With the X-Waiver repealed, officials urge providers to begin prescribing buprenorphine for opioid addiction

The White House, federal agencies and lawmakers today marked the elimination of the DATA-Waiver Program, better known as the X-Waiver requirement, with calls for providers to begin incorporating opioid use disorder treatment buprenorphine in everyday patient care.

The X-Waiver requirement only permitted doctors who had received specialized training and federal permissions to prescribe the opioid partial agonist, which is a controlled substance.

The barrier came from the Drug Addiction Treatment Act of 2000, which was “rooted in stigma” and unnecessarily restricted the lifesaving treatment, Sen. Maggie Hassan, D-New Hampshire, who spearheaded the Mainstreaming Addiction Treatment (MAT) Act first introduced in 2019, said during today’s White House event.

The act’s push for a repeal was ultimately folded into the omnibus bill passed in late December. The Drug Enforcement Administration (DEA) notified registrants that it recognized the elimination of the X-Waiver in a Jan. 12 letter (PDF).

Going forward, buprenorphine prescriptions only require a standard DEA registration number similar to other controlled substances, the agency wrote, and there are no longer any caps on how many patients a provider may treat for opioid use disorder using buprenorphine. New training requirements also outlined by the legislation will go into effect for all prescribers June 21, the DEA wrote.

“At a time when our nation has experienced 107,000 drug overdoses and poisoning in just one year’s time, this change could not have come sooner,” said Rahul Gupta, M.D., director of the White House’s Office of National Drug Control Policy, during today’s event.

“But it’s not enough. We have a long way to go. But because of this bill, led by the Biden-Harris administration, healthcare providers across the nation can help us get there. They can do this by beginning to treat addiction, a disease of the brain, just as they treat diabetes or heart disease or emphysema,” he said.

More than 46 million Americans aged 12 or older, or about 16.5% of the population, met the criteria for substance use disorder, per the Substance Abuse and Mental Health Services Administration’s most recent estimate.

Elimination of the X-Waiver increases the number of potential buprenorphine prescribers from 130,000 to 1.8 million, DEA Administrator Anne Milgram said during the event.

Prior to the elimination, about 40% of U.S. counties did not have any providers who could prescribe the treatment, Hassan said. She, along with other legislators and administration officials, described the law’s passage as a bipartisan achievement and stressed the continued work ahead for government officials and healthcare providers alike.

“This is only one part of the comprehensive approach that we need to continue to take to address the opioid epidemic,” Hassan said. “Breaking the back of this epidemic will require teamwork, teamwork among healthcare professionals, the recovery community, lawmakers and executives at every single level of government, first responders and law enforcement.”

“While the legislative fight on MAT is over, the battle just begins to make treatment on demand a reality and to save lives, that is well underway,” Rep. Paul Tonko, D-New York, said during the event. “We need to inform everyone that this needs to be part of routine medical practice. We need to keep pushing.”

Gupta also highlighted National Institutes of Health and Centers for Disease Control and Prevention (CDC) study data showing that telehealth treatment with buprenorphine didn’t lead to additional deaths. The virtual prescriptions were made available in recent years due to pandemic telehealth waivers.

The White House’s drug control head said those data support buprenorphine’s value as an addiction treatment and cement the need for telehealth deregulations to remain in place.

“The administration is working hard to make permanent two of these COVID-era flexibilities, including buprenorphine induction through telehealth and take-home medications,” he said.

Opioid use disorders have an outsized impact on medically underserved populations, and care utilization for the condition is not uniform across the country, according to new data released today by PINC AI, the applied data science division of healthcare improvement firm Premier Inc.

Patients diagnosed with the condition are more likely to live below the poverty line than those without and are more frequently on Medicaid or uninsured, based on the firm’s nationwide discharge data. Diagnosed patients are more often younger, more likely to be male and Native American or white.

Fourteen states and the District of Columbia treated a higher percentage of patients for opioid use disorder than the national average across both ED inpatient and ED outpatient settings, per another PINC AI analysis. The burden was greatest in New Mexico and New Jersey.

Substance use disorders are also a drain on the U.S. healthcare system’s resources.

PINC AI estimates that care for opioid use disorders received in the hospital setting is costing more than $95 billion each year. CDC data recently published in JAMA estimate that substance use disorder treatments cost employer-sponsored insurance $35.3 billion per year.