This story originally appeared at KHN.
Days typically start early for patients undergoing opioid addiction treatment at Denver Recovery Group’s six methadone clinics in Colorado. They get up before dawn. Some take three buses to a clinic at 5 a.m. for a 15-minute chat with a counselor and their daily dose of methadone, all before going to work or taking their children to school. Some drive over an hour each way from Longmont or Steamboat Springs.
“They come from a billion miles away,” said Dr. Andreas Edrich, the clinics’ chief medical officer, noting their strong motivation to seek treatment compared to other patients who struggle to stick to a drug regimen. simple. “Most people can’t take their blood pressure to save their life, and it’s in their kitchen cabinet.”
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Patients taking methadone, a synthetic narcotic used to treat opioid addiction, must navigate more hurdles than perhaps any other patient group in the United States due to rules dating back five decades. Proponents of loosening the rules say the pandemic has shown that some constraints serve more as barriers to care than as protections. And consensus is growing among clinicians, patients and regulators that it’s time for change.
“There are probably very few people working in the field who think we should maintain the status quo,” said Dr. Shawn Ryan, board member of the American Society of Addiction Medicine.
Now, officials at the Substance Abuse and Mental Health Services Administration are considering permanent changes to the federal methadone rules. A National Academy of Medicine workshop on methadone regulation on March 3-4 could signal an inflection point.
Also, the senses. Ed Markey (D-Mass.) and Rand Paul (R-Ky.) introduced a bill that would codify relaxed rules during the pandemic, which allowed flexibility on take-home doses, telehealth and treatment vans . It would also allow pharmacies to dispense methadone for the treatment of opioid use.
There are entities that have a financial interest in keeping things as they are… Change costs money.
– Dr. Shawn Ryan, American Society of Addiction Medicine
However, any changes to the federal rules could face significant resistance from methadone clinics – many of which are for-profit – whose financial models rely on daily patient encounters, counseling and regular drug testing. .
“Some entities have a financial interest in keeping things the way they are,” Ryan said. “Change costs money.”
Currently, methadone can only be dispensed through federally regulated opioid treatment centers. Patients, at least initially, had to come in person every day to get their dose until they proved stable, mostly for fear of selling the methadone or taking more than their daily dose, risking a overdose.
But the COVID-19 pandemic has prompted federal authorities to loosen methadone regulations, allowing more patients to take doses home and rely on telehealth consultations instead of in-person visits. Studies have shown that flexibility does not lead to an increase in overdoses, illicit sales of methadone doses, or treatment dropouts. Instead, patients reported greater satisfaction and willingness to follow their diets.
“From that perspective, the pandemic was an absolute blessing in disguise,” Edrich said.
A study found that the number of take-home doses of methadone nearly doubled during the pandemic.
In most other western countries, including Canada, it is much easier to get methadone treatment… You can get it at most pharmacies.
– Ofer Amram, assistant professor at Washington State University
“We really couldn’t see any difference in terms of treatment adherence,” said Ofer Amram, an assistant professor studying health disparities at Washington State University.
This real-world experience showed that many of the methadone rules might not be necessary.
“In most other western countries, including Canada, it’s much easier to get access to methadone treatment,” Amram said. “You can get it at most pharmacies.”
But an Oregon Health & Science University survey of 170 methadone clinics found that less than half allowed new patients to take home a 14-day supply despite relaxed guidelines, and about two-thirds allowed patients existing and stable to receive the full 28 days. allocation allowed.
“Ultimately, patients with opioid use disorder want to be treated like everyone else,” said Dr. Ximena Levander, assistant professor of medicine at OHSU and co-author of the study. “There are many other high-risk drugs that we dispense in medicine, but it’s only for this drug that patients have to go to that specific place for treatment.”
Opioid treatment programs are generally reimbursed on a fee-for-service model: the more services they provide and the more tests they perform, the more they are paid. Moving to a model where a person only comes to the clinic once a month could severely limit their income. According to a federal survey of methadone clinics, 41% were operated by private, for-profit companies in 2020, up from 30% in 2010.
“Most of these patients are paying cash,” said Taleed El-Sabawi, a professor of addiction and public policy at Georgetown University. “So if you need urine tests often, if you require patients to come in, if you require them to go through other hoops, they pay for it.”
And with cash payments, she said, there’s no health plan involved to question whether the services are medically necessary.
Denise Vincioni, regional director of the Denver Recovery Group and former director of Colorado’s State Opioid Treatment Authority, defended the existing regulatory framework.
“Rules and regulations protect our patients, give us parameters to work with, and also protect us as providers,” she said. “It’s a very risky business because you’re managing people’s lives with narcotics.”
Many patients, she says, come to appreciate the routine that creates the good habit of taking their methadone at the same time each day. Patients who haven’t put in the time or shown that they don’t use illicit substances “have not demonstrated some of that entitlement,” Vincioni said. “The loose structure has been to their detriment.”
Vincioni suggested that clinics should have more leeway to decide when someone is ready for take-home doses and rely on their clinical judgment rather than strict parameters. Currently, if doses are diverted or if the patient overdoses, the clinic could suffer repercussions.
“If anything happens, it’s your ass,” she said. “That’s part of what kept us from doing a lot of slacking.”
In the world of addiction treatment, methadone patients are treated differently than patients who use other opioid addiction treatments, such as buprenorphine or Suboxone. Generally, buprenorphine is considered safer than methadone, with less risk of overdose, but methadone may be a better option for patients with chronic pain or who have been exposed to large amounts of fentanyl.
There is also a racial equity component. Black patients are often said to be given methadone, which carries a stigma, while their white counterparts are given Suboxone, a drug that prevents opioid cravings. This is partly because methadone clinics are often located in minority neighborhoods.
Levander said the recent focus on racial justice is giving impetus to methadone rule changes.
“A lot of federal regulations have a very racist history and connotation,” she said. “One of the things that helps catalyze this change is this motivation to try to right a wrong.”
Christopher Garrett, a spokesman for SAMHSA, said the agency can make some changes to methadone regulations on its own and is reviewing the flexibility given during the pandemic. The agency said it plans to extend take-home dose flexibility for another year, regardless of the end of the public health emergency.
Advocates warn that federal and state rules often conflict with each other and are sometimes misaligned with the payment structure of Medicare, Medicaid and other health plans. An analysis by Pew Charitable Trusts, for example, found that in many states less than half of opioid treatment providers accept Medicaid.
The National Academy of Medicine’s two-day workshop this month is expected to result in a report with possible recommendations for policy change.
“Hopefully the momentum is now finally here,” said Dr. Gavin Bart, director of addiction medicine at Hennepin Healthcare in Minneapolis. “This is now taken very seriously.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Along with policy analysis and polls, KHN is one of the three main operating programs of the KFF (Kaiser Family Foundation). KFF is an endowed non-profit organization providing information on health issues to the nation.