“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 about a day’s worth of training before they could prescribe buprenorphine for opioid use disorder. The Trump administration sought to go around Congress’ 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 also drew 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.
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 that 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. “The Biden administration has so much work to do to get their programs and policies into place, and to do something like this at the 11th hour that could get doctors into trouble — it’s heinous.”
HHS did not immediately respond to a request for comment. But a department official, speaking on the condition of anonymity because they were not authorized to discuss it, said the agency would continue to pursue other options to reduce the 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 involved in the decision to halt the guidelines, speaking on condition of anonymity. “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.”
Health department 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.