Recent Federal Policy Changes Improve Buprenorphine Access, but X-Waiver Remains a Barrier for Opioid Use Disorder Treatment
October 20, 2021
Overview
The medications for opioid use disorder (MOUD) methadone and buprenorphine provide many individual and community benefits, including reducing deaths by over 50 percent among people with opioid use disorder. Unfortunately, many people who want to access these medications are unable to do so, largely because of federal and state legal restrictions that make it more difficult to access them than nearly any other medication.
As we’ve written, the federal government has taken several steps to increase access to these lifesaving medications during the COVID emergency, including permitting buprenorphine to be prescribed via telemedicine. However, the greatest barrier to wider buprenorphine access continues to be the fact that only providers who obtain an “X-Waiver” are eligible to prescribe it to treat opioid use disorder. While the requirement itself is statutory and can only be changed by Congress, the departments of Justice and Health and Human Services (HHS) have a great deal of autonomy is determining its exact contours.
Until 2016, only physicians were permitted to obtain an X-waiver, and, in most cases, could only do so after completing eight hours of additional training. They were generally limited to treating 30 patients in their first year of holding a waiver, increasing to 100 patients in subsequent years. In August 2016 these regulations were updated to permit waivered physicians to treat up to 275 patients at one time in some circumstances. The Comprehensive Addiction and Recovery Act modified the relevant statute that same year to permit some nurse practitioners and physician assistants to become waivered, although they were generally required to complete 24 hours of training.
In the waning days of the Trump administration, HHS introduced practice guidelines that purported to permit physicians to treat up to 30 OUD patients with buprenorphine without obtaining an X-waiver. However, because the X-waiver requirement is statutory the legal basis for these guidelines was shaky, and they were rescinded by the Biden administration only weeks after they were issued. The Biden administration published its own version of these practice guidelines in April 2021.
These guidelines, which are currently in effect, make two changes from the Trump administration guidelines. First, they permit not only physicians but also many physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives to prescribe buprenorphine to up to 30 patients at a time without completing the required eight or 24- hour training and complying with certain other requirements.
Second, they do not waive the requirement that these individuals receive an X-waiver. Rather, they permit most prescribers who are otherwise authorized under federal and state law to prescribe controlled substances to obtain a limited X-waiver that permits them to treat up to 30 patients without completing the otherwise required training. This this can be accomplished by filling out a form on the SAMHSA website and waiting for approval. When doing so, mid-level practitioners should check “Providers Clinical Support System (PCSS)” in the “Certification of Qualifying Criteria” section and enter “practice guidelines” in the text box for the date. Physicians should select “Other” and type “practice guidelines” in the text box for the city of the training. The training date should be the application date.
Legislation has been introduced to “X the X-Waiver,” but its fate is uncertain. Unless and until the X-waiver is removed, these practice guidelines should permit many more providers to prescribe this lifesaving medication to individuals with OUD.
If you have any questions about these changes or access to MOUD generally, please don’t hesitate to contact us at harmreduction@networkforphl.org.
This post written by Corey Davis, Deputy Director, Network for Public Health Law Southeastern Region Office; Director, Network for Public Health Law Harm Reduction Legal Project.
The Network for Public Health Law provides information and technical assistance on issues related to public health. The legal information and assistance provided in this document do not constitute legal advice or legal representation. For legal advice, readers should consult a lawyer in their state.
Support for the Network is provided by the Robert Wood Johnson Foundation (RWJF). The views expressed in this post do not represent the views of (and should not be attributed to) RWJF.