The Drug Enforcement Administration is proposing a rule in the Biden administration’s final days that would establish a special registration process for remote prescribing of certain drugs.
On Wednesday, the DEA released a proposed rule that would set up a special registration process for remote prescribing of Schedule II-V controlled substances such as Xanax, Vicodin and Adderall. It also released a final rule for its 2023 proposal that sets up a special registration process for remote prescribing of buprenorphine, a medication used to treat opioid use disorder.
Related: 3 Biden healthcare regulations Trump will have to finalize
Both regulations will be published in the federal register on Friday, three days before President-elect Donald Trump is inaugurated. The buprenorphine final rule won't go into effect until Feb. 17, while the proposed rule is pending, which means Trump's administration will determine the fate of both rules.
The proposed rule for remote prescribing of controlled substances sets up a special registration process for providers based on three tiers.
The first tier, called the telemedicine prescribing registration, would authorize qualified clinician practitioners such as doctors and mid-level practitioners to prescribe Schedule III-V controlled substances via telemedicine. The second tier, called the advanced telemedicine prescribing registration, would allow qualified specialists such as psychiatrists and hospice care physicians to prescribe Schedule II-V controlled substances via telemedicine. The third tier, called the telemedicine platform registration, would let covered online telemedicine platforms dispense Schedule II-V controlled substances.
For all eligible providers, the DEA is proposing to require that registrants maintain a state-level registration in each state they practice or dispense in. In the past, this proposed requirement has drawn sharp industry criticism for the chaos and care delays telemedicine advocates say it would cause. Applications for one of the three tiers would occur on a three-year cycle using a new form, the DEA proposes.
The agency also wants to institute requirements that prescriptions only be issued once a provider has checked patients’ records in the Prescription Drug Monitoring Program, a network that tracks prescriptions of controlled substances. This practice would not start until three years after the rule is finalized. In the interim, providers would need to check the state where the patient lives and where the provider is registered.
The DEA also proposes that at least 50% of providers' prescriptions for Schedule II drugs such as Adderall would need to be issued during in-person appointments.
As part of the COVID-19 public health emergency, providers were allowed to remotely prescribe controlled substances regardless of the state they practiced in. As that public health emergency wound down, the DEA issued a proposal in February 2023 that removed those flexibilities and reinstated in-person requirements. After receiving industry criticism that called the proposal too restrictive, the DEA decided to extend the COVID-19-era flexibilities multiple times, most recently through 2025.
In the fall, a purported draft version of the general proposed rule — the DEA’s second attempt at crafting the regulation — leaked to Politico, sparking a similar firestorm.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires that patients receive an in-person medical evaluation before they can be prescribed certain medications. The Support for Patients and Communities Act of 2018 required the DEA to create a registry of providers who prescribe controlled substances.
The DEA also finalized when and how patients can receive buprenorphine without an in-person appointment. Under the buprenorphine-related final rule, DEA-registered practitioners are required to review the Prescription Drug Monitoring Program data of the states where patients are located when they access their telemedicine appointment.
Comments on the proposed rule are due March 17.
