Biden Administration to Halt Plans to Nix X-Waiver Requirement

A decision made by HHS in the waning days of the Trump presidency to publish new guidelines that include an exemption from certain requirements under the Controlled Substances Act for physicians who are licensed under state law and possess DEA registration to prescribe buprenorphine appears to be poised for reversal under the Biden administration.

HHS on Jan. 14 announced plans to publish new Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder, which would eliminate the X-waiver requirement for DEA-licensed physicians. Late Monday, however, the Washington Post reported the new administration planned to reverse course, with a source telling the Post that the new guidelines “had significant legal and clinical concerns,” namely that HHS potentially lacked the authority to issue such guidelines that allowed for physicians to bypass requirements set by Congress.

The new guidelines are no longer available on the HHS website.

According to the Post, Elinore McCance-Katz, assistant HHS secretary for mental health and substance use, who resigned Jan. 7, had opposed the Trump administration’s plan over concerns that buprenorphine could become overused, following a similar path of opioid overprescribing that was a major contributing factor to the nation’s opioid epidemic.

Many within the field, however, had supported the new guidelines. Among them, National Harm Reduction Coalition medical director Kimberly Sue, MD, PhD, who in a tweet called the Biden administration’s decision “extremely disheartening,” adding that buprenorphine should be made more accessible to providers, especially as overdose death rates are on the rise again.

The American Society of Addiction Medicine, meanwhile, called on Congress to “act swiftly to eliminate the X-Waiver in its entirety & ensure SUD education & training are widely disseminated in med schools and beyond. It’s time to be bold.”

HHS officials speaking to the Post on the condition of anonymity said the agency is still pursuing alternatives for reducing requirements for doctors to prescribe buprenorphine.