Review of VA Clinical Guidance for the Health Conditions Identified by the Camp Lejeune Legislation (2015)

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Use of the Guidance

The U.S. Department of Veterans Affairs (VA) created the Camp Lejeune Health Program in response to the 2012 Janey Ensminger Act. To implement the program, VA has developed guidance to help clinicians and other health care providers make decisions about whether veterans and family members who are administratively eligible¹ for the program, have a medical condition that is covered by the act. Should a qualifying medical condition be found, veterans have their co-payments waived for treatments of the covered condition, and VA will reimburse family members as the last payer for private sector health care related to the conditions. The VA guidance was developed with input from specialists in the conditions that are covered by the act (e.g., neurology, gastroenterology, oncology, nephrology, gynecology, and mental health) (Walters 2014a,b).

VA asked the committee to assess the scientific soundness of the guidance for the designated health outcomes. The committee was not asked to comment on the broader issues of the implementation of, administration of, training for, or evaluation of the Camp Lejeune Health Program itself. While the broader context of the overall Camp Lejeune Health Program is important to the success of the guidance, assessing the entire program was not part of the committee’s charge. The guidance materials are based not only on scientific evidence, but also on existing VA policies and congressional mandates in the legislation. In part, this is because there is a lack of definitive scientific evidence on which to base some decisions such as the role of environmental contaminants in the development of cancer. The act itself states that hospital care and medical services are to be provided “notwithstanding that there are insufficient medical evidence to conclude that such illnesses or conditions are attributable to such service” at Camp Lejeune. There are also various precedents for the coverage of treatment for veterans who have been exposed to toxicants, such as those established by the Agent Orange Act of 1991 (P.L. 102-4) and Gulf War legislation (Veterans Health Care Act of 1992, P.L. 102-585). Such policy decisions can help reduce the administrative burden that Camp Lejeune veterans and family members—and their health care providers—face in proving an association between residing at Camp Lejeune during the period of drinking water contamination and the concurrent or subsequent development of a covered health condition.

Users of the guidance may include not only VA clinicians who treat veterans, but also community providers and others who treat veterans and their family members. The users may also include VA financial services center personnel who review claims for reimbursement for treatment costs from veterans and their family members. This is the first time that VA has extended benefits to family members. Thus, the program presents VA with adminis-

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¹ Lived at Camp Lejeune for at least 30 days between January 1, 1957, and December 31, 1987.

trative and outreach challenges, including attempting to locate the Marine Corps veterans and their families who resided at Camp Lejeune more than 25 years ago.

In this chapter, the committee considers the utility of the guidance for clinicians and discusses those aspects of the guidance for which clarification may be helpful or where the presentation might be improved. The committee’s ability to offer comments was limited by the fact that the guidance is in draft form and has not been widely disseminated or used. The committee did not attend any training sessions for clinicians on using the guidance nor did it hear from any clinicians who have experience following the guidance with their patients. VA has stated that changes to the guidance are expected in the future as it is implemented throughout the department and across the country. The full text of the guidance and the algorithms are available in Appendix B.

PURPOSE OF THE GUIDANCE AND ALGORITHMS

The stated purposes of the guidance (page 1) are to (1) help a health care provider determine if a veteran or family member has a condition that is covered by the Camp Lejeune legislation, and (2) determine if an episode of care is related to the covered condition. The majority of the guidance focuses on assisting health care providers—VA, purchased care, or community clinicians—to determine if the veteran or family member has a condition that is covered by the Camp Lejeune legislation. In particular, the algorithms that accompany the guidance, both the core algorithm and the four condition-specific ones, are easy-to-follow tools that can be used to help determine whether the veteran or family member has the condition or whether alternative causes may preclude coverage for the condition. In the prior chapters, the committee has made specific recommendations for improving the algorithms for the covered conditions.

The second purpose of the guidance—to determine if a treatment or service is associated with a covered condition—is not discussed substantively in the guidance with the exception of the three bullets on page 6 that describe the extent of comprehensive coverage during active cancer treatment and the reimbursement of family members for primary and secondary conditions. Because treatment of the covered conditions is highly individualized and the specific treatments for covered conditions are not further elaborated upon in the guidance, it may be most appropriate to delete this stated purpose on page 1. This is because a clinician or family members may expect that the guidance can help them determine if a particular treatment will be covered. More discussion of treating covered conditions is included in the following section on decision points.

In the Background section of the guidance (page 3), there is information on the extent of VA coverage of hospital care and medical services—including screening procedures—pertaining to the conditions in the legislation. The guidance specifies that VA will reimburse eligible family members for screenings related to the 15 covered conditions if clinically indicated or if recommended by the U.S. Preventive Services Task Force only if the outcome of that screening leads to the diagnosis of a covered condition.

Clinically indicated screenings for Camp Lejeune veterans enrolled in VA health care are included in their comprehensive health benefits and thus do not require a co-pay. The committee finds that the diagnosis of a covered condition may require screening as well as a diagnostic evaluation at the discretion of the clinician, but the guidance does not indicate whether a diagnostic evaluation will be covered.

DECISION POINTS

As described in Chapter 1, the guidance uses three decision points to assess whether an illness, injury, or medical condition is eligible for coverage under the Camp Lejeune program. The decision points are incorporated into the algorithms in the guidance for each covered condition. In the sections below, the committee considers

the usefulness of the decision points and indicates where improvements to the guidance and the algorithms might increase clarity and where inconsistencies could be corrected.

The committee considered three topics for this decision point: referrals, secondary conditions, and symptom onset and duration. These topics are discussed below.

Referrals

The committee expects that although many of the health conditions in the Janey Ensminger Act are familiar to primary care physicians, internists, family practitioners, and other health care professionals—and may be indicated by some screening and diagnostic evaluations—a specialist may be required for the diagnosis of some of those conditions (including differential diagnosis) and for treatment. Such specialists might include an oncologist for cancer; a nephrologist for some kidney diseases; a psychologist, psychiatrist, developmental pediatrician, or neurologist (including experts in substance use) from neurobehavioral effects; and a rheumatologist for scleroderma.

The guidance does not indicate when referrals to specialists should be made, nor who would review any medical records to see if a diagnosis for inclusion in the Camp Lejeune program was correct.

Secondary Conditions

The guidance states that VA has the authority to reimburse family members for medical conditions that are secondary to a covered condition. The committee finds that although the algorithm for female health in the guidance acknowledges that medical complications may ensue following female infertility or miscarriage as a result of residing at Camp Lejeune, no further guidance is given for these conditions. Furthermore, there is no acknowledgment in the descriptions or algorithms for the other covered conditions that secondary conditions and medical complications can result not only from the presence of the condition itself, but also from disease progression and from treatment for the condition. Examples include hepatic steatosis progressing to cirrhosis, a miscarriage or infertility that result in prolonged depression, or a treatment for breast cancer leading to lymphedema that requires treatment even if the cancer is in remission.

Symptom Onset and Duration

In general the committee notes that, where specified, the determinations of the time of onset and duration of the covered conditions are appropriate. However, the time of onset and duration are not specified for every condition and can vary. For example, miscarriage or infertility is expected to occur during residence at Camp Lejeune but not after exposure has ceased, while a cancer will generally not occur for many years after exposure and may not exist or be evident at the time of exposure or for years afterward. In addition, some information, such as other possible causes or diagnostic criteria, is not reported consistently for each outcome. VA has made a policy decision that the time of onset matters for miscarriage and infertility but is not a consideration for cancer. This variability in criteria for each outcome may result in confusion on the part of the Camp Lejeune veterans, their family members, and clinicians. The committee has proposed a table to capture these domains for each outcome (see Table 5-1). This

TABLE 5-1 Criteria for Onset, Duration, and Exclusions for All Covered Conditions

NOTE: ACR = American College of Rheumatology; ADHD = attention deficit hyperactivity disorder; ALS = amyotrophic lateral sclerosis; CL = Camp Lejeune; CT = computerized tomography; eGFR = estimated glomerular filtration rate; HIV = human immunodeficiency virus; MRI = magnetic resonance imaging; n/a = not available; OCD = obsessive compulsive disorder; PTSD = posttraumatic stress disorder; red = committee additions.
This table assumes that the patient is administratively eligible for the program (served on active duty or resided at CL for not less than 30 days between January 1, 1957, and December 31, 1987).

table includes more information than is available in the guidance and algorithms and is based on the committee’s expertise and discussion in the previous chapters.

In general, the committee finds that the guidance is correct in indicating that some of the conditions or their symptoms will be evident during the time the veteran or family member resided at Camp Lejeune and was exposed to the contaminated drinking water. This is not explicitly stated in the guidance; however, for some conditions, such as cancer, the guidance does not state that cancer may have been evident at the time of exposure, only that it can have a long latency period.

It would be helpful if the guidance included a table (such as Table 5-1) or had a standardized format for the discussion of each health outcome to allow the clinician to quickly determine the criteria for the onset of the condition, the duration of the condition, and the exclusionary factors for each condition. There could be a comment section in the table or text that would indicate any mitigating or other factors that should be considered when determining if the patient had a covered health condition. Alternatively, the annotations to the algorithms could present this information in a standardized format. In the current guidance, the format and content of the annotations for each algorithm are variable, and the annotations do not always track with the algorithm boxes that refer to them. The committee believes that when assessing a patient in real time clinicians are more likely to refer quickly to a table or algorithm than they are to read a lengthy text in the guidance.

The committee considered this decision point to be the most problematic, in part because there is some discrepancy with the original legislation and in part because the terminology used to assess covered conditions is inconsistent throughout the guidance. On page 1 in the second bullet under Key Points, the guidance states, “[H]ospital care and medical services may not be furnished…for an illness or condition of a Camp Lejeune Veteran or family member that is found, in accordance with guidelines issued by the Under Secretary for Health, to have resulted from a cause other than the residence at Camp Lejeune.” On pages 3 and 4, the guidance states again that veterans cannot receive care for a covered condition if the condition has resulted from a cause other than residence at Camp Lejeune. However, this language is in contradiction to both the act and the language on page 4 of the guidance in the first sentence under Decision Point #2.

The guidance also uses inconsistent terminology in assisting clinicians in determining whether the condition has another cause. For example, for neurobehavioral effects, the clinician should determine if the symptoms “are as likely as not, related to exposure to volatile organics in the past” (page 8); for renal toxicity, the clinician “should consider whether it is probable” that the kidney disease results from something other than solvent exposure, and the clinician “might reasonably conclude that the renal disease is as likely as not associated” with another cause (page 10). Finally for hepatic steatosis, the guidance also asks the clinician to “consider whether it is more likely than not” that the fatty liver disease has another cause (page 10). This mix of terminology may be confusing to both the patient and the clinician, and no assistance is given on how to determine what is “more likely than not,” particularly in light of the following statement, which appears early in the guidance: “In cases where there is

reasonable doubt as to the diagnosis or primary cause for the diagnosis, clinicians should resolve in favor of the Camp Lejeune Veteran or family member” (page 2). Although the text accompanying the algorithms provides some information on what is meant by “consistent,” VA may want to consider providing more information for clinicians as the program evolves. Furthermore, veterans and family members with cancer or scleroderma are not assessed for other possible causes for their disease and clinicians are not required to rule out other causes, such as smoking as a possible cause of lung cancer.

The committee finds that the language in the guidance is inconsistent with regard to the level of association necessary to link exposure to drinking water at Camp Lejeune with a covered condition.

In several instances the guidance asks clinicians to “verify” or “certify” information pertaining to whether or not a specific visit, treatment, or secondary condition is related to a covered condition (“Certify” appears on page 6 in bullets 1 and 3; “verify” appears on page 5 in the first paragraph in Decision Point #3). When the committee asked for clarification of these terms, VA indicated that it expects clinicians to document whether the encounter or treatment is related to a condition in their note for billing purposes (Walters, 2014a). In the case of cancer, VA intends to ask that the clinician “certify” the duration of treatment. While this may be clear to VA clinicians, it may not be evident to non-VA clinicians who treat family members. There is no further information in the guidance on record keeping or on how a clinician should “verify” or “certify” pertinent information.

The committee finds that the guidance is unclear regarding what health care providers must do in order to certify or verify that a treatment or service is provided for one of the covered conditions and what documentation must be submitted, particularly by non-VA health care providers in order to ensure the treatment is covered (and that there is no co-pay for veterans). It would be helpful if instructions on providing this information was electronically available, e.g., on the VA Camp Lejeune website, so that both participants and their health care providers could access it. It would be useful if such information were included in the clinical guidance or, at the very least, if the clinical guidance contained a reference or link to where more information could be obtained.

FUTURE CONSIDERATIONS

The committee expects—and VA has indicated—that the guidance will be revised as VA receives feedback from clinicians on its utility and clarity, and as additional scientific information becomes available pertaining to the covered outcomes and their relationship to drinking water contaminants. This may be of particular importance for the neurobehavioral effects and renal toxicity endpoints as epidemiologic and toxicologic research continues on the association between exposure to the drinking water contaminants found at Camp Lejeune and adverse health effects in those two domains. As new research is published, VA may want to consider a process to evaluate periodically new research on all endpoints and to revise the guidance accordingly to ensure that it fulfills its intended purpose—as is now done for the VA/U.S. Department of Defense Clinical Practice Guidelines for various health conditions.

The committee recognizes that the VA guidance can only address the illnesses and medical conditions listed in the Janey Ensminger Act. However, unlike the Agent Orange and Gulf War legislation, the Camp Lejeune legislation does not allow VA to incorporate new scientific evidence that may indicate new associations between

Camp Lejeune exposure and adverse health conditions or to revise the ones listed in the legislation. Even the act recognizes “that there is insufficient medical evidence to conclude that such illnesses or conditions are attributable to such service.” Future information may show clear links with diseases not currently listed in the act, may provide convincing evidence that health outcomes currently associated with contaminated drinking water are spurious or explained by other factors, or may more clearly define specific neurobehavioral domains and kidney pathology affected by those exposures.

Important information sources include new studies and meta-analyses by authoritative bodies such as the International Agency for Cancer Research (IARC) and the U.S. Environmental Protection Agency. For example, in 2014, IARC released updated assessments of the carcinogenicity of trichloroethylene (TCE) and perchloroethylene (PCE) that found there was limited evidence of an association between exposure to PCE and bladder cancer, and that there was sufficient evidence in animals and humans of an association between exposure to TCE and both non-Hodgkin’s lymphoma and liver cancer (IARC, 2014). Future research may provide new associations with other critical health conditions such as those in children where an emerging literature suggests that solvent exposure may be linked with posttraumatic stress disorder, schizophrenia, and other neurobehavioral effects (Aschengrau et al., 2012).

The committee appreciates that much of the clinical guidance is the result of VA policy decisions and interpretations of congressional intent in the legislation. The committee also understands that the guidance was not developed based solely on scientific evidence (e.g., acceptance of all specified cancers without regard for their latency or for possible contributing factors such as smoking), and in fact this “insufficient medical evidence to conclude that such illnesses or conditions are attributable to such service” is specifically stated in the legislation. The committee agrees with the VA guidance for clinical conditions with poorly defined diagnostic criteria that states “In cases where there is reasonable doubt as to the diagnosis or primary cause for the diagnosis, clinicians should resolve in favor of the Camp Lejeune Veteran or family member” (page 5). In its assessment of the clinical guidance and the scientific evidence used to characterize renal toxicity and neurobehavioral effects, the committee has tried to give the benefit of the doubt to the veteran and family members, particularly when expert judgment was required.

VA has done a commendable job in dealing with a scientifically and administratively complex task. The committee hopes that the above recommendations in this report will clarify and enhance the guidance document so that Camp Lejeune veterans and their family members can receive hospital care and medical services under the Janey Ensminger Act with a minimum of confusion for them and for the clinicians from whom they seek care.

REFERENCES

Aschengrau, A., J. M. Weinberg, P. A. Janulewicz, M. E. Romano, L. G. Gallagher, M. R. Winter, B. R. Martin, V. M. Vieira, T. F. Webster, R. F. White, and D. M. Ozonoff. 2012. Occurrence of mental illness following prenatal and early childhood exposure to tetrachloroethylene (PCE)-contaminated drinking water: A retrospective cohort study. Environmental Health 11:2.

IARC (International Agency for Research on Cancer). 2014. Trichloroethylene. In IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 106. Lyon, France: International Agency for Research on Cancer.

Walters, T. 2014a. Presentation and Charge to Committee: Institute of Medicine Committee to Define Clinical Terms in P.L. 112-154 & Review Clinical Guidelines. Washington, DC, May 15, 2014.

Walters, T. 2014b. Questions posed by IOM committee and subsequent answers from Dr. Terry Walters, U.S. Department of Veterans Affairs, July 8, 2014.