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Improving the Presumptive Disability Decision-Making Process for Veterans 13 Recommendations In meeting its charge, the Committee has heard presentations and received information from past and present congressional staff members as well as representatives of the Department of Veterans Affairs (VA), the Department of Defense (DoD), the Institute of Medicine (IOM), various stakeholder groups (e.g., veterans service organizations [VSOs]), individual veterans and the general public. The Committee has reviewed an extensive amount of information including (but not limited to): documents provided by the Veterans’ Disability Benefits Commission, public laws and their supporting House and Senate committee reports, Federal Register notices, VA documents (i.e., cost estimates), DoD documents, and IOM reports that have been commissioned by VA and DoD. The Committee has completed case studies that analyze a wide variety of circumstances in which presumptions have been established by Congress and VA. Additionally, the Committee has considered how to use scientific evidence in guiding the process for making decisions that impact the compensation of veterans. It has covered the evaluation of evidence for inferring association and causation as well as the quantification of the contribution of an agent to disease causation in populations and the extension of this quantification to individuals. Based on its extensive evaluation of the current process for establishing presumptive disability decisions and its consideration of alternative approaches, the Committee has a series of recommendations for an approach that is both more strongly grounded in scientific evidence and more responsive and open to veterans. Chapter 12 describes that process. We propose a transformation of the current presumptive disability decision-making process for veterans. We recognize that considerable time
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Improving the Presumptive Disability Decision-Making Process for Veterans will be needed to implement some of these recommendations and will require investment in tracking the exposures and health of current military service men and women as well as veterans. Progress depends on greater research capacity and changes in the evaluation and use of scientific evidence in making compensation decisions. The Committee finds that there are sufficient remediable shortcomings within the current process to warrant immediate action as Congress and VA move toward implementation of a new approach. The Committee concluded that improvements are needed throughout the presumptive disability decision-making process. The recommendations that follow are based on the Committee’s proposed framework for making presumptive decisions (see Chapter 12). We list the recommendations in relation to the appropriate body. In recommending the organizational structure below, the Committee recognizes that Congress and VA might pursue alternative structures to achieve the Committee’s overall goal of having an evidence-based presumptive disability decision-making process. However, the Committee believes that its proposal is feasible and practical over time, many of the elements in its proposal can and should be implemented without delay and that the Committee’s proposal would significantly improve the presumptive disability decision-making process for veterans. CONGRESS Recommendation 1. Congress should create a formal advisory committee (Advisory Committee) to VA to consider and advise the VA Secretary on disability-related questions requiring scientific research and review to assist in the consideration of possible presumptions. The investigation and evaluation of the relationships of exposures during military service and subsequent disabilities experienced by veterans have not been sufficiently prompt and comprehensive. To assure that research and review are timely and on target, the Committee recommends creation of an Advisory Committee to VA composed of veterans and recognized experts in disciplines such as epidemiology, toxicology, exposure assessment and biostatistics to identify and assess issues for referral to the VA Secretary and then to the Science Review Board, which would carry out the subsequent full, comprehensive scientific evaluation of the evidence (see Recommendation 2). In the Committee’s recommended approach, the Advisory Committee has two key roles: screening exposures and illnesses proposed for review for possible presumptive compensation, and providing guidance to VA on research needs and planning. The multidisciplinary Advisory Committee
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Improving the Presumptive Disability Decision-Making Process for Veterans should include stakeholder representatives and have a permanent staff to support its function. The Advisory Committee would also receive the proposals for exposures and illnesses of concern made by stakeholders and other groups. With staff, the Advisory Committee would evaluate the candidates for potential presumptions and make recommendations to the VA Secretary as to whether a full, comprehensive scientific review by the Science Review Board should be carried out. Recommendations made to the VA Secretary and his or her responses thereto should be reported to Congress on an annual basis. To assist the Advisory Committee, a VA tracking system should be developed to identify filed disability claims that suggest the need for further investigation of the relationship linking exposures to health conditions during service. Additionally, claims filed and decided following the creation of a presumption should be tracked to validate previous estimates of case load and to project future claims arising secondarily from the primary condition for service connection. Recommendation 2. Congress should authorize a permanent independent review body (Science Review Board) operating with a well-defined process that will use evaluation criteria as outlined in this Committee’s recommendations to evaluate scientific evidence for VA’s use in considering future service-connected presumptions. Current statutory authority for independent evaluation of scientific evidence for potential service-connected presumptions has too often resulted from ad hoc responses to the pressing questions of the moment. Absent a permanent committee and staff to consider and evaluate the evidence relevant to particular potential presumptions, approaches to evaluation have not been uniform and have not always provided VA with evidence syntheses that fully used the available evidence. The implementation of the Science Review Board, or a comparable entity, is central to the Committee’s recommended changes to the presumptive disability decision-making process. The Science Review Board would implement a well-defined, consistent, and transparent evidence-based approach as described in this report. It should be housed within an organization or institution that can assure the highest level of credibility for its process and reports. The existence of a permanently staffed body would also allow it to be proactive rather than reactive to veterans’ concerns. Recognizing that the development of sufficient scientific evidence to warrant a positive presumptive decision does not always occur quickly, Congress should also consider granting VA discretionary authority to provide provisional medical treatment to veterans while research findings are pending.
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Improving the Presumptive Disability Decision-Making Process for Veterans DEPARTMENT OF VETERANS AFFAIRS Recommendation 3. VA should develop and publish a formal process for consideration of disability presumptions that is uniform and transparent and clearly sets forth all evidence considered and the reasons for the decisions reached. Pursuant to statute, VA is directed to make decisions concerning the establishment of service-connected presumptions for Agent Orange determined on the basis of sound medical and scientific evidence. In making such decisions, VA is required to consider pertinent reports from the National Academy of Sciences and “all other sound medical and scientific information and analyses available” (Agent Orange Act of 1991. Public Law 102-4. 102d Cong., 1st Sess.). The Committee found that VA (1) has no formal published rules governing this process, (2) does not thoroughly disclose and discuss what “other” medical and scientific information it considered, and (3) publishes abbreviated and insufficiently informative explanations of why a presumption was or was not granted. The closed nature of VA practices does not foster public understanding of the reasoning behind the VA’s decisions; the Committee believes that a move by VA to a more transparent process would better meet the expectations of the nation’s veterans and of the public at large. The Committee recommends that VA promulgate, without delay, a more formal procedure for establishing presumptive disability decisions. The procedure needs to be transparent and consistent with the practices of federal regulatory agencies. The word “uniform” in the recommendation refers to a process that works in a consistent fashion with regards to its procedures and outcomes; in other words, given a similar body of evidence for different diseases, the end result of the process should be similar. Members of internal working groups should be disclosed; all evidence considered should be disclosed; and a thorough discussion of the weight attached to the evidence considered should be published so that veterans and the public have a clear understanding of the basis for the decision reached. SCIENCE REVIEW BOARD The recommendations that follow are directed toward the proposed, future Science Review Board, the entity to be established in the Committee’s proposed approach. Recommendation 4. The Committee recommends that the goal of the presumptive disability decision-making process be to ensure compen-
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Improving the Presumptive Disability Decision-Making Process for Veterans sation for veterans whose diseases are caused by military service and that this goal must serve as the foundation for the work of the Science Review Board. The Committee recommends that the Science Review Board implement its proposed two-step process. Previous IOM Agent Orange committees have focused on strength of evidence for an association when causal language has also been included in their charge (IOM, 1994, 1996, 1999, 2000b, 2001, 2003b, 2005b). Agent Orange legislation calls for establishing the presence of an “association” between exposure and disease; however, the enabling legislation also called for consideration of study bias and biologic mechanisms, which address the underlying question of causation (Agent Orange Act of 1991. Public Law 102-4. 102d Cong., 1st Sess.). IOM Gulf War committees have established evidence categorizations based upon both causation and association (IOM, 2000a, 2003a, 2005a, 2006, 2007). The enabling legislation for Gulf War actions did not specify the strength of evidence to be used in scientific reviews (Veterans’ Benefits Improvements Act of 1994. Public Law 103-446. 103rd Cong., 2d Sess., codified as Compensation for Disabilities Occurring in Persian Gulf War Veterans. 2006. 38 U.S.C. § 1117; Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1998 (Part II). Public Law 105-277. 105th Cong., 2d Sess.). The IOM committee that evaluated mustard gas and lewisite based its evidence categorization solely upon causation (IOM, 1993). The Committee therefore recommends that the focus be shifted to the question most fundamental to presumptions, namely whether a military exposure is able to cause a disease. Recommendation 5. The Committee recommends that the Science Review Board use the proposed four-level classification scheme, as follows, in the first step of its evaluation. The Committee recommends that a standard be adopted for “causal effect” such that if there is at least as much evidence in favor of the exposure having a causal effect on the frequency or severity of disease as there is evidence against, then a service-connected presumption will be considered. The Committee recognizes that gathering and synthesizing the evidence necessary to prove a causal effect can be daunting, but expert groups have repeatedly done so using replicable approaches and standard classification schemes. The Science Review Board should adopt a written protocol for evidence review and apply the Committee’s recommended four-level scheme: Sufficient: The evidence is sufficient to conclude that a causal relationship exists. Equipoise and Above: The evidence is sufficient to conclude that a
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Improving the Presumptive Disability Decision-Making Process for Veterans causal relationship is at least as likely as not, but not sufficient to conclude that a causal relationship exists. Below Equipoise: The evidence is not sufficient to conclude that a causal relationship is at least as likely as not, or is not sufficient to make a scientifically informed judgment. Against: The evidence suggests the lack of a causal relationship. Using this scheme, the Committee recommends that the presumption of a causal effect be considered when an expert scientific evaluation finds the evidence considered in support of a causal effect to be at least as strong as the evidence against. We express this criterion as “Equipoise and Above.” Recommendation 6. The Committee recommends that a broad spectrum of evidence, including epidemiologic, animal, and mechanistic data, be considered when evaluating causation. Past decisions on presumptions have sometimes been based largely on epidemiologic evidence. The Committee recommends that evidence to evaluate causation be derived not only from epidemiologic studies of veterans and other exposed groups, but also from toxicological studies of animals or tissue, mechanistic studies of biological mechanisms related to the exposure or the disease process, and any other relevant scientific evidence. There are a number of existing approaches used by other organizations that the Science Review Board should consider. Recommendation 7. When the causal evidence is at Equipoise and Above or Sufficient, the Committee recommends that an estimate also be made of the size of the causal effect among those exposed. In past evaluations, the primary question has been whether there is an association between an exposure and disease. The Committee recommends that future evaluations should, in addition, provide an estimate of the strength of this association. In the crudest setting, this may be a simple ratio of the risk among the exposed compared with the risk among the unexposed (the relative risk). More sophisticated estimates may also be made, for example when there are dose-response data that can be applied to levels of military exposure. Recommendation 8. The Committee recommends that, as the second part of the two-step evaluation, the relative risk and exposure prevalence be used to estimate an attributable fraction for the disease in the military setting (i.e., service-attributable fraction).
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Improving the Presumptive Disability Decision-Making Process for Veterans The relative risk can be used to make a rough estimate of the fraction of diseased persons exposed in the military setting whose disease was actually caused by their military exposure. Although this number is only roughly approximate, it does provide an estimate of the burden of disease caused by the military exposure and could be useful for projecting future costs. This estimate may be useful to VA in its decision-making process and to the veterans themselves in assessing the need for a presumption. DEPARTMENT OF DEFENSE AND THE DEPARTMENT OF VETERANS AFFAIRS The following recommendations are intended to improve the evidence on exposures and health status of veterans: Recommendation 9. Inventory research related to the health of veterans, including research funded by DoD and VA, and research funded by the National Institutes of Health and other organizations. Recommendation 10. Develop a strategic plan for research on the health of veterans, particularly those returning from conflicts in the Gulf and Afghanistan. Models are available for planning major long-term research agendas that are intended to identify critical gaps in the availability of evidence. For example, a National Research Council committee provided a national agenda for research on airborne particles (NRC, 1998) that was used by the Environmental Protection Agency to initiate and track a major research program. Recommendation 11. Develop a plan for augmenting research capability within DoD and VA to more systematically generate evidence on the health of veterans. Recommendation 12. Assess the potential for enhancing research through record linkage using DoD and VA administrative and health record databases. Recommendation 13. Conduct a critical evaluation of Gulf War troop tracking and environmental exposure monitoring data so that improvements can be made in this key DoD strategy for characterizing exposures during deployment. Characterizing personnel exposures during deployment depends extensively on a system of troop location tracking and environmental monitoring
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Improving the Presumptive Disability Decision-Making Process for Veterans that can be coordinated to characterize Service members’ exposures. This approach is relatively new and, while promising, faces some key limitations as currently implemented that may significantly affect the degree to which the approach can adequately characterize individual Service member exposures. Experience acquired during the Gulf War, and subsequent uses of tracking systems in Afghanistan and Iraq, offer important opportunities to evaluate effectiveness so that refinements can be implemented. Recommendation 14. Establish registries of Service members and veterans based on exposure, deployment, and disease histories. Creating registries of Service members based on common groupings that may be important for future health surveillance or research is most easily performed at the time the Service members are together in those groupings. Making lists years after the common experience can lead to inaccuracies from lost records and recall bias. Groupings for registries can be based on many characteristics, including common exposures, common jobs, common deployment experiences, or common illnesses. Recommendation 15. Develop a plan for an overall integrated surveillance strategy for the health of Service members and veterans. DoD and VA need to work together to define a common strategy for integrated health surveillance of Service members and veterans. The need for surveillance can be identified at many points along a veteran’s service to post-service experience. Surveillance studies that are initiated during a Service member’s service career may need to extend beyond the period of military service. Data requirements for the specific surveillance activity may have been generated during military service, after military service, or both. Recommendation 16. Improve the data linkage between the electronic health record data systems used by DoD and VA—including capabilities for handling individual Service member exposure information that is included as part of the individual’s health record. There is immediate benefit to be gained by a robust electronic sharing of military health records, including exposure information, by DoD with VA. DoD has mandated inclusion of service exposure records into its health records. Military health records are a routine part of VA’s approach to assessing veteran health and disability. The final link in the chain is the complete transfer of those exposure and health records from DoD to VA.
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Improving the Presumptive Disability Decision-Making Process for Veterans Recommendation 17. Ensure implementation of the DoD strategy for improved exposure assessment and exposure data collection. DoD has an ambitious and robust plan for improving the breadth and depth of its exposure evaluations and in consolidating records and approaches. These data would be especially useful for the longitudinal characterization of Service member exposures. Given the importance of the success of this initiative to the future understanding of service-related exposures, it is critical that the plan be fully implemented. The Committee recommends that the Veterans’ Disability Benefits Commission work through Congress to establish a specific DoD budget line for the Defense Occupational and Environmental Health Readiness System (DOEHRS) implementation, including the appropriate training of personnel in exposure assessment and in use of the system, and that Congress receive annual reports from DoD on the status of DOEHRS development and implementation. Recommendation 18. Develop a data interface that allows VA to access the electronic exposure data systems used by DoD. DoD continues to invest heavily in electronic systems for documenting exposures experienced by Service members during their military service. These data are critical to VA’s ability to manage veteran health and disabilities and to the presumptive disability decision-making process, yet VA has direct access to little of DoD’s data. DoD and VA should begin to work together immediately to assess the available systems and to define and construct appropriate interfaces for these systems. The Committee recommends that the Veterans’ Disability Benefits Commission work through Congress to establish specific DoD and VA budget lines to enable the development and implementation of a data interface that allows electronic access between DoD and VA records, and that Congress receive annual reports from DoD and VA on the development and implementation efforts. Recommendation 19. DoD and VA should establish and implement mechanisms to identify, monitor, track, and medically treat individuals involved in research and other activities that have been classified and are secret. The major requirements for interaction between DoD and VA regarding classified activities would be the following: Prospectively identify classified studies and activities involving humans.
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Improving the Presumptive Disability Decision-Making Process for Veterans Develop a registry of Service members involved in the studies and activities. Develop a tracking mechanism to maintain contact with the Service members involved. Provide periodic medical evaluations and surveillance of Service members involved. Determine appropriate medical treatment if an adverse health effect is detected. Develop a mechanism to make information public as necessary. Keep the veterans, and families as applicable, fully informed regarding potential health effects of the materials that were used in the studies and activities. The Advisory Committee, mentioned previously, could be assigned to oversee these functions. REFERENCES IOM. 1993. Veterans at risk: The health effects of mustard gas and lewisite. Washington, DC: National Academy Press. IOM. 1994. Veterans and Agent Orange: Health effects of herbicides used in Vietnam. Washington, DC: National Academy Press. IOM. 1996. Veterans and Agent Orange: Update 1996. Washington, DC: National Academy Press. IOM. 1999. Veterans and Agent Orange: Update 1998. Washington, DC: National Academy Press. IOM. 2000a. Gulf War and health, volume 1: Depleted uranium, pyridostigmine bromide, sarin, vaccines. Washington, DC: National Academy Press. IOM. 2000b. Veterans and Agent Orange: Herbicide/dioxin exposure and type 2 diabetes. Washington, DC: National Academy Press. IOM. 2001. Veterans and Agent Orange: Update 2000. Washington, DC: National Academy Press. IOM. 2003a. Gulf War and health, volume 2: Insecticides and solvents. Washington, DC: The National Academies Press. IOM. 2003b. Veterans and Agent Orange: Update 2002. Washington, DC: The National Academies Press. IOM. 2005a. Gulf War and health, volume 3: Fuels, combustion products, and propellants. Washington, DC: The National Academies Press. IOM. 2005b. Veterans and Agent Orange: Update 2004. Washington, DC: The National Academies Press. IOM. 2006. Gulf War and health, volume 4: Health effects of serving in the Gulf War. Washington, DC: The National Academies Press. IOM. 2007. Gulf War and health, volume 5: Infectious diseases. Washington, DC: The National Academies Press. NRC (National Research Council). 1998. Research priorities for airborne particulate matter: I. Immediate priorities and a long-range research portfolio. Washington, DC: National Academy Press.