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, including in Alabama, 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 methadone unsupervised at home. Research showed 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. Oct. 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, 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. Numerous studies 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.
In Arizona, clinics now get $15 per in-person dose from the state's Medicaid program vs. 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.
A movement to ‘liberate methadone’
The methadone clinic system dates to 1974, when the U.S. saw fewer than 7,000 overdose deaths a year. Some longtime patients 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 new federal rules 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 one-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.
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.
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.
