The Drug Enforcement Administration (DEA) and the U.S. Division of Well being & Human Companies (HHS) simply finalized their March 2023 proposed rule concerning telemedicine prescribing of buprenorphine. The closing rule, efficient February 17, 2025, permits DEA‑registered practitioners to prescribe Schedule III-V managed substances, i.e., buprenorphine, to deal with opioid use dysfunction (OUD) via audio-video visits and thru audio-only visits in particular circumstances after sure necessities are met. Though these practices are at present allowed underneath the COVID-era telemedicine prescribing flexibilities via the top of the 2025, the ultimate rule introduces further necessities for these prescriptions.
Necessities of the Ultimate Rule
PDMP Examine
Earlier than prescribing a Schedule III-V managed substance authorised by the U.S. Meals & Drug Administration (FDA) to deal with OUD by way of telemedicine (at present restricted to buprenorphine), DEA-registered practitioners should evaluation the prescription drug monitoring program (PDMP) database of the state by which the affected person is positioned on the time of the encounter.
- Scope of Evaluation: Practitioners should examine PDMP knowledge for any managed substances issued to the affected person throughout the previous 12 months. If lower than a 12 months of knowledge is accessible, practitioners should evaluation the complete obtainable interval.
- Preliminary Prescription:
- After reviewing the PDMP knowledge and documenting the evaluation, practitioners might concern an preliminary six-month provide of buprenorphine, which can be divided throughout a number of prescriptions, totaling six calendar months.
- If the PDMP knowledge just isn’t obtainable however the try and entry it’s documented, practitioners might prescribe solely a seven-day provide of buprenorphine. Practitioners should proceed to examine the PDMP database to concern subsequent prescriptions. If, after checking, the PDMP stays unavailable and entry makes an attempt are documented, practitioners might prescribe subsequent seven-day provides, as much as the six-month restrict.
Observe-Up Prescriptions
After the preliminary six-month provide, practitioners might concern further prescriptions in the event that they both:
- Conduct an in-person medical examination; or
- Meet one of many seven slim exceptions underneath the Ryan Haight Act (mentioned under) for telemedicine practitioners.
As soon as an in-person medical examination has been carried out, the practitioner and affected person are now not thought of to be engaged within the observe of telemedicine, and the obligations outlined within the closing rule will now not apply.
Pharmacist Verification
Earlier than allotting these prescriptions, pharmacists should confirm the identification of the affected person utilizing one of many following:
- A state government-issued ID;
- A federal government-issued ID; or
- Different acceptable documentation, resembling a paycheck, financial institution or bank card assertion, utility invoice, tax invoice, or voter registration card.
A Transient Historical past
The foundations stem from the Ryan Haight Act, which amended the Managed Substances Act to limit practitioners from prescribing managed substances except the practitioner conducts an in-person examination of the affected person. The Ryan Haight Act (at 21 U.S.C. § 802(54)) outlines seven exceptions underneath which practitioners might prescribe managed substances by way of telemedicine with out an in-person examination. The fifth exception includes practitioners who’ve obtained the long-awaited particular registration. (Keep tuned for our dialogue on the DEA’s proposed rule establishing a particular registration.) The seventh exception includes different circumstances specified by regulation.
In the course of the COVID-19 Public Well being Emergency (PHE), the DEA issued letters on March 25, 2020, and March 31, 2020, granting short-term exceptions to the Ryan Haight Act and its implementing guidelines that enabled DEA-registered practitioners to prescribe managed substances with out an in-person examination and with a DEA registration in just one state. These telemedicine flexibilities enabled practitioners to prescribe Schedule II-V managed substances via audio-video visits and audio-only visits. Audio-only visits are permitted if the practitioner has the aptitude to make use of audio-video, however the affected person is both unable to make use of video or doesn’t consent to it.
In March 2023, in anticipation of the PHE ending, the DEA issued a proposed rule concerning the enlargement of telemedicine prescribing of buprenorphine, which acquired important criticism from stakeholders. In response, the DEA rapidly rescinded the proposed rule and prolonged the COVID-era flexibilities in Might 2023. The flexibilities had been subsequently prolonged in October 2023 and November 2024 and are actually set to run out on December 31, 2025. (For extra particulars, see our earlier discussions on the DEA’s proposed guidelines for telemedicine prescribing of managed substances and the first, second, and third short-term guidelines extending COVID-era flexibilities.) Now, in an effort to not lose floor on the enlargement of telemedicine prescribing of buprenorphine, particularly if the telemedicine flexibilities expire with the incoming Trump administration, the DEA and HHS have revised and finalized their proposed buprenorphine rule.
Evaluating the Proposed and Ultimate Guidelines
The ultimate rule introduces a number of modifications to the proposed rule, a few of that are described under:
- Provide Limitation: The preliminary 30-day prescription provide limitation by way of audio-only was elevated to a six-month provide.
- In-Particular person Medical Analysis: The requirement to have an in-person medical analysis, with three choices for conducting it, to prescribe greater than the preliminary provide of buprenorphine was eliminated.
- Recordkeeping: The detailed recordkeeping necessities for every prescription a practitioner points via a telemedicine encounter, resembling whether or not the encounter was carried out by way of audio-video or audio-only, had been eliminated.
- PDMP Evaluation: Though reviewing the PDMP database of the state by which the affected person is positioned on the time of the encounter remains to be required, the specs and recordkeeping necessities for the evaluation had been modified.
The DEA and HHS state that these modifications are prone to tackle and alleviate most of the considerations raised by commentors, acknowledging that a number of the beforehand proposed necessities would have positioned undue burdens on each sufferers and practitioners.
Conclusion
We anticipate that many stakeholders will likely be dissatisfied with the ultimate rule, notably with the six-month period for an preliminary provide, which can nonetheless be too brief, and the nationwide PDMP examine requirement, which is overly burdensome given the absence of a nationwide PDMP database — a burden the DEA continues to underestimate.
If the COVID-era telemedicine prescribing flexibilities expire with out additional extension, the ultimate rule presents safety for prescribing buprenorphine to deal with OUD. Nevertheless, that safety is contingent on establishing a official particular registration course of, which the DEA has but to suggest or implement. Given the uncertainty surrounding the incoming Trump administration’s priorities and its views on telemedicine prescribing of managed substances, it’s unclear whether or not the ultimate rule will likely be withdrawn or left as-is. There’s additionally uncertainty about whether or not the telemedicine prescribing flexibilities will expire after 2025. We’ll proceed to watch developments concerning the flexibilities all year long.
For extra info on telemedicine, telehealth, digital care, distant affected person monitoring, digital well being, and different well being improvements, together with the workforce, publications, and consultant expertise, go to Foley’s Telemedicine & Digital Well being Business Workforce
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