WASHINGTON — The Obama administration is proposing to double the number of patients a doctor may treat with a controversial heroin addiction medication — an idea that is drawing praise from public health officials, but also questions about the impact it could have on the nation's opioid epidemic.
The Department of Health and Human Services, confronting a dramatic increase in overdoses from prescription drugs and heroin, is considering a regulation that would permit physicians to treat up to 200 patients with buprenorphine — a drug considered safer and more convenient than methadone.
Health officials have sought for years to lift the current cap of 100 patients — arguing it limits access to treatment — and are receiving broader support as opioid abuse has spiked. About 28,000 people died of overdoses in the United States in 2014, four times the number in 2000.
Baltimore Health Commissioner Leana Wen has lobbied for the change.
"It makes no sense that there's a cap at all, especially at a time when we're addressing a national health emergency" she said. "We need to do everything we can to lift the barriers to addiction treatment."
Heroin claimed 578 lives in Maryland in 2014, a 25 percent increase from 2013, and double the number who died in 2010. Wen said 344 people in Baltimore died from drug and alcohol overdoses in the first three quarters of 2015, up from the 303 who died in all of 2014.
The effort is part of a larger White House initiative to address opioid abuse. The administration is also seeking $1.1 billion to expand treatment.
Congress, meanwhile, is advancing legislation to create grant programs that would build treatment capacity. The legislation does not offer new funding to pay for those programs.
Bipartisan legislation drafted by Sens. Edward Markey, a Massachusetts Democrat, and Rand Paul, a Kentucky Republican, would not only lift the patient cap on buprenorphine but also allow nurse practitioners and physician assistants to prescribe the drug. The measure was approved by a committee and is awaiting a full vote by the Senate.
Buprenorphine was approved by the Food and Drug Administration in 2002 to help patients get off heroin and other opiates, including some pain relievers. But Congress, fearing abuse and hoping to head off a repeat of the controversy that surruonded the widespread introduction of methdaone in the 1970s, already had passed a law limiting its prescription.
Supporters of expanding access to buprenorphine acknowledge the HHS regulation, which was proposed in late March, will not address what is perhaps the greatest impediment to buprenorphine's use: A hesitation by physicians to get into the drug treatment business in the first place.
No one has published data to show how many doctors are maxed out at 100 patients. So it is not clear how many new patients would gain access to the treatment if the new regulation were approved.
About 32,850 doctors are certified to prescribe the drug nationwide.
Still, advocates say, the proposed regulation could at least help to address a substantial shortage of the drug.
Desiree, a 31-year-old Army veteran from Baltimore County, said she spent years searching for a doctor who would help her wean off the painkillers she was prescribed to deal with injuries sustained in Afghanistan and Iraq. (She asked The Baltimore Sun not to publish her last name.)
She had medical insurance, and was willing to pay additional money out of pocket. But she said multiple practices steered her back to painkillers — in part because they didn't prescribe buprenorphine, or because they felt her underlying conditions were still affecting her.
Other clinics already had reached their cap.
"It is so much easier to get opiates of any kind than it is to get Suboxone," said Desiree, referring to the brand name of a drug that includes buprenorphine. "I didn't have any idea this was going to happen to me. I had never done a drug in my life."
She connected with the Institutes for Behavior Resources in Charles North, which offers treatment and other services, and is now weaning off buprenorphine. But she said she can easily see how others, with less support, wind up transitioning to heroin instead.
"They're going to go to the streets looking for the cheapest next thing, which is heroin," she said.
Dr. Yngvild Olsen, medical director at the Institutes for Behavior Resources, said Desiree's story is common.
"In many places across the country, particularly in rural Maryland, there may be only one or two prescribers," she said. "And if they're already maxed out at their 100 patients, then they often have to turn people away."
Buprenorphine carries fewer side effects than methadone, and can be taken at home. Some say the greater degree of autonomy means physicians have less insight into whether their patients are using the drug correctly, and receiving other services, such as counseling.
Mark Parrino is president of the American Association for the Treatment of Opioid Dependence, which represents methadone clinic operators.
"Are [doctors who prescribe buprenorphine] tracking patient outcomes?" he asked. "Are they conducting toxicology tests?
"The question for the [health] department to consider is, aside from the use of the medication, what standards of care will physicians be required to follow?" he said.
Wen, the city's health commissioner, said she believes long-standing questions about misuse of buprenorphine and wrap-around services strengthen the argument for raising the cap. Physicians that are prescribing the medication on a large scale, she said, are the ones who know best how to do it properly.
"The doctors who are prescribing buprenorphine to many patients now are the ones that will have the infrastructure in place," she said.