By DANIEL AYYASH

Wachler & Associates, P.C.

On Dec. 31, 2025, the Drug Enforcement Administration (DEA) released a fourth temporary Rule extending certain controlled substance prescribing flexibilities through Dec. 31, 2026. The Rule maintains the DEA’s position on controlled substance prescribing via telehealth that has been in place since the beginning of the COVID-19 public health emergency (PHE). By extending these flexibilities, healthcare providers have extra time to make preparations in the event that pre-PHE telemedicine prescribing requirements are revived, and also gives the DEA time to evaluate whether a more permanent framework for telemedicine controlled substance prescribing can be implemented.

Background

Prior to the beginning of the COVID-19 PHE and the prescribing flexibilities that came with it, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) required a telemedicine provider to perform an in-person medical evaluation of a patient before a controlled substance could be prescribed, with certain limited exceptions. Once a provider had conducted at least one in-person medical evaluation of a particular patient, the specific requirements of the Ryan Haight Act related to remote prescribing of controlled substances no longer applied to that particular provider-patient relationship, and the provider could prescribe certain controlled substances via telemedicine indefinitely.

In response to the COVID-19 PHE, in January 2020, the DEA granted temporary exceptions to the remote prescribing requirements of the Ryan Haight Act, which remained in place through the end of the federally declared PHE. Then, in May 2023, the DEA issued the first temporary rule, carving out an exception to the Ryan Haight Act to allow telemedicine providers to prescribe Schedule II – V controlled substances by telemedicine without the need for an initial in-person medical evaluation. As extended, those initial flexibilities were effective through Nov. 11, 2023. Although the flexibilities themselves were originally set to expire after November 11, 2023, the first temporary rule included a one-year grace period to any provider-patient relationships that had been or would be established on or before Nov. 11, 2023, with those relationships permitted to take advantage of the flexibilities through Nov. 11, 2024.

In October 2023, after soliciting industry input from providers and other stakeholders, the DEA issued the second temporary rule, further extending the telemedicine controlled substance prescribing flexibilities through December 31, 2024. The second temporary rule superseded the first rule’s grace period, and applied to all provider-patient relationships until the end of 2024, not only those established prior to Nov. 11, 2023. Then, in November 2024, the DEA issued a third temporary rule, again extending these flexibilities and allowing controlled substances to be prescribed via telemedicine without an in-person medical evaluation through Dec. 31, 2025. Most recently, in December 2025, the DEA issued a fourth temporary Rule, which maintains these telemedicine controlled substance prescribing flexibilities through Dec. 31, 2026.

Special Registration Process for Telemedicine Providers

 Shortly after the DEA issued the third temporary rule, in January 2025, the DEA published a notice of proposed rulemaking (NPRM) titled, “Special Registration for Telemedicine and Limited State Telemedicine Registrations.” Specifically, the NPRM proposed a framework for a Special Registration for Telemedicine, which would authorize physicians and mid-level practitioners with the Special Registration to prescribe controlled substances via audio-video telemedicine (and in limited instances, audio-only telemedicine) without needing to ever conduct an in-person medical evaluation of the patient, so long as those authorized providers comply with the proposed prescription, recordkeeping, and reporting requirements. The NPRM also proposed to allow registration of certain direct-to-consumer (DTC) telemedicine platforms that function as intermediaries and are often integral to the provider-patient relationship. The DEA received over 6,475 comments in response to the NPRM. Presently, it remains unclear whether the DEA and current administration will move forward with the proposed rule on telemedicine-specific registration.

The Impending Telemedicine Cliff

As many healthcare providers who prescribe or treat patients via telemedicine are acutely aware, there are widespread concerns from providers, patients, and other stakeholders that expiration of the current telemedicine flexibilities could abruptly limit patients’ access to care, until a more permanent framework or final set of regulations is put in place. The potentially abrupt end to broad telemedicine flexibilities currently in place, including providers’ ability to prescribe controlled substances to patients without an initial in-person medical evaluation, is often referred to as the “telemedicine cliff.” As a frame of reference for the scope of the issue, the DEA in its most recent temporary Rule explains that according to “unpublished data reviewed by Epic, Johns Hopkins, and Stanford: of an estimated 44.6 million prescriptions for controlled substances prescribed across 258 organizations in 2024, more than 7 million, approximately 16 percent, were issued without a prior in-person medical evaluation.”

The potential dangers of the telemedicine cliff can be put into context by examining the recent sunsetting of the COVID-era, congressionally-implemented Medicare telemedicine flexibilities to observe the negative impacts on patients’ access to care when no permanent laws or regulations are in place. In the days immediately following Medicare’s telemedicine flexibilities original lapse on September 30, 2025, there was a significant decrease nationwide in Medicare fee-for-service telemedicine visits, with some states seeing such decreases of 40 percent or greater. Congress temporarily extended those flexibilities once more, but the disruption in access to care and loss of timely critical services caused substantial harm to both providers and patients. Telemedicine provides broad benefits and removes barriers to care for numerous patients. Without a permanent framework or further regulation, the end of telemedicine flexibilities would re-introduce unnecessary barriers and likely cause access to care restrictions.

Looking Ahead

The DEA’s latest temporary Rule extends controlled substance prescribing via telemedicine without an initial in-person medical evaluation through Dec. 31, 2026. In addition to its efforts to avoid consequences of the telemedicine cliff, the DEA states in the Rule that “the extension will provide time for DEA to promulgate a final set of regulations,” and “to ensure a smooth transition for patients and providers that have come to rely on the availability of telemedicine.” Further, the DEA states that the extension will “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.”

Taken together, the DEA’s comments in its most recent Rule suggest that the DEA does not intend to further extend telemedicine controlled substance prescribing flexibilities. Rather, the DEA appears poised to propose a final set of regulations to implement a more permanent framework for telemedicine’s role in controlled substance prescribing. While the specific elements of a final rule on telemedicine controlled substance prescribing remain unclear, providers and stakeholders should monitor these developments and engage with policymakers to express their feedback and desired policy outcomes.