On January 17, the Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) jointly published two final rules addressing the prescription of controlled substances via telemedicine in limited contexts: prescription of buprenorphine and prescriptions by Department of Veterans Affairs (VA) practitioners to VA patients. The same day, the DEA also published a proposed rule that seeks to establish a “special registration” framework that would broadly permit the prescription of controlled substances via telemedicine without an in-person evaluation. This trio of final and proposed rules provides a window into a future in which telemedicine prescription of controlled substances may be permitted long-term, without an in-person medical evaluation.
The final rule addressing buprenorphine treatment via telemedicine (the Buprenorphine Final Rule or Final Rule) establishes circumstances under which DEA-registered practitioners are authorized to prescribe Schedule III-V controlled substances approved by the Food and Drug Administration (FDA) for the treatment of opioid use disorder (OUD) via a telemedicine encounter for a patient who has not been seen in-person by the practitioner. In brief, a practitioner may prescribe an initial six-month supply of buprenorphine via telemedicine, including through audio-only means, to treat a patient with OUD. Additional prescriptions can be issued after an in-person medical evaluation or as otherwise permitted under the Controlled Substances Act (CSA). The finalized policy is a tightening of the telemedicine prescribing framework permitted under regulatory flexibilities implemented during the COVID-19 pandemic and subsequently extended several times, but it is still a significant expansion beyond what was permitted prior to the COVID-19 flexibilities. It was a long road to the Buprenorphine Final Rule, as the agencies wrestled to strike an appropriate balance between expanding access to OUD treatment (by expanding telemedicine prescription of buprenorphine) and mitigating the risk of diversion.
The Buprenorphine Final Rule takes effect February 16, 2025. However, the latest temporary extension of COVID-19 flexibilities continues to permit remote prescribing of controlled substances through December 31, 2025, providing a grace period through the end of the year for providers to align their practices with the new policies. Once the temporary extension expires, the remote prescription of buprenorphine will not be permissible without conducting an in-person medical evaluation. However, if the Final Rule is implemented together with a proposed rule that seeks to establish a “Special Registration” framework (Special Registration Rule), long-term buprenorphine treatment via telemedicine would be permissible without an in-person medical evaluation – provided the Special Registration Rule is finalized in its proposed form. This potential future framework is further explored below, along with the final rule addressing telemedicine prescriptions by VA practitioners.
We note that none of the three telemedicine rules issued by the DEA and/or HHS on January 17 apply to telemedicine visits when the practitioner has already conducted an in-person medical evaluation with the patient to whom controlled substances are being prescribed. Once an in-person medical evaluation has been conducted by a practitioner, that practitioner may prescribe controlled substances through telemedicine for the patient indefinitely. In addition, we caution that state laws may also apply to the issuance of prescriptions via telemedicine and may be more restrictive than federal law.
The CSA Framework and Evolution of Telehealth Prescribing Rules
DEA implements and enforces the CSA, which is part of a statutory framework intended to ensure an adequate supply of controlled substances for legitimate purposes and prevent the diversion of controlled substances for illicit purposes. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008, primarily focused on the distribution and dispensing of controlled substances over the internet, amended the CSA in a way that has significantly constrained the prescription of controlled substances via telemedicine.
The CSA generally requires a healthcare practitioner to have conducted at least one in-person medical exam (i.e., the patient and practitioner are both physically present) prior to prescribing a controlled substance via telemedicine, unless a specific “practice of telemedicine” exception applies. There are seven such exceptions permitting the practice of telemedicine, each of which is relatively restrictive and must be conducted with appropriate technology (audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site practitioner). Three of those exceptions, describing the circumstances under which the practice of telemedicine is permitted, are:
- During a public health emergency declared under the Public Health Service Act involving patients in designated areas and designated controlled substances.
- When conducted by a practitioner who has obtained a “special registration.”
- Under other circumstances specified in regulation by the DEA and HHS as determined to be consistent with effective diversion controls and otherwise consistent with public health and safety.
In March 2020, in response to the COVID-19 public health emergency (COVID-19 PHE), DEA-registered practitioners were permitted to prescribe all Schedule II-V controlled substances without an in-person medical evaluation, provided certain requirements were met. The DEA also permitted authorized practitioners to prescribe buprenorphine to both new and existing patients for OUD by audio-only telephone communication without first conducting an in-person examination. These flexibilities were intended to prevent lapses in care during the COVID-19 PHE and were therefore set to continue for the duration of the PHE. As the end of the PHE came into sight and the federal government prepared to wind-down various flexibilities, there was significant concern in both patient and provider communities about continued access to care.
In March 2023, the DEA published two proposed rules (a general telemedicine rule and a buprenorphine-focused rule), proposing to make permanent some – but not all – of the pandemic-era flexibilities. These proposed rules sparked significant public interest and, in many cases, strong objections, as evidenced by the over 38,000 public comments submitted in response to the proposed rules. In May 2023, weeks before the end of the PHE, the DEA and HHS, issued a temporary rule extending the full set of COVID-19 PHE telemedicine flexibilities for six months. The extension authorized all DEA-registered practitioners to prescribe Schedule II-V controlled medications via telemedicine through November 11, 2023, regardless of whether the patient and practitioner have previously established a telemedicine relationship (a lengthier extension period applied for established practitioner-patient telemedicine relationships). A second temporary extension of the COVID-19 PHE telemedicine flexibilities was issued in October 2023, extending the full set of flexibilities through calendar year 2024.
Also in the fall of 2023, the DEA held public listening sessions to inform its future rulemaking on prescription of controlled substances via telemedicine. The agency indicated it was open to implementing the “special registration” process to effectuate the “special registration” exception permitted under the CSA. Congress, clinicians and others have been pushing for this pathway for many years. In June 2024, the DEA submitted a proposed telemedicine prescribing rule to the Office of Management and Budget for review. Although the proposed rule was never officially proposed or released to the public, parts of the rule were purportedly leaked, stirring controversy. In October 2024, with the clock ticking, the DEA issued a third temporary extension of the COVID-19 PHE telemedicine flexibilities, extending the flexibilities through calendar year 2025.
Finally a Final Rule: A New Framework for Prescribing Buprenorphine
The Buprenorphine Final Rule, issued jointly by the DEA and HHS, establishes a framework for the prescription of buprenorphine under one of the CSA exceptions for permissible telemedicine practice. The new regulations permit DEA-registered practitioners to prescribe up to an initial six-month supply of buprenorphine pursuant to an audio-visual or audio-only telemedicine encounter, without conducting an in-person medical exam, provided certain conditions are satisfied, as outlined below. After the six-month period, additional prescriptions may be issued only after an in-person medical evaluation is conducted or under a different permissible practice of telemedicine exception. The agencies stated that the new regulation is “consistent with the effective controls against diversion and with public health and safety.”
The following conditions apply for buprenorphine prescriptions issued under this framework:
Prescription Drug Monitoring Program Check
Before prescribing buprenorphine to a patient via telemedicine (audio-only or audio-visual), the Final Rule requires the practitioner to conduct a Prescription Drug Monitoring Program (PDMP) check, reviewing the PDMP data of the state in which the patient is located at the time of the telemedicine encounter. The last year of PDMP data must be reviewed, if possible. The practitioner must ensure that the date and time of the review is annotated in the patient’s record. If the PDMP data cannot be reviewed for a patient (e.g., due to technological issues with a state’s PDMP), the prescribing practitioner should note their attempt and the reason the review could not be completed. When the practitioner cannot review the PDMP data, the practitioner is limited to prescribing an initial seven-day supply of buprenorphine. If PDMP data remains unavailable or inaccessible, the practitioner is authorized to issue additional seven-day supplies up until the six-month limitation is reached, provided that the date and time of each PDMP review attempt are annotated in the patient’s record. The PDMP check requirement is intended to ensure that practitioners have the information needed about a patient’s controlled substances prescription history in order to make the clinical decision regarding whether to prescribe buprenorphine.
Time Limitation: Six Month Supply
Based on a telemedicine encounter, a practitioner may prescribe an up to six-month supply of buprenorphine, which must be split across multiple prescriptions or refills as medically appropriate (not issued at one time). The six-month limitation will come as a relief to providers, as it is a significant extension of the 30-day supply limitation initially proposed by the DEA and HHS. The agencies acknowledged that increasing the limit to a six-month supply gives patients and prescribing practitioners more time to schedule follow-up appointments, reduces the risk of relapse by a patient due to lack of medicine and allows practitioners greater flexibility in managing their patient populations.
Identification Requirement for Pharmacists
Prior to filling a prescription issued under the buprenorphine telemedicine framework described above, pharmacists must verify that the identity of the individual picking up the prescription at the pharmacy matches the name of the patient listed on the prescription. Pharmacists can do so by inspecting the patient’s state or federal government-issued photographic identification card or any other documentation showing that the person is the same as the patient listed on the prescription. The Final Rule does not provide an exhaustive list of acceptable forms of identification, but it offers several examples. The agencies noted that the identification requirement is a codification of widely employed current practices and is already required by law in many states.
Drug Limitation: Buprenorphine for OUD
Notably, the new flexibilities created under the Buprenorphine Final Rule only apply to buprenorphine prescribed to treat OUD and not for any other medical purpose (e.g., they do not apply to buprenorphine prescribed to treat acute moderate-to-severe pain). Moreover, the flexibilities are currently limited to buprenorphine – because it is the only drug approved by the FDA for the treatment of OUD. The finalized regulation is drafted so that the same framework will automatically apply to additional drugs that are, in the future, approved by the FDA to treat OUD.
Beyond the Buprenorphine Final Rule: What Happens After Six Months?
The Buprenorphine Final Rule provides a degree of certainty to practitioners prescribing buprenorphine for the treatment of OUD, which is a widespread public health crisis. At long last, it moves the provider and patient communities beyond reliance on the temporary extensions of the COVID-19 PHE telemedicine flexibilities. However, it leaves a significant question to be addressed: what happens after the six-month supply limitation?
First, we highlight that the Final Rule appears to have an externally provided grace period, as telemedicine prescriptions may continue under the third temporary extension of the COVID-19 PHE telemedicine flexibilities until December 31, 2025.
Outside of the COVID-19 PHE flexibilities, however, continued prescription of buprenorphine via telemedicine beyond the six-month period will be challenging under the Final Rule’s framework, absent further regulatory action. To prescribe beyond six months, the practitioner must either: (1) conduct an in-personal medical evaluation or (2) continue treating the patient via another “practice of telemedicine” exception set forth under the CSA and its implementing regulations.
As noted above, most of the seven permitted practice of telemedicine exceptions are generally quite restrictive. However, one of those categories – a “special registration” framework – has long been discussed, lobbied for, and even congressionally mandated (The SUPPORT for Patient and Communities Act required the DEA to implement a special registration framework by October 2019), but that has never been implemented.
Concurrently with the Buprenorphine Final Rule, the DEA issued a proposed rule that (finally!) seeks to establish a Special Registration framework. The Special Registration Rule would, if finalized in its current form, permit long-term buprenorphine treatment via telemedicine without an in-person medical evaluation. It would also permit telemedicine prescriptions more broadly, beyond buprenorphine, allowing DEA-registered practitioners to issue prescriptions via telemedicine (audio-video telecommunications system; not audio-only) for Schedule II–V medications without an in-person medical evaluation.
The DEA proposed three types of special registrations:
- A Telemedicine Prescribing Registration, which would authorize qualified practitioners to prescribe Schedule III–V controlled substances.
- An Advanced Telemedicine Prescribing Registration, which would authorize qualified, specialized practitioners (e.g., psychiatrists) to prescribe Schedule II–V controlled substances.
- A Telemedicine Platform Registration, which would authorize covered online telemedicine platforms to dispense Schedule II–V controlled substances.
The proposed rule would also require each special registrant practitioner to maintain a State Telemedicine Registration, to be issued by the DEA, for every state in which a patient is treated by the special registrant. The proposed rule includes many guardrails, such as a nationwide PDMP check requirement; however, in recognition of the fact that a national PDMP system does not yet exist, that requirement would have a delayed effective date. In the meantime, less stringent state-level PDMP check requirements would apply. Some of the proposed guardrails would vary based on the Schedule of the controlled substance at issue. For example, a special registrant prescribing a Schedule II controlled substance would be required to be physically located in the same state in which the patient was located at the time of the telemedicine encounter. The DEA is seeking comments on the Special Registration Rule. The proposed rule is currently open for public comment; comments are due by March 18, 2025.
Final Rule for VA Practitioners
Beyond the new final and proposed rules discussed above, the DEA and HHS concurrently published a third telemedicine rule, “Continuity of Care via Telemedicine for Veterans Affairs Patients” (VA Final Rule). In brief, this final rule permits VA practitioners acting within the scope of their VA employment to prescribe controlled substances via telemedicine to VA patients without an in-person medical evaluation, provided that another VA practitioner has previously conducted an in-person medical evaluation of the patient, provided various conditions are satisfied. The VA Final Rule effectively exempts VA practitioners from the need to obtain a DEA Special Registration.
Just as the Framework Comes into Focus: Uncertainty with the New Presidential Administration
The trio of telemedicine rules was published in the Federal Register on January 17, just three days before President Trump took office. The Trump administration’s priorities are emerging, but uncertainty remains regarding its views on telemedicine prescribing of controlled substances.
On his first day in office, President Trump issued a presidential memorandum ordering a regulatory freeze (a now standard and expected move when a new administration assumes power), instructing agencies to consider postponing for 60 days the effective date for any rules that have been published in the Federal Register but that have not yet taken effect. This delay directive may push back the effective dates of the Buprenorphine Final Rule and VA Final Rules discussed above. If desired, the new presidential administration may seek to walk back one or both of these final rules. To do so, the DEA and HHS would be subject to rulemaking requirements of the Administrative Procedure Act. Alternatively, a final rule that has not yet taken effect can be overturned by Congress through ordinary legislation or nullified under the Congressional Review Act. The Congressional Review Act provides a fast-track option that requires a joint notice of disapproval to be submitted within a limited timeframe, passed by Congress, and signed by the president.
The Special Registration Rule, as a proposed rule, is subject to withdrawal by the new administration. If desired, the new administration can effectively erase the proposal, sending the DEA back to the drawing board (although it may be worth noting that a law passed during President Trump’s first term mandated the promulgation of final regulations implementing a special registration framework).
Our team continues to monitor evolving telemedicine rules. If you have any questions about the Buprenorphine Final Rule, the Special Registration Rule, the VA Final Rule, or how these rules could impact your organization’s operations, please contact the authors.