New HHS Practice Guidelines
Due to new legislation passed in the Consolidated Appropriations Act (CAA), 2023, the HHS buprenorphine practice guidelines that remove the training requirement for the X-waiver are no longer relevant.
For information about the Mainstreaming Addiction Treatment Act which removes the X waiver requirement for prescribing buprenorphine for opioid use disorder, visit our page on the MAT and MATE Acts: MAT & MATE Acts
In an effort to provide evidenced-based treatment to more individuals with opioid use disorder, the Department of Health and Human Services (HHS) released new buprenorphine practice guidelines that remove a longtime requirement for additional training that many practitioners cited as a barrier to obtaining their waiver to prescribe buprenorphine. (HHS, 2021)
HHS Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder
FAQs about the new practice guidelines for buprenorphine administration
Did the requirements for the X waiver change?
Yes, HHS guidance now permits practitioners (physicians, NPs, PAs, midwives) with a DEA registration to apply for an X waiver to treat up to 30 patients without (1) completing extra training (2) attesting to provision of psychosocial treatment or counseling. These requirements have not changed for outpatient practitioners who want to prescribe to more than 30 patients.
Do I still need to apply for the X waiver?
Yes, the provider must have a valid DEA registration and a valid state medical license for the state in which they provide care. These two items must be submitted when applying for the Notice of Intent. We’d like to note that individuals should have their own DEA number and residents are still not able to get the waiver using the institutional DEA number.
Do providers still need a DEA registration to prescribe buprenorphine?
Yes, the new guidelines exempt eligible practitioners from certification requirements for extra training and the provision of psychosocial services that had been required when prescribing buprenorphine for the treatment of opioid use disorder (OUD) to 30 or fewer patients. Submission and approval of a Notice of Intent (NOI) remains legally necessary in order to use buprenorphine in the treatment of patients with OUD (https://www.samhsa.gov/medication-assisted-treatment/become-buprenorphine-waivered-practitioner).
How do I write a prescription using my X waiver?
Once you have received your X waiver, you write a prescription for buprenorphine for opioid use disorder by indicating your X waiver license number on the prescription. The pharmacist will have no indication if the X waiver license was obtained after additional training or not. You can e-prescribe buprenorphine for opioid use disorder by indicating your X waiver license number in the “notes to pharmacy” section or NADEAN: x-license number section in the EHR.
Why is the limit set at 30?
The 30-patient limit is the first tier set by the Controlled Substances Act (CSA). The rationale for the new guideline only applying to the 30 patient limit is grounded in the idea that this is an initial step in decreasing barriers to prescribing buprenorphine. The impact of this policy will be examined before expanding the exemption to cover practitioners treating more than 30 patients. Those who want to treat more than 30 patients still are required to satisfy all existing statutory certification requirements relative to training and psychosocial services.
I practice in both Maryland and DC. Do I need an X waiver for each state I practice in?
The X waiver is attached to only one DEA number. A practitioner may only have one X-waiver. The X-waiver is valid in all USA States and Territories. The practitioner may have multiple practice locations or DEA number, they may be in any US States or Territories. Therefore, if a provider already has a valid X number, they may add practice location(s) which may be in multiple States or Territories. To use your waiver with another DEA number, you must submit both the X-waiver number along with the other DEA number to prescribe. Practitioners can update their contact information, including adding practice locations.
How do I access additional resources on the X waiver process?
HHS New Buprenorphine Practice Guidelines
SAMHSA HHS Practice Guideline Resources
Call 1-855-337-DACS (6227) with questions about the new guidelines or prescribing buprenorphine for opioid use disorder.
References
SAMHSA: FAQs About the New Buprenorphine Practice Guidelines
CA Bridge: New HHS Practice Guidelines FAQs