Since March, when the Substance Abuse and Mental Health Services Administration (SAMHSA) relaxed rules for methadone take-homes to decrease exposure to the coronavirus, opioid treatment programs (OTPs) have been exercising this unprecedented freedom. Specifically, SAMHSA said March 16 that all states with declared states of emergency may request blanket exemption (from SAMHSA) for all stable patients to receive 28 days of take-home doses of methadone, and up to 14 days for “patients who are less stable but who the OTP believes can safely handle” those take-homes. For states without a declared emergency, each individual OTP may request blanket exemptions.
OTPs support the flexibility, as do patients. Originally, limiting take-homes was done to reduce the possibility of diversion or overdose. However, reports are that even the “less stable” patients getting up to 14 days are doing well, AT Forum has learned.
“Our experience has been quite good,” said Steve Straubing, MD, medical director for a facility of Meridian Behavioral Healthcare, which has OTPs with methadone as well as buprenorphine/Vivitrol clinics in north central Florida.
Out of a total of 440 Meridian patients, 197 are receiving extended take-homes under the exemptions: 28 days, 14 days, or, in some cases, 7 days. Most are receiving 28 days – which the clinic did not give at all prior to COVID. “There are very few negative experiences,” Dr. Straubing told AT Forum. “There are no overdoses, seven reports of stolen methadone, and about a dozen failed callbacks,” he said (callbacks are when patients are asked to come into the clinic; a failed callback is when the patient doesn’t respond or has an incorrect number of bottles left). “These are relatively small numbers,” he said..
How did he decide which patients to put on 28, 14, or 7 days? “We used the SAMHSA recommendations as a starting point,” said Dr. Straubing. “We looked at patients who have been stable, which for us meant compliance with clinic attendance prior to COVID, compliance with the counseling sessions to some degree, and on recent urine drug screens.” If there was a great deal of illicit drug use, the clinic did not give extended take-homes.
It’s important to remember that clinicians have the discretion to decide who gets take-home doses and how many; it’s also important to remember that OTPs, not SAMHSA or states, are liable for consequences – patients or others overdosing, for example.
Among the three Meridian clinics in Florida, 47 patients were getting one week of take-homes.
Linda E. Hurley, president and CEO of CODAC in Rhode Island, started planning early for extended take-homes “because we knew changes were coming,” she told AT Forum. “We knew providers would have the opportunity for relaxed regulations, and that we would rely on the medical discernment of our providers in terms of which patients would safely self manage additional take-home medication.”
CODAC gave out almost 160,000 bottles of methadone that they would ordinarily not have provided as take-homes, as of late June when we spoke to Ms. Hurley.
Out of those 160,000 doses that went out in the community, four individuals self-reported problems – that is a percentage of .0025%. “One individual came in and said they lost their medicine. Two said they must have taken too much. One was stolen, and there was a police report. Nobody reported that they had sold it.”
In a state with a population of around a little over a million, 160,000 take-homes are a lot. “The number of take-homes increased by about 50%. About 30% of CODAC patients got 28 days. CODAC has 2,700 patients divided between eight sites, about half of the people with opioid use disorders in the state utilizing methadone in their treatment.
Take-home criteria at CODAC
At CODAC, patients who had been coming in daily were given one week’s worth of take-homes. Patients who were coming in one to two times a week were given 14 days. In addition, the program used other criteria. “We were worried about patients who were active in their disease,” said Ms. Hurley. “What’s the bigger risk for this patient – to try to manage it by giving them take-homes, or to have them come into the community where there is exposure to the virus? We gave them all six days, unless someone demonstrated that they couldn’t manage their medication. We called them every day, asking if they felt okay.” Patients who were doing “a bit better” got called two to three times a week – mainly for medication-management checkups, said Ms. Hurley. Patients who were already well-stabilized and getting 28 days of medication still got a weekly phone call “because of the remarkable societal stress.”
At CODAC, anybody who came in with COVID-19 symptoms was told to go home (with extended take-homes), and not to come back until he or she had self quarantined for two weeks. “Screening questions related to symptoms and travel history is self-report,” said Ms. Hurley, noting that methadone patients are as trustworthy as other patients. “Everybody’s biggest fear is that people are going to say they’re sick so they can get 13 days,” she said sadly, adding as an observation, “We always go to the dark side.”
And here’s the bottom line: There is no bump in any finding of illicit use or diversion of methadone, according to the Rhode Island state police as of May 15th, said Ms. Hurley.
Limiting coronavirus exposure
The importance of take-homes is not just to keep patients from exposure in the clinic. The main reasons are transportation problems – many patients use a van service, coming from outlying rural areas, said Meridian’s Dr. Straubing. “Putting six to eight people in a van – that was one of our biggest concerns.”
Another issue is the waiting line for medication. This is why the clinic tries to space out the two-week take-home dispensations over a few days. “When we started giving the extended take homes, we found there was a long line outside the clinic,” said Dr. Straubing. “We’ve had to go out and mandate social distancing in the line.”
Architecturally, OTPs were not made for social distancing.
Not one patient had been infected with COVID when we spoke with Dr. Straubing in late June that he was aware of.
Missing the clinic
Some patients actually like coming to the clinic, said Dr. Straubing. “They say it gives them to opportunity to get out of the house.”
This was particularly true for buprenorphine patients, he said. “Twenty-five percent of them could to their visits by telephone, but they tell me that going to the clinic is like a day out for them,” he said. “They like to come in and sit down and talk.”
In addition, some patients “have realized how much they missed the mandated group meetings,” said Dr. Straubing. “They are saying that the meetings were an important part of their program and are asking when they will be resumed.”
At CODAC, there has been a 25% increase in follow-up counseling sessions now that they can be done over the phone, said Ms. Hurley. “It’s been remarkable. Counselors say there are far fewer no-shows, and that they don’t have to call twice now that the access issues are significantly decreased.” Patients are happy that they no longer have to leave their child in the car with family while they go into the clinic for face to face encounters, for example. “There’s absolutely no negative response to the medication management calls.”
The biggest challenge is to make sure patients have the technology to be able to participate, said Ms. Hurley. “The Rhode Island Department of Health allocated dollars to us – they called us in March about it, but we haven’t seen the money yet.” The funding would go toward discounts for smart phones through phone companies – these would be for limited access phones which could primarily be used between the patient and CODAC. So far, between the Centers for Disease Control and the Rhode Island Foundation, CODAC has obtained 200 such phones.
“We’re very concerned about how people are functioning during this time,” said Meridian’s Dr. Straubing. Stress increases cravings, and most of the talk during counseling sessions is about stress. “We question patients intensely on how they’re doing,” he said. Many patients are in the fast food industry, and have not lost their jobs, he said. “If anything, they’ve noticed an increase in business because of takeout.” The stress comes from having children at home because there is no school, and many patients have additional children to care for – friends who are going in to work leave them with people who can stay home. Additionally, many have experienced a sense of isolation because of lockdowns.
Some patients had temporary increases to doses, whether they were on methadone or buprenorphine, to deal with the increased cravings, said Dr. Straubing.
Pharmacology of methadone inductions
The Drug Enforcement Administration now allows telephone inductions of buprenorphine, but not of methadone. Dr. Straubing agrees with that policy. “I cannot foresee home inductions of methadone, especially since we have to titrate dose,” he said. The first week or two of treatment with methadone is the most dangerous, because patients are getting increasing doses of a medication with a long half-life which builds up in the body.
Dr. Straubing explains: “Methadone has an average half life of 24 hours. That means if I give the maximum starting dose of 30 milligrams on day one, on day two, there are still 15 milligrams that are leaching out of whatever tissues have absorbed the first dose. So on day two, when you give the patient 30 milligrams again, the patient is actually experiencing the effect of 45 milligrams. On day 3, another 30 milligrams for the patient feels like 52. And that’s getting only 30 milligrams every day. If every day you escalate the dose by 10, by day 6, you’re going to have a greatly increased effective dose. And many people have had a disastrous outcome up to and including death.”
On the other hand, once the patient is on a stable dose of methadone – after two or three months, for example – the possibility of extended take-homes should be considered, said Dr. Straubing. “But what I worry about is not so much the physical stability at three months, but the psychosocial stability.” Getting psychosocial issues stabilized takes time, and many are best addressed in a group counseling session where patients “can bounce things off their peers.” While it’s true that research is pointing to the pharmacotherapy being the most important element of treatment, “very few people are saying that the psychosocial aspect plays no part at all.”.
The New York experience
“Overall, this has been working,” said Allegra Schorr, president of the Coalition of Medication-Assisted Treatment Providers and Advocates (COMPA) of New York, and owner and vice president of West Midtown Medical Group, a Manhattan-based practice that dispenses methadone and buprenorphine. “Programs have been monitoring patients with extended take-homes through telehealth – frequently audio only,” she told AT Forum.
Patients who were not able to manage extended take-homes were identified and returned to more frequent pick-ups, said Ms. Schorr.
“There’s a consensus that the patients who are less stable in treatment tend to be the patients who have had more issues with the extended take-home schedule and are more likely to be returned to a more frequent pick-ups,” she said. “Very few patients who were already receiving more take-homes had trouble managing more.”
One of the questions for OTPs is how to be adequately reimbursed for patients who are coming into the clinic less often, but whom the OTP is responsible for. New York State established an emergency COVID bundled Medicaid reimbursement that allows programs to submit a bundled claim for a patient who receives at least seven days (six take-homes plus one day of medication administration), said Ms. Schorr. The bundled claim can also be billed for a week in which the patient isn’t coming to the program to receive medication (i.e., has take-homes) but does receive tele-practice visits (counseling and medication monitoring), she said. “This ensures that programs can continue to engage patients while they are out of the clinic.” Patients who attend more often during the week are not eligible for the bundled reimbursement.
Almost everyone wants to see the extended take-homes continue post-COVID, but Schorr specifies that “some adjustments need to be made to support fully stable patients who do not require counseling, as well as continuing the use of New York’s billing codes (APGs) for intensive and add-on services for patients who need more support.” It’s also important to keep in mind that the results of extended take-home schedules are generally being reported while shelter-in-place and other limitations from COVID-19 remain, or are slowly being lifted, said Ms. Schorr “There shouldn’t be an automatic assumption that the results will be the same post-pandemic,” she told AT Forum.
“Nevertheless, the emergency blanket waivers have changed the way programs manage patients. A sustainable reimbursement and managing risk through a patient-centered lens could allow these positive changes to continue.”
Interestingly, the ability to get extended take-homes seems to have a “contingency management” effect on patients, who are willing to be compliant with counseling and less drug use in order to get win the 28 days, said Dr. Straubing. “A significant number of previously semi-compliant patients have become compliant, and others have discussed how they are working very hard on earning the take-homes.”