On October 10, the Drug Enforcement Administration (“DEA”), jointly with HHS, issued its second temporary rule (“Second Temporary Rule”) extending the full set of telemedicine flexibilities regarding the prescription of controlled medications as were in place during the COVID–19 Public Health Emergency (PHE), through December 31, 2024.
Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act), a prescribing practitioner—subject to certain exceptions—may prescribe controlled medications to a patient only after conducting an in-person evaluation of that patient. However, in response to the PHE, the DEA granted temporary exceptions to the Ryan Haight Act.
On March 1, 2023, DEA, in concert with HHS, promulgated two notices of proposed rulemaking—“Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation” (the General Telemedicine Rule) and “Expansion of Induction of Buprenorphine via Telemedicine Encounter” (the Buprenorphine Rule)—which proposed to expand patient access to prescriptions for controlled medications via telemedicine. The purpose of the two proposed rules was to make permanent some of the telemedicine flexibilities established during the COVID–19 PHE in order to facilitate patient access to controlled medications via telemedicine when consistent with public health and safety, while maintaining effective controls against diversion. These policy proposals generated a total of 38,369 public comments—35,454 comments on the General Telemedicine Rule and 2,915 comments on the Buprenorphine Rule.
Our Take: It will be difficult to complete a final rule for these policies in 2024. Why? There are two agencies responsible for coming up with a final policy, and they will need time to review and debate the differing public opinions.
For additional resources on federal policy initiatives impacting behavioral health and substance use disorder recovery, check out these resources.
CMS Cross-Cutting Initiative: Behavioral Health Strategy. https://www.cms.gov/files/document/cms-behavioral-health-strategy.pdf
HHS Roadmap for Behavioral Health Integration. https://aspe.hhs.gov/sites/default/files/documents/4e2fff45d3f5706d35326b320ed842b3/roadmap-behavioral-health-integration.pdf
HHS Overdose Prevention Strategy. https://www.hhs.gov/overdose-prevention/
Center for Medicaid & CHIP Services Mental Health and Substance Use Disorder Action Plan. https://www.medicaid.gov/sites/default/files/2023-07/cmcs-mntl-helth-substnce-disrdr-actn-plan.pdf