On January 12, 2023, the US Drug Enforcement Administration (DEA) released a letter to registrants announcing DEA’s support of Congress’s recent removal of the requirement that healthcare providers possess a DATA-Waiver, commonly referred to as an X-Waiver, to prescribe buprenorphine to treat opioid use disorder (OUD). The elimination of the X-Waiver will help increase access to buprenorphine, a lifesaving medication, for those with OUD, and has potentially significant operational implications for office-based opioid treatment (OBOT) practices.

IN DEPTH

BACKGROUND

On December 29, 2022, the US Congress signed into effect a year-end omnibus legislative package, the Consolidated Appropriations Act, 2023 (CAA 2023), consisting of all 12 fiscal year 2023 appropriations bills and many other provisions, including health policy changes. The bipartisan Mainstreaming Addiction Treatment Act included in the omnibus package eliminated the DATA-Waiver Program under the Drug Addiction Treatment Act (DATA 2000). DATA 2000 had required that healthcare providers possess an X-Waiver to prescribe buprenorphine, a Schedule III drug, for outpatient use for the treatment of OUD.

For a provider to prescribe buprenorphine for OUD, DATA 2000 required practitioners to submit a notification of intent to the Substance Abuse and Mental Health Services Administration (SAMHSA), hold an active state medical license, have a current DEA registration number and obtain an additional certification in addiction through an approved eight-hour training course, among other requirements. DEA would then issue the provider an X-Waiver, named after the additional DEA number that begins with the letter “X” given to providers who obtain the waiver. The number of patients a provider could treat under an X-Waiver was strictly capped. In a provider’s first year with the waiver, the provider could prescribe buprenorphine for up to 30 patients at a time. After their first year, eligible providers could apply to treat up to 100 patients, followed by up to 275 patients thereafter.

In recent years, the Biden Administration has incrementally loosened the requirements for providers to obtain an X-Waiver while also expanding the use of the waiver. In 2021, the US Department of Health and Human Services issued guidance removing the eight-hour training requirement for practitioners who treat no more than 30 patients at a time. The guidance also expanded waiver eligibility to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives. The provision included in the CAA 2023 has now eliminated the X-Waiver requirement entirely. In turn, any healthcare provider with a standard DEA controlled medication license can now prescribe buprenorphine, subject to state requirements, without any federal patient caps.

DEA SUPPORTS ELIMINATION OF THE X-WAIVER

On January 12, 2023, DEA announced its full support for Congress’s policy reform, explaining that the removal of the X-Waiver will help increase access to buprenorphine for those in need nationwide. In concert with the change, all DEA registrants should be aware of the following:

• An X-Waiver registration is no longer required to treat patients with buprenorphine for OUD.

• All future prescriptions for buprenorphine only require a standard DEA registration number. X-Waiver registration numbers are no longer needed for any prescription.

• There are no longer any limits or patient caps on the number of patients a prescriber may treat for OUD with buprenorphine.

• CAA 2023 does not impact existing state laws or regulations that may be applicable.

SAMHSA and DEA are also working on the implementation of a separate provision of the CAA 2023 related to training requirements for DEA registration. The provision requires all providers who apply for a DEA license to prescribe controlled substances to undergo a one-time, non-repetitive, eight-hour training on managing patients with opioid and other substance use disorders. These requirements will go into effect on June 21, 2023.

IMPLICATIONS FOR OBOT PRACTICES

The elimination of the X-Waiver has potentially significant operational implications for OBOT practices. To increase “prescribing power” relative to the federal patient caps, OBOT practices engaged more prescribers (whether physicians, physician assistants or nurse practitioners) than would otherwise be optimal operationally, often on a part-time basis. The removal of federal patient caps means that OBOT practices can move to more optimal modes of engaging providers, shifting prescribing capability to full-time prescribers, and future recruitment can occur on that basis. This shift in provider engagement may allow practices to satisfy certain Stark Law exceptions, as well as Ant-Kickback Statute and Eliminating Kickbacks in Recovery Act safe harbors, that permit flexibilities on payment of clinical productivity compensation.

KEY TAKEAWAYS

The removal of the X-Waiver requirement presents a significant opportunity to expand access to buprenorphine treatment for OUD and reflects the DEA’s recent trend of liberalizing access to treatment for OUD. It also presents significant operational implications for OBOT practices, allowing practices to move to a more optimal mode of engaging clinicians, including full-time clinicians, which may allow for flexibilities on payment of clinical productivity compensation.