On October 10, 2023, the Drug Enforcement Administration (“DEA”) and the Substance Abuse and Mental Health Services Administration (“SAMHSA”) published a second temporary rule (the “Second Temporary Rule”) that will extend certain telemedicine flexibilities made available during the COVID-19 Public Health Emergency (“PHE”) for the second time. The Second Temporary Rule will extend exceptions to existing DEA regulations for all practitioner-patient relationships through December 31, 2024. Like its predecessor, the Second Temporary Rule is intended to provide patients with uninterrupted care while allowing adequate time for providers to come into compliance with any new standards or safeguards the agencies promulgate in future final rules.

Background

Under normal circumstances, prescribing practitioners are required to conduct an in-person evaluation of patients before prescribing controlled substance medications, as mandated by the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”). Due to unprecedented challenges presented during the COVID-19 PHE, however, DEA granted prescribing practitioners temporary exceptions designed to ensure the continuity of care for patients through telemedicine encounters.

In March 2020, DEA granted temporary exceptions to the Ryan Haight Act allowing for the prescription of controlled substances via telemedicine encounters, even in situations where the prescribing practitioner had not conducted an in-person medical evaluation with the patient. These telemedicine flexibilities authorized practitioners to prescribe schedule II-V controlled substance medications via audio-video telemedicine encounters, including FDA-approved schedule III-V narcotic controlled substance medications, without an in-person medical evaluation, provided that such prescriptions otherwise complied with the requirements outlined in DEA guidance documents, regulations, and applicable Federal and State law.

On May 11, 2023, DEA and SAMHSA published the first temporary rule extending the telemedicine flexibilities that were introduced during the COVID-19 PHE (the “First Temporary Rule”). The First Temporary Rule extended the telemedicine flexibilities for prescribing controlled medications through November 11, 2023. As a result, prescribing practitioners could continue to utilize telemedicine platforms to prescribe controlled substances to their patients, even when the practitioner has not yet conducted an in-person medical evaluation of the patient. The First Temporary Rule granted an additional twelve-month grace period for practitioner-patient telemedicine relationships established on or before November 11, 2023. As a result, if a practitioner and patient established a telemedicine relationship on or before November 11, 2023, they could rely on the full set of telemedicine flexibilities through November 11, 2024.

Summary of Temporary Rule Changes

Effective November 11, 2023, the Second Temporary Rule will extend the temporary exceptions promulgated in the First Temporary Rule through December 31, 2024. Specifically, the Second Temporary Rule will temporarily extend the full set of telemedicine flexibilities that were introduced during the COVID-19 PHE, including those regarding the prescription of controlled medications, through December 31, 2024. The extension will authorize 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 is effectively subsumed by the Second Temporary Rule, which will continue 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.

The purpose of the Second Temporary Rule, like the First Temporary Rule, is to ensure a smooth transition for patients and practitioners who have come to rely on the availability of telemedicine for prescriptions of controlled medications, as well as to allow adequate time for providers to come into compliance with any new standards or safeguards that DEA and/or SAMHSA promulgate in future final rules. In addition to that overarching purpose, the Second Temporary Rule is also intended to:

• Prevent a reduction in access to care for patients who have not yet established a telemedicine relationship with their practitioners;
• For relationships established during the COVID-19 PHE and shortly thereafter, prevent backlogs with respect to in-person medical evaluations in the months shortly before and after the expiration of the telemedicine flexibilities;
• Address the urgent public health need for continued access to buprenorphine as medication for opioid use disorder;
• Allow patients, practitioners, and other service providers sufficient time to prepare for the implementation of any future regulations; and
• Avoid incentivizing the investment necessary to develop new telemedicine companies that might encourage or enable problematic prescribing practices by limiting the second extension of flexibilities to a short, time-limited period.

Ultimately, DEA anticipates implementing a final set of regulations permitting the practice of telemedicine under circumstances that are consistent with public health and safety, while maintaining effective controls against diversion. DEA plans to issue one or more final rules based on the two proposed rules published on March 1, 2023. In the first of these proposed rules, DEA proposes to expand the circumstances under which individual practitioners are permitted to prescribe buprenorphine via telemedicine encounter. The second of the proposed rule details the prescription of controlled substances via telemedicine encounter when the prescribing practitioner and the patient have not had a prior in-person medical evaluation. DEA received more than 38,000 comments on the proposed rules, and received additional input from the public during two public listening sessions held in September 2023. DEA anticipates publication of one or more final rules by the Fall of 2024.

Koley Jessen will continue to monitor further developments in this area. If you have questions about the impact these rules may have on your organization or current telemedicine rules, please contact an attorney in our Health Law practice group.

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