On January 16, 2025, the Drug Enforcement Administration (DEA) announced two final rules and a proposed rule for telemedicine flexibilities. In 2024, the DEA issued a one-year extension of the COVID-era telemedicine flexibilities when it became clear there was significant industry opposition to an alleged DEA rule that was publicly leaked to the press in August 2024 (the Unpublished Rule). The Unpublished Rule reportedly proposed to (i) restrict Schedule II substances from being prescribed unless an in-person visit had occurred, (ii) permit Schedule III-V substances to be prescribed based solely on a telehealth visit, and (iii) only allow providers to do fifty percent of prescribing online or via telemedicine.
Final Rule for Expansion of Telehealth Buprenorphine Prescribing
This final rule provides patients with increased remote access to buprenorphine, a medicine used to treat opioid use disorder. Patients will be permitted to receive a six-month supply of buprenorphine through a telephone consultation with a provider. Further prescriptions of buprenorphine beyond the six-month supply will require an in-person visit to a medical provider. This rule was published in the Federal Register on January 17, 2025, and is effective February 18, 2025.
Proposed Rule for Special Registrations for Telemedicine
This proposed rule would establish three types of “special registrations” to permit patients to receive prescribed medications through telemedicine visits without an in-person medical evaluation from a medical provider. Predicated upon the level of scrutiny required for the specific prescribing practices, the special registrations would be divided as follows:
- The first special registration would apply to mid-level practitioners seeking to prescribe Schedule III-V controlled substances via telehealth.
- The second, or advanced special registration, would be for providers seeking to prescribe Schedule II controlled substances, which are considered riskier and more susceptible to diversion. This type of special registration would include additional safeguards and oversight. Specifically, this type of advanced registration would only be available to providers in certain specialties, like psychiatry, hospice and palliative care, and pediatricians. Additionally, the patient and provider must be located in the same state, and a provider with an advanced special registration could prescribe no more than half of Schedule II prescriptions via telehealth.
- The third type of special registration would regulate telemedicine platforms seeking to prescribe Schedule II-V controlled substances with the DEA.
The proposed rule would also increase prescription recordkeeping requirements and require the establishment of a national prescription drug monitoring program to help protect against abuse and the diversion of controlled substances into the illegal drug market.
This proposed rule was published in the Federal Register on January 17, 2025, and comments to this proposed rule must be submitted before March 18, 2025.
Final Rule for Continuity of Care via Telemedicine for Veterans Affairs Patients
An additional rule was finalized in consultation with the Department of Veterans Affairs (VA). This final rule exempts VA practitioners from Special Registrations requirements. Once a patient has received an in-person medical examination from a VA medical practitioner, the provider-patient relationship is extended to all VA practitioners engaging in telemedicine with the patient. This final rule was published in the Federal Register on January 17, 2025, and is effective February 18, 2025.
