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The Biden administration quietly eliminated a barrier to medication for opioid addiction

In his State of the Union address, Biden touted the end of a requirement that doctors obtain waivers to prescribe buprenorphine to treat opioid use disorder.
Packets of buprenorphine, a drug which controls heroin and opioid cravings.
Packets of buprenorphine, a painkiller that controls heroin and opioid cravings.Elise Amendola / AP file

In his State of the Union address on Tuesday, President Biden highlighted a recent policy change aimed at increasing access to a medication for opioid use disorder. 

"Together, we passed a law making it easier for doctors to prescribe effective treatments for opioid addiction," he said.

He was referring to a provision wrapped into the omnibus funding bill, which Biden signed into law in December. It eliminated a requirement that medical providers obtain special waivers to prescribe buprenorphine, a painkiller that also reduces opioid cravings and withdrawal symptoms.

That requirement had been in place for two decades, and its reversal had been a priority for some activists because the policy discouraged doctors from prescribing the drug. To get the waiver — known as an "x-waiver" — providers had to do either an 8- or 24-hour training, depending on their levels of experience. Once they’d obtained the waiver, they were subject to random Drug Enforcement Administration audits and the number of patients they could prescribe buprenorphine for was capped.

One study found that just 10% of primary care providers in the U.S. were certified to prescribe buprenorphine from 2007 to 2017.

"The waiver requirement really served to limit access to an effective treatment for opioid use disorder during an unprecedented opioid crisis," said Lindsey Vuolo, the vice president of health law and policy at the nonprofit organization Partnership to End Addiction.

Jennifer Potter, vice president for research at UT Health San Antonio, said medical experts had been wanting to get rid of the waiver for "years, if not a decade or more."

The bulk of scientific evidence suggests that medicine is the most effective treatment for opioid use disorder; buprenorphine and methadone are the two leading options. A 2018 study found that methadone decreased opioid overdose deaths by 59% and buprenorphine by 38% relative to the absence of medication-assisted treatment.

Dr. Margaret Lowenstein, an assistant professor of medicine at the Perelman School of Medicine at the University of Pennsylvania, said buprenorphine "is actually safer than most opioids that we prescribe in general care settings."

Unlike methadone, which until the pandemic had been administered in-person through opioid treatment programs, buprenorphine is generally taken at home like other prescription medications, usually as a tablet or thin strip that dissolves under the tongue.

Because of the recent policy change, any provider can prescribe buprenorphine as long as they have a DEA number, which allows them to write prescriptions for controlled substances.

That shift arrived amid skyrocketing opioid overdose deaths: Provisional data from the Centers for Disease Control and Prevention indicates that these deaths rose 15% from 2020 to 2021 alone. Overdose deaths from synthetic opioids (excluding methadone) increased 97-fold from 1999 to 2021, according to data from the Department of Health and Human Services. 

Most of these deaths were linked to fentanyl, a synthetic opioid up 50 times more potent than heroin.

"Fentanyl is killing more than 70,000 Americans a year," Biden said in Tuesday's remarks, referring to the CDC estimates.

New Hampshire Sen. Maggie Hassan originally proposed eliminating the waiver rule in a bill introduced in 2021. In the end, it was folded into the omnibus. 

"Although there is still more work we need to do to address this crisis — including educating doctors and nurses about medication-assisted treatment — our law is a critical step forward in helping more Americans access this gold standard of treatment," Hassan said in a statement to NBC News.

Medical and policy experts said that until the waiver rule's elimination, it was especially hard for people of color and those living in rural areas to access buprenorphine. The old policy also further stigmatized the drug, they said.

"Getting the x-waiver itself wasn’t a terribly onerous barrier, but it created the impression, 'Watch out. This is a scary medication,'"  said Dr. Brian Hurley, medical director of the Division of Substance Abuse Prevention and Control at the Los Angeles County Department of Public Health.

But both Hurley and Potter questioned whether eliminating the waiver requirement will prompt significant change.

"People have this impression that treating addiction is necessarily complicated or difficult or undesirable in some way," Hurley said.

He added that of the roughly 1,000 people he trained to obtain x-waivers, only a quarter ever prescribed buprenorphine through L.A. County’s public health system.

"The bill alone is not going to unleash a whole bunch of buprenorphine access," he said. "We still have to do the work of preparing clinicians and systems to treat people with opioid use disorder."

Vuolo said co-pays or drug costs present additional hurdles for some patients.

"We continue to hear that cost and affordability continue to be major barriers," she said.