The Substance Abuse and Mental Health Services Administration (SAMHSA) wants to revise outdated guidelines for methadone clinics. The agency issued a notice of proposed rulemaking in December, as Filter reported. Its proposed changes address numerous issues, from take-home doses to the use of telehealth to stigmatizing language. These “seek to make treatment in Opioid Treatment Programs (OTPs) more accessible to patients, easier to deliver for providers and supportive of evidence-based and patient-centered care,” states the federal agency, amid “a growing overdose epidemic, exacerbated by the COVID-19 public health emergency.”
It was in February, during the public comment period for this notice, that the American Association for the Treatment of Opioid Dependence (AATOD) weighed in.
AATOD is the principal trade organization representing the interests of OTPs, such as BayMark, one of the largest for-profit chains in the United States (Jason Kletter, its CEO, is an AATOD board member).
In a nine-page letter, AATOD President Mark Parrino outlines the changes the organization supports and those it opposes. He demands that SAMHSA “remind other federal agencies of the value of the OTPs,” and that “OTPs are an extremely valuable treatment option, especially in an age of fentanyl use.”
The letter is in part an angry response—not to the thousands of patients who are sick of OTPs’ restrictive, punishing rules, but to unprecedented criticism in mainstream media.
US Representative Donald W. Norcross (D-NJ) and Senator Edward J. Markey (D-MA) have lambasted the clinic system in recent months. Markey called out AATOD itself: “Their lobbyists want to bottleneck access to clinics to increase profits.” Norcross declared: “We must end the monopoly on this life-saving medicine that only serves to enrich a cartel of for-profit clinics and stigmatize patients.”
Norcross and Markey are right. And AATOD is furious about the introduction of the Modernizing Opioid Treatment Access (MOTA) Act in Congress. This limited legislation, based on the Opioid Treatment Access Act of 2022, would allow only board-certified addiction physicians and addiction psychiatrists (a small group of specialists) to prescribe methadone, and for pharmacy dispensing. AATOD opposes the MOTA Act because it bypasses OTPs. Their shareholders’ profits come before increasing access to a lifesaving medication, even just a little.
In terms of SAMHSA’s proposed rule changes, though, AATOD has nothing to fear. It has always had a close working relationship with the agency. SAMHSA Administrator Miriam E. Delphin-Rittmon spoke at AATOD’s conference last year. SAMHSA has never publicly rebuked the industry for its numerous failures, most notably disastrous retention rates in the era of hundreds of thousands of opioid-involved deaths.
That epic failure alone should immediately shut down every OTP and allow any health care provider to prescribe methadone. That would save lives right now. Instead, SAMHSA has proposed nice-sounding but futile reforms to a clinic system that is all but reform-proof.
AATOD needs the public to believe the fiction that OTPs’ billable counseling services are vital.
AATOD supports the majority of SAMHSA’s proposals because they maintain clinics’ power, tweaking outdated regulations to enable more patients to enter the system, thus increasing profits. AATOD is in favor of inducting methadone patients via audio-visual telehealth; considering under-18s for treatment; counseling via telehealth; and eliminating the minimum one-year history of opioid use disorder as a condition for entering treatment.
But AATOD opposes eliminating the term “medication-assisted treatment” (MAT), which harm reductionists criticize for implying that medication alone is not treatment. SAMHSA wants to replace it with “medications for opioid use disorder” (MOUD).
AATOD’s reason is that MOUD “…does not capture the holistic care provided to patients at OTPs,” claiming, “this is more of a political approach rather than an evidence-based clinical approach.”
The notion that clinics provide much needed, evidence-based, holistic care is false. AATOD needs the public to believe the fiction that OTPs’ billable counseling services are vital, and that, as their astroturf campaign’s catchphrase asserts, “Program Not a Pill” is key. People who take methadone have told Filter that OTP counseling sessions are a 15-minute farce, and a requirement that can drive people out of treatment.
The SAMHSA rule-change with the capacity to profoundly impact patients’ lives revises take-home criteria—potentially releasing people from the daily clinic attendance that disrupts lives, a barrier to both initiation and retention. The agency acknowledged: “Evidence from multiple studies has shown that increases in take-home doses following the SAMHSA [COVID] exemption did not lead to worse treatment outcomes, higher overdose rates, or diversion of medication, but instead resulted in increased treatment engagement and improved patient satisfaction with care.”
Parrino evokes two red herrings straight from the DEA playbook.
Its new proposal expands the maximum allowable number of take-home doses to “up to 7 days of take home doses during the first 14 days of treatment, up to 14 take home doses from 15 days of treatment and up to 28 take home doses from 31 days in treatment.” Patients can start receiving take-home doses as soon as they enter treatment.
AATOD says it supports this rule change. But Parrino evokes two red herrings straight from the Drug Enforcement Administration (DEA) playbook: overdose and diversion. He states the association is still looking at methadone overdose data and that its members had “robust diversion control mechanisms” in place during the pandemic.
This continued, misplaced emphasis on overdose and diversion, despite overwhelming evidence to the contrary signifies that OTPs won’t accept the real lessons of COVID flexibilities. Instead, they will continue to deny increases in take-home medication. Which isn’t surprising. Because around the country, patients I interviewed for my new documentary didn’t even know they could get two or four weeks of take-home bottles. Those lucky few who did receive an increase reported they were quickly scaled back, often to daily dosing.
Parrino makes it absolutely clear that OTP staff still have all the power. There will be no “shared decision making” or “patient-centered care” as SAMHSA recommends. Referencing the COVID flexibilities, his letter states, “At no time were OTPs required to provide such medication if it went against the staff’s clinical judgment … and that remains true at the present time.”
And the president of AATOD said he doesn’t believe that patients have an “inalienable right to receive take-home medication if the risks outweigh the benefits.”
If OTPs didn’t give 14 or 28 take-home bottles to patients who met the criteria at the height of a deadly pandemic, they certainly won’t now.
AATOD is devious. Parrino writes cryptically about new “technical improvements” to “…observe patients taking their medications outside the confines of a direct nurse/pharmacist observation at the OTPs.” He doesn’t admit that the new technology, which is already being tested, will expand the policing of patients to their own homes, as Filter recently reported.
If clinics follow the updated SAMHSA take-home rules—and that’s a big if—they will make in-home surveillance mandatory.
Dr. Kenneth Stoller, another AATOD board member, was an investigator on a study funded by the National Institute on Drug Abuse (NIDA) that evaluated the “MedMinder,” nicknamed “Jon.” Jon is an electronic, cellular-enabled, secure pillbox that provides real-time monitoring to remotely manage take-home doses of methadone.
Developing and deploying surveillance technology to monitor methadone patients at home is AATOD’s response to the prospect of rapid increases in home dosing. It ignores one of the biggest lessons learned during the pandemic—that patients can be trusted to manage take-home medication without being watched.
OTPs don’t trust patients. It’s not in their interests to do so, because how can their existence be justified if people show they can take methadone like any other medicine? Constant urine testing and bottle recalls symbolize that self-interested distrust.
If clinics follow the updated SAMHSA take-home rules—and that’s a big if—they will make in-home surveillance mandatory. “Jon” will be watching, and the OTP will get paid for an observed dose. The “liquid handcuffs” will merely have moved from the clinic to the community.
Christopher Garrett, senior media adviser at SAMHSA told Filter that “SAMHSA is currently reviewing public comments and these will inform the final rule. Publication of the final rule will occur after review across federal agencies.” He said there is no time estimate of when the review will be finished.
But in many ways the updated rule proposals are performative, because SAMHSA doesn’t have enforcement powers. And AATOD knows this.
In a January webinar, Dr. Neeraj Gandotra, SAMHSA’s chief medical officer, stated: “We are limited in our scope. While we can draft these federal regulations, it is up to the individual OTPs to exercise some of these options … State restrictions still hold. It’s all left to the discretion of the provider and the State Opioid Treatment Authority.”
When power and profits are your concerns—and liberating a lifesaving medication would jeopardize both—choosing not to “exercise some of these options” is a no-brainer.
Photographs by Helen Redmond