Two days ahead of the expiration of the COVID-19 Public Health Emergency (PHE), the Drug Enforcement Agency (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary rule extending PHE flexibilities for prescribing controlled substances via telemedicine. The temporary rule will take effect on May 11, 2023, and allows for the following:
- Temporarily extends COVID-19 PHE controlled substance prescribing flexibilities through November 11, 2023; granting practitioners an additional six months to prescribe controlled substances via telemedicine without having to evaluate the patient in person.
- Grants an additional one-year grace period through November 11, 2024, to patients and practitioners who established a telemedicine relationship on or before November 11, 2023. The one-year grace period only applies if a "telemedicine relationship" exists, which requires the practitioner to have issued a prescription for controlled substances to a patient pursuant to the telemedicine flexibilities that were available during the COVID-19 PHE and through November 11, 2023, as extended by the temporary rule.
As a result of the PHE, the DEA granted temporary exceptions to the Ryan Haight Act and the DEA's implementing regulations under 21 U.S.C. 802(54)(D), allowing the prescribing of controlled substances via telemedicine absent an in-person medical evaluation of the patient. The PHE telemedicine flexibilities authorize practitioners to prescribe schedule II-V controlled substances via audio-video telemedicine encounters, and 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, without requiring an in-person medical evaluation. Because of the temporary rule, these flexibilities will be extended through November 11, 2023, for all patients, and through November 11, 2024, for patients with an established telemedicine relationship.
The temporary rule follows the DEA's February 2023 release of two Notices of Proposed Rulemaking (NPRM), which elicited wide-spread criticism and led to over 38,000 comments. As drafted, the proposed rules would reinstate strict limitations on the virtual prescribing of controlled substances and would significantly roll back the in-person medical evaluation flexibilities extended during the PHE. After reviewing the comments, the DEA noted that the temporary rule will facilitate continuity of care and address the urgent public health need for the initiation of buprenorphine as medication for opioid use disorder. The rule will also enable the DEA, jointly with SAMHSA, to review and respond to the 38,000+ comments they received to the two proposed rules and determine if regulatory alternatives exist to expand access to telemedicine encounters in a manner that is consistent with public health and safety and effective controls against diversion.
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