Third Extension of COVID-19 Telemedicine Flexibilities for Controlled Substances: Ensuring Access and Preparing for Future Regulations

As expected, the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) just released a new rule temporarily extending flexibilities for prescribing controlled substances via telemedicine. This third extension continues the full set of telemedicine prescribing flexibilities, with a new expiration date of Dec. 31, 2025. Practitioners may continue to prescribe Schedule II-V controlled substances via telemedicine without having conducted an in-person evaluation of the patient, as required under the Ryan Haight Act, if certain conditions are met, and maintain a DEA registration in at least one state. The extension serves as a bridge between the temporary emergency measures initiated during the COVID-19 pandemic and a more permanent regulatory structure that is yet to be established.

Background and Purpose

At the core of the regulatory changes is the Ryan Haight Act, which lays the groundwork for regulating the prescription of controlled substances. The Act, named after a young man who died from an overdose after obtaining medications online, was designed to limit the risk of drug abuse facilitated by telemedicine. The law, and its implementing regulations, required healthcare providers to conduct in-person medical evaluations before prescribing controlled substances. The intention was to curb the misuse and abuse of controlled medications, especially opioids. However, the onset of the COVID-19 Public Health Emergency (PHE) in 2020 prompted a shift in healthcare delivery, making in-person visits challenging or even dangerous. Recognizing this barrier, the DEA allowed controlled medications listed under Schedules II to V to be prescribed through telemedicine without requiring an in-person evaluation. This decision was pivotal in ensuring that patients, particularly those with chronic conditions or substance use disorders, could continue receiving necessary care without interruption. In May and October 2023, the DEA and HHS jointly issued extensions to the PHE flexibilities creating an ultimate expiration date of Dec. 31, 2024.

The new, and third, extension aims to maintain continuity of care by prolonging the flexibility granted to healthcare providers during the pandemic and allow practitioners time to come into compliance with any new regulations when they are adopted. This measure will remain in place while a more permanent set of rules is developed, reflecting a commitment to patient health and safety and the importance of modernizing healthcare delivery methods.

Previous Extensions

The first extension of telemedicine flexibilities occurred on May 10, 2023, shortly after the official end of the COVID-19 PHE. This extension was intended to allow practitioners and patients time to adjust to the gradual lifting of pandemic-related healthcare measures. It set a deadline of Nov. 11, 2023, for new telehealth relationships, with a grace period lasting until November 2024 for existing relationships. However, it became clear that further guidance was needed as the regulatory landscape continued to evolve.

In response, a second extension was announced on Oct. 10, 2023. This extension broadened the applicability of the rule by extending telemedicine flexibilities until Dece. 31, 2024, covering all established telemedicine relationships. This was seen as an acknowledgment of the ongoing challenges faced by patients and providers and the need for a seamless transition away from emergency measures. The second extension also allowed for the consideration of challenges faced by tribal communities and any potential impact changes to the existing regulations would have.

The latest, third extension moves the expiration date to Dec. 31, 2025, and maintains the provisions that have been in place since March 2020. This additional time allows stakeholders to navigate the complexities of prescribing controlled substances in a virtual setting while more comprehensive and permanent rules are developed. It also allows the DEA, and HHS, where joint action is needed, additional time to consider the 38,369 public comments received after two notices of proposed rulemaking (NPRMs) were issued on this subject in March 2023.

Key Aspects of the Third Extension

Under this extension, DEA-registered practitioners retain the ability to prescribe controlled substances, ranging from Schedule II to Schedule V, through telemedicine without an in-person examination. This applies to telemedicine interactions conducted via both audio-video and audio-only systems, as long as specific conditions are met. These conditions include ensuring that prescriptions serve a legitimate medical purpose, adhering to federal regulations, and using compliant telecommunication systems.

This regulatory decision seeks to avoid any disruptions in patient care, especially for individuals who rely on medications like buprenorphine, a common treatment for opioid use disorder, and to avoid potential diversion from such treatment. The opioid crisis, which predated the COVID-19 pandemic, remains a significant public health issue, and the continuation of telemedicine flexibilities is seen as a measure to mitigate the risks associated with treatment interruptions. Additionally, the extension grants the DEA and HHS additional time to review feedback from stakeholders, including consultations with Tribal organizations, before finalizing permanent rules.

Regulatory and Legal Context

The Ryan Haight Act allows for certain exceptions for prescribing controlled substances, including in the context of public health emergencies, under the authority of the Attorney General and the HHS Secretary. The current temporary rule, implemented without the standard notice-and-comment period typically required under the Administrative Procedure Act, leverages a “good cause” exception. This exception allows for expedited rule-making when there is a pressing need, and in this case, the need is to ensure uninterrupted access to necessary care. The decision to bypass the usual regulatory process reflects the urgency of addressing potential gaps in healthcare delivery that could arise if the temporary telehealth flexibilities were to expire without a more permanent solution in place.

Impact and Implications

The extension is expected to have several notable impacts. First and foremost, it maintains access to prescriptions for controlled substances during a transitional phase in healthcare regulation. This continuity is crucial for patients who have come to rely on telemedicine for their care, including those living in rural, tribal, or underserved areas where healthcare access can be limited. Telemedicine has proven to be a cost-effective way to expand healthcare reach, and the continuation of these flexibilities will likely benefit both patients and providers by reducing travel and associated costs.

For healthcare providers, the extension mitigates the risk of investing in new telemedicine infrastructure or business models that could become obsolete if regulations were to change suddenly. By maintaining the status quo through 2025, the rule provides a stable environment for healthcare practitioners to adapt to future regulations. This decision is also in line with several executive orders focused on reducing regulatory burdens, avoiding regulatory waste, and fostering civil justice reform, as well as considerations related to federalism and tribal impact.

Conditions for Prescribing Under the Extension

Despite the continued flexibility, the prescription of controlled substances through telemedicine remains subject to several conditions to ensure safety and compliance. A prescription must serve a legitimate medical purpose, and the interaction must take place using an approved telecommunications system. Additionally, the healthcare provider must be registered with the DEA or qualify for an exemption, and all prescriptions must align with DEA and federal requirements. These conditions aim to maintain the integrity of the prescribing process while acknowledging the unique circumstances that telemedicine presents.

Future Developments

Looking ahead, the DEA and HHS are working toward establishing a more permanent set of regulations that will strike a balance between patient access to care, public health and safety, and the need for safeguards against the misuse of controlled substances. This process involves a thorough review of public comments, listening sessions, and feedback from diverse stakeholders, including healthcare practitioners, pharmacists, and tribal representatives. The aim is to create a regulatory environment that supports telemedicine while implementing controls that prevent drug diversion and abuse.

The final rules expected to be crafted will likely introduce new standards and safeguards for telemedicine-based prescribing of controlled substances. Providers and patients will have time to adjust to these changes, allowing for a smoother transition as the healthcare system moves from the emergency provisions of the pandemic to a more stable, long-term framework. This period of regulatory review and adaptation is critical in ensuring that the rules reflect both the lessons learned during the pandemic and the ongoing needs of the healthcare system and demonstrates an understanding that rushing to conclusions could have a detrimental impact on overall public health.

Conclusion

The third extension of telemedicine flexibilities for prescribing controlled substances reflects a recognition of the evolving healthcare landscape and the need to adapt to new challenges. By extending these measures until the end of 2025, the DEA and HHS are taking a cautious approach to regulation, allowing time for careful consideration of public input and the development of a comprehensive, permanent regulatory framework. This period of transition seeks to balance the need for access to care with the imperative to prevent substance misuse and diversion from substance abuse treatment, paving the way for a more resilient and responsive healthcare system and improved public health in the years to come.

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