DEA and HHS propose telemedicine special registration and finalize buprenorphine telemedicine prescribing rules
On January 17, 2025, the US Drug Enforcement Administration (DEA) and the US Department of Health and Human Services (HHS) published two rules regarding telemedicine prescribing of controlled substances: a proposed rule implementing the DEA special registration as an exception to the Ryan Haight Act’s in-person medical evaluation requirement (Special Registration Proposed Rule) and a final rule on telemedicine prescribing of buprenorphine (Buprenorphine Final Rule) (together, the Rules).
Each of the Rules establish pathways for prescribing certain controlled substances via telemedicine without a prior in-person examination beyond the scheduled COVID-19 extended prescribing flexibilities, set to expire December 31, 2025.
Importantly, the Special Registration Proposed Rule outlines DEA’s proposed three categories of special registrations, each offering an exception to the in-person medical evaluation requirement:
- The Telemedicine Prescribing Registration authorizing qualified practitioners to prescribe Schedule III–V controlled substances via telemedicine
- The Advanced Telemedicine Prescribing Registration, authorizing qualified specialized practitioners (eg, psychiatrists, hospice care physicians) to prescribe Schedule II–V controlled substances via telemedicine, and
- The Telemedicine Platform Registration, authorizing covered online telemedicine platforms, in their capacity as platform practitioners, to dispense Schedule II–V controlled substances.
The Special Registration Proposed Rule also requires practitioners to obtain a state registration for every state in which such special registrant treats a patient, unless an exemption applies. Comments to the Special Registration Proposed Rule are due by March 18, 2025.
Additionally, the Buprenorphine Final Rule enables practitioners to prescribe a six-month initial supply of Schedule III–V controlled substances to treat opioid use disorder (OUD) via audio-only telemedicine interactions and without a prior in-person evaluation. This marks an expansion from the 30-day supply previously authorized. Thereafter, practitioners may prescribe additional controlled substances to treat OUD only via other “practice of telemedicine” (as defined in 21 U.S.C. § 802(54)) encounters, or after an in-person encounter, subject to certain additional requirements. Notably, the special registration requirements, as outlined in the Special Registration Proposed Rule, would not apply to practitioners prescribing buprenorphine for OUD under the Buprenorphine Final Rule.
Background of the Rules
Both Rules stem from the federal Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act), which requires healthcare providers to conduct an in-person examination before prescribing or otherwise dispensing controlled substances “by means of the Internet,” except when engaged in the practice of telemedicine.[1] The Ryan Haight Act contains seven “practice of telemedicine” exceptions to the in-person medical examination requirement to allow for telemedicine prescribing of controlled substances, including, in relevant part, an exception for practitioners who have obtained a “special registration” and “other circumstances specified by regulation.” The Special Registration Proposed Rule would fall under the former exception, and the Buprenorphine Final Rule under the latter. Notably, the other existing telemedicine exceptions under the Ryan Haight Act are extremely narrow in their application, and virtual care proponents have long encouraged DEA to adopt a telemedicine special registration pursuant to their authority.
During the COVID-19 public health emergency (PHE), DEA waived the in-person examination requirement under the Ryan Haight Act under the public health emergency exception, thereby allowing DEA-registered prescribers to issue prescriptions for controlled substances via telemedicine without a prior in-person evaluation, provided that the prescription was for a legitimate medical purpose and the practitioner acted in accordance with state law. The PHE’s regulatory flexibilities for the prescribing of controlled substances were subsequently extended following the conclusion of the PHE in recognition of the need to continue to permit needed access to prescription medications via virtual care delivery post-pandemic. Absent these flexibilities, the Ryan Haight Act would require an in-person examination of the patient prior to initial or continuing prescriptions for controlled substances except in very limited circumstances.
DEA and the US Substance Abuse and Mental Health Services Administration (SAMHSA) previously issued proposed rules for telemedicine prescribing in February 2023 (see our prior DLA Piper alert) which received significant industry pushback for being seen as too restrictive. Notably, the February 2023 proposed rule did not include a process for a special registration. These 2023 proposed rules were not finalized, and DEA subsequently extended the PHE flexibilities through the current expiration date of December 31, 2025. It remains to be seen whether the new Trump Administration will chart a different course or allow the current proposed rules to remain open for comment.
The Proposed Special Registration Rule
The three registration types
Currently, an applicant for a special registration is already required to maintain one or more DEA registrations under 21 U.S.C. §823(g) to prescribe or dispense controlled substances in a state in which they are licensed, registered, or otherwise permitted to prescribe or dispense controlled substances through telemedicine, unless otherwise exempted. If an applicant maintains such a registration, then under the Proposed Special Registration Rule, if such an applicant wishes to prescribe controlled substances via telemedicine, the applicant may submit a new registration application, Form 224S, to obtain a Special Registration (defined below).
Under the Proposed Special Registration Rule, DEA establishes three separate special registrations (each a Special Registration) to “allow more comprehensive prescribing[.]”[2] The Special Registration would permit the prescribing of Schedule II and narcotic and non-narcotic controlled substances in limited circumstances by properly registered physicians and mid-level practitioners (Practitioners and, once registered, Clinician Special Registrants), as well as dispensing by qualifying online telemedicine platforms as described further below (Covered Online Telemedicine Platforms and, once registered, Platform Special Registrants).
The three types of Special Registrations are described below. Each Special Registration requires a showing that the Practitioner, or Covered Online Telemedicine Platform, has a “legitimate need” for the Special Registration, and depending on the Special Registration, such legitimate need requires an explanation of the need to prescribe that specific Schedule of controlled substances. As set forth below, DEA provided limited examples to demonstrate such need.
- Telemedicine Prescribing Registration. The Telemedicine Prescribing Registration authorizes qualified Practitioners to prescribe Schedule III–V controlled substances via telemedicine. According to DEA, “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 requiring in-person medical evaluations prior to prescribing Schedule III–V controlled substances could impose significant burdens on bona fide practitioner-patient relationships” (eg, patients living in remote or distant areas).[3]
- Advanced Telemedicine Prescribing Registration. The Advanced Telemedicine Prescribing Registration authorizes qualified and specialized Practitioners to prescribe Schedule II–V controlled substances via telemedicine. DEA determined that certain specialized physicians and board-certified mid-level practitioners, including, but not limited to, psychiatrists, hospice care physicians, pediatricians, and neurologists, have a legitimate need to prescribe Schedule II controlled substances via telemedicine when treating particularly vulnerable patient populations (eg, patients with significant healthcare accessibility challenges or who suffer from particularly debilitating or terminal illnesses).[4] DEA seeks comments 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.
- Telemedicine Platform Registration. The Telemedicine Platform Registration authorizes Covered Online Telemedicine Platforms to dispense[5] Schedule II–V controlled substances. DEA has proposed a definition for Covered Online Telemedicine Platforms as:
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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 (4) following criteria: (i) the entity explicitly promotes or advertises the prescribing of controlled substances via the platform; (ii) the entity has financial interests (directly or indirectly) in the volume or types of controlled substance prescriptions issued through the platform; (iii) the entity exerts control or influence over clinical decision-making including but not limited to issuing prescribing guidelines or protocols, the consideration of Practitioner’s prescribing patterns in hiring, retention or compensation decisions, or directing patients to preferred pharmacies; or (iv) the entity has custody or control of the prescriptions or medical records of patients who are prescribing controlled substances through the platform.[6]
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legitimate need to dispense Schedules II through 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 Practitioners’ prescribing practices, and take measures to prioritize patient safety and prevent diversion, abuse, or misuse of controlled substances.[7]
The State Registration Requirement
In addition to the Special Registration, each registrant must obtain a state telemedicine registration for every state in which a patient is treated by the registrant, unless otherwise exempted (the State Telemedicine Registration). The State Telemedicine Registration is a DEA (not-state) registration requirement. The State Telemedicine Registration for a given state would allow the special registrant to prescribe only via telemedicine encounters as to that state, and only for the scheduled controlled substances authorized by the registrant’s respective Special Registration. This State Telemedicine Registration would apply to both Clinician Special Registrants and Platform Special Registrants.
There is a limited exception to the State Telemedicine Requirement, if the Practitioner is (1) an “official of the U.S. Army, Navy, Marine Corps, Air Force, Space Force, Coast Guard, Public Health Service, or Bureau of Prisons who is authorized to prescribe, dispense, or administer” or (2) a VA employee or contractor acting in the scope of such employment or contract, and is registered under §823(g) in any state or is utilizing the registration of a hospital or clinic operated by the VA.[8]
Heightened requirements for prescriptions issued under Special Registrations
The Proposed Rule further delineates heightened prescription requirements, as well as the additional elements required to be included on a Special Registration prescription, including, but not limited to, the following:
- Clinician Special Registrants must be physically present in the US when conducting a telemedicine encounter and issuing a prescription pursuant to the Special Registration.
- Clinician Special Registrants must hold the proper licensure and authorization within the state and territory where the Clinician Special Registrant is located when the telemedicine encounter takes place, as well as where the patient is located pursuant to the relevant State Telemedicine Registration.
- Prescriptions issued under the Special Registration must be prescribed through electronic prescribing for controlled substances.
- Clinician Special Registrants must verify the identity of the patient and conduct a nationwide Prescription Drug Monitoring Program (PDMP) check prior to issuing a prescription under a Special Registration. Notably, however, DEA delayed this nationwide PDMP check requirement for three years. In the interim, for all Schedule II–V controlled substances, Special Registrants would be required to conduct a PDMP check in the state/territory where (1) the patient is located, (2) the Clinician Special Registrant is located, and (3) there is a PDMP reciprocity agreement with the states/territories where the Clinician Special Registrant and patient are located.
- Clinician Special Registrants must utilize both audio and video components of an audio-video telecommunications system to prescribe under a Special Registration.
- With respect to the Advanced Telemedicine Prescribing Registration, Clinician Special Registrants must be physically located in the same state as the patient when issuing a prescription for a Schedule II controlled substance. Additionally, the average number of prescriptions for Schedule II controlled substances issued under such Special Registration must 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. Essentially, this prohibits a Clinician Special Registrant to issue Schedule II prescriptions if the Clinician Special Registrant is exclusively or primarily a virtual care provider.
The Proposed Rule also introduces additional requirements related to the elements of the prescription itself, recordkeeping, and reporting. Importantly, special registration prescriptions 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.
The Buprenorphine Final Rule
Under the Buprenorphine Final Rule, a DEA-registered practitioner may prescribe an initial six-month supply of buprenorphine via an audio-only or audio-video telemedicine encounter. However, before a DEA-registered practitioner issues such a prescription, the practitioner must first conduct a PDMP check in the state(s) in which the patient was located in the previous year (or for the entire period if less than one year is available) and annotate in the patient’s electronic health record that the practitioner conducted such review. If the PDMP data cannot be reviewed, then the practitioner may only prescribe an initial seven-day supply of buprenorphine and may not prescribe an additional supply without again checking the PDMP data for that patient. Under the Buprenorphine Final Rule, the practitioner is authorized to issue additional limited seven-day supply prescriptions (until the six-calendar month limitation is reached) if the PDMP check remains unavailable or inaccessible, as long as each time the practitioner attempts such a review and notes the date and time of each such attempt in the patient’s record.
Following the initial six-month supply of buprenorphine, practitioners may prescribe buprenorphine only by other forms of telemedicine, as the practice of telemedicine is defined under 21 U.S.C. § 802(54), or through practices authorized by the federal Controlled Substances Act, or after conducting an in-person medical examination. When dispensing buprenorphine, pharmacists are required to verify the identity of the patient with either a state or federal government-issued photographic identification card or other form of identification prior to dispensing the medication to the patient.
Implications for the telemedicine practice
While the Special Registration Proposed Rule and the Buprenorphine Final Rule offer certain flexibilities as compared to the Ryan Haight Act, these Rules are a marked change from the telemedicine prescribing flexibilities in place over the past five years during the PHE and under the temporary extensions of such COVID-19 flexibilities. In particular, the process to obtain a Special Registration and the underlying requirements related to the Special Registration and State Telemedicine Registration, including the nationwide PDMP check requirement under the Special Registration Proposed Rule, presents additional regulatory and administrative burdens for providers. Most notably, some of the current flexibilities extended under the PHE would not be available via the Special Registration to providers that operate exclusively or primarily via telemedicine. Instead, those additional flexibilities would be afforded only to those providers with a hybrid practice model.
Further, the six-month limitation of an initial prescription of buprenorphine under the Buprenorphine Final Rule may present access-to-care issues for patients.
However, given the recent administration change, it is unclear whether these Rules will be revised, withdrawn, or left as is. Additionally, should the administration choose to leave the comment period open for the Special Registration Proposed Rule, the industry could provide feedback that may encourage the administration to make further changes before finalizing the Special Registration Proposed Rule. The administration change, coupled with the scheduled end of the PHE telemedicine prescribing flexibilities in December 2025, create uncertainty as to the future of controlled substance prescribing practices via telemedicine.
Thus, given the complex and shifting regulatory landscape, we encourage healthcare entities and providers to work with healthcare counsel to carefully evaluate their practices, reevaluate their business strategies, and conform current treatment models to comply with the changing requirements.
If you have any questions about the Special Registration Proposed Rule, the Buprenorphine Final Rule, or related matters, please contact your DLA Piper relationship partner, the authors of this alert, or any member of our Healthcare industry group.
[1] See Pub. L. §110-425 (2008).
[2] 90 Fed. Reg. 6541, 6542 (Jan. 17, 2025).
[3] 90 Fed. Reg. 6541, 6549 (Jan. 17, 2025).
[4] Id.
[5] 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.” DEA further notes that “[t]he online telemedicine platforms serving as intermediaries for the prescribing of controlled substances fall squarely within the CSA’s broad definition of ‘practitioner.’’’ See id. at 6547.
[6] 90 Fed. Reg. 6541, 6560 (Jan. 17, 2025).
[7] Id., at 6550.
[8] Id., at 6551.