Regulation relaxed on prescribing addiction medication buprenorphine

Days after a new report showed 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 on 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. For Dr. Peter Jacoby, chairman of the emergency department at Saint Mary’s Hospital, the decision is a welcome relief. It will allow doctors to prescribe an opioid treatment drug immediately in the emergency department without waiting weeks for a waiver.

“Buprenorphine is a great medication for treating opioid disorder,” he said. “Prior to this, you had to take classes and then wait 60 to 90 days to receive the waiver. What they’ve done is made it even easier.”

He said that Saint Mary’s had been in discussion with Wellmore Behavioral Health in Waterbury to establish a program to allow the emergency department to prescribe the first dose of buprenorphine and then get patients into treatment there. He said the pandemic had delayed implementation of the program.

“What we are really looking to do is that if someone needs help, we would see the patient, start them on a day’s supply and then get them into treatment at Wellmore,” he said. Despite the setback caused by the pandemic, Jacoby believes the providers could establish the program by this summer.

Gary Steck, chief executive at Wellmore, said he looks forward to the possibility as a way to combat the opioid epidemic. “The piece we want to formalize is where (Saint Mary’s) would be willing to start people on (medication addiction treatment) and then hand them over to us,” he said. “So the ER would directly connect them with us or one of the other addiction recovery centers so that you stop." “This is a model across the United States that is catching on. It makes a great deal of sense to us. It has great promise. This is where we want to move to in the future, where people get direct access to immediate care.This is a real promising step forward.” MORE THAN 81,000 people in the U.S. died of drug overdose in the year leading up to May 2020, which surpassed record highs, the Centers for Disease Control and Prevention reported recently. “The disruption to daily life due to the COVID-19 pandemic has hit those with substance use disorder hard,” Dr. Robert Redfield, the CDC director, said in a statement. “As we continue the fight to end this pandemic, it’s important to not lose sight of different groups being affected in other ways. We need to take care of people suffering from unintended consequences.” In a statement, the American College of Emergency Physicians applauded the HHS decision, saying it would help their ability to utilize medication-assisted treatment for patients struggling with opioid use disorder. “As emergency physicians, we see every day the devastating effects that the opioid crisis has had on the communities we serve — a crisis that has unfortunately only worsened during the COVID-19 pandemic,” said Mark Rosenberg, president of the organization. “Buprenorphine is the most important medication in our arsenal for treating opioid use disorder, which is currently one of the most lethal diseases for Americans.” 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. With its decision, HHS removed the waiver requirement. All physicians now need is a DEA registration that nearly every doctor in the country already needs to prescribe drugs. “If you really want to stop using opioids, this is a means to not have you go through all those cravings and also get you into a program rapidly, where you can be seen and get off of the tremendous craving for opioids that you have,” Jacoby said. “So if we can do something to say, ‘I can get you started on this and get you into treatment,’ we are in favor of it.” 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.

Priya Mammen, an emergency physician and public health advocate in Philadelphia, 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 on prescribing buprenorphine gave her hope that the federal government is realizing that some policies on addiction are outmoded and harmful to patients, and that the concerns of advocates are being heard.

Jacoby said the pandemic has led to increasing numbers of overdoses from opioids. “People are not coping as well and so they turn to drugs,” he said. “This has been rough on everybody. Therefore, we’ve got to really work on it.” The federal government has implemented other addiction treatment changes since the pandemic began. In the early days of the coronavirus pandemic, federal authorities began allowing buprenorphine providers to prescribe 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.”

Republican-American staff writer Tracey O’Shaughnessy contributed to this report by Aubrey Whelan of the Philadelphia Inquirer