Methadone treatment gets first major update in over 20 years

The federal government is unveiling new regulations meant to modernize methadone treatment, the first major update to patient care standards at methadone clinics in more than 20 years.

The new rules are aimed at increasing access to methadone, which has been used to treat opioid addiction in the U.S. since the early 1970s. The medication is highly effective: Studies show that people taking it are roughly 60% less likely to die of an opioid overdose. Still, even amid the opioid crisis, methadone treatment remains stigmatized and often inaccessible to those who need it most. To receive methadone, most patients must submit to frequent drug testing, participate in counseling sessions, and show up daily to receive a single dose. 

Beginning in April, however, patients and clinicians at methadone clinics will enjoy far greater flexibility. Amid complaints that methadone doses are too low to stave off withdrawal, clinic doctors will have flexibility to prescribe methadone in larger doses to new patients. Clinics will also have more freedom to prescribe patients “take-home” medication, meaning they would be required to show up at the clinic less often. 

“At HHS, we believe there should be no wrong door for people who are seeking support and care to manage their behavioral health challenges, including when it comes to getting treatment for substance use disorder,” Andrea Palm, the deputy secretary of the Department of Health and Human Services, said in a statement. “The easier we make it for people to access the treatments they need, the more lives we can save. With these announcements, we are dramatically expanding access to life-saving medications and continuing our efforts to meet people where they are in their recovery journeys.” 

More than 600,000 patients across the country receive methadone treatment from roughly 2,000 specialized clinics, also known as opioid treatment programs or OTPs. But despite the medication’s effectiveness, many patients view the restrictions that come with methadone treatment as impossibly burdensome — even bestowing it with the nickname “liquid handcuffs.”

 Methadone treatment became far more flexible during the coronavirus pandemic, however, when the federal government enacted a number of changes meant to help patients avoid constant clinic visits and avoid Covid-19. Most significantly, those emergency flexibilities allowed clinics to be far more liberal with “take-home” medications. Studies show that despite the improved access, methadone misuse and overdoses involving methadone did not increase. 

More broadly, the regulations are aimed at centering patients in their care and reducing barriers and stigma that prevent people from getting methadone, according to the Substance Abuse and Mental Health Services Administration, an agency within HHS that oversees methadone clinics. 

Among other changes, the new regulations admonish clinics not to use the results of drug toxicology testing “punitively.” They removed language that policymakers considered to be stigmatizing, like “drug abuse” or “detoxification treatment,” replacing them with more neutral terms like “substance use” or “withdrawal management.” And they stress that clinics should consider basic life circumstances that can be helpful to recovery, like patients’ need to attend school or hold a job, as reasons not to require daily clinic attendance. 

Despite the new flexibilities at the federal level, however, it is unclear how much patients will benefit. States typically regulate methadone clinics more strictly than the federal government, and some clinics often impose stricter standards on their patients than required. While SAMHSA sets minimum standards, the agency has little practical mechanism for forcing individual clinics to be more permissive. 

Moreover, even amid widespread calls for reforms of the methadone treatment system, the regulations do little to change the core realities of methadone treatment. Patients will still be required to submit drug tests at least eight times per year and participate in counseling, and methadone will still be available exclusively at specialized methadone clinics. 

The regulations come amid a broader debate about methadone treatment that has pitted Democratic and Republican lawmakers, the American Society of Addiction Medicine, and the American Medical Association against the American Association for the Treatment of Opioid Dependence, a trade group representing methadone clinics. 

Two of those lawmakers, Sen. Ed Markey (D-Mass.) and Rep. Don Norcross (D-N.J.) have argued that clinics currently possess a de facto monopoly over the medication, and Norcross has referred to methadone clinics as “cartels.” As a result, they argue, methadone is vastly underutilized even as opioid overdoses claim roughly 85,000 American lives each year.

Along with several Republicans, Markey and Norcross have pushed to allow board-certified addiction doctors to prescribe methadone directly to their patients, which is currently illegal. The bill has received support from ASAM, the AMA, and other major addiction policy groups. 

Methadone clinics, however, have strongly pushed back with a public-relations blitz titled “Program, Not a Pill,” arguing that methadone treatment is more than the medication itself and that significantly expanding methadone access could do more harm than good, destabilizing the treatment system and leading to an increase in overdoses involving methadone. 

In separate statements, Markey and ASAM welcomed the new regulation, but argued it does not go far enough. Markey said the rule is “exacerbating a two-tiered system” that allows OTPs to dispense methadone but prohibits board-certified addiction doctors from doing the same. Meanwhile, ASAM’s president, Brian Hurley, pointed to a provision that gives decision-making power to non-physicians at methadone clinics, like nurse practitioners and physician assistants, as more evidence that doctors specializing in addiction medicine should be allowed to use the medication in their own practices.

“Given SAMHSA’s decision to allow non-physician, OTP practitioners to make clinical determinations as to which patients can safely handle take-home methadone doses, certainly Congress can now allow board certified physicians in addiction medicine and addiction psychiatry to do the same,” Hurley said.

STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.