Take-home methadone doses of up to 14 days

More telemedicine, fewer clinic visits

State and federal regulators have agreed to rule changes that will make life easier (and safer) for methadone patients.

The most important change: Many methadone patients can get enough take-home medicine to last two weeks, if their doctor approves.

Patients who are confirmed to have the COVID-19 virus automatically qualify for take-home methadone doses. How many doses is up to the prescriber. Patients who have signs of respiratory illness — even without COVID-19 confirmation — also qualify for take-home doses, as many as the doctor allows.

Patients over 60 or who have serious and chronic health issues related to pulmonary, renal, cardiac or liver disease also qualify for extended doses, as do those with suppressed immune systems. The document does not say explicitly, but it seems certain that people with HIV, Hepatitis C and related disease qualify for extended take-home dosing.

To get a take-home dose, patients must have a lockable container to keep it in.

New patients (under 90 days) may be put on two-day dosing, so that the clinic can create a staggered schedule for all its patients. In other words, half the patients would come in one day and half the next. The two-day limit for newer patients is designed to reduce overdose risk. If a patient’s urine test shows use of fentanyl or a fentanyl analog, they can pretty much forget about take-home dosing of any duration because of elevated overdose risk.

In a nutshell, doctors will have a lot more discretion for the next two weeks (at least) and, in effect, can make decisions on a case-by-case basis.

Suboxone clinics unchanged

The details of the new rules are outlined in a five-page guidance issued Saturday. The Ohio Department of Mental Health and Addiction Services (OHMAS) and and the federal Substance Abuse and Mental Health Services Administration (SAMHSA) agreed to the plan Friday night.

Click to read state summary of new rules

Methadone, the most effective treatment of opioid use disorder, is heavily regulated and restricted by the federal government under a law Congress passed in 1974. However, to the state’s credit, it has used its regulatory authority and Medicaid reimbursement policies to increase methadone access across Ohio. In the last two years, the number of methadone clinics in Ohio has grown from about 30 to about 49.

Still, the dominant form of medication-assisted-treatment in Ohio is Suboxone and Vivitrol. Almost every town and county in the state has one or more clinics and a few emergency rooms will start people on this treatment after an overdose or other medical emergency.

The state guidance issued Saturday said no changes in dosing rules were made for Suboxone or Vivitrol. Reason: those patients can already get two weeks worth of their drugs immediately. (In contrast, methadone patients need to wait at least 90 days to get freed from the standard regimen of going to the methadone clinic every day for a single does (with a few exceptions, such as perhaps getting an extra weekend dose).

Suboxone or methadone shortages?

A new methadone clinic in Mansfield

Suboxone patients across Ohio have reported worrying about losing access to their medication, forcing an unplanned detox or relapse. However, these fears do not appear to have come true on a broad scale, at least not yet. It’s not clear what Suboxone clinics will do for people who get COVID-19.

In theory, Suboxone, usually provided in strips placed under the tongue, can be delivered to a person at home. Methadone can be delivered this way, too, the new guidance says. However, it’s unclear clinics will do this resource-intensive customer service.

One change that will benefit new patients for Suboxone clinics was approved in a separate set of regulatory changes on telemedicine.  Now, new patients can start via telemedicine without having to go into the clinic’s office. The state also dropped burdensome rules of what equipment is needed to use telemedicine. Now, a person can use everyday technology, such as FaceTime, to connect with a physician or counselor.

It’s unclear what effect COVID-19 will have on the illegal drug supply. But temporary shortage of drugs, especially opioids, could send people to clinics to avoid detoxing suddenly. Already, people have turned to the ultra-efficient and deregulated illegal markets to stock up on Suboxone in case the creaky, hard-to-use legal markets can get patients what they need.

The state reports there have not been shortages of methadone or Suboxone. Methadone clinics are required to have at least a ten day supply of methadone on hand for its patients.

Also, methadone clinics should remain open throughout the coronavirus problem, the state says, because they are considered high-level medical facilities.

Access to better dosing likely quick (but not immediate)

Methadone clinics need to approved by the federal to make the dosing changes described above. This requires not an insignificant amount of paperwork to get an official “exception” to the usual terrible rules.

Methadone clinics can do this on a patient-by-patient basis or seek a blanket except for their entire methadone practice. The latter seems more practical since it gives methadone clinics discretion to make exceptions themselves.

For clinic-wide exceptions, the clinic’s medical director must “include details about agencies policies and procedures, including but not limited to, changes in urine drug screen frequency, changes in counseling frequency, rationale for changing phase requirements for each phase of treatment, and plans for handling patients in a crisis and/or relapse situations.”

The exceptions only last two weeks and must be applied for again if the COVID-19 problem continues, as our federal and state health authorities are saying is likely.