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1 Background and Policy Context
Pages 17-40

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From page 17...
... uses "condition" to refer to any adverse human health outcome, including a mental health condition, and the committee adopts VA's terminology throughout the report. For some medical conditions that develop after or are exacerbated by military service, the scientific information needed to link them to service may be incomplete.
From page 18...
... In June 2022, VA released an eight-page pre-decisional document of its revised presumption decision process. PACT Act Section 202 §1176 calls for a review of that document by the National Academies of Sciences, Engineering, and Medicine (the National Academies)
From page 19...
... can be difficult for a number of reasons, including lack of documentation on the exposures encountered during service, the lag time between an exposure and the manifestation of the disability, and the lack of scientific evidence to link or make an association between a specific exposure and a particular disability. In some cases, VA "presumes that specific disabilities diagnosed in certain veterans were caused by exposures during military service or by their service" (VA, 2020)
From page 20...
... This presumption applies to veterans who served on active military, naval, or air service in the Southwest Asia theater of operations during the 1990–1991 Gulf War and post-9/11 operations or in Afghanistan, Syria, Djibouti, or Uzbekistan on or after September 19, 2001. If a veteran is a member of a specific group, defined by dates and locations of service, and has a diagnosed disability that has been determined to be service connected, then the veteran may be entitled to compensation and associated medical care without having to prove that the disability was the result of their military service; that is, the veteran no longer has the burden of proof.
From page 21...
... PL 91-376 Section 3 specified that POWs from World War II, the Korean War, and the Vietnam War were service connected for a number of physical and mental health conditions. In 1979, ischemic heart disease and other cardiovascular disease were presumptively associated with service for amputation of one lower extremity at or above the knee or amputations of both lower extremities at or above the ankles (Federal Register, 1979)
From page 22...
... established service connection for medical conditions associated with exposure to biologic, chemical, or toxic agents; environmental or war time hazards; or preventive medicines or vaccines associated with service in the Southwest Asia theater of operations during the 1990–1991 Gulf War. In the 2000s, additional cancer presumptions for radiation exposure and new presumptions, including for Type 2 diabetes for tactical herbicide agent exposure, were added, and the list of presumptive diseases for POWs was expanded (Federal Register, 2001a)
From page 23...
... VA has used both of these activities to inform its determinations of presumptive service connections for a variety of exposures and health conditions. Presumption Decision Process The 2008 National Academies report Improving the Presumptive Disability Decision-Making Process for Veterans, requested by the Veterans' Disability Benefits Commission and conducted under contract with VA, sought to improve the often decades-long process to establish a presumption for a service-connected health condition.
From page 24...
... In 2020, the National Academies released Respiratory Health Effects of Airborne Hazards Exposures in the Southwest Asia Theater of Military Operations. It found limited or suggestive evidence of an association between fine particulate matter and respiratory symptoms and also examined the evidence for an association with 26 other respiratory conditions, including asthma and the development of asthma, rhinitis, and sinusitis, but concluded that the evidence was insufficient or inadequate for any of these conditions.
From page 25...
... . Although not based on any National Academies reports, on April 25, 2022, VA established another presumptive service connection for nine rare respiratory cancers (squamous cell carcinoma of the larynx, squamous cell carcinoma of the trachea, adenocarcinoma of the trachea, salivary glandtype tumors of the trachea, adenosquamous carcinoma of the lung, large cell carcinoma of the lung, salivary gland-type tumors of the lung, s­ arcomatoid carcinoma of the lung, and typical and atypical carcinoid of the lung)
From page 26...
... . ORGANIZATION OF THE REPORT VA's eight-page pre-decisional presumption decision process document is reproduced verbatim as an annex to this chapter.
From page 27...
... Chapters 3 and 4 also p­ resent conclusions and recommendations. Chapter 5 provides a synthesis of the common and overarching themes identified in the committee's assessment of the governance and scientific aspects of the presumption decision process.
From page 28...
... 2022. Rule: Department of Veterans Affairs -- presumptive service connection for rare respiratory cancers due to exposure to fine particulate matter.
From page 29...
... The National Academies of Sciences, Engineering, and Medicine (NASEM) in their 2008 report noted: For some medical conditions that develop after military service, the scientific information needed to connect the health conditions to the circumstances of service may be incomplete.
From page 30...
... The Secretary of Veterans Affairs directed VA to update the Presumption Decision Process (PDP) to assess the available scientific data in as timely a fashion as possible, consider the addition of other relevant information, including VBA claims data, and enhance the transparency of the process.
From page 31...
... b. Data gathering: VHA and VBA data for the conditions of inter est, including those that come from the Federal Register feed back, will be compiled and submitted to the Environmental Exposures Sub-Council (EESC)
From page 32...
... In the event that the strength of the evidence is at equipoise, (that is, when the weight of the evidence is equally balanced as to whether an association exists) , VA will make the determina tion after review of VBA claims data and other factors.
From page 33...
... VA will also examine VHA health outcomes clinical data and VBA claims data for trends that may signal an association between the target condition and
From page 34...
... . Though full consensus regarding presumptive status is the objective, an 80% majority with notation of disagreement is the benchmark for presumptive status recommendations that will be sent to the Secretary for final decision-making.
From page 35...
... PECOTS SCHEMATIC Decreasing Level of Single Increasing Level of Question Evidence Logic Chain Evidence Establish Military Establish Exposure Establish Establish Biological Level of Evidence Biological Mechanism Activity in Equipoise Activity In military Humans Composite personnel, what is the evidence for exposure to X? What is the What is the In humans, what relationship relationship is the relationship between exposure between exposure between Establish to X and results Y to X and results Y exposure to Military Risk in in vitro studies?
From page 36...
... For example, a template can be provided for data extractors to identify key data elements (e.g., number of patients, type of exposure, exposure duration, etc.) to facilitate evaluation by subject matter experts (SME)
From page 37...
... Artificial Intelligence / Machine Learning - Academic and VA Steps for topic: 9-18 months 4. Federal Register Notice 1.
From page 38...
... If the panel concludes an association exists or does not exist, the panel will submit its recommendations, for or against, in the form of a written report to the Environmental Exposures Sub-Council (EESC)
From page 39...
... Points of Contact for this report: Ms. Laurine Carson Deputy Executive Director, Policy and Procedures, Compensation Service VBACO Dr.


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