At the Drug Enforcement Agency Drug Diversion Division listening sessions earlier this month, DEA Administrator Anne Milgram said the agency would hold a second comment period on its March NPRM in the months ahead.
WHY IT MATTERS
The Drug Diversion Division said it was conducting public listening sessions to get input on prescribing controlled substances on telemedicine platforms and to learn about the types of data and its accessibility for use in detecting unlawful drug diversion. The agency invited those interested in presenting to reach out with information about potential safeguards.
At the outset, Milgram highlighted the sessions’ mission to find a path forward and said, “We will also have another comment period this fall for written comments before any telemedicine regulations are finalized.”
The sessions were highly curated with Deputy Assistant Administrator Matthew Strait moderating. He said in the “run of show” on day two that the DEA chose 30 presentations per day from the more than 1,000 inquiries. Each presenter – about half virtual each day – would have 10 minutes each and Milgram and Deputy Assistant Administrator Tom Prevoznik could ask questions.
“If I believe that your comments stray substantially from the scope of our rulemaking, I will interrupt your presentation and remind you to keep your comments to the practice of telemedicine relating to controlled substances,” Strait said.
Dr. Brian Clear, chief medical officer and addiction medicine physician at Bicycle Health, presented on day two and said that the experts he listened to had a variety of recommendations around what safety considerations may be helpful to the DEA to find and stop the overprescribing of controlled medications for profit.
“The DEA heard statements from a variety of experts in the field, and the clear consensus from clinicians was that it is often necessary and safe to treat patients entirely via telemedicine, and DEA should avoid arbitrary practice restrictions, and especially should avoid in-person requirements,” he said by email.
“There was a consensus that some safety guardrails are needed, but there was no clear consensus on what those should be,” he noted.
THE LARGER TREND
On March 1, DEA and the Department of Health and Human Services issued notices of proposed rulemaking to allow for prescribing of certain controlled medications via telemedicine. Then on May 9, DEA and HHS extended COVID-19 telemedicine flexibilities for an additional six months to consider the more than 38,000 comments on the proposed rule.
The American Telemedicine Association announced that it would comment on its opposition to the government requiring patients who initiated treatment by telehealth during the pandemic to visit a provider for prescriptions because it would trigger widespread patient harm. ATA called leaving a telehealth controlled substance registry out of the rulemaking “a missed opportunity” and applauded the Drug Diversion Division announcement that it would host listening sessions to discuss one.
On the second day, Congressional leaders sent a letter to DEA reminding the agency of its responsibilities to create one under the SUPPORT Act – and not as an “option.”
While DEA did not respond to a request for comment, Nathan Beaver, an attorney at Foley & Lardner, said the agency should listen to the senators and incorporate feedback provided by thousands of commenters who argue the rules “are insufficient to meet the healthcare needs of patients.”
“Senators [Mark Warner (D-Va.), John Thune (R-S.D.)] and their colleagues correctly note that DEA’s Proposed Telemedicine rule does not fulfill DEA’s obligation to create a special registration – for which practitioners would not be subject to the mandatory in-person evaluation requirement of the Ryan Haight Act,” he told Healthcare IT News by email.
“Yesterday’s completed listening session on this topic was a good first step,” he added.
ON THE RECORD
“Specifically in addressing the opioid overdose crisis, telemedicine care has shown remarkable advantages over in-person practice for many patients, and to continue to build on that success, we need the ability to continue using controlled medications for OUD care through telemedicine,” Clear said by email.
“When an in-person requirement became state law in Alabama in 2022, the consequences for our patients were disastrous, and no one wants to see that repeated on a national level.”
Andrea Fox is senior editor of Healthcare IT News.
Healthcare IT News is a HIMSS Media publication.