DEA Proposes a Special Registry for Telehealth Providers of Controlled Substances

Physicians would have to register with the Drug Enforcement Administration (DEA) for telehealth prescribing of certain controlled substances under a proposed rule issued Wednesday by the agency.

“DEA’s goal is to provide telehealth access for needed medications while ensuring patient safety and preventing the diversion of medications into the illicit drug market,” DEA Administrator Anne Milgram said in a press release. “We understand the difficulties some patients have accessing medical providers in-person, and we want to ease this burden while also providing safeguards to keep patients safe.”

Under the rule, providers who prescribe Schedule III-V controlled substances would need to apply for a special registration; substances in Schedule III-V include alprazolam (Xanax), ketamine, and diazepam (Valium). The special registration will also be available to Schedule II providers who are board-certified in psychiatry, hospice care, pediatrics, or long-term care; that registration would apply to medications “identified as the most addictive and prone to diversion to the illegal drug market,” according to the press release; however, Schedule II prescribers would have to be located in the same state as the patient. Schedule II drugs include codeine and amphetamine-dextroamphetamine (Adderall).

In addition, online platforms that allow for telehealth prescribing would have to register with the DEA for the first time. “This is critical, as DEA has found some unscrupulous medical providers on online platforms have used flexible telemedicine rules to put profit ahead of the well-being of patients,” the release noted.

The DEA also issued a final rule on Wednesday allowing for opioid use disorder patients to receive a 6-month supply of buprenorphine through a telephone consultation with a provider; further prescriptions of buprenorphine will require an in-person visit to a medical provider, the DEA said.

Interest groups responded cautiously to the rules’ release. “While we are still digesting the DEA’s Special Registration framework … it is clear that these updates carry significant implications for the telehealth community,” Kyle Zebley, executive director at the American Telemedicine Association’s ATA Action organization. “Early indications suggest the proposed rule includes elements that represent significant operational challenges. All stakeholders need time to carefully review this important proposal, which appears to incorporate valuable elements and other potentially unworkable restrictions that focus on maintaining compliance with patient verification, electronic recordkeeping, and ongoing monitoring.”

As to the buprenorphine final rule, “upon initial review, we are hopeful that this will allow for the continued delivery of care for those vulnerable Americans receiving buprenorphine treatment via telehealth,” Zebley said. “Like the special registration proposed rule, more analysis will be forthcoming.”

The Alliance for Connected Care, which represents telemedicine providers, gave a mixed review. “We are pleased to see the DEA propose a special registration, as required by statute, to allow comprehensive medical care through telemedicine, including Schedule II medications,” the group said in a statement. “These treatments are important in providing mental health, end-of-life care, substance use treatment, and many other services.”

“However, the alliance is very concerned to see language in the proposed rulemaking mandating what portion of patient care can be offered through telemedicine, as this is not an appropriate guardrail for a telehealth service,” the statement continued. “Similarly, restricting the geography in which telemedicine can be offered undermines the value of creating virtual access for those patients who need it most. Restricting access to telemedicine will lead to harsh consequences for many Americans relying on telehealth for mental health, substance use disorder, sleep disorders, terminal illness, and many other medical issues.”

Marika Miller, JD, an associate at the Chicago office of Foley & Lardner who advises telehealth companies and healthcare providers, wasn’t surprised by the announcement. “I was not expecting the DEA to dust off their highly criticized rules from March 2023 and release revised versions, but I am not surprised they did,” she said in an email to MedPage Today. “Had the rules not been published before January 20th, they were likely to have been abandoned by the incoming Trump administration.”

“We have been waiting for a special registration process for more than 15 years, but what has been proposed does not live up to stakeholders’ expectations,” she continued. “We anticipate the industry will urge the DEA for a re-write, which will take some time.”

She noted that the final buprenorphine rule introduces restrictions for prescribing buprenorphine via telemedicine, including a nationwide prescription drug monitoring program review and the 6-month initial supply. “With the proposed special registration process unlikely to be finalized this year, maintaining DEA telemedicine flexibilities will be crucial for continued buprenorphine prescriptions via telemedicine,” she said. “There is too much uncertainty about what the Trump administration will prioritize over the next 4 years to know if the final buprenorphine rule will stick.”

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