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)
Did the requirements for the X waiver change?
Yes, HHS guidance now permits practitioners (physicians, APRNs, PAs) 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.
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.
How do I access additional resources on the X waiver process?
The Maryland Addiction Service (MACS) provides free services and support to prescribers and their practices in addressing the needs of their patients with substance use disorders and chronic pain management. We offer phone consultations for clinical questions, resources or referral information. We also offer education and training opportunities related to substance use disorders (SUDs). In addition to these services, we provide individualized technical assistance and capacity building to practices that are implementing or expanding office-based addiction treatment services.
Additional questions about the new guidelines?
MACS team of addiction medicine experts are here to help: 1-855-337-MACS (6227).
CA Bridge: New HHS Practice Guidelines FAQs
The Maryland Addiction Consultation Service is administered by the University of Maryland School of Medicine and funded by the Maryland Department of Health, Behavioral Health Administration.