DEA announces new rule for telehealth controlled substance prescriptions

Author(s):

Austin Littrell

Key Takeaways

DEA's new rules enable special registrations for telehealth prescriptions of Schedule II-V medications, bypassing in-person evaluations.
Expanded buprenorphine access allows a 6-month supply via telehealth, with subsequent prescriptions requiring in-person visits.
VA practitioners can prescribe controlled substances to patients after any prior in-person examination, exempt from special registration.
ATA Action criticizes the DEA's proposal, citing operational challenges and urging withdrawal of the draft framework.

The administration announced three new telehealth rules, making permanent some temporary pandemic-era flexibilities and establishing new patient protections.

The U.S. Drug Enforcement Administration (DEA) has announced three new telehealth-related rules, making permanent some temporary telehealth flexibilities established during the COVID-19 pandemic and establishing new patient protections. Most notably, a new rule would create special registrations that would authorize medical providers and telehealth companies to prescribe Schedule II to V medications. Additional rules include a finalized regulation allowing registered practitioners to prescribe buprenorphine, and a rule that exempts Veterans Affairs (VA) practitioners from special regulations requirements.

“DEA’s goal is to provide telehealth access for needed medications while ensuring patient safety and preventing the diversion of medications into the illicit drug market,” Anne Milgram, administrator of the DEA, said in a news release.

“We understand the difficulties some patients have accessing medical providers in-person, and we want to ease this burden while also providing safeguards to keep patients safe. These rules also mark a significant step forward for patient safety be requiring online telemedicine platforms to register with DEA and taking steps to establish a nationwide Prescription Drug Monitoring Program (PDMP).”

Special registrations for prescribing controlled substances via telehealth

The most notable regulation included in the DEA release, this proposed rule would establish special registrations permitting a patient to receive prescribed medications through telemedicine visits without ever having an in-person medical evaluation. Prior to the COVID-19 pandemic, controlled substances could not be prescribed without an in-person visit. Those rules were relaxed in an effort to preserve care during the pandemic and the flexibilities were extended multiple times.

This rule is framework for a permanent rule that would create special registrations for providers offering controlled substance prescriptions over telemedicine appointments. One special registration is available to medical providers who treat patients who would be prescribed Schedule III-V controlled substances.

An Advanced Telemedicine Prescribing Registration is available for Schedule II medications for specialized providers, including psychiatrists, hospice care physicians, physicians rendering treatment at long-term care facilities and pediatricians for the prescribing of medications identified as the most addictive and prone to diversion on the illegal drug market. This regulation allows specialized medical providers to prescribe Schedule II-V medications.

In a call for public comment, the DEA proposed the idea that Schedule II medications only be prescribed to patients located in the same state, and that clinicians’ telemedicine Schedule II prescriptions make up less than 50% of their monthly Schedule II prescriptions.

The rule also requires online platforms that facilitate connections between patients and medical providers that result in the prescription of medications to register with the DEA. The rule would also establish a national PDMP, which would provide pharmacists and medical practitioners with visibility of a patient’s prescribed medication history.

Pushback from ATA Action

The American Telemedicine Association’s (ATA’s) affiliated trade organization, ATA Action, issued a statement expressing their concern over the DEA’s proposal, calling it a “life-or-death issue,” urging President-elect Trump to “make it his urgent priority to withdraw this proposal immediately following his inauguration on January 20.”

“Upon careful review of the DEA’s draft Special Registration for remote prescribing of controlled substances, we have serious concerns about the feasibility of this proposal. As written, the draft framework creates unworkable restrictions and could not be operationalized, which would be a major setback, should this become the final rule,” Kyle Zebley, senior vice president, public policy, ATA Action, said in an ATA release.

Additional telehealth rules

In addition to the rule establishing special registrations for controlled substance prescriptions, the DEA announced two additional telehealth-related rules:

Expansion of buprenorphine treatment via telehealth: This rule change allows patients to receive a 6-month supply of buprenorphine, the medicine used to treat opioid use disorder, through a telephone consultation with a health care provider. Any further prescriptions of buprenorphine would require an in-person visit.
Continuity of care via telehealth for VA patients: This rule, completed in consultation with the U.S. Department of Veterans Affairs, exempts VA practitioners from special registrations requirements. VA practitioners are permitted to prescribe controlled substances to VA patients if they have ever previously conducted an in-person medical examination.