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1
Introduction

Veterans and their families have served the American people and our country in ways that cannot easily be summarized or measured. Our nation has long recognized and honored military veterans’ service and sacrifices. From the very beginning, benefits have been provided to those whose illnesses were incurred or aggravated by their military service. Ascertaining whether an illness is service connected is not unduly difficult when the illness emerges while the person is engaged in military service. But when an adverse health effect becomes manifest after military service, at times many years later, determining and proving a service connection may raise complex scientific and policy questions.

Presumptions enable veterans to be granted service connection who, through no fault of their own, are unable to establish that the injury was caused by their military service. Since 1921, Congress and the Department of Veterans Affairs (VA) have created numerous presumptions to assist veterans in establishing that they have a service-connected disease entitling them to disability payments (see Appendix D for an historical overview).

Much has happened since 1921 that has made the presumptive disability decision-making process more critical and complex. Fortunately, a far greater percentage of service men and women are surviving combat injuries, and the life expectancy of all veterans has greatly increased. As a result, disability payments are made for much longer periods, and recipients may develop medical complications that were much less frequent when presumptions were first employed. In addition, warfare has changed. Service personnel are subjected to numerous new types of exposures, about some of which we know very little. On the other hand, we understand a good



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1 Introduction Veterans and their families have served the American people and our country in ways that cannot easily be summarized or measured. Our nation has long recognized and honored military veterans’ service and sacrifices. From the very beginning, benefits have been provided to those whose ill- nesses were incurred or aggravated by their military service. Ascertaining whether an illness is service connected is not unduly difficult when the ill- ness emerges while the person is engaged in military service. But when an adverse health effect becomes manifest after military service, at times many years later, determining and proving a service connection may raise complex scientific and policy questions. Presumptions enable veterans to be granted service connection who, through no fault of their own, are unable to establish that the injury was caused by their military service. Since 1921, Congress and the Department of Veterans Affairs (VA) have created numerous presumptions to assist veterans in establishing that they have a service-connected disease entitling them to disability payments (see Appendix D for an historical overview). Much has happened since 1921 that has made the presumptive dis- ability decision-making process more critical and complex. Fortunately, a far greater percentage of service men and women are surviving combat injuries, and the life expectancy of all veterans has greatly increased. As a result, disability payments are made for much longer periods, and recipients may develop medical complications that were much less frequent when pre- sumptions were first employed. In addition, warfare has changed. Service personnel are subjected to numerous new types of exposures, about some of which we know very little. On the other hand, we understand a good 

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 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS deal more now about disease processes because of recent research based in epidemiology, toxicology, and genetics. This report proposes a framework for presumptive disability decision making that would employ our best scientific understanding while protecting the interests of veterans and other stakeholders by including them in the decision-making process. It provides findings from a committee convened to assess the current approach of the presumptive disability decision-making process for veterans and to provide a framework for a future approach. The committee was appointed by the Institute of Medicine (IOM) of the National Academies at the request of a special congressional commission (see below). VETERANS’ DISABILITY BENEFITS COMMISSION The Veterans’ Disability Benefits Commission (Commission) was created by the National Defense Authorization Act of 2004 (Public Law 108-136. 108th Cong., 1st Sess.). The Commission is charged with “studying the benefits provided to compensate and assist veterans for disabilities attribut- able to military service. The Commission was mandated to consult with the Institute of Medicine (IOM) of the National Academy of Sciences with respect to the medical aspects of contemporary disability compensation poli- cies” (VDBC, 2006, p. 1; as found in Appendix A). The Commission was asked to evaluate and assess the following: • The appropriateness of benefits • The appropriateness of the level of those benefits • The appropriate standard(s) for determining whether the disability should be compensated (VDBC, 2006, p. 1; as found in Appendix A) To meet its goals, “the Commission produced a list of 31 research questions to be answered during its investigation” (VDBC, 2006, p. 1; as found in Appendix A). The Commission requested two studies from IOM. This report will address the issue of presumptions. Another committee, the Committee on Medical Evaluation of Veterans for Disability Com- pensation, issued a report entitled A 1st Century System for Evaluating Veterans for Disability Benefits, in June 2007. That report made recom- mendations to the Commission on how several components of VA’s medi- cal evaluation and disability rating process for veterans could be updated and improved. The independent Commission “consists of 13 members who were appointed by the President and the leaders of Congress” (VDBC, 2006, p. 1; as found in Appendix A) and is funded by VA. Twelve of the commis- sioners have served in the military. Nine members have combat experience. “The Commission is charged to submit its report by October 1, 2007, to

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 INTRODUCTION the President and Congress” (VDBC, 2006, p. 1; as found in Appendix A). The Commission’s website is www.vetscommission.org. IOM COMMITTEE CHARGE AND APPROACH In response to a request from the Veterans’ Disability Benefits Com- mission, IOM constituted the Committee on Evaluation of the Presumptive Disability Decision-Making Process for Veterans (Committee). To address the charge from the Commission, IOM assembled 14 full committee mem- bers, 1 volunteer scientific consultant, and 1 paid consultant—all with diverse backgrounds and expertise. The Committee’s website is www.iom. edu/pddm. As the independent Commission does not have its own funding source, this study was funded by VA. The task order description provided by VA is to (1) describe and evaluate the current model used to recognize diseases that are subject to service connection on a presumptive basis; and (2) if appropriate, propose a scientific framework that would justify recognizing or not recognizing conditions as presumptive. The Committee gained many insights from a four-page statement clari- fying the task order that was presented to the Committee at its first meet- ing by Commissioner John Grady (Grady, 2006; VDBC, 2006; as found in Appendix A). The statement emphasized that the granting of a presump- tive service connection be “based on the best scientific evidence available” (VDBC, 2006, p. 4; as found in Appendix A). The Commission asked the Committee to “evaluate the current model used to determine diseases that qualify for service connection on a presumptive basis, and if appropri- ate, propose improvements in the model” (VDBC, 2006, p. 1; as found in Appendix A). The Commission emphasized that “having a method of granting service connection quickly and fairly based on a presumption is of critical importance to our disabled veterans and their surviving spouses,” and asked the Committee to consider process improvements to address the long periods of elapsed time before presumptions are established (VDBC, 2006, pp. 3-4; as found in Appendix A). During the first meeting, the Committee asked questions of the com- missioners to further clarify the charge. In responding, the Commission indicated that it did not expect a full, exhaustive review of all presumptions established since 1921 and that a review of case studies would facilitate the Committee’s understanding of the current process. The Commission also clarified the scope of the evaluation, indicating that it would like the Committee to evaluate all participants in the current process—including Congress, VA, IOM, veterans stakeholders, and any others—and to thor- oughly assess the processes currently used to make presumptions, as well as in the past, since an understanding of past processes would be instructive in

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0 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS considering possible future processes (as stated during Commission Panel discussion on May 31, 2006; VDBC, 2006, as found in Appendix A). The Committee approached the review of present and past processes and prac- tice, including the roles and responsibilities of the different parties involved, through a series of case studies (see Appendix I). The Commission asked if there should “be a defined process in place at VA to review and estab- lish presumptions” and if “the same or a different process should be used periodically to review existing presumptions” (VDBC, 2006, p. 3; as found in Appendix A). The Committee deliberated the case studies to learn the past processes of presumptive decisions and to develop its proposed frame- work for the future of the presumptive disability decision-making process. At the heart of such processes are the principles used by participants for evaluating evidence on whether or not an effect was caused by military service. The Commission therefore asked about the “amount of increase in occurrence rate . . . to warrant compensation” and for “advice, from an epidemiologic and statistical standpoint, on what strength of evidence would be the appropriate requirement when the Secretary of Veterans Affairs considers whether to establish a presumption” (VDBC, 2006, p. 3; as found in Appendix A). These requests address considerations of mag- nitude of risk and strength of evidence in making presumptive decisions, and the methodology used in determining causal relationships. These issues became a cornerstone for future Committee discussions regarding the use of causation versus association, interpretation of population versus individual risks, and use of attributable fraction or probability of causation for com- pensation purposes. An important legal definition the Committee discussed throughout the study process was that “an association is considered ‘positive’ if the credible evidence for the association is equal to or outweighs the credible evidence against the association” (VA, 1996, p. 41368). This legal definition was an important part of deliberations for the Committee and became the founda- tion for the Committee’s proposed strength of evidence categories. Finally, the Commission asked the Committee to address some specific issues. First, several presumptions have been established “because it was not possible to document exposure to biological, chemical, radiological, or other environmental agents by accurate information on the exact locations to which military [S]ervice members were assigned during precise periods of time” (VDBC, 2006, p. 2; as found in Appendix A). The Commission stated the Committee “may be able to provide substantive advice concern- ing how to ensure that this situation is not repeated in the future” (VDBC, 2006, p. 3; as found in Appendix A). Second, in its statement, the Com- mission asked if the case of Vietnam veterans with diabetes and prostate cancer was fully supported by medical evidence for these presumptions (VDBC, 2006; as found in Appendix A). When the Committee questioned

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1 INTRODUCTION the commissioners whether the intent was for the Committee to reevaluate the body of evidence for these presumptions, it was determined that this was beyond the charge of the Committee (as stated during Commission Panel discussion on May 31, 2006; VDBC, 2006; as found in Appendix A). However, the Committee did decide to include these two presumptions as part of the case study series to learn more about the processes that put these presumptions in place. INFORMATION GATHERING BY THE COMMITTEE The Committee engaged in extensive information gathering while con- ducting its inquiries. This enabled the Committee to develop the case study series, review the work and processes of VA and of the National Acad- emies’ (IOM and National Research Council [NRC]) committees, consider congressional mandates and intent, consider future possible approaches for making presumptions, and review the underlying current and planned Service member and veteran surveillance systems at the Department of Defense (DoD) and VA that could support the presumptive decision-making process. The Committee collected and reviewed hundreds of public laws, congressional committee reports, federal government reports, National Academies’ (IOM and NRC) reports, as well as other documents. The Committee also held three open session meetings—on May 31, July 27, and October 4, 2006—for information gathering purposes. The agendas for these meetings may be found in Appendix B. The Committee heard from the key participants in the presumptive disability decision- making process for veterans during these meetings—past and present congressional staff, VA representatives, IOM representatives, DoD repre- sentatives, veterans service organizations (VSOs), veterans, and the general public. Among the VSOs the Committee heard from were the American Legion, AMVETS, NAM-POWS Corporation, Non-Commissioned Offi- cers Association, Texas Veterans Commission, United Spinal Association, Veterans for America, Veterans of Foreign Wars of the United States, and Vietnam Veterans of America. The individuals who participated are noted in the acknowledgments. To better and more clearly understand VA’s process and how it uses the National Academies’ (IOM and NRC) reports, the Committee asked VA for task force reports, working group documents, and cost estimate documents that related to specific, past presumptive decisions. VA declined the request to release these documents on the basis of the predecisional nature of the documents (Mansfield, 2006). As an alternative, VA offered to respond to questions offered by the Committee. A list of questions was prepared in writing by the Committee. VA did not respond to all of the Committee’s questions and cited similar reasons for not responding as were expressed

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 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS previously with regard to release of VA’s task force documents (Dunne, 2006). Availability of VA Documents The IOM Committee sought to review VA’s decision-making documents to better understand the factors considered in making recommendations by the working group and task force. These were not made available because VA considered them to be predecisional and possibly sensitive. As an alter- native, VA prepared a white paper (found in Appendix G) that provides a general description of VA’s decision process following the receipt of an IOM report on Agent Orange or the Gulf War. VA also offered to respond to Committee questions regarding VA’s presumptive decision-making pro- cedures. The Committee submitted questions, and VA responded to several but not all of them (VA, 2006). In a letter to the Committee Chair, VA explained it was reluctant to respond to some of the questions for the following reasons:1 • The requested answers would cause VA to describe the contents of memoranda and notes of internal meetings that are pre-decisional, and reflective of internal deliberations of VA personnel who advise the Secretary of Veterans Affairs on matters of policy and law. • In order to ensure that the Secretary receives the best possible advice, VA personnel must remain free to engage in vigorous discussion of important issues facing the Department without the constraints that necessarily would apply, if their deliberations were subject to external review. • Statements made in the context of robust deliberations, if viewed apart from that context, may be misconstrued or misrepresented. • The possibility of public disclosure may inhibit free discussion in future deliberations and needlessly limit the thorough and thoughtful con- sideration that must attend the formulation of policies affecting our Nation’s veterans. • Providing the requested answers to the Presumptions Committee may effectively waive any protections VA would have against broader public disclosure of this pre-decisional information. It should be noted that the Committee offered to receive redacted docu- ments in accordance with the provisions of the Freedom of Information Act, but that offer was not accepted by VA. Similar reasons were given for not providing working group and task force reports to the Committee. In a separate letter to IOM, the Deputy Secretary of Veterans Affairs, Gordon 1Personal communication, P. W. Dunne, Department of Veterans Affairs, December 2006.

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 INTRODUCTION H. Mansfield, indicated VA was “concerned that statements made in the context of robust deliberations, if viewed apart from that context, may be misconstrued or misrepresented for purposes of litigation or other ends.”2 The Committee believes that this report has been limited to some degree by lack of access to requested documents, to an extent we cannot assess without actually seeing the documents. ORGANIZATION OF THE REPORT This report is organized into 13 chapters with supporting appendixes. Chapters 2 through 5 address the historical and current presumptive dis- ability decision-making process for veterans and describe how it is working. An overview of presumptive disability decisions established by Congress and VA since 1921 is found in Chapter 2. Chapter 3 describes the current presumptive disability decision-making process, and the roles of Congress, VA, and IOM. The legislative background pursuant to the more current presumptions of Radiation, Agent Orange, and Gulf War is included in Chapter 4. Chapter 5 summarizes the past and current practices found in the Committee’s 10 case studies (see Appendix I): • Mental Disorders’ Presumptions • Multiple Sclerosis Presumption • Prisoners of War Presumptions • Amputees and Cardiovascular Disease Presumption • Radiation Presumptions • Mustard Gas and Lewisite Presumptions • Gulf War Presumptions • Agent Orange and Prostate Cancer Presumption • Agent Orange and Type 2 Diabetes Presumption • Spina Bifida Program (VA program but not a presumption) The lessons learned from these case studies provided valuable insights into past and current processes, as well as presenting opportunities for process improvements by all participants in the presumptive disability decision-making process. The second part of the report (Chapters 6-13) focuses on methodologi- cal aspects of the process, laying the foundation for a path forward, and proposes a process for establishing presumptions in the future. Following an overview of an evidence-based framework for making presumptive deci- sions in Chapter 6, Chapters 7 and 8 lay the groundwork for developing 2 Personal communication, G. H. Mansfield, Department of Veterans Affairs, December 2006.

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 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS methods to consider whether a substance or exposure may cause a specific health condition of concern. Chapter 9 then focuses on to what extent mili- tary service could be responsible for a specific health condition in veterans (in general or in a group of veterans)—taking as a given that an exposure during military service can cause the illness. Accurate evidence is critical for the process of conducting the assessments discussed in Chapters 7 through 9. Chapter 10 summarizes health and exposure data systems within DoD for collecting exposure, incidence, and health status information during service, and within VA and other organizations for following military personnel after they leave service and through the remainder of their lives. Chapter 10 offers suggestions for improved research and surveillance to better support the presumptive disability decision-making process. Secrecy leads to gaps in evidence, and Chapter 11 therefore addresses governmental classification and secrecy. These earlier chapters are preparatory to Chapter 12, which introduces “The Way Forward” with the Committee’s proposed framework for the future of presumptive disability decision making for vet- erans. Chapter 13 presents the Committee’s recommendations to Congress, VA, a Science Review Board, and DoD. The appendixes contain information organized by the Committee and IOM staff that may assist the reader who wishes to further delve into the issues and historical background on presumptions. In addition to the appendix material introduced earlier (i.e., Commission statement, meeting agendas), the appendixes include acronyms, abbreviations, and a glossary (Appendix C), an overview of the current compensation system and its his- torical context (Appendix D), summary tables of the presumptive decisions established by Congress and VA since 1921 (Appendix F), VA’s White Paper (Appendix G), IOM’s Agent Orange and Gulf War Statements of Tasks and Conclusions (Appendix H), the complete series of case study chapters (Appendix I), additional background material on causation and statistical causal methods (Appendix J), additional background material on exposure and health data for veterans (Appendix K), and additional classification and secrecy information (Appendix L). Finally, Appendix M provides brief bio- graphical information for Committee members, consultants, and selected staff responsible for this effort. The Committee was not asked to and did not make judgments regard- ing specific cases in which individual veterans have claimed injuries and ill- nesses. This report neither supports nor criticizes the presumptive decisions Congress and VA have established since 1921. As well, the Committee did not make recommendations for any new, specific presumptions. These areas were beyond the Committee’s charge. However, the Committee did review, analyze, and report on the available information regarding the presumptive disability decision-making process for veterans.

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 INTRODUCTION COMMITTEE MEMBERS’ COMMITMENT TO VETERANS All Committee members agreed to serve on this effort because of the importance of the issue and because of their deep gratitude and respect for those serving in the military and veterans who have served in the past. We submit this report with the hope that our effort will be to the benefit of those who have served in the past and who will serve in the future. REFERENCES Dunne, P. W. 2006. Department of Veterans Affairs responses: Questions following from the Veteran’s Disability Benefits Commission’s charge. Letter to Jonathan M. Samet. Grady, J. 2006. Statement presented at the first committee meeting of the IOM’s Committee on the Evaluation of the Presumptive Disability Decision-Making Process for Veterans. Washington, DC. Mansfield, G. H. 2006. Internal VA process for reviewing reports on the Institute of Medicine under the Agent Orange Act of 11 and the Persian Gulf War Veterans Act of 1. Letter to Susanne A. Stoiber. VA (Department of Veterans Affairs). 1996. Diseases associated with exposure to certain herbicide agents. Proposed Rule. Federal Register 61(154):41368-41371. VA. 2006. Department of Veterans Affairs responses: Questions following from the Veteran’s Disability Benefits Commission’s charge. Washington, DC: Department of Veterans Affairs. VDBC (Veterans Disability Benefits Commission). 2006. Statement of the Veterans’ Disability Benefits Commission to the IOM’s Committee on Presumptive Disability Decision Making Process. Washington, DC.