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Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
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B

Workshop Agenda

Methadone Treatment for Opioid Use Disorder:
Examining Federal Regulations and Laws
A Workshop

March 3–4, 2022 | Virtual

Workshop Objectives:

A planning committee of the National Academies of Sciences, Engineering, and Medicine will organize and conduct a 2-day public workshop that brings together experts and key stakeholders to examine the current federal regulatory and legal landscape regarding provision of and access to methadone for the treatment of opioid use disorder.

Invited presentations and discussions will be designed to:

  • Examine current federal regulations governing methadone treatment services, including the current COVID-19 emergency regulatory relief;
  • Discuss the impact of these regulations relative to other factors affecting treatment services;
  • Explore potential options for modifying federal regulations and laws to expand access to quality treatment with methadone; and
  • Explore state laws that may conflict with federal regulations.
Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×

DAY 1: THURSDAY, MARCH 3, 2022

9:30am ET Welcome and Opening Remarks
Alan Leshner,
CEO Emeritus, American Association for the Advancement of Science; Workshop Chair
9:35am Opening Talks Highlighting Lived Experiences

Abby Coulter, Urban Survivors Union; co-author of the Methadone Manifesto; Planning Committee Member

Walter Ginter, Medication Assisted Recovery Support Team

Brenda Davis, National Alliance for Medication Assisted Recovery, Inc.

SESSION 1: METHADONE TREATMENT AND REGULATION – HISTORICAL PERSPECTIVE AND OVERVIEW OF WHERE WE ARE TODAY

Session Objective: Examine the history and current status of methadone treatment and regulations in the United States.

Key Discussion Questions:

  • How have methadone regulations evolved to where they are today?
  • What are the effects of methadone regulation on health inequities, including social barriers to treatment, and the considerations for special populations?
  • What are some of the federal priorities and collaborative efforts aimed at addressing longstanding barriers and improving access to quality treatment?
10:05am Session Overview

Helena Hansen, University of California, Los Angeles; Planning Committee Member; Session Moderator

10:10am The Politics of Stigma and Racialization in the Early Years of Methadone Maintenance Regulation

Samuel Kelton Roberts, Jr., Columbia University

10:25am Racial Disparities in Access, Initiation, and Retention in Methadone Treatment and Implications for Policy Formulation

Magdalena Cerdá, New York University; Planning Committee Member

Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
10:40am Considerations for Special Populations and Circumstances
  • Pregnant/Parenting People

    Mishka Terplan, Friends Research Institute

  • People Living with HIV & LGBTQIA+ Populations

    Alex Keuroghlian, The Fenway Institute; Harvard Medical School

  • Older Adults

    Ximena Levander, Oregon Health & Science University

11:10am Moderated Discussion with the Speakers and Q&A
11:30am BREAK
11:40am ONDCP Presentation – Goals and Priorities of the Administration

Rahul Gupta, Director, Office of National Drug Control Policy, Executive Office of the President

11:50am Overview of the Current Regulatory Landscape and Flexible Responses during COVID-19
  • U.S. Department of Health and Human Services (HHS)

    Rebecca Haffajee, Acting Assistant Secretary for Planning and Evaluation

  • Substance Abuse and Mental Health Services Administration (SAMHSA)

    Yngvild Olsen, Acting Director of the Center for Substance Abuse Treatment

  • Drug Enforcement Administration (DEA)

    Kristi O’Malley, Special Advisor to the Administrator

12:20am Lessons Learned from COVID-19 and Regulatory Change in the Wake of Necessity

Noa Krawczyk, New York University

Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
12:35pm Overview of The Pew Charitable Trusts’ 50-State Analysis of Methadone Regulations

Frances McGaffey, The Pew Charitable Trusts

12:45pm Moderated Discussion with the Speakers and Q&A
1:05pm LUNCH

SESSION 2: IMPROVING ACCESS TO QUALITY TREATMENT IN OTPS THROUGH REGULATORY INNOVATION

Session Objective: Explore broad implementation of innovations, supported by evidence, and best practices to ensure access and quality treatment in opioid treatment programs (OTPs): What is allowed now and what requires regulatory change?

Key Discussion Questions:

  • What innovations and best practices, including those from the COVID-19 pandemic, could be more broadly implemented within the existing regulatory framework to support a) access, b) quality, and c) safety?
    • What evidence is available regarding the effect of regulatory innovation and flexibility implemented during the COVID-19 pandemic?
    • Other opportunities for regulatory flexibility
  • What potentially useful innovations would require formal rulemaking or legislative action?
    • What specifically would that look like?
  • What steps would enhance health equity?
1:40pm Session Overview

Ken Stoller, Johns Hopkins University; Planning Committee Member; Session Moderator

1:45pm Legal Analysis

Bridget Dooling, George Washington University; Planning Committee Member

2:00pm Pharmacy Dispensing as an Extension of OTPs

Robert Brooner, Friends Research Institute

2:15pm Mobile Units

Valerie Mielke, New Jersey Department of Human Services

Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
2:30pm OTPs as Hub Sites in Systemic Expansion

Mark Parrino, American Association for the Treatment of Opioid Dependence, Inc.

2:45pm Moderated Discussion with the Speakers and Q&A
3:10pm BREAK

SESSION 3: IMPROVING ACCESS TO QUALITY TREATMENT IN THE CRIMINAL JUSTICE SYSTEM AND OTHER INSTITUTIONAL SETTINGS

Session Objective: Explore possible regulatory initiatives at the federal level that would improve access to quality treatment with methadone in federal, state, and local correctional settings, and in other institutional settings.

Key Discussion Questions:

  • What available discretion in existing regulations could be better leveraged to support a) access, b) quality, and c) safety in institutional settings?
  • What evidence is available regarding the effect of the innovations and regulatory flexibility implemented during the COVID-19 pandemic?
  • What regulatory (or statutory?) changes at the federal level are needed to improve access and quality in federal, state, and local institutional settings? What exactly would that look like?
  • What steps would enhance health equity?
3:25pm Session Overview

Tracie Gardner, Legal Action Center, Planning Committee Member; Session Moderator

3:30pm Crosscutting Regulatory Issues that Impact Corrections Facilities at All Levels and Other Institutions

Josiah “Jody” Rich, Brown University; Planning Committee Member

3:45pm Transitional Clinic Networks

Emily Wang, Yale School of Medicine

Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
4:00pm A State Trial Court Perspective

Judge Michael Barrasse, Lackawanna County Court of Common Pleas, Pennsylvania

4:15pm Civil Rights Litigation to Enable Methadone Treatment in Institutions

Rachael Rollins and Greg Dorchak, U.S. States Attorneys’ Offices–Massachusetts

4:30pm Moderated Discussion with the Speakers and Q&A
4:55pm Day 1 Closing Remarks

Alan Leshner, CEO Emeritus, American Association for the Advancement of Science; Workshop Chair

5:00pm ADJOURN

DAY 2: Friday, March 4, 2022

9:30am Welcome and Recap of Day 1

Alan Leshner, CEO Emeritus, American Association for the Advancement of Science; Workshop Chair

SESSION 4: EXPANDING ACCESS TO METHADONE THROUGH REGULATORY INNOVATION

Session Objective: Explore broad implementation of innovations, supported by evidence, and best practices to ensure access and quality treatment using models and settings other than OTPs: What is allowed now and what requires regulatory change?

Key Discussion Questions:

  • What innovations and best practices involving models and settings other than OTPs could be implemented more broadly within the existing regulatory framework to support a) access, b) quality, and c) safety?
    • Are there available regulatory opportunities not currently understood or leveraged?
  • What innovations require formal rulemaking or legislative action?
    • What concretely would that look like?
  • What steps would enhance health equity?
Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
9:40am Session Overview

Gavin Bart, Hennepin Healthcare; University of Minnesota Medical School; Planning Committee Member; Session Moderator

9:45am Office-Based Methadone

Robert Schwartz, Friends Research Institute

10:00am Pharmacy-Based Dispensing

Li-Tzy Wu, Duke University School of Medicine

10:15am International Models of Pharmacy-Based Dispensing

Janie Sheridan, University of Auckland

Suzanne Nielsen, Monash University

10:30am Innovative Models of Initiation under Existing Regulations – Inpatient and Outpatient Settings

Alexander Walley, Boston University and Massachusetts Department of Public Health

10:45am Potential New Treatment Modalities/Settings that Could be Opened up with Regulatory Changes

Ayana Jordan, New York University

Kamilla Venner, University of New Mexico

11:15am BREAK
11:30am Regulatory Opportunities to Remove Current Barriers

Corey Davis, The Network for Public Health Law

11:45am Regulatory Incentives to Facilitate Access to Quality Treatment

Matthew Lawrence, Emory University School of Law; Planning Committee Member

12:00pm Moderated Discussion with the Speakers and Q&A
12:45pm LUNCH
Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×

SESSION 5: ASSESSING POTENTIAL LEGAL AND REGULATORY CHANGES

Session Objective: Explore a framework that might guide the assessment of potential legal and regulatory changes that would yield the most benefit for improving access to quality methadone treatment for all.

Key Discussion Question:

  • How can the potential impact of the different regulatory mechanisms discussed throughout the workshop be assessed and prioritized? For example:
    • When considering the evidence, how many more people might have access to treatment?
    • What might the health outcomes be, and at what cost?
    • What inroads can such actions make on health equity?
    • How can a framework address both public health and diversion concerns?
1:30pm Overview

Alan Leshner, CEO Emeritus, American Association for the Advancement of Science; Workshop Chair; Session Moderator

1:35pm A Policy Analysis Framework to Support Health Policy Decisions

Richard Frank, Harvard Medical School; The Brookings Institution

1:55pm A Cost-Effectiveness Framework to Assess Potential Legal and Regulatory Changes

Michael French, University of Miami

2:15pm Moderated Discussion with Speakers and Q&A
2:35pm BREAK
2:50pm Synthesis and Prioritization of Legal and Regulatory Actions

Richard Bonnie, University of Virginia, Planning Committee Member

Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
3:00pm Panel Discussion on Concrete Actions

John Brooklyn, BAART St. Albans and Howard Center Burlington Vermont

Chinazo Cunningham, New York State Office of Addiction Services and Supports

David Frank, New York University

Joy Rucker, Former Executive Director, Texas Harm Reduction Alliance

Brendan Saloner, Johns Hopkins University

Shelly Weizman, O’Neill Institute for National and Global Health Law, Georgetown Law

3:45pm Audience Q&A
4:25pm Acknowledgments and Concluding Remarks

Alan Leshner, CEO Emeritus, American Association for the Advancement of Science; Workshop Chair

4:30pm ADJOURN WORKSHOP
Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×

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Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
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Page 125
Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
Page 126
Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
Page 127
Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
Page 128
Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
Page 129
Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
Page 130
Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
Page 131
Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
Page 132
Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
Page 133
Suggested Citation:"Appendix B: Workshop Agenda." 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. doi: 10.17226/26635.
×
Page 134
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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.

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