Biden administration loosens restrictions on meds for opioid use disorder amid rise in deaths

The Biden administration has loosened restrictions on prescribing medication to treat opioid use disorder Tuesday in a move to increase access as overdose deaths have climbed during the COVID-19 pandemic. 

The Department of Health and Human Services (HHS) on Tuesday released federal guidelines that allow more providers to prescribe buprenorphine and nix the eight-hour training requirement to prescribe the drug. For years, experts have said that the “X-waiver” needed to prescribe the drug creates an unnecessary hurdle to treating opioid addiction.  

Buprenorphine is one of three drugs approved by the Food and Drug Administration (FDA) for addressing opioid use disorder. It is intended to help reduce cravings, limit or eliminate withdrawal symptoms and, according to clinical trials, decrease the risk of overdose deaths.

Under the new guidelines, qualified physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives are exempt from undergoing training to treat up to 30 patients with buprenorphine.

“Americans with this chronic disease need and deserve readily available access to life-saving evidence-based treatment options,” Tom Coderre, the acting assistant secretary for mental health and substance use, said during a briefing. “These new guidelines are an important step in the right direction and will ultimately save lives and help more people find recovery.”

Under the current system, Coderre said slightly fewer than 100,000 practitioners out of 1 million physicians have a waiver to prescribe buprenorphine.

Despite the training exemptions, providers are still required to send a notice of intent to prescribe buprenorphine from HHS’s Substance Abuse and Mental Health Services Administration (SAMHSA). Health care workers who intend to treat more than 30 patients will need additional training and federal waivers.  

The administration’s announcement comes as overdose deaths reached their highest point over the 12-month period ending in September, the most recent data available, with more than 97,000 fatalities. A total of 55 percent of those deaths were attributed to synthetic opioids, including fentanyl. 

A SAMHSA survey from 2019 found that only 18 percent of the 1.6 million people with opioid use disorder received medication assisted treatment. 

“This alarming increase in overdose deaths underlines the need for more accessible treatment services,” HHS Assistant Secretary Rachel Levine said. “And studies have clearly shown that medication based treatment supports long-term recovery from opioid use disorder.”

In January, former President Trump’s administration revealed a similar proposal to ease regulations on buprenorphine prescriptions before Biden’s administration halted the plan.

Biden officials’ current plan goes further by opening up prescriptions to more kinds of providers.

The American Society of Addiction Medicine praised HHS’s easing of prescription restrictions, with President William Haning describing it as “an important step toward improving our patients’ access to this medication.”

“An elimination of the X-waiver coupled with increased addiction training has the potential to save thousands of lives and free [Drug Enforcement Administration]-registered prescribers of unnecessary barriers that have too long impeded them from helping their patients,” Haning said in a statement.