A new rule posted on the Office of Management and Budget (OMB) registry suggests that the Drug Enforcement Administration (DEA) is planning an additional extension of COVID-19 flexibilities for telemedicine prescribing of controlled substances, beyond the current expiration date of December 31, 2024.
The new rule is entitled “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” and is not yet available for public review. Rules must clear OMB review before being published in the Federal Register; there is no minimum period for this review.
McDermott+ and the McDermott digital health team are closely monitoring for updates and will publish further details of the extension as they become available.
WHY IT MATTERS
BACKGROUND
Under the Ryan Haight Act of 2008, a telemedicine provider is first required to perform an in-person medical evaluation of a patient prior to prescribing a controlled substance (with certain limited exceptions). However, the controlled substance-prescribing flexibilities, invoked in March 2020 in response to the COVID-19 Public Health Emergency, allow for prescribing controlled substances via telemedicine without an initial in-person visit. The current extension of the flexibilities, pursuant to an October 2023 rule, authorizes all DEA-registered practitioners to prescribe Schedule II-V controlled medications via telemedicine without an initial in-person examination through December 31, 2024.
The current extension of the telemedicine flexibilities came after the DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA) proposed two rules in February 2023 (the General Telemedicine Rule and the Buprenorphine Rule).
The two proposed rules would have established additional potential pathways for prescribing certain controlled substances in limited quantities via telemedicine without an initial in-person medical examination, while also imposing detailed recordkeeping requirements. Notably, the proposed rules did not include a “special registration” process for telemedicine providers.
The DEA received a record 38,000 comments in response to the proposed telemedicine rules, including comments from federal lawmakers. Many stakeholders pointed out that the requirement for an in-person evaluation would make it more challenging for certain patients – those facing significant barriers to accessing care without telemedicine – to continue receiving the controlled medications they need. Subsequently, DEA issued temporary rules in May 2023 and October 2023 extending the telemedicine flexibilities through December 31, 2024, and stated that it anticipated releasing a final rule addressing telemedicine prescription of controlled substances in fall 2024.
A rule entitled “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have not had a Prior In-Person Medical Evaluation” has been with OMB since June 13, 2024, but has not yet been published in the Federal Register for public review. The title suggests it is the updated proposal from the DEA. Of note, regulations do not often remain at OMB for longer than 90 days unless agencies are still engaging in review and potential policy changes. This suggests that there has been significant feedback that the agencies are still working through. With time running short on finalizing a policy before the current flexibilities are set to end, lawmakers also recently began expressing concern.
With the expiration of the current telemedicine flexibilities looming, the new rule is an indication that the DEA will further extend the telemedicine flexibilities. Because the text of the new rule will not be publicly available until it clears OMB review, it is unclear how long such an extension would be and whether there are any limitations on the extension.
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Telehealth is an important development in care delivery, but the regulatory patchwork is complicated. The McDermott digital health team works alongside the industry’s leading providers, payors and technology innovators to help them enter new markets, break down barriers to delivering accessible care and mitigate enforcement risk through proactive compliance. Are you working to make healthcare more accessible through telehealth? Let us help you transform telehealth.
For more information, please contact Rachel Stauffer, Lisa Mazur (McDermott Will & Emery – Partner), Grayson Dimick (McDermott Will & Emery – Associate), Jayda Greco (McDermott Will & Emery – Associate), Marshall Jackson, Jr. (McDermott Will & Emery – Partner), Stacey Callaghan (McDermott Will & Emery – Partner), Amanda Enyeart (McDermott Will & Emery – Partner), Patrick Zanayed (McDermott Will & Emery – Partner), or Dale Van Demark (McDermott Will & Emery – Partner).
