DEA & HHS Extend Telehealth Flexibilities for Controlled Substances
The U.S. Drug Enforcement Administration (DEA) and U.S. Department of Health and Human Services (HHS) on Wednesday proceeded with rulemaking related to the prescribing of controlled substances via telehealth without ever having conducted an in-person medical evaluation, which would partially extend current flexibilities that have been in place since the COVID-19 pandemic.
In particular, (1) DEA and HHS issued a final rule focused on buprenorphine for the treatment of opioid use disorder (OUD), and (2) DEA issued a notice of proposed rulemaking (NPRM) for special registrations focused on all Schedule II-V controlled substances.
The final rule will allow practitioners to prescribe Schedule III-V controlled substances for OUD (i.e., buprenorphine) for up to six months via audiovisual or audio-only telehealth before conducting an initial in-person medical evaluation, after which the practitioner must conduct an in-person medical evaluation or engage in other telehealth practices permitted by regulation to continue prescribing. The final rule also includes requirements related to prescription drug monitoring program (PDMP) review and pharmacist verification of patient identify. It is estimated that this rule will become effective on Feb. 16, 2025.
The NPRM would create multiple special registrations for practitioners and online telemedicine platforms (i.e., entities that facilitate connections between patients and practitioners) to prescribe controlled substances via telehealth indefinitely. For practitioners, there would be a Telemedicine Prescribing Registration covering Schedules III-V; and an Advanced Telemedicine Prescribing Registration covering Schedules II-V, which would be limited to practitioners who specialize in psychiatry, hospice care, palliative care, pediatrics, or neurology (unrelated to pain management), and practitioners in long-term care facilities.
Online telemedicine platforms would be eligible for a Telemedicine Platform Registration if they provide oversight of practitioners’ prescribing practices and undertake efforts to promote patient safety and prevent misuse and diversion. In addition to obtaining one of these three special registrations, entities would generally be required to obtain a State Telemedicine Registration for each state in which patients who receive special registration prescriptions are located.
Other requirements for practitioners include maintaining photographic records on patient identity, maintaining all special registration records at a single location, including a special registration number on applicable prescriptions, and annual reporting to DEA of special registration prescriptions for all Schedule II and select Schedule III-V controlled substances (pharmacies would also be required to report similar data monthly). For Schedule II controlled substances, additional limitations are proposed, including that special registration prescriptions could only be issued to treat conditions within the practitioner’s specialty, pediatric specialists could only issue prescriptions to patients up to age 18 and when a parent/guardian is in the same room, practitioners must be physically located in the same state as a patient when issuing a prescription, and the number of special registration Schedule II prescriptions must be less than 50% of the total number Schedule II prescriptions issued in a calendar month.
In addition, DEA proposes that for the first three years after implementation, practitioners would need to check the PDMPs of the state where the patient is located, the state where the practitioner is located, and any states with which each of the previous states have reciprocity agreements. After three years, practitioners would need to conduct a nationwide PDMP check. If that is not possible, however, practitioners would follow the prior requirements.
Finally, all telehealth encounters would need to be conducted using audiovisual technology, except audio-only technology would be permitted for the prescribing of Schedule III-V narcotic-controlled substances to treat OUD (i.e., buprenorphine) after a telehealth evaluation is conducted using audiovisual technology.
NABH staff will coordinate with relevant NABH committees to develop a response to the NPRM. We expect that comments will be due by March 18, 2025.