Removal of “X-Waiver” Promises Increased and More Equitable Access to Opioid Use Disorder Treatment
March 2, 2023
Although it’s been shown to reduce many of the harms associated with opioid use disorder, including overdose deaths, access to the medication buprenorphine has been hampered by several legal restrictions. The recently passed 2023 Consolidation Appropriations Act includes a provision that removes a key barrier: the X-waiver requirement, which will increase access to buprenorphine, as well as improve provider knowledge of evidence-based substance use disorder treatment, and address disparities in access to care.
Buprenorphine, a partial opioid antagonist, has been approved in the U.S. for the treatment of opioid use disorder (OUD) since 2002. It is associated with reductions in many harms associated with OUD, including a substantial reduction in both overdose-related and non-overdose-related deaths. Despite its efficacy, however, access to buprenorphine has been hampered by a number of legal restrictions, including limitations on the types of prescribers who could prescribe it and the number of patients they could treat at a time. Perhaps the most significant barrier was a requirement that providers obtain a special registration from the U.S. Drug Enforcement Administration (DEA), termed an “X-waiver,” to prescribe buprenorphine for OUD. For most prescribers, this required completing either eight or 24 hours of training from an approved provider.
In part because of these restrictions, this “gold standard” medication for OUD was difficult to access, as only approximately 5 percent of U.S. physicians obtained a waiver. Over 40 percent of counties did not have a single waivered prescriber, a deficit that increased to 60 percent for rural counties. In light of the unprecedented increase in overdose deaths and after urging from clinicians, advocates, and provider organizations, in April 2021, the Biden Administration issued practice guidelines that permitted many providers including physicians, physician assistants, and advanced practice nurses to prescribe buprenorphine to up to 30 patients at a time without completing the previously required training. However, because the X-waiver was statutory, it needed Congressional action to remove.
That action came on December 29, 2022, when President Biden signed the 2023 Consolidation Appropriations Act (Act) into law. Among many other provisions, the Act permanently removed the X-waiver requirement and associated limitations on the types of providers permitted to prescribe buprenorphine for OUD and the number of patients that can be treated. All prescribers who are authorized to prescribe the medication under federal and state law can now prescribe it for their patients with OUD.
The Act also contained a new requirement that all prescribers other than veterinarians obtain certain training as a condition of obtaining or renewing what is typically referred to as a “DEA number” to prescribe controlled substances. These training requirements, which go into effect on June 21, 2023, are broader than those previously required to obtain an X-waiver, and include training on treating patients with substance use disorders, screening, brief intervention and referral to treatment, and how to make appropriate referrals for treatment. Providers who are board certified in addiction psychiatry or addiction medicine are deemed to meet the requirement, as are graduates of medical or dental school who have received at least eight hours of relevant training and graduated in the five years before applying to DEA.
For much more information on these changes, which should increase access to buprenorphine, improve provider knowledge of evidence-based SUD treatment, and address disparities in access to care, please see our recent factsheet on the topic.
This post was written by Corey Davis, J.D., M.S.P.H., Director, Network for Public Health Law Harm Reduction Legal Project.
The Network for Public Health Law provides information and technical assistance on issues related to public health. The legal information and assistance provided in this document do not constitute legal advice or legal representation. For legal advice, readers should consult a lawyer in their state.
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