“Unfortunately, the Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder announced by the Trump administration in its last days had significant legal and clinical concerns,” according to a draft announcement obtained by The Washington Post. “The Biden Administration will not issue the Guidelines previously announced.”
Under the Jan. 14 announcement, many physicians would have been exempted from the “X” waiver — a two-decade-old requirement, first mandated by Congress, to undergo a day’s training before they could prescribe buprenorphine for opioid use disorder. The Trump administration sought to go around Congress’s requirements by issuing new “clinical guidelines” that would have enabled doctors with a Drug Enforcement Administration narcotics prescribing license to avoid the training.
The plan had also drawn fire from Elinore McCance-Katz, the Trump administration’s assistant HHS secretary for mental health and substance use, who resigned Jan. 7 in the wake of the Capitol riots. Two officials said the Trump administration had rushed the plan after McCance-Katz’s sudden departure by installing an acting replacement who greenlit the policy. One official said the administration had moved so quickly that it failed to get necessary clearance from the White House budget office.
McCance-Katz had spent weeks attempting to block the plan, arguing that the nation’s opioid epidemic had been fueled by overprescribing opioids, and that additional safeguards were important to ensure buprenorphine was not similarly overused.
The people who made this decision don’t treat opioid use disorder,” she said in an interview with Alcoholism & Drug Abuse Weekly dated Monday, further framing the move as “unfair” to the Biden administration. To “do something like this at the 11th hour that could get doctors into trouble — it’s heinous.”
But advocates expressed disappointment to learn the policy would not move forward.
Kim Sue, medical director for the National Harm Reduction Coalition, said she is “heartily dismayed and disheartened that something that could begin to save lives immediately is being held up.”
“Buprenorphine is a simple, lifesaving medication that’s currently locked up by the X waiver,” said Sue, an addiction medicine physician, adding the medication is much safer than oxycodone, the opioid chiefly responsible for the overdose crisis in the United States.
“There is no other medication in the country where you have to take an eight-hour training to prescribe it,” Sue said.
Kevin Roy, chief public policy officer for the advocacy group Shatterproof, said regardless of the legal and technical considerations, removing the barrier to more doctors prescribing buprenorphine is critical, especially after the sharp rise in opioid overdoses in 2020.
“The weight of the evidence supports removing the X waiver,” Roy said, “and the weight of the evidence shows it will save lives.”
HHS did not immediately respond to a request for comment. But one of the department officials who spoke on the condition of anonymity said the agency would continue to pursue other options to reduce requirements on doctors before they can prescribe the drug.
“Practice guidelines [that] have implications both clinically and legally for practitioners and patients should not be issued for political purposes,” said another HHS official who spoke to The Post and who was involved in the decision to halt the guidelines. “The patient and provider community depends on us to take these issues as seriously as possible and design solutions, which are legally sound and clinically evidence-based.”
HHS leaders on Monday afternoon were still debating how to announce the reversal of the policy, said two of the officials, who added there was broad agreement it would be difficult to execute.