SAMHSA’s “Medications for the treatment of opioid use disorder: Final rule”

I’ve been doing some light reading: from the Federal Register Vol. 89, No. 23 Friday, February 2, 2024, Rules and Regulations. It is titled “Medication for the Treatment of Opioid Use Disorder” and runs from page 7528 to 7563.

These new rules from SAMHSA apply to treatment provided at opioid treatment programs and are due to go into effect on April 2, 2024.

This document contains historic changes.

Overall, the tone is much more patient-centered and advocates for more provider autonomy to do what is best for each patient, rather than listing a set of rules about what providers can and can’t do for patients at an opioid treatment program. These rules repeatedly mention how patients should participate in decision-making with their provider.

Here are some of the most interesting to me.

First of all, regarding treatment initiation, patients who meet the diagnostic criteria for opioid use disorder moderate or severe no longer have to meet the one-year daily use requirement. In the past, a patient with severe symptoms who had daily use of less than one year could still be admitted to the opioid treatment program, but we had to request an exception from CSAT before we could give the first dose. That didn’t take much time, but it could delay initiation of treatment by a day.

Also, people under the age of 18 no longer must fail two abstinence-based treatment programs before they can be admitted to the opioid treatment program. Because of the reduction of overdose death rate in these adolescents, they can be admitted and started on buprenorphine or methadone at the OTP.

Providers no longer must see patients face-to-face to start methadone at the opioid treatment program. Telehealth is sufficient if they use both audio and visual components that function well enough to satisfy the provider that information being transmitted is adequate. The rules go a step further for buprenorphine admissions: a patient can be admitted with audio only and no visual component of the assessment.

This is epic. Even during the pandemic, providers were not allowed to admit patients onto methadone using telehealth, so this is a big reversal of rules.

Starting dose on the first day of methadone treatment can be as high as 50mg.

Honestly, I thought this was a little nutty but maybe not. Since 2001 providers could give as much as 40mg on the first day but it had to be in divided doses and 30mg was the highest one-time dose. But the new rules allow a total of 50mg on day one and don’t come with any caveats or instructions. If I wanted to give a brand-new patient a dose of 50mg, I could.

But I don’t think I will.

I can’t say I would never do this…but I can say it would be very unusual for me to think this was in the patient’s best interest.

Regular readers of my blog will know I’m careful about methadone induction due to a series of methadone deaths we had at a program I worked for twenty years ago. It was a different time, and patients back then were more likely to use benzos in combination with the opioids they were prescribed. We had no prescription monitoring program (until 2007) to see what other medications our patients were getting. Those rural counties were awash in benzos and OxyContin.

At that program, which had eight or so different locations, we had four lawsuits filed by families of patients who died during methadone induction. I was fortunate I wasn’t named in any of the lawsuits, but two of my very good colleagues were. I saw them go through difficult times as their reputation and judgments as physicians were brutally questioned by the plantiffs’ lawyer (the same lawyer brought all four cases). Three of the deaths involved starting doses of 40mg and advancing by 5mg per day, and one patient was started at 35mg instead of 30mg and died on day 4 after increasing her dose by 5mg daily.

I remember the plantiffs’ lawyer explaining, with lawyer logic, that the physicians should have started methadone at a dose of 5mg per day, which was preposterous. The cases were settled out of court against the physicians and the opioid treatment program.

Times are different now and fentanyl is killing even more people than OxyContin did back in its prime. Maybe higher starting doses are indicated. I’ve loosened up some around my prescribing habits, but only because I can see new patients much more frequently during induction than I could twenty years ago.

 I like to see new patients on the first day and then several times during the first two weeks so I can ask them about sedation and continued fentanyl use. I frequently prescribe an extra increase when I see them, to get their dose up more quickly.

But it makes me nervous.

I don’t want anyone to die. And I don’t want to kill anyone.

Back to the SAMHSA rules…

The most striking changes were in the number of take-home doses allowed under the new rules:

Patients in treatment from zero to fourteen days may receive up to 7 unsupervised take home doses of methadone.

Patients in treatment from 15 to 30 days of treatment may receive up to 14 unsupervised take home doses of methadone.

Patients in treatment for 31 or more days may receive up to 28 unsupervised take-home doses of methadone.

Prescribing a week of take homes to a new patient feels risky to me. Could I increase the dose during the week? Or would they be stuck at one dose for the whole week? How could I know how the patient was responding to the dose I selected?

Maybe these new guidelines are meant to make things easier for patients in supervised facilities like jails, prisons, or halfway houses. In these settings there’s sometimes supervision for dosing.

Also remember that just because a higher number of take homes is allowable does not mean it is recommended for all, or even most patients. Also remember that the risk of take homes for buprenorphine products is much lower than for methadone, due to the pharmacology of both medications.

Here are the other criteria to consider when deciding take home doses:

1. “Absence of active substance use disorders, other physical or behavioral health conditions that increase the risk of patient harm as it relates to the potential for overdose, or the ability to function safely.”
2. “Regularity of attendance for supervised medication administration.”
3. “Absence of serious behavioral problems that endanger the patient, the public, or others.
4. “Absence of known recent diversion activity.”

5. “Whether take home medication can be safely transported and stored.”
6. “Any other criteria that the medical director or medical practitioner consider relevant to the patient’s safety and the public health.”

In the past, methadone initiation required daily dosing for extended time (3 months). This interfered with employment, educational activities, and other life activities. It discouraged people from enrolling at OTPs. These new changes allow medical providers more room to personalize treatment, but we must know our patients very well to make the best decisions.

Rules about split dosing changed, in that there are no rules for split dosing after these changes take effect April 2, 2024. Providers no longer need to submit exceptions to get permission to split a patient’s total dose into a morning and evening dose. Once daily dosing works well for most patients, but one or two percent of the population have the genetics that make them rapid metabolizers for methadone. Those patients usually feel better with split dosing. These new regulations no longer require that peak and trough levels be drawn to demonstrate this fast metabolism, but probably are still a good idea.

The new regulations really took a jump from what felt to me like overly restrictive, to what now feels like too loosy-goosy. But is that just my natural disinclination towards change, which is perfectly normal, or are these regulations really too loose?

Time will tell. I think to do the best job for patients means I will need to get to know them even better and rely on the other people at the OTP to know them well, so we can make the best choices.