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.
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 |
10:40am |
Considerations for Special Populations and Circumstances
|
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
|
12:20am |
Lessons Learned from COVID-19 and Regulatory Change in the Wake of Necessity
Noa Krawczyk, New York University |
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 |
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 |
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?
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 |
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 |
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 |
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