A report from the George Washington University Regulatory Studies Center released August 11 calls for federal regulations to lift limitation on access to methadone, focusing only on the legal methods two federal agencies can use to dismantle the current provider system. Noting that methadone is an effective treatment for opioid use disorder (OUD), the report, “A Vast and Discretionary Regime: Federal Regulation of Methadone as a Treatment for Opioid Use Disorder,” specifically cites four barriers to treatment:
Regulations limit who may provide treatment, who may receive it, how much medicine patients may take home, and more.
The prohibition on prescribing methadone—as opposed to dispensing it directly—requires patients to travel to their opioid treatment program (OTP) to collect their medicine rather than collecting it from a pharmacy.
Methadone’s categorization as a Schedule II controlled substance limits it further.
The cumulative effect of various entry barriers and operating costs depresses the available supply of treatment providers.
“Methadone is an effective treatment for opioid use disorder, which makes it a key tool to address the opioid crisis,” the report notes. Authors found that “in almost every instance, federal regulators have clear statutory authority to amend or remove these regulatory barriers to treatment.”
The report details the legal steps which agencies – notably, the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Drug Enforcement Administration (DEA) can take to make changes. But the report stops short of saying whether these changes should be made. It just explains the legal authority which the agencies have to make these changes. The next step, the report states, is to “determine which changes to make, a complex decision that should draw upon the best available evidence.”
The report was supported by The Pew Charitable Trusts, and written by Bridget C.E.Dooling, research professor at the GW Regulatory Studies Center, and Laura E. Stanley of Pew.
Currently, more than 400,000 patients receive methadone from OTPs in the United States, according to the report. There are actually 600,000 OTP patients, according to AATOD and NASADAD. However, the report cites estimates of millions of people suffering from OUD in the United States.
The commonly cited arguments against methadone being controlled in the OTP system are cited in this report:
Other opioids such as oxycodone and hydrocodone can be prescribed by office-based providers, which methadone can only be dispensed by OTPs.
Patients are required to go to an OTP “almost every day” (this is not true, the federal government allows up to 28 days of take-homes, and since March 2020 has allowed up to 14 days even for less than stable patients).
The report did acknowledge that most of the more stringent requirements come from state and local governments, not the federal government.
“As of August 2022, there were only 1,948 opioid treatment programs in the United States,” the report stated.
The report underscored the value of mobile treatment, citing studies which found that patients who had to travel far were less likely to complete treatment. For this reason, the DEA allowed mobile methadone, which is just now starting to be implemented. The vans cost money, and simply allowing OTPs to operate them doesn’t guarantee that they will miraculously appear.
The report looked closely at which regulatory barriers to accessing methadone “could be removed or amended by executive branch agencies and which are mandated by statute and therefore require Congress to make a legislative change to remove or otherwise adjust” them.
The report takes the approach that it would be better for the changes to occur in the agencies, and not to have to return to Congress, but it also stated that the agencies could of course go farther to seek statutory changes.
The report found that SAMHSA has statutory authority to remove or amend patient care regulations, either through the rulemaking process or through subregulatory guidance. One of these regulations, that patients have a documented one-year or more history of addiction to an opioid in order to be admitted to an OTP, could be removed by SAMHSA parent agency the Department of Health and Human Services. Likewise, SAMHSA could remove or amend the eight criteria for take-home medication. Finally, “interim” maintenance treatment, which is medication only, could also be changed, requiring that only minimal ancillary services be provided.
SAMHSA already “created a pathway” to exempt OTPs on a case-by-case basis, done in March 2020 because of the COVID-19 pandemic, to make it easier for patients to get take-homes and thus not go out to the clinic in order to be exposed or expose others to the virus. For OTPs to give less than stable patients was a huge change from previous requirements, and the liability was the OTP’s in doing this. Nobody died from an overdose of methadone as a result of this policy, according to the federal government (see https://atforum.com/2022/07/liberalized-take-homes/). This was due to the fact that OTPs decided which patients were stable enough to receive a certain number of days of take-home methadone; no patients were automatically given 14 days of take-homes. Although there were no deaths, thankfully, there were methadone overdoses during this time period.
The report concludes that SAMHSA and DEA “have significant discretion to remove or alter these regulatory barriers to methadone treatment, many of which have been in place since the 1970s.”
For the report, go to https://regulatorystudies.columbian.gwu.edu/federal-regulation-of-methadone
Many parties are now writing about what should change in the world of methadone maintenance treatment and its regulatory oversight, noted Mark Parrino, president of the American Association for the Treatment of Opioid Dependence (AATOD), asked to respond to the PEW article. “The driving force behind these policy recommendations is the increasing number of opioid related overdoses, especially in an era of fentanyl use,” he told AT Forum. “These policy recommendations are generally in the context of public health policy, which does not take into account the clinically related issues of treating opioid use disorder.”
The federal agencies which have jurisdiction in the oversight of OTPs are already deep into reevaluating their positions. “They do not need any further prodding at this time,” he said. And it’s important to note that AATOD itself has pushed for years for many of these changes.
One of the issues under consideration is removing the one-year pretreatment clinical requirement of being addicted to an opioid. “AATOD has supported this policy change through written recommendation,” said Mr. Parrino, adding that the Substance Abuse and Mental Health Services Administration (SAMHSA) “is not waiting for congressional legislation to make such changes.”
SAMHSA knows what it is doing, as does the Drug Enforcement Administration (DEA). They understand the regulatory apparatus.
In terms of other PEW recommendations, Mr. Parrino focused on what may not happen and why. “It is highly unlikely that the DEA would change methadone from a Schedule II-controlled substance to a Schedule III,” he said. “The system of scheduling medications is related to their safety profiles. Buprenorphine is a Schedule III due to its safety profile, based on the combination of an agonist and antagonist. I do not think that many of the parties that are making such recommendations understand this scheduling process. There is a great difference between the pharmacology of methadone and the pharmacology of buprenorphine. It is important to keep in mind that methadone is a pure agonist, which requires special handling by knowledgeable professionals.”
Methadone is “a lifesaving medication when used properly and is unforgiving when used improperly,” noted Mr. Parrino. “We all remember what happened when practitioners were prescribing methadone to treat pain, which began in the late 1990s. Federal agencies published five reports on methadone related mortality between 2003 and 2010 and they all arrived at the same conclusion: Methadone mortality rates increased sharply as a direct result of this prescribing where such prescriptions were filled in community pharmacies. It would appear that many of these policy officials have forgotten the lessons learned.”