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Appendix G
VA’s White Paper on the Presumptive Disability Decision-Making Process

Internal VA Process for Reviewing Reports of the Institute of Medicine Under the Agent Orange Act of 1991 and the Persian Gulf War Veterans Act of 1998

BACKGROUND

The Agent Orange Act of 1991, Pub. L. No 102-4 (codified in part at 38 U.S.C. § 1116) and the Persian Gulf War Veterans Act of 1998, Pub. L. No. 105-277, title XVI (codified in part at 38 U.S.C. § 1118), direct the Secretary of Veterans Affairs to contract with the National Academy of Sciences (NAS) to evaluate the available evidence concerning the health effects of exposure to herbicides and exposure to certain hazards suspected to be associated with Gulf War service and to prepare biennial reports to the Secretary summarizing its findings based on such evidence. Pursuant to those statutes, NAS’s Institute of Medicine (IOM) prepares such reports and provides them to the Secretary.

Upon receipt of each such report, the Secretary is required to determine whether a presumption of service connection is warranted for any diseases discussed in the report, based on the Secretary’s finding that there is a “positive association” between the exposure in question and the development of the disease. For this purpose, a “positive association” exists if the credible evidence for an association is equal to or outweighs the credible evidence against the association. In making those determinations, the Secretary is required to take into account the IOM’s report and all other sound scientific and medical evidence available to the Secretary. Additionally, in evaluating any study for this purpose, the Secretary is directed to consider “whether the results are statistically significant, are capable of replication, and withstand peer review.”

If the Secretary determines that a presumption is warranted for any disease, the Secretary must issue rules through notice-and-comment rule-making procedures to establish the presumption. Additionally, if the Secretary determines that presumptions are not warranted for certain diseases discussed in the IOM report, the Secretary must publish in the Federal Register a notice explaining the scientific bases for such determination.

The IOM reports prepared pursuant to these two laws typically state conclusions for each disease with reference to one of four or five general categories describing the strength of the available evidence for an association between the disease and the exposure under investigation.



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Appendix G VA’s White Paper on the Presumptive Disability Decision-Making Process Internal VA Process for Reviewing Reports of the Institute of Medicine Under the Agent Orange Act of 1991 and the Persian Gulf War Veterans Act of 1998 BACKGROUND The Agent Orange Act of 1991, Pub. L. No 102-4 (codified in part at 38 U.S.C. § 1116) and the Persian Gulf War Veterans Act of 1998, Pub. L. No. 105-277, title XVI (codified in part at 38 U.S.C. § 1118), direct the Secretary of Veterans Affairs to contract with the National Acad- emy of Sciences (NAS) to evaluate the available evidence concerning the health effects of expo- sure to herbicides and exposure to certain hazards suspected to be associated with Gulf War ser- vice and to prepare biennial reports to the Secretary summarizing its findings based on such evidence. Pursuant to those statutes, NAS’s Institute of Medicine (IOM) prepares such reports and provides them to the Secretary. Upon receipt of each such report, the Secretary is required to determine whether a presump- tion of service connection is warranted for any diseases discussed in the report, based on the Sec- retary’s finding that there is a “positive association” between the exposure in question and the development of the disease. For this purpose, a “positive association” exists if the credible evi- dence for an association is equal to or outweighs the credible evidence against the association. In making those determinations, the Secretary is required to take into account the IOM’s report and all other sound scientific and medical evidence available to the Secretary. Additionally, in evalu- ating any study for this purpose, the Secretary is directed to consider “whether the results are sta- tistically significant, are capable of replication, and withstand peer review.” If the Secretary determines that a presumption is warranted for any disease, the Secretary must issue rules through notice-and-comment rule-making procedures to establish the presump- tion. Additionally, if the Secretary determines that presumptions are not warranted for certain diseases discussed in the IOM report, the Secretary must publish in the Federal Register a notice explaining the scientific bases for such determination. The IOM reports prepared pursuant to these two laws typically state conclusions for each disease with reference to one of four or five general categories describing the strength of the available evidence for an association between the disease and the exposure under investigation. G-1

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G-2 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS The four categories used in the IOM reports under both laws are “sufficient evidence of an asso- ciation,” “limited/suggestive evidence of an association,” “inadequate/insufficient evidence to determine whether an association exists,” and “limited/suggestive evidence of no association.” The IOM reports under the Persian Gulf War Veterans Act include a fifth category, “sufficient evidence of a causal relationship.” The IOM categories intentionally do not address the central issue in the Secretary’s determination, i.e., the existence of a “positive association.” Accordingly, the Secretary is ultimately responsible for determining how the IOM’s findings, together with any other evidence available to the Secretary, bear upon the resolution of that ultimate question. This paper describes the process by which the Department of Veterans Affairs (VA) evalu- ates the IOM reports in order to assist the Secretary in making the determinations described above. RECEIPT OF REPORT AND IOM COMMITTEE BRIEFING VA ordinarily receives an embargoed copy of the IOM report a short period (about one week) prior to the date of the report’s public release. On or about the day of the public release, a representative of the IOM committee ordinarily provides VA a briefing on the report. The brief- ing typically identifies any significant findings in the report, any changes in the IOM’s categori- zation of specific diseases in comparison to prior reports, and any significant changes in the scope or methodology of the IOM’s investigation in comparison to prior reports, and responds to any questions from VA participants. The briefing is ordinarily attended by the members of VA’s Working Group (described below) and other interested VA personnel. SUMMARY OF VA’S REVIEW PROCESS VA has not adopted formal procedures governing its internal review of IOM reports under the two statutes discussed above. However, a general practice has developed that VA usually, though not always, follows in conducting its internal review. The general practice involves a three-tiered review. In the first tier, a “Working Group” of VA employees from different opera- tional elements of VA reviews the IOM report and any other relevant evidence and prepares a summary of its assessment and a statement of recommendations or options. This summary is in- tended for the benefit of a “Task Force” composed of high-level VA officials. In the second tier, the Task Force, based on the Working Group’s input, provides recommendations to the Secre- tary, usually in the form of a separate written report. In the third tier, the Secretary determines, based on the Task Force’s input, whether a presumption of service connection is warranted for any disease. VA WORKING GROUP The Working Group ordinarily consists of members of the Office of Public Health and Envi- ronmental Hazards (OPHEH) of the Veterans Health Administration (VHA), the Compensation and Pension Service (C&P Service) of the Veterans Benefits Administration (VBA), and Profes- sional Staff Group II (PSG II) of the Office of the General Counsel (OGC). Additionally, the Working Group often includes other VHA personnel with specialized medical training or experi- ence concerning a health issue implicated by a particular IOM report. The members generally are assigned to the Working Group by supervisory personnel within VHA, VBA, and OGC.

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APPENDIX G G-3 The Working Group generally convenes within a short time after receiving the briefing from the IOM committee. Prior to the meeting, VHA personnel usually will seek to identify, based on the IOM report and the committee briefing, the diseases that may warrant special consideration because the IOM’s findings with respect to those diseases appear to be potentially significant. Prior to or at the initial Working Group meeting, VHA generally provides the Working Group members with additional information concerning those diseases, including copies of any signifi- cant scientific studies identified in the IOM report and other information concerning matters such as the course of the disease, known causes or risk factors, related conditions or health effects, latency periods (if any), and any other known relevant information. At the initial Working Group meeting, the OGC representative briefs the Working Group on the legal standard governing the Secretary’s decision. Members of the Working Group generally will discuss whether any of the IOM’s findings appear to be potentially significant, in that they might warrant a presumption of service connection for a particular disease or diseases, and will discuss the strength of the scientific evidence with respect to such diseases. The Working Group will try to reach consensus as to whether the scientific evidence appears to warrant a presump- tion of service connection for any diseases under the applicable legal standard. If the Working Group reaches agreement that a presumption is or is not warranted on the basis of the scientific evidence and the legal standard, it will agree to put forth a recommendation based on that con- clusion. In arriving at such recommendations, the Working Group relies on scientific evidence and the legal standard, and generally does not consider matters of governmental policy or cost. If the Working Group concludes that the scientific evidence and legal standard do not pro- vide a clear basis for recommending for or against establishing a presumption, but permit a range of options, the Working Group generally will agree to set forth a range of options for decision by VA policy-making officials. In those circumstances, the Working Group will discuss the factors that preclude a clear recommendation, which may include ambiguity in the governing statutory standard as applied to certain IOM findings, the limited or conditional nature of the IOM’s find- ings with respect to certain diseases, or other factors. The Working Group will discuss the deci- sional options available to the Secretary and may also discuss the factors that may be relevant to the Secretary’s decision among those options. To this extent, the Working Group may discuss the policy considerations that would be relevant to the Secretary’s choice among permissible courses of action. Once the Working Group has reached agreement concerning its recommendations or presen- tation of options, members of the group will prepare a written report. The Working Group Report typically will contain (1) a summary of the issues to be decided under applicable law and the IOM report, (2) a summary of the findings contained in the IOM report, (3) a summary of the legal standard governing VA’s decision, (4) a summary of the Working Group’s analysis of the medical evidence in relation to the legal standard, particularly with respect to any potentially significant findings in the IOM report, and (5) a statement of the Working Group’s recommenda- tions or of the options identified by the Working Group. The Working Group does not prepare or obtain a cost estimate for the options, although it may provide general information concerning, e.g., the prevalence rates of certain diseases under consideration. If the Working Group report lists a range of options available to the Secretary, it ordinarily would identify the scientific and legal considerations relevant to the Secretary’s choice among those options, and may also iden- tify policy implications associated with various options.

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G-4 IMPROVING THE PRESUMPTIVE DISABILITY DECISION-MAKING PROCESS FOR VETERANS VA TASK FORCE The Task Force ordinarily consists of the Under Secretary for Health, the Under Secretary for Benefits, the General Counsel, and the Assistant Secretary for Policy and Planning. There is no generally established procedure for the Task Force’s deliberations. Task Force members gener- ally receive a copy of the Working Group report and, based on that report, provide advice to the Secretary concerning the Secretary’s determination, which may include recommendations based upon the options, if any, outlined by the Working Group. The Task Force often, though not al- ways, provides a separate report to the Secretary, which is based largely upon the Working Group’s report and is usually similar to the Working Group’s report in format and content. As a practical matter, these Task Force reports are usually drafted by members of the Working Group, based on guidance from members of the Task Force. Once the report is drafted, it is circulated to the Task Force members for signature and is then transmitted to the Secretary. SECRETARY Based on the Task Force’s report, the Secretary determines whether to establish presump- tions for any diseases discussed in the IOM report and directs appropriate action to implement the decision. ESTABLISHMENT OF PRESUMPTIONS If the Secretary determines that a presumption of service connection is warranted for any dis- ease, VBA (through the C&P Service staff) will prepare proposed rules to establish such pre- sumptions. The preamble to the proposed rule will explain the scientific and legal basis for the presumption and will invite comments from the public on the rule. VBA staff will prepare an es- timate of the costs associated with the rule, as required by executive order. Once drafted, the proposed rule will be circulated to appropriate VA offices, including VHA and OGC, for review and concurrence. Once all offices concur, VA will transmit the proposed rule and cost estimate to the Office of Management and Budget (OMB) for review. If OMB approves the proposed rule, it will be transmitted to the Secretary for signature. VA will then transmit the rule to the Federal Register for publication. Once the period for providing public comments on the rule has ended, VBA will prepare a final rule. Subject to the same process described above for internal concurrence, OMB review, and the Secretary’s signature, VA will submit the final rule to the Federal Register for publication. In certain circumstances, additional review procedures may be required. For example, if a proposed or final rule would have an annual budgetary impact of $100 million or more, VA must provide a copy of the rule to Congress for review prior to publication of the rule. NOTICE OF DECISION NOT TO ESTABLISH PRESUMPTIONS If the Secretary determines that a presumption of service connection is not warranted for certain diseases, VBA will prepare a notice explaining the scientific basis for that decision with respect to each such disease. The notice is circulated for concurrence within VA in the same manner as a proposed rule, although VA does not prepare cost estimates with respect to the dis- eases concerned in this notice. The notice also may be subject to review by OMB prior to publi- cation. Once the Secretary has signed the notice, VA will transmit it to the Federal Register for publication.