Telehealth companies are unsure they'll feel the impact of the Drug Enforcement Administration's proposed rule on remote prescribing of controlled substances.
The proposed rule, released Wednesday and scheduled to publish in the federal register on Friday, would establish a special registration process for the remote prescribing of Schedule II-V controlled substances such as Xanax, Vicodin and Adderall. The timing of the proposal, issued in the final days of Biden administration, has led to uncertainty among telehealth companies that aren't sure if the Trump administration will finalize it.
Related: Biden's DEA pushes out remote prescribing proposal
“It’s hard to tell yet what the business implications may be because some of the aspects of the rule might not look the same at the end of the rulemaking process,” said Jessica Rigsby, vice president at opioid use disorder treatment telehealth company Ophelia.
The DEA also released a final rule on Wednesday for its 2023 proposal that sets up a special registration process for remote prescribing of buprenorphine, a medication used to treat opioid use disorder. The buprenorphine final rule won't go into effect until Feb. 17, while the proposed rule is pending, which means Trump's administration will determine the fate of both rules.
Kyle Zebley, executive director of the American Telemedicine Association’s lobbying arm, ATA Action, said it appears the Biden administration is trying to quickly tie up loose ends before he leaves office. The Trump administration could pause the proposal or make adjustments, he said.
The proposed rule for remote prescribing of controlled substances sets up a special registration process for providers based on three tiers. For all eligible providers, the DEA is proposing to require that providers maintain a state-level registration in each state they practice or dispense in.
The agency is also proposing that at least 50% of providers' prescriptions for Schedule II drugs issued in a given month would need to be issued during in-person appointments. These proposals, if finalized, would be challenging for many telehealth companies, advocates say.
Jeremy Sherer, a healthcare partner at law firm Orrick focusing on digital health and healthcare technology, said in an email the proposal would make it very hard for virtual-only telepsychiatry practices treating conditions like attention deficit hyperactivity disorder to operate in a compliant manner. This is especially true for multi-state telehealth practices regularly treating patients with medications that are classified as Schedule II controlled substances, he said.
The Alliance for Connected Care, an industry group, said in a statement it was “very concerned” with the proposed rule and believed the guardrails set forth by the DEA were not appropriate.
Zebley and the ATA is urging the Trump administration to roll back the proposed rule.
Robert Krayn, CEO and co-founder at virtual mental healthcare company Talkiatry, said he was disappointed that the proposed rule was unable to provide greater access to patients while satisfying the DEA’s diversion efforts. The latest proposal has loopholes that bad actors could exploit, he said.
Talkiatry, which secured $130 million in funding round last June, prescribes Schedule II medications but Krayn declined to disclose a breakdown of how many patients would be affected by the proposal. Despite the potential impact, Krayn is not immediately preparing his company to satisfy the proposed rules.
“The whole reason that something's proposed is [that] it's built to be changed and adapted based on feedback,” Krayn said. “So, I think it'll be premature to make dramatic changes.”
As part of the COVID-19 public health emergency, providers were allowed to remotely prescribe of controlled substances regardless of the state they practiced in. As that public health emergency wound down, DEA issued a proposal in February 2023 that removed those flexibilities and reinstated in-person requirements. After receiving industry criticism that called the proposal too restrictive, DEA decided to extend the COVID-19-era flexibilities multiple times, most recently through 2025.
Bridget Early contributed.