The first big update to U.S. methadone regulations in 20 years is poised to expand access to the life-saving drug starting next month, but experts say the addiction treatment changes could fall flat if state governments and methadone clinics fail to act.
For decades, strict rules required most methadone patients to line up at special clinics every morning to sip their daily dose of the liquid medicine while being watched. The rules, built on distrust of people in the grip of opioid addiction, were meant to prevent overdoses and diversion -- the illicit selling or sharing of methadone.
The COVID-19 pandemic changed the risk calculation. To prevent the spread of the coronavirus at crowded clinics, emergency rules allowed patients to take .
the looser practice was safe. Overdose deaths and drug diversion didn't increase. And people stayed in treatment longer.
With evidence mounting, the U.S. government made the changes permanent early this year. October 2 is the date when clinics must comply with the new rules -- unless they're in a state with more restrictive regulations.
Alabama -- where about 7,000 people take methadone for opioid use disorder -- plans to align with the new flexible rules, said Nicole Walden, SSA, a state official overseeing substance use services.
"This is a step toward the country -- and everybody -- saying this is not a bad thing," Walden said. "People don't have to show up every day to get a medication that can help save their lives."
Is Methadone an Opioid?
Methadone, an opioid itself, can be dangerous in large amounts. When taken correctly, it can stop drug cravings without causing a high. have shown it reduces the risk of overdose and the spread of hepatitis C and HIV. But it cannot be prescribed for opioid addiction outside of the nation's 2,100 methadone clinics, which on a given day treat nearly 500,000 U.S. patients with the drug.
The new federal rules allow stable patients to take home 28 days' worth of methadone. Colorado, New York, and Massachusetts are among states taking steps to update their rules to align with the new flexibility. Some others have not, including West Virginia and Tennessee -- the states with the nation's highest drug overdose death rates.
"Where you live matters," said University of Arizona researcher Beth Meyerson, MDiv, PhD, who studies methadone policy.
Phoenix resident Irene Garnett, 44, would welcome more take-home methadone doses. Her clinic now requires her to come in twice a week, even though she's been a patient there more than 10 years, "which is just bonkers," she said.
Garnett, who works as a grant manager for a harm reduction agency, lives 25 minutes away from the clinic. She said 28 days of take-home methadone, the maximum allowed under the new federal rules, would give her more freedom to travel and a "more normal quality of life."
"This is the only medication where you have to disrupt your life by going someplace every day," she said.
Under the new rules, which Arizona plans to embrace, clinics will have broad discretion about which people qualify for take-home doses. Ideally, such decisions will be made jointly between doctors and patients. But money will play a role too, experts said.
Frances McGaffey, who researches substance use treatments for the nonprofit Pew Charitable Trusts, said payments to clinics are sometimes tied to in-person dosing, which can discourage take-home treatment.
"States should be looking at their payment policy and see what kind of care they're incentivizing," she said.
In Arizona, clinics now get $15 per in-person dose from the state's Medicaid program versus about $4 per take-home dose. The state is considering options including making those amounts equal or adopting what's called "bundled payment," a model that reflects the overall cost of treatment.
New York's Medicaid program uses a bundled payment model so there's no financial incentive for in-person dosing.
Longtime methadone patient David Frank, PhD, a 52-year-old New York University sociologist, gets 4 weeks of take-home methadone in wafer form from his clinic.
"I never in a million years could have gone back to school, got my PhD, done research or taught -- any of that stuff -- if I had to go to a clinic every day," Frank said. "It's night and day in terms of your ability to live a stable, happy, quality life."
A Movement to 'Liberate Methadone'
The methadone clinic system dates back to 1974, when the U.S. saw fewer than 7,000 overdose deaths a year. Some longtime patients -- including Garnett and Frank -- are organizing a movement to "liberate methadone" as annual overdose deaths now top 107,000. They support legislation to allow addiction specialist physicians to prescribe methadone and pharmacies to fill those prescriptions.
The don't go that far, but they include other changes, such as:
- In states that adopt the rules, methadone treatment can start faster; people will no longer need to demonstrate a 1-year history of opioid addiction
- Counseling can be optional instead of mandatory
- Telehealth can be used to assess patients, improving access for rural residents
- Nurse practitioners and physician assistants -- not just doctors -- can start people on methadone
"It really is up to states to adopt these changes in order to increase access to care," said Mark Parrino, MPA, president of the American Association for the Treatment of Opioid Dependence.
Tennessee officials have drafted new rules that are stricter than the federal government's. The state's proposal would increase random urine drug screening, make counseling mandatory for many patients and obligate clinics to hire pharmacists if they want to dispense take-home doses.
The state's proposed rules "are duplicative, contradictory, prescriptive, rigid, and written in a way that seeks to punish versus heal people living with an opioid use disorder," wrote Zac Talbott, who operates four methadone clinics in Tennessee, Georgia, and North Carolina.
In states that do adopt the federal rules, the changes will be a heavy lift for some clinics, experts said. Some clinic leaders may disagree with the patient-centered philosophy behind the changes. Some may balk at the legal liability that goes with judgment calls about which people can safely take methadone at home.
"Not all opioid treatment programs are created equal," said Linda Hurley, CEO of Rhode Island's oldest methadone program, CODAC Behavioral Healthcare.
Clinics are used to operating within a highly restrictive environment, said Meyerson, the University of Arizona researcher.
"We have regulated them into a corner for years," Meyerson said. The new rules allow the clinics to put the well-being of patients at the center of care.
"The question is," she said, "can they do it?"