Will the Death of the “X-waiver” Result in Enhanced Treatment for Opioid Use Disorder?
Amidst the typical end-of-year chaos and brouhaha over the House speakership, many may have missed recent improvements to how America combats its current opioid abuse problem. Tucked into the 2023 Consolidated Appropriations Act omnibus spending bill (The Act) were several provisions aimed at enhancing healthcare providers’ abilities to address opioid use disorder (OUD). The most significant of which is the removal of the “X-waiver.”
The X-waiver was born from the Drug Addiction Treatment Act of 2000 (DATA 2000). Prior to that act, medical assisted treatment (MAT) was done through the dispensing of methadone (an opioid used to treat OUD) at a treatment facility. Because methadone is a Schedule II controlled substance, it must be dispensed, i.e., given to the patient by the practitioner, at a medical facility and may not, at least initially, be self-administered by the patient at home. This means that a patient could not be prescribed OUD medication to be filled at a pharmacy and taken as directed, but rather required that the patient receive his/her dose daily at a treatment facility, often waiting in line with others to do so. In addition to the daily burden of the task, it also lacked anonymity to those receiving the treatment.
The “waiver” part of the X-waiver allowed a qualifying physician to waive the requirement of the Controlled Substances Act (CSA) to obtain a separate registration from the Drug Enforcement Administration (DEA) to dispense MAT drugs. In order to track these qualifying MAT providers, DEA utilized an X as a prefix to the providers’ standard DEA registration. In sum, X-waived providers were authorized by the federal government to prescribe buprenorphine (also an opioid) for drug treatment to patients from their medical practice. For the patients, it provided access to buprenorphine as an alternative to methadone and also the opportunity to retain privacy during treatment.
However, the X-waiver did not offer carte blanche in the prescribing of buprenorphine by MAT providers. The DATA 2000 came with several restrictions, including that the provider needed to be a physician (this requirement was later loosened to include mid-level practitioners as well), set limits on the number of patients a MAT provider could treat, imposed additional record-keeping requirements, and required eight to twenty-four hours of training before applying for the waiver.
Although the intent of the X-waiver was to improve treatment, it did have its limitations. First, the additional requirements may have seemed too onerous to some practitioners to fulfill. Second, some have posited that the X requirement created the impression that prescribing buprenorphine was too complicated or hazardous. Third, and most important, the DATA 2000 created restrictions to the prescribing of a drug used to treat OUD, while ironically offering no requirements or restrictions on the prescribing of opioids that may lead to OUD.
Now that the X-waiver is dead, policy makers are hopeful that more providers will be willing to provide MAT to OUD patients. The removal of the additional administrative requirements for MAT providers are intended to increase the number of practitioners who offer MAT, with a concomitant increase in the number of patients who can receive treatment. As touted by the White House in late December, the change is meant to address the need where less than 10% of those seeking treatment can access it. The Act also addresses the historic disparity between restrictive OUD treatment requirements, yet no requirements for the problematic prescribing of opioids that may lead to OUD. Toward that end, The Act mandates that all practitioners (except veterinarians) undergo OUD training as a requisite to being granted a DEA registration, a step that may also bear preventative benefits, as well.
The DEA and the Substance Abuse and Mental Health Services Administration (SAMSHA), the two federal agencies charged with regulating MAT providers and OUD treatment, report that they are currently working on providing updated guidance to the changes resulting from The Act. Only time will tell if the changes yield the positive results needed to help ameliorate America’s current opioid issues.
References:
Consolidated Appropriations Act of 2023, Pub. L. 117-328. (2022). https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf
Controlled Substances Act, 18 U.S.C. § 823 (2023). https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section823&num=0&edition=prelim
D'Ambrosio, A. (2023, January 5). The X Waiver Is Officially Dead. MedPageToday.com. Retrieved January 8, 2023, from https://www.medpagetoday.com/special-reports/features/102520#:~:text=Previously%2C%20obtaining%20an%20X%20waiver,who%20wanted%20to%20prescribe%20buprenorphine.
DEA (2023). DATA-Waived Registration Update. Retrieved January 8, 2023, from https://www.deadiversion.usdoj.gov/pubs/docs/index.html
DEA (2022). Pharmacist’s Manual. Retrieved January 8, 2023, from https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EO-DEA154R1)_Pharmacist's_Manual_DEA.pdf
Schin, A., & Bates, H. (2021, February 8). Policy Shift in the Opioid Epidemic: An Update on the X-Waiver. EMResident.orh. Retrieved January 8, 2023, from https://www.emra.org/emresident/article/x-waiver-update/
Snyder, J. (2023, January 3). Congress Eliminates X-Waiver Requirement to Prescribe Buprenorphine to Treat OUD. PAProviders.org. Retrieved January 8, 2023, from https://www.paproviders.org/congress-eliminates-x-waiver-requirement-to-prescribe-buprenorphine-to-treat-oud/#:~:text=With%20the%20passage%20and%20signing,(OUD)%20has%20been%20eliminated.
Substance Abuse and Mental Health Services Administration (n.d.). Drug Addiction Treatment Act of 2000 (DATA 2000). SAMHSA.gov. Retrieved January 8, 2023, from https://www.samhsa.gov/medication-assisted-treatment/statutes-regulations-guidelines#:~:text=Drug%20Addiction%20Treatment%20Act%20of,treatment%20settings%20other%20than%20OTPs.
The White House, ONDCP. (2022, December 23). Dr. Gupta Applauds Omnibus Appropriations Bill That Will Expand Access to Treatment for Substance Use Disorder [Press Release]. Retrieved January 8, 2023, from https://www.whitehouse.gov/ondcp/briefing-room/2022/12/23/dr-gupta-applauds-omnibus-appropriations-bill-that-will-expand-access-to-treatment-for-substance-use-disorder/
(Originally published on LinkedIn here: https://www.linkedin.com/pulse/end-x-waiver-result-enhanced-treatment-opioid-use-prough-phd-cfe/?trackingId=L5145CZ0SxWABBxx1EpA%2Bg%3D%3D)