The Biden administration's recent spending bill contained under-the-radar changes for addiction medicine, including eliminating the X waiver requirement for clinicians who treat opioid use disorder with medication-assisted treatment (MAT).
The X waiver, a special Drug Enforcement Administration (DEA) certification that allowed clinicians to prescribe buprenorphine (Suboxone), a partial opioid agonist that curbs opioid cravings, has long been considered a bureaucratic hurdle to improving treatment access for patients who struggle with opioid addiction.
While the administration has incrementally loosened the requirements for providers to obtain an X waiver in recent years, the provision included in December's omnibus bill eliminates the certification entirely. The abolishment of the X waiver is included in the bipartisan Mainstreaming Addiction Treatment (MAT) Act.
"Treatment for opioid use disorder is limited by there not being enough people that offer medications for opioid use disorder," said Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine (ASAM). "Removal of the X waiver opens up the capability of prescribing to a much broader group of clinicians."
Previously, obtaining an X waiver required 8 hours of training on prescribing MAT to patients with opioid use disorder. But in April 2021, the Biden administration nixed the training requirement for doctors, nurse practitioners, and other providers who wanted to prescribe buprenorphine. Providers simply had to register for the waiver to prescribe.
But also included in the omnibus bill was another provision that bolsters training requirements for clinicians prescribing all controlled substances -- not just MAT -- called the Medication Access and Training Expansion (MATE) Act.
This law requires all providers who apply for a DEA license to prescribe controlled substances to undergo a one-time, non-repetitive, 8-hour training on managing patients with opioid and other substance use disorders.
"That training is for you to get your DEA license, so that means, obviously, your controlled substance license," said Rahul Gupta, MD, MPH, MBA, director of the Office of National Drug Control Policy, in an interview with MedPage Today. "That's different from what used to be the X waiver training, which was primarily focused on prescribing of buprenorphine and opioid [abuse treatments]."
Hurley said ASAM is a "strong supporter of education for clinicians that have controlled substances prescribing authority, really to help preserve the safety of the patients that we treat." As all controlled substances do carry a risk, it is critical for clinicians to understand how to prescribe them, and buprenorphine should not be singled out, he said.
Removing the X waiver does more than just make it easier to prescribe buprenorphine, Hurley said, adding that this action could pave the way for further de-stigmitization of MAT for opioid use disorder.
"When you put buprenorphine behind the X waiver, it creates the impression that the medication is complex or dangerous," Hurley said. Clinicians routinely prescribe other medications that are more dangerous than buprenorphine -- such as other opioids -- which have not previously required additional training, Hurley said.
"So not only does the elimination of the X waiver create the regulatory pathway" for clinicians to prescribe buprenorphine without a separate certification, Hurley said. "It also removes the impression that the treatment of opioid use disorder with buprenorphine is a highly specialized, complex, or dangerous activity."
While removing the X waiver is a positive change for addiction medicine, more action is needed to encourage providers to actually treat patients with addiction, said Allister Martin, MD, an emergency medicine doctor in Boston and CEO of the non-profit A Healthier Democracy.
"There are some parts of the population that could have been prescribing buprenorphine but simply because of the X waiver, they did not," Martin said in an interview. "That's the group that we now need to mobilize."
Shannon Firth and Joyce Frieden contributed reporting for this story.