On January 15, 2025, the US Drug Enforcement Administration (DEA) released a proposed rule entitled Special Registrations for Telemedicine and Limited State Telemedicine Registrations. This proposed rule would establish three special registrations, creating pathways for telehealth practitioners to prescribe, and online platforms to dispense, certain controlled substances via telemedicine after flexibilities expire on December 31, 2025. However, it is unclear whether the incoming Trump administration will move forward with the proposed approach for special registration.

IN DEPTH

WHY IT MATTERS

• Current federal telehealth-focused controlled substance prescribing flexibilities, initially invoked in response to the COVID-19 public health emergency (PHE), will expire December 31, 2025.
• Absent the flexibilities, current law would require telemedicine providers to perform an in-person medical evaluation of a patient prior to prescribing a controlled substance, with certain limited exceptions. One such exception is for providers who hold a “special registration,” the details of which were left within the DEA’s purview. This is the first time the DEA has proposed a special registration since the passage of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, when it was originally required.
• The proposed rule would establish three types of special registrations for telemedicine:
  • Telemedicine Prescribing Registration, authorizing qualified clinician practitioners to prescribe Schedule III – V controlled substances via telemedicine
  • Advanced Telemedicine Prescribing Registration, authorizing qualified specialized clinician practitioners (e.g., psychiatrists and hospice care physicians) to prescribe Schedule II – V controlled substances via telemedicine
  • Telemedicine Platform Registration, authorizing covered online telemedicine platforms, in their capacity as platform practitioners, to dispense Schedule II – V controlled substances.
• Special registrants would be required to maintain a State Telemedicine Registration (issued by the DEA) for every state in which the special registrant treats patients, unless otherwise exempted.
• The proposed rule would also impose detailed requirements for practice standards, prescription information, and documentation, including requirements related to prescription drug monitoring program (PDMP) checks, use of audio-video technology, restrictions on Schedule II controlled substances, data reporting to the DEA, identity verification, clinician credentialing, and record retention.
• The proposed rule was released just days before the incoming Trump administration takes office. Whether the new administration will allow the proposed rule to remain open for public comment or take a different approach remains unclear.

BACKGROUND

Under the Ryan Haight Act, a telemedicine provider is required to perform an in-person medical evaluation of a patient prior to prescribing a controlled substance, with certain limited exceptions. One such exception is for providers who hold a “special registration.” The Ryan Haight Act requires the DEA to establish the circumstances and procedures under which a special registration may be issued. In the more than 16 years since the act’s passage, the DEA has failed to implement such a process, even though Congress imposed a deadline of October 2019 in the 2018 SUPPORT for Patients and Communities Act for the promulgation of final regulations.

In March 2020, in response to the PHE, the DEA invoked flexibilities that allow for prescribing controlled substances via telemedicine without an initial in-person visit. The current extension of the flexibilities, pursuant to a November 2024 rule, authorizes all DEA-registered practitioners to prescribe Schedule II – V controlled medications via telemedicine without an initial in-person examination through December 31, 2025.

Stakeholders had hoped that the DEA would permanently adopt flexibilities for telemedicine prescribing of controlled substances after the PHE, including finally adopting a special registration process. In February 2023, the DEA and the Substance Abuse and Mental Health Services Administration proposed two rules: the general telemedicine rule and the buprenorphine rule. The two proposals would have established additional potential pathways for prescribing certain controlled substances in limited quantities via telemedicine without an initial in-person medical examination while also imposing detailed recordkeeping requirements. Notably, the proposed rules did not include a special registration process for telemedicine providers.

The DEA received a record 38,000 comments in response to the February 2023 proposed rules, including comments from federal lawmakers. Many stakeholders pointed out that the requirement for an in-person evaluation would make it more challenging for certain patients – those facing significant barriers to accessing care without telemedicine – to continue receiving the controlled medications they need. Subsequently, the DEA issued temporary rules in May 2023 and October 2023 extending the telemedicine flexibilities through December 31, 2024, and stated that it anticipated releasing a final rule addressing telemedicine prescription of controlled substances in fall 2024. In November 2024, the DEA further extended the flexibilities through December 31, 2025, stating that the extension would give it time to promulgate proposed and final rules on telemedicine prescribing and “ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled substance prescriptions.”

THE PROPOSED RULE

The DEA stated that it has determined that the best course of action to ensure patient access to care while maintaining sufficient safeguards to detect and protect against the diversion of controlled substances is to establish and maintain a separate special registration process for telemedicine.

The special registration would only apply where the prescribing practitioner intends to prescribe controlled substances and has not conducted an in-person medical evaluation of the patient prior to the issuance of the prescription. The proposed special registration would not be applicable to practitioner-patient relationships in which there has been a prior in-person medical evaluation of the patient by the practitioner. The special registration also would not apply to the other forms of the practice of telemedicine authorized under the Ryan Haight Act, including those authorized under the 2025 Expansion of Buprenorphine Treatment via Telemedicine Encounter final rule.

THREE REGISTRATION TYPES

The DEA proposes three types of special registrations for telemedicine. To be eligible for a special registration, the applicant would need to demonstrate a legitimate need for a special registration. An applicant for a special registration also would be required to already have one or more DEA registrations to prescribe (if a clinician practitioner) or dispense (if a platform practitioner), unless otherwise exempt.

The Telemedicine Prescribing Registration would authorize qualified clinician practitioners to prescribe Schedule III – V controlled substances via telemedicine.

The DEA determined that clinician practitioners have a legitimate need to prescribe Schedule III – V controlled substances when they anticipate treating patients for whom requiring an in-person medical evaluation prior to prescribing could impose significant burdens on bona fide practitioner-patient relationships (e.g., severe weather conditions, living in remote or distant areas, or having communicable diseases).

The Advanced Telemedicine Prescribing Registration would authorize qualified specialized physicians and board-certified mid-level practitioners to prescribe Schedule II – V controlled substances via telemedicine.

To be eligible for an advanced telemedicine prescribing registration, physicians and board-certified mid-level practitioners would need to demonstrate a legitimate need for a telemedicine prescribing registration, as described above, as well as a legitimate need for the prescribing of Schedule II controlled substances. Balancing concerns for vulnerable populations and the high potential for abuse of Schedule II controlled substances, the DEA determined that only the following seven categories of specialized physicians and board-certified mid-level practitioners have a legitimate need for the advanced telemedicine prescribing registration:

• Psychiatrists
• Hospice care physicians
• Palliative care physicians
• Physicians rendering treatment at long-term care facilities
• Pediatricians
• Neurologists
• 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.

Clinician practitioners would be required to furnish information on the special registration application that demonstrates their specialized training – for example, board certification, specialized training, or the percentage of their overall practice that falls within one of the specialized practices). Mid-level practitioners would be required to be board-certified. The DEA seeks input on whether other types of practitioners should be included if they can demonstrate specific training and expertise in managing conditions that are traditionally treated with Schedule II controlled substances, and on alternative methods to ensure that practitioners seeking to prescribe Schedule II controlled substances have the appropriate training and expertise to do so safely.

The Telemedicine Platform Registration would authorize covered online telemedicine platforms to dispense Schedule II – V controlled substances through a clinician practitioner possessing either a telemedicine prescribing registration or an advanced telemedicine prescribing registration.

The DEA notes that the term “dispense” in the Controlled Substances Act means “to deliver a controlled substance to an ultimate user, which includes the prescribing and administering of a controlled substance” and encompasses “not only the physical act of handing out medications, but the broader process of providing medications to patients under the direction of a licensed healthcare provider.” The DEA also notes that by serving as intermediaries for the prescribing of controlled substances, covered online telemedicine platforms qualify as “practitioners” engaged in dispensing.

The DEA proposes to define “covered online telemedicine platform” as 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; or directing patients to preferred pharmacies.
• The entity has control or custody of the prescriptions or medical records of patients who are prescribed controlled substances through the platform.

The DEA states that this definition is intended to limit the special registration requirements to only those direct-to-consumer online telemedicine platforms that play a substantial and integral role as intermediaries in the remote dispensing of controlled substances. The DEA notes that ownership and operation of the online or digital system or platform on which the virtual visit takes place are not mandatory criteria within the proposed definition of a covered online telemedicine platform. Similarly, an entity solely operating a platform or system that merely provides the technological service or conduit for a telemedicine encounter to occur, without the presence of one of the additional four factors, would not constitute a covered online telemedicine platform. The definition of covered online telemedicine platform also explicitly excludes certain types of entities whose primary business operations do not rely on, or center around, telemedicine services, including hospitals, clinics, insurance providers, and local in-person medical practices (defined as medical practices where less than 50% of the prescriptions for controlled substances collectively issued by the practice’s physicians and mid-level practitioners are issued via telemedicine in any given calendar month).

The DEA has determined that covered online telemedicine platforms, in their capacity as platform practitioners, have a legitimate need to dispense Schedule 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
• Take measures to prioritize patient safety and prevent diversion, abuse, or misuse of controlled substances.

STATE TELEMEDICINE REGISTRATIONS

The DEA would also require the special registrant to maintain a state telemedicine registration for every state in which the special registrant treats patients, unless otherwise exempted. This registration would be issued by the DEA and not by individual states and would operate as an ancillary credential, contingent on the special registration held by the special registrant.

Both clinician practitioners and online telemedicine platforms would be subject to this requirement.

APPLICATION PROCESS

Creation of Form 224S, Form 224S-M, and Fees

The DEA proposes issuing a new registration application, Form 224S, Application for Special Registration for Telemedicine Under the Controlled Substances Act, tailored for special registrations. The registration would last for three years. The registration fee would be $888 for any one of the three types of special registration. 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 seeks a state telemedicine registration. The DEA notes in its discussion that fees for the state telemedicine registration for clinician practitioners would be discounted to account for the expected lower volume of telemedicine that would be conducted by clinician practitioners compared to covered online telemedicine platforms.

Registrants would be required to notify the DEA within 14 business days of any modification or changes to the information provided in their original application (Form 224S) via a new form, Form 224S-M. For example, if a clinician holding a special registration began employment with a new direct-to-consumer online telemedicine platform not previously disclosed on the clinician’s original Form 224S, the clinician would be required to submit a Form 224S-M.

Physical Location Requirement

All applicants would be required to designate one of their existing 21 U.S.C. 823(g) registered locations as the registered location/physical address (special registered location) of their special registration. The special registered location would serve as the physical point of contact for DEA inquiries and compliance actions. As discussed below, records arising from telemedicine encounters under the special registration would be required to be maintained at the special registered location.

Additional Disclosures

The applicant would be required to provide certain disclosures and attestations on Form 224S, which the DEA states will “enhance transparency, patient safety, and anti-diversion efforts”:

• Platform practitioners applying for the telemedicine platform registration would be required to attest to all employment, contractual relationships, or professional affiliations with any clinician special registrant and online pharmacy, and their respective registration numbers. Likewise, clinician practitioners applying for the telemedicine prescribing registration or the advanced telemedicine prescribing registration would be required to attest to all employment, contractual relationships, and professional affiliations, including but not limited to those with covered online telemedicine platforms (and the respective online telemedicine platform’s telemedicine platform special registration number, if applicable).
• Clinician practitioners and platform practitioners would be required to attest that they have devised and are committed to maintaining anti-diversion policies and procedures.
• Clinician practitioners applying for the advanced telemedicine prescribing registration would be required to disclose their practice specialties.
• For each type of special registration, applicants would be required to attest to their legitimate need on their special registration application.

PRACTICE STANDARDS

Under the proposed rule, registrants would be required to adhere to certain practice standards, such as:

• Prescription Origination Within the United States. A clinician special registrant must be physically present in the United States when conducting a telemedicine encounter and issuing a special registration prescription. The clinician also would be required to hold the proper licensure and authorization within the state and territory where the practitioner is located when the telemedicine encounter takes place.
• Electronic Prescribing for Controlled Substances (ECPS). All special registration prescriptions must be issued through ECPS.
• PDMP Adherence. For the first three years after enactment of the special registration process, clinician special registrants would be required to check the PDMPs for the state or territory where the patient is located, the state or territory where the clinician practitioner is located, and any state or territory with PDMP reciprocity agreements with either the state or territory where the patient is located or the state or territory where the clinician practitioner is located. After three years, all clinician special registrants would be required to verify the identity of the patient and run a nationwide PDMP check of all 50 states and any US district or territory that maintains its own PDMP (referred to as the nationwide PDMP check).
  • If there is no mechanism to perform the nationwide PDMP check after three years, individual special registrants would continue to be required to perform PDMP checks of the states in the three categories described above. Individual special registrants would only be able to issue special registration prescriptions for Schedule II controlled substances to patients located within the same state as the individual special registrant.
  • The DEA acknowledges that it is currently unlikely that any one healthcare provider has access to all PDMPs nationwide but recognizes that current efforts to standardize, centralize, and interconnect PDMP data are making headway.
• Audio-Video Telecommunications. A clinician special registrant would be required to utilize both audio and video components of an audio-video telecommunications system to prescribe under the special registration framework for every telemedicine encounter, whether for an initial visit or subsequent visit or follow-up.
• Schedule III – V Special Registration Prescriptions for Opioid Use Disorder. Clinician special registrants would be allowed to issue special registration prescriptions for, and platform special registrants would be allowed to dispense, Schedule III – V controlled substances approved by the US Food and Drug Administration (FDA) for the treatment of opioid use disorder (OUD) through the use of an audio-only telecommunications system, provided that the treatment was initiated through the use of an audio-video telecommunications system. Currently, the only Schedule III – V narcotic drug approved by the FDA for the treatment of OUD is buprenorphine.
  • The DEA acknowledges that the Expansion of Buprenorphine Treatment via Telemedicine Encounter final rule allows a DEA-registered practitioner without a special registration to issue a prescription for a Schedule III – V controlled substance approved by the FDA for the treatment of OUD via audio-only or audio-video telemedicine for an initial consecutive six-month supply. Following the initial six-month supply, practitioners may prescribe the controlled substance by other forms of the practice of telemedicine authorized under the Controlled Substances Act (such as pursuant to a special registration) or after conducting an in-person medical evaluation.
• Schedule II Controlled Substance Prescriptions. The DEA proposes two requirements for special registration prescriptions for Schedule II controlled substances, indicating that it anticipates imposing one or both requirements based on stakeholder comments.
  • The first proposed requirement would require that the clinician special registrant be physically located in the same state as the patient when issuing a special registration prescription for a Schedule II controlled substance.
  • The second proposed requirement would require that the average number of special registration prescriptions for Schedule II controlled substances constitute less than 50% 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.
• Schedule II Controlled Substance Prescriptions for Minors. In addition to the proposed requirements for Schedule II controlled substances described above, clinician special registrants who are pediatricians or board-certified in pediatric care prescribing Schedule II controlled substances to a minor would be required to prescribe in the presence of the minor’s parent or guardian.
• State Law Considerations. When issuing a special registration prescription, a special registrant must comply with the laws and regulations of the state in which the special registrant is located and the state in which the patient is located during the telemedicine encounter.

PRESCRIPTION REQUIREMENTS AND “RED FLAG” CONSIDERATIONS

All prescriptions for controlled substances, whether issued via telemedicine or on the basis of an in-person encounter, are required to include the elements specified in 21 CFR 1306.05(a): signature of the prescriber; issue date; patient’s full name and address; drug details (name, strength, dosage form, and quantity); directions for use; and the practitioner’s name, address, and DEA registration number. The special registration proposed rule would require two additional elements for special registration prescriptions:

• The special registration numbers of the clinician practitioner and, if a platform practitioner facilitated the prescription, the platform practitioner
• The state telemedicine registration numbers of the clinician practitioner and, if a platform practitioner facilitated the prescription, the platform practitioner (unless exempt from the state telemedicine registration requirements).

The DEA indicates that the inclusion of the special registration number would allow pharmacists to determine if the clinician practitioner has the authority to prescribe a Schedule II controlled substance under the special registration while the inclusion of the state telemedicine registration numbers would allow pharmacists to verify that patients are only being prescribed special registration prescriptions by special registrants authorized to practice in the specific state where the patient is located. The DEA notes that pharmacists occasionally encounter what they may perceive as “red flags” for certain telemedicine prescriptions, which can stem from the nature of telemedicine itself, where patients may receive prescriptions from prescribers located at distances far away (both inside and outside the state where the patient is located). The geographical distance can raise doubts about the legitimacy of the prescription and could lead pharmacists to question its validity and refuse to fill the prescription. The DEA suggests that by verifying state telemedicine registration numbers, pharmacists would receive a level of assurance that a special registration prescription is legitimate when it originates from a prescriber located a significant distance from the patient.

DOCUMENTATION REQUIREMENTS

The special registration proposed rule includes the following documentation requirements:

• Patient Verification and Photographic Record. Clinician special registrants would be required to establish and maintain photographic records for patient verification. The DEA would require that these records be maintained for two years from the date of the telemedicine encounter.
  • If the patient does not consent to their photo being captured, the clinician special registrant (or a delegated employee or contractor under the special registrant’s direct supervision) would be allowed to accept a copy of the patient’s federal or state government-issued photo identification card or other forms of documentation provided by the patient.
• Special Registration Telemedicine Encounter Record. Clinician special registrants would be required to maintain a record of the date and time of the telemedicine encounter, the address of the patient during the telemedicine encounter, and the home address of the patient. The DEA would require that these records be maintained for two years from the date of the telemedicine encounter.
• Credentialing and Clinician Records. Platform special registrants would be required to maintain and update records related to clinician special registrants with whom they enter and maintain a covered platform relationship, including:
  • Verification of the clinician special registrant credentials, including but not limited to records on education, training, board or specialty certifications, and special registration number and state telemedicine registration number(s)
  • The employment contract and any other contract between the platform special registrant and the clinician special registrant
  • Any disciplinary actions or sanctions, or documentation of complaints, disputes, or incidents involving the practice of telemedicine.

Platform special registrants would be required to maintain and update these records every two years and make them readily available to the DEA.

• Data Reporting. Pharmacies dispensing special registration prescriptions would be required to report monthly aggregated special registration prescription data on Schedule II controlled substances and certain Schedule III – V controlled substances. Special registrants would be required to report annually aggregated information about their telemedicine practice, including the number of new patients they treat through telemedicine and the total number of special registration prescriptions for Schedule II controlled substances and certain Schedule III – V controlled substances dispensed for the preceding year.
• Recordkeeping at the Special Registration Location. The proposed rule would require that records arising from telemedicine encounters under the special registration framework be kept at the special registered location. The DEA acknowledges that, given telemedicine’s nationwide reach – where a special registrant could serve patients in any state – it would pose an unreasonable administrative burden to require the special registrant to maintain records in every state where telemedicine patients are located.

NEXT STEPS AND INCOMING TRUMP ADMINISTRATION

Stakeholders will have 60 days to comment after publication of the special registration proposed rule in the Federal Register. The DEA encourages input on appropriate implementation timelines, or on-ramps for phased or gradual adoption, to help ensure a smoother transition when the final rule takes effect. Practitioners, pharmacies, and industry stakeholders are encouraged to provide their input on the time necessary to operationalize the proposed requirements.

However, the upcoming administration change may affect when – or if – the special registration proposed rule is adopted. Once in office, President-elect Donald Trump is expected to sign an executive order pausing many of the rules proposed by the Biden administration. It is unclear if this rule will be included. Because this proposed rule is a long-awaited attempt by the DEA to create a special registration, the incoming administration may choose to keep the proposed rule open in order to review public comments on the proposed approach. These comments could help inform future rulemaking. If the proposed rule remains open for public comment, stakeholders should consider providing feedback to help educate and inform the new administration on this approach.