The Biden administration will reverse relaxed guidelines around buprenorphine prescribing.
The Biden administration will reverse an opioid guideline put into place by the Trump administration which would allow doctors to prescribe medication-assisted treatment more quickly. Trump’s plan was supported by medical professionals advocating for relaxing restrictions that they claimed caused them to respond slowly to the opioid epidemic. However, experts contended the Department of Health and Human Services lacked the authority to issue guidelines enabling physicians to avoid requirements established by Congress.
Trump introduced new addiction treatment mandates in mid-January to give doctors more prescribing flexibility around buprenorphine, an FDA-approved drug that is used to reduce opioid cravings and treat an opioid use disorder (OUD). It’s taken as a replacement in the treatment of heroin and methadone dependence, and before the rules were relaxed, physicians were required to undergo an eight-hour course to receive licensing termed the “X-waiver.”
“The medical evidence is clear: access to medication-assisted treatment, including buprenorphine that can be prescribed in office-based settings, is the gold standard for treating individuals suffering from opioid use disorder,” Adm. Brett P. Giroir, assistant secretary for health, said. “Removing some of the certification requirements for an X-waiver for physicians is a step toward providing more people struggling with this chronic disease access to medication-assisted treatment.”
However, a current presidential announcement indicated, “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. The Biden Administration will not issue the Guidelines previously announced.”
Kevin Roy, chief public policy officer for Shatterproof, said regardless of the legality issues, removing the barriers to prescribing buprenorphine is critical in reducing overdose deaths. “The weight of the evidence supports removing the X waiver,” Roy said, “and the weight of the evidence shows it will save lives.”
Since buprenorphine a long-acting opioid itself, some to misuse it to get high, and patients who have prescriptions for buprenorphine sometimes sell it on the black market. It is mainly because it’s difficult to obtain, providers need to be certified to prescribe it, and there’s a cap on the number of patients they treat. If it were made more readily available by practitioners, there would be less of a reason for addicts to go underground. Plus, many experts have stated the benefits largely outweigh the risks.
Dr. Kelly Clark, president of the American Society of Addiction Medicine, said, “The risks of overdose with buprenorphine are minimal.” It is possible to overdose on buprenorphine, but this is rare. The drug’s effects are less potent than heroin and fentanyl. More people use buprenorphine to prevent withdrawal and to stay away from other illegal drugs than to get high. Self-treatment with buprenorphine is more likely to save lives of those caught in the vicious cycle of opioid addict than contribute to overdose fatailities.
“It was not diverted buprenorphine that’s responsible for our current situation,” said Dr. Zev Schuman-Olivier with Harvard Medical School. “The majority of people are using it in a way that reduces their risk of overdose.”