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External News: DEA Seeks to temporarily extend virtual prescribing of controlled substances

DEA is considering whether patients must see doctors face-to-face to get controlled substance prescriptions

Analysis by McKenzie Beard with research by Rachel Roubein

The federal government is trying to buy itself more time to nail down the details of whether doctors can virtually prescribe controlled substances as the pandemic wanes.

The Drug Enforcement Administration is seeking to temporarily extend telehealth flexibilities, which would otherwise expire along with the coronavirus public health emergency on May 11, according to a request filed with the Office of Management and Budget last week and an HHS official who confirmed the move.

The request follows a barrage of complaints lobbed at the DEA over its February proposal to reinstate stricter limits around the prescribing of controlled substances via telehealth, which were loosened considerably during the pandemic. This includes medications such as Adderall, oxycodone and buprenorphine, a key drug used to treat opioid addiction. 

The draft rules, developed in conjunction with the Department of Health and Human Services, would once again require patients to be evaluated in-person by a doctor to receive certain controlled medications. Advocates and providers have panned the proposal, arguing that it would create barriers to care.

The Health 202 talked with two people familiar with the matter who spoke on the condition of anonymity to discuss details that weren’t public, and they said the flood of public comments on the proposal is just one factor delaying the release of a final rule. Dueling priorities between the federal agencies involved are also complicating the ongoing negotiation process, they said.

But one thing is clear: The Biden administration won’t be rolling out final telehealth prescribing rules by May 11, according to the two people. However, it’s still unclear how long the temporary flexibilities will be extended, or when the DEA would release the highly anticipated final rules.

The American Academy of Family Physicians:

How we got here

Physicians have been allowed to issue first-time prescriptions for controlled substances online for nearly three years due to an emergency rule issued by the Trump administration shortly after the coronavirus outbreak.

With the public health emergency set to end next week, the DEA said in its announcement of the rules that it needs to transition to an approach that extends many of the flexibilities adopted during the pandemic, but with appropriate safeguards to protect patients.

Under the draft rules, doctors would be able to remotely prescribe an initial 30-day supply of some controlled medications, such as buprenorphine for opioid addiction, but patients looking to get refills beyond that would need to see a physician in-person. Other drugs with a higher risk for abuse or dependency, like Ritalin for attention-deficit/hyperactivity disorder, would require an in-person evaluation from the start.

  • If the proposals are approved as currently written, patients who had already been receiving prescriptions virtually would have a 180-day grace period to comply with the requirement.

  • The tighter standards are aimed at ensuring patients are being adequately screened by their doctor and to combat potential abuses, such as improper prescribing of controlled medications by telehealth companies or diversion, the DEA said.

The response

The pair of draft rules received nearly 40,000 public comments, many of them from patients and industry groups who argue the rules are more restrictive than necessary and could alienate vulnerable people, including those who are homeless, live in rural areas or have disabilities that limit their mobility.

The pressure appears to have slowed the effort to establish the final rules before the end of the public health emergency. The agency is legally required to consider all of the comments it received on the proposed rule and respond to a substantial portion of them, which officials are still in the process of doing, people familiar with the effort said. The DEA declined to comment. 

Various groups are divided over the proposal, putting pressure on the agencies to address their concerns. Law enforcement, state prosecutors and some providers are among those who back the draft rules, citing concerns about the emergence of digital “pill mills” during the pandemic, where people can get prescription drugs without a legitimate medical reason.

On the other side, patient and physician advocacy groupstelemedicine lobbyists and even some members of Congress are pressing HHS to waive the in-person requirement, saying the mandate could harm patients and place an extra burden on doctors who are already stretched thin.

  • Opponents are particularly concerned about the proposal’s impact on patients receiving medication-assisted treatment for opioid use disorder. Nora Volkow, the director of the National Institute on Drug Abuse, said in an interview last month that allowing telehealth prescriptions for buprenorphine amid the pandemic amounted to “lifesaving” care.

  • Implementing a rule that could limit access to the medication “actually threatens public safety, it doesn’t protect it,” Brian Hurley, the president-elect of the American Society of Addiction Medicine, which fiercely opposes the proposed 30-day limit, said in an interview last month.

The agencies are asking OMB for an extension of the current telehealth flexibilities to preserve the status quo while they work through their policy differences. “We’re working together to ensure patient care is not interrupted,” an HHS official said.