People wait in line for a methadone clinic to open in Hoquiam, Wash., in 2017. As a chorus of physicians and advocates calls for loosening methadone restrictions, states have been slower to adopt new relaxed federal rules. (David Goldman/The Associated Press)
Matt Haney’s home in San Francisco isn’t far from a methadone clinic.
The 42-year-old state lawmaker has watched people line up early each morning outside the clinic in the Tenderloin, a community long considered the epicenter of the city’s substance use epidemic. His neighbors wait for the daily dose of methadone that relieves their cravings and minimizes opioid withdrawal symptoms.
Despite methadone’s effectiveness, a labyrinth of state and federal rules — meant to guard against its misuse — keeps it inaccessible to many people who desperately need it, Haney said.
“What kind of normal person with a job, a life and a family can line up for medication every morning, sometimes far from where they live?”
The Democratic assemblymember and majority whip noted that California is one of many states with rules that are stricter than federal regulations on when, where and how people can access opioid treatments like methadone.
“It’s almost comical how difficult it is to get this medication and stay on it,” he said.
Yet addiction treatment in the United States is poised for change. This year, the federal Substance Abuse and Mental Health Services Administration, known as SAMHSA, made permanent a set of pandemic-era rules that loosened several restrictions, including those on take-home doses of methadone.
It’s a move that a broad consensus of academics, advocates and providers says will improve treatment access and success rates. Having the flexibility to take medication at home can mean patients can get to work or get their kids to school on time. They can deal with family emergencies and unexpected travel. And they avoid the stigma of waiting in line at a clinic.
What kind of normal person with a job, a life and a family can line up for medication every morning, sometimes far from where they live?
– Matt Haney, a Democratic member of the California State Assembly
In theory, the new federal rules make more take-home methadone doses available to a wider subset of patients. But what’s less clear is how the rules will trickle down to states. There’s concern states that didn’t preserve the relaxed regulations they had during the pandemic might be slow to adopt them now.
“A number of states will have to revise their regulations if they’re going to be in alignment with what SAMHSA has released,” Mark Parrino, founder and president of the American Association for the Treatment of Opioid Dependence Inc., a national trade group that supports the new federal regulations. “What could delay implementation would be the state regulators.”
Later this month at his group’s annual conference, SAMHSA will convene a closed-door meeting of regulators from all 50 states to discuss the new federal rules and how states might bring their own standards into compliance, Parrino said.
It’s all happening as the opioid crisis, driven by rising fentanyl overdoses, has prompted a chorus of physicians and advocates to call for loosening methadone restrictions even further — a move that leaders at many opioid treatment programs oppose.
‘Liquid handcuffs’
Medications that treat opioid use disorder — such as methadone, buprenorphine and naltrexone — are rigorously regulated by the government. They block the effects of opioids or halt withdrawal symptoms and reduce cravings without causing the same feelings of euphoria.
But while medications like buprenorphine can be prescribed by a physician and taken at home, methadone can only be prescribed and dispensed in the United States through federally certified clinics called opioid treatment programs. Methadone can be taken as a liquid, a pill or an injectable.
Currently, about 1,800 certified opioid treatment programs operate in the United States, giving methadone treatment to about 400,000 people.
That’s just 19% of the estimated 2.1 million people in the United States who have opioid use disorder.
As Fentanyl Use Spikes, Feds Urge States to Ease Methadone Rules
Until the pandemic, most methadone patients had to visit a clinic daily to take their doses while a provider watched. Restrictions stem from concern that methadone can be abused or resold. Even though it does not produce an intense high, it’s possible to overdose if it’s not taken as prescribed.
But the tight regulation created a system that keeps patients tethered to the nearest methadone clinic with what some have called “liquid handcuffs.” Long clinic lines, varying hours, counseling requirements and inflexible rules around rescheduling appointments make it difficult for patients to juggle job and family responsibilities.
One pregnant patient in a 2021 study reported being required to remain in line at her methadone clinic even after her water broke. Other patients said they were refused take-home doses for family emergency situations or were randomly required to make additional clinic visits. Ten states require methadone providers to observe patients during urine sample collection, according to a 2021 analysis by The Pew Charitable Trusts.
“There’s no other medical condition where we feel like patients need to earn the right to treatment,” said Ximena Levander, an addiction medicine physician and researcher at Oregon Health & Science University. “What SAMHSA has done with these new rules is to try to shift that paradigm from a punitive, ‘you need to earn this’ model to a patient-centered, individualized treatment plan.
“But it’s going to take time for that culture change to happen.”
A power imbalance
At the outset of the COVID-19 pandemic, federal officials allowed states to give more methadone patients up to 28 days of take-home doses. In February of this year, SAMHSA made these new, looser rules permanent. They went into effect last month, and opioid treatment programs have until October to comply.
“That’s an ambitious timeline,” said Parrino, of the trade group. His association represents more than 1,300 opioid treatment clinics.
At least 10 states had “stability criteria” for take-home doses that were stricter than federal rules as of June 2021. Individual opioid treatment programs might be more conservative still. Some, for example, won’t allow take-home doses for patients who drink alcohol or use cannabis. Even individual clinicians might have their own views about what patients must do before being allowed take-home doses.
The requirements help keep patients safe, Parrino said: “Methadone is an incredibly successful medication and it’s extremely effective, but it’s deadly if used unwisely.”
Yet for patients, opioid treatment programs’ monopoly on methadone treatment represents a power imbalance that’s not as apparent in other areas of medicine.
Levander recalled one patient who said her treatment program had increased her required clinic visits from once a month to once every two weeks, and she felt like she had no recourse to challenge that decision.
“Patients know if they lose access to their medication, they may not have another methadone program nearby and they could return to use [of illicit drugs],” Levander said. “The opioid treatment programs have all the power and control. There’s not a lot of desire from patients to rock the boat.”
Haney, the California state lawmaker, has introduced a bill that would remove several barriers to methadone access, including allowing physicians outside of opioid treatment clinics to temporarily prescribe take-home doses. The bill passed out of committee late last month with bipartisan support.
Minnesota lawmakers introduced a bill this year, still in committee, that would bring the state’s rules for dispensing take-home doses in line with federal rules. Some states, such as Massachusetts, issued executive orders adopting many of the new federal guidelines. State agencies in places including Minnesota and Colorado have shifted their rules to adopt a more patient-centered approach to addiction medicine.
But other states haven’t yet followed suit.
“It’s so highly variable as far as where states are on this issue,” said Bobby Mukkamala, a physician in Flint, Michigan, who is on the board of trustees at the American Medical Association. “Some states are way ahead at truly looking at substance use disorder as a medical condition, not something to be punished.”
Methadone monopoly
Meanwhile, a bipartisan bill in Congress could further deregulate the opioid treatment industry and open methadone treatment nationally to physicians outside of clinics. U.S. Sen. Edward Markey, a Democrat from Massachusetts, and U.S. Sen. Rand Paul, a Republican from Kentucky, have introduced legislation that would allow physicians trained in addiction treatment to prescribe methadone outside of a clinic.
It’s a move supported by several national organizations, including the American Medical Association.
“If it’s the restriction that’s stopping patients with these issues from seeing a physician to help, then we need to remove it,” said Mukkamala.
But the opioid treatment program industry is pushing back. Parrino noted that many opioid use disorder patients have other associated conditions, from HIV to emotional trauma, that require the kind of comprehensive and regimented treatment available from a certified clinic.
Earlier this year, Markey suggested opioid treatment clinics have more financially driven motivations for their opposition to expanding methadone to non-clinic settings.
“Ultimately, tethering methadone exclusively to opioid treatment programs is less about access, or health and safety, but about control, and for many investors in those programs, it is about profit,” he said in a February statement about the new rules.
Nearly two-thirds of opioid treatment programs are operated by for-profit companies. At least 562 of those are financed by private equity firms, according to a STAT News analysis. Private equity’s involvement in health care has been the subject of an avalanche of scrutiny from lawmakers, advocates and researchers in recent years.
A growing body of research supports methadone’s deregulation. A 2022 survey of opioid treatment patients in a Midwest community found more than half reported travel and work conflicts kept them from treatment. Last year, researchers found that flexible methadone take-home policies were associated with fewer overdose deaths among Black and Hispanic men. Another recent study found that take-home flexibility of methadone did not lead to more methadone-involved deaths.
Haney, the California lawmaker, thinks moving methadone beyond clinic walls would benefit not just people with opioid use disorder, but also their surrounding communities, such as the Tenderloin.
“These outdated policies come from a fear of these patients and a fear of this medication that’s misguided,” he said. “It’s fueling the crisis that we are now facing.”
This story is republished from Stateline, a sister publication of the Kentucky Lantern and part of the States Newsroom network.
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