The Drug Enforcement Administration has pushed back (PDF) the effective dates of two rules that expand prescribing of buprenorphine via telehealth and controlled substance prescribing for patients at the Department of Veterans Affairs until December 31, 2025.
The two telehealth final rules were supposed to go into effect on Friday, March 21, after the DEA delayed their effective dates a month ago. Now, all telehealth prescribing hangs in the balance until the end of the calendar year.
The buprenorphine prescribing rule would have permanently allowed for providers to prescribe new patients a six-month supply of buprenorphine, a gold standard drug for treating opioid use disorder, via telehealth. After the six-month mark, the rule requires patients to see a provider in person.
The VA prescribing rule would permanently allow veterans to receive controlled substances pursuant to a telehealth visit, so long as they’ve previously seen another VA provider in person in the past. The rule has been lauded as a win for veterans who live in rural areas, have mobility issues, or lack transportation to the clinic.
The unpublished DEA final rule, which hit the Federal Register Friday morning, says that the two rules can be delayed until the end of the year because the general telehealth prescribing flexibilities are available until that same date. The expanded prescribing flexibilities were made possible under the first Trump administration’s response to the COVID-19 pandemic.
The trifecta of telemedicine prescribing rules were released in January, in the last weeks of the Biden administration. The agency released three rules at once: a proposed special telehealth registration rule, the final buprenorphine rule, and the final VA rule.
All the rules were affected by the regulatory freeze, which is a standard procedure for new presidential administrations. The freeze stopped rulemaking in its tracks until mid-February. The buprenorphine and VA rules would have become effective at the end of the freeze, but the Trump DEA pushed back the effective date, until today.
National telehealth OUD treatment provider Bicycle Health previously told Fierce Healthcare the buprenorphine prescribing 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.
“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,” Brian Clear, M.D., chief medical officer of Bicycle Health, said in an interview. “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.