The Biden administration has rescinded practice guidelines issued in the waning days of the Trump administration that would have made it easier for physicians to provide treatment for opioid use disorder in their offices.
Under the guidelines from the U.S. Department of Health and Human Services (HHS), physicians with a Drug Enforcement Administration registration number no longer would have been required to take an eight-hour training course and apply for a separate waiver to prescribe buprenorphine for the treatment of opioid use disorder.
The guidelines were applauded by physicians as a way to improve access to treatment as deaths due to opioid overdoses are skyrocketing.
However, the guidelines were rescinded, and the following statement was posted on the Substance Abuse and Mental Health Services Administration website: “On January 14, 2021, HHS announced forthcoming Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder. Unfortunately, the announcement was made prematurely. Therefore, the Guidelines previously announced cannot be issued at this time. However, HHS and ONDCP (Office of National Drug Control Policy) are committed to working with interagency partners to examine ways to increase access to buprenorphine, reduce overdose rates and save lives.”
“It's certainly an emotional letdown for many of us, but we'll have to be patient,” Lucien Gonzalez, M.D., M.S., FAAP, chair of the AAP Committee on Substance Use and Prevention, said after the announcement. “The discussions that have been occurring certainly leave room for continued optimism that some easing of requirements is coming.”
More than 83,000 opioid overdose deaths were reported from June 2019 to June 2020, the highest number ever recorded in a 12-month period, according to provisional data from the Centers for Disease Control and Prevention.
The most recent figures from National Survey on Drug Use and Health showed that 87,000 12- to 17-year-olds and 227,000 18- to 25-year-olds in the U.S. had opioid use disorder in 2019.
The Food and Drug Administration approved the use of buprenorphine, a partial opioid agonist, in patients 16 years and older in 2002. Physicians could prescribe the medication in general medical settings but first had to complete eight hours of training and apply for the waiver.
In 2016, the AAP published a policy statement that encouraged pediatricians to offer medication for the treatment of opioid use disorder in adolescents and young adults. The AAP also has supported changes to make it easier to prescribe buprenorphine and endorsed a bill in 2020 that would have eliminated the need for a waiver.
Congress still could take up the issue, if the administration does not.
“It is important for individuals to continue to speak out about the lifesaving importance of access to this treatment and the real barriers posed by training requirements,” Dr. Gonzalez said.