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19 - Changes in Methadone Regulation During COVID-19

from Part V - Opening New Pathways for Health Care Delivery and Access

Published online by Cambridge University Press:  27 October 2023

I. Glenn Cohen
Affiliation:
Harvard Law School, Massachusetts
Abbe R. Gluck
Affiliation:
Yale University, Connecticut
Katherine Kraschel
Affiliation:
Yale University, Connecticut
Carmel Shachar
Affiliation:
Harvard Law School, Massachusetts

Summary

Methadone, a medication used to treat opioid use disorder (OUD), has resulted in decreased opioid overdose deaths, while increasing treatment retention and lowering the rates of infectious diseases associated with intravenous substance use. Access to methadone is limited in the United States due to federal laws and regulatory policies that are rooted in racist “criminal justice approaches” to substance use. Unlike other controlled prescription medications, methadone is subject to restrictions on the number of doses a person can receive at any given time, known as “take-home doses” (THDs). Federal regulations mandate that patients receiving methadone must travel to government-certified clinics known as opioid treatment programs (OTPs) almost daily to receive medication for at least the first 90 days of treatment. Due to the need to practice social distancing during COVID-19, the Substance Abuse and Mental Health Services Administration (SAMHSA) – the regulatory agency which sets the accreditation standards for OTPs – released a federal waiver in March 2020 granting significant exemptions to THD regulations. Thousands of patients have now received increased THDs, a historic and impactful shift in care for people with OUD. This chapter begins with an overview of the regulation of methadone for OUD before COVID-19. Next, it reviews the evidence for regulatory reform alongside our analysis of qualitative data we collected during COVID-19 that reflects patients’ experiences with increased access to THDs. Based on the findings of our qualitative study and the empirical literature, we conclude the chapter with recommendations for modifications of THD regulations.

Information

Figure 0

Figure 19.1 Number of THDs per participant pre- and post-COVID-19 exemption

Figure 1

Table 19.1 Demographics of research participants from Nashville OTPThe second column indicates gender and race/ethnicity options read aloud to patients. The third column indicates the number of participants with the corresponding percentages that chose each option.

Figure 2

Table 19.2 Safety measure quantitative responsesThe first column represents an abbreviated description of the question asked to each participant (see Section III.A.1 for full-length survey questions). The second column indicates the options read aloud for participants. The third column indicates the number of participants who chose each option.

Figure 3

Table 19.3 Patient preference quantitative responsesThe first column represents an abbreviated description of the question asked to each participant (see methods for full-length survey questions). The second column indicates the options read aloud for participants. The third column indicates the number of participants who chose each option.

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