Methadone access regulations need to be reformed to increase availability, however, progress remains limited in several locations

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 around the treatment for opioid addiction.

But many patients are still not benefitting from those changes.

Kellyann Kaiser, 30, is among those in recovery who had been waiting eagerly for greater access to methadone. She said she was addicted to opioids from the age of 13 into her late 20s. She tried several different addiction medications, including buprenorphine and naltrexone.

“I think just methadone is what got me sober,” she said. “Without that, I think I would still be using.”

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

“And I have three little children, so I would have to find a babysitter for them. Go out there and come back,” she said. “I used to have to go every single day.”

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

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

In contrast, newer anti-addiction drugs like buprenorphine and Vivitrol can be prescribed in a primary care office and picked up at a pharmacy.

Since they have a different chemistry, those medications can’t be abused in the same way as methadone. But for many people, Potee said, methadone works better against the potent new street drugs like Fentanyl and Xylazine. She calls methadone a “miracle drug.”

“It doesn’t take any length of time to get on to it,” she said. “You get to a stable dose and then you stay there. You don’t really develop tolerance to it.”

A COVID-era experiment with methadone rules proves successful

Methadone, which locks up 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 a law-enforcement approach to drug abuse.

At the time, methadone’s high street value and potential for abuse led the federal government to set up strict rules around how to get it, including daily visits to a high security methadone clinic and mandatory counseling.

“They just built the rules in this one way that made it incredibly restrictive,” Potee said, “And they never went back to change it, despite decades of increasing addiction.”

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

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

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

“This did not increase the rate of methadone-related mortality, for example, which had been one of the concerns prior to this kind of natural experiment,” she said.

The agency also put in guardrails to limit abuse and black-market sales. For instance, 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,” she said. “And then you have to take a class, like a safety class, on what you do with your methadone, how you keep it safe in your home.”

Kaiser lost custody of her son when she was using illegal opioids. She credits methadone with getting him back and the new rules with helping her stick to treatment.

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

Kaiser lives in Massachusetts, a state that embraced the new flexibility around methadone. Not all places have. The federal standards are voluntary. Olsen says states can choose to keep their rules more strict, including daily check-ins.

“There are some states that are still really looking at and figuring out what’s going to work best for their state and to what extent they will align [with the federal rules.]”

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

“Substance use treatment programs love rules,” said Brian Hurley, who heads the American Society for Addiction Medicine. “It takes time both for state regs 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 mired in the way things have always been done. So starting in Los Angeles where he’s based, he’s trying to help local clinics set up new protocols, “shifting the approach from a rules-based to a patient-centered approach.”

But there are reasons some providers are going slowly.

“When you look at a whole system of 2000-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 the Treatment of Opioid Dependence, a trade group for methadone clinics. “It does so, but it does so carefully.”

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

“Methadone is a very therapeutic medication when it’s used wisely,” Parrino said. “But if it’s used unwisely, it’s unforgiving.”

Parrino also brought up a financial concern. He said 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, “the programs absolutely lose money. Some would not be able to continue.”

But even if the federal rules are put into wide practice, many addiction doctors and advocates say they don’t go far enough.

“They won’t be enough until methadone is freed from methadone clinics generally,” said Massachusetts U.S. Senator Ed Markey, who is sponsoring legislation he says would break the clinics’ monopoly on methadone.

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

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