DEA suggests 2nd comment period for post-PHE online Rx registration
During 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 the March NPRM in the coming months.
WHY IT MATTERS
The Drug Diversion Division said it was hosting public listening sessions to gain input on prescribing controlled substances on telemedicine platforms and to learn more about the types of data and its accessibility for use in detecting illicit drug abuse. The agency invited interested parties to present to provide information on possible safeguards.
Early on, Milgram emphasized the sessions’ mission to find a way forward, saying, “We will also have another comment period for written comments this fall before any telemedicine regulations are finalized.”
The sessions were very well put together, with Deputy Assistant Administrator Matthew Strait serving as moderator. He said in the “run of show” on day two, the DEA chose 30 presentations per day from more than 1,000 questions. Each presenter – about half virtual each day – would get 10 minutes each and Milgram and Deputy Assistant Administrator Tom Prevoznik could ask questions.
“If I believe that your comments deviate significantly from the scope of our regulations, I will interrupt your presentation and remind you to maintain your comments regarding the practice of telemedicine related to controlled substances,” Strait said.
Dr. Brian Clear, chief medical officer and physician of addiction medicine at Bicycle Health, presented on day two and said the experts he listened to had a variety of recommendations about what safety considerations might be helpful to the DEA in preventing overprescribing controlled drugs for profit.
“The DEA heard testimony from a variety of experts in the field, and the clear consensus from physicians was that it is often necessary and safe to treat patients entirely via telemedicine, and that DEA should avoid arbitrary practice restrictions, and especially avoid in-person encounters . demands,” he said by email.
“There was a consensus that safety railings are needed, but there was no clear consensus on what they should be,” he noted.
THE BIG TREND
On March 1, the DEA and the Department of Health and Human Services published notices of proposed rulemaking to allow prescribing of certain controlled medications via telemedicine. Then, on May 9, DEA and HHS extended COVID-19 telemedicine flexibility for another six months to account for more than 38,000 comments on the proposed rule.
The American Telemedicine Association announced it would comment on its opposition to the administration requiring patients who initiated treatment via telehealth during the pandemic to visit a provider for prescriptions, saying it would cause widespread patient harm. ATA called keeping a telehealth controlled substance registry out of regulation “a missed opportunity” and applauded the Drug Diversion Division’s announcement that it would host listening sessions to discuss one.
On the second day, congressional leaders sent a letter to the DEA reminding the agency of its responsibilities to create one under the SUPPORT Act — and not as an “option.”
Although DEA did not respond to a request for comment, Nathan Beaver, an attorney with Foley & Lardner, said the agency should listen to senators and consider feedback from thousands of commenters who argue that the rules are “insufficient to meet the health care needs of to satisfy the population’. patients.”
“Senators (Mark Warner (D-Va.), John Thune (R.S.D.)) and their colleagues rightly note that DEA’s proposed telemedicine rule does not meet DEA’s obligation to create a special registry – which requires practitioners would not be subject to the mandatory in-person evaluation requirement of the Ryan Haight Act,” he shared Healthcare IT news by email.
“Yesterday’s listening session on this topic was a good first step,” he added.
ON THE RECORD
“Specifically in addressing the opioid overdose crisis, telemedicine has provided notable benefits over in-person practice for many patients, and 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 this repeated nationally.”
Andrea Fox is editor-in-chief of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.