The new rules should make it easier to get methadone, but change is slow in many places

It should be easier to get methadone today than it has been in decades.

In April 2024, the federal government relaxed some of the rules on opioid addiction treatment.

But many patients are still not benefiting from these changes.

Kellyann Kaiser, 30, is among the people in recovery who have been eagerly awaiting greater access to methadone. She said she was addicted to opioids from age 13 until she was 20. He tried several addiction medications, including buprenorphine and naltrexone.

“I think only methadone is what got me sober,” he said. “Without that, I think I’d still be using.”

But it hasn’t always been easy for her to get hold of the sticky pink liquid, taken daily, that eases her opioid cravings and withdrawal symptoms. At first, he had to drive an hour from his home in western Massachusetts to a methadone clinic.

“And I have three small children, so I would have to find a nanny for them. Go out and back,” he said. “I used to have to go every day.”

Now, there is a clinic closer to her home and Kaiser only has to go once a month. That’s because new federal rules allow you to take methadone bottles home, rather than taking each dose at the clinic.

“(Under) the old rules, you had to be in the clinic for 90 days and you never had to miss a day to get a bottle. So that’s a lot of perfection,” says Dr. Ruth Potee, who oversees the Kaiser’s nonprofit behavioral health network, based in Springfield, Mass. Potee is also a national advocate for better addiction treatment.

In contrast, newer addiction medications such as buprenorphine and Vivitrol can be prescribed in a primary care office and picked up at a pharmacy.

Because they have different chemistry, these drugs cannot be abused in the same way as methadone. But for many people, Potee said, methadone works better against powerful new drugs like fentanyl and xylazine. She says methadone is a “miracle drug.”

“It doesn’t take long to get into it,” he said. “You get to a stable dose and then you stay there. You don’t really develop a tolerance to it.”

A COVID-19-era experiment with methadone rules succeeds

Methadone, which shuts down opiate receptors in the brain, was first introduced to treat addiction in the 1960s, just as the Nixon administration’s war on drugs was doubling down on law enforcement approach to drug abuse.

At the time, methadone’s high value and potential for abuse led the federal government to establish strict rules on how to obtain it, including daily visits to a high-security methadone clinic and mandatory counseling.

“They created the rules in a way that made it incredibly restrictive,” Potee said, “And they never changed it again, despite decades of growing addiction.”

But last spring, the federal agency that oversees substance abuse and mental health services, called SAMHSA, changed the rules on methadone for the first time in decades.

Under the new rules, patients still have to get methadone from clinics, but if they meet the criteria, they can take home weeks worth of bottles and receive counseling via telehealth, and providers have more leeway to prescribe individual doses .

Dr. Yngvild Olsen, who leads substance abuse treatment for SAMHSA, said regulators first tested the new rules as a COVID measure and, she said, the sky didn’t fall.

“This did not increase the death rate related to methadone, for example, which had been one of the concerns before this kind of natural experiment,” he said.

The agency also put up barriers to limit abuse and black market sales. For example, Kellyann Kaiser said she had to earn the right to take methadone at home.

“I had to pass so many drug tests to get it,” he said. “And then you have to take a class, like a safety class, about what you do with your methadone, how you store it in your house.”

Kaiser lost custody of her son when she used illegal opioids. She credits the methadone with getting him back on track, and the new rules have helped him stick with treatment.

Adoption of the new rules is slow and patchy, leaving many out

Kaiser lives in Massachusetts, a state that embraced the new flexibility around methadone. Not all sites have them. Federal rules are voluntary. Olsen says states can choose to keep their rules stricter, including daily records.

“There are some states that are still looking and figuring out what’s going to work best for their state and how closely they’re going to align (with the federal rules).”

Olsen said his staff is encouraging states to fully implement the federal guidelines before the official (albeit voluntary) compliance date in October, but many advocates say adoption has been frustratingly slow.

“Substance use treatment programs love the rules,” said Brian Hurley, who heads the American Society of Addiction Medicine. “It takes time both for state regulations to change and, frankly, for business operations and clinical practices to evolve.”

He says the general culture of methadone clinics, also called Opioid Treatment Programs or OTPs, is rooted in the way things have always been done. So starting in Los Angeles, where he’s based, he’s trying to help local clinics establish new protocols, “shifting the focus from a rule-based approach to a patient-centered approach.”

But there are reasons why some providers are slow.

“When you look at an entire system of 2,000-plus treatment programs, it’s like watching an aircraft carrier change course in the middle of the ocean,” said Mark Parrino, head of the American Association for Addiction Treatment Opioids, a trade group. for methadone clinics. “He does, but he does it very carefully.”

Parrino said his group approves of the new flexibility, but that members worry about liability when patients are not closely monitored. He noted that patients can overdose on methadone, which is itself an opioid.

“Methadone is a very therapeutic drug when used wisely,” Parrino said. “But if used recklessly, it’s relentless.”

Parrino also raised a financial concern. He said the clinics, many of them for-profit and run by private equity firms, are waiting to see if Medicaid changes how it pays for methadone treatment when patients come in less frequently. Otherwise, he said, “programs absolutely lose money. Some would not be able to continue.”

But even if the federal rules are widely enforced, many doctors and addiction advocates say they don’t go far enough.

“They won’t be enough until methadone is released from methadone clinics in general,” said U.S. Sen. Ed Markey of Massachusetts, who is sponsoring legislation that he says would break the methadone monopoly of clinics

Markey’s legislation, known as the Modernizing Opioid Treatment Access Act (MOTAA), would allow any board-certified addiction doctor to prescribe methadone and pick it up at a regular pharmacy.

The American Society of Addiction Medicine supports the proposed legislation. The clinic’s trade association opposes it.

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