DEA and HHS issue third temporary extension of COVID-19 telemedicine flexibilities for prescribing of controlled substances

On November 15, 2024, the US Drug Enforcement Administration (DEA) and the US Department of Health and Human Services (HHS) jointly issued the third temporary extension of telemedicine flexibilities instituted during the COVID-19 public health emergency (the PHE) for the prescribing of controlled substances (the Third Temporary Rule), effective from January 1, 2025, through December 31, 2025.

The Third Temporary Rule follows prior extensions jointly issued by the DEA and HHS in May 2023 and October 2023 (the First and Second Temporary Rules, respectively). In light of the pending expiration of the Second Temporary Rule on December 31, 2024, the Third Temporary Rule was issued to “prevent reduced access to care for patients that do not yet have an existing telemedicine relationship with their practitioners pending [the DEA and HHS’] promulgation of a final rule or rules addressing telemedicine.”

Background

As discussed in our prior client alert, on February 24, 2023, the DEA issued proposed rules (the Telemedicine Controlled Substance Proposed Rule and the Telemedicine Buprenorphine Proposed Rule – together, the Proposed Rules) that addressed the prescribing of controlled substances via telemedicine beyond the scheduled end of the PHE.

During the PHE, the in-person examination requirement under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act) was waived, thereby allowing DEA-registered prescribers to issue prescriptions for controlled substances via telemedicine without a prior in-person evaluation, provided that the prescription was for a legitimate medical purpose, and the practitioner was acting in accordance with state law.

The Proposed Rules attempted to balance concerns of patient access to prescription medications with concerns over appropriate prescribing practices, and the potential for abuse or diversion of controlled substances. However, as the Proposed Rules were extremely complex and more restrictive than the PHE-era flexibilities, the DEA announced plans to promulgate a final set of telemedicine regulations by the fall of 2024.

The Third Temporary Rule and the final telemedicine regulations

With the issuance of the Third Temporary Rule, the DEA and HHS implicitly acknowledge that the final set of telemedicine regulations will not be issued this fall as previously anticipated. Instead, the Third Temporary Rule appears to be a stop-gap measure to ensure continued access to controlled substances by patients and practitioners relying on telemedicine while the DEA and HHS promulgate proposed and final telemedicine regulations.

According to the DEA and HHS, the Third Temporary Rule will allow adequate time for practitioners to comply with any new standards or safeguards eventually adopted in a final set of regulations.

Further, the DEA and HHS reiterate that the purpose of the Third Temporary Rule, as well as the previous Temporary Rules, is to extend, for a limited period of time, the telemedicine flexibilities that existed during the PHE, to, among other things, prevent a reduction in access to care for patients without an existing telemedicine relationship, prevent backlogs for in-person medical evaluations, ensure the availability of telemedicine for practitioners and patients, address the urgent public health need for continued access to buprenorphine as a treatment for opioid use disorder, and avoid incentivizing or enabling problematic prescribing practices.

The Third Temporary Rule does not create or remove any regulatory requirements to 21 C.F.R. § 1307.41 or 42 C.F.R. § 12.1, which address temporary extensions of certain COVID-19 telemedicine flexibilities for prescription of controlled medications.

Key takeaways

Absent from the Third Temporary Rule is any mention of the incoming Trump Administration and what impact, if any, a new administration will have on the promulgation of a final set of telemedicine regulations after the Proposed Rules, or even the issuance of the Third Temporary Rule. However, the Third Temporary Rule, as well as the prior Temporary Rules and the Proposed Rules, signal an acknowledgement by the DEA and HHS of the importance of telemedicine in the provision of care to patients. But, without the issuance of a final set of telemedicine regulations, it is unclear how the DEA and HHS will balance this apparent recognition of the value of telemedicine with ongoing, stated concerns related to appropriate prescribing practices, and the potential for harm in prescribing controlled substances via telemedicine.

Further, as the Third Temporary Rule is set to expire on December 31, 2025, the issuance of a final set of telemedicine regulations will likely be crucial to understanding any ongoing telemedicine flexibilities. Given the potential for policy changes at the DEA and HHS, as well as the complex nature of the regulatory landscape surrounding prescribing controlled substances via telemedicine, healthcare entities and providers are encouraged to carefully monitor this space for updates.

For more information about the Third Temporary Rule or the Proposed Rules, please contact your DLA Piper relationship attorney, the authors of this alert, or any member of our Healthcare Regulatory group.