DEA Creates New Hoops for Getting Pills Online
Published Date: 1/17/2025
Proposed Rule
Summary
The DEA is proposing new rules to make it easier for doctors to prescribe certain controlled medicines through telemedicine, without needing an in-person visit first. These rules create special registrations for telemedicine providers and add new record-keeping and reporting steps to keep things safe. If you’re a healthcare provider, get ready to comment by March 18, 2025, and prepare for some new paperwork and processes.
Analyzed Economic Effects
5 provisions identified: 2 benefits, 2 costs, 1 mixed.
New Special Registrations for Telemedicine
DEA proposes three Special Registrations for telemedicine: (1) a Telemedicine Prescribing Registration to allow clinician practitioners to prescribe Schedule III-V controlled substances via telemedicine; (2) an Advanced Telemedicine Prescribing Registration to allow qualified specialists to prescribe Schedule II-V; and (3) a Telemedicine Platform Registration to allow covered online telemedicine platforms to dispense Schedule II-V. These registrations would let certain practitioners and platforms prescribe or dispense more comprehensive controlled-substance medications via telemedicine when they meet the Special Registration rules.
DEA State Telemedicine Registration Requirement
Under the proposal, a special registrant must also maintain a State Telemedicine Registration for every state where a patient is treated; those State Telemedicine Registrations would be issued by DEA as an ancillary credential and would be contingent on the Special Registration. The rule says these State Telemedicine Registrations are required unless an exception applies.
New E-Prescribing and PDMP Checks
Special registration prescriptions would have to be issued using electronic prescribing for controlled substances (EPCS). The rule would require a nationwide Prescription Drug Monitoring Program (PDMP) check of all 50 states and any U.S. district/territory with its own PDMP after a delayed effective date of three years; meanwhile, for all Schedule II-V controlled substances clinicians must check the PDMP in (1) the state/territory where the patient is located, (2) the state/territory where the clinician is located, and (3) any state/territory with a PDMP reciprocity agreement. Special registration and State Telemedicine Registration numbers must also appear on special registration prescriptions.
Heightened Recordkeeping and Reporting Rules
The proposal would add new recordkeeping and reporting requirements for special registrants and platforms, including patient verification photographic records, special-registration telemedicine encounter records, credentials verification and conduct-related documentation, centralized recordkeeping at the special registered location, pharmacy reporting of special registration prescription data, and individual special registrant reporting of aggregated prescription data. These records and reports are intended to help detect and prevent diversion.
Rules Only for No Prior In-Person Evaluations
The proposed Special Registration rules would apply only when the prescribing practitioner has never conducted an in-person medical evaluation of the patient before issuing the prescription. The proposal would not apply to other telemedicine categories in the Ryan Haight Act (21 U.S.C. 802(54)(A)-(D), (F), and (G)), including the Expansion of Buprenorphine Treatment and certain VA telemedicine rules referenced in the Federal Register.
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