The Drug Enforcement Administration (DEA) and the U.S. Department of Health & Human Services (HHS) just finalized their March 2023 proposed rule regarding telemedicine prescribing of buprenorphine. The final rule, effective February 18, 2025, allows DEA‑registered practitioners to prescribe Schedule III-V controlled substances, i.e., buprenorphine, to treat opioid use disorder (OUD) through audio-video visits and through audio-only visits in specific circumstances after certain requirements are met. Although these practices are currently allowed under the COVID-era telemedicine prescribing flexibilities through the end of the 2025, the final rule introduces additional requirements for these prescriptions.
Requirements of the Final Rule
PDMP Check
Before prescribing a Schedule III-V controlled substance approved by the U.S. Food & Drug Administration (FDA) to treat OUD via telemedicine (currently limited to buprenorphine), DEA-registered practitioners must review the prescription drug monitoring program (PDMP) database of the state in which the patient is located at the time of the encounter.
- Scope of Review: Practitioners must check PDMP data for any controlled substances issued to the patient within the past year. If less than a year of data is available, practitioners must review the entire available period.
- Initial Prescription:
- After reviewing the PDMP data and documenting the review, practitioners may issue an initial six-month supply of buprenorphine, which may be divided across several prescriptions, totaling six calendar months.
- If the PDMP data is not available but the attempt to access it is documented, practitioners may prescribe only a seven-day supply of buprenorphine. Practitioners must continue to check the PDMP database to issue subsequent prescriptions. If, after checking, the PDMP remains unavailable and access attempts are documented, practitioners may prescribe subsequent seven-day supplies, up to the six-month limit.
Follow-Up Prescriptions
After the initial six-month supply, practitioners may issue additional prescriptions if they either:
- Conduct an in-person medical exam; or
- Meet one of the seven narrow exceptions under the Ryan Haight Act (discussed below) for telemedicine practitioners.
Once an in-person medical exam has been conducted, the practitioner and patient are no longer considered to be engaged in the practice of telemedicine, and the obligations outlined in the final rule will no longer apply.
Pharmacist Verification
Before dispensing these prescriptions, pharmacists must verify the identity of the patient using one of the following:
- A state government-issued ID;
- A federal government-issued ID; or
- Other acceptable documentation, such as a paycheck, bank or credit card statement, utility bill, tax bill, or voter registration card.
A Brief History
The rules stem 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 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. The fifth exception involves practitioners who have obtained the long-awaited special registration. (Stay tuned for our discussion on the DEA’s proposed rule establishing a special registration.) The seventh exception involves other circumstances specified by regulation.
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. These telemedicine flexibilities enabled practitioners to prescribe Schedule II-V controlled substances through audio-video visits and audio-only visits. Audio-only visits are 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.
In March 2023, in anticipation of the PHE ending, the DEA issued a proposed rule regarding the expansion of telemedicine prescribing of buprenorphine, which received significant criticism from stakeholders. In response, the DEA quickly rescinded the proposed rule and extended the COVID-era flexibilities in May 2023. The flexibilities were subsequently extended in October 2023 and 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.) Now, in an effort to not lose ground on the expansion of telemedicine prescribing of buprenorphine, especially if the telemedicine flexibilities expire with the incoming Trump administration, the DEA and HHS have revised and finalized their proposed buprenorphine rule.
Comparing the Proposed and Final Rules
The final rule introduces several changes to the proposed rule, some of which are described below:
- Supply Limitation: The initial 30-day prescription supply limitation via audio-only was increased to a six-month supply.
- In-Person Medical Evaluation: The requirement to have an in-person medical evaluation, with three options for conducting it, to prescribe more than the initial supply of buprenorphine was removed.
- Recordkeeping: The detailed recordkeeping requirements for each prescription a practitioner issues through a telemedicine encounter, such as whether the encounter was conducted via audio-video or audio-only, were removed.
- PDMP Review: Although reviewing the PDMP database of the state in which the patient is located at the time of the encounter is still required, the specifications and recordkeeping requirements for the review were changed.
The DEA and HHS state that these changes are likely to address and alleviate many of the concerns raised by commentors, acknowledging that some of the previously proposed requirements would have placed undue burdens on both patients and practitioners.
Make Your Voice Heard
President Trump’s initial round of executive orders includes a regulatory freeze. Under the Regulatory Freeze Pending Review Executive Order, executive departments, the DEA, and HHS could delay for 60 days from January 20, 2025, the effective date of the final rule for the purpose of reviewing any questions of fact, law, and policy the rules may raise. During this 60-day period, executive departments, the DEA, and HHS may also open a comment period to gather input from interested parties on these issues.
Stakeholders with concerns about the final rule can urge the DEA and the White House to delay the final rule’s effective date via the following channels:
- Email the DEA
- Send a letter or email to the White House
Conclusion
We anticipate that many stakeholders will be dissatisfied with the final rule, particularly with the six-month duration for an initial supply, which may still be too short. If the COVID-era telemedicine prescribing flexibilities expire without further extension, the final rule offers protection for prescribing buprenorphine to treat OUD. However, that protection is contingent on establishing a legitimate special registration process, which the DEA has yet to propose or implement. Given the uncertainty surrounding the incoming Trump administration’s priorities and its views on telemedicine prescribing of controlled substances, it is unclear whether the final rule will be withdrawn or left as-is. There is also uncertainty about whether the telemedicine prescribing flexibilities will expire after 2025. We will continue to monitor developments regarding the flexibilities throughout the year.
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.
