DEA Unveils Long-Overdue Special Registration for Telemedicine in Proposed Rule

In the final days of the Biden administration, the Drug Enforcement Administration (DEA) released a proposed rule that would allow practitioners with a Special Registration to prescribe Schedule III-V, and in limited circumstances Schedule II, controlled substances via telemedicine.

Practitioners with a Special Registration would still need to obtain a DEA registration in each state where they prescribe or dispense controlled substances. However, the proposed rule establishes a limited, less expensive State Telemedicine Registration as an alternative to the traditional DEA registration. The proposed rule imposes several obligations on practitioners with Special Registrations when they prescribe controlled substances via telemedicine. Of note, practitioners would need to be located in the same state as the patient at the time of the encounter when issuing a Schedule II controlled substance prescription, and the average monthly number of Schedule II controlled substances prescribed via telemedicine would need to be limited to less than 50% of the practitioner’s total Schedule II prescriptions (including both telemedicine prescriptions and non-telemedicine prescriptions).

If finalized, the Special Registration process would provide an alternative pathway for practitioners to prescribe controlled substances via telemedicine if the DEA telemedicine prescribing flexibilities currently in place through December 31, 2025, expire. We provide a summary of some of the key provisions of the proposed rule below.

Definitions

The proposed rule introduces several new definitions, some of which include:

Clinician practitioner — an individual practitioner who provides direct patient care or assesses, diagnoses, or treats medical conditions.
Platform practitioner — a covered online telemedicine platform that dispenses controlled substances by virtue of its central involvement as an intermediary in the remote prescribing of controlled substances by an individual practitioner. Platform practitioners are subject to the requirements imposed upon non-pharmacist practitioners under the Controlled Substances Act, 21 U.S.C. Sections 801-904, and its regulations.
Covered online telemedicine platform — an entity that facilitates 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, but is not a hospital, clinic, local in-person medical practice, or insurance provider, and meets one or more of the following criteria:
- The entity explicitly promotes or advertises the prescribing of controlled substances through the platform;
- The entity has financial interests, whether direct incentives or otherwise, tied to the volume or types of controlled substance prescriptions issued through the platform, including but not limited to, ownership interest in pharmacies used to fill patients’ prescriptions, or rebates from those pharmacies;
- The entity exerts control or influence on clinical decision-making processes or prescribing related to controlled substances, including, but not limited to: prescribing guidelines or protocols for clinician practitioners employed or contracted by the platform; consideration of clinician practitioner prescribing rates in the entity’s hiring, retention, or compensation decisions; imposing explicit or de facto prescribing quotas; directing patients to preferred pharmacies; and/or
- The entity has control or custody of the prescriptions or medical records of patients who are prescribed controlled substances through the platform.

Special Registrations

Categories and Eligibility

The proposed rule establishes the following categories of Special Registrations and eligibility requirements:

Telemedicine Prescribing Registration: This registration would allow clinician practitioners to prescribe Schedule III-V controlled substances.
- Clinician practitioners would need to demonstrate a legitimate need for the registration.
- Physicians, nurse practitioners, physicians, and other mid-level practitioners defined under 21 C.F.R. § 1300.01 (“mid-level practitioners”) would have a legitimate need to prescribe Schedule III-V controlled substances if they expect to treat patients for whom in-person exams would be burdensome.
  - Examples include patients who experience severe weather conditions, live in remote or distant areas, or have communicable diseases.
Advanced Telemedicine Prescribing Registration: This registration would allow certain specialized clinician practitioners to prescribe Schedule II-V controlled substances.
- Specialized clinician practitioners would need to demonstrate a legitimate need for the registration and justify the additional authorization to prescribe Schedule II medications. These practitioners would need to provide information demonstrating their specialized training on their Special Registration application.
- Specialized physicians and board-certified mid-level practitioners would have a legitimate need to prescribe Schedule II-V controlled substances when treating vulnerable patient populations. This includes individuals who face significant barriers to accessing care and who suffer from debilitating or terminal illnesses.
- Only specialized physicians and board-certified mid-level practitioners in the following limited circumstances or practice specialties are eligible:
  - Psychiatrists;
  - Hospice care physicians;
  - Palliative care physicians;
  - Practitioners 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.
Telemedicine Platform Registration: This registration would allow covered online telemedicine platforms to dispense Schedule II-V controlled substances through a clinician practitioner who holds a Telemedicine Prescribing Registration or Advanced Telemedicine Prescribing Registration (i.e., a platform practitioner).
- Covered online telemedicine platforms would need to demonstrate a legitimate need for the registration.
- Covered online telemedicine platforms, in their capacity as platform practitioners, would have a legitimate need to dispense Schedule II-V controlled substances when they:
  - Expect to provide necessary services that connect patients with clinician practitioners via telemedicine for the diagnosis, treatment, and prescription of controlled substances;
  - Comply with federal and state regulations;
  - Oversee the clinician practitioner’s prescribing practices; and
  - Implement safeguards to prioritize patient safety and prevent diversion, abuse, or misuse of controlled substances.
- Platform practitioners would need to attest to their legitimate need on their Special Registration application.

Special Registration numbers would be formatted distinctly, allowing pharmacists to easily differentiate between practitioners with a Special Registration and those with a traditional DEA registration.

Application Requirements

In the proposed rule, the DEA outlines several Special Registration application requirements. Notably, applicants would need to provide a physical address as their registered location, and platform practitioners would need to disclose all employment relationships, contractual relationships, and professional affiliations with any clinician practitioner with a Special Registration and online pharmacy.

State Telemedicine Registration

In addition to a Special Registration, clinician practitioners and platform practitioners, unless exempt, would still need to obtain a DEA registration in each state in which they intend to prescribe or dispense controlled substances to patients via telemedicine. However, in lieu of the traditional DEA registration, the proposed rule establishes a limited State Telemedicine Registration, which would be less expensive for clinician practitioners. The proposed fee is $50 for clinician practitioners, reflecting a significant reduction from the cost of a traditional DEA registration, and $888 for platform practitioners, which matches the cost of a traditional DEA registration. Similar to Special Registrations, State Telemedicine Registration numbers would be formatted distinctly, allowing pharmacists to easily differentiate between practitioners with a State Telemedicine Registration and those with a traditional DEA registration.

Requirements of the Proposed Rule

Telehealth Modality

Similar to the final rule regarding telemedicine prescribing of buprenorphine, practitioners would be permitted to prescribe Schedule III-V controlled substances approved by the U.S. Food & Drug Administration to treat opioid use disorder via telemedicine (currently limited to buprenorphine) through an audio-only visit. (See our discussion on the DEA’s final buprenorphine rule here.) Audio-only visits would only be permitted if the practitioner has the capability to use audio-video, but the patient is either unable to use video or does not consent to it. However, unlike the final buprenorphine rule, treatment would need to be initiated through an audio-video visit, and the practitioner would need to have conducted at least one medical exam of the patient via audio-video. Prescriptions not meeting the criteria described above would only be able to be issued through an audio-video visit.

Schedule II Controlled Substances

Practitioners would only be permitted to prescribe Schedule II controlled substances via telemedicine if they are physically located in the same state as the patient at the time of the encounter when the prescription is issued. Additionally, the number of Schedule II controlled substances prescribed via telemedicine, averaged monthly, would be limited to less than 50% of the practitioner’s total Schedule II prescriptions (including both telemedicine prescriptions and non-telemedicine prescriptions).

PDMP Check

Effective immediately, if the proposed rule is finalized, practitioners with a Special Registration would need to check the patient’s controlled substance prescription data in Prescription Drug Monitoring Programs (PDMPs) of certain jurisdictions before issuing a prescription for controlled substances via telemedicine. The practitioner would need to review the PDMPs for any controlled substance prescriptions issued to the patient within the last year, or, if less than a year is available, for the entire available period. The relevant jurisdictions include:

The state where the patient is located;
The state where the practitioner is located; and
Any U.S. jurisdiction with PDMP reciprocity agreements with either of the states above.

Three years after the effective date, before issuing a prescription for controlled substances via telemedicine, practitioners with a Special Registration would need to check the PDMPs of all U.S. jurisdictions for controlled substance prescriptions issued to the patient within the last year, or, if less than a year is available, for the entire available period. If there is no means to perform this nationwide PDMP check, the practitioner would continue performing the PDMP checks as described above. We note that there is currently no nationwide PDMP database in operation.

Additional Requirements and Commentary

The proposed rule also:

Sets forth certain recordkeeping, patient identification verification, reporting, prescription, and e-prescribing requirements for those with Special Registrations;
Notes that practitioners with Special Registrations would need to be located within the U.S. when issuing a prescription via telemedicine and would need to still comply with any applicable state requirements and restrictions regarding prescribing controlled substances;
Emphasizes that once an in-person medical exam has been conducted, the practitioner and patient would no longer be considered to be engaged in the practice of telemedicine, and the requirements of the proposed rule would not apply; and
Establishes reporting requirements for pharmacies filling Special Registration prescriptions.

A Brief History

The rule stems from the Ryan Haight Act, which amended the Controlled Substances Act to restrict practitioners from prescribing controlled substances unless the practitioner conducts an in-person examination of the patient. The Controlled Substances Act also requires practitioners obtain a separate DEA registration in each state where their patients are located. The Ryan Haight Act (at 21 U.S.C. § 802(54)) outlines seven exceptions under which practitioners may prescribe controlled substances via telemedicine without an in-person exam, one of which involves practitioners who have obtained a special registration. Congress expected the DEA to issue the special registration rule shortly after the Ryan Haight Act was signed into law in 2008. After years of DEA failing to do so, Congress and the White House signed the SUPPORT Act of 2018, a federal law that mandated DEA promulgate the special registration rule by October 2019.

During the COVID-19 Public Health Emergency (PHE), the DEA issued letters on March 25, 2020, and March 31, 2020, granting temporary exceptions to the Ryan Haight Act and its implementing rules that enabled DEA-registered practitioners to prescribe controlled substances without an in-person exam and with a DEA registration in only one state. In March 2023, two months before the end of the PHE, the DEA proposed a rule on telemedicine prescribing of controlled substances, but the rule did not include a special registration framework and was not favorably-viewed. In response, the DEA quickly rescinded the proposed rule and extended the COVID-era flexibilities in May 2023 and again in October 2023. In June 2024, the DEA submitted a special registration rule for Office of Management and Budget clearance that was so unworkable for stakeholders that it was not published. Instead, the flexibilities were further extended in November 2024, and are now set to expire on December 31, 2025. (For more details, see our previous discussions on the DEA’s proposed rules for telemedicine prescribing of controlled substances and the first, second, and third temporary rules extending COVID-era flexibilities.)

Make Your Voice Heard

The DEA is soliciting comments until 11:59 p.m. ET March 18, 2025. Stakeholders may submit comments electronically here or via regular or express mail to the following address:

Drug Enforcement Administration
Attn: DEA Federal Register Representative/DPW
8701 Morrissette Drive, Springfield, VA 22152

All correspondence, including attachments, must include a reference to “Docket No. DEA-407”.

Additionally, those with concerns about the proposed rule can share their feedback by contacting their White House.

What Comes Next

With the widespread frustration that met the March 2023 and June 2024 versions of this rule, there is little chance that the proposed rule will be finalized close to its current form. A key point of contention for stakeholders in the proposed rule is the nationwide PDMP check requirement, which is seen as overly burdensome given the absence of a nationwide PDMP database — a burden the DEA continues to underestimate. However, the future of the Special Registration is unclear due to the change in administration and potentially changing priorities and approaches.

President Trump’s first round of executive orders included a regulatory freeze. However, the Regulatory Freeze Pending Review Executive Order does not affect the proposed rule. To influence the direction of the proposed rule, ATA Action has urged President Trump to prioritize the immediate withdrawal of it. If the proposed rule undergoes another set of revisions and round of notice-and-comment rulemaking, it is unlikely that practitioners will have access to a special registration in 2025. Without a special registration process this year, another extension of the DEA telemedicine flexibilities will be crucial. We will continue to closely monitor any developments regarding the special registration process.

For more information on telemedicine, telehealth, virtual care, remote patient monitoring, digital health, and other health innovations, including the team, publications, and representative experience, visit Foley’s Telemedicine & Digital Health Industry Team.

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