8
Use for Informing VA Policies and Processes
Among its many purposes, the Department of Veterans Affairs (VA) has stated that the Airborne Hazards and Open Burn Pit (AH&OBP) Registry information “is intended to improve VA and DoD research efforts, claims, and clinical care” (VA, 2020, slide 11). This chapter explores the use of the registry in assisting veterans filing benefits claims and other VA processes and as a source of supportive evidence for VA or national policy on veterans’ health and welfare. The first section discusses the use of the AH&OBP Registry to inform VA evidence-based policy and process, specifically determinations of presumptive service connections that affect veterans’ access to health care, and benefit claims. A presumptive service connection, or presumption, refers to a VA decision “that certain disabilities were caused by military service,” making a veteran with the condition eligible for disability compensation (VA, 2021a). The award of a presumptive service-connected disability, in turn, can provide a veteran with eligibility for VA health care.
INFORMING POLICY
Federal law requires that federal agencies base policy and budget decisions on evidence and be clear about the data sources and strategies for that evidence.1 This law requires VA, for example, to explain in its strategic plan how evidence for key policies will be generated. In response to the committee’s information request about how exactly VA uses registry data to inform policy, VA cited only the 2019 Veterans Health Administration (VHA) Directive 1307: Airborne Hazards and Open Burn Pit Registry (AHOBPR), which is scheduled to be recertified in 2024 (VA, 2019a, 2021b). This directive standardized the AH&OBP Registry administrative and clinical processes, particularly for the registry health evaluation, but it is unclear to the committee how any data from the registry was used to inform the processes delineated in the directive, which is intended for VA clinicians (see Chapter 7 for more information on VHA Directive 1307). This directive was rescinded on March 25, 2022, and replaced with VHA Directive 1308 (VA, 2022e), which moved details of the eligibility criteria and evaluation protocols for six VA registry programs, including the AH&OBP Registry, to the VA Health Outcomes Military Exposures intranet so they are no longer publicly available.
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1 PL 115-435 Foundations for Evidence-Based Policymaking Act of 2018. https://www.congress.gov/115/plaws/publ435/PLAW-115publ435.pdf (accessed June 14, 2022).
Rigorous evaluation is part of the process of building evidence on programs’ effectiveness and efficiency (White House, 2019). VA has stated that it does not rely on registry information for internal policy decisions because the program is too new (VA, 2021b). VA experience with other registries, including the conceptually similar Gulf War Registry (now in its third decade), would suggest that VA staff have sufficient expertise to apply AH&OBP Registry data to VA policies should it be appropriate. In response to committee inquiries on how the Gulf War Registry data have been used to inform policy, VA responded that it “has had limited recent utility for policy or epidemiologic research” (VA, 2021c). Taken together, the 7 years of AH&OBP Registry operations and VA’s experience with its other exposure registries, including the Gulf War Registry, suggest that time is not the barrier to using AH&OBP Registry data to support VA policy decisions.
The use of a registry to inform policy goals would need to be built into the registry’s design. At the same time, it may not be possible to align the registry’s goals with its design retroactively. A registry that can be used to meet ambitious research and policy goals or to inform administrative processes, such as claims adjudication, requires a greater initial investment than one that is only meant to serve as a roster for educational or communication purposes (Arrandale et al., 2016).
Informing Program Development and Budget Processes
VA has not used registry data to inform its policies to date, but the committee finds that VA could use AH&OBP Registry data to inform program development and budgeting processes related to the registry, especially those relating to the registry health evaluation.
For example, the registry data may help to identify logistical bottlenecks in clinical care, such as the lag time for completing the registry health evaluation for participants who have indicated an interest in it. Determinations of how long participants can reasonably expect to wait for a health evaluation are internal policy decisions. VHA Directives 1307 and 1308 require that the optional health evaluation be completed within 90 days of a participant requesting one (VA, 2019a, 2022e). As discussed in Chapter 7, an analysis of the registry’s health evaluation data determined that the time between requesting and receiving a registry health evaluation can be years.
A recent report from the VA’s Office of Inspector General noted a backlog of over 100,000 veterans waiting for registry health evaluations as of November 2021 (VA OIG, 2022). The report commented on the failure of the VHA program office to respond as the backlog mounted and to take steps that could have eased the administrative burden, such as implementing and using performance metrics. A lack of clarity may have also contributed to the problem, with some veterans expecting to be contacted to schedule their clinical evaluation, not realizing that they had to initiate that process. The report recommended to the VA under secretary for health that VHA “[implement] processes and metrics to ensure exams are completed,” (VA OIG, 2022, p. vii) including using performance data from the registry, which could require updating its information management system. Given this recommendation, it is likely that VA will use registry data to track progress on scheduling and completing registry health evaluations in the future.
The same registry health evaluation data could be used in budgeting and financial forecasting related to the registry program. In the example of the wait time between requesting and receiving a health evaluation, VA has indicated that resource constraints have limited its ability to complete health evaluations (VA, 2022d). As a result, increasing the clinical capacity to perform the evaluations would have budgetary implications, possibly requiring the recruitment or training of additional staff or directing funds or other resources to specific VA medical centers that are not meeting evaluation metrics. Such steps would allow registry health evaluation data to help guide the management of the AH&OBP Registry program and to better meet veterans’ expressed needs.
Using the AH&OBP Registry to Set Research Priorities
In setting its research agenda, VA considers pressing knowledge gaps in specific areas of veterans’ health (Hahm et al., 2021). VA’s strategic priorities for research reflect an interest in tailoring a research portfolio to best respond to veterans’ concerns (VA, 2021d). AH&OBP Registry data, such as the distribution of health conditions
among participants, might be useful for identifying common concerns among veterans, allowing VA to make these concerns policy priorities. These priorities could in turn influence a research agenda. For example, if there is a signal or indication that participants are reporting a rare outcome, such as idiopathic pulmonary fibrosis, more frequently than would be expected, this outcome might become a research priority. Despite the AH&OBP Registry’s design and questionnaire flaws as described in the previous chapters, the registry is currently the best data source available for documenting the range of concerns and health experiences of veterans and service members exposed to airborne hazards, albeit limited to those health outcomes included in the questionnaire.
As an example of using a registry to inform research, VA used Gulf War Registry findings to inform its design of the National Health Survey of Gulf War Veterans and Their Families (see Chapter 4 for more information on this survey). Analyses of Gulf War Registry data prompted VA to examine several conditions, including chronic fatigue syndrome, fibromyalgia, and gastrointestinal disorders such as irritable bowel syndrome; these conditions were eventually determined to warrant compensation (VA, 2019b). Even when Gulf War Registry data were inconclusive or difficult to interpret, as in the case of chronic multisymptom illness, they contributed to the body of evidence needed to inform VA’s determination of a presumption of service-connected disability (VA, 2021i).
Legislative Mandates and Directives Regarding the AH&OBP Registry
VA has an obligation to be responsive to Congress, which may be challenging when congressional directives are at odds with internally driven VA policies. In assessing the AH&OBP Registry’s use for policy making, it is important to acknowledge VA’s obligation to respond to congressional mandates or directives. These mandates are usually based on constituents’ concerns or societal considerations rather than on any scientific or analytical criteria. Between 2018 and 2022, Congress considered over 30 pieces of legislation, including PL 117-168 signed August 10, 2022,2 that would affect the AH&OBP Registry in some way and that reflected Congress’s prioritization of veterans’ health (see Chapter 1).3 Several of these legislative changes would affect aspects of the registry, such as eligibility; however, these changes may have unintended effects on the registry’s ability to fulfill its intended purposes. For example, increasing participation in the AH&OBP Registry is a priority for both VA and Congress, although the underlying reasons may be different. Well-intentioned changes to expand the number of eligible countries for the registry in order to increase the number of participants may have the unintended consequence of obscuring the frequency or types of deployment exposures, particularly for a time period or region or country (see chapters 3 and 5). In particular, continuous changes to eligibility criteria have contributed to the registry’s unsuitability for use in etiologic research on the causal relationships between exposure to airborne hazards and health outcomes.
INFORMING PROCESSES
VA has stated that one of the purposes of the AH&OBP Registry is to support VA’s administrative process, namely, adjudicating claims for VA service-connected disabilities (hereafter “disability claims”) (VA, 2020). PL 117-168 aims to improve the process for disability claims related to airborne hazards and other environmental exposures. It also aims to improve veterans’ awareness of their potential eligibility for disability claims and to decrease the administrative burden of adjudicating the claims (White House, 2022). Related VA programming seeks to improve the information that veterans can access about burn pit exposures, encourage enrollment in the registry and VHA, and promote the idea that participation will advance research done on veterans’ behalf (VA, 2020). Providing better clarity on the relationship between the registry and VA claims or access to health care is an important aspect of the new strategy (VA, 2020, slide 14).
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2 PL 117-168 Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act of 2022.
3 The AH&OBP Registry was mentioned in 13 pieces of federal legislation introduced in the 117th Congress (2021–2022), 12 pieces of legislation in the 116th Congress (2019–2020), and 6 pieces of legislation in the 115th Congress (2018–2019).
Disability Claims Adjudication
Data from exposure registries can be used to ease the process of both filing and adjudicating disability claims, especially if individuals participate soon after deployment when their recollections of relevant exposures are more accurate and might be less biased. The use of registry data for benefits or disability claims adjudication depends heavily on the registry’s stated goals and should be reflected in its design (Arrandale et al., 2016).
Although improving the process of filing disability claims is one of VHA’s stated goals for the AH&OBP Registry, filing and review of claims submitted to the Veterans Benefits Administration is a completely separate, structured process from a veteran’s registry participation. Conflating registry participation with a participant’s ability to file a claim or the successful receipt of VA disability benefits could create the inaccurate perception that the registry health evaluation is a substitute for a disability benefits rating examination; it is not since the disability rating examination has specific criteria that may not met by health examinations designed for other purposes. It could also create an unfair barrier to entitlements or unnecessary pressure to participate in the registry, although the registry website makes it clear that a veteran does not need to participate in the registry to apply for compensation and benefits or VA health care. Far from being an integral component of the disability claims process, the registry may instead be a means to engage veterans who have not enrolled in the VA health system or applied for any VA benefits.
Although the registry’s website explains the relationship between the registry and benefits and VHA, other public information materials about the AH&OBP Registry also need to be clear that participation in the registry is voluntary, that it does not guarantee any eligibility for benefits, and that lack of registry participation will not harm the veteran’s ability to access disability compensation. VA’s website reminds participants, “[Y]ou may save and submit your responses to the registry questionnaire and notes from optional medical assessment4 to support your VA claim if you choose” (VA, 2021e). The registry information page reiterates this point several times, as does the factsheet Health Care Options for Airborne Hazards and Burn Pit Exposure, which encourages veterans to file a claim for compensation and benefits (VA, 2022a). The registry home page also contains embedded hyperlinks to the main VA webpages for information on the process for accessing VA health care (VA, 2022b) and the step-by-step process for filing a disability claim (VA, 2022c). The AH&OBP Registry could serve as one potential source of information supporting the veteran’s claim, even though registry participation is not a substitute for filing a claim and the registry responses are not guaranteed to influence VA’s disability claim decision or rating.
The AH&OBP Registry is not a mechanism for filing or adjudicating claims. At most, responses to the self-assessment questionnaire could be saved (the option to save or print questionnaire responses is available after a participant clicks “Submit”). Since the registry questionnaire captures information about specific locations, dates, exposures, and self-reported health outcomes, a printout of the participant’s responses to it may serve as one component of the information submitted in support of a disability claim. The registry questionnaire is lengthy and yet not comprehensive enough to cover veterans’ widely varying concerns, nor is the registry questionnaire compliant with the criteria needed to support a disability claim. For example, DoD databases are used as the official source of deployment information, and therefore, deployment segments that a participant has entered on the questionnaire may not be considered without subsequent documentation. Although VA has clearly stated that participation in the AH&OBP Registry is separate from the benefit claims process, even implying a relationship between registry participation and the claims process may create confusion among veterans.
A qualitative assessment of AH&OBP Registry communication materials by registry participants and nonparticipants indicated that there was some misperception that joining the AH&OBP Registry could facilitate the claims process (VA, 2021f). In response, VA has revised the messages promoted on the registry website and sponsored an advertising campaign to increase participation (VA, 2021g).
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4 Several terms are used for the health evaluation portion of the registry that may be requested by veterans and service members. The questionnaire uses the term “free health evaluation” and “exam” as of October 26, 2021, but previously the terms “health concerns” and “health examination” (in VHA Directive 1307, August 19, 2019) were used. The committee opted to use the term “health evaluation” for the clinical examination and discussion between the veteran and health provider that may be initiated through the AH&OBP Registry questionnaire.
The committee finds that the registry questionnaire and health evaluation summary are, at best, supportive evidence for the claims process.
The committee concludes that VA messages that overstate, even slightly, the relationship between the registry and the claims process may cause confusion among veterans and thus be counterproductive.
Determination of Presumptive Service Connections
VA’s interim final rule, released in August 2021, established the presumptive service connection, or presumption, between exposure to fine particulate matter for veterans who served in the Southwest Asia theater since 1990 as well as those who served in Afghanistan, Syria, Djibouti, or Uzbekistan after September 19, 2001, and having asthma, rhinitis, and sinusitis (Federal Register, 2021). VA notified AH&OBP Registry participants that the information they had provided helped inform this rule and encouraged eligible participants to file a disability claim. The same correspondence encouraged participants to alert their former combat partners to also join the registry.5 On closer inspection, however, it appears that the presumptive connection was based, appropriately, on analyses of VA claims and published literature (Federal Register, 2021) rather than on registry data. The semiannual publications on registry participants’ self-reported health status support the assumption that burn pit exposures are related to symptoms such as cough, wheezing, and shortness of breath (VA, 2021h). AH&OBP participants report asthma along with other respiratory conditions, such as chronic bronchitis, that could be mistaken for or related to sinusitis or rhinitis (VA, 2021h). While the AH&OBP Registry questionnaire does not include any diagnosis of sinusitis, rhinitis, or rhinosinusitis, the registry data provide a snapshot of reported health conditions largely consistent with the epidemiologic data and claims analysis that informed VA’s presumptive connection. Registry data on respiratory conditions may have affirmed, or at least did not contradict, the presumptive connection in question. To say that it informed the policy, however, may be an overstatement.
The committee finds that these connections appear to be based on published literature, claims analysis, or both, and notes that rhinitis and sinusitis do not appear on the list of health outcomes in the registry questionnaire.
Similarly, in April 2022, VA announced that nine rare respiratory cancers would also be service-connected to exposure to fine particulate matter during service in the Southwest Asia theater after August 2, 1990, or in Afghanistan, Syria, Djibouti, or Uzbekistan after September 19, 2001 (Federal Register, 2022). VA has not indicated that the AH&OBP Registry data or information from the health evaluations was used as evidence to support or inform this presumption, which is not surprising since the types of cancer diagnoses in the questionnaire are not granular enough to include these specific and rare cancers. The question remains as to how AH&OBP Registry data might be used to support or inform these types of policy decisions.
The expectation that AH&OBP Registry data might be needed to inform decisions about presumptive connection may have changed with the August 2022 signing of PL 117-168. The act substantially expanded the list of presumptive conditions for which veterans or their survivors can access health care or disability compensation. It also specifically mentions presumptive connections between military service and 11 respiratory conditions6 as well as most cancers, and acknowledges the possibility of expanding the list to other diseases based on established associations with airborne hazards. It is possible that registry data might be used to identify common health concerns among registry participants.
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5 Personal communication, Dr. Eric Shuping, director, Post-9/11 Era Environmental Health Program, Health Outcomes Military Exposures, VA. August 17, 2021.
6 The 11 conditions are: “asthma diagnosed after service, chronic bronchitis, chronic obstructive pulmonary disease, constrictive bronchiolitis or obliterative bronchiolitis, emphysema, interstitial lung disease, pleuritis, pulmonary fibrosis, sarcoidosis, chronic sinusitis, chronic rhinitis” (PL 117-168 Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act of 2022).
SYNOPSIS
VA has stated that the AH&OBP Registry can serve as a source of evidence for policy and for internal processes. Yet in response to committee questions on this point, VA explained that it does not rely on registry information for internal policy decisions because the program is too new (VA, 2021b). Nevertheless, VA has 7 years of experience with the AH&OBP Registry and decades of experience with other exposure registries, including the Gulf War Registry, suggesting that time is not the barrier to using AH&OBP Registry data to support policy decisions.
VA has not used registry data to inform its policies to date, but the committee finds that VA could use AH&OBP Registry data to inform program development and budgeting processes related to the registry, especially those relating to the registry health evaluation.
The registry may prove to be a useful source of performance measurement data, measuring demand for clinical examinations and adjusting clinical capacity to meet this demand. Such data could also be used in budgeting and financial forecasting, as expanding clinical capacity would have staffing, training, and budgetary implications. Additionally, AH&OBP Registry data, such as the distribution of health conditions among participants, might be useful for identifying common concerns among veterans, allowing VA to make these concerns policy priorities. These priorities could in turn influence a research agenda.
Between 2018 and 2022, Congress considered over 30 pieces of legislation that would affect the AH&OBP Registry in some way and that reflected Congress’s prioritization of veterans’ health. Several of these legislative changes would affect aspects of the registry, such as eligibility, and were usually in response to constituents’ concerns or societal considerations rather than to any scientific or analytical criteria. These well-intentioned changes may have unintended effects on the registry’s ability to fulfill its intended purposes. Expanding the number of eligible countries, and therefore the number of eligible veterans, for example, has contributed to the registry’s unsuitability for use in etiologic research on the causal relationships between exposure to airborne hazards and health outcomes.
VA also maintains that the AH&OBP Registry questionnaire can support a claim for disability benefits (VA, 2021b). This may be an overstatement, as registry participation confers neither an advantage nor a penalty in the claims adjudication process. Filing and review of claims submitted to the Veterans Benefits Administration is a completely separate, structured process from a veteran’s registry participation. At most, a veteran might save and print a copy of their completed registry questionnaire and results from their health evaluation (if they had one) to refer to when filing a claim, particularly for a list of deployment locations, although the committee has no data to indicate how many participants use the registry printout to do so. Furthermore, DoD databases are used as the official source of deployment information, and therefore, deployment segments that a participant has entered on the questionnaire may not be considered without subsequent documentation. In public factsheets and online information about the AH&OBP Registry, VA encourages veterans to file for compensation and benefits, with a link on the registry’s website to instructions on the claims process.
The committee finds that the registry questionnaire and health evaluation summary are, at best, supportive evidence for the claims process.
The committee concludes that VA messages that overstate, even slightly, the relationship between the registry and the claims process may cause confusion among veterans and thus be counterproductive.
PL 117-168 substantially expanded the list of presumptive conditions for veterans that have been deployed to the Southwest Asia theater; it also acknowledged the possibility of further expanding this list of presumptions to include other diseases associated with airborne hazards. It is possible that registry data might be used to identify common health concerns among registry participants, providing, for example, a set of participants’ health complaints for which further research on the association with airborne hazards exposures may be necessary. In the case of the presumptive connection between burn pit exposure and asthma, rhinitis, and sinusitis, the registry provides a glimpse of health complaints that may have affirmed, or at least did not contradict, the data that informed the presumptive connection.
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