On January 17, 2025, the Drug Enforcement Administration (DEA) announced a proposed rule to establish a special registration framework for prescribing controlled substance medications via telemedicine in the post-COVID era (the 2025 Proposed Rule).  The DEA  had, in an earlier proposed rule from March 2023 (the 2023 Proposed Rule), rejected the same framework as too burdensome for both prospective telemedicine providers and patients.

In its simplest form, the 2025 Proposed Rule seeks to impose separate special registrations with highlighted regulations on both clinician and platform practitioners who prescribe or dispense Schedule II-V narcotic and non-narcotic controlled substances via telemedicine without an in-person medical evaluation.  The rule is complex, more restrictive than the telemedicine flexibilities allowed during the COVID-19 era, and, more importantly, presents a significant departure from the regulations put forth in the 2023 Proposed Rule.

Considering the uncertainty surrounding the priorities and perspectives of the Trump administration regarding telemedicine prescribing of controlled substances, it remains unclear whether the 2025 Proposed Rule will be finalized as-is or if a different overhaul is forthcoming.

Background

The 2025 Proposed Rule is statutorily based on the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act), which was enacted after the death of an 18-year-old high school student in California due to under-regulated internet pharmacies in the early 2000s. The Ryan Haight Act amended the Controlled Substances Act to require all practitioners to conduct at least one in-person medical evaluation of the patient before prescribing or otherwise dispensing controlled substances “by means of the Internet, except when engaged in the practice of telemedicine.”

The Ryan Haight Act provides seven “practice of telemedicine” exceptions to the in-person medical evaluation requirement for telemedicine prescribing of controlled substances. Among these exceptions, the fourth exception permits treatment during a Public Health Emergency (PHE) as declared by the Secretary of Health and Human Services (HHS), while the fifth exception involves practitioners who have obtained the telemedicine special registration.

During the COVID-19 PHE, the Ryan Haight Act’s in-person medical evaluation requirement was lifted under the fourth exception, thereby allowing DEA-registered practitioners to prescribe Schedule II-V controlled substances during audio-video telemedicine encounters and certain audio-only visits without requiring a prior in-person medical evaluation.

The 2023 Proposed Rule and Flexibility Extensions

When the PHE was expired in May 2023, the telemedicine prescribing flexibilities were also scheduled to end.  To alleviate an abrupt cut-off of medications prescribed through telemedicine, while also balancing concerns with respect to appropriate prescribing and potentially harmful practices, on March 1, 2023, DEA released the 2023 Proposed Rule.

The notice of proposed rulemaking generated 35,454 public comments, delaying the DEA’s previously announced plans to promulgate a final set of telemedicine regulations by the fall of 2024.  DEA, jointly with HHS, has extended the COVID-19 telemedicine flexibilities three times, while evaluating the best course of action given the comments received in response to the 2023 Proposed Rule.  The third temporary extension was set to be effective from January 1, 2025, through December 31, 2025.  Two months after the announcement of the third temporary extension DEA issued the 2025 Proposed Rule.

Special Registration Types in the 2025 Proposed Rule

The 2025 Proposed Rule seeks to establish a separate special registration framework for telemedicine under the fifth exception set forth in the Ryan Haight Act, which, if finalized, would offer three distinct categories of special registration.  To prescribe or dispense controlled substances via telemedicine without a prior in-person medical evaluation, practitioners – including both clinician and platform practitioners – would need to apply for a special registration, using a newly created Form 224S and paying a registration fee of $888 for a three-year cycle. 

What follows is a description of the three registration types:

Telemedicine Prescribing Registration: would allow clinician practitioners to prescribe Schedules III-V, but not Schedule II controlled substances, if they demonstrate a “legitimate need” for the special registration.  The standard of a “legitimate need,” is not specifically spelled out, but a prior in-person medical evaluation that significantly burdens the practitioner-patient relationship – such as when a patient faces significant challenges in attending an in-person visit due to severe weather conditions, living in a remote area, or having communicable disease – would qualify as a “legitimate need.”

Advanced Telemedicine Prescribing Registration: would authorize certain specialized clinician practitioners the privilege to prescribe not only Schedule III-V but Schedule II controlled substances as well.  However, only the following limited circumstances or practice specialties would be eligible for this category:

(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 treating psychiatric or psychological disorders, hospice care, palliative care, pediatric care, or neurological disorders unrelated to pain management.

To qualify for this type of special registration, clinician practitioners must meet the requirements set forth in the first category and demonstrate a “legitimate need” to prescribe Schedule II controlled substances via telemedicine.  Again, it seems unclear how restrictive the “legitimate need” standard would be.  The 2025 Proposed Rule indicates that this authorization would be reserved only for the most “compelling” use cases to ensure the necessary use of telemedicine prescribing of Schedule II.  Although the rule does not specify what would constitute a use case “compelling,” DEA suggests that practitioners who treat particularly vulnerable patients who face significant healthcare accessibility challenges or those suffering from particularly debilitating or terminal illnesses would qualify for this special registration.

Telemedicine Platform Registration: This category would permit covered online telemedicine platforms – in their capacity as platform practitioners – to dispense Schedules II-V controlled substances through a clinician practitioner possessing either a telemedicine prescribing registration or an advanced telemedicine prescribing registration. To qualify for this registration, a covered online telemedicine platform must again demonstrate a “legitimate need” for a special registration.  The 2025 Proposed Rule states that covered online telemedicine platforms have a “legitimate need” to dispense Schedules II-V controlled substances when they facilitate connections between patients and clinician practitioners for telemedicine services, provided that they comply with federal and state regulations, oversee prescribing practices, prioritize patient safety, and take steps to prevent diversion, misuse, or abuse of controlled substances, and attest to this need on their special registration application.

Additional Requirements

In addition, DEA would require special registrants—both clinician and platform practitioners—to both maintain a state telemedicine registration for every state in which they treat patients, unless otherwise exempted.  The state telemedicine registration, issued by DEA rather than the states, would serve as an ancillary credential, contingent upon the special registration held by the registrant. Practitioners would use the same Form 224S for one of the three types of special registration to apply for a state telemedicine registration.  The registration fee would be $50 for a clinician practitioner for each state where she/he intends to issue prescriptions for controlled substances to patients via telemedicine, whereas the fee for a platform practitioner is $888 for every state in which it dispenses controlled substances to a patient. 

The 2025 Proposed Rule indicates that all practitioners, including platform practitioners who have never been required to have a conventional DEA registration, must have an existing conventional registration with DEA before obtaining a Special Registration, unless otherwise exempted.

Highlighted Regulations in the Context of Special Registration

Under the 2025 Proposed Rule, in addition to continuing to comply with the laws and regulations of the state in which they are registered and the laws and regulations of the state in which they issue special registration prescriptions via telemedicine, special registrants would be subject to a series of highlighted rules, significantly:

  • A Nationwide Prescription Drug Monitoring Program (PDMP) Check
  • A limitation on tele-prescriptions for Schedule II controlled substances based on the same state and amount.
  • Mandatory presence of a parent or guardian when prescribing schedule II substances to a minor
  • Use of both audio and video components in a telemedicine encounter
  • Use of a state/federal-government identification to verify identity of patients seeking tele-treatment
  • Annual data reporting on the total number of new patients in each registered state
  • Platform special registrants must maintain credential verification and conduct related documentation related to clinician special registrants with whom they enter and maintain a covered platform relationship

Other proposed heightened requirements for prescriptions, recordkeeping, and reporting include, for example, two additional elements for special registration prescriptions, centralized recordkeeping at the special registered location, and pharmacy monthly reporting of special registration prescription data.

Please note, the 2025 Proposed Rule will not apply to the telemedicine practice outlined in the final rules for Continuity of Care via Telemedicine for Veterans Affairs Patients (Final Rule) and Expansion of Buprenorphine Treatment via Telemedicine Encounter (Final Rule), both of which were published on January 17, 2025.

Future Implications for Telemedicine Practice

The 2025 Proposed Rule represents a significant shift from the 2023 Proposed Rule, if not deemed a complete overhaul.  In contrast to the 2023 Proposed Rule, the 2025 Proposed Rule offers expanded flexibilities to allow for more telemedicine-based care.  However, practitioners will likely face continued regulatory obstacles when providing telemedicine services, because the 2025 Proposed Rule does not preempt any state laws.  Instead, it makes it clear that the “special registrant would be required to follow the more restrictive state law and regulations” of the states in which they are registered and where they issue prescriptions via telemedicine encounters.

Compared to the telemedicine flexibilities permitted during the COVID-19 era, the 2025 Proposed Rule is noticeably more restrictive.  For example, it introduces a double-registration requirement for all practitioners, which particularly impacts platform practitioners who have not previously registered with DEA. Thus, the 2025 Proposed Rule is likely to result in regulatory hurdles that burden patients and providers alike.

Although a registry for telemedicine practitioners, similar to the existing conventional registration system, has been long awaited, the telemedicine community may feel dissatisfied with the 2025 Proposed Rule after digesting the significant operational challenges it presents.  A nationwide PDMP check will be overly burdensome, especially given the current lack of access to all PDMPs.

The 2025 Proposed Rule was intended to “enhance patient access to care;” however, it will likely have the opposite effect on telemedicine practices that have benefited from expanded flexibilities over the past four years.  The restraints outlined under the 2025 Proposed Rule will result in a return to access barriers many patients experienced before the pandemic. 

The language in the proposed rulemaking regarding, for example, the portion of patient care that can be provided through telemedicine, and the conditions and specialties under which Schedule II prescriptions may be issued, may be perceived as an inappropriate guardrail, a point acknowledged by DEA in the Proposed Rule.

Reed Smith will continue to follow developments with regard to the telemedicine prescribing of controlled substances. If you have any questions about how the 2025 Proposed Rule applies to or impacts your organization, please reach out to the authors of this alert or the health care lawyers at Reed Smith.