Member Article

The Drug Enforcement Administration (DEA) is once again extending telemedicine prescribing flexibilities for controlled substances. On October 6, 2023, the DEA jointly with the U.S. Department of Health and Human Services (HHS) announced a Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (the “Second Extension”).[i] This is a follow-up to a May of 2023 extension of telemedicine flexibilities implemented during the COVID-19 Public Health Emergency (PHE).[ii] This latest extension becomes effective November 11, 2023, and lasts through December 31, 2024.

Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”)[iii], a registered practitioner can generally prescribe controlled substances only if they have conducted an in-person evaluation of the patient. Due to COVID-19, the DEA granted temporary exceptions to the Ryan Haight Act allowing practitioners to prescribe controlled substances to patients without conducting an initial in-person medical evaluation. Instead, practitioners were permitted to prescribe controlled substances via audio-video telemedicine, if the prescriptions otherwise complied with the requirements outlined in DEA regulations, as well as other provisions of federal and state law.

While the exceptions to the Ryan Haight Act were originally tied to the federal PHE declaration, the exceptions were extended after the DEA, along with the Substance Abuse and Mental Health Services Administration (SAMHSA), enacted the first temporary rule titled Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. This initial extension was set to last through November 11, 2023. While the PHE for COVID-19 is no longer in effect, the DEA is still looking to work with practitioners to ease the transition back to in-person examination mandates, pursuant to the Ryan Haight Act, for most practice settings. The Second Extension will allow time for practitioners to adjust their practices and prepare for compliance with two proposed rules issued in February of 2023 respectively titled, Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had Prior Medical Evaluation and the Expansion of Induction of Buprenorphine via Telemedicine Encounter.[iv]

There is currently no official date for the two proposed rules to be implemented. The DEA and HHS anticipate promulgating a final set of regulations in the near future to provide more clarity on telemedicine prescribing requirements for controlled substances. As new regulations continue to develop, Dinsmore will keep you apprised of any updates. If you have any questions about the latest temporary extension or proposed rules, please contact your Dinsmore attorney.

[i] https://www.federalregister.gov/documents/2023/10/10/2023-22406/second-temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled

[ii] 2023-09936.pdf (federalregister.gov)

[iii] https://www.congress.gov/110/plaws/publ425/PLAW-110publ425.pdf

[iv] https://www.govinfo.gov/content/pkg/FR-2023-03-01/pdf/2023-04248.pdf