States are rushing to relax decades-old restrictions on methadone treatment for opioid addiction, potentially freeing patients from burdensome requirements and making the medication more accessible for millions of people.
The changes have swept across the country in a matter of months, reflecting the dramatic shift — accelerated by the Covid-19 pandemic — in regulators’ approach to the drug.
California is the latest state to take action. Gov. Gavin Newsom (D) signed a bill Friday that introduces flexibilities intended to make it easier for providers and patients to start and stick to an effective treatment plan, such as allowing methadone patients to take up to a week’s worth of the medication at home.
“Dealers are much better at getting fentanyl and heroin into people’s hands than we are at getting them addiction medication,” California Assemblymember Matt Haney (D), the bill sponsor, said in a statement. “We have to reverse that entirely if we want to save people’s lives.”
The California bill was designed to reflect federal rules announced in February that marked the first major overhaul of the regulations since the 1970s.
Eighteen other jurisdictions, including states, territories and Washington, D.C., have made similar changes in recent months. Thirty-six more plan to be in full alignment with the federal rule change by the time it goes into effect in October, according to an official at the federal Substance Abuse and Mental Health Services Administration.
Methadone is a synthetic opioid that binds to the same receptors in the brain as heroin and fentanyl. But it is slower acting, which makes it effective for treating cravings and other withdrawal symptoms without producing the same euphoric effect.
It is one of three medications considered safe and effective by the U.S. Food and Drug Administration to treat opioid use disorder and has been shown to reduce the likelihood of a fatal overdose by more than 50%.
But its use has been strictly regulated since the Nixon administration set national rules that prioritized monitoring patients and preventing so-called diversion: selling the drug on the street. Patients had to submit to frequent drug testing and undergo routine counseling and could only get treatment through accredited clinics. The last revision to the federal rules was made in 2001, and the core requirements remained unchanged.
States had to at a minimum adhere to federal guidelines. But most enacted their own regulations that either reflected the federal rules or created additional restrictions, according to Frances McGaffey, associate manager of the substance use prevention and treatment initiative at the Pew Charitable Trusts, which tracks state methadone laws.
In 2021, for example, about half of the states required methadone patients to attend in-person counseling on a set schedule to remain in treatment. Other states required additional urine screenings and prohibitions on obtaining doses from convenient clinics during travel.
“This was a crime reduction strategy,” McGaffey said. “The understanding in the Nixon administration was that people who use drugs were fueling a crime wave, so we’re going to treat them in order to reduce crime, not to improve the lives of the people using, at that time, heroin. So it was not patient-centered. Flexibility and patient needs and preferences were not a priority.”
Critics have long argued that such regulations stigmatize patients and make it hard for them to maintain other responsibilities, often putting the treatment out of reach. In California, for example, fewer than 5% of the nearly 1 million residents with opioid use disorder receive methadone treatment, according to committee testimony by Jeffrey Horn, a physician at the San Francisco Department of Public Health.
“We must increase access if we are to turn this crisis around and save lives,” he said.
The pandemic provided a case study in what would happen if methadone restrictions were relaxed. To allow patients to continue treatment during lockdowns, federal regulators temporarily allowed patient counseling and check-ins via telehealth and increased the number of take-home doses allowed at one time, even at early stages of treatment.
Resulting data showed that there were no significant changes in rates of diversion, patients were more likely to stay in treatment and report better quality of care, and methadone-related deaths didn’t rise.
The federal rule change referenced the growing body of evidence supporting more relaxed restrictions but acknowledged concerns that it would make little difference in states that had superseding regulations.
Most of the states that have modified their regulations did so quietly, through administrative or regulatory bodies. Minnesota tucked the language into an omnibus bill.
California is the only legislature so far to pass a standalone bill that enumerates the changes.
The bill would allow doctors to prescribe up to 72 hours worth of take-home methadone, previously available only through a clinic. It would also increase the amount of methadone a patient can take home from a clinic, loosen restrictions on entry and participation in treatment programs, and give doctors more discretion to determine the proper dosage of methadone for their patients.
Both chambers passed it unanimously without any recorded opposition. Advocates for less restrictive methadone laws said they hoped that the new law would encourage other states to take additional steps, such as revising Medicaid payment models that incentivize in-person treatment by reimbursing opioid treatment centers more for daily doses.
Treatment centers, many of which are for-profit, have raised concerns that methadone-related overdose deaths could spike if patient supervision is relaxed. The American Association for the Treatment of Opioid Dependence, a treatment center trade group, did not respond to requests for comment.
“The most important thing that we’ll have to look at going forward is: You can align the laws, but if the providers are not actually doing these new practices, nothing has really changed,” said Noa Krawczyk, a professor at NYU Langone Health who has studied methadone laws.