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The first major update to US methadone regulation in 20 years is poised to expand access to the life-saving drug from next month, but experts say addiction treatment The changes could fall flat if state governments and methadone clinics do not act.
For decades, strict rules required most methadone patients to line up at special clinics each morning to drink their daily dose of the liquid medicine while being watched. The rules, built on the distrust of people in the grip of opioid addiction, were intended to prevent overdose and diversion – the illicit sale or sharing of methadone.
The COVID-19 pandemic has changed the calculus of risk. To prevent the spread of coronavirus in crowded clinics, emergency rules allow patients to take unsupervised methadone at home.
Research has shown the wider practice was safe. Overdose deaths and drug diversion have not increased. And people are staying in treatment longer.
With the growing evidence, the US government made the changes permanent earlier this year. October 2nd is the date when clinics must comply with the new rules – unless they are 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 who oversees substance use services.
“This is a step towards the country – and everyone – saying this is not bad,” Walden said. “People don’t have to show up every day to get a medication that can help save their life.”
Methadone, an opioid itself, can be dangerous in large amounts. When taken correctly, it can stop drug cravings without causing a high. Numerous studies they have shown to reduce 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 any given day treat nearly 500,000 American patients with the drug.
The new federal rules allow stable patients to take home 28 days of methadone. Colorado, New York and Massachusetts are among the 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 highest drug overdose death rates in the nation.
“Where you live matters,” said University of Arizona researcher Beth Meyerson, who studies methadone policy.
Phoenix resident Irene Garnett, 44, welcomes more doses of methadone to take home. Her clinic now requires her to come twice a week, even though she’s been a patient there for more than 10 years, “which is just scary,” 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 somewhere every day,” he said.
Under the new rules, which Arizona plans to adopt, clinics have broad discretion over which people qualify for take-home doses. Ideally, such decisions would be made jointly between doctors and patients. But money also plays a role, experts said.
Frances McGaffey, who studies substance use treatments for the nonprofit Pew Charitable Trusts, said payments to clinics are sometimes tied to in-person dosing, which can discourage home treatment.
“States should look at their payment policies and see what kind of care they’re incentivizing,” he said.
In Arizona, clinics now receive $15 per in-person dose from the state’s Medicaid program versus about $4 per take-home dose. The state considers options including the equality of those amounts or the adoption of what is called “bundle payment”, a model that reflects the overall cost of treatment.
New York’s Medicaid program uses a bundled payment model so there is no financial incentive for in-person dosing.
Longtime patient David Frank, a 52-year-old New York University sociologist, receives four weeks of methadone in wafer form from his clinic.
“Never in a million years could I go back to school, get my Ph.D., do research or teach — any of those things — 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.”
The methadone clinic system dates back to 1974, when the United States saw fewer than 7,000 overdose deaths annually. Some longtime patients — including Garnett and Frank — are organizing a movement to “free the methadone” as annual overdose deaths now number 107,000. They support legislation to allow addiction specialists to prescribe methadone and pharmacies to fill those prescriptions.
The new federal regulations don’t go that far, but include other changes, such as:
– In states that adopt the rules, methadone treatment can start faster. People no longer need to show a one-year history of opioid addiction.
– Advice 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’s really up to the states to adopt these changes to increase access to care,” said Mark Parrino, president of the American Opioid Addiction Treatment Association.
Tennessee officials have drawn up new rules that are stricter than those of the federal government. The state’s proposal would increase random urine drug screening, make counseling mandatory for many patients and force 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 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 extol the legal liability that goes with making 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 in a highly restrictive environment, said Meyerson, the University of Arizona researcher.
“We’ve backed ourselves into a corner for years,” Meyerson said. The new rules allow clinics to put patients’ well-being at the center of care.
“The question is,” he said, “can they do it?”
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The Department of Health and Science of the Associated Press receives support from the Science and Media Education Group of the Howard Hughes Medical Institute. The AP is solely responsible for all content.