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DEA proposes special registrations for telehealth prescribing
The DEA's new special registrations framework allows telehealth prescribing for controlled substances but also requires checks for patient identity and PDMP monitoring.
The DEA is set to publish a proposal for a special registrations framework that would allow certain healthcare practitioners to prescribe controlled substances via telehealth without performing an in-person exam first.
The unpublished proposal made available on the Federal Register details the special registrations framework, which includes three types of registrations:
- A telemedicine prescribing registration would authorize qualified clinician practitioners, including registered physicians and midlevel practitioners, to prescribe Schedule III-V controlled substances via telehealth.
- An advanced telemedicine prescribing registration would allow specialized clinician practitioners, such as psychiatrists and hospice care physicians, to prescribe Schedule II-V controlled substances via telehealth.
- A telemedicine platform registration would authorize covered online telehealth platforms to dispense Schedule II-V controlled substances.
Once registered, clinician practitioners would be considered clinician special registrants, and covered online telehealth platforms would be regarded as platform special registrants.
The proposal also requires the registrants to maintain a state telemedicine registration for every state where a patient is treated. The DEA will issue the state telemedicine registration, which, along with the other registrations, would run on a three-year cycle.
Further, the proposal requires controlled substance prescriptions issued by registrants to be prescribed electronically after the patient's identity is confirmed. Registrants will also be required to conduct a nationwide prescription drug monitoring program (PDMP) check; however, this requirement will not go into effect for another three years. Until then, registrants are required to conduct a PDMP check of the state/territory where the patient is located, the state/territory where the registrant is located and any state/territory that has a PDMP reciprocity agreement with the states where the patient and registrant are located.
The DEA has also proposed additional requirements for telehealth prescriptions of Schedule II medications, including Adderall and Vicodin. One mandates that the clinician must be physically located in the same state as the patient, and the other limits the average number of controlled substance prescriptions to less than 50% of the total number of Schedule II prescriptions issued by the clinician via telehealth.
The proposal is the first move toward solidifying rules governing the virtual prescribing of controlled substances. Currently, a COVID-19 pandemic-era flexibility that allows healthcare practitioners to prescribe controlled substances via telehealth without a prior in-person exam is slated to expire on Dec. 31, 2025.
The decision to extend the flexibility followed years of back and forth between the government and the healthcare industry. In 2023, the DEA proposed eliminating the flexibility for telehealth prescribing of certain controlled substances. This proposal was met with significant pushback from the industry, even amid documented instances of fraud, waste and abuse stemming from telehealth prescribing.
Still, the benefits of telehealth prescribing without in-person limitations are notable, and industry groups expressed some concerns regarding the new special registrations proposal.
In an emailed statement, Kyle Zebley, senior vice president of public policy at the American Telemedicine Association and executive director of its advocacy arm, ATA Action, noted that the proposal "appears to incorporate valuable elements and other potentially unworkable restrictions that focus on maintaining compliance with patient verification, electronic recordkeeping and ongoing monitoring."
The DEA proposal will be published in the Federal Register on Jan. 17.
Anuja Vaidya has covered the healthcare industry since 2012. She currently covers the virtual healthcare landscape, including telehealth, remote patient monitoring and digital therapeutics.