Up until recently, medical clinicians who wanted to prescribe buprenorphine were required to complete training and permission from the federal government in the form of the “X-Waiver.” In December 2022, Congress passed the Consolidated Appropriations Act (CAA), which eliminated the X-Waiver.[i],[ii] Any clinician with a DEA license to prescribe a Schedule III drug can now prescribe buprenorphine for opioid use disorder unless existing state law has additional limitations. The CAA also eliminates the limits on the number of patients a clinician could prescribe buprenorphine to each month.
The CAA also called for implementing additional training as part of the requirements for obtaining or renewing a Drug Enforcement Agency (DEA) license; the Substance Abuse and Mental Health Administration (SAMHSA) and the DEA are working to implement this provision, which takes effect in June 2023. To date, no additional information has been released about what the required education will entail.
What does this mean for medical clinicians?
- Medical clinicians with a DEA license to prescribe Schedule III drugs can prescribe buprenorphine for opioid use disorder (OUD) as long as state laws don’t impose additional restrictions.
- All prescriptions for buprenorphine require only a standard DEA registration number.
- Although medical clinicians can legally prescribe buprenorphine for OUD without completing the previously required education or obtaining an X-Waiver, some education about diagnosing OUD and prescribing buprenorphine will be helpful to clinicians new to prescribing buprenorphine. Resources for these clinicians include:
- Providers Clinical Support System (PCSS), Free online buprenorphine training
- PCSS Mentoring for treating individuals with OUD
- University of California, San Francisco, Free clinician case consultation
- CA Bridge, Prescribing resources
- If SAMHSA and the DEA implement the CAA education on the timeline specified in the CAA, medical clinicians applying for a DEA license or renewing a DEA license after June 2023 will need to complete additional education, though the details of that education have not been released yet.
- Continue to check the SAMHSA website for more information.
What systems do we need to consider?
- All medical clinicians in your clinic/system need to know about the elimination of the waiver and agree about who will prescribe buprenorphine for OUD, including individuals covering after-hours call.
- All team members will need to develop and agree upon basic guidance for clinicians who have never previously prescribed buprenorphine regarding basic guidance regarding refill duration, follow up frequency, and general dosing parameters.
- Some electronic prescribing systems were set up so that buprenorphine prescriptions can only be sent electronically if the medical clinician had an X-Waiver number.
- Check with your vendor to find out if such stop gaps exist in your system and when they can be removed.
- If medical clinicians have a DEA license to prescribe Schedule III drugs and no other state laws prohibit them prescribing buprenorphine, they can call prescriptions into pharmacies until the electronic prescribing system is updated.
- Some pharmacies had systems in place to require an X-Waiver number when receiving the prescription.
- Larger pharmacy systems (e.g., CVS, Walgreens, Walmart) have made updates to allow buprenorphine prescriptions to come through without an X-Waiver license number.
- If your clinic works with smaller (particularly non-chain) pharmacies, you should contact them to make sure they are aware of this federal change and remove any systems in place requiring an X-Waiver number.
- Credentialing departments should be aware that all medical clinicians who previously had an X-Waiver were sent a new DEA license electronically. The previous DEA licenses that included the X-Waiver number should be removed from files, and the new DEA license with a single DEA number should be kept on file.
Elimination of the X-Waiver provides an opportunity to expand access to buprenorphine for the treatment of OUD. Clinics can support clinicians by ensuring that they have sufficient education and information to prescribe safely and that the systems are in place to support their prescribing.