HHS Relaxes Guidelines for Prescribing Buprenorphine Treatment for Opioid Use Disorder

April 29th, 2021

By Jill Drachenberg, Editor, Relias Media

Providers seeking to prescribe buprenorphine to treat patients with opioid used disorder (OUD) will have fewer barriers to the practice, according to update practice guidelines from the Department of Health and Human Services (HHS).

Under the revised guidelines, providers can prescribe buprenorphine to up to 30 patients at a time without an X-waiver. They can forgo some certification requirements of buprenorphine treatment, including an eight-hour training course that many found burdensome. The guidelines also expand the range of eligible practitioners to include physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. They do not affect emergency physicians who administer buprenorphine in the emergency department.

The guidelines were praised by industry groups, including the American Medical Association (AMA). “With this change, office-based physicians and physician-led teams working with patients to manage their other medical conditions can also treat them for their opioid use disorder without being subjected to separate, burdensome and stigmatizing requirements,” Patrice Harris, MD, MA, chair of the AMA Opioid Task Force, said in a statement. “Physicians should become educated about managing patients with opioid use disorder to help stem the nationwide overdose epidemic and ease the persistent health disparities facing these patients.

The American College of Emergency Physicians (ACEP), which has long advocated for expanded access to buprenorphine treatment, noted the changes are “steps in the right direction for patients and clinicians. However, more action is needed to ensure more patients receive treatment for OUD, said ACEP President Mark Rosenberg, DO, MBA, FACEP.

“Expanding patient access to medication-assisted treatment in the emergency department is one of the most effective methods for addressing opioid use disorder or overdose,” he said in a statement. “We urgently need federal action to slow these alarming trends and create more opportunities for emergency physicians to save lives — that starts with eliminating the X-waiver.”

Obtaining an X-waiver allows providers to treat more than 30 patients at a time — although it comes with stringent, burdensome certification requirements. HHS under the Trump administration moved to eliminate the X-waiver and associated requirements, but efforts were paused by the Biden administration to review the legality. Only legislative action can remove X-waiver requirements. In February, Congress revived the Mainstreaming Addiction Treatment Act to remove the X-waiver.

Action to remove barriers to OUD treatment are more necessary than ever. The Centers for Disease Control and Prevention reported 90,000 drug overdose deaths from September 2019 to September 2020, the highest 12-month number ever recorded.

"Increases in overdose deaths emphasize the need to expand access to evidence-based treatments, including buprenorphine that can be prescribed in office-based settings," said Assistant Secretary for Health Rachel Levine, MD. "These guidelines provide another tool to help communities respond to the evolving overdose crisis, equipping providers to save lives in their communities."