The Biden administration has halted a Trump administration initiative that would have allowed more physicians to prescribe buprenorphine for opioid use disorder (OUD).
Under the Trump administration’s plan, many doctors would be exempt from taking a day’s training before they could prescribe buprenorphine for OUD.
On Jan. 25, 2021, citing anonymous sources, the Washington Post reported that this action by the Biden administration was likely. At the time, there were concerns about whether the Department of Health & Human Services had the legal authority to make this policy change, the Post reported. The Substance Abuse and Mental Health Services Administration subsequently announced the derailment of the buprenorphine proposal on its website.
In SAMHSA’s view, the proposal was made “prematurely.” The SAMHSA statement did not detail the reasons for abandoning the Jan. 14 proposal. It had been scheduled to take effect upon publication in the Federal Register.
Instead of finalizing it in this way, the HHS said it would work with other federal agencies to “increase access to buprenorphine, reduce overdose rates and save lives.”
The HHS decision to scupper the proposal disappointed many physician groups. In a letter dated Jan. 27, several physician groups called on the Biden administration to proceed with the Trump proposal.
Under current federal law, physicians who wish to prescribe buprenorphine outside of opioid treatment programs must take an 8-hour course and receive a waiver from the Drug Enforcement Administration, the letter noted. It was signed by the American College of Emergency Physicians, the American Medical Association, and other organizations.
Treatment barrier
After taking the training course, it can take 60-90 days for physicians to receive the waiver. The license application can then be submitted. Physician groups argue that this so-called X-waiver requirement creates a barrier to providing medication-assisted treatment.
“Due to the stigma, some clinicians are not willing to pursue this DEA license or even engage in treatment of patients with [OUD],” the letter said.
The Trump administration’s proposal would have limited most physicians to treating no more than 30 patients with buprenorphine for OUD at any one time. This cap would not have applied to hospital-based physicians, such as those practicing emergency medicine, the HHS noted in a statement. The policy would have applied to only physicians who already have registered with the DEA.
Patrice A. Harris, MD, the immediate past president of the AMA and chair of the organization’s Opioid Task Force, was among the many physicians who supported the Trump administration proposal.
“It is estimated that more than 2 million Americans need treatment for opioid use disorder, but only a small percentage actually receive treatment,” Dr. Harris said in statement. Dr. Harris also noted that overdose deaths have reportedly accelerated during the COVID-19 pandemic.
Centers for Disease Control and Prevention data show there were more than 83,000 drug overdose deaths in the United States in the 12 months ending in June 2020. That is the highest number of overdose deaths ever recorded in a 12-month period and is an increase of more than 21%, compared with the previous year.