The End of the X-Waiver: What Practitioners Need to Know
The federal requirement for practitioners to obtain a special Drug Enforcement Administration (DEA) X-waiver (DATA-waiver) to prescribe buprenorphine for opioid use disorder (OUD) has been permanently removed following the Consolidated Appropriations Act, 2023. This change eliminated federal patient limits, allowing any DEA-registered practitioner with Schedule III authority to prescribe buprenorphine for OUD, subject to state laws. This aimed to expand access to medication-assisted treatment (MAT) by allowing more providers to offer buprenorphine.
New Mandatory Training Requirements
Effective June 27, 2023, the MAT Act also introduced a one-time mandatory training for all DEA-registered practitioners who prescribe controlled substances. New and renewing registrants must confirm they have completed at least eight hours of training on opioid and other substance use disorders. Exemptions apply to certain practitioners, such as those board-certified in addiction medicine or recent graduates with qualifying SUD curriculum.
Expanded Telemedicine Access with New Safeguards
On January 17, 2025, the DEA and the Department of Health and Human Services (HHS) finalized new rules for telemedicine prescribing of buprenorphine, building on the flexibilities seen during the COVID-19 pandemic. Temporary flexibilities are extended until December 31, 2025, with new rules effective January 1, 2026.
Requirements for Remote Prescribing
The finalized telemedicine rules for buprenorphine include several requirements. For patients without a prior in-person visit, practitioners can initially prescribe up to a six-month supply after an audio-only telemedicine visit. Subsequent prescriptions require an in-person or authorized audio-visual telemedicine encounter. Practitioners must check the state's Prescription Drug Monitoring Program (PDMP) before prescribing via telemedicine. Pharmacists must verify patient identity with photo ID before dispensing. These rules do not change prescribing for established patients who have had an in-person evaluation.
Impact and Considerations for Healthcare Providers
The removal of the X-waiver and the establishment of a permanent telemedicine framework create both opportunities and new compliance obligations. The streamlined process can improve access to treatment, but it is accompanied by new oversight measures to prevent diversion and ensure patient safety.
Telemedicine Rule Comparison: Old vs. New
| Feature | Prior to Consolidated Appropriations Act (2023) | Current Rules (Temporarily extended until Dec 31, 2025) | Finalized Telemedicine Rule (Effective Jan 1, 2026) |
|---|---|---|---|
| X-Waiver | Required for all practitioners to prescribe buprenorphine for OUD | Eliminated for all practitioners. Standard DEA registration with Schedule III authority is sufficient. | Eliminated. Standard DEA registration with Schedule III authority is sufficient. |
| Patient Caps | Federal limits on the number of patients a practitioner could treat at one time | Eliminated. No federal patient limits for buprenorphine prescribing for OUD. | Eliminated. No federal patient limits. |
| Telemedicine (Audio-Only) | Generally restricted by Ryan Haight Act, but COVID-19 waivers allowed greater flexibility | Allowed initiation and continued treatment via audio-only visits for OUD treatment | Allows initial 6-month supply via audio-only, but subsequent prescriptions require in-person or other authorized telemedicine encounter. |
| Telemedicine (Audio-Video) | Flexible prescribing allowed under COVID-19 waivers | Allowed initiation and continued treatment via audio-video visits | Continued prescribing is allowed via audio-video after the initial 6-month period. |
| Practitioner Training | Specialized training required for X-waiver | 8-hour SUD training required for DEA registration (effective June 2023). | 8-hour SUD training required for DEA registration. |
| PDMP Review | Not a universal federal requirement for telehealth prescribing | Mandated before prescribing buprenorphine via telehealth. | Mandated before prescribing buprenorphine via telehealth. |
Conclusion
The new buprenorphine regulations aim to balance expanded access to treatment with responsible oversight. The removal of the X-waiver seeks to normalize OUD treatment. Permanent telemedicine rules and mandatory training establish a clear framework. Practitioners and pharmacists should stay informed for continuous and safe patient care. Further information can be found on {Link: AASM website https://aasm.org/dea-publishes-final-rule-on-expansion-of-buprenorphine-treatment-via-telemedicine/} and {Link: federalregister.gov https://www.federalregister.gov/documents/2025/01/17/2025-01049/expansion-of-buprenorphine-treatment-via-telemedicine-encounter}.
