With New Final Methadone Rule, SAMHSA Isn’t Coming to Save Us

    People on methadone in the United States have been thrown under the bus yet again amid the continuing devastation of the opioid-involved overdose crisis. Tellingly, confirmation of a round of inadequate, toothless reforms has been welcomed by supporters of the punitive clinic system that restricts access to the lifesaving medication.

    On February 2, the Substance Abuse and Mental Health Services Administration announced the finalization of its new rule on methadone access, originally proposed in December 2022. Changes to the 42 CFR part 8 regulations for opioid treatment programs (OTP, or methadone clinics), will take effect on April 2.

    The most important update concerns the ability of people attending clinics to get a greater number of take-home doses faster. The sped-up timetable has the potential to free more people from a daily trek to a clinic to drink a single dose of liquid methadone.

    Those changes sound real good. But they don’t go anywhere near far enough, and there’s another catch.

    Other positive changes include increasing the starting dose for new patients from 30 milligrams to 50; making access to medication not contingent upon compliance with counseling services; and not relying solely on urine toxicologies to make decisions about take-homes.

    Those changes sound real good. But they don’t go anywhere near far enough, and there’s another catch. The final rule cannot be enforced by SAMHSA. As always, it’s left up to each OTP to decide if it wants to enact any, some or none of the revised treatment standards. State and local regulations also impact which federal changes can be implemented.

    The reaction from Mark Parrino, president of the American Association for the Treatment of Opioid Dependence (AATOD), which represents OTP, tells us all we need to know.

    “These enlightened and thoughtful regulations have been in preparation for over one year and we appreciate the fact that these regulations have been reviewed by the Drug Enforcement Administration,” he said in a press release. “We extend our gratitude to SAMHSA for hearing our concerns so that we can improve our ability to care for our patients.”

    If AATOD deems the final rule “thoughtful” and “enlightened,” you can be sure it doesn’t threaten the cartel-like stranglehold of the clinics. Parrino knows this, when his organization has worked closely with both federal agencies for decades.

    For patients, it means the majority will continue to suffer under the clinics’ culture of cruelty, as documented in the Urban Survivors Union’s Methadone Manifesto.

    The changes have Parrino’s support because they enact measures that put more patients in the clinics’ “liquid handcuffs,” increasing profit margins. Minors with opioid use disorder can now be admitted for treatment without prior attempts to detox; patients can be in interim treatment for longer (starting on methadone without yet receiving other services, like counseling); clinics can deploy mobile methadone vans; and patients can be inducted onto methadone through audio-visual telehealth appointments… before being medicated at the OTP.

    “Those of us on methadone see this for what it is, another blatant attempt to undermine our cries for humane medical care.”

    Again, these changes are positive as far as they go. But none alter the structural dynamic of patients being under the control of clinics, with access far more restricted than if methadone could be picked up from pharmacies like any other medication.

    The more things change, the more they stay the same

    “Those of us on methadone see this for what it is, another blatant attempt to undermine our cries for humane medical care free from the abuse of OTPs,” Melissa Burkholder, a methadone patient from Virginia, told Filter. “The only people praising SAMHSA and acting as if these new rules are going to improve methadone access are either completely ignorant to how these carceral clinics operate or they’re blatantly misleading the public.”

    “It’s no mistake that SAMHSA doesn’t mention that the clinics are free to ignore the updated rules entirely,” Burkholder added. “And we know that they will.”

    Despite the final rule, the methadone regulatory system will remain a confusing, contradictory, fragmented, opaque hellscape with guidelines subject to broad interpretation.

    Without a trace of remorse or regret, SAMHSA noted: “This final rule is the first substantial update to the OTP treatment standards in over 20 years.”

    From 1999-2021, nearly 645,000 people died of an opioid-involved overdose.

    Why didn’t SAMHSA update its regulations in all that time? When methadone cuts the risk of overdose death among people with opioid use disorder by over 50 percent?

    “It took a global pandemic to get more take-homes,” Louis Vincent, the executive director of the National Survivors Union, told me previously. For the agency to budge even an inch, a lethal global event was required; without that, nothing would have happened. Hundreds of thousands of preventable overdose deaths didn’t convince SAMHSA to make methadone more accessible.

    So the agency deserves no accolades for finally updating OTP rules, when more people would be alive today if it had taken action during the first wave of overdose deaths.

    SAMHSA couldn’t be clearer on this point: “The decision to provide take-home doses rests with the treating practitioner.”

    The COVID pandemic and its stay-at-home restrictions meant SAMHSA could no longer just ignore how difficult-to-impossible it is to “earn” take-home medication, compelling the agency to modify the rules for unsupervised dosing.

    In 2020, SAMHSA temporarily relaxed rigid methadone take‐home rules. In theory, “stable” patients could now take home up to a 28‐day supply of medication, with 14 days for “less stable” patients.

    In reality, pandemic access to more take-homes was uneven across the country with at least one state reporting that “nothing really changed.” Some patients reported that after a few months of take-homes, these were suddenly taken away, and they were forced back to near-daily dosing.

    The final rule now permanently allows up to seven days of take-home doses during the first 14 days of treatment; up to 14 from day 15 of treatment; and up to 28 from day 31. Previously, patients had to be in treatment for two years to be eligible for 28 take-home bottles.

    To support that change, SAMHSA cites research during the pandemic showing no increase in overdose deaths and little “diversion” as a result of increased take-homes.

    And yet SAMHSA couldn’t be clearer on this point: “The decision to provide take-home doses rests with the treating practitioner and their use of clinical judgment.” Under the final rule, staff can at any time rescind take-home medication for myriad reasons, which they often do. This is devastating to patients.

    In case you didn’t know, SAMHSA has always had the statutory authority to remove or amend the patient care regulations it created. But with this new update, the agency chose to amend regulations instead of eliminating them. It’s a decision that reveals SAMHSA is committed to maintaining a racist and inhumane for-profit clinic system.

    The final rule is full of new language that advocates  “a patient-centered perspective,” “shared decision-making for all care plans,” and “a patient-centered approach to care.”

    What empty nonsense! OTP are predicated on the idea that the medication they dispense is a privilege, not a right. Patients have to demonstrate, on an almost daily basis, that they deserve to take methadone. Under this massive power imbalance, the notion that treatment will be “patient-centered” or foster “shared decision-making” is ludicrous. Patients will continue to be policed and punished.

    “It’s profit-centered and DEA decision-making, full stop,” Burkholder said. “There’s absolutely nothing patient-centered about what these clinics practice. We are treated like scum.”

    Hopes were high that after 50 years, patients would finally be freed from the cruelty of the clinic system. Instead, the foxes are left guarding the henhouse.

    Sure enough, SAMHSA’s revised list of criteria for take-homes eligibility doesn’t differ much from the old list, and continues to criminalize and stigmatize patients. 

    The new criteria include

    * “Absence of active substance use disorders, other physical or behavioral health conditions that increase the risk of patient harm as it relates to the potential for overdose, or the ability to function safely;” 

    * “Regularity of attendance for supervised medication administration;” 

    * “Absence of serious behavioral problems that endanger the patient, the public and no recent diversion activity;” 

    * “Whether take-home medication can be safely transported and stored;” 

    * “Any other criteria that the medical director or medical practitioner considers relevant to the patient’s safety and the public’s health.”


    OTP discretion could hardly get wider than that. The clinics effectively have unlimited reasons to deny take-homes or to snatch them back. The benchmarks continue to ignore the structural drivers of inequality, racism and poverty that allow only “model” methadone patients to dose at home.

    The COVID-19 pandemic was a historic opportunity for fundamental change to how methadone is dispensed in the US. Hopes were high that after 50 years, patients would finally be freed from the cruelty of the clinic system.

    Instead, the foxes are left guarding the henhouse. A 20-year wait as hundreds of thousands of deaths piled up—our loved ones—and all we got was this? Despite what some methadone reform activists want to believe, SAMHSA isn’t coming to save us.  



    Photograph of methadone clinic in Maryland by Helen Redmond


    • Helen is Filter‘s senior editor and a multimedia journalist. She is on the methadone, vaping and nicotine train. Helen is also a filmmaker. Her two documentaries about methadone are Liquid Handcuffs and Swallow THIS. As an LCSW, she has worked with people who use drugs for over two decades. Helen is an adjunct assistant professor and teaches a course about the War on Drugs at NYU. She lives in Harlem.

    • Show Comments

    You May Also Like