DEA, HHS Jointly Issue 3rd Temporary Extension of Telemedicine Prescribing Flexibilities

Alliance Daily | Nov. 20, 2024

On November 15, the U.S. Department of Health and Human Services (HHS) jointly with the Drug Enforcement Administration (DEA) issued a rule, titled ‘Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications’. This Third Temporary Rule extends the telemedicine flexibilities that have been in effect since March 2020 for the prescribing of controlled medications through December 31, 2025. They were originally set to expire on December 31, 2024, a full year earlier. The Alliance is pleased to see this extension, which underscores our continued engagement on this issue and reinforces our commitment to ensuring uninterrupted and appropriate access to care for beneficiaries receiving care in the home.

As background, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) amended the Controlled Substances Act (CSA) to generally mandate that dispensing controlled medications via the internet requires a valid prescription, which includes at least one in-person medical evaluation. However, it also created certain telemedicine exceptions that allow a practitioner to prescribe controlled substances to a patient without an in-person evaluation, as long as the practice complies with applicable federal and state laws and meets other specific requirements. In response to the COVID-19 Public Health Emergency (PHE), the DEA granted temporary extensions to the Ryan Haight Act to prevent lapses in care by permitting in certain instances the prescribing of controlled medications via telemedicine encounters even when there had been no in-person prior medical evaluation.

Upon conclusion of the PHE in May 2023, and in response to stakeholder feedback—including from both legacy organizations of the Alliance[1]—the DEA and HHS announced via a temporary rule an extension of certain telemedicine prescribing flexibilities that had been in place during the COVID-19 public health emergency, from May 12, 2023 through November 11, 2023. This flexibility permits DEA-registered practitioners to, among other things, prescribe schedule II-V controlled medications via telemedicine without a prior telemedicine relationship on or before November 11, 2023, when criteria at 21 CFR § 1307.41(e) are met (outlined below). In October 2023, the DEA again extended via a second temporary rule this flexibility through the end of December 31, 2024.

Conditions which must be met for practitioners to issue prescriptions pursuant to the temporary rule include:

  • The prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
  • The prescription must be issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system referred to in regulation at 42 CFR 410.78(a)(3) as:
    • audio and video equipment permitting two-way, real-time interactive communication or,
    • for prescriptions to treat a mental health disorder – which include, but are not limited to, prescriptions for buprenorphine for opioid use disorder – a two-way, real-time audio-only communication if the distant site physician or practitioner is technically capable of using an interactive audio-video telecommunications system, but the patient is not capable of, or does not consent to, the use of video technology.
    • The practitioner must be authorized under their registration to prescribe the basic class of controlled medications specified on the prescription or exempt from obtaining a registration to dispense controlled medications.
    • The prescription must be consistent with all other requirements.

In implementing this third temporary extension, the DEA and HHS considered stakeholder feedback from White House Office of Management and Budget E.O. 12866 meetings[2]— in which the Alliance participated— as well as the impending expiration of existing flexibilities, and input from Telemedicine Listening Sessions and Tribal Consultations.

The DEA and HHS anticipate releasing a final set of regulations in the future, but no specific timeframe has been provided. Stay tuned to Alliance Daily for updates.

[1] On March 1, 2023, the DEA, along with HHS, issued two notices of proposed rulemakings (NPRMs) seeking feedback on proposals that would enable the prescribing of controlled medications via telemedicine in certain situations where the prescribing practitioner had never conducted an in-person visit with a patient: Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation and Expansion of Induction of Buprenorphine via Telemedicine Encounter. Collectively, these rules received over 38,000 comments, including from both legacy organizations of the Alliance. In addition, the DEA held listening sessions in September 2023 to gather input from various stakeholders and further inform rulemaking.

[2] Executive Order 12866 sets the process for OIRA’s review of significant regulatory actions and allows public engagement during the review of proposed and final rules. These meetings, known as E.O. 12866 meetings, enable stakeholders to share their views on regulatory actions under consideration.