Days after a new report showing that fatal overdoses have skyrocketed to record highs during the COVID-19 pandemic, the federal Department of Health and Human Services has relaxed a regulation around prescribing addiction medication in an effort to combat the rising death toll.
Buprenorphine, a popular opioid addiction treatment drug, has long had its prescribing restricted by the federal government. Physicians must undergo special training to obtain what’s known as an “x-waiver” from the federal Drug Enforcement Administration in order to prescribe the drug, which is itself an opioid.
Only a fraction of doctors in the country had x-waivers, and about half of waivered physicians didn’t prescribe buprenorphine to clients anyway.
Advocates had long called for the elimination of the x-waiver, saying it kept addiction medication from being more widely distributed, and pointing out the irony that doctors don’t need to undergo special training to prescribe the painkillers widely blamed for sparking the first wave of the opioid crisis.
On Thursday, HHS officials did just that: physicians are no longer required to have a waiver to prescribe buprenorphine — just a DEA registration that nearly every doctor in the country already needs to prescribe drugs.
“The medical evidence is clear: access to medication-assisted treatment, including buprenorphine that can be prescribed in office-based settings, is the gold standard for treating individuals suffering from opioid use disorder,” Adm. Brett P. Giroir, assistant secretary for health, said in a news release.
“Removing some of the certification requirements for an X-waiver for physicians is a step toward providing more people struggling with this chronic disease access to medication assisted treatment.”
Some restrictions remain around prescribing buprenorphine. Physicians without x-waivers can only treat patients in their own state, and the new directives are limited to doctors; nurse practitioners and physicians’ assistants still need an x-waiver to prescribe the drug.
Doctors without the waiver can treat up to 30 patients; doctors with the waiver can eventually treat up to 275.
In Philadelphia, physicians who have long advocated for people with addiction welcomed the new directive. Jeanmarie Perrone, the director of the University of Pennsylvania’s Division of Medical Toxicology and Addiction Medicine Initiatives, who spearheaded efforts to get more doctors waivered across her hospital system, said the decision had “taken away a major, major hurdle.”
“It really allows a lot more clinicians to be part of the solution,” she said. She added that she hoped restrictions around buprenorphine prescribing from nurse practitioners and physicians’ assistants would also be relaxed.
Priya Mammen, an emergency physician and public health advocate, said making physicians undergo special training to prescribe buprenorphine contributed to the stigma that paints addiction as “different than any other physical illness.”
“That’s an old-school belief, not based in evidence and not based in the research of the last several years,” she said. “Keeping addiction on the mental/behavioral health side, with all of these regulations and hoops to jump through made it easier for doctors to shut their minds to it.”
Mammen said relaxing regulations around buprenorphine prescribing gave her hope that the federal government is realizing that some policies around addiction are outmoded and harmful to patients, and that the concerns of advocates are being heard.
Eliminating the x-waiver is only the latest change in how the federal government regulates addiction treatment.
In the early days of the coronavirus pandemic, federal authorities began allowing buprenorphine providers to begin prescribing through telehealth, and methadone clinics — which dispense the most heavily regulated opioid addiction medication — were permitted to allow clients to take home more medication than they normally would in an effort to promote social distancing.
“COVID has given us so much heartache and so many barriers,” Mammen said. “But it has also shown us that these preconceived notions [around addiction medication] are only preconceived notions, they are not reality. This is the first step of taking those barriers away.”
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