After years of waiting, the Drug Enforcement Administration (DEA) on Friday released a new proposal aimed at better formalizing the prescription of telehealth controlled substances. While the announcement represents a step toward regulating virtual prescribing, it falls short of the long-awaited registration process for addiction treatment mandated by Congress.
Instead, the DEA’s proposal seems to revert parts of telehealth controlled substances prescribing to a pre-pandemic regulatory environment, raising concerns among telemedicine providers, behavioral health advocates, and patients who have come to rely on virtual care.
Industry Leaders Question the Proposal
Robert Krayn, co-founder and CEO of telepsychiatry company Talkiatry, criticized the proposal, arguing that it reintroduces “obsolete and counterproductive in-person requirements under the guise of novelty.” Krayn added that sending patients back to in-person only prescribing requirements could disrupt care for millions who rely on telehealth controlled substances for behavioral health and addiction treatment.
Several companies have built their businesses around virtual prescribing over the past few years, particularly for mental health and addiction care. DEA’s proposal could pose a significant challenge to their operational viability, potentially limiting access to care for patients who have benefited from telehealth controlled substances services during the pandemic.
DEA’s Stated Goals: Balancing Access and Safety
DEA Administrator Anne Milgram emphasized the agency’s commitment to expanding telemedicine while implementing safeguards to prevent the online overprescribing of telehealth controlled substances. According to the DEA, the proposed rule would allow providers to prescribe 30-day supplies of Schedule III-V non-narcotic medications and buprenorphine for the treatment of opioid use disorder (OUD) via telehealth without a prior in-person exam.
However, the proposal also stipulates that controlled substances cannot be prescribed without an in-person examination if the patient is new or has not had a qualifying prior visit. Providers would be required to document when a prescription is issued via telehealth and maintain tracking records for all telehealth controlled substances prescriptions.
Background: The Ryan Haight Act and COVID-19 Flexibilities
The DEA’s proposal revisits restrictions under the Ryan Haight Act of 2008, which limited prescribing of controlled substances via telehealth and required in-person exams. The law was named after Ryan Haight, a California teenager who died after overdosing on medication purchased from a rogue online pharmacy.
During the COVID-19 public health emergency (PHE), the federal government temporarily lifted these in-person exam requirements, allowing broader access to telehealth controlled substances, particularly for medications essential for behavioral health treatment. Many patients have come to rely on these flexibilities for treatments such as buprenorphine, Adderall, and alprazolam.
The DEA’s new proposal, while maintaining some of these flexibilities, would reimpose in-person requirements for certain medications, including buprenorphine, potentially disrupting access to essential treatment for patients with OUD.
Legal and Industry Reactions
Industry experts and legal professionals have expressed concern over the proposal’s potential impact. Nathaniel Lacktman, partner at Foley & Lardner, described the rules as “more restrictive than necessary,” noting that they could impose significant limitations and burdens on both clinicians and patients.
The American Telemedicine Association (ATA) also criticized the proposed rule, warning that continuity of care for countless Americans could be disrupted, leaving vulnerable populations without access to telehealth controlled substances and other necessary medications.
Legislative Mandates and Delays
The DEA’s telehealth proposal comes more than five years after Congress passed the SUPPORT Act of 2018, which mandated a process for telehealth-based addiction treatment. Delays in finalizing this process have complicated access to telehealth controlled substances for patients relying on medication-assisted treatment (MAT) for OUD and other conditions.
During the pandemic, relaxed regulations allowed digital behavioral health providers, including Cerebral and Done, to expand telehealth prescribing. However, these companies later faced federal scrutiny for prescribing telehealth controlled substances under temporary PHE flexibilities.
Cerebral stopped accepting new OUD patients in December 2022 and began transitioning existing clients to alternative care, with all current clients expected to be safely transitioned by mid-March 2023.
DEA’s Perspective
The DEA frames the rule as a continuation of the Ryan Haight Act’s mission to protect patients from unsafe online pharmacies. The agency emphasizes that in-person exams are a key component of a valid doctor-patient relationship, asserting that easy online access without medical supervision can lead to tragic consequences.
Implications for Patients and Providers
If finalized, the rule could have broad implications:
- For patients: Access to essential telehealth controlled substances may be delayed or disrupted, particularly for those in rural or underserved areas.
- For providers: Telehealth companies may face administrative challenges, including documenting and tracking prescriptions.
- For the industry: Growth of virtual prescribing models could slow, impacting MAT-focused telemedicine providers.
Looking Ahead
The DEA’s proposed rule represents an attempt to balance patient safety with access to telemedicine. However, many industry stakeholders worry it may unnecessarily restrict access to telehealth controlled substances, reversing progress made during the pandemic. As public comment opens, providers, advocacy groups, and legal experts are expected to weigh in, shaping the future of virtual prescribing and behavioral health care delivery in the U.S.
