On January 15, 2025, the federal Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking (NPRM) regarding prescribing controlled substances via telemedicine. The NPRM seeks to impose special registrations and safety measures on practitioners and online platforms that prescribe or dispense Schedules II-V controlled substances via telemedicine. If finalized, the rule will likely take effect following the December 31, 2025, expiration of the COVID-19 telemedicine prescribing flexibilities. If finalized in its current form, the proposed rule would:
- Significantly limit direct-to-consumer (DTC) telemedicine companies’ abilities to prescribe Schedules II-V controlled substances without an in-person visit, including stimulants Adderall and Ritalin for the treatment of attention deficit disorders.
- Limit the prescribing of Schedule II controlled substances to a limited group of “specialized” practitioners (e.g., psychiatrists and hospice care physicians).
- Require burdensome registration requirements with the DEA, including requiring the registration of the telemedicine platforms in their capacity as “platform practitioners.”
- Only permit approval of such registrations if the DEA determines there is a “legitimate need.”
- Require clinicians to visually confirm a patient’s identity in real time and maintain a photographic record of each patient’s photo ID.
- Require that a minor’s parent or guardian be present when a clinician prescribes a Schedule II controlled substance to a minor.
- Require clinicians to be physically located in the same state as the patient to prescribe Schedule II controlled substances.
- Require that the average number of prescriptions for Schedule II controlled substances constitute less than 50 percent of the total number of Schedule II prescriptions issued by the clinician in their telemedicine and non-telemedicine practices in a calendar month, which will significantly impact those providers that only have a telemedicine practice and no brick-and-mortar location.
For elements 7 and 8 above, the NPRM describes how the DEA may adopt one or both proposals.
The appointment of a lead for the DEA by President-elect Donald Trump remains pending, leaving uncertainty about the new administration's stance on this proposal. Companies and investors negatively impacted by this rule should consider submitting written comments to the DEA and taking other steps to advocate for modifications to the proposed rules. Written comments will be due 60 days after the NPRM is published in the federal register (the NPRM is scheduled to be published on January 17, 2025).
Below is a detailed background of the proposed rule.
Background
Subject to certain exceptions, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act) requires that a prescribing practitioner conduct an in-person evaluation of a patient before prescribing controlled medications to that patient. To ensure care continuity during the COVID-19 pandemic, the DEA granted a temporary exception to the in-person medical evaluation requirement and allowed DEA-registered practitioners to prescribe controlled medications via telemedicine encounters even when the practitioner had not conducted an in-person medical evaluation of the patient. This exception was extended in May 2023, October 2023, and again in November 2024.
DEA Highlights Concerns with Telemedicine Prescribing
In the NPRM, the DEA acknowledges that the COVID-19 telemedicine prescribing flexibilities were necessary to prevent lapses of care during the pandemic but cautions that these flexibilities have also “facilitated the emergence of concerning business models engaged in the widespread diversion of controlled substances.” The NPRM describes the DEA’s belief that telemedicine platforms incentivize practitioners to prescribe controlled substances to patients and exert control over medications prescribed to patients as evidence of such concerning business models. Recent enforcement actions against such platforms, such as the Done Global Inc. and Done Health P.C. prosecutions in June 2024, highlight the federal government’s focus on these business models. In response, the DEA claims the NPRM will help to oversee these business models and enforce any violations of law.
In-Person Medical Evaluation Required for Prescribing Controlled Substances
The NPRM seeks to remove the COVID-19 prescribing flexibilities and re-impose the Ryan Haight Act’s requirement that a practitioner must conduct an in-person medical evaluation prior to prescribing controlled medications to a patient. Notably, this change will only impact those practitioner-patient relationships where the prescribing practitioner intends to prescribe controlled substances but has never conducted an in-person medical evaluation of the patient prior to the issuance of the prescription. If there has ever been a prior in-person medical evaluation of the patient by the practitioner, these changes will not apply.
Special Registrations
To give the DEA better oversight and control of telemedicine prescribing activity, the NPRM proposes establishing special registrations (Special Registrations) for any practitioners or online telemedicine platforms (each, a Special Registrant) that desire to prescribe or dispense controlled substances via telemedicine. Any such Special Registrant would need to obtain a Special Registration prior to prescribing or dispensing controlled substances using a newly created Special Registration application form (Form 224S). The Special Registration would be in addition to the Special Registrant’s standard DEA registration and would cost $888 per registration. The Special Registration would need to be renewed every three years.
The NPRM proposes creating the following three types of Special Registrations:
1. Telemedicine Prescribing Registration
The proposed Telemedicine Prescribing Registration authorizes qualified clinician practitioners to prescribe Schedules III-V controlled substances, but not Schedule II controlled substances, via telemedicine. To be eligible for this registration, clinician practitioners would need to demonstrate that they have a “legitimate need” for a Special Registration, but it is unclear how limiting the “legitimate need” standard will be. The NPRM describes how the DEA will determine that physicians and board-certified mid-level practitioners have a legitimate need to prescribe Schedules III-V controlled substances when they “anticipate that they will be treating patients for whom requiring in-person medical evaluations prior to prescribing Schedules III-V controlled substances could impose significant burdens on bona fide practitioner-patient relationships.” For example, the NPRM suggests that practitioners may have a need for this Special Registration “when their patients face significant challenges in attending in-person medical evaluations, such as severe weather conditions, living in remote or distant areas, or having communicable diseases, which make in-person appointments difficult or even unadvisable,” which would significantly limit current DTC models.
2. Advanced Telemedicine Prescribing Registration
The proposed Advanced Telemedicine Prescribing Registration authorizes qualified, specialized clinician practitioners to prescribe more than just Schedules III-V, but also Schedule II controlled substances via telemedicine. However, only the following “specialized” physicians and board-certified mid-level practitioners would be eligible for this registration: 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 the treatment of psychiatric or psychological disorders, hospice care, palliative care, pediatric care, or neurological disorders unrelated to the treatment and management of pain. This rule could limit DTC models to using psychiatrists and other providers who are board-certified in the treatment of psychiatric or psychological disorders, which are known to be in shortage and in enormous demand.
Further, to be eligible for this registration, physicians and mid-level practitioners would not only need to demonstrate that they have a “legitimate need” for the Special Registration but that such need “warrants” the authorization of prescribing Schedule II controlled substances in addition to Schedules III-V controlled substances. The NPRM describes how such authorization would be reserved only for the most “compelling” use cases, ensuring that Schedule II prescribing via telemedicine is used “only when necessary.” Though the NPRM does not describe what would make a use case “compelling,” DEA suggests that practitioners who treat especially vulnerable patients, patients who face significant healthcare accessibility challenges, or patients who suffer from particularly debilitating or terminal illnesses would qualify for this Special Registration. Like the Telemedicine Prescribing Registration, this proposal would place significant restrictions on DTC models.
3. Telemedicine Platform Registration
This registration authorizes covered online telemedicine platforms to dispense Schedules II-V controlled substances. To be eligible for this registration, covered online telemedicine platforms would need to again demonstrate that they have a “legitimate need” for a Special Registration. DEA has determined that covered online telemedicine platforms have a legitimate need to dispense Schedules II-V controlled substances when they anticipate providing necessary services to introduce or facilitate connections between patients and clinician practitioners via telemedicine for the diagnosis, treatment, and prescription of controlled substances, are compliant with federal and state regulations, provide oversight over clinician practitioners’ prescribing practices, and take measures to prioritize patient safety and prevent diversion, abuse, or misuse of controlled substances.
State Telemedicine Registration
Under the NPRM, DEA would also require a Special Registrant to maintain a State Telemedicine Registration for every state in which a patient is treated by the Special Registrant unless otherwise exempted. The State Telemedicine Registration would be issued by DEA, not the states, and operate as an ancillary credential, contingent on the Special Registration held by the Special Registrant.
A clinician would be required to obtain a State Telemedicine Registration for every state in which they intend to issue prescriptions for controlled substances to patients via telemedicine. The fee for this registration would be $50 per state.
Further, the telemedicine platform would be required to obtain a State Telemedicine Registration for every state in which it dispenses controlled substances to a patient. The fee for this registration would be $888 per state.
Electronic Prescribing/PDMP Checks
Under the NPRM, Special Registrants would be required to utilize electronic prescribing for controlled substances. Additionally, Special Registrants would be required to verify the identity of the patient and carry out a nationwide Prescription Drug Monitoring Program (PDMP) check of all 50 states and any U.S. district or territory that maintains its own PDMP.
However, this nationwide PDMP check requirement would have a delayed effective date of three years to give Special Registrants time to prepare and for the industry to put in place a mechanism to perform these nationwide checks. In the meantime, for all Schedules II-V controlled substances, Special Registrants would be required to conduct a PDMP check of:
- the state/territory where the patient is located;
- the state/territory where the Special Registrant is located; and
- any state/territory that has a PDMP reciprocity agreement with the states/territories where the patient and Special Registrant are located.
Prescribing Schedule II Controlled Substances to Minors
In the NPRM, the DEA highlights its commitment to safeguarding the well-being of minors and expresses concerns with the risks associated with prescribing Schedule II controlled substances, in particular, opioids, to minors. To reduce these risks, the NPRM proposes to require that a minor’s parent or guardian be present whenever a clinician Special Registrant who is a pediatrician or board-certified in pediatric care prescribes a Schedule II controlled substance to the minor. The DEA acknowledges potential concerns of minors who may view this requirement as an intrusion on their privacy, but reasons that direct parental or guardian supervision would help to discourage any potential misuse or attempts to acquire a Schedule II controlled substance for non-medical reasons.
Additional Requirements for Prescribing Schedule II Controlled Substances
Given the higher potential for abuse and dependence of Schedule II controlled substances, DEA also proposed two additional requirements for clinicians issuing a prescription for a Schedule II controlled substance, requiring that:
- a clinician be physically located in the same state as the patient when issuing a prescription for a Schedule II controlled substance; and
- the average number of prescriptions for Schedule II controlled substances constitutes less than 50 percent of the total number of Schedule II prescriptions issued by the clinician in their telemedicine and non-telemedicine practice in a calendar month.
In the NPRM, DEA states that it intends to finalize at least one, if not both, of these additional requirements. These proposed changes would require DTC companies to have psychiatrists physically located (not just licensed) in the states where prescriptions are issued and would significantly limit the use of clinicians who only have telemedicine and not brick-and-mortar practices.
Audio-Video Telecommunication Systems
The NPRM would mandate that a clinician utilize both audio and video to prescribe controlled substances for every telemedicine encounter, whether an initial visit, subsequent visit, or follow-up.
Patient Verification Photographic Record
The NPRM would require that a clinician Special Registrant, or a delegated employee or contractor under the direct supervision of a clinician Special Registrant, verify the identity of a patient seeking treatment via telemedicine by requiring that the patient present a state or federal government-issued photo ID through the patient’s live camera. The clinician would be required to take a photo of the patient holding their photo ID and use that photo to confirm the patient’s identity in subsequent telemedicine encounters. To ensure patient privacy is protected, the photo would be securely stored in the patient’s medical record. If the patient does not consent to having their photo taken, the clinician could accept a copy of the patient’s photo ID.
Annual Reporting
The NPRM also proposes that Special Registrants must report annual data on the total number of new patients in each state for which they issued at least one prescription for a Schedule II controlled substance or certain Schedules III-V controlled substances; the total number of prescriptions for Schedule II controlled substances issued by the Special Registrant, in aggregate and across all states; and the total number of prescriptions for certain Schedules III-V controlled substances issued by the Special Registrant, in aggregate and across all states. The DEA would use this data to monitor for trends that they believe signal inappropriate prescribing behaviors and would likely increase the scrutiny on telemedicine companies and the number of enforcement actions related to online prescribing of controlled substances.
Changes to Registration
The NPRM would require Special Registrants to promptly notify DEA of any changes to the information provided in their original Special Registration application (Form 224S) within 14 business days on Form 224S-M.
Other Final Rules
Notably, these proposed regulations would not apply to the practice of telemedicine authorized under the Expansion of Buprenorphine Treatment via Telemedicine Encounter final rule or the Continuity of Care via Telemedicine for Veterans Affairs Patients final rule, both of which are scheduled to be published on January 17, 2025.
