Josie Xu, PharmD, Welia Health
At the end of 2022, the Consolidated Appropriations Act of 2023 was announced, removing the X-waiver requirements outlined in The Drug Addiction Treatment Act of 2000. Prescriptions for buprenorphine will no longer require physicians and mid-level practitioners to include their X-waiver number. Additionally, there are no longer limits on the number of patients that providers can treat with buprenorphine. Previously, providers were restricted to treating 30 patients in the first year of X-waiver certification and 100 patients after the first year.
Under the new act, providers with a valid DEA registration and Schedule III authority, including pharmacists, can prescribe buprenorphine without an X-waiver number. New training requirements have been introduced for prescribers seeking or renewing their DEA registrations. These requirements include having board certification, graduating from a program with an opioid or substance use disorder curriculum in the last five years (of at least eight hours), or completing an 8-hour training course. These requirements took effect on June 27, 2023, and the DEA and Substance Abuse and Mental Health Services Administration (SAMHSA) are actively providing further guidance.
While the removal of the X-waiver requirements brings benefits, there are also potential challenges to consider. Buprenorphine, like other opioid medications, can be diverted and misused. Simply expanding buprenorphine prescribing without sufficient resources for comprehensive treatment may lead to incomplete care. Moreover, there may be resistance due to the lingering stigma associated with medication-assisted treatment. Overcoming these misconceptions and promoting understanding is crucial for broad acceptance and access.
Increasing buprenorphine prescribing offers several benefits. It enables more individuals struggling with opioid use disorder to receive evidence-based treatment. Those at risk of overdose gain greater access to a medication that can stabilize their opioid use, reduce cravings, and lower the risk of fatal overdoses. Furthermore, it supports the recognition of addiction as a chronic medical condition. With this change, buprenorphine prescribing can potentially be integrated into a comprehensive approach that includes counseling, support services, and a multi-sector effort to prevent opioid misuse, promote public education, and address the underlying factors contributing to the opioid crisis in the United States.
- Keyes KM, Rutherford C, Hamilton A, et al. What is the prevalence of and trend in opioid use disorder in the United States from 2010 to 2019? Using multiplier approaches to estimate prevalence for an unknown population size. Drug Alcohol Depend Rep. 2022;3:100052. doi:10.1016/j.dadr.2022.100052
- DATA-2000 law 30/100 patient limit on prescribing Suboxone (buprenorphine / naloxone) for the treatment of opioid addiction. www.naabt.org. Accessed April 7, 2023. http://www.naabt.org/30_patient_limit.cfm
- Removal of DATA Waiver (X-Waiver) Requirement. www.samhsa.gov. https://www.samhsa.gov/medications-substance-use-disorders/removal-data-waiver-requirement
- Opioid Treatment Providers Resources and Information. www.samhsa.gov. https://www.samhsa.gov/medications-substance-use-disorders/otp-resources