The Drug Enforcement Administration said Wednesday it is temporarily extending flexibilities that allow providers to prescribe certain controlled substances without an in-person appointment.
The agency did not specify how long it would extend the flexibilities, which were set to expire May 11 at the end of the public health emergency. Full details will be made available when the extension is published in the Federal Register, according to the DEA.
Related: Digital mental health startups scramble as in-person visit rule looms
Flexibilities for remote prescribing were put in place at the beginning of the COVID-19 pandemic. The DEA released a proposed rule in February that ended those flexibilities for most controlled substances and essentially reinstated the 2008 Ryan Haight Act.
The proposed rule stated that prescriptions for Schedule II substances like Vicodin, OxyContin, Adderall and Ritalin would return to requiring an in-person visit before they could prescribed virtually. Schedule III-V substances like codeine, Xanax and Ambien as well as buprenorphine, a narcotic used to treat opioid addiction, could only be prescribed over telehealth for an initial 30-day dose. After the 30 days, patients would need to see a doctor once to get a refill.
The DEA also proposed a six-month grace period from when the final rule would take effect for the Schedule II-V drugs.
The agency said it received a record 38,000 comments on the proposed rule, many critical of the agency. The agency is considering those comments carefully, Administrator Anne Milgram said in a statement.
Extending the flexibilities allows companies to continue prescribing Schedule II-V medications to new patients via telehealth, at least for now.
“This is welcome but it does not offer any short- or long-term clarity about what next steps are going to be for those stakeholders,” said Jeremy Sherer, a partner and co-chair of the digital health practice at law firm Hooper, Lundy & Bookman. Sherer represents providers and telehealth companies.
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In the proposed rule in February, the agency did not include an outline of how prescribers can register to waive the in-person requirement, which is required as part of the Ryan Haight Act and reinforced in the SUPPORT Act of 2018. In a response to the temporary extension, industry stakeholders are asking the DEA to outline this process.
“We are relieved that the DEA is listening to the mental health and substance abuse communities, and taking a pause to re-balance access to care with guarding against abuse,” Krista Drobac, executive director at telehealth lobbying group Alliance for Connected Care, said in a statement. “We hope they go back to the original special registration process as called for by Congress.”
The Alliance for Connected Care, which represents providers, insurers, retail pharmacies, technology and telecommunications companies interested in virtual health, provided one of the 38,000 comments submitted. Along with urging the DEA to outline the special registration process, the group called certain provisions of the proposal "unclear and erratic."
Ankit Gupta, founder and CEO at Bicycle Health, a virtual care startup providing opioid use disorder treatments, said he welcomed the delay and called on the agency to outline the special registration process.
This story first appeared in Digital Health Business & Technology.