Under new rules, methadone clinics can offer more take-home doses. Will they?

Danielle Russell is, as she says, a “poster child” for methadone. For more than a decade, the medication — one of the most effective treatments for opioid addiction — has helped her move past the heroin she used to use. She finished a series of degrees, and is now a Ph.D. student in justice studies at Arizona State University.

As life-changing as methadone is, the catch is that taking the tightly regulated medication requires reporting to a special clinic nearly every day to get one’s dose. When the Covid-19 pandemic arrived, that changed. In an effort to reduce contact among people at clinics, federal health officials said that providers could give up to 14 days of take-home doses to patients broadly, and up to 28 days to “stable” patients — patients, Russell thought, like her.

Russell, who had been going to her Phoenix clinic six days a week prior to Covid, did get an increase in her take-home allowance, but nowhere near 28 days. Instead, the clinic allowed her to come in three days a week, she said, giving her one extra take-home dose with each visit and still requiring her to make multiple trips a week to a crowded building during the height of the pandemic.

“It was pretty bleak how clear it was how little they cared about us,” Russell said.

Russell was not alone. While many of the country’s 1,900 methadone clinics — called opioid treatment programs, or OTPs — extended some take-home flexibility, particularly early in the pandemic, a fraction of patients got the full weeks of take-home doses that the government enabled clinics to offer, according to studies and interviews with patients, advocates, and researchers. Some clinics, sometimes required by more stringent state rules, have since rolled back the flexibility they did provide.

The tension between looser rules on paper and the resistance among some clinics and states to take-home methadone will only intensify. Last week, the Substance Abuse and Mental Health Services Administration announced it was moving to make the pandemic-era flexibilities permanent, pointing to evidence that expanded take-homes improved patients’ quality of life and didn’t introduce new harms. Experts and advocates have largely celebrated the move. But they also wonder how widely states and individual clinics — which have great autonomy in offering patients take-home doses, and rescinding them — will adopt the changes even with a permanent policy.

“Even though they were given those flexibilities, many didn’t enact those flexibilities” during the pandemic, said Ximena Levander, an addiction medicine physician at Oregon Health & Science University, who has surveyed clinics and patients about take-home policies. “So how much is this going to help?”

How widely clinics will start providing their patients with more doses of methadone is “the million dollar question,” said Erin Madden, a health services researcher at Wayne State University, who has studied the uneasiness of providers to loosen methadone rules.  Expanding treatment options as widely as possible is crucial, she and other experts say: 107,000 people died of overdoses in 2021, largely as a result of opioids.

OTPs have historically defended the system by arguing that addiction treatment requires the expert and comprehensive care they provide, and that a structured routine can help people avoid illicit drugs. But notably, the industry group that represents most OTPs, the American Association for the Treatment of Opioid Dependence, has endorsed SAMHSA’s move, with its president, Mark Parrino, calling it a step that is “enlightened and will move the field forward.”

Parrino noted that the policy gives providers the discretion to offer more take-homes. He said providers still have to consider the patients they’re treating and the risk that patients could misuse methadone, which is an opioid itself.

“These are opportunities,” Parrino said. “It is the clinicians and the programs that make the decisions.”

Yngvild Olsen, who leads SAMHSA’s Center for Substance Abuse Treatment, said the agency was focused on finalizing the more flexible policy, and didn’t address questions about whether or how the government would try to get clinics to expand take-homes. But she said that such a substantial shift in methadone rules could itself serve as a motivation to broaden access, and that the experience of take-homes during the pandemic demonstrated the benefits of such a policy.

“This is the first major proposed change to these regulations that has happened in 20 years,” Olsen told STAT.

In Arizona, when Russell found out she wouldn’t be getting the take-home doses she thought she should, and after hearing similar stories, she set out to document what was going on. She and colleagues launched a project that involved interviewing Arizonans on methadone — as well as another medication for opioid use disorder, buprenorphine — about any changes to medication access they saw during the pandemic. As they reported in October, not one person interviewed got a full two weeks of take-home methadone doses, let alone four weeks. Forty percent of patients had to keep going to the clinic every day.

The OTP system dates back five decades, a structure that advocates and many experts have long criticized as paternalistic and burdensome. They say that the hoops patients have to jump through for a medication that’s been proven to tame cravings and reduce deaths pushes some off the treatment, because they don’t want to or simply can’t get to the clinic every day. Experts also note that Black patients are more likely to be routed to methadone clinics, while white patients are more likely to be prescribed buprenorphine, which is not as tightly controlled — a dynamic at play in the growing racial disparities in overdose deaths.

A burgeoning movement has called for making methadone available at pharmacies with a prescription, a policy in other countries like Canada and Australia. Supporters point to the fact that only 400,000 of the millions of Americans with opioid use disorder are on methadone as a sign that the barriers keep people off treatment. Mandating treatment at opioid treatment programs also creates geographic obstacles. A quarter of the U.S. population doesn’t have an OTP in their county. Wyoming has none.

Many OTPs have resisted relaxing the regulations. They note that as an opioid, methadone poses a risk of diversion — that people will sell their doses — and of overdose, and thus warrants supervision and specialized care. OTPs are also equipped to provide additional services like counseling.

The pandemic-inspired flexibility seemed like an intermediate step at loosening the methadone rules. Before Covid, patients could get take-homes, but they had to earn them by adhering to clinic rules and making months of daily trips before becoming eligible. But in March 2020, the government issued its blanket take-home policy, with patients able to get several weeks of doses depending on how “stable” their providers assessed them to be. If a state accepted the new policy, clinics there could offer more take-homes.

The policy was met with enthusiasm. All but seven states allowed clinics to follow SAMHSA’s new flexibility, according to Olsen. A survey of 142 OTPs in June 2020 found that 127 of them had increased take-home doses — though not always to the full extent the rules allowed.

Surveys of patients found that the take-homes helped them lead more normal lives, with time for work and family. While some value the structure of daily clinic visits, many said the take-homes made them feel like they were taking a regular medication, no longer penalized for their past drug use.

“I don’t have to stop what I am doing to come in to dose. And it also helps me with my recovery just to get these benefits of take-homes…It makes me feel proud of myself,” one patient reported. Another patient said, “When you get your take-homes it’s like you feel you are being trusted to take care of yourself, and do the right thing.”

Getting a week’s worth of take-home doses was “huge” for Irene Garnett, a Phoenix woman who’s been on methadone for a decade. Some periods during the pandemic, Garnett didn’t have access to a car, and bus service was rolled back, so it was a relief not to have to make daily trips.

But Garnett wondered if getting even a week of take-homes made her an exception. She is involved with a local drug policy advocacy board, and helped conduct the interviews for the paper on which she and Russell were co-authors. Other patients barely had any increase in take-homes, perhaps a day or two of extra doses.

“The inconsistency with which these policies were implemented was really frustrating,” Garnett said.

Months into the pandemic, some clinics started to reimpose normal rules, researchers say. Some patients reported that their clinics returned to in-person dosing as early as summer 2020. By summer 2021, at least five states that allowed for expanded take-homes had already rescinded the policy, and three others said they planned to rescind the policy before the end of the pandemic, according to a Pew Charitable Trusts survey. Many states, however, said they intended to keep the policy as long as the federal government would allow.

The results from the pandemic-era methadone experiment have been positive. Not only did it improve quality of life, but a recent study found that patients who got more take-homes were more likely to remain on treatment and were less likely to use illicit opioids. Diversion was rare, researchers found. Moreover, a study found that methadone-involved overdoses remained stable, suggesting that expanding take-homes will not exacerbate the overdose crisis, which is largely driven by illicit fentanyl.

The flexibilities allowed not only for patients and OTP staff to stay safe from Covid, “but have also very much supported people’s ongoing recovery — their ability to be employed, go to work, take care of their families, really practice the recovery they’re engaged in,” said SAMHSA’s Olsen. She described making the flexibility permanent as a shift from “a very rule-based” system, to one based on a provider’s decisions for individual patients.

So why didn’t more clinics offer more take-homes? It could be that providers simply didn’t see many patients qualifying as “stable” according to SAMHSA’s definition, which included factors such as how long patients had been on methadone, how well they adhered to clinic rules, and whether providers thought they could store their take-home doses. Perhaps some clinics didn’t want to extend take-homes under a temporary policy, and will become more open when the flexibility becomes permanent.

Critics of the system also argue that clinics have a financial incentive to maintain the status quo. They can bill insurance or charge patients (many clinics take cash) for more services, from drug tests to counseling sessions, when people come in more frequently. Giving patients more take-homes could amount to lost revenue, at a time when for-profit organizations have been growing their footprint in addiction treatment services.

AATOD’s Parrino called such criticisms “disingenuous.” He said that clinics provide services in the best interest of patients. He also noted that providers have to consider their legal and licensing liability if the medication they prescribe isn’t taken on-site and is misused.

Still, in supporting making permanent the take-home rules, Parrino noted that the flexibility during the pandemic resulted in better retention rates. AATOD has also called on states to align their policies — some of which are stricter than federal rules — with SAMHSA’s regulations.

“It’s wise to give greater clinical flexibility to the clinicians in the OTPs,” he said.

Advocates and experts stress that they support SAMHSA’s move to make the pandemic-era policies permanent, which would also allow patients to start methadone faster and ease access to buprenorphine. They also agree that providers should have discretion in treating their patients.

But they worry that clinics will be slow to offer more take-homes, at a time when they argue that the benefits of widening access to take-home doses for many patients far outweigh the risks. Many OTPs have long histories of enforcing strict rules, sometimes cutting patients off if they don’t remain abstinent, for example, and may not feel a need to change their programs.

“Whether or not the rule is on the books, you’re going to see a lot of” clinics not offering more take-homes, said Noa Krawczyk, a substance use epidemiologist at New York University’s Center for Opioid Epidemiology and Policy. “If you’re the only OTP for 100 miles, you can do whatever you want. Patients are dependent on methadone, and they don’t have another choice.”

For her part, Russell eventually got a month’s worth of take-home doses, after her OTP changed owners. She went from weekly drug tests to monthly.

No longer needing to go to the clinic so often, Russell had more time to devote to school and research, she said. She traveled internationally, including to Australia, where she saw a friend pick up methadone at a pharmacy.

She said she hadn’t realized how limiting the visits to the clinic were until she stopped having to make them.

“It was life-changing,” Russell said. “I knew I hated going in that frequently, but because I had been doing it for so long, I just did it. When it changed, I had all that time back in my life. I felt like a normal person.”

To find treatment options for substance use disorders, visit findtreatment.gov or call 800-662-HELP (4357).

This story is part of a series on addiction in 2022, supported by a grant from the National Institute of Health Care Management. Previous articles covered the spike in overdose deaths among Black Americans, the Americans with Disabilities Act’s protection of people with addiction histories, the debate about “safer supply” programs, and the rise of the tranquilizer xylazine in the drug supply. 

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