Authored by: Lydia Kotowski, JD, MHA (March 20, 2025)
Update (March 21, 2025): After this publication of this blog and recording of this webinar, the DEA filed a second delay with the Federal Register. The final rule for prescribing buprenorphine via telehealth to treat Opioid Use Disorder will now go into effect on Dec. 31, 2025.
In January, the Drug Enforcement Administration (DEA) published a final rule related to the prescription of controlled substances via a telemedicine encounter. The rule builds upon the temporary flexibilities allowed during the COVID-19 public health emergency.
Here’s what healthcare practitioners need to know about telehealth prescribing flexibilities and how they will change this month.
This blog post is meant to be educational and does not constitute legal advice. Consult your own counsel to determine how your organization needs to comply with this rule.
Review of Pandemic-Era Flexibilities
In 2008, Congress passed the Ryan Haight Act to amend the Controlled Substances Act. The amendment established a requirement that a practitioner conduct an in-person medical evaluation of a patient before prescribing a controlled substance unless one of seven narrow exceptions was met.
A few weeks into the COVID-19 pandemic, the DEA and HHS issued two Dear Registrant letters creating temporary flexibilities for prescribing controlled substances.
“Dear Registrant” Letter 1 | “Dear Registrant” Letter 2 | |
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Telehealth Flexibility Type | Audio-video telehealth | Audio-only telehealth |
How Flexibility May be Used | Allows prescription of Schedule II-V controlled substances using two-way, real time interactive audio-video telehealth without an initial or subsequent in-person visit. | Allows prescription of Schedule III-V controlled substances, defined as buprenorphine—to treat Opioid Use Disorder (OUD) using two-way, real-time, audio-only telehealth without an initial or subsequent in-person visit. |
Date Flexibility Will Change | Dec. 31, 2025 | March 21, 2025 |
Changes to Telehealth Prescribing Flexibilities
On Jan. 17, 2025, HHS issued two final rules. The one relevant to this blog post is the “Expansion of Buprenorphine Treatment Via Telemedicine Encounter.” This rule alters the flexibilities for prescribing buprenorphine to treat OUD established in the second Dear Registrant letter:
- Change 1 | 6 Month Initial Prescribing Cap. The rule maintains the ability of practitioners to initiate a buprenorphine prescription to treat OUD via audio-only telehealth but institutes a 6-month cap on that flexibility. At the 6-month mark, the practitioner must do one of the following:
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- Conduct an interactive audio-video telehealth evaluation. This option is only available until December 31, 2025, when the third extension expires.
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- Conduct an in-person medical evaluation for prescribing to continue (absent the applicability of one of the narrow exceptions added to the Controlled Substances Act by the Ryan Haight Act).
- Change 2 | Updates Administrative Requirements. The rule specifies requirements for practitioners and pharmacists.
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- If PDMP is available practitioners must:
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- Be registered by the DEA to prescribe controlled substances
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- Be authorized to access the prescription drug monitoring program (PDMP) of the state in which the patient is located in at the time of the telemedicine encounter
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- Check the patient’s data for the state that patient is located in at the time of the telemedicine encounter before they prescribe the initial six-month supply
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- Document the PDMP review in the patient’s EHR
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- If PDMP is not available practitioners must:
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- Limit prescriptions to a 7-day supply and document each attempt to review PDMP data in the patient’s EHR if PDMP is unavailable
- Limit prescriptions to a 7-day supply and document each attempt to review PDMP data in the patient’s EHR if PDMP is unavailable
- Pharmacists must:
- Verify the patient ID using a government-ID
- Verify the patient ID using a government-ID
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- If you are a practitioner who has been using audio-only telehealth to prescribe buprenorphine to treat OUD, you need must conduct either an audio-video telehealth visit, or in-person examination within 6 months of the March 21, 2025.
The current Administration delayed the effective date of this rule to March 21, 2025.
Conclusion
In sum, practitioners initiate prescribing buprenorphine to treat OUD using audio-only telehealth issue prescriptions for 6 months. At that point, the practitioner must either conduct an audio-video telehealth visit or conduct an in-person examination. The flexibility for an audio-video visit is currently only available through Dec. 31, 2025. Practitioners and pharmacists will also need to comply with the administrative requirements laid out in the final rule.
The new rule for prescribing buprenorphine to treat OUD using audio-only telehealth without an initial in-person visit goes into effect on March 21. Practitioners should ensure they understand the new timeline and requirements for such prescriptions and communicate the new requirements to patients who are being prescribed buprenorphine to treat OUD via audio-only telehealth.
Current Telehealth Flexibility March 21, 2025 Sept. 21, 2025 (6 months) Jan. 1, 2026+
Prescribing Schedule II-V without in-person Initiate via interactive audio-video Initiate and continue via interactive audio-video Initiate and continue via interactive audio-video Revert to pre-COVID rules
Prescribing Schedule III-V Buprenorphine for OUD Initiate via interactive audio-video or audio-only Initiate and continue via interactive audio-video Must conduct either an in-person visit, or audio-video telehealth visit if previously using audio-only to continue prescribing No change
At the end of the year, the audio-video flexibility is currently set to expire, so check back with CTRC to stay in the know. The CTRC will continue to monitor for rules or laws impacting these flexibilities.
View our webinar on this topic HERE.
Sources:
- Controlled Substances Act: https://uscode.house.gov/view.xhtml?path=/prelim@title21/chapter13&edition=prelim
- Ryan Haight Act: https://www.congress.gov/110/plaws/publ425/PLAW-110publ425.pdf
- Regulation Listing Exceptions 21 CFR § 1300.04(i): https://www.ecfr.gov/current/title-21/chapter-II/part-1300/section-1300.04
- Dear Registrant Letter 1: https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf
- Dear Registrant Letter 2: https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Final)%20+Esign.pdf
- Delay of Effective Date: https://www.federalregister.gov/documents/2025/02/19/2025-02793/expansion-of-buprenorphine-treatment-via-telemedicine-encounter-and-continuity-of-care-via
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