb. 18 to March 21. Also delayed is the effective date of the "Continuity of Care via Telemedicine for Veterans Affairs Patients" final rule.
The administration specified that its pushback will not impede telemedicine prescribing in the interim, as those covered under the two rules are still permitted to do so under temporary COVID-19 telehealth flexibilities that run through the end of this year.
The government is soliciting public comments on the final rules through March 21, and specifically wants to her from the public on "on whether there may be a need for their effective dates to be extended beyond that date, and address issues of fact, law and policy raised by these rules, for consideration by officials of the two agencies."
Virtual prescribers of controlled substance and the broader telemedicine industry (PDF) have previously raised concerns about the buprenorphine final rule, which only allows virtual prescribing for a six-month period before requiring an in-person evaluation. See more on that in the story below.
The fate of virtual OUD treatment lies in a mess of intertwined final and proposed regulations
Feb. 7
A binding rule published in the final days of the Biden administration changes the way providers prescribe medications for opioid use disorder via telehealth.
The Drug Enforcement Administration (DEA) rule allows for six months of prescribing buprenorphine virtually to a new patient. National telehealth OUD treatment provider Bicycle Health says the rule is toothless for virtual-only providers, which need a bigger debate to be settled before OUD treatment is fully protected: a special telehealth registration framework for prescribing all controlled substances via telehealth.
The access to buprenorphine final rule was part of a set of three rules, which included a proposed special telemedicine registration framework that has been the subject of a yearslong pressure campaign to promulgate. When the DEA first attempted to propose a framework in March 2023—which was an alternative to a special registration—the agency received a record-breaking 38,000 comments.
While the department scrapped the general telemedicine prescribing rule, it was working to finalize a buprenorphine rule also released in October 2023. Biden’s DEA revealed its buprenorphine final rule in its last days to prevent the work from being lost before it handed over the agency Jan. 20, sources said.
But the buprenorphine rule, on its own, does not provide a lasting solution to the issue of prescribing the OUD treatment via telehealth. In the DEA’s rule, a provider can prescribe a total of six months worth of medication, beyond which it has to evaluate a patient in person or else cease prescription of the controlled substance.
“The buprenorphine final rule by itself doesn't make much sense. It doesn't allow for effective online treatment of opioid use disorder,” Brian Clear, M.D., chief medical officer of Bicycle Health, said in an interview.
Bicycle Health, which rose to prominence during the COVID-19 pandemic, has already faced a prescribing cliff in Alabama, when the state implemented a requirement to see a patient in person at least once a year to prescribe controlled substances via telehealth. Despite a massive effort to fly providers down to the state and see patients in person, Bicycle lost about half of its patients in the state.
They could face the same circumstances at national scale if the Trump administration does not extend the pandemic-era prescribing flexibilities. The pandemic waiver for prescribing Schedule 2 through 5 medications via telehealth was extended several times by the Biden administration, and the relaxed permissions lapse Dec. 31, 2025.
“If taken together with a rule that permits telemedicine care beyond six months, then it gives us a workable solution to continue providing care via telemedicine for opioid use disorder,” Clear said. “By itself, it doesn't do that because it still places this arbitrary time limit on opioid use disorder care.”
The buprenorphine final rule gives telehealth OUD providers a runway of six months to prescribe buprenorphine virtually to new patients. After the six months, DEA gave two options: to see a clinician in person or to rely on one of the other telehealth flexibilities.
Option two—i.e., a final special registration system for telehealth—does not currently exist.
“There's nothing that's allowed except for VA (Veterans Affairs) patients treated by VA providers,” Clear said. “That's the one. That's the only exception that exists. So it's strange how they did it, and they did it this way because of the administration in transition. DEA did not want all their work on tele-buprenorphine prescribing to be completely thrown away, and started over. So they basically pushed out what they had already, even though it's incomplete.”
Bicycle Health, along with a slew of other organizations like the American Telemedicine Association (ATA), is pushing the Trump administration to withdraw the proposed special telemedicine registration rule and propose a new one.
“Upon careful review of the DEA’s draft Special Registration for remote prescribing of controlled substances, we have serious concerns about the feasibility of this proposal,” Kyle Zebley, senior vice president for public policy of the ATA and executive director of ATA Action, said in a letter to the new administration. “As written, the draft framework creates unworkable restrictions and could not be operationalized, which would be a major setback, should this become the final rule.”
Many of the ATA’s objections pertain to the beefed-up rules for prescribing Schedule 2 substances and a requirement to check all state prescription drug monitoring programs.
Though the telemedicine special registration system would essentially allow unfettered tele-buprenorphine prescribing for OUD patients as proposed, Bicycle said it wants a special registration system that works for everyone.
The rule is also complicated and expensive, Clear said. Among the issues, Clear explained that under the special telemedicine registration rule, a buprenorphine prescription at the pharmacy could have up to six DEA registration numbers for the pharmacist to decipher. The administrative complexity of compliance alone would prevent smaller organizations from being able to register as telemedicine providers.
Foley & Lardner lawyers Marika Miller and Alexandra Maulden published a detailed description of the final rule on the law firm’s website.
“If the COVID-era telemedicine prescribing flexibilities expire without further extension, the final rule offers protection for prescribing buprenorphine to treat OUD,” they wrote. “However, that protection is contingent on establishing a legitimate special registration process, which the DEA has yet to propose or implement. Given the uncertainty surrounding the incoming Trump administration’s priorities and its views on telemedicine prescribing of controlled substances, it is unclear whether the final rule will be withdrawn or left as-is.”