If there’s any question that the proposed legislation entitled the Opioid Treatment Access Act (OTAA) now before Congress brings to mind, it’s this: Access to what? It may be access to methadone, period.
Mark Parrino, president of the American Association for the Treatment of Opioid Dependence (AATOD), asked that question vehemently at the Coalition of Medication-Assisted Treatment Providers and Advocates (COMPA) methadone symposium held this summer Albert Einstein College of Medicine/Montefiore Medical Center in New York City (see https://atforum.com/2022/07/methadone-reform-ny-part-2/). “What care?” he rhetorically asked the roomful of mainly opioid treatment program (OTP) officials, when panelists mentioned the need for an increase in “access to care” in light of the opioid overdose epidemic.
Under longstanding federal rules, methadone, a schedule II drug, can be prescribed for opioid use disorder (OUD) only by OTPs. Buprenorphine, which is schedule III and has a higher safety profile, can be prescribed by office-based physicians.
[Myth: One of the oft-cited objections to methadone from OTPs only is that patients must go daily to pick up their medication. This is false. The federal government allows 28 days of take-home doses for stable patients (the same amount buprenorphine patients are likely to get from their pharmacies). Some states do, it’s true, have further restrictions. ]
The increased access is, apparently, to methadone itself, without the surrounding treatment components. Whether in the form of increased take-homes from OTPs, prescribing by office-based physicians and dispensing by pharmacies, or other methods, “medication first,” or, what is more likely to become “medication only” following the buprenorphine model, is up for heated discussion.
AATOD is in favor of increased access to medication providing that OTPs are involved in the clinical decision-making around what patients can get the increased take-homes. (Under COVID-19, the federal government ruled that even less than stable patients could receive up to 14 days of take-homes to reduce exposure to and transmission of the virus, see https://atforum.com/2022/03/samhsa-guidance-take-home/). Mr. Parrino has been quoted extensively in this publication on the reasons for continued OTP involvement in patient care , including risks of overdose and diversion, the history of overdose deaths when office-based physicians prescribed methadone for pain, and patients’ need for quality care (most recently, see https://atforum.com/2022/08/reduce-restrictions-methadone/).
The American Society of Addiction Medicine (ASAM) is at direct odds with AATOD, saying that office-based physicians with adequate training should be able to prescribe methadone for OUD.
SAMHSA’s take-home criteria
For now, however, the first step is making it easier for OTP patients to get take-home methadone, based on federal initiatives.
Neeraj Gandotra, M.D., Chief Medical Officer of the Substance Abuse and Mental Health Services Administration (SAMHSA), which regulates, along with the Drug Enforcement Administration, OTPs, told AT Forum that the agency has published criteria for extended take-homes which are more flexible than the eight criteria established in 2008.
The current, exemption-based criteria are, according to the SAMHSA web page:
“Stable patients” within the meaning of this exemption are defined as patients who have completed a minimum of 60 days in treatment, and whose medical record fully documents the following:
(a) that the benefits of providing unsupervised doses to an individual outweigh the risks;
(b) that the individual demonstrates total adherence per the OTP’s discretion with their treatment plan for at least 60 days;
(c) negative toxicology tests for 60 calendar days;
(d) an absence of serious behavioral problems;
(e) stability in their living arrangements and social relationships;
(f) an absence of substance misuse-related behaviors;
(g) an absence recent diversion activity; and
(h) assurance that the medication can be safely stored.
Patients who do not meet all 8 criteria, listed above, are not eligible for treatment as “stable” patients under this exemption.
“Less stable” patients within the meaning of this exemption are defined as patients who have completed a minimum of 30 days in treatment, and whose medical record fully documents the following:
(a) that the benefits of providing unsupervised doses of methadone to the individual outweigh the risks;
(b) that the patient demonstrates partial adherence with their treatment plan for at least 30 days;
(c) 30 days of negative toxicology tests;
(d) an absence recent diversion activity; and
(e) assurance that that the medication can be safely stored.
Patients who do not meet all 5 criteria, listed above, are not eligible for treatment as “less stable” patients under this exemption.
It remains within the OTP provider’s discretion to determine the number of take-home doses within each category of ‘stable’ or ‘less stable’.
The eight criteria for take-home doses established in 2008 by SAMHSA are:
- Absence of recent abuse of drugs (opioid or nonnarcotic), including alcohol;
- Regularity of clinic attendance;
- Absence of serious behavioral problems at the clinic;
- Absence of known recent criminal activity, e.g., drug dealing; 5
- Stability of the patient’s home environment and social relationships;
- Length of time in comprehensive maintenance treatment;
- Assurance that take-home medication can be safely stored within thepatient’s home; and
- Whether the rehabilitative benefit the patient derived from decreasing the frequency of clinic attendance outweighs the potential risks of diversion
Exactly what the new proposal will say is unclear yet, but according to Dr. Gandotra, the new criteria for stable and unstable are “a safe step.”
Dr. Gandotra added most people with substance use disorders are not in treatment. “We are in line with trying to take safe steps to improve treatment access,” he said. “We have information from our European partners as well, and OTPs have a number of items they could potentially utilize.”
AATOD calls for OTP involvement
AATOD is not opposed to more flexibility for take-homes, as long as OTPs are involved.
“The good news that nobody died from a methadone overdose as a result of the emergency take-homes allowed by SAMHSA,” he told AT Forum. “SAMHSA did execute emergency action at the beginning of COVID-19 during March/April of 2020 so that OTPs could provide more take-home medication to patients. It is true that our nation did not experience a greater number of methadone deaths as a result of this ruling. It is also important to point out that the clinical teams of OTP professionals would keep monitoring how patients responded to receiving greater amounts of take-home medication. A number of current policy recommendations do not take this into account. It is interesting that such recommendations are coming from individuals, who have never set foot inside an OTP or they do not have any idea how to effectively treat opioid use disorder. There were a number of anecdotal reports about overdoses but that was not as significant as a methadone related death.”
Still, Mr. Parrino is very concerned about calls to take methadone completely out of the OTP system, and even to dismantle the OTP system. “Throughout my 40-year career, I have never seen so many recommendations coming from so many uninformed people, who do not understand how this system operates,” he told AT Forum. “So many people talk about evidence-based practices and then make recommendations to the contrary.”
The harm reduction side
We did talk to one treatment provider who is also in recovery from OUD, and who is a former researcher in the field. Sam Snodgrass, Ph.D. would like the counseling requirement eliminated, for example.
“We’re the only country that regulates [methadone treatment] like this,” said Dr. Snodgrass, who works at a clinic. “It’s very difficult to do research on methadone and assess whether counseling is effective or not, because everybody has to have counseling,” he said.
Making take-home rules more flexible will not solve the problem with access, said Dr. Snodgrass. “I think it should be able to be prescribed by doctors and dispensed by pharmacies.” What about the dangers of methadone? “I won’t say there won’t be some people who overdose on methadone,” he said. “But, if so there will be far fewer deaths” than there are now, from illicit fentanyl.
Not surprisingly, Dr. Snodgrass also favors overdose prevention centers (safe injection sites) as a way to reduce overdoses. “There are overdose prevention centers all through Europe,” he said. “They look at this is a medical problem, not a criminal one.”
We interviewed Dr. Snodgrass because, of all of the harm reduction proponents we know, he has the most credentials: drug research, in recovery from opioid addiction, currently working with patients are are in buprenorphine treatment, and passionate about the patients he treats. In addition, Dr. Snodgrass himself was a patient in an OTP, taking methadone, for 12 years.
Dr. Snodgrass, who refers to people with OUD as “we” instead of “they” as many researchers do – because he in fact was one – explained what craving is like. “We have shut down our endogenous opioid system to the point that it is not functional,” he said. “We need it to survive. If it’s non-functional, then we starve for those exogenous opioids.That’s why we do what we do.”
Methadone and buprenorphine both normalize the function of the endorphins, said Dr. Snodgrass. “If we could get methadone outside of the OTP system, we would be ecstatic.
The thing about an OTP is you have to jump through their hoops, come in with a smile on your face, you’re treated like a child and the OTP is the parent,” he said.
However, OTPs are liable for their patients, and there is a serious issue with methadone – it builds up in the body, even if people are taking it as prescribed.
NABH: The middle ground
The National Association for Behavioral Healthcare (NABH), which, like AATOD, has many OTP members, supports increased access to methadone, said Sarah Wattenberg, director of quality and addiction services. “In the fentanyl era, buprenorphine may not be enough, but there are some crucial changes that are long overdue for the methadone regulations.”
However, she said the OTAA does not suffice, as it allows for medication only. “OTPs support comprehensive treatment, not just medication,” said Ms. Wattenberg. “We need to address the very high rates of mental health issues” in OTP patients. “NABH believes that everyone should have an opportunity for medication, but we also think that everyone should have acces to psychosocial services, counseling supports, and more.”
The OTAA model “does not have mechanisms in place to ensure that people get other services,” she said. “We have concerns about non-OTP prescribing and pharmacy dispensing.”
And speaking realistically, “we can’t even get pharmacies to stock buprenorphine,” said Ms. Wattenberg.
Diversion is an issue as well, she said. “We know that there’s diversion of buprenorphine, and we can assume there will also be diversion of methadone.”
There is a difference: “if you give buprenorphine to a friend, they’ll probably be fine,” said Ms. Wattenberg. That can’t be assumed about methadone.
“At NABH, we’re all about incremental change when there are safety issues, because you can’t anticipate the unintended consequences.”
Looking forward, NABH “could get on board to working with office based prescribing, for people who are stabilized on methadone,” said Wattenberg. In the meantime, it’s important to remember that “it takes the brain a year to heal,” she said.
And looking at the big picture, Wattenberg is concerned about the future of OTPs. “I think that if you take the OTAA along with the National Academics of Science workshops [see https://atforum.com/2022/03/nasem-methadone-expand-access-primary-care/], and you have a lot of people out there who are saying OTPs don’t work and patients don’t like them – I don’t think that’s the whole story,” she said.
“There are a lot of things we can still do: get rid of the one-year requirement, get rid of the two-fail requirements for under 18, telehealth induction,” said Ms. Wattenberg. Even the methadone vans won’t solve the access problem, “because it’s very expensive to send one doctor out in a van, it’s really hard to find these guys,” she said.
What is needed is a “broader treatment structure to help these patients,” said Ms. Wattenberg.
What patients want
According to Zachary C. Talbott, president of NAMA Recovery, a patient advocacy organization, supports the move to increase methadone take-homes, and also not only supports but helped spearhead OTAA. As he told AT Forum last year, “the the majority of methadone patients have the agency to take our medication without a nurse watching us, just like patients of any other chronic disorder.” Mr. Talbott is also in recovery from OUD, owns several OTPs which he founded, and is a methadone patient.
For SAMHSA’s application for its rulemaking, which has not yet been announced, see https://www.reginfo.gov/public/do/eoDetails?rrid=265962.
For the OTAA, see https://www.congress.gov/bill/117th-congress/senate-bill/3629/all-info