The COVID-19 pandemic and record overdose tolls have continued to pressure the Substance Abuse and Mental Health Services Administration (SAMHSA) to reform the dysfunctional methadone clinic system. Last month, the agency published aNotice of Proposed Rulemaking (NPRM) to update federal regulations to make the medication more accessible and “close the treatment gap.”
Among its numerous proposals: allowing audio-visual telemedicine intakes; eliminating stigmatizing language; and expanding the definition of “counseling services” to include psycho-educational recovery services and harm reduction interventions. The most important new rule-change from a patient perspective is speeding up and loosening the process of getting take-home doses. Dozens more rule-change proposals related to accreditation and certification standards are buried in the 135-page official document. A public comment period will close on February 14.
“These proposed updates would address longstanding barriers to treatment in the regulations—most of which have not been revised in more than 20 years,” stated Miriam E. Delphin-Rittmon, the assistant secretary for Mental Health and Substance Use in the US Department of Health and Human Services and the SAMHSA administrator. “I am committed to moving these forward as quickly as possible because we have heard from both providers and patients how urgent the need is for treatment.”
Many of the new proposals are welcome, as far as they go. But the agency has expressed no remorse for its decades of inaction.
Now it’s urgent. But where was SAMHSA’s urgency to enact treatment reforms during waves of the opioid-involved overdose crisis that, on its watch, have cumulatively claimed the lives of more than a million people? Last year over 107,000 people died—an increase of more than 15 percent from 2020. Many of the new proposals are welcome, as far as they go. But the agency has expressed no remorse for its decades of inaction.
A comprehensive report published last year by researchers at George Washington University examined federal methadone regulations and showed that in almost every instance, SAMHSA has always had clear statutory authority to amend or remove regulatory barriers to treatment. No involvement of Congress is needed. What is the point of a federal agency whose singular goal is to assist people with substance use disorders, but in practice maintains obstacles to their health and safety?
COVID-19 was the catalyst for SAMHSA to confront the disaster that is opioid treatment programs (OTPs, also known as methadone clinics). For the first time ever, and only because of the publicized lethal threat of COVID, the agency relaxed guidelines for take-home doses. OTPs could immediately dispense 14 or 28 take-home bottles to patients deemed “stable.”
The DEA and SAMHSA have always maintained that “diversion” and overdose are the reasons access to unsupervised dosing has to be restricted. Research conducted during the pandemic found diversion of methadone was rare and overdose deaths didn’t increase among people who got take-homes. For those who did, it was a rare experience of freedom and normalcy. “Finally, my prescribed medication was being treated like a prescribed medication,” one patient wrote in Filter.
SAMHSA proposed revised criteria allow up to seven days of take-home doses during the first 14 days of treatment, up to 14 after 15 days of treatment and up to 28 after 31 days. Under pre-pandemic rules, it took months or years to “earn” this many take-home bottles of medication.
The NPRM talks about patients in a more inclusive way. Now there is a need for “shared decision making,” offering “services a patient needs and wishes to pursue,” and emphasizing the importance of the “practitioner-patient relationship.” And there is at least an admission of problems in the clinic system: “These prior standards were established early in the history of methadone and the criteria for determining whether a patient may be allowed to take homes were restrictive, requiring daily visits to the OTP for extended periods of time … These criteria can pose disruption to employment and daily activities for patients, and several of the criteria reflect outdated biases that promote stigma and discourage people from engaging in care in OTPs.” Ya think?
“People get so overwhelmed with disappointment with how these clinics operate. You get treated like an idiot and that leads to not giving a fuck.”
There was certainly no “shared decision making” between Damon and staff at his OTP. Damon, who lives in Utah, has taken methadone on and off for many years.
“They gave me three days at a time during the pandemic,” he told Filter. “I had just started, so I was still actively using [illicit opioids] until I adjusted to my dose. The next month I had a positive urine test and they made me come everyday. I wonder how many people they killed doing that?”
“Also, staff told me I couldn’t use cannabis even though I had a medical cannabis card,” he continued. “I told them it’s a state law and they said they don’t have to follow state regs … I left that clinic. Something needs to give at these places. People get so overwhelmed with disappointment with how these clinics operate. You get treated like an idiot and that leads to not giving a fuck.”
SAMHSA’s new proposals are also geared to help “those who reside far from an OTP or who lack access to reliable transportation to receive treatment … care for loved ones and engage in other required activities of daily living.” That’s good, because 90 percent of clinics are in urban areas.
To be sure, the recognition of harmful past practices and that patients should be partners in treatment decisions is positive, but at the same time SAMHSA believes: “Much of what is proposed will not represent a significant burden for OTPs … The proposed rule supports OTPs in their on-going provision of equitable and evidence-based care to often marginalized patients with opioid use disorder.”
Nothing could be further from the truth. It’s well documented by countless studies, a Consensus Study Report last year by the National Academies of Sciences, Engineering and Medicine, and the National Urban Survivors Union that OTPs don’t offer equitable or evidence-based care. Instead, they offer a punishing culture of cruelty and constant surveillance. Created by the Drug Enforcement Administration (DEA,) clinics are carceral, racist institutions where patients are criminalized, humiliated and forced to dose daily under the suspicious eye of a nurse. This is why retention rates in treatment are so damn low! The inherent nature of OTPs, and that they are intentionally siloed off from mainstream medical and pharmacy services, is the problem.
Criticisms of methadone regulations and calls for fundamental reform are growing much louder. They’re coming from leaders like Nora Volkow, the director of the National Institute of Drug Abuse, from the American Society of Addiction Medicine, from patients, doctors and politicians.
US Congressman Donald Norcross (D-NJ) has proposed legislation to allow physicians outside of OTPs to prescribe methadone and pharmacy dispensing. “The idea of having to go to this one location [OTP] to pick up your meds is just nuts,” he said. Norcross is right. There are over 60,000 pharmacies in the US, but only 1,920 OTPs that serve over 650,000 patients. The math conspires to keep thousands out of treatment or missing doses.
“Part of the problem has always been that SAMHSA doesn’t mandate or have the ability to enforce reforms.”
Tragically, the NPRM keeps OTPs in charge of treatment. If Mark W. Parrino—president of the American Association for the Treatment of Opioid Dependence (ATTOD) and an enemy of any fundamental reforms—wholeheartedly supports it, there’s no doubt nothing will really change. “We enthusiastically support the balance of these new proposals and encourage the states to follow suit,” he gushed. “We certainly hope that state regulatory policies will evolve to be in greater alignment with SAMHSA’s regulatory provisions … In our judgment, these flexibilities will provide greater opportunity for patients to enter and remain in treatment.”
Don’t count on it. And note Parrino’s use of the words “encourage” “hope” and “evolve.” No sense of urgency here!
Part of the problem has always been that SAMHSA doesn’t mandate or have the ability to enforce reforms. It’s completely voluntary for the states and OTPs to adopt them—and during the pandemic, the consequences for patients like Damon were clear. AATOD can support these reforms because of their non-binding nature.
“The federal government can say anything they want and OTPs will resist the changes,” Dr. Ruth Potee, an addiction medicine doctor who runs five nonprofit methadone clinics in Western Massachusetts, told Filter. “SAMHSA can propose great changes, but there is no incentive for OTPs to operate any differently.”
For example, clinics have complete discretion to implement SAMHSA’s take-home reforms, regardless of time in treatment. Patient reports from around the country during the pandemic don’t bode well. The flexibilities were not widely adopted, and many OTPs chose not to implement them at all—or did for a few months, but then forced patients back to daily dosing.
SAMHSA is clear that these new proposals “do not supersede State rules and regulations in which the OTP is licensed,” and that “States may have or draft regulations that are more restrictive than the proposed rule.”
Filter received an email response from SAMHSA’s press office that did little to inspire confidence in the agency’s powers: “SAMHSA’s enforcement entails reviewing accrediting bodies survey results for recertification; when questionable prescribing practices arise, SAMHSA may inform other oversight authorities (such as the Drug Enforcement Administration or the respective state) as appropriate. Patients always have the right to file complaints with their respective states….”
“I don’t believe anything will change because the clinic is a business and they can’t charge for seeing patients if they don’t come in.”
Jordan*, a methadone patient who lives in the Midwest, read through the NPRM and is skeptical. “The idea of patient-centered care is just a buzzword,” she told Filter. “Despite increasing how many take-homes the clinic is allowed to give patients, the decision and interpretation of the guidelines is still left up to the doctor. I’ve never even met the doctor in charge [at my clinic]. I don’t believe anything will change because the clinic is a business and they can’t charge for seeing patients if they don’t come in.”
Jordan is also concerned about language that expands the definition of counseling services and implies that successful treatment isn’t medication alone. “No! The medication is the treatment! None of that other stuff! Just send the script to CVS!” she implored.
The methadone clinic system depends on cartel-like control over access to the medication, power over patients, and profits. AATOD and OTPs will defend this inhumane status quo using their deep connections and cozy relationships with the DEA and SAMHSA.
The Opioid Treatment Access Act of 2022 (OTAA) sponsored by US Congressman Donald Norcross (D-NJ) would expand access to methadone. Section 4 in the bill allows a small group of addiction certified doctors outside of OTPs to prescribe methadone to be picked up at a pharmacy. The bill passed the House in June 2022 as part of the Restoring Hope for Mental Health and Well-Being Act, but Section 4 was stripped out. US Senators Ed Markey (D-MA) and Rand Paul (R-KY) led an effort to pass the Senate version of the bill, which included Section 4, in an end-of-year legislative package.
But AATOD unleashed its lobbyists and a disinformation campaign. An op-ed in STAT by Jason Kletter—the legislative and committee chair for AATOD and the president of BayMark Health Services, a mega, for-profit OTP chain—was full of scaremongering lies. Offering no evidence, he warned, “Section 4 of the bill is a step backward. It would allow methadone to be dispensed at neighborhood pharmacies with no oversight or diversion control mechanisms, putting patients and communities at risk for even greater overdose and misuse.”
The DEA couldn’t have said it any better.
For a number of reasons, the OTAA didn’t make it into the massive, 1.7 trillion Consolidated Appropriations Act, 2023 that President Biden signed into law on December 29. “Representative Norcross will continue to champion legislation that expands access to treatment and lowers barriers to care,” Britton T. Burdick, his communications director, told Filter.
In supporting SAMHSA’s NPRM, Norcross called out AATOD: “It is unacceptable that a cartel of methadone clinics is trying to stop people from receiving the treatment they need to live healthy, full lives. SAMHSA’s new proposed regulationsare a great step in the right direction—but at a time when we’re losing hundreds of thousands of American lives a year due to drug overdose, we must do more.”
SAMHSA can propose new rules to expand access, but left up to AATOD and the profit-driven clinics, that won’t happen.
In all the discussions of new rule proposals, the experiences and suffering of people who are desperate to be liberated from oppressive OTPs are dismissed or ignored.
One of them is Anne Marie Kelley-Cosio, a California resident who shared a shocking comment in response to a Health Affairs article that advocated for fundamental change in methadone dispensing.
“I could describe so many years of stress, anxiety and mistreatment by the staff at the clinics I have been forced to attend to get the medication that saved my life,” she wrote. “During COVID, a new ‘manager’ showed up and instead of following SAMHSA recommendations she TOOK my 27 take-homes with NO explanation and not just mine. People with cancer, people who could barely walk were forced to come into the clinic and forced to meet in windowless rooms with their counselors during the height of the pandemic. It was beyond words. Since there are many people who can’t fight back, I contacted SAMHSA, they did NOTHING.”
Ending the monopoly OTPs have over methadone is critical to saving lives. SAMHSA can propose new rules to expand access, but left up to AATOD and the profit-driven clinics, that won’t happen.
*Name changed to protect privacy at source’s request.
Photographs by Helen Redmond