The Doctor Will Stream You Now: DEA’s Proposed Telemedicine Framework

On January 17, 2025, the U.S. Drug Enforcement Administration (“DEA”) published a notice of proposed new rulemaking (“NPRM”) to make permanent some temporary telemedicine flexibilities that arose from the COVID-19 pandemic. The NPRM would create three types of special registrations for prescribing or dispensing controlled substances through telemedicine and also require state-specific registrations to ensure compliance with federal and state laws.

The legal framework surrounding telemedicine prescribing has undergone significant changes since the onset of the COVID-19 pandemic. Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, clinicians were generally required to conduct an in-person evaluation before prescribing controlled substances. However, under an exception applicable to public health emergencies, the DEA temporarily waived this requirement to ensure continuity of care during the pandemic, allowing controlled medications to be prescribed via telemedicine without an in-person visit. These temporary flexibilities were extended multiple times, most recently through a November 2024 rulemaking that preserved them through the end of 2025. In response to ongoing concerns about maintaining patient access while addressing potential risks of improper prescribing, this NPRM proposes a permanent framework to regulate telemedicine prescriptions for controlled substances. The framework is oriented around special registrations:

1. Telemedicine Prescribing Registration (Schedules III–V)

The Telemedicine Prescribing Registration would allow clinician practitioners to prescribe controlled substances in Schedules III through V via telemedicine, where the clinician is able to demonstrate a legitimate need for the registration

• Legitimate Need: Demonstrating a legitimate need is a prerequisite for a Telemedicine Prescribing Registration. The DEA has determined that physicians and board-certified mid-level practitioners have a legitimate need to prescribe Schedules III through V controlled substances when they anticipate that they will be treating patients for whom prior in-person medical evaluations could impose significant burdens on bona fide practitioner-patient relationships. For example:
• Geographic barriers: Patients in remote or rural areas may not have reasonable access to practitioners.
• Health-related challenges: Patients with communicable diseases or severe mobility issues might struggle with in-person visits.
• Emergency needs: Some patients may need timely prescriptions that cannot wait for an in-person evaluation.

Clinician practitioners must already hold a DEA registration to be eligible for a Telemedicine Prescribing Registration.

2. Advanced Telemedicine Prescribing Registration (Schedules II–V)

The Advanced Telemedicine Prescribing Registration would allow certain specialized clinical practitioners to prescribe Schedule II controlled substances in addition to Schedules III-V. The type of specialized practitioners and board-certified mid-level practitioners eligible for the advanced registration typically treat patients who face significant healthcare accessibility challenges and, in some cases, suffer from particularly debilitating or terminal illnesses. Here, a prescriber would not only need to demonstrate a legitimate need for the registration but also that such need warrants the authorization of prescribing Schedule II controlled substances.

• Legitimate Need: The DEA has determined that legitimate need exists for specialized physicians and board-certified mid-level practitioners when treating vulnerable patient populations and reserved to only the most compelling use cases.
• Specialized Physicians and Mid-Level Providers: The advanced registration is likewise limited to the following limited circumstances or practice specialties:
• psychiatrists;
• hospice care physicians;
• palliative care physicians;
• physicians rendering treatment at long-term care facilities;
• pediatricians;
• neurologists; and
• 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.

Based on stakeholder feedback to the NPRM, the DEA also anticipates imposing one or both of the following requirements when issuing an Advanced Telemedicine Prescribing Registration:

• Same state restriction: The first requirement would require that the prescriber be physically located in the same state as the patient when issuing a special registration prescription for a Schedule II controlled substance. Under this same-state limitation, when issuing a Schedule II special registration prescription, a clinician special registrant would not only need the Advanced Telemedicine Prescribing Registration and a State Telemedicine Registration in the state in which the patient is located, but the clinician special registrant would also have to be physically located in the same state as the patient.
• Average number of Schedule II prescriptions: The second of the two proposed requirements would require that the average number of special registration prescriptions for Schedule II controlled substances constitute 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.

3. Telemedicine Platform Registration (Schedules II–V)

The Telemedicine Platform Registration is tailored for online telemedicine platforms that act as intermediaries between patients and clinicians, facilitating diagnosis, treatment, and the prescribing of Schedules II through V substances. To be eligible for the Telemedicine Platform Registration covered, online telemedicine platforms would need to demonstrate that they have a legitimate need for a Special Registration.

The DEA has proposed that a legitimate need exists when the platform:

• 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;
• is compliant with federal and state regulations;
• provides oversight over clinician practitioners’ prescribing practices; and
• implements safeguards to prevent misuse, such as monitoring for “doctor shopping” or fraudulent activity.

The DEA admits that while telemedicine platforms can enhance access to care, they also introduce potential risks. Financial incentives tied to prescriptions and insufficient oversight of clinician credentials can create vulnerabilities, making the platform registration process crucial. This framework requires platforms to attest to their legitimate need when applying for a platform registration. False claims or misuse can result in penalties, including revocation of registration. The DEA’s goal is to strike a balance: leveraging telemedicine’s ability to expand access while addressing the unique risks associated with remote prescribing of controlled substances.

State Telemedicine Registration

In addition to the federal framework, the proposed rule introduces the State Telemedicine Registration requirement. A clinician or platform special registrant would be required to obtain a State Telemedicine Registration, which is a DEA-issued registration and not a registration issued by the individual states, for every state in which they intend to issue prescriptions for or dispense controlled substances to patients via telemedicine.

• State-specific registration: Practitioners and platforms must register for every state where the patients to whom they prescribe or dispense controlled substances via telemedicine are located.
• Fees: The fee for the Platform Practitioner State Telemedicine Registration would be $888 for each state in which a State Telemedicine Registration is sought; however, the Clinician Practitioner State Telemedicine Registration would be discounted to $50 for each state in which the clinician practitioner sought a State Telemedicine Registration.

• Exceptions: Generally, a clinician special registrant would not be required to obtain a state registration in each patient state to prescribe via telemedicine if the clinician special registrant is either: (1) subject to a regulatory exemption applicable to all states pursuant to 21 U.S.C. 822(d) primarily for military personnel, or (2) the clinician special registrant is an employee or contractor of the VA.

Beyond the new telemedicine registration requirements, the NPRM also includes new patient photo verification requirements, and new recordkeeping requirements for special registrants and for pharmacies that fill special registration prescriptions. Further, the NPRM requires special registrants to check state prescription drug monitoring program databases before prescribing and encourages the development of a national prescription drug monitoring program. These requirements aim to enhance oversight and ensure compliance, with additional records required for patient verification, telemedicine encounters, and credential updates.

The deadline for submitting comments regarding the NPRM to the DEA is March 18, 2025. The proposed rules will not go into effect until after the DEA has reviewed the comments and published the proposed rules in final form.

If you have any questions about the information in this alert, please contact, Kathleen Reed (kreed@dykema.com or 734-214-7661), David Padalino (dpadalino@dykema.com or 734-214-7616), or your Dykema relationship attorney.