The Consolidated Appropriations Act of 2023 (CAA), the massive $1.7 billion spending bill signed into law on December 29, 2022, had a number of important healthcare “gems” included. A critical provision for substance use disorder treatment providers eliminated the X-Waiver and thereby enhanced providers’ ability to prescribe buprenorphine to Opioid Use Disorder (OUD) patients.
By amending the Controlled Substances Act to eliminate the X-Waiver, the CAA opened the door for any Drug Enforcement Agency (DEA)–registered provider with Schedule III prescriptive authority to prescribe buprenorphine for the treatment of OUD.
Previous Requirements Under the X-Waiver
Prior to this amendment, the DEA required providers to obtain a waiver in order to administer, dispense, and prescribe buprenorphine for the treatment of OUD in settings outside of federally registered opioid treatment programs. Promulgated through the Drug Addiction Treatment Act of 2000 (DATA), this waiver—known as the “X-Waiver”—required providers to submit a letter of intent to the Substance Abuse and Mental Health Services Administration (SAMHSA) and complete specialized training prior to dispensing buprenorphine.
Although the goal of the X-Waiver was to increase access to treatment for individuals with OUD, restrictions associated with the X-Waiver in practice imposed significant additional limitations on patient access. For example, when providers first obtain an X-Waiver, they are only allowed to prescribe buprenorphine for up to 30 patients at a time. To become eligible for an increase beyond the 30-patient cap, providers must maintain the X-Waiver for a minimum of one year, at which point the provider can become eligible for a patient cap increase of 100 to 275 patients, depending on a number of factors.
Removal of the X-Waiver
Through an amendment to Section 303(g) of the Controlled Substances Act, the CAA exempted certain Schedule III, IV, and V narcotic drugs from the X-Waiver requirements. As a Schedule III narcotic, buprenorphine may now be prescribed as an OUD treatment by any DEA-registered prescriber with Schedule III authority, without any corresponding cap on the number of patients the prescriber may treat.
Importantly, although it removed the X-Waiver caps, the CAA also added a new training requirement for DEA registrants. As of June 21, 2023, all prescribers of controlled substances must participate in a one-time eight-hour training program prior to obtaining or renewing their DEA registration. We are still waiting on guidance from the DEA and SAMHSA on the training requirement, but it will likely be forthcoming prior to that effective date.
Implications
As a result of the elimination of the X-Waiver, any practitioner holding a DEA registration with Schedule III authority may prescribe buprenorphine for the treatment of OUD in accordance with applicable state law. Without the patient cap, prescribers will have more flexibility to treat a greater number of patients with OUD. Elimination of the X-Waiver also vastly increases the number of potential providers eligible to prescribe buprenorphine, marking a significant improvement in equity and access to care for the OUD population.
Additionally, while both buprenorphine and methadone are effective treatments for OUD, buprenorphine is the only treatment that is widely authorized for at-home administration. Therefore, elimination of the X-Waiver also gives providers the opportunity to incorporate OUD treatment more routinely into patient treatment plans and foster greater self-management of such treatment plans for OUD patients. Organizations offering substance use disorder treatment services, especially physician groups operating office-based opioid treatment (OBOT) programs, will now have the opportunity to rethink their staffing levels and patient management thresholds to ensure they can serve patients as efficiently as possible while ensuring these patients get the care they need.
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