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Appendix A
Statement of the Veterans’ Disability Benefits Commission to the Institute of Medicine’s Committee on the Presumptive Disability Decision-Making Process, May 31, 2006

The Veterans’ Disability Benefits Commission created by Public Law 108-136 is charged with studying the benefits provided to compensate and assist veterans for disabilities attributable 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 policies. The Commission will evaluate and assess:

  • The appropriateness of benefits

  • The appropriateness of the level of those benefits

  • The appropriate standard(s) for determining whether the disability should be compensated

In order to meet the three goals above, the Commission produced a list of 31 research questions to be answered during its investigation. IOM has established four committees that will address some of these questions in whole or in part. Your Committee will research and report on presumptions. Another committee, the Committee on Medical Evaluation of Veterans for Disability Compensation, was created to research and report on several aspects of compensation policies. IOM also established two committees to deal with various aspects of PTSD including diagnosis, treatment, and compensation. The Commission encourages your Committee to collaborate with the other three committees since there are many areas of overlapping and complementary interests.



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Appendix A Statement of the Veterans’ Disability Benefits Commission to the Institute of Medicine’s Committee on the Presumptive Disability Decision-Making Process, May 31, 2006 The Veterans’ Disability Benefits Commission created by Public Law 108-136 is charged with studying the benefits provided to compensate and assist veterans for disabilities attributable to military service. The Com- mission 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 policies. The Commission will evaluate and assess: • The appropriateness of benefits • The appropriateness of the level of those benefits • The appropriate standard(s) for determining whether the disability should be compensated In order to meet the three goals above, the Commission produced a list of 31 research questions to be answered during its investigation. IOM has established four committees that will address some of these questions in whole or in part. Your Committee will research and report on pre- sumptions. Another committee, the Committee on Medical Evaluation of Veterans for Disability Compensation, was created to research and report on several aspects of compensation policies. IOM also established two committees to deal with various aspects of PTSD including diagnosis, treat- ment, and compensation. The Commission encourages your Committee to collaborate with the other three committees since there are many areas of overlapping and complementary interests. 

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0 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS The Commission consists of 13 members who were appointed by the President and the leaders of Congress. Twelve of the Commissions have served in the military. Nine members have combat experience. Combined, the members have over 260 years of military experience. The establishing statute requires that seven members have received combat decorations such as the Silver Star or higher. The Commission is charged to submit its report by October 1, 2007, to the President and Congress. The Commission is looking forward to receiving expert advice from your Committee regarding the process by which presumptions of service connections are established. The Commission asks that you evaluate the current model used to determine diseases that qualify for service connec- tion on a presumptive basis, and if appropriate, propose improvements in the model. The Commission requests that your Committee assess the overall pro- cess used to establish a presumption. Currently, in determining if a herbicide disease should have a presumption established, the Secretary must deter- mine that the results upon which the presumption is based are statistically significant, are capable of replication, and withstand peer review. The Commission previously provided IOM an analysis of the history of presumptions completed by the VA Office of General Counsel in 1993. The Commission also provided an analysis completed this year by Mr. Donald Zeglin, legal consultant to the Commission, which summarized the General Counsel analysis and analyzed decisions on presumptions that occurred since the completion of the General Counsel analysis. A presumptive condition is an injury or illness in which VA presumes a relationship exists between service and the conditions being claimed. A recurring theme within the compensation program has been the expan- sion of the definition of service connection, mainly under the presumption basis. In general terms, presumptions shift the burden of proof from the vet- eran to the Government. Among the earliest presumptions, not dealing with service connection, are the presumption of sound condition upon entry on active military duty, the presumption relating to aggravation of pre-existing conditions during service, and the presumption of death after an absence of seven years. In many instances, presumptions of service connection have been cre- ated when the manifestation of disability is remote from the veteran’s ser- vice. This could be because medical science could not determine the origin or cause of some disabilities such as multiple sclerosis or how long the time period should be between exposure to the origin and initial diagnosis. In some cases, delayed onset is recognized as a feature of a disability such as posttraumatic stress disorder. In other cases, evidence supporting the need for a presumption can only be obtained through epidemiological studies

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1 APPENDIX A of the frequency of disease among groups of people and research into the effects of various exposures on health. Some presumptions were mandated by statute and some of those were based more on a political decision than a scientific decision. Often, the basis for presumption consisted of a combination of expert opinion, advocacy from organizations and individuals, and Congress’ sense of justice, rather than scientific evidence. The Commission would like you to thoroughly assess the processes used in the past and at the current time to make decisions on presumptions. In some cases, you may find that the processes are ad hoc in nature, varying from time to time and depending on the political and management philosophies of those involved. An understanding of past processes will be very instructive in deciding what the most appropriate process should be in the future. The Commission is aware, as is the Institute of Medicine, that several presumptions were approved because it was not possible to document expo- sure to biological, chemical, radiological, or other environmental agents by accurate information on the exact locations to which military service mem- bers were assigned during precise periods of time. This lack of information prevented definitive studies. Your Committee may be able to provide sub- stantive advice concerning how to ensure that this situation is not repeated in the future. Currently everyone who served in Vietnam is presumed to have been exposed to dioxin from Agent Orange. Do we have a better way of making these determinations? A review of the history of the process for some presumption deter- minations indicates that many years can elapse between the onset of the disease and the establishment of the presumption. Examples of this include diseases associated with herbicide exposure during Vietnam service and experimental exposure to mustard gas during WWII service. Such long periods of time without compensation have no doubt resulted in significant hardship for many veterans and their families. What are the factors that contribute to these long periods of elapsed time? What can be done about these factors to improve the result? Agent Orange, Radiation, and Gulf War Syndrome have resulted in a rapidly growing area of environmental presumptions that have prompted some to raise questions about the disability compensation program. War often affects men and women in profound ways that are not easily explain- able or treatable. Many veterans experience problems/diseases that they attribute to chemical or radiation exposure. Leaving aside questions of the possible effect of psychic injuries inflicted by war on these questions, it seems that science cannot easily or quickly resolve these issues particularly where (1) chemical/radiation exposure levels are often unknowable or dif- ficult to ascertain and (2) the effect of exposure on diseases experienced is scientifically unsettled.

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 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS Notwithstanding this uncertainty, the intense emotions surrounding those genuinely suffering and the perceived unfairness of forcing veterans to “prove” the environments or places where they served related to their possible exposure has led Congress and the Executive Branch to create presumptions. Certain studies (not even necessarily involving veterans), for example, showing that those exposed to dioxin have slightly higher rates of diabetes or prostate cancer, have resulted in an inexorable push to compen- sate all veterans with diabetes/prostate cancer even if it is likely that dioxin exposure is a determinative factor in only a small percentage of cases. Since it is impossible to know what role dioxin played in any particular case, all Vietnam veterans with diabetes and prostate cancer have been and are being granted presumptive service connection. Is this presumption fully supported by medical evidence? What amount of increase in occurrence rate is enough to warrant compensation? What approaches could be considered to allevi- ate this costly result? Your Committee should consider if a different methodology should be used in determining causal relationships other than the environmental aspect used for the current method. Should the Committee on Presumptions review the Gulf War Illness presumptions? Should there be a defined process in place at VA to review and establish presumptions? Should the same or a different process be used periodically to review existing presumptions? The Commission also requests that your Committee provide advice, from an epidemiological and statistical standpoint, on what strength of evidence would be the appropriate requirement when the Secretary of Vet- erans Affairs considers whether to establish a presumption. Currently, in determining if a herbicide disease should have a presumption established, the Secretary must determine that the results upon which the presumption is based are statistically significant, are capable of replication, and with- stand peer review. And, an association is considered positive if the credible evidence for the association is equal to or outweighs the credible evidence against the association. Should the standards for inferential statistical evi- dence in finding an association between causative factors and disabili- ties change? From whom should VA accept sound medical and scientific information to analyze and to consider whether a condition be added as a presumption? Are medical advancements occurring so rapidly and new medical find- ings becoming available so quickly that a formal regulatory process for presumption impedes decision making? How could a regulatory process react in a timely manner to the accelerating changes in medical science? Is a significant change in the methodology used to establish a presumption something to be considered? During your Committee’s review, the Commission would ask you to analyze all key documents and literature regarding presumptions to include

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 APPENDIX A all legislative and committee reports. We also encourage you to review published research on and medical studies of disease exposure and the subsequent development of those diseases. Requesting your Committee to study these issues underlining the research question should not be taken as directing any disposition or find- ing with respect to the research question. Rather the Commission is asking that particular attention be focused on the issue. SUMMARY The Commission recognizes the challenges that the Committee on Presumptive Disability Decision Making Process faces in dealing with this issue. Your Committee has been asked to help ensure that future veterans are granted service connection under a presumption basis based on the best scientific evidence available. Your advice is crucial. The Commission anticipates that you will provide suggestions that will improve the processes that establish future presumptions. Presumptions are intended to protect a service member from being denied service connection for a disease or injury because he/she is unable to confirm the incurrence of the injury during combat or exposure to the disease through no fault of his or her own. To the extent possible, suggestions that will avoid the necessity for many future presumptions by ensuring that exposure of service members is documented and scientific evidence is made available would be important. 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. A through review of the present processes is needed. The presumptions must also be understandable to raters to allow for uniform and equitable application to veterans’ claims regardless of where the rating is prepared. Ensuring that future presumption processes reflect the then current medical knowledge about the causal relationship would benefit entire veteran community. Your suggestions will be considered by the Commission in determining the appropriateness of benefits, the appropriateness of the level of such ben- efits, and the appropriate standard or standards for determining whether a disability or death of a veteran should be compensated. The Commission will consider the Committee’s findings and suggestions in framing its response to the charge from Congress and the President. We look forward to hearing the results of your Committee’s delibera- tions in the coming months.