Institute of Medicine Report:
Improving the Presumptive Disability Decision-making Process for Veterans
Scott L. Zeger PhD
Member, Committee on Evaluation of the Presumptive Disability Decision-Making Process for Veterans
Board on Military and Veterans Affairs
Institute of Medicine
The National Academies
Frank Hurley - Catharine Dorrier Chair and Professor
Department of Biostatistics
The Johns Hopkins Bloomberg School of Public Health
Committee on Veterans' Affairs
February 27, 2008
Good afternoon Senator Akaka and members of the Senate Committee on Veterans' Affairs. I am Scott L. Zeger, Professor of Biostatistics from Johns Hopkins University in Baltimore, Maryland, a member of the Institute of Medicine Committee who recently authored the report, Improving the Presumptive Disability Decision-making Process for Veterans. On behalf of Dr. Jon Samet, our committee chair and the rest of the 16 members who represent a diversity of scientific and medical disciplines, I am pleased to present a summary of our key findings to you today.
Our Institute of Medicine Committee worked for a year to describe the current process for making presumptive decisions for veterans who have health conditions arising from military service and to propose a more sound scientific framework for making such presumptive decisions in the future.
To address its charge, the Committee met with many stakeholders: past and present staffers from Congress, the Veterans Administration (VA), the Institute of Medicine, veteran's service organizations, and individual veterans. The Department of Defense (DoD) gave the Committee information about how it tracks exposures and health conditions of personnel. The Committee attempted to formally capture how the current approach works and completed a series of case studies to identify "lessons learned". The Committee also considered how information is obtained on the health of veterans and how exposures during military service can be linked to any health consequences via scientific investigation. It gave substantial attention to the process by which information can best be synthesized to determine if a particular exposure causes a risk to health.
Veterans who have been injured by their service, whether their injury appears during service or afterwards, are owed appropriate health care and disability compensation. For some medical conditions that develop after military service, the scientific information needed to determine that the health condition was caused by their service may be incomplete. In such a situation, Congress or the Department of Veterans Affairs (VA) may elect to make a "presumption" of service-connection so that a group of veterans can be appropriately compensated. Presumptions are made in order to reach decisions in the face of unavailable or incomplete information.
Presumptions were first established in 1921. More recently, several presumptions have been made about Agent Orange exposure during service in Vietnam and around the health risks sustained by military personnel in the first Persian Gulf War.
The present approach to presumptive disability decision-making largely flows from the Agent Orange Act of 1991, which started a model for decision-making that is still in place. In that law, Congress asked the VA to contract with an independent organization, the Institute of Medicine, to review the scientific evidence for the health effects of Agent Orange . Subsequently, the Institute of Medicine has produced reports on Agent Orange, evaluating whether there is evidence that Agent Orange is associated with various health outcomes. The Institute of Medicine provides its reports to the VA, which then acts through its own internal decision-making process to determine if a presumption is to be made.
The case studies conducted by the Committee probed this process. The case studies pointed to a number of difficulties that need to be addressed in any future approach:
The Committee discussed in great depth the optimum approach to establishing a scientific foundation for presumptive disability decision-making, including the methods used to determine if exposure to some factor increases risk for disease. This assessment and the findings of the case studies led to recommendations to improve the process:
To support the Committee's recommendations, we suggest the creation of two panels. One is an Advisory Committee (advisory to VA), that would assemble, consider and give priority to the exposures and health conditions proposed for possible presumptive evaluation. Nominations for presumptions could come from veterans and other stakeholders as well as from health tracking, surveillance and research. The second panel would be a Science Review Board, an independent body, which would evaluate the strength of the evidence (based on causation) which links a health condition to a military exposure and then estimates the fraction of exposed veterans whose health condition could be attributed to their military exposure. The Science Review Board's report and recommendations would go to the VA for its consideration. The VA would use explicit criteria to render a decision by the VA Secretary with regard to whether a presumption would be established. In addition, the Science Review Board would monitor information on the health of veterans as it accumulates over time in the DoD and VA tracking systems, and nominate new exposures or health conditions for evaluation as appropriate.
This Committee recommends that the following principles be adopted in establishing this new approach:
1. Stakeholder inclusiveness
2. Evidence-based decisions
3. Transparent process
6. Causation, not just association, as the target for decision making.
The last principle needs further discussion, as it departs from the current approach. In proposing causation as the target, the Committee had concern that the approach of relying on association, particularly if based on findings of one study, could lead to "false-positive" presumptions. The Committee calls for a broad interpretation of evidence to judge whether a factor causes a disease in order to assure that relevant findings from laboratory studies are adequately considered. The Committee also recommends that benefits be considered when there is at least a 50% likelihood of a causal relationship, and does not call for full certainty on the part of the Science Review Board.
The Committee suggests that its framework be considered as the model to guide the evolution of the current approach. While some aspects of the approach may appear challenging or infeasible at present, feasibility would be improved by the provision of appropriate resources to all of the participants in the presumptive disability decision-making process for veterans and future methodological developments. Veterans deserve to have these improvements accomplished as soon as possible.
The Committee recognized that action by Congress will be needed to implement its proposed approach. Legislation to create the two panels is needed and Congress should also act to assure that needed resources are available to create and sustain exposure and health tracking for service personnel and veterans. Many of the changes proposed by the Committee could be implemented now, even as steps are taken to move the DoD and VA towards implementing the model recommended. Veterans deserve to have an improved system as soon as possible.
Thank you for the opportunity to testify. I would be happy to address any questions the Subcommittee might have.
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