DEA Proposes Three-Tiered Special Registration System for Prescribing and Dispensing of Controlled Substances

On January 15, 2025, the Department of Health and Human Services (HHS) and Drug Enforcement Administration (DEA) issued a series of rules relating to the telemedicine prescribing of controlled substances, including a proposed rule that seeks to impose a three-tiered special registration system on practitioners and telemedicine platforms that prescribe or dispense controlled substances via telemedicine. The proposed rule comes one month after the HHS and DEA issued a joint regulation extending, for the third time, COVID-19 flexibilities relating to prescribing controlled substances through the use of telemedicine (see our analysis of the joint regulation here). The DEA’s proposed rule seeks to remove these COVID-19 flexibilities and reestablish the Ryan Haight Act’s requirement that a practitioner conduct an in-person medical evaluation prior to prescribing or dispensing controlled substances alongside new registration requirements.

Implementing Special Registrations

The proposed rule introduces three distinct categories for telemedicine providers and platforms, each with varying levels of scrutiny, that prescribe or dispense controlled substances (each referred to as a special registrant). Special registrants would be required to obtain these special registrations prior to prescribing or dispensing controlled substances via telemedicine in addition to existing DEA registrations. The three categories of special registrations are as follows:

1. Telemedicine Prescribing Registration (Schedules III – V): The proposed Telemedicine Prescribing Registration authorizes qualified clinician practitioners to prescribe Schedule III – V controlled substances. To be eligible, the practitioner must demonstrate that they have a “legitimate need” for the special registration. For example, a practitioner has a “legitimate need” when they anticipate that they will be treating patients for whom requiring in-person medical evaluations prior to prescribing Schedule III – V controlled substances could impose significant burdens on bona fide practitioner – patient relationships. The DEA provides examples of this, including severe weather conditions, living in remote or distant areas, or having communicable diseases.
2. Advanced Telemedicine Prescribing Registration (Schedules II – V): The proposed Advanced Telemedicine Prescribing Registration authorizes qualified specialized clinician practitioners to prescribe Schedule II – V controlled substances if they demonstrate that they have a “legitimate need” to prescribe Schedule II – V substances and are of a certain specialty. These specialties include: psychiatrists, hospice care physicians, palliative care physicians, physicians rendering treatment at long-term care facilities, pediatricians, neurologists, and midlevel 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. The DEA clarifies that this level of authorization is reserved only for the most compelling use cases, a standard which goes beyond “legitimate need,” ensuring that Schedule II prescribing via telemedicine is used only when necessary. Though the proposed rule does not define what makes a case “compelling,” it explains that challenges of significant healthcare accessibility and debilitating or terminal illness would qualify. 
3. Telemedicine Platform Registration (Schedules II – V): The proposed Telemedicine Platform Registration authorizes qualified covered online telemedicine platforms to dispense Schedule II – V controlled substances in their capacity as platform practitioners. Such platforms are entities that facilitate 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; such platforms are not hospitals, clinics, local in-person medical practices, or insurance providers, and they must meet certain other criteria as set forth under the proposed rule. Similar to the other two special registrations, the platform practitioner would be required to attest to its “legitimate need” on its special registration application. The platform practitioner would have a legitimate need to dispense Schedules II – V controlled substances when it: (A) anticipates providing necessary services to introduce or facilitate connections between patients and clinician practitioners via telemedicine for the diagnosis, treatment, and prescription of controlled substances; (B) is compliant with federal and state regulations; (C) provides oversight over clinician practitioners’ prescribing practices; and (D) takes measures to prioritize patient safety and prevent diversion, abuse, or misuse of controlled substances.

In addition to the special registrations detailed above, the DEA proposes to require each special registrant to maintain a State Telemedicine Registration for every state in which a patient resides to whom they prescribe or dispense. These additional registrations would be administered by the DEA, not the states to which they apply. Additionally, special registrants would be required to perform searches in a nationwide Prescription Drug Monitoring Program to verify each patient’s identity. However, this requirement would not apply until several years after the final rule’s promulgation.

Additional Proposals

The proposed rule seeks to impose two additional requirements for special registrants that prescribe Schedule II substances. The first requirement is that clinicians be physically located in the same state as the patient to whom they are prescribing. The second requirement is that less than half of a clinician’s Schedule II prescriptions come from special registration prescriptions. The DEA explains that it may adopt either or both of these proposed requirements.

The proposed rule contains additional proposals related to prescribing to minors, use of audio/video telecommunications, patient verification via government-issued identification, and annual reporting.

What to Expect

The proposed rule seeks to impose new requirements involving multiple registrations and extensive recordkeeping practices. Such changes are likely to have a dramatic impact on direct-to-consumer telemedicine companies’ abilities to perform the services that they attempt to offer. If finalized, the rule would heavily affect those platforms and practices that focus their efforts more on telemedicine prescribing, especially those that do not maintain a physical location.

Comments on the proposed rule are due March 15, 2025. Please contact any of the authors or your Goodwin attorney if you have any questions about this final guidance.

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This informational piece, which may be considered advertising under the ethical rules of certain jurisdictions, is provided on the understanding that it does not constitute the rendering of legal advice or other professional advice by Goodwin or its lawyers. Prior results do not guarantee similar outcomes.