Third 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-ZA06</RIN> DEPARTMENT OF HEALTH AND HUMAN SERVICES <CFR>42 CFR Part 12</CFR> <SUBJECT>Third 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) in concert with the Department of Health and Human Services (HHS) is issuing a third extension of telemedicine flexibilities for the prescribing of controlled medications, through December 31, 2025. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective January 1, 2025, through December 31, 2025. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Heather E. 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> <HD SOURCE="HD2">Overview</HD> 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. In response to the COVID-19 Public Health Emergency (COVID-19 PHE), as declared by the Secretary (the Secretary) of the Department of Health and Human Services (HHS) on January 31, 2020, pursuant to the authority under section 319 of the Public Health Service Act (42 U.S.C. 247), the Drug Enforcement Administration (DEA) granted temporary exceptions to the Ryan Haight Act and DEA's implementing regulations under 21 U.S.C. 802(54)(D). In order to prevent lapses in care, these exceptions allowed for the prescribing of controlled medications via telemedicine encounters even when the prescribing practitioner had not conducted an in-person medical evaluation of the patient. These 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 Ryan Haight Act 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>2</SU> <FTREF/> <FTNT> <SU>2</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> On March 1, 2023, DEA, in concert 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>3</SU> <FTREF/> (the General Telemedicine NPRM) and “Expansion of Induction of Buprenorphine via Telemedicine Encounter”  <SU>4</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 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 to the proposed regulations in the two March 2023 NPRMs. <FTNT> <SU>3</SU>  88 FR 12875 (Mar. 1, 2023). </FTNT> <FTNT> <SU>4</SU>  88 FR 12890 (Mar. 1, 2023). </FTNT> 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 (First Temporary Rule), which extended the full set of telemedicine flexibilities regarding the prescribing of controlled medications, as had been in place under the COVID-19 PHE, through November 11, 2023. <SU>5</SU> <FTREF/> The First Temporary Rule also provided a one-year grace period, through November 11, 2024, to any practitioner-patient telemedicine 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 established a telemedicine relationship on 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>5</SU>  Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, 88 FR 30037 (May 10, 2023). </FTNT> On August 7, 2023, DEA announced that it would host Telemedicine Listening Sessions on September 12 and 13, 2023, in order to receive additional input concerning the practice of telemedicine with regards to prescribing controlled medications 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 (Second Temporary Rule) extending the full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE, through December 31, 2024. <SU>6</SU> <FTREF/> This extension authorized all DEA-registered practitioners to prescribe schedule II-V controlled medications via telemedicine through December 31, 2024, whether or not the patient and practitioner established a telemedicine relationship on or before November 11, 2023. In other words, the grace period provided in the First Temporary Rule was effectively subsumed by this Second Temporary Rule, which continued the extension of the current flexibilities for all practitioner-patient relationships—not just those established on or before November 11, 2023—until the end of 2024. <FTNT> <SU>6</SU>  Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, 88 FR 69879 (October 10, 2023). </FTNT> On June 13 and 27, 2024, DEA held virtual Tribal Consultations with numerous Tribal governments and organizations in order to elicit further comment from interested Tribal parties regarding the prescribing of controlled medications via telemedicine and its impact on Tribal persons. Additionally, in June 2024, DEA transmitted a new draft telemedicine NPRM to the Office of Management and Budget (OMB) for review under Executive Order (E.O.) 12866. Since then, DEA has also attended several meetings with interested parties coordinated by OMB pursuant to E.O. 12866, which have provided interested parties with the opportunity to provide further views to OMB. With the deadline of December 31, 2024, granted by the Second Temporary Rule quickly approaching, DEA, jointly with HHS, is now issuing a third temporary extension (Third Temporary Rule) to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions. This additional time will allow DEA (and also HHS, for rules that must be issued jointly) to promulgate proposed and final regulations that are consistent with public health and safety, and that also effectively mitigate the risk of possible diversion. Furthermore, this Third Temporary Rule will allow adequate time for providers to come into compliance with any new standards or safeguards eventually adopted in a final set of regulations. DEA remains committed to carefully evaluating the comments received in response to the prior NPRMs, as well as the information and perspectives presented at the Telemedicine Listening Sessions, the Tribal Consultations, and the E.O. 12866 meetings. <HD SOURCE="HD1">II. Legal Authority</HD> The Ryan Haight Act amended the Controlled Substances Act (CSA) to generally require that the dispensing of controlled medications by means of the internet be predicated on a valid prescription involving at least one in-person medical evaluation. <SU>7</SU> <FTREF/> At the same time, it also established excepted categories of telemedicine pursuant to which a practitioner may presc ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 32k characters. 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