Methadone is a Food and Drug Administration- (FDA-) approved medication for treating opioid use disorder (OUD), a chronic brain disease that affects more than 2.7 million people in the United States aged 12 and older. Despite its effectiveness in saving lives, many barriers impede access to, initiation of, and retention in methadone treatment for OUD. To address these barriers, on March 3 and 4, 2022, the National Academies of Sciences, Engineering, and Medicine hosted a workshop on “Methadone Treatment for Opioid Use Disorder: Examining Federal Regulations and Laws,” at the request of the Office of National Drug Control Policy in the Executive Office of the President. This publication summarizes the presentation and discussion of the workshop.

Contents

• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• PLANNING COMMITTEE ON METHADONE TREATMENT FOR OPIOID USE DISORDER: EXAMINING FEDERAL REGULATIONS AND LAWS
• Reviewers
• 1. Introduction and Background
  • WORKSHOP OBJECTIVES
  • ORGANIZATION OF PROCEEDINGS
• 2. Methadone Treatment: Personal Perspectives
  • SUSTAINED RECOVERY MAY REQUIRE CONTINUED METHADONE TREATMENT
  • RECOVERY MAY TAKE MANY FORMS
  • THE NEED FOR A PATIENT-CENTERED FOCUS
• 3. The History of Methadone and Barriers to Access for Different Populations
  • THE EARLY YEARS OF METHADONE MAINTENANCE REGULATION AND THE POLITICS OF STIGMA AND RACIALIZATION
  • CURRENT BARRIERS TO ACCESS, INITIATION, AND RETENTION IN METHADONE TREATMENT
• 4. Current Federal Priorities and Regulatory Flexibilities during the COVID-19 Pandemic
  • GOALS AND PRIORITIES OF THE CURRENT ADMINISTRATION
  • REGULATORY CHANGE IN THE WAKE OF NECESSITY: LESSONS LEARNED FROM COVID-19
  • UNDERSTANDING THE DISCONNECT BETWEEN STATE AND FEDERAL REGULATIONS
• 5. Improving Access to Quality Treatment in Opioid Treatment Programs through Regulatory Innovation
  • FEDERAL STATUTES AND REGULATIONS THAT GOVERN OPIOID TREATMENT PROGRAMS
  • PHARMACY DISPENSING AS AN EXTENSION OF OTPs
  • MOBILE MEDICATION UNITS—A DEMONSTRATION PROJECT IN NEW JERSEY
  • OTPs AS HUB SITES IN SYSTEMIC EXPANSION
  • OTHER STRATEGIES TO EXPANDING ACCESS THROUGH OTPs DISCUSSED BY INDIVIDUAL WORKSHOP PARTICIPANTS
• 6. Improving Access to Quality Treatment in the Criminal Justice System and Other Institutional Settings
  • CROSSCUTTING REGULATORY ISSUES THAT IMPACT CORRECTIONAL FACILITIES AND OTHER INSTITUTIONS
  • TRANSITIONING FROM INCARCERATION TO THE COMMUNITY
  • A STATE TRIAL COURT PERSPECTIVE
  • CIVIL RIGHTS LITIGATION TO ENABLE METHADONE TREATMENT IN INSTITUTIONS
• 7. Expanding Access to Methadone through Regulatory Innovation: Envisioning Approaches Outside the Opioid Treatment Program System
  • OFFICE-BASED METHADONE
  • INTERNATIONAL MODELS OF PHARMACY-BASED DISPENSING
  • INNOVATIVE MODELS OF INITIATION UNDER EXISTING REGULATIONS—INPATIENT AND OUTPATIENT SETTINGS
  • POTENTIAL NEW TREATMENT MODALITIES AND SETTINGS THAT COULD BE OPENED UP WITH REGULATORY CHANGES
• 8. Ensuring Equitable Access to Methadone by Removing Current Barriers and Providing Incentives
  • REGULATORY OPPORTUNITIES TO REMOVE CURRENT BARRIERS
  • REGULATORY INCENTIVES TO FACILITATE ACCESS TO QUALITY TREATMENT
• 9. Frameworks to Guide the Assessment of Legal and Regulatory Challenges
  • A POLICY ANALYSIS FRAMEWORK TO SUPPORT HEALTH POLICY DECISIONS
  • A COST-EFFECTIVENESS FRAMEWORK TO ASSESS POTENTIAL LEGAL AND REGULATORY CHANGES
• 10. Moving Forward: Potential Concrete Legal and Regulatory Actions
  • LEGAL AND REGULATORY REFORMS
  • EXPLORING OPPORTUNITIES TO REFORM METHADONE TREATMENT
  • REFORMING METHADONE TREATMENT WITHIN THE BROADER CONTEXT FOR IMPROVING ACCESS TO MEDICATIONS FOR OPIOID USE DISORDER
  • CLOSING REMARKS
• A. References
• B. Workshop Agenda
• Appendix C. Commissioned Papers

Suggested citation:

National Academies of Sciences, Engineering, and Medicine. 2022. Methadone treatment for opioid use disorder: Improving access through regulatory and legal change: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/26635.

Digital Object Identifier: https://doi.org/10.17226/26635

This publication is available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

Printed in the United States of America.