January 23, 2025

DEA Extends Access to Telehealth Treatment with New Rules

Holland & Knight Alert
Ben Steinberg | Shalyn Watkins

Highlights

  • The U.S. Drug Enforcement Agency (DEA) recently issued three new rules making permanent multiple COVID-era telemedicine flexibilities, as well as adopting associated patient protections.
  • The Expansion of Buprenorphine Treatment rule seeks to ensure accessible treatment for opioid use disorder (OUD) while also protecting against the improper distribution of this medication.
  • The Special Registrations for Telemedicine and Limited State Telemedicine Registrations rule aims for more comprehensive prescription of certain controlled medications while also ensuring that practitioners and platforms are properly vetted to process such prescriptions.
  • The Continuity of Care via Telemedicine for Veterans Affairs Patients rule ensures that veterans continue to have access to medications even if their current U.S. Department of Veterans Affairs (VA) practitioner did not conduct an in-person medical evaluation.

The U.S. Drug Enforcement Agency (DEA) announced on Jan. 16, 2025, three new rules intended to implement patient protections and permanently extend certain COVID-era telemedicine prescription flexibilities. These new rules apply only in circumstances where the patient has not had an in-person visit with a medical provider. If there has already been an in-person visit or if medication prescription is not involved, the rules do not apply.

The announcement comes just two months after the U.S. Department of Health and Human Services (HHS), in conjunction with the DEA, issued a third extension of COVID-era telemedicine flexibilities for prescribing certain controlled substances. (See previous Holland & Knight alert, "DEA, HHS, Extend Telemedicine Flexibilities for Controlled Substance Prescriptions Through 2025," Nov. 26, 2024.)

Expansion of Buprenorphine Treatment via Telemedicine Encounter (Final Rule)

The final rule addresses the use of buprenorphine for the treatment of opioid use disorder (OUD). Specifically, it authorizes providers to prescribe U.S. Food and Drug Administration (FDA)-approved Schedule III-V controlled substances via telemedicine, without requiring an in-patient visit, for the purpose of treating OUD. The rule requires the provider to be registered with the DEA and review the prescription drug monitoring program (PDMP) data of the state in which the patient is located at the time of the telemedicine encounter. Additionally, the pharmacist filling the prescription must verify the patient's identity. Following this framework permits the provider to prescribe up to a six-month supply of medication. A subsequent in-person medical evaluation is required for additional prescriptions unless otherwise permitted by the Controlled Substances Act.

Special Registrations for Telemedicine and Limited State Telemedicine Registrations (Proposed Rule)

The DEA proposed this rule with an eye toward allowing more comprehensive prescription of Schedule II and narcotic and non-narcotic controlled substances via telemedicine, while also preventing and detecting diversion of such substances. The notice of proposed rulemaking introduces three types of Special Registrations for Telemedicine:

  1. Telemedicine Prescribing Registration authorizes clinician practitioners, as defined in the rule, who are qualified to prescribe Schedule III-V controlled substances via telemedicine.
  2. Advanced Telemedicine Prescribing Registration authorizes qualified, specialized clinician practitioners, as also defined in the rule, to prescribe Schedule II-V controlled substances via telemedicine.
  3. Telemedicine Platform Registration authorizes covered online telemedicine platforms to dispense Schedule II-V controlled substances.

By falling into one of these categories, the registration holder would be considered a "special registrant." The rule would also require that the special registrant maintain a State Telemedicine Registration, issued by the DEA, for each state in which the registrant provides services. The proposed rule would create a new form intended to streamline the application process for these registrations, which would be valid three years.

Additionally, the rule would implement stricter requirements for medications prescribed under a special registration. Special registration prescriptions must be prescribed through electronic prescribing for controlled substances (EPCS) after verifying the patient's identity and conducting a nationwide PDMP check. The nationwide PDMP check would become mandatory in three years; until then, registrants must check the PDMP to confirm 1) the patient's state, 2) the special registrant's state and 3) any other state with a PDMP reciprocity agreement with either of the foregoing states. Finally, clinician and platform registrants would be assigned identifying numbers for both their Special and State Telemedicine Registrations, which must include these numbers when writing and fulfilling a "special registration prescription." This will enable pharmacies to easily confirm whether the prescribing clinician and the facilitating platform practitioner are authorized to prescribe and dispense controlled substances under this framework.

Although this rule is not final, its proposal suggests sweeping change toward telehealth prescribing of controlled substances. Comments must be submitted by before March 18, 2025.

Continuity of Care via Telemedicine for Veterans Affairs Patients (Final Rule)

As its name suggests, the purpose of this rule is to ensure the continuity of care for veterans in need of prescriptions for certain controlled substances. This rule permits U.S. Department of Veterans Affairs (VA) practitioners (acting within their scope of employment with the VA) to prescribe controlled substances via telemedicine without having conducted an in-person evaluation of the patient if another VA practitioner already conducted one.

The provider seeking to prescribe a Schedule II-V controlled substance must also review the patient's VA electronic health record (EHR) and the PDMP data for the patient's state to confirm the patient's history with controlled substances. In cases where there is a VA EHR and PDMP, but one is not available or operational, then the prescription may be only for a seven-day period. The provider must later review the VA EHR and PDMP to continue prescribing via telemedicine. If no PDMP exists, the practitioner must review the VA EHR in order to prescribe for greater than a seven-day period.

Holland & Knight continues to monitor developments in this area. For questions, please contact the authors.


Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.


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