Review of the Department
of Veterans Affairs
Presumption Decision Process

_____

Anne N. Styka and Bruce N. Calonge, Editors

Committee to Review the Department of Veterans Affairs
Presumption Decision Process

Board on Population Health and Public Health Practice

Health and Medicine Division

Consensus Study Report

NATIONAL ACADEMIES PRESS 500 Fifth Street, NW, Washington, DC 20001

This activity was supported by a contract between the National Academy of Sciences and the Department of Veterans Affairs (#36C24518D0171 / 36C24523N0197). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-70701-5
International Standard Book Number-10: 0-309-70701-3
Digital Object Identifier: https://doi.org/10.17226/27166

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2023. Review of the Department of Veterans Affairs Presumption Decision Process. Washington, DC: The National Academies Press. https://doi.org/10.17226/27166.

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COMMITTEE TO REVIEW THE DEPARTMENT OF VETERANS AFFAIRS PRESUMPTION DECISION PROCESS

BRUCE N. CALONGE (Chair), Associate Dean of Public Health Practice; Associate Professor of Family Medicine, University of Colorado School of Medicine

LAWRENCE DEYTON, Murdock Head Professor of Medicine and Health Policy and Senior Associate Dean for Clinical Public Health, The George Washington University School of Medicine and Health Sciences

JAVIER I. ESCOBAR, Professor Emeritus of Psychiatry and Family Medicine, Rutgers University

JAMES GIORDANO, Pellegrino Center Professor of Neurology, Biochemistry, and Ethics, Georgetown University Medical Center

FRANCINE LADEN, Professor of Environmental Epidemiology, Harvard T.H. Chan School of Public Health

JULEEN LAM, Assistant Professor, Department of Public Health, California State University East Bay

ROGER LEWIS, Senior Physician, Los Angeles County Department of Health Services; Professor, David Geffen School of Medicine at UCLA; Senior Medical Scientist, Berry Consultants LLC

JENNIFER S. LIN, Director, Kaiser Permanente Evidence-Based Practice Center; Senior Investigator, Kaiser Permanente Northwest, Center for Health Research

LORENZ RHOMBERG, Advising Principal, Gradient

DANIELE WIKOFF, Principal; Practice Director, Health Sciences Practice, ToxStrategies, LLC

Health and Medicine Division Staff

ANNE N. STYKA, Study Director

ROBERTA WEDGE, Senior Program Officer

ALEXANDRA MCKAY, Research Associate

NERISSA HART, Senior Program Assistant (through May 2023)

ROSE MARIE MARTINEZ, Director, Board on Population Health and Public Health Practice

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Reviewers

This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.

We thank the following individuals for their review of this report:

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by KENNETH W. KIZER, Stanford University, and ENRIQUETA C. BOND, Burroughs Wellcome Fund, QE Philanthropic Advisors. They were responsible for making certain

that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

Contents

BOXES, FIGURES, AND TABLE

PREFACE

ACRONYMS AND ABBREVIATIONS

SUMMARY

Study Origin and Approach

Governance of the Presumption Decision Process

Scientific Aspects of the Presumption Decision Process

Synthesis of the Presumption Decision Process Assessment

Final Observations

1 BACKGROUND AND POLICY CONTEXT

Defining Presumption

History of Service-Connected Disability Decisions

Statement of Task

Committee Composition and Approach

Organization of the Report

References

Annex: Improving VA’s Presumption Decision Process (PDP)

2 COMMITTEE’S APPROACH TO ITS STATEMENT OF TASK

Interpretation of the Statement of Task

Information Gathering

Desired Characteristics of the Presumption Decision Process

Causation Versus Association

References

3 GOVERNANCE OF THE PRESUMPTION DECISION PROCESS

Overall Governance Process for Determining Presumption

Governance Process for Generating a List of Conditions to Be Considered

Governance Process of Evaluation and Review of Each Condition Being Considered for Presumptive Service Connection

Conclusions and Recommendations Related to Presumption Decision Process Governance

References

4 SCIENTIFIC ASPECTS OF THE PRESUMPTION DECISION PROCESS

Overall Scientific Approach

Planning and Preparatory Phase

Conduct of a Standardized Evaluation

References

5 SYNTHESIS OF THE PRESUMPTION DECISION PROCESS ASSESSMENT

Overarching Themes

Future Evaluation and Assessment

Final Observations

References

Appendix A Applicable Excerpts of Public Law 117-168

Appendix B Public Meeting Agenda

Appendix C Committee Member and Staff Biographies

Boxes, Figures, and Table

BOXES

S-1 Statement of Task

1-1 Statement of Task

3-1 Evidence-Based Policy Council Membership

FIGURES

S-1 The committee’s understanding of the VA presumption decision process governance as given in the presumption decision process document

S-2 The presumption decision process flow diagram from the VA presumption decision process document shows the steps and time frames of the process

3-1 The committee’s understanding of the VA presumption decision process governance as given in the presumption decision process document

3-2 The presumption decision process flow diagram from the VA presumption decision process document shows the steps and time frames of the process

3-3 VA review process for a contracted NASEM report

4-1 The presumption decision process flow diagram from the VA presumption decision process document shows the steps and time frames of the process

4-2 Schematic of the National Toxicology Program’s Office of Health Assessment and Translation approach for systematic review and evidence integration for literature-based environmental health assessments

4-3 The PECOTS schematic as presented in the VA presumption decision process document

TABLE

4-1 The VA PICOTS Framework for the Presumptive Service Connection for Respiratory Conditions Due to Exposure to Particulate Matter

Preface

The service and sacrifice of American veterans have always been critical to our nation’s very existence and identity. Those serving in our armed forces put themselves in harm’s way to protect our country’s security and interests. The public, and the Congress that represents us, have recognized that we are responsible for supporting veterans after they leave service, especially for addressing disabilities associated with specific physical and mental health conditions that arise due to exposures that occurred during the performance of their duties.

Determining whether conditions are or may be due to service-related exposures is complex. The major chronic illnesses that impact American adults, including atherosclerosis, diabetes, chronic lung disease, and cancer, are multifactorial in etiology and occur commonly in individuals with no history of military service. As policy makers and decision makers consider their overarching social and fiscal responsibilities, they must balance the likelihood that a given condition is associated with a service-related exposure when making a determination of presumption.

In 2008, the National Academies of Sciences, Engineering, and Medicine (the National Academies) published a consensus study report, Improving the Presumptive Disability Decision-Making Process for Veterans. That study committee evaluated the process used by the Department of Veterans Affairs (VA) to determine presumptive disability, a decision that linked disability support with service-related exposures and associated medical conditions. That report outlined a process that would apply current scientific approaches to evaluating positive associations between exposure and medical conditions and support presumptive disability decisions that were consistent and

transparent. With a desire to be more flexible and timely and to implement an internal process, VA began using elements of the 2008 report guidance, with revisions and adherence to legislative requirements, to begin internally assessing conditions. VA’s intent is to use the internal process when appropriate and commission external evidence reviews when needed.

In commissioning this review of its revised presumption decision process, VA is asking the National Academies whether the pre-decisional process meets the current scientific standards for evidence-based decision making for environmental exposures and human health and is fair, consistent, and veteran centric. The committee appreciated the focus on veterans and support for decisions that would put veterans’ interests first when balancing the uncertainty that often accompanies evidence synthesis and evidence-based decision making. The committee elevated these values in all of our deliberations and hopes that our recommendations are useful to VA in supporting the implementation of its decision process.

The committee wishes to acknowledge Dr. Patricia Hastings, Chief Consultant, Health Outcomes Military Exposures, who responded to our requests for additional information and clarification related to the presumption decision process. We are also grateful to the many experts who presented and provided materials during and after the committee’s open session on March 7, 2023, including Dr. Patricia Hastings; the panel of professional congressional staff comprised of Simon Coon, Senate Committee on Veterans’ Affairs–Majority Staff; Lindsay Dearing, Senate Committee on Veterans’ Affairs–Minority Staff; and Katherine Smith, Staff Director, Subcommittee on Disability Assistance and Memorial Affairs, House Committee on Veterans’ Affairs–Majority Staff, who provided congressional perspective on the PACT Act sections pertaining to the presumption decision process; and Dr. Jon Samet, University of Colorado School of Public Health, who chaired the 2008 National Academies report Improving the Presumptive Disability Decision-Making Process for Veterans and gave an overview of that report. The committee appreciates the responsiveness of the VA leaders involved with the report in answering our questions and providing guidance on our work.

Finally, I want to acknowledge the hard and collaborative work from all our committee members, who worked diligently within the time frames required and the limits of evidence review and decision-making language crafted in statute. And, of course, the committee members all recognize the work of National Academies study staff that made this report possible: director and responsible staff officer, Anne Styka, and her extremely capable and conscientious colleagues, Roberta Wedge and Alexandra McKay. They provided a critical understanding of VA processes, kept the committee focused on fully responding to its charge, and, more broadly, informed and guided the committee’s work without constraining its deliberations. We

also thank Nerissa Hart and Grace Reading for providing administrative and logistical support to the committee during and between its meetings. A thank you is also extended to Misrak Dabi, Financial Business Partner, for this project and the Research Center staff who assisted with fact checking, referencing, and obtaining information sources.

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Acronyms and Abbreviations