New DEA requirements may limit access to buprenorphine, a popular drug for opioid recovery

Doctors and advocates are concerned a federal proposal to roll back a pandemic policy allowing remote prescribing of a common opioid substitute medicine could jeopardize those recovering from addiction.

With the public health emergency set to end May 11, the Drug Enforcement Administration proposal would require people to visit a doctor or clinic within 30 days of getting a telehealth prescription for buprenorphine.

The proposal could change how more than 1 million Americans recovering from addiction can access this opioid-substitute medicine, used to stop cravings and block withdrawal symptoms for opioid-use disorder.

Since 2020, the federal government allowed telehealth providers to prescribe the medication without a medical visit to ensure people could still get it during lockdowns and reduce exposure to COVID.

The DEA, which regulates controlled substances such as buprenorphine, said the in-person visit is a necessary compromise that would allow people to still get the medication from a telehealth provider while reducing the likelihood buprenorphine is diverted for illicit purposes. In its proposed rule, the agency argues doctors also can order tests such as drug and toxicology screens and check for infectious diseases such as hepatitis.

The DEA has said will consider the more than 2,900 public comments as the agency drafts final regulations. The agency has not announced when it will release final rules, expected after the public health emergency ends May 11.

Amid rising overdose deaths, experts want to make it easier to get buprenorphine

Advocates warn the new rule could disrupt access and make it difficult for some to continue recovery from opioid-use disorder. People who live in remote communities without access to a nearby clinic, in particular, could struggle to obtain doses.

Kevin Roy is chief policy officer with Shatterproof, a nonprofit that addresses addiction treatment.

He said studies show fears buprenorphine would be misused or diverted were "not a concern." He cited a National Institute on Drug Abuse and Centers for Disease Control and Prevention study that found opioid overdose deaths involving buprenorphine didn't increase after remote prescribing was allowed.

Because the studies showed the medication wasn't diverted and buprenorphine deaths didn't increase, Roy sees little purpose for the DEA's proposed rule.

"What problem are they trying to solve with that 30-day limit?" Roy said.

Nearly 107,000 U.S. residents died from a drug overdose in 2021; about 75% of those deaths involved an opioid, mostly illicit fentanyl.

To counter the stubbornly high number of overdose deaths, "we should try to work with people to make it easy as possible," to start or continue buprenorphine or other addiction-treatment medications, Roy said.

Others worry people won't be able to get a medical appointment if they have to go to a doctor a clinic to get a prescription. There's already a lack of medical providers who prescribe buprenorphine and two other opioid substitutes, methadone and naltrexone.

In a public comment, the National Rural Health Association said the DEA’s proposal is "overly restrictive" and risks "destabilizing current patients, leading to a dangerous disruption of maintenance treatment potentially triggering relapses or overdoses."

The rural association said telehealth is essential because about one third of rural residents live in a county without a doctor or clinic that offers buprenorphine treatments.

Others say the DEA rule penalizes telehealth providers who have bridged the provider shortage, especially in rural areas or other communities with a shortage of doctors willing to prescribe.

"Telehealth really fixed a large gap for people," said Jason Gibbons, a health economist at Johns Hopkins University. "This is just another barrier to access."

Gibbons studied how missed buprenorphine doses affect patients. In a study of 34,505 patients, he found people who missed doses were nearly two to four times more likely to overdose than those who took regular doses.

People have a much easier time staying on the medication when they have the option of remote prescribing, Gibbons said. A shortage of prescribers has been a long-standing problem. A 2020 Department of Health and Human Services Office of Inspector General report found 40% of U.S. counties did not have a single doctor or clinic who prescribed buprenorphine.

That makes it difficult for some who might not have the transportation to make it to a far-flung clinics. It also can be difficult taking time off work or arranging child care, said Renee Johnson, an associate professor at Johns Hopkins Bloomberg School of Public Health.

While requiring a doctor's appointment within 30 days seems like a good idea, Johnson said it could discourage people already facing difficult circumstances. The key, she said, is to "make it real easy to get on that on ramp to recovery and stay on that on ramp to recovery."

Army veteran

Army veteran Bill Bradley worries the DEA's proposal could disrupt routines for many people in recovery.

Bradley lives Fairmont, West Virginia, a town in the north-central part of the state that has no doctors or clinics that prescribe buprenorphine, he said.

The community opened a drop-in shelter a few years ago for the homeless and those who need food, clothes and hygiene supplies. Those with drug dependency issues can meet with a licensed social worker and recovery coaches. Many use the center to make telehealth appointments so they can get buprenorphine, Bradley said

If the DEA proposal is adopted, those residents would need to travel more than a dozen miles north to Morgantown or more than 20 miles south to Clarksburg for an appointment with a prescriber.

Bradley has been on buprenorphine for over a decade after he became dependent on opioid pain medications prescribed to treat his kidney stones. His doctor, located in Pittsburgh, allows him to get mail-order buprenorphine doses because he's been steady on the medication for so long. And if he needs to see the doctor, transportation is provided through the Department of Veterans Affairs.

But he worries others in his town might not stay on buprenorphine if they have to travel out of town for a medical appointment. Many don't have transportation or the money to pay for a cab or Uber ride.

"I'm afraid it's going to put them back into, 'I'll get what's closer. I'll just pick up (illicit drugs) again,'" Bradley said.

Addiction treatment medications 'vastly underused'

National Institute on Drug Abuse Director Nora Volkow said medications for opioid use disorder "continue to be vastly underused."

Congress has sought to make it easier for more doctors to prescribe the medication. Last December, President Joe Biden signed the Mainstreaming Addiction Treatment Act that eliminates a waiver doctors were required to secure before prescribing buprenorphine. Only 1 in 5 patients with opioid-use disorder get buprenorphine or other medication to treat their addiction.

“Expanding more equitable access to these medications for people with substance use disorders is a critical part of our nation’s response to the overdose crisis," Volkow said in a news release.

Ken Alltucker is on Twitter at @kalltucker, or can be emailed at [email protected]

This article originally appeared on USA TODAY: DEA tightens rules for Buprenorphine, opioid epidemic's lifeline drug