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21 February 2025

Telehealth Regulations Under Scrutiny Amid New DEA Rules

American Telemedicine Association calls for adjustments to access regulations for controlled substances.

The telehealth industry is currently facing significant regulatory challenges as the U.S. Drug Enforcement Administration (DEA) proposes new rules aimed at managing the prescription of controlled substances through virtual platforms. This development has ignited responses from key stakeholders, particularly the American Telemedicine Association (ATA) and its advocacy branch, ATA Action, who stress the need for meaningful adjustments to avoid leaving millions of patients underserved.

According to ATA, the DEA's January proposal to mandate special registrations for telehealth providers prescribing certain controlled substances—including Schedule II prescription medications without requiring prior in-person consultations—could create unnecessary barriers to access. Kyle Zebley, the senior vice president of public policy at ATA Action, highlighted several concerns about the proposal's provisions, saying, "Many aspects of the rule are workable for the telehealth community," but cautioned, "without changes, the provisions will create unnecessary barriers to care."

On February 14, 2025, ATA Action submitted comments urging the DEA to clarify nine operational and technical issues inherent to the rule. One of the primary concerns was the requirement detailing how often providers must prescribe controlled substances, which may hinder specialized practitioners such as psychiatrists and pain management specialists from effectively serving their patients through telehealth. Zebley noted, "This requirement does not account for unique needs of specialized providers who routinely prescribe Schedule II substances." This could, he warned, disrupt the continuity of care for patients reliant on these medications.

The discussion surrounding the rule raises broader questions about balancing the need for accessibility to virtual healthcare with the necessary safeguards against misuse of prescription medications. ATA underscored the need for the DEA to re-evaluate its authority to impose such stringent regulations under the Controlled Substances Act and to demonstrate its capacity to process special registration applications efficiently.

The stakes are high; millions of patients have become accustomed to the convenience of telehealth services—especially as Medicare has expanded its coverage for telehealth during the COVID-19 pandemic. Fortunately, Congress recently passed the American Relief Act, which extends various Medicare telehealth waivers to March 31, 2025. These extensions include providing virtual care for both general and mental health services and removing geographic restrictions on telehealth services. The broader implication is a continuing commitment to virtual care as part of the healthcare fabric of America.

Importantly, patients will maintain access to audio-only consultations—a relief for those unable to engage through video platforms, and clinics such as Federally Qualified Health Centers can continue operating as distant-site providers for these services. Beyond just maintaining current telehealth capabilities, the new regulations and extensions recognized the necessity of behavioral healthcare access from home without geographic limitations, highlighting the shift telehealth has prompted within the healthcare system.

While the DEA's proposed rule aims to establish clearer guidelines and frameworks, ATA believes it must also accommodate the realities faced by patients and practitioners today. "The proposed rule authorizes qualified, specialized practitioners to prescribe Schedule II-V controlled substances through telemedicine by creating two distinct prescriber registration frameworks," Zebley remarked, adding, "however, the proposal introduces several restrictive measures on prescribing Schedule II-V controlled substances." This duality presents both opportunities and challenges as the industry adapts.

Beyond the immediate responses to the DEA's regulations, the future of telehealth hangs on continuous dialogue among legislators, advocates, and industry leaders. Many Americans rely on these services, particularly those living in rural communities, where access to traditional healthcare facilities can be limited. The challenge now is ensuring these voices are heard as new policies develop.

While the final decisions on telehealth regulations are still pending, many entities involved are prepared for the potential repercussions these changes might render. With significant developments underway, stakeholders are called to remain vigilant and proactive, ready to adapt as healthcare's digital transformation continues. The dynamics of telehealth remain compulsory topics of discussion as the industry progresses, seeking to balance the intricacies of patient needs with the safeguards necessary to maintain safe healthcare practices.

The evolution of telehealth offers lessons on flexibility and access within the healthcare domain, positioning itself as not just beneficial but necessary for maintaining continuity of care during challenging times. Changes to telehealth regulations will significantly impact how this service evolves, ensuring it meets patient needs and provider capabilities as the healthcare sector navigates the post-pandemic world.