In announcing the altered rules, administration health officials emphasized that fostering medication-assisted treatment is especially important because opioid addictions and deaths have ratcheted up during the coronavirus pandemic.
“The need for more accessible medication-based services has never been more urgent than it is today,” said Tom Coderre, acting assistant secretary for the Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration.
Preliminary federal figures suggest that 90,000 people in the United States died of drug overdoses in the 12 months ending in September, a record number. Nearly 67,000 of them were fatal overdoses from opioids.
During a news briefing Tuesday, Coderre and Rachel L. Levine, HHS assistant secretary for health, emphasized that the change is intended to help integrate treatment for addictions into primary care by internists and family physicians, as well as in hospital emergency rooms.
Addiction specialists and medical groups welcomed the rewritten rules as a useful, if limited, step. They contended the action does not go far enough in removing federal limits on buprenorphine prescribing — rules that do not exist for any other medication.
The limitations originated in a law adopted by Congress in 2000 that made the medication, a type of opioid itself that is safer than methadone, available for use in the United States starting in 2002.
To prescribe buprenorphine for opioid-use disorder, doctors were required to undergo eight hours of federally specified training and counseling that would qualify them for what is called an “X” waiver. When other health-care practitioners were allowed to prescribe it years later, they were compelled to undergo longer training.
Under the new guidelines, physicians and other health-care practitioners still must apply to the Drug Enforcement Administration for a waiver but no longer need to go through training, as long as they are prescribing the medication for no more than 30 patients at a time.
Tuesday’s announcement came three months after administration health officials canceled a related plan announced during the final days of the Trump administration. The Trump-era guidelines were marred by legal and other flaws, the Biden administration said, including a failure to secure required clearance from the Office of Management and Budget. The rules drafted by the previous administration would have eliminated the waiver entirely — something that Biden officials pointed out only Congress has authority to do.
As a candidate, Joe Biden said that, if elected, he would ensure the removal of “undue restrictions on prescribing” buprenorphine. And the new administration drew criticism for stepping in the path of its predecessor’s plan, even though the new President Biden’s health and drug-policy aides said they would develop their own plan.
While the Trump-era version would have dispensed with training and other requirements for physicians only, the new guidelines also eliminate them for physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives.
“This will benefit those who need help the most,” Levine said during the news briefing. She said that the pandemic has been accompanied by “a startling rise in opioid addiction and mental health issues” and that “addressing these underlying issues is critical to moving forward as a country.”
Patrice A. Harris, the American Medical Association’s immediate past president and chair of its opioid task force, said the guidelines are “a critically important first step” that remove “burdensome and stigmatizing requirements” that have discouraged doctors from being certified to prescribe buprenorphine.
But Harris and other physicians called on Congress to pass legislation that would get rid of waivers for the prescription of the drug, rather than merely making it easier to get permission.
Miriam Komaromy, medical director of Boston Medical Center’s Grayken Center for Addiction, predicted the new rules will have “a measurable but modest effect.”
Komaromy said the guidelines could make it easier for a doctor or other practitioner to “get a taste of doing this kind of work,” by seeking a waiver without taking time for the training. Still, she said, compelling specific federal permission to prescribe the treatment has a chilling effect.
“It’s not going to be the solution we’re looking for,” she said, “to conquering the opioid overdose epidemic.”