Methadone Rules Requiring In-Person Visits Are Putting Patients At Risk Of Coronavirus

“There were people wrapped around the building,” said Tanna Mortensen, recalling the scene when she showed up to her Tacoma, Washington, opioid treatment provider on March 23. She arrived at around 5 a.m. It was a chilly day and drizzling. Patients huddled together next to the building, trying to stay dry and keep their place in line—the exact opposite of the social distancing recommended as COVID-19 sweeps the nation. But they didn’t have a choice. Like Mortensen, they were there to receive methadone, a long-acting synthetic opioid prescribed to treat opioid addiction. Without it, they would be subject to painful withdrawal.

Hundreds of thousands of people utilize methadone treatment from one of approximately 1,500 specially licensed opioid treatment providers, colloquially called methadone clinics, spread out across the United States. For many of these patients, sheltering in place during the coronavirus outbreak is impossible.

Methadone is highly regulated at both the state and federal levels. Normally, patients are required to show up every morning to dose in front of a staff member. Over time, patients who meet certain criteria, which include abstinence from non-prescribed substances and housing stability, can earn take-home doses.

On March 16, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued national guidance that radically relaxed the federal regulations around take-home doses. These included allowances for states and clinics to request blanket 28-day take-home requests for all patients considered stable, and 14-day take-home requests for patients who are less stable but whom the clinic has deemed able to safely handle the extra medication. Now, states and providers are tasked with striking a balance between infection control and risk of diversion or overdose. 

“What we’re hearing is the implementation of that [extended take-home license] has been really spotty on the ground and, day-to-day, folks that go to clinics in some parts of the county aren’t seeing that’s actually feasible and clinics aren’t saying that’s what they will do,” said Sheila Vakharia, deputy director of the Department of Research and Academic Engagement for the Drug Policy Alliance. 

“You don’t want to cause patients … greater exposure because it’s such a contagious virus and it does have a fair amount of mortality in a vulnerable population, but on the other hand you don’t want to give a lot of unstable patients a lot of take-homes because there is a risk,” said Mark Parrino, president of the American Association for the Treatment of Opioid Dependence. His association issued guidance for providers in response to COVID-19 that include screening patients for symptoms when they arrive, and using clean water when mopping floors.  

In Ohio, implementation has been especially rough because of a requirement that clinics dispense naloxone, the opioid overdose reversal drug, along with take-homes. Some clinics in the state don’t have enough naloxone on hand to meet the sudden need for more take-homes. Ohio is one of the states hit hardest by fentanyl; the uber potent opioid was involved in 73 percent of the state’s drug overdose deaths in 2018. 

“At this point, we are not utilizing the 28-day take-home provisions,” said Rick Massatti, the state’s opioid treatment authority with the Ohio Department of Mental Health and Addiction Services, citing high opioid overdose rates as the reason. Massatti has granted clinics the ability to dispense one to two weeks’ worth of take-home doses to patients who have tested positive for COVID-19, are exhibiting symptoms, or are considered high-risk for COVID-19. Stable patients are also eligible to have their take-home amounts raised.

Still, those with eyes on the ground say it isn’t enough.

“The federal and state governments have done what they can to give the options to clinics to stop [lines and crowding], but some old school methadone providers are attached to the daily dose,” said Dennis Cauchon, president of Harm Reduction Ohio, which pushed the state pharmacy to supply 12,000 doses of naloxone to clinics in Ohio.

Some providers are utilizing curbside dosing for patients who are sick or who suspect exposure to the coronavirus. Jana Burson, an addiction medicine physician who works at an opioid treatment provider in North Carolina, wrote on her blog that they were offering curbside dosing and take-home doses to patients who had symptoms of COVID-19, like cough and fever. 

“Initially we decided we would do this only for confirmed cases, but that idea appears unworkable, both because not many patients are being tested, and because of the delay in results of a week or more,” she wrote. She added that her clinic treats about 600 patients, but that most days they were not seeing significant delays in dosing.

Another issue looming over opioid treatment providers is a shortage of personal protective equipment and medical-grade cleaning supplies. “Some clinics are saying they will be running out this week, and some are saying they will be running out next week” reported Massatti about programs in Ohio. “As we move forward, we really have to think about—how do we continue doing normal operations without the presence of personal protective equipment?”

Mortensen, who doses every other day, says she still encounters lines at her clinic, but none as long as the one on March 23. After talking to other patients, she learned that select patients were being given 28 take-homes that day, causing the long delay. But she remains concerned about the way her clinic is handling infection control. 

“We’re standing in a line outside huddled together almost practically shoulder to shoulder because they say they can only allow 10 people inside at a time,” Mortensen said. “[Once inside,] we all just kinda sit in the chairs that are provided and just keep moving.” She added that she has never seen anyone wipe down the metal chairs and other shared surfaces. 

“Keep in mind some programs are not getting access to cleaning materials … because they are not seen as a priority,“ Parrino said. “So when a patient may say ‘hey, there’s not a lot of disinfecting going on,’ you have to question, does the program have access to the necessary disinfection agents?”

Some patients around the country are echoing Mortensen’s concerns. Facebook posts in patient support groups are brimming with complaints about crowded clinics, long lines, and lack of visible cleaning. Many are also expressing increased anxieties around paying for their treatment, which can cost between $12 and $18 per day. Self-pay patients who lost their jobs due to the pandemic are left to find alternative means of payment, and can’t wait for the arrival of unemployment benefits or stimulus checks. 

Melissa Lucas coruns a peer group on Facebook called Medication Assisted Treatment Information and Support. Although fundraising is typically disallowed, she recently began a thread for patients experiencing financial hardship. So far, she says every patient who has expressed need has received help with at least one dose. “I know what I would feel if I was in their position. I would be just as panicked, just as scared. I think that’s why all the members have decided to help. We know what it’s like to feel withdrawal,” Lucas said. 

Payment issues are not limited to the uninsured. In many states, Medicaid doesn’t cover take-home doses, forcing patients to come up with hundreds of dollars for take-homes, or else continue dosing daily.

“There is no [billing] code for methadone take-home doses,” explained Zac Talbott, president of the National Alliance for Medication Assisted Recovery, who also owns several opioid treatment programs in the Southern U.S. “Traditional healthcare bills for each service rendered … which is why healthcare hasn’t covered methadone historically.” 

Some clinics have found creative ways around the problem, but those who haven’t are now left scrambling. In Georgia, for example, the state opioid treatment authority collaborated with state health agencies to allow programs to bill Medicaid for remote-supervised home dosing, including by phone. But this remains a partial solution as it still excludes patients who don’t have home devices or cell phone minutes. 

“Take-homes can be monitored via telephonic or online check-in. We recognize that this can be a challenge for some, but for many, it has provided much-needed access to medication-assisted treatment (MAT) while maintaining safety and helping reduce the spread of COVID-19,” wrote Angelyn Dionysatos McDonald, the press secretary for the Georgia Department of Behavioral Health and Developmental Disabilities.

“To the extent that patients are self paying, nothing really changes in that regard,” Parrino said. He added that he is asking SAMHSA to put together a grant or fund for self-pay patients who lose their jobs during the crisis, and described a resolution as “in development.”

“These are really well-intentioned federal guidelines, but implementation has been a challenge. Some would say these policies haven’t gone far enough,” Vakharia said.

The Drug Policy Alliance, the National Alliance for Medication Assisted Recovery, and a number of other prominent advocacy groups and individuals signed a letter drafted by the Urban Survivor’s Union requesting, among other stipulations, that all take-home doses in the U.S. “be expanded to the maximum extent possible, limited only by available supply and operations for delivery,” regardless of patient circumstances, that Medicaid cover all take-home costs, and that “in states that did not expand Medicaid, the state shall be the payor of last resort.”