Biden Administration to Reverse Trump's HHS Directive Expanding OUD MAT Prescribing Policy

We last alerted you on the Trump administration's last-minute directive on reducing the "X-waiver" mandate which limits prescribers' ability to prescribe medications aimed at battling the opioid use disorder (OUD) epidemic. According to the American Medical Association, the OUD epidemic has seen a sharp rise in 2020, especially in overdose-related deaths. Issue brief: Reports of increases in opioid-related overdose during COVID pandemic | AMA (ama-assn.org). In response, the Trump administration hurried through this HHS directive to enable more physician-prescribers to readily treat OUD. This January 14, 2021 move was applauded by prescribers and patient advocate groups who view the "X-waiver" as an unnecessary burden in prescribing medication-assisted therapies (MAT) for OUD patients.

Previously, to obtain an "X-waiver, prescribers were required to undergo an eight-hour training series before being permitted to prescribe drugs such as buprenorphine. Buprenorphine is an opioid medication approved by the FDA to treat OUD. According to the HHS' Substance Abuse and Mental Health Services Administration (SAMSHA):

[b]uprenorphine is an opioid partial agonist. It produces effects such as euphoria or respiratory depression at low to moderate doses. With buprenorphine, however, these effects are weaker than full opioid agonists such as methadone and heroin. When taken as prescribed, buprenorphine is safe and effective. Buprenorphine has unique pharmacological properties that help:

• Diminish the effects of physical dependency to opioids, such as withdrawal symptoms and cravings;
• Increase safety in cases of overdose, and
• Lower the potential for misuse.

The January 14, 2021 directive eliminated the need for physicians to obtain an "X-waiver" to treat their OUD patients with buprenorphine. To ensure patient safety and greatly lessen the potential for abuse, physicians without an "X-waiver" were limited to treatment of only 30 in-state patients. Non-physician prescribers such as NPs and PAs were still required to obtain the waiver.

In what many frontline operators in the OUD battle see as a disappointing move, the Biden Administration plans to retract this Trump administration HHS directive. While the immediate reason is unclear, anonymous sources in the Biden administration hint that they are concerned with the Trump directive's authority to effectuate limited the "X-waiver" program by possibly circumventing Congress' authority and the speed with which it went through HHS. Biden moving to nix Trump plan on opioid-treatment prescriptions - The Washington Post. This is particularly surprising because Biden's campaign platform vowed to expand OUD treatment and lift undue restrictions on prescribing medications for substance use disorder. See The Biden Plan to End the Opioid Crisis | Joe Biden for President: Official Campaign Website. The hope is, perhaps, the Biden administration will keep its campaign promises to better combat the OUD epidemic by effectuating their own changes to MAT limitations.

For more information regarding the newest OUD policy change, please contact your Quarles & Brady attorney or:

• Ed Holloran, III: (317) 399-2892 / ed.holloran@quarles.com