WASHINGTON — The Biden administration on Tuesday announced it would move forward with a dramatic deregulation of addiction medicine first proposed by the Trump administration in January.
The change would allow almost any prescriber to treat patients using the drug buprenorphine, the most effective medication for opioid addiction. Currently, doctors, physician assistants, and nurse practitioners must undergo a separate training and apply for a waiver before they’re allowed to prescribe the drug to patients.
For years, many addiction physicians and public health advocates have argued that the “X-waiver,” as the special buprenorphine license is known, poses a barrier to basic care for patients with opioid addiction. In particular, many have argued that if a doctor can prescribe potentially addictive prescription pain drugs, they should also be able to prescribe the medicine used to treat the addiction.
“Increases in overdose deaths emphasize the need to expand access to evidence-based treatments, including buprenorphine that can be prescribed in office-based settings,” Rachel Levine, the assistant secretary for health, said in a statement. “These guidelines provide another tool to help communities respond to the evolving overdose crisis, equipping providers to save lives in their communities.”
The move comes amid a worse-than-ever drug overdose crisis, which has taken a dire turn amid the Covid-19 pandemic. More than 87,000 Americans died of overdoses during the 12-month period that ended in September 2020, according to estimates from the Centers for Disease Control. Data for the full 2020 calendar year isn’t available yet, but most addiction policy officials expect the death toll will climb even higher.
The Trump administration first announced it would move to deregulate buprenorphine on Jan. 14, the administration’s final week in office. The Biden administration froze the proposal along with most other regulations issued late in the Trump administration soon after taking power.
During a confirmation hearing in February, health secretary Xavier Becerra hinted that the administration didn’t necessarily oppose the Trump-era proposal, suggesting it wasn’t legally sound.
“The president’s goal was to get it right,” he told Sen. Maggie Hassan (D-N.H.). “We don’t want to end up in court and delayed even further.”
The Biden administration’s new policy, issued as Department of Health and Human Services practice guidelines, goes slightly further than the Trump administration’s. In light of the announcement, physicians, nurse practitioners, physician assistants, clinical nurse specialists, certified nurse anesthetists, and certified nurse midwives will be allowed to treat up to 30 patients with buprenorphine.
Those providers will still need to submit a notice of intent to the Substance Abuse and Mental Health Services Administration that they intend to prescribe buprenorphine, Levine said, though they’ll now be exempted from training requirements.
The announcement represents the Biden administration’s first major action on drug overdoses. President Biden campaigned aggressively on addiction issues, specifically pledging to repeal the X-waiver and make treatment more widely available.
The Department of Health and Human Services estimated in January that just 66,000 of the country’s roughly 1 million physicians, and 25,000 non-physician prescribers like NPs or PAs, have a waiver to prescribe buprenorphine.
The Biden administration’s action is likely to win approval from major medical groups. In January, when the Trump administration announced its highly similar proposal, it earned the quick endorsement of the American Medical Association and a bipartisan group of lawmakers on Capitol Hill.
A separate effort to fully repeal the X-waiver is still pending before Congress. Its author, Rep. Paul Tonko (D-N.Y.), lauded the Trump administration change in January and has since called for Biden to endorse his bill, known as the Mainstreaming Addiction Treatment Act.
While some drug policy officials have resisted the change in the past, citing buprenorphine’s status as a controlled substance, Trump officials argued in January that rising overdose rates compelled them to act.
“Many people will say this has gone too far, but I believe more people will say this has not gone far enough,” said Brett Giroir, who served as the Trump administration’s assistant secretary for health. “This is a measured, logical, appropriate, evidence-based, and patient-centered intervention that may save tens of thousands of lives.”