The landscape of telehealth has undergone a monumental transformation in the last few years, driven in large part by the COVID-19 pandemic. Telehealth has allowed healthcare providers to continue caring for patients remotely, providing a critical service, especially during times of social distancing and widespread health concerns. Among the most crucial developments during this time has been the ability for healthcare providers to prescribe controlled substances via telehealth, a practice that has offered convenience, accessibility, and efficiency. However, as we approach the end of 2024, healthcare providers who have utilized these flexibilities are now facing uncertainty about the future, as the Drug Enforcement Administration (DEA) weighs the continuation of telehealth regulations that govern controlled substance prescribing.
The Telehealth Cliff: A Potential Crisis for Behavioral Health
Since the onset of the pandemic, the DEA has extended temporary rules that provided broad flexibility for prescribing controlled substances via telehealth. These regulations allowed healthcare providers to prescribe controlled substances, including medications for mental health disorders, addiction treatment, and pain management, without the requirement for an in-person visit. This flexibility has been instrumental in maintaining care continuity for patients who might otherwise struggle to access treatment, especially those living in rural areas or who face other barriers to in-person appointments.
However, these temporary flexibilities are set to expire at the end of 2024. As it stands, without further action, the DEA plans to reinstate pre-pandemic telehealth regulations that require patients to first be seen in person before they can receive prescriptions for controlled substances through telehealth. The expiration of these telehealth flexibilities would create significant challenges for healthcare providers and their patients, particularly in the behavioral health sector.
Telehealth has become a lifeline in behavioral health care, as evidenced by health claims data showing that more than two-thirds of all telehealth claims are related to behavioral health. For many patients, particularly those managing mental health conditions or substance use disorders, the ability to access telehealth services has been essential for continuity of care. Behavioral health providers, addiction treatment professionals, and their patients are deeply concerned about the potential impact of returning to pre-pandemic regulatory conditions, which could create serious disruptions in care.
The DEA’s Ongoing Rulemaking Process
The uncertainty surrounding the future of telehealth prescribing has been compounded by the ongoing rulemaking process within the DEA. On October 10, 2024, the DEA submitted a final rule to the White House’s Office of Management and Budget (OMB), which is responsible for coordinating and reviewing executive branch actions. While this represents a step closer to finalizing the new telehealth regulations, the details of the rule have not yet been made public. The OMB’s review process is often the final hurdle before new regulations are released, but the lack of transparency surrounding the rule has left providers and advocates in a state of confusion.
For more than a year, the DEA has been working on creating a new regulatory framework for telehealth prescribing that reflects the growing role telehealth plays in the healthcare system, especially in behavioral health. The challenge has been to create a balanced approach that both ensures patient safety and accommodates the realities of telehealth as an essential mode of care delivery. The new rules, when finalized, will attempt to establish a post-COVID paradigm that accommodates telehealth prescribing, while addressing concerns about the potential misuse of controlled substances.
The rulemaking process has proven to be a long and winding road, with the DEA facing intense scrutiny from both advocacy groups and lawmakers. The issue has been particularly contentious in the field of behavioral health, where telehealth has emerged as a key tool for providers and patients alike. Many behavioral health providers, addiction specialists, and patients argue that the current telehealth regulations are not sufficient to support the unique needs of their care models.
Advocates Push for Flexibility and a Permanent Solution
In response to the uncertainty surrounding the future of telehealth regulations, advocacy groups like the American Hospital Association (AHA) have been vocal in calling for a two-year extension of the current telehealth flexibilities. In a letter sent to the U.S. Department of Health & Human Services (HHS) and the DEA, the AHA stressed the need to prevent interruptions in care for patients who rely on virtual prescribing without an in-person evaluation. This request is based on the concern that discontinuing these flexibilities could disrupt the delivery of critical care, particularly for patients with behavioral health conditions who have become accustomed to receiving their medications and therapy remotely.
The AHA’s call for a two-year extension is also a plea for more time to establish a permanent regulatory framework that can sustain telehealth-based prescribing in a way that is both secure and patient-centered. The AHA argues that a permanent solution should take into account the evolving nature of telehealth and the increasing reliance on virtual care in specific sectors of healthcare, like behavioral health and addiction treatment.
This extension request also highlights the challenges providers face in navigating a regulatory environment that has been slow to evolve. While telehealth has been an essential tool in managing patient care, the regulatory framework governing its use, particularly for controlled substances, has struggled to keep pace with technological advancements and changing patient needs.
The Ryan Haight Act and the Need for Special Registration
The issue of telehealth prescribing for controlled substances is not new. In fact, the Ryan Haight Act of 2008 and the SUPPORT for Patients and Communities Act of 2018 each mandated that the DEA create a special registration process that would allow healthcare providers to prescribe certain controlled substances remotely. However, despite these legislative directives, the DEA has failed to implement the required registration process, leaving many healthcare providers in a state of uncertainty.
Advocates for addiction treatment and behavioral health providers have long called for a clear and efficient registration process that would allow them to prescribe controlled substances via telehealth without the need for an in-person visit. They argue that such a process would enable them to continue offering care remotely while maintaining appropriate safeguards to prevent misuse. However, some addiction treatment advocates believe that the focus on creating a special registration process is misguided, and that a broader, more flexible approach to telehealth regulations would better meet the needs of both providers and patients.
In 2023, the DEA released two interrelated rules, one governing most Schedule II controlled substances and the other applying specifically to medications used in addiction treatment. These rules were met with significant opposition from advocacy groups, who argued that the new regulations would harm patients who rely on telehealth for ongoing treatment, particularly in the addiction treatment sector. The rules were effectively shouted down, leading to further extensions of the temporary flexibilities.
The Road Ahead: What’s Next for Telehealth Prescribing?
As the December 31, 2024 deadline looms, healthcare providers and patients alike are bracing for the potential disruption that could come with the return to pre-pandemic telehealth regulations. The finalization of the DEA’s new rules, whether they result in an extension of existing flexibilities or a shift toward a more restrictive regulatory framework, will have profound implications for the future of telehealth prescribing.
For now, healthcare providers are advised to stay engaged with the rulemaking process and remain informed about any updates from the DEA or other relevant authorities. Advocacy efforts will undoubtedly continue to push for the preservation of telehealth flexibility, particularly for behavioral health providers who have seen the benefits of virtual care firsthand.
Ultimately, the DEA’s decision on telehealth prescribing will shape the future of remote healthcare for years to come. Ensuring that the regulatory environment supports both patient safety and the growing demand for telehealth services will be key to maintaining access to care for millions of patients who depend on it. Whether through an extension of existing regulations, a permanent solution, or a new compromise, the next steps in telehealth regulation will be crucial in determining how the healthcare system adapts to the needs of a rapidly changing world.
