The first major overhaul of U.S. methadone regulations in two decades is set to expand access to the life-saving drug starting next month, but experts say addiction treatment reform could fail unless state governments and methadone clinics take action.
Oregon is one of the states covered by this expansion policy.
For decades, strict rules required most methadone patients to line up at special clinics every morning to receive a daily, supervised dose of the liquid drug. Instituted out of mistrust for people addicted to opioids, the rules were meant to prevent overdoses and diversion (the illegal sale or sharing of methadone).
The COVID-19 pandemic has changed how risk is calculated: To prevent the spread of the coronavirus in crowded clinics, emergency rules allow patients to take methadone at home, unsupervised.
Studies have found that less stringent treatment is safer — there are no more overdose deaths or drug diversions — and people stay in treatment longer.
As evidence mounted, the US government made the changes permanent earlier this year. On October 2nd, clinics must follow the new rules unless they are in a state with stricter restrictions.
About 7,000 people in Alabama take methadone for opioid use disorder, and the state will follow the new, flexible rules, said Nicole Walden, a state official who oversees substance use services.
“This is a step forward for the country, for all people, to say this is not a bad thing,” Walden said. “People don’t need to come into the hospital every day to get life-saving medicine.”
Is methadone an opioid?
Methadone is an opioid that can be dangerous in large doses. When taken correctly, it can suppress drug cravings without getting you high. Many studies have shown it can reduce the risk of overdose and the spread of Hepatitis C and HIV. However, it cannot be prescribed for opioid addiction outside of the 2,100 methadone clinics in the country. These clinics treat about 500,000 American patients with methadone on any given day. According to John W. McIlveen of the Oregon Health Authority, between 13,000 and 14,000 people in Oregon are treated with methadone.
New federal rules allow stable patients to take home a 28-day supply of methadone. Colorado, New York, and Massachusetts are among states that have taken steps to update their rules to accommodate this new flexibility. Others, including West Virginia and Tennessee, which have the highest drug overdose death rates in the country, have not yet done so.
“Where you live matters,” said Beth Myerson, a University of Arizona researcher who studies methadone policy.
Eileen Garnett, 44, of Phoenix, welcomes the increased availability of take-home methadone doses. She has been going to the clinic for more than 10 years, but now has to come twice a week, which she said is “just crazy.”
Garnett, who works as a grants administrator for a harm reduction organization and lives 25 minutes from the clinic, said 28 days of takeaway methadone — the maximum allowed under new federal rules — gives her more freedom to travel and a “more normal quality of life.”
“It’s the only medication that requires me to go somewhere every day and put my life on hold,” she said.
New rules Arizona plans to adopt would give clinics broad discretion over who is eligible for a take-home vaccine. Ideally, those decisions would be made jointly by doctor and patient. But money will also come into play, experts say.
Payments to clinics are sometimes tied to in-person medication administration, which can discourage treatment at home, said Frances McGuffey, who studies substance use treatment at the nonprofit Pew Charitable Trusts.
“States should review their payment policies and determine what type of care they are incentivizing,” she said.
In Arizona, clinics currently receive $15 for each in-person shot from the state’s Medicaid program, compared with about $4 for each take-home shot. The state is considering options such as matching those amounts or adopting a “bundled payment,” a model that reflects the full cost of care.
New York’s Medicaid program uses a bundled payment model, so there is no financial incentive for in-person administration.
Longtime methadone patient David Frank, 52, a sociologist at New York University, receives take-home methadone in wafer form from the clinic for four weeks.
“I would never have been able to go back to school and get my PhD, do research, teach, or anything like that if I had to go to the clinic every day,” Frank says. “It makes all the difference between having a stable, happy, high-quality life.”
“Free Methadone” Campaign
The methadone clinic system began in 1974, when the number of overdose deaths in the U.S. was fewer than 7,000 per year. With the annual overdose death toll now exceed 107,000, some longtime patients, including Garnett and Frank, have organized a “Free Methadone” movement. They support legislation that would allow addiction specialists to prescribe methadone and allow pharmacies to fill those prescriptions.
The new federal rules don’t go that far, but they do include other changes, including:
— States that adopt the rule would allow methadone treatment to begin sooner, and patients would no longer have to prove a one-year history of opioid addiction.
— Counseling can be made optional, not mandatory.
— Telemedicine can be used to evaluate patients, improving access for rural residents.
— Doctors, as well as nurse practitioners and physician assistants, can start patients on methadone.
“It’s up to states to adopt these changes to increase access to treatment,” said Mark Parrino, president of the American Association for Opioid Addiction Treatment.
Tennessee officials have drafted new rules that are stricter than the federal ones, and the state’s proposal would increase random urine drug testing, require counseling for many patients and require clinics that want to dispense take-home pills to hire pharmacists.
The states’ proposed rules are “duplicative, contradictory, prescriptive, rigid and written with the intent to punish, not treat, people living with opioid use disorder,” wrote Zach Talbott, who runs four methadone clinics in Tennessee, Georgia and North Carolina.
In states that adopt the federal rules, the changes will be a big burden for some clinics, experts say: Some clinic leaders may not agree with the patient-centered philosophy behind the changes, or balk at the legal liability that comes with deciding who can safely take methadone at home.
“Not all opioid treatment programs are the same,” said Linda Hurley, CEO of CODAC Behavioral Healthcare, Rhode Island’s oldest methadone program.
Myerson, the University of Arizona researcher, said clinics are used to operating in very restrictive environments.
“We’ve been putting them in a bind for years,” Myerson said. The new rules will allow clinics to put patients’ health at the center of their care.
“The question is, can they do it?” she said.
—AP Medical Writer Carla K. Johnson
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science Education Media Group. The AP is solely responsible for all content.
