At a Crossroads: Opioid Use Disorder, the X-Waiver, and the Road Ahead

Abstract

Background: Buprenorphine/naloxone (Suboxone) is widely considered the first-line treatment for opioid use disorder (OUD), which causes significant morbidity and mortality in the United States, but prior to 2023, practitioners interested in prescribing buprenorphine/naloxone for OUD needed a special Drug Enforcement Administration certification (the X-Waiver) that imposed a patient cap and other limitations. The Consolidated Appropriations Act of 2023 considerably decreased the restrictions on prescribing practitioners. Buprenorphine/naloxone can now be prescribed like any other prescription opioid, excluding methadone. The historic context for the opioid crisis, OUD, the X-Waiver, and additional initiatives that may be needed beyond legislative change to effectively address OUD are the subjects of this review. Methods: To develop this review of the opioid crisis, OUD, and OUD treatment, we conducted a literature search of the PubMed database and constructed a timeline of the opioid crisis and changes in OUD treatment, specifically the X-Waiver, to characterize the historic context of OUD and the X-Waiver against the background of the opioid crisis. Results: The opioid crisis has had pervasive public health and economic impacts in the United States. Major changes to the treatment of OUD have occurred as a result of the Drug Addiction Treatment Act of 2000 that imposed the X-Waiver and the Consolidated Appropriations Act of 2023 that repealed the X-Waiver. Conclusion: The repeal of the X-Waiver is predicted to increase the accessibility of buprenorphine/naloxone in the United States. However, additional work beyond legislative change, including institutional support and reduction of stigma and disparities, is needed to substantially improve outcomes for OUD patients.

Keywords: Addiction medicine; analgesics–opioid; buprenorphine–naloxone drug combination; opioid-related disorders; psychiatry.