DEA Issues Long-Awaited Telemedicine Prescribing Special Registration Framework, But to What Effect?

Earlier this week, DEA issued a draft proposed rule (Proposed Rule) to address the prescription of controlled medications via telemedicine, in anticipation of the expiration of telemedicine flexibilities granted in connection with the COVID-19 Public Health Emergency (PHE). The Proposed Rule, which was posted for public inspection and is scheduled to be published in the Federal Register on Friday, January 17, would establish a new Special Registration framework, pursuant to which registrants would be granted authorization to prescribe or dispense controlled medications through telemedicine in circumstances where the prescribing clinician has not previously conducted an in-person medical evaluation of the patient. The Proposed Rule also contains heightened prescription, dispensing, recordkeeping, and reporting requirements for telemedicine prescribers and platforms.

Background

Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act), a clinician generally is required to conduct an in-person evaluation of a patient before prescribing controlled medications to that patient.¹ During the COVID-19 PHE, DEA granted temporary exceptions to this in-person requirement to ensure continuity of care. Specifically, DEA permitted clinicians to prescribe controlled medications via telemedicine encounters even when the prescribing clinician had not conducted an in-person medical evaluation of the patient, provided that other DEA requirements were met.²  DEA, jointly with HHS, has extended the COVID-era telemedicine flexibilities three times, most recently via an interim final rule issued in November 2024, which extends the current telemedicine flexibilities for prescribing controlled medications through December 31, 2025.³

Proposed Rule

In the Proposed Rule, DEA creates a Special Registration framework to enable clinicians to continue prescribing controlled medications without an in-person evaluation, while also adding safeguards aimed at preventing and detecting diversion of controlled substances prescribed via telemedicine. The Proposed Rule introduces three different types of Special Registrations:⁴

• Telemedicine Prescribing Registration. This registration would authorize physicians and mid-level practitioners to prescribe Schedule III through V controlled substances via telemedicine without a prior in-person evaluation.

• Advanced Telemedicine Prescribing Registration. This registration would authorize certain specialized physicians and board-certified mid-level practitioners⁵ to prescribe Schedule II through V controlled substances via telemedicine without a prior in-person evaluation.

• Telemedicine Platform Registration. This registration would authorize covered online telemedicine platforms⁶ (in their capacity of platform practitioners) to dispense Schedule II through V controlled substances prescribed by clinicians who have obtained one of the previously listed Special Registrations.

Once registered under the Special Registration framework, clinicians and telemedicine platforms would be considered “special registrants.” Prescriptions issued by special registrants (i.e., for patients who have not been subject to a prior in-person evaluation) are referred to as “special registration prescriptions.”

Notably, under the Proposed Rule, clinician registrants would be required to (1) verify the identity of the patient by obtaining a photo or a copy of the patient’s federal or state government-issued photo identification card or other identifying document and (2) perform a Prescription Drug Monitoring Program (PDMP) check before issuing a special registration prescription.

For the first three years after the final rule becomes effective, clinician special registrants would be required to conduct a PDMP check of: (1) the state/territory where the patient is located; (2) the state/territory where the clinician special registrant is located; and (3) any state/territory that has a PDMP reciprocity agreement with the states/territories where the patient and clinician special registrant are located. After the three-year mark, clinician special registrants would be required to check the PDMPs of all 50 states and any US district or territory that maintains its own PDMP. In the Proposed Rule, DEA explained that it was delaying the implementation of a national PDMP check requirement to allow special registrants and the industry sufficient time to come into compliance.

The Proposed Rule also would require clinician special registrants to use audio and video capabilities when issuing special registration prescriptions, regardless of whether an encounter with a patient is an initial visit or a follow-up visit. That said, the Proposed Rule contains an exception to the audio-video requirement for buprenorphine and other controlled substances used to treat opioid use disorder.⁷

The Proposed Rule also includes additional requirements for the prescription of  Schedule II controlled substances (such as Adderall, Ritalin, and methadone), due to their “higher potential for abuse and dependence.” In the Proposed Rule, DEA states that it anticipates imposing  one or both of the following requirements on clinician special registrants with respect to special registration  prescriptions for Schedule II controlled substances:

• A clinician special registrant must be physically located in the same state as the patient when issuing a special registration prescription for a Schedule II controlled substance via telemedicine.

• Special registration prescriptions for Schedule II controlled substances must, on average, make up “less than 50 percent of the total number of Schedule II prescriptions issued by the clinician special registrant in their telemedicine and non-telemedicine practice in a calendar month.”

What’s Ahead?

If finalized, the Proposed Rule has the potential to make permanent certain prescribing flexibilities provided as a result of the COVID-19 PHE. That said, it is unclear whether the Proposed Rule will get that far. The incoming Trump Administration, like the Biden Administration in 2021 and President-Elect Trump’s first term, is expected to issue a mandatory regulatory freeze on all pending rules, which puts the Proposed Rule’s eventual finalization in question.

1. Pub. L. No. 110-425. ↩︎
2. William T. McDermott, DEA Dear Registrant letter, Drug Enforcement Administration (March 25, 2020), https://www.deadiversion.usdoj.gov/​GDP/​(DEA-DC-018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf;Thomas W. Prevoznik, DEA Dear Registrant letter, Drug Enforcement Administration (March 31, 2020), https://www.deadiversion.usdoj.gov/​GDP/​(DEA-DC-022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Final)%20+​Esign.pdf. ↩︎
3. 89 Fed. Reg. 91253 (Nov. 19, 2024). ↩︎
4. This “Special Registration” framework was initially called-for in the Ryan Haight Act. ↩︎
5. The practitioners that would be eligible for this Special Registration fall include: (1) psychiatrists; (2) hospice care physicians; (3) palliative care physicians; (4) physicians rendering treatment at long term care facilities; (5) pediatricians; (6) neurologists; and (7) mid-level practitioners and physicians from other specialties who are board certified in the treatment of psychiatric or psychological disorders, hospice care, palliative care, pediatric care, or neurological disorders unrelated to the treatment and management of pain. ↩︎
6. A covered online telemedicine platform means “an entity that facilitates connections between patients and clinician practitioners, via an audio-video telecommunications system, for the diagnosis and treatment of patients that may result in the prescription of controlled substances, but is not a hospital, clinic, local in-person medical practice, or insurance provider, and meets one or more of the following criteria:
   (1) The entity explicitly promotes or advertises the prescribing of controlled substances through the platform;
   (2) The entity has financial interests, whether direct incentives or otherwise, tied to the volume or types of controlled substance prescriptions issued through the platform, including but not limited to, ownership interest in pharmacies used to fill patients’ prescriptions, or rebates from those pharmacies;
   (3) The entity exerts control or influence on clinical decision-making processes or prescribing related to controlled substances, including, but not limited to: prescribing guidelines or protocols for clinician practitioners employed or contracted by the platform; consideration of clinician practitioner prescribing rates in the entity’s hiring, retention, or compensation decisions; imposing explicit or de facto prescribing quotas; directing patients to preferred pharmacies; and/or
   (4) The entity has control or custody of the prescriptions or medical records of patients who are prescribed controlled substances through the platform.” ↩︎
7. This week, the DEA and SAMHSA also issued a Final Rule (scheduled for publication on January 17, 2025) which amended their regulations to expand the circumstances under which practitioners registered by the DEA are authorized to prescribe Schedule III-V controlled substances that are FDA-approved for the treatment of opioid use disorder via a telemedicine encounter, including an audio-only telemedicine encounter. ↩︎