Methadone Treatment for Opioid Use Disorder Improving Access Through Regulatory and Legal Change: Proceedings of a Workshop (2022) / Chapter Skim
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4 Current Federal Priorities and Regulatory Flexibilities during the COVID-19 Pandemic
4 Current Federal Priorities and Regulatory Flexibilities during the COVID-19 Pandemic
Pages 29-44
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From page 29... ...
. • Methadone has been shown to reduce opioid cravings, illicit opioid use, and risk of overdose, while also increasing reten tion; however, it is the least readily available of the three Food and Drug Administration–approved medications to treat opi oid use disorder (Haffajee)
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. • Stigma around the use of methadone limits the potential impact of regulatory changes and needs to be addressed both in the general population and among health care professionals (Olsen)
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First-year policy priorities included reviewing methadone treatment policies and modernizing the way methadone is used. The President's inaugural national drug strategy2 also prioritizes expanding access to quality treatment and reducing racial inequities related to addiction, especially in health care and the criminal justice system.
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Despite evidence showing that methadone reduces opioid cravings, illicit opioid use, and risk of overdose, while also increasing retention, it is the least readily available of the three approved MOUDs. NOTE: DATA = Drug Addiction Treatment Act; MOUD = medications for opioid use disorder; OTPs = opioid treatment programs.
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in 67 urban and rural communities across 4 states, said Haffajee. To address concerns about providing treatment for OUD within the criminal justice system, the NIH HEAL Initiative is also testing different interventions to enhance quality care through the Justice Community Opioid Innovation Network (JCOIN)
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Helena Hansen added that adolescents are often overlooked for methadone treatment as well. SAMHSA Efforts to Improve OUD Treatment Beyond the HHS overdose prevention strategy, the Substance Abuse and Mental Health Services Administration (SAMHSA)
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, and other federal agencies issued a flurry of exceptions to regulations impacting OTPs, said Olsen. Most significant, she said, was the blanket exception10 that allows OTP medical directors to provide up to 28 days of methadone take-homes to stable patients, and up to 14 days for unstable patients, if the OTP believes they can safely manage these doses.
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"So not only do we need to address stigma broadly across the board, but the health care profession at large needs significant training around methadone," she said. Another challenge that needs to be addressed, said Olsen, is how to optimize quality of care for people with moderate to severe OUD, who often present with "a complex mix of multiple substance use disorders, physical and mental health conditions, the effects of trauma and discrimination, and other factors related to social determinants of health." In 2015, SAMHSA issued guidelines that describe a framework for what a high-quality specialty treatment system that includes methadone within the context of 42 CFR section 8 might look like (SAMHSA, 2015)
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In coordination with SAMHSA, they have also waived certain parts of regulations for take-home doses of methadone to ensure that stable patients "can receive medication even if they are unable to leave their homes," said O'Malley, and they have promulgated regulations to implement a provision of the SUPPORT Act, which authorizes a pharmacy to deliver a controlled substance to an administering practitioner for the purposes of providing MOUD. She said "this step forward in patient care streamlines the process, because previously a patient needed to get the medication dispensed at the pharmacy, take it to the treatment provider, and then get it administered, and now that step has been removed." In July 2021, DEA also passed a regulation that allows the expansion of mobile narcotic treatment programs by "allowing DEA registrants who are authorized to dispense methadone for OUD to implement a mobile component to their registration, eliminating the separate registration requirement." She added that they have been working with SAMHSA and the Bureau of Prisons (BOP)
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These varied from 12 During the open discussion period, workshop attendees were provided an opportunity to provide comments via an online chat platform. In this regard, Susan Staats Combs, co-owner of the Shelby County Treatment Center and Chilton County Treatment Center in Alabama, cautioned against the use of terms like "liquid handcuffs," which are hurtful and can increase stigma.
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. Moreover, she said, methadone-related poisonings, overdose deaths, and diversion also changed very little following COVID-19 regulatory changes.
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continues to be involved in only 5 percent of opioid-related overdose deaths. SOURCES: Presented by Noa Krawczyk, March 3, 2022; CDC, 2022.
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. 14 During the open discussion period, workshop attendee Ruth Potee added that while she believes methadone should be prescribed by primary care doctors, just changing the regulation may not be sufficient, because less than 10 percent of primary care physicians have obtained the waivers necessary to prescribe buprenorphine, and far fewer actually prescribe it.
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. • Although federal guidelines recommend avoiding administrative discharge of patients for violating program rules, such as for con tinued drug use, this practice is explicitly permitted in 27 states and prohibited in only 2 states, Massachusetts and South Carolina.
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"Federal policy makers will have to work very closely with their partners in the states to make sure that changes are implemented on the ground and that patients actually receive methadone that meets their needs." She added that state policy makers are often unaware of the areas of misalignment with federal regulations. One of the goals of Pew's research, she said, is to raise awareness of the areas in which state regulations are not based on evidence.15 Individual workshop participants discussing current federal methadone regulations and regulatory flexibilities introduced in response to the COVID-19 pandemic offered potential ways forward to improve methadone access within the context of the existing regulatory landscape (see Box 4-1)
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. • Developing policies to help opium treatment programs become more cultur ally and linguistically accessible to all patients (Gupta)
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