Why it matters

• The flexibilities were invoked in March 2020 in response to the COVID-19 public health emergency (PHE) and allow prescribing of controlled substances via telemedicine without an initial in-person visit.
• The current telemedicine flexibilities regarding prescribing controlled substances are set to expire December 31, 2025, without further action by the DEA or Congress.
• In November 2024, the DEA provided the most recent extension of the flexibilities through December 31, 2025, stating that the extension would give the agency time to promulgate proposed and final rules on telemedicine prescribing and “ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled substance prescriptions.”
• On January 15, 2025, in the final days of the Biden administration, the DEA released a proposed rule that would establish three special registrations, creating pathways for telehealth practitioners to prescribe – and online platforms to dispense – certain controlled substances via telemedicine after flexibilities expire on December 31, 2025. To date, the Trump administration has not moved forward with finalizing the proposed approach for special registration.
• Patients and providers are likely to welcome an extension, as they have been operating in a highly uncertain environment.
• Any extension would provide additional time for stakeholders to engage with policymakers.

Background

Under the Ryan Haight Act of 2008, a telemedicine provider is required to perform an in-person medical evaluation of a patient prior to prescribing a controlled substance (with certain limited exceptions). However, the flexibilities invoked in March 2020 in response to the COVID-19 PHE allow for prescribing controlled substances via telemedicine without an initial in-person visit. The current extension of the flexibilities, pursuant to a November 2024 rule, authorizes all DEA-registered practitioners to prescribe Schedule II – V controlled medications via telemedicine without an initial in-person examination through December 31, 2025.

Stakeholders had hoped that the DEA would permanently adopt flexibilities for telemedicine prescribing of controlled substances after the PHE, including finally adopting a special registration process. In February 2023, the DEA and the Substance Abuse and Mental Health Services Administration proposed two rules: the general telemedicine rule and the buprenorphine rule. The two proposals would have established additional potential pathways for prescribing certain controlled substances in limited quantities via telemedicine without an initial in-person medical examination while also imposing detailed recordkeeping requirements. Notably, the proposed rules did not include a special registration process for telemedicine providers.

The DEA received a record 38,000 comments in response to the February 2023 proposed rules, including comments from federal lawmakers. Many stakeholders pointed out that the requirement for an in-person evaluation would make it more challenging for certain patients (those facing significant barriers to accessing care without telemedicine) to continue receiving the controlled medications they need. Subsequently, the DEA issued temporary rules extending the telemedicine flexibilities through December 31, 2024, and stated that it anticipated releasing a final rule addressing telemedicine prescription of controlled substances in fall 2024. In November 2024, the DEA further extended the flexibilities through December 31, 2025, stating that the extension would give it time to promulgate proposed and final rules on telemedicine prescribing and “ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled substance prescriptions.”

In January 2025, the Biden administration released a proposed rule entitled Special Registrations for Telemedicine and Limited State Telemedicine Registrations, which addressed the long-awaited pathway for a telemedicine special registration. The proposed rule sought to establish three special registrations, creating pathways for telehealth practitioners to prescribe – and online platforms to dispense – certain controlled substances via telemedicine. The proposed rule would also impose detailed requirements for practice standards, prescription information, and documentation, including requirements related to prescription drug monitoring program checks, use of audio-video technology, restrictions on Schedule II controlled substances, data reporting to the DEA, identity verification, clinician credentialing, and record retention. It remains unclear whether the Trump administration will move forward with the proposed rule.

Next steps

With the expiration of the current telemedicine flexibilities looming, the new rule is an indication that the DEA will further extend the telemedicine flexibilities. Because the text of the new rule will not be publicly available until it clears OMB review, it is unclear how long such an extension would be and whether there are any limitations on the extension.

Please contact the authors of this article or your regular McDermott Will & Schulte lawyer with any questions.