January 28, 2021

X-ing the X-Waiver: The Fight Continues!

As many of you know, as avid readers of Regs & Eggs, the U.S. Department of Health and Human Services (HHS) released practice guidelines on January 14, 2021 that created a broad exemption to the current “X-waiver” requirement for physicians prescribing buprenorphine for the treatment of patients with opioid use disorder (OUD). Removing the X-waiver has been a top priority for ACEP, and while fully eliminating this requirement requires legislation from Congress, we believe the practice guidelines represent a critical intermediary step as we wait for Congressional action. Therefore, we immediately issued a press statement praising the move. We also hosted a webinar on January 20 that went over the guidelines and answered some of your initial questions.

From the beginning, we understood that the practice guidelines would become effective once they were published in the Federal Register—which we were initially told to be “any day.” However, the publication timeline became a little less clear once the Biden Administration issued a directive halting all pending regulations and subjecting them to further review (as noted in last week’s Regs & Eggs blog, the outgoing Trump Administration issued a plethora of last-minute regs—so it was definitely appropriate for the new administration to review them to ensure that they align with its priorities.)

Once the directive was released, ACEP immediately began working on a sign-on letter to HHS requesting that the practice guidelines be published in the Federal Register as soon as possible. Our critical request became even more urgent when we read in The Washington Post that HHS is considering nixing the practice guidelines completely due to legal and clinical concerns.

We sent the letter to HHS yesterday morning. A total of 16 organizations signed on, representing hundreds of thousands of physicians who care for patients with OUD. These organizations included:

  • American College of Emergency Physicians
  • American Academy of Clinical Toxicology
  • American Academy of Physical Medicine and Rehabilitation
  • American College of Obstetricians and Gynecologists
  • American College of Osteopathic Emergency Physicians
  • American Medical Association
  • American Osteopathic Association
  • American Society of Regional Anesthesia and Pain Medicine
  • CA Bridge
  • California Medical Association
  • End SUD
  • Massachusetts Medical Society
  • Shatterproof
  • Society of Hospital Medicine
  • Vituity
  • Well Being Trust

In the letter, we acknowledge there may be some challenges with finalizing these guidelines in their current form but stress that there is no time to waste in addressing this major barrier to care. We are at the height of two major epidemics in this country, the COVID-19 pandemic and the opioid crisis, and physicians like you need regulatory flexibility now to provide the best available treatment to patients and save lives.

Unfortunately, the letter does not seem to have worked (at least for now). In late breaking news, HHS and the Office of National Drug Control Policy (ONDCP) announced last night that the guidelines were released prematurely and “cannot be issued at this time.” HHS and ONDCP also state that they are “committed to working with interagency partners to examine ways to increase access to buprenorphine, reduce overdose rates and save lives.” While this is definitely disappointing news, we will keep up the fight to X the X-waiver! On the bright side, we do have the upcoming changes to the “Three-day Rule” to look forward to, which (once finalized in June) will allow health care practitioners to dispense a three-day supply of buprenorphine to one person at one time.

Until next week, this is Jeffrey saying, enjoy reading regs with your eggs.

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