The US Drug Enforcement Administration (DEA) further extended flexibilities that allow providers to prescribe controlled substances via telemedicine without first performing an in-person visit. The flexibilities were initially provided during the COVID-19 public health emergency (PHE) and were scheduled to expire on December 31, 2024. This extension extends the flexibilities through December 31, 2025. The DEA stated that this extension will give it time to promulgate proposed and final rules on telemedicine prescribing, although it is unclear what such rulemaking will include.
WHY IT MATTERS
BACKGROUND
Ryan Haight Act and Special Registration
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires a telemedicine provider to perform an in-person medical evaluation of a patient prior to prescribing a controlled substance to that patient, unless an exception applies. Under the Ryan Haight Act, there is a broad exception to the in-person medical evaluation requirement for practitioners engaged in the “practice of telemedicine.” However, the Ryan Haight Act defines “practice of telemedicine” quite narrowly, limiting it to a handful of specified categories that do not apply the majority of medical providers.
One of the categories authorizes the Attorney General and the US Department of Health and Human Services (HHS) Secretary to jointly promulgate rules that would allow practitioners to prescribe medications for patients via telemedicine without having had an in-person evaluation when such telemedicine practice is in accordance with applicable federal and state laws, uses an approved telecommunications system, and is conducted under circumstances that the Secretary and Attorney General determine to be consistent with effective controls against diversion and otherwise consistent with the public health and safety. This language was used to invoke telemedicine prescribing flexibilities in January 2020 in response to the PHE and has been used as the basis for subsequent extensions of the flexibilities.
Notably, another category allows for telemedicine prescribing of controlled substances by a provider who holds a “special registration.” Providers and other stakeholders have long been awaiting the development of the “special registration.” In the 16 years since the Ryan Haight Act’s passage, the DEA has failed to implement such a process, even though Congress imposed an October 2019 deadline in the SUPPORT for Patients and Communities Act for the promulgation of final regulations regarding a special registration.
The DEA’s Attempts to Address Telemedicine Prescribing Post-PHE
The DEA’s first attempt at addressing telemedicine prescribing of controlled substance came in February 2023, when the DEA and the Substance Abuse and Mental Health Services Administration proposed 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, and received additional stakeholder input via listening sessions. 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. Moreover, a bipartisan group of senators wrote to the DEA expressing concerns with the current proposed rule and imploring the DEA to create a special registration process. The senators noted that the goal of the special registration is to allow medical evaluations via telehealth more broadly, which the senators stated the proposed rules did not accomplish. Subsequently, the DEA issued temporary rules in May 2023 and October 2023 ultimately extending the telemedicine flexibilities through December 31, 2024, and stated that it anticipated releasing a final rule addressing telemedicine prescribing of controlled substances in fall 2024.
The DEA has not yet released additional proposed or final rules addressing telemedicine prescribing. The DEA transmitted a new draft proposed rule regarding telemedicine prescribing of controlled substances to the Office of Management and Budget for review in June 2024. While the text of the draft rule has not been released, reporting indicates that the proposal would have resulted in significant barriers for telemedicine prescribing, including a requirement that half of a provider’s controlled substance prescribing occur in person. Reportedly, HHS did not agree with the proposal. In fall 2024, stakeholders and lawmakers again urged the DEA to extend the telemedicine flexibilities and/or adopt permanent telemedicine regulations, including a special registration process.
Looking Forward
The DEA stated that the extension will allow it time to promulgate proposed and final regulations addressing telemedicine prescribing of controlled substances. The DEA also stated that the extension will give providers adequate time to come into compliance with any new standards or safeguards for telemedicine prescribing eventually adopted in a final set of regulations. The DEA indicated that it remains committed to evaluating the comments received in response to the February 2023 proposed rules, in the listening sessions, and in meetings with interested parties in response to its draft proposal from June 2024.
While it is unclear what future DEA proposals on telemedicine prescribing of controlled substances will look like, stakeholders should continue to engage with policymakers to express their views and desired policy outcomes. McDermott+ and the McDermott digital health team will continue to closely watch for developments.
For more information, please contact Rachel Stauffer, Lisa Mazur (McDermott Will & Emery – Partner), Dale C. Van Demark (McDermott Will & Emery – Partner), Amanda Enyeart (McDermott Will & Emery – Partner), Marshall E. Jackson, Jr. (McDermott Will & Emery – Partner), Patrick Zanayed (McDermott Will & Emery – Partner), Stacey L. Callaghan (McDermott Will & Emery – Partner), Jayda Greco (McDermott Will & Emery – Associate), or Grayson I. Dimick (McDermott Will & Emery – Associate).
