Earlier this month, the United States Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) issued a temporary rule extending certain flexibilities for the prescription of controlled substances via telemedicine. Specifically, this action extends the full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID–19 Public Health Emergency (“COVID–19 PHE”), through December 31, 2024.
Background & COVID-19 PHE Flexibilities
Prior to the COVID–19 PHE, pursuant to the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, a practitioner could only prescribe controlled medications to a patient after conducting an in-person evaluation of that patient, with limited exceptions. Due to the COVID-19 PHE, DEA granted temporary exceptions to the Ryan Haight Act, which allowed authorized practitioners to prescribe Schedule II-V controlled medications via audio-video telemedicine encounters (i.e., the general telemedicine exception), as well as Schedule III-V narcotic controlled medications approved by the Food and Drug Administration (“FDA”) for maintenance and withdrawal management treatment of opioid use disorder via audio-only telemedicine encounters (i.e., the Buprenorphine exception), provided that the prescriptions otherwise comply with the DEA guidance and applicable federal and state laws. On March 1, 2023, DEA and HHS issued two proposed rules that proposed to expand patient access to prescriptions for controlled medications via telemedicine encounters relative to the pre-COVID-19 PHE landscape.
Post-COVID-19 PHE Extensions
Following the expiration of the COVID-19 PHE, DEA and HHS issued a temporary rule in May 2023, continuing the COVID-era exceptions to allow for prescribing of controlled medications through the practice of telemedicine in instances where the prescribing practitioner has never conducted an in-person medical evaluation of the patient (the “First Temporary Rule”). The First Temporary Rule extended the exceptions until November 11, 2023, and included a one-year grace period, through November 11, 2024, to any practitioner-patient telemedicine relationships established on or before November 11, 2023.
In September, DEA hosted Telemedicine Listening Sessions to receive additional input concerning the practice of telemedicine with regards to prescribing controlled medications and potential safeguards that could effectively prevent and detect diversion of controlled substances prescribed via telemedicine. As DEA and HHS continue to consider the comments received in response to the March 1, 2023, proposed rules and the listening sessions, DEA and HHS determined to further extend the exceptions to existing DEA regulations for new practitioner-patient relationships through December 31, 2024.
The second extension was issued via a temporary rule titled “Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications,” and was published in the Federal Register on October 10, 2023 (the “Second Temporary Rule”). Through the Second Temporary Rule, all DEA-registered practitioners are authorized to prescribe Schedule II-V controlled medications via telemedicine through December 31, 2024, whether or not the patient and practitioner established a telemedicine relationship on or before November 11, 2023.
DEA and HHS have indicated that the purpose of the Second Temporary Rule is to provide for a smooth transition for patients and practitioners that have relied on the increased availability of telemedicine for controlled medication prescriptions during the COVID-19 PHE, while also allowing adequate time for practitioners to come into compliance with any new standards or safeguards that may be established. DEA is expected to promulgate new standards or safeguards by the fall of 2024.
DEA and HHS’s decision to temporarily extend the telemedicine prescribing flexibilities mirrors similar telemedicine expansions across the healthcare industry as a whole following the end of the COVID-19 PHE. For example, the Centers for Medicare and Medicaid Services (“CMS”) also implemented both temporary and permanent changes to Medicare’s telehealth coverage policies. Permanent changes include widespread expansions for behavioral/mental telehealth services and making Rural Emergency Hospitals (“REHs”) eligible originated sites. Medicare’s temporary changes, which currently remain in effect through December 31, 2024, include but are not limited to allowing Medicare patients to receive telehealth services in their home, eliminating geographic restrictions for the originating site for non-behavioral/mental telehealth services, and permitting all eligible Medicare providers to provide telehealth services. Providers should remain attuned to ongoing revisions to telehealth rules and regulations as the landscape continues to evolve following the expiration of the COVID-19 PHE.
For additional information or assistance with telehealth compliance requirements, please contact Madison Pool, Charmaine Mech, or Kadeja Watts.