Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications

<RULE> DEPARTMENT OF JUSTICE <SUBAGY>Drug Enforcement Administration</SUBAGY> <CFR>21 CFR Part 1307</CFR> <DEPDOC>[Docket No. DEA-407]</DEPDOC> <RIN>RIN 1117-AB40, 1117-AB78, and 1117-ZA07</RIN> DEPARTMENT OF HEALTH AND HUMAN SERVICES <CFR>42 CFR Part 12</CFR> <SUBJECT>Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Drug Enforcement Administration, Department of Justice; Substance Abuse and Mental Health Services Administration, Department of Health and Human Services. <HD SOURCE="HED">ACTION:</HD> Temporary rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Drug Enforcement Administration (DEA) jointly with the Department of Health and Human Services (HHS) is issuing a fourth extension of telemedicine flexibilities for the prescribing of controlled medications through December 31, 2026. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective January 1, 2026 through December 31, 2026. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Heather Achbach, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (571) 776-3882. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> Under the <E T="03">Ryan Haight Online Pharmacy Consumer Protection Act of 2008</E> (the <E T="03">Ryan Haight Act</E> ), a prescribing practitioner—subject to certain exceptions—may remotely prescribe controlled substances to a patient (colloquially referred to as “telemedicine”)  <SU>1</SU> <FTREF/> only after conducting at least one in-person medical evaluation of that patient in the course of their practitioner-patient relationship. Once a practitioner has conducted at least one in-person medical evaluation of a particular patient, the specific requirements of the <E T="03">Ryan Haight Act</E> related to remote prescribing of controlled substances no longer apply to that specific practitioner-patient relationship. This permits the practitioner to remotely prescribe controlled substances to that patient indefinitely, regardless of how much time has passed since the initial in-person medical evaluation or whether that evaluation was for a separate medical concern, so long as such prescriptions are issued for a legitimate medical purpose while acting in the usual course of professional practice and in compliance with other relevant federal and state statutes and regulations. Regardless of whether a practitioner-patient relationship is subject to the specific remote prescribing rules of the <E T="03">Ryan Haight Act,</E> however, the practitioner must still comply with all other applicable DEA regulations. <FTNT> <SU>1</SU>  It is important to distinguish the colloquial understanding of “telemedicine” in this context from its statutory definition in the <E T="03">Ryan Haight Act,</E> 21 U.S.C. 802(54). The statutory term refers to the remote practice of medicine, via certain telecommunication systems, where a practitioner (other than a pharmacist) prescribes a controlled substance to a patient whom the practitioner has never conducted an in-person medical evaluation. This is permissible only under one of seven specific, congressionally approved circumstances as detailed in 21 U.S.C. 802(54)(A)-(G). </FTNT> In response to the COVID-19 Public Health Emergency (COVID-19 PHE), as declared by the Secretary of HHS (the “Secretary”) on January 31, 2020, pursuant to the authority under section 319 of the <E T="03">Public Health Service Act</E> (42 U.S.C. 247), DEA granted temporary exceptions to the remote prescribing requirements of the <E T="03">Ryan Haight Act</E> and DEA's implementing regulations under the authority granted by 21 U.S.C. 802(54)(D). These exceptions, often referred to as the “telemedicine flexibilities,” authorized practitioners to prescribe Schedule II-V controlled medications via audio-video telemedicine encounters, including 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, provided that such prescriptions otherwise comply with the requirements outlined in DEA guidance documents, DEA regulations, and applicable Federal and State law. DEA granted those temporary exceptions to the <E T="03">Ryan Haight Act</E> and DEA's implementing regulations via two letters published in March 2020: • A March 25, 2020 “Dear Registrant” letter signed by William T. McDermott, DEA's then-Assistant Administrator, Diversion Control Division (the McDermott Letter);   William T. McDermott, DEA Dear Registrant letter, Drug Enforcement Administration (March 25, 2020), <E T="03">https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf.</E> </FTNT> • A March 31, 2020 “Dear Registrant” letter signed by Thomas W. Prevoznik, DEA's then-Deputy Assistant Administrator, Diversion Control Division (the Prevoznik Letter). <SU>3</SU> <FTREF/> <FTNT> <SU>3</SU>  Thomas W. Prevoznik, DEA Dear Registrant letter, Drug Enforcement Administration (March 31, 2020), <E T="03">https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Final)%20+Esign.pdf.</E> </FTNT> <HD SOURCE="HD2">The 2023 Telemedicine NPRMs</HD> On March 1, 2023, DEA, jointly with HHS, promulgated two notices of proposed rulemaking (NPRMs) in the <E T="04">Federal Register</E> —“Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation”  <SU>4</SU> <FTREF/> (the “General Telemedicine NPRM”) and “Expansion of Induction of Buprenorphine via Telemedicine Encounter”  <SU>5</SU> <FTREF/> (the “Buprenorphine NPRM”)—which proposed to expand patient access to prescriptions for controlled medications via telemedicine encounters relative to the pre-COVID-19 Public Health Emergency (PHE) landscape. 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. The comment period for these two NPRMs closed on March 31, 2023. Those NPRMs generated a total of 38,369 public comments—35,454 comments on the General Telemedicine NPRM and 2,915 comments on the Buprenorphine NPRM. Many of those comments requested changes of varying degrees. <FTNT> <SU>4</SU>  88 FR 12875 (Mar. 1, 2023). </FTNT> <FTNT> <SU>5</SU>  88 FR 12890 (Mar. 1, 2023). </FTNT> <HD SOURCE="HD2">The First Temporary Rule</HD> On May 10, 2023, DEA, jointly with HHS (with the Substance Abuse and Mental Health Services Administration (SAMHSA) acting on behalf of HHS), issued the first temporary extension (the “First Temporary Rule”), which extended the full set of the telemedicine flexibilities that had been in place under the COVID-19 PHE, through November 11, 2023. <SU>6</SU> <FTREF/> The First Temporary Rule also provided a one-year grace period, through November 11, 2024, to any practitioner-patient relationships that had been or would be established on or before November 11, 2023. In other words, under the First Temporary Rule, if a patient and a practitioner had remotely established a practitioner-patient relationship by or before November 11, 2023, the same telemedicine flexibilities that had governed the relationship to that point would continue to apply through November 11, 2024. <FTNT> <SU>6</SU>  Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, 88 FR 30037 (May 10, 2023). </FTNT> <HD SOURCE="HD2">The Second Temporary Rule</HD> On August 7, 2023, DEA announced that it would host Telemedicine Listening Sessions on September 12 and 13, 2023, for the purpose of obtaining additional input on the practice of telemedicine and potential safeguards that could effectively prevent and detect diversion of controlled substances prescribed via telemedicine. On October 10, 2023, DEA, jointly with HHS, issued a second temporary extension (the “Second Temporary Rule”) again extending the full set of telemedicine flexibilities through December 31, 2024. <SU>7</SU> <FTREF/> The Second Temporary Rule, like the preceding extension, authorized all DEA-registered practitioners to remotely prescribe Schedules II-V controlled substances through December 31, 2024, without an in-person medical evaluation. This rule superseded the grace period from the First Temporary Rule by applying the telemedicine flexibilities to all practitioner-patient relationships until the end of 2024, not just those established by November 11, 2023. <FTNT> <SU>7</SU>  Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, 88 FR 69879 (October 10, 2023). </FTNT> <HD SOURCE="HD2">Third Temporary Rule</HD> On November 19, 2024, DEA, jointly with SAMHSA/HHS, issued a third temporary extension (the “Third Temporary Rule”) extending the full set of telemedicine flexibilities through December 31, 2025. <SU>8</SU> <FTREF/> Like the two preceding extensions, the Third Temporary Rule authorized all DEA-registered practitioners to remotely prescribe Schedules II-V controlled substances through December 31, 2025, so as to prevent lapses in patient care by allowing DEA more time to develop permanent regulations for prescribing controlled substances via telemedicine. The extension ensured and provided time for stakeholders to prepare for new rules. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 39k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━