On Friday, November 15, 2024, the Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) filed a Third Temporary Extension of the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (“Third Temporary Extension”), extending the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency (“PHE”) through December 31, 2025.
The Third Temporary Extension is scheduled for publication in the Federal Register on November 19, 2024.
This means the DEA will continue to allow DEA registered practitioners (“Practitioners”) to prescribe controlled substances via telemedicine without having previously conducted an in-person patient examination. Likewise, and of particular interest to telemedicine providers that practice in multiple states, Practitioners may continue prescribing via telemedicine to patients physically located in any state in which the Practitioners are licensed to practice medicine, without needing to have a separate DEA registration in each such state, subject to compliance with state prescribing requirements.
Background – PHE Flexibilities, NPRMs, First and Second Temporary Extensions, and OMB Submissions
Before the PHE, Practitioners were required to have at least one in-person visit with a patient before prescribing a controlled substance, with limited exceptions. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“the Act”) amended the Controlled Substances Act to generally prevent the illegal distribution and dispensing of controlled substances via the internet without a valid patient-provider relationship, meaning that, under the Act, at least one in-person medical evaluation is required.
During the pandemic, under the authority of a PHE, DEA temporarily waived the in-person visit requirement, allowing Practitioners to establish a valid patient-provider relationship and prescribe controlled substances via a two-way, interactive, audio-visual communication. DEA also provided a temporary exception to a separate requirement that Practitioners possess a DEA registration in every state where a patient receiving a prescription was located. That waiver allows Practitioners to prescribe to patients located in any state where the Practitioner is authorized to prescribe under state law, with a single DEA registration in any state.
As explained in EBG’s podcast, “The DEA Is Knocking at Your Door…Are You Prepared,” providers and patients have come to rely on telemedicine prescribing as a means to facilitate access to treatment, especially for patients diagnosed with Substance Use Disorders. Buprenorphine, a partial opioid agonist, is a commonly prescribed maintenance medication for patients with Opioid Use Disorder but is classified as a Schedule III controlled substance due to its mild euphoric effects and potential for abuse. When the Biden Administration declared that the PHE would expire in May of 2023, the telemedicine prescribing flexibilities were slated to end as well, sparking concern from industry stakeholders.
As covered in detail in one of our previous posts, on March 1, 2023, the DEA published two notices of proposed rulemaking (“NPRMs”) in the Federal Register, which were more restrictive than the DEA PHE waivers to which Practitioners have become accustom over the last four years, but less restrictive in comparison to the pre-PHE regulations applicable to telemedicine prescribing. The proposed rules, “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Visit” and “Expansion of Induction of Buprenorphine via Telemedicine Encounter,” received a record number of comments—over 38,000—which seemingly made the agency reconsider its position. Commenters were unhappy with the proposed requirement that prescribers perform an in-person evaluation for a Schedule II drug, and a host of other conditions limiting the circumstances under which Schedule III-V medications could be prescribed.
In May 2023, days before the end of the PHE, in order to further evaluate the best course of permanent action given the record-breaking number of comments received, DEA issued a temporary rule, published May 10, 2023 (the “First Temporary Extension”), extending the full set of telemedicine flexibilities adopted during the PHE through November 11, 2023, and providing a one-year grace period, through November 11, 2024, to any provider-patient telemedicine relationships established on or before November 11, 2023. Evidently wanting additional feedback, DEA also hosted public listening sessions in September 2023. Then, instead of finalizing the proposed rules, DEA once again extended the full telemedicine prescribing flexibilities through a second temporary rule, December 31, 2024 (the “Second Temporary Extension”), to allow further time to evaluate the information and perspectives presented at the listening sessions, and the comments received in response to the proposed permanent rules.
On June 13, 2024, with the Second Temporary Extension set to expire at the end of 2024, DEA submitted a new proposed rule to the Office of Management and Budget (“OMB”), “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have not had a Prior In-Person Medical Evaluation,” where it sat pending for months. In August 2024, Politico reported that, according to an anonymous source within DEA, the new proposed rules would again seek to significantly limit telemedicine prescribing of controlled substances. However, instead of moving forward with the proposed rule pending at the OMB, DEA submitted the Third Temporary Extension to OMB on October 10, 2024, which was ultimately filed in the Federal Register on November 15, 2024, once again extending the COVID-era flexibilities for telemedicine prescribing of controlled substances.
Current Telemedicine Prescribing Flexibilities
The incoming Trump administration will now have to come up with a solution on how to transition post-pandemic telemedicine prescribing, with the outgoing Biden Administration electing to punt on the issue. In the meantime, Practitioners may continue to prescribe controlled substances without having previously examined a patient in-person, to patients physically located in any state, where: (1) the prescription is issued for a legitimate medical purpose by the Practitioner acting in the usual course of that Practitioner’s professional practice; (2) the prescription is issued pursuant to a communication between the Practitioner and patient using an interactive audio-visual telecommunication system; and (3) such prescription complies with other requirements included in applicable federal law, state laws (including state licensure requirements), and DEA regulations and guidance.
Epstein Becker Green is closely following all related news and developments. For additional information about the issues discussed above, or if you have any other telemedicine or digital health concerns, please contact the Epstein Becker Green attorney who regularly handles your legal matters, or one of the authors of this blog post. Read more about our expansive capabilities and offerings here and more generally on EBG’s website at www.ebglaw.com.
Epstein Becker Green Attorney Ann W. Parks contributed to the preparation of this post.
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