Why it matters

• The current telemedicine flexibilities regarding prescribing controlled substances were set to expire December 31, 2025. The flexibilities will now expire December 31, 2026. The DEA stated that the extension will prevent the reinstatement of the pre-pandemic restrictions (also known as the “telemedicine cliff”), which would abruptly limit patients’ access to care until promulgation of a final set of regulations. This extension is in addition to the final rule allowing for the prescription of buprenorphine via telemedicine encounter.
• 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 termination of the flexibilities, then set to expire on December 31, 2025.
• To date, the Trump administration has not moved forward with finalizing the proposed approach for special registration. However, the DEA stated that the new extension will give it time to promulgate a final rule on telemedicine prescribing and will allow sufficient time for providers to come into compliance with any new registration, recordkeeping, or security requirements eventually adopted in a final rule.
• The extension will 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 previous extension of the flexibilities, pursuant to a November 2024 rule, authorized 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. 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.

Looking forward

The new rule extends the flexibilities through December 31, 2026. The DEA stated that the extension would give it time to promulgate a final set of regulations on telemedicine prescribing, as well as “allow sufficient time for providers to come into compliance with any new DEA registration, recordkeeping, or security requirements eventually adopted in a final set of regulations.” The DEA further stated that the extension will “ensure a smooth transition for patients and providers that have come to rely on the availability of telemedicine to prescribe controlled substances to patients for whom they have never had an in person medical evaluation.”

The DEA’s statements indicate that it is not planning to issue a new proposed rule regarding telemedicine prescribing and will instead finalize one of its previous proposed rules. The DEA acknowledged the abrupt 41-day cessation of Medicare’s telemedicine flexibilities on September 30, 2025, which previewed the negative impact a “telemedicine cliff” has on patients’ access to care when no permanent laws or regulations are in place when such flexibilities expire. While it is unclear what a final rule on telemedicine prescribing of controlled substances will look like, stakeholders should continue to engage with policymakers to express their views and desired policy outcomes.

McDermott Will & Schulte will continue to closely watch for developments. Please contact the authors of this article or your regular McDermott Will & Schulte lawyer with any questions.