DEA Releases Rules on Telemedicine Prescribing of Controlled Substances, Proposes Special Registrations

On January 15, 2025, in the waning days of the Biden administration, the Drug Enforcement Administration ("DEA") released three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule. DEA also issued final rules: (i) to exempt VA practitioners from special registration requirements; and (ii) on prescribing buprenorphine (an opioid used to treat opioid use disorder) following a telemedicine encounter. 

Although the new administration may withdraw, modify, or take other actions regarding each of these regulations (or Congress may overturn the final rules under the Congressional Review Act), there has not yet been any indication that they plan to do so.

PROPOSED REGULATION: SPECIAL REGISTRATIONS FOR TELEMEDICINE AND LIMITED STATE TELEMEDICINE REGISTRATIONS

The Proposed Rule would finally establish the "special registration" framework contemplated in legislation enacted 17 years ago—the Ryan Haight Act—and again required by Congress in 2018 in the SUPPORT for Patients and Communities Act. Further, the Proposed Rule follows DEA's prior attempt at proposed telemedicine prescribing regulations in early 2023 (which prompted 38,000 comment letters) ("2023 Proposed Rule"), its Telemedicine Listening Sessions in September 2023, and its virtual consultations with tribal governments and organizations in June 2024. 

Under the Ryan Haight Act, a prescription for controlled substances requires a "valid prescription," typically necessitating a prior in-person evaluation by a prescriber. The special registration framework in the Proposed Rule would establish another option for health care providers to achieve a "valid prescription" when engaging with patients utilizing only telemedicine. 

Three Types of Special Registration

Specifically, the Proposed Rule would establish three categories of special registration issued pursuant to an application process wherein prospective registrants demonstrate eligibility in the applicable category. Notably, in each case, applicants are required to demonstrate a "legitimate need" for special registration.

Telemedicine Prescribing Registration, which would authorize qualified mid-level and physician practitioners to prescribe Schedule III-V controlled substances (e.g., Sch. III substances like anabolic steroids, codeine products with aspirin, some barbiturates; Sch. IV substances like Xanax, Ambien; and Sch. V substances like cough medicines with codeine).

Advanced Telemedicine Prescribing Registration, which would authorize qualified specialized mid-level and physician practitioners (psychiatrists, hospice care physicians and palliative care physicians, pediatricians, neurologists, physicians rendering treatment at long-term care facilities, and certain mid-level practitioners and physicians from other specialties who are board certified in the treatment of psychological disorders, hospice care, palliative care, pediatric care, or neurological disorders unrelated to the treatment of pain) to prescribe Schedule II-V controlled substances (e.g., Sch. II substances like amphetamine, morphine, methadone, hydrocodone, in addition to the scheduled medications that can be prescribed pursuant to a Telemedicine Prescribing Registration). Notably, the 2023 Proposed Rule did not present an option for prescribing Schedule II substances without a prior in-person evaluation or meeting one of the Historic Telemedicine Exceptions (described below).

Telemedicine Platform Registration, which would authorize qualified covered online telemedicine platforms that demonstrate a legitimate need for a special registration (viewed by DEA as "intermediaries in the remote dispensing of controlled substances"), to dispense Schedule II-V controlled substances. An entity constitutes a "covered online telemedicine platform" if: (i) such entity facilitates connections between patients and mid-level and physician practitioners via audio-video communications that may result in prescribing controlled substances, but is not a hospital, clinic, local in-person practice or insurer; and (ii) at least one of the following four factors is present:

• The entity promotes or advertises the prescription of controlled substances through the platform;
• The entity has direct or indirect financial interests in volume of controlled substance prescriptions (including, e.g., ownership interest in pharmacies used to fill prescriptions);
• The entity exercises control or influence on clinical decision-making processes or prescribing related to controlled substances (e.g., prescribing guidelines or protocols); or
• The entity has control or custody of prescriptions or medical records of patients who are prescribed controlled substances through the platform.

Additional State-Specific Registration

In addition to obtaining special registration at the federal level, under the Proposed Rule, DEA would require registrants to maintain a separate State Telemedicine Registration, issued by DEA, for each state in which the registrant intends to issue prescriptions or dispense controlled substances based on telemedicine alone (i.e., the state where the patient is located). DEA proposes a three-year cycle for both the special registrations and the State Telemedicine Registrations. 

Additional Notable Requirements

The Proposed Rule would heighten requirements for prescriptions issued under the special registration framework and propose geographic limitations, modality requirements, and recordkeeping and reporting obligations on registrants.

• Individual clinician special registrants would be required to be physically located within the United States when conducting a telemedicine encounter and issuing a special registration prescription.
• Individual clinician special registrants would be required to perform specific Prescription Drug Monitoring Program ("PDMP") checks. Ultimately, in three years, such checks would necessitate a review of all 50 states and any U.S. district or territory that maintains its own PDMP.
• Individual clinician special registrants would generally be required to utilize both audio and video components for each encounter (initial, subsequent, follow-up) in order to prescribe under the special registration framework, with audio-only encounters permissible only in certain cases (e.g., for treatment of opioid use disorder).
• Individual clinician special registrants prescribing Schedule II controlled substances would be subject to additional requirements, such as requiring the presence of a patient's parent or guardian when prescribing to a minor, requiring that the clinician special registrant be physically located in the same state as the patient, and requiring that such special registration prescriptions for Schedule II controlled substances constitute less than 50% of the clinician's Schedule II prescriptions issued by the clinician in a month.
• Electronic prescribing would be required for all special registration prescriptions.
• Special registration prescriptions would need to incorporate unique special registration numbers (federal and state) linked with the prescriber.
• Individual clinician special registrants would be required to maintain certain records of telemedicine encounters, including to capture a government-issued photo identification card to verify the patient's identity.
• Platform special registrants would be required to maintain certain records related to clinician special registrants with whom they enter and maintain a "covered platform relationship."

Both individual clinician special registrants and platform special registrants would need to meet various reporting obligations to DEA, including, on an annual basis, reporting the number of new patients in each state receiving special registration prescriptions. The Proposed Rule would also require pharmacies to make a variety of reports to DEA, including within the first seven days of the start of every month, aggregate data for special registration prescriptions filled during the previous month. 

Other Existing Options for Prescribers Using Telemedicine

Existing allowances for telemedicine-based prescribers to prescribe controlled substances would remain in place, and the special registration described in the Proposed Rule would become yet another option. Specifically, the Ryan Haight Act and prior DEA regulations authorize several circumstances in which a practitioner may prescribe a controlled medication based on a telemedicine encounter, despite not evaluating a patient in-person at the time of the encounter. These Historic Telemedicine Exceptions include situations where:

• The practitioner has previously conducted an in-person evaluation of the patient;
• The practitioner is covering for another practitioner who has evaluated the patient in-person;
• The patient is being treated in a DEA-registered facility;
• The patient is in the physical presence of another DEA-registered practitioner;
• A declared public health emergency exists;
• Actions are taken by the Department of Health and Human Services ("HHS") and DEA to allow for certain offerings (as is the current circumstance allowing audio/video-based telemedicine encounters under a thrice extended temporary regulation).

The temporary rule in effect through December 31, 2025, allows prescribers to rely upon exceptions similar to those authorized during the COVID-19 public health emergency for prescribing controlled substances based on a telemedicine encounter. Without further extension of the temporary rule beyond 2025, prescribers would need to meet one of the Historic Telemedicine Exceptions or participate in the proposed special registration to prescribe most controlled substances. 

State Laws Remain Applicable to Prescribers

The Proposed Rule takes the opportunity to remind prescribers that state laws and regulations remain applicable to prescribers, including that any special registrants and prescribers must comply with any state laws that are more restrictive.

Comments on the Proposed Rule are due on March 18, 2025; however, the new administration could modify or withdraw the proposal. Stakeholders should consider whether it may be beneficial to provide comments regarding the Proposed Rule. 

FINAL REGULATION: CONTINUITY OF CARE VIA TELEMEDICINE FOR VETERANS AFFAIRS PATIENTS

The final rule, issued jointly by DEA and HHS, exempts VA practitioners from the proposed special registration requirements. It authorizes practitioners acting within the scope of their VA employment to prescribe controlled substances via a telemedicine encounter to a VA patient for whom they have not previously conducted an in-person medical evaluation, if another practitioner acting within the scope of their VA employment has previously evaluated the patient in-person. The rule requires reviews of both the patient's VA electronic health record and PDMP data for the state in which the patient is located during the encounter. The rule is effective on February 18, 2025; however, the new administration could delay the effective date or Congress could disapprove the final rule. 

FINAL REGULATION: EXPANSION OF BUPRENORPHINE TREATMENT VIA TELEMEDICINE ENCOUNTER

The final rule, issued jointly by DEA and HHS, permits an authorized practitioner (regardless of special registration status) to prescribe based on a telemedicine encounter alone, including audio-only means, an initial six-month supply of buprenorphine for opioid use disorder (split among several prescriptions totaling six calendar months), after review of a patient's PDMP data for the state in which the patient is located during a telemedicine encounter. The prescribing practitioner is required to document the date and time of this review in the patient's electronic or paper medical record. Additional prescriptions can be issued under other forms of telemedicine as authorized under the Controlled Substances Act or after an in-person medical evaluation is conducted. The rule is effective February 18, 2025; however, the new administration could delay the effective date or Congress could disapprove the final rule.