The Drug Enforcement Administration (DEA), in concert with other federal agencies, has taken various steps in the past few months to strengthen a practitioner’s ability to prescribe controlled substances via telemedicine, a flexibility that started during the COVID-19 pandemic and has not been revoked. The DEA has taken steps to make these flexibilities more permanent under certain circumstances and with specific registrations with a temporary rule, a final rule, and a proposed rule. Summaries of each appear below.
DEA Further Extends Telehealth Prescribing Flexibilities Through 2025
Telehealth flexibilities for the prescription of controlled substances have been extended for another year, for the third year in a row since COVID-19 started. The DEA, together with the Department of Health and Human Services (HHS), published a temporary rule further extending telemedicine flexibilities through December 31, 2025.
Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act), prescribing practitioners (subject to certain exceptions) may only prescribe controlled substances to a patient after conducting an in-person evaluation of that patient. However, in response to COVID-19, on January 31, 2020, the DEA granted temporary exceptions to the Ryan Haight Act and DEA’s implementing regulations under 21 U.S.C. 802(54)(D), thereby allowing practitioners to prescribe certain controlled substances to a patient via telemedicine under certain circumstances.
The temporary rule further extends these flexibilities. As noted below, the DEA has already finalized a rule regarding the treatment of opioid use disorder with the use of telemedicine. In addition, the DEA has proposed a rule seeking to make some of the flexibilities under the temporary rule permanent, and practitioners should anticipate that the DEA will seek to finalize this proposed rule in the upcoming year.
Final Rule on the Expansion of Buprenorphine Treatment via Telemedicine Encounter
On January 17, 2025, the DEA and HHS published a final rule, 90 FR 6504, which amends federal regulations to expand the circumstances under which practitioners registered by the DEA are authorized to prescribe Schedule III-V controlled substances approved by the Food and Drug Administration for the treatment of opioid use disorder via a telemedicine encounter, including audio-only.
The new regulations permit a practitioner to prescribe an initial six-month supply of medications from review of a patient’s prescription drug monitoring program data for the state in which the patient is located during the telemedicine encounter, which may be audio-only. The practitioner can then prescribe additional prescriptions under other forms of telemedicine as authorized under the Controlled Substances Act, or after an in-person medical evaluation is conducted. This new regulation is an exception to the Ryan Haight Act, which generally requires an in-person medical evaluation prior to prescription of a controlled substance.
The final rule is effective as of February 18, 2025.
Proposed Rule for Special Registrations for Telemedicine and Limited State Telemedicine Registrations
On January 17, 2025, the DEA and the Department of Justice published a proposed rule, 90 FR 6541, which seeks to establish a Special Registration framework by authorizing three types of Special Registration for practitioners prescribing controlled substances pursuant to a telemedicine appointment. The proposed rule also provides for heightened prescription recordkeeping and reporting requirements by the practitioner. The DEA stated that it believes such changes are necessary to effectively expand patient access to controlled substances via telemedicine while mitigating the risks of diversion associated with such expansion.
The proposed rule would create three types of Special Registration for DEA-registered practitioners to prescribe via telemedicine. They include: (1) the Telemedicine Prescribing Registration, which would authorize qualified clinician practitioners to prescribe Schedule III-V controlled substances; (2) the Advanced Telemedicine Prescribing Registration, which would authorize qualified specialized clinician practitioners to prescribe Schedule II-V controlled substances; and (3) the Telemedicine Platform Registration, which would authorize qualified covered online telemedicine platforms, in their capacity as platform practitioners, to dispense Schedule II-V controlled substances.
The Special Registration under this proposed rule also serves as an exception to the Ryan Haight Act. Comments to the proposed rule are due on or before March 18, 2025.