PETITION FOR RULEMAKING TO PROMULGATE REGULATIONS GOVERNING PRESUMPTION OF SERVICE CONNECTION FOR DISEASES ASSOCIATED WITH EXPOSURE TO CERTAIN HERBICIDE AGENTS FOR VETERANS WHO SERVED IN THE REPUBLIC OF VIETNAM
SUBMITTED TO THE UNITED STATES DEPARTMENT OF VETERANS AFFAIRS
by Robert M. Hunter, Veteran
I. EXECUTIVE SUMMARY
Robert M. Hunter (“Petitioner”) hereby petitions the Secretary of Veterans Affairs (the “Secretary”) to amend Department of Veterans Affairs (“VA”) regulations by finding that Monoclonal Gammopathy of Undetermined Significance (“MGUS”) is positively associated with herbicide agent exposure in accordance with 38 U.S. Code § 1116(a) and 38 CFR 3.307 and adding MGUS to the list of presumptive diseases found in 38 CFR 3.309(e). Furthermore, Petitioner requests that the Secretary amend or promulgate rules and regulations expressly including no-cost (to the veteran) medically-necessary health screening for and monitoring of MGUS and no-cost treatment of its sequelae and secondary conditions for veterans who were exposed to certain herbicide agents during their service in the medical benefits package provided to veterans under the VA health care system.
Recent research by researchers from the National Institute of Health, Centers for Disease Control and Prevention, and other institutions has determined that the prevalence of MGUS is two-fold higher among Operation Ranch Hand veterans than veterans with similar duties in Southeast Asia during the same period who were not involved in herbicide spray operations (Landgren et al., 2015). The accepted standard of care after MGUS has been diagnosed is life-long monitoring of the patient to ensure that progression to a malignancy or a related condition is not occurring (Merlini et al., 2012; Kyle et al., 2011). Furthermore, other recent research has shown that patients with multiple myeloma who had a prior diagnosis of MGUS survived longer after being diagnosed with multiple myeloma (Sigurdardottir et al., 2015).
II. INTRODUCTION
When Congress enacted the Veterans Health Care Eligibility Reform Act of 1996 (Pub. L. 104-262), establishing the current framework for veteran eligibility for medical benefits under the VA health care system, the United States sought to ensure that the medical needs of all American veterans would be met through the provision of quality health care.
III. LEGAL AUTHORITY
Congress granted the Secretary of Veterans Affairs the “authority to prescribe all rules and regulations which are necessary or appropriate to carry out the laws administered by the Department,” which include laws governing veterans’ benefits. 38 U.S.C. § 501(a). The Secretary thus has the authority to amend or repeal the rules and regulations that are the focus of this petition, and to issue appropriate rules and regulations in their place.
Furthermore, 38 U.S. Code § 1116(a)(1)(B) stipulates that “each additional disease (if any) that (i) the Secretary determines in regulations prescribed under this section warrants a presumption of service-connection by reason of having positive association with exposure to an herbicide agent, and (ii) becomes manifest within the period (if any) prescribed in such regulations in a veteran who, during active military, naval, or air service, served in the Republic of Vietnam during the period beginning on January 9, 1962, and ending on May 7, 1975, and while so serving was exposed to that herbicide agent, shall be considered to have been incurred in or aggravated by such service, notwithstanding that there is no record of evidence of such disease during the period of such service.”
IV. PETITIONER
Petitioner has the statutory right to petition the Department for rulemaking pursuant to 5 U.S.C. § 553(e), which requires “[e]ach agency [to] give an interested person the right to petition for the issuance, amendment, or repeal of a rule.” Petitioner also satisfies the standing requirements of Article III of the United States Constitution.
Dr. Robert M. Hunter (last four 0679) is a veteran of the U.S. Army who served in the Republic of Vietnam during the period 29 JUL 70 to 4 JUN 71. He was awarded a Bronze Star for his service in Vietnam. As the Engineer Officer of a U.S. Military Assistance Command (MACV) province advisory team (Team 91), he was exposed to herbicide agents in the performance of his duties. Those duties included frequent monitoring the state of defoliation of areas within Binh Duong Province, supervising and participating in the application of a herbicide agent to the mine field surrounding the team’s compound, and purchasing (and consuming) local food items for consumption in the team’s Officer’s Club and Enlisted Men’s Club.
Dr. Hunter experienced a service-related disability, high frequency hearing loss, during his service and is provided hearing aids by the VA. In 2016, doctors at the San Francisco Veterans Medical Center confirmed an earlier (also in 2016) diagnosis by the Mayo Clinic of IgM-MGUS, a condition that can progress to non-Hodgin’s lymphoma or other cancers. The risk of progression after diagnosis of IgM-MGUS is higher than that of MGUS in general. IgM-MGUS has a cumulative incidence rate of about 1.5 percent per year, so in 10 years about 15 percent of those diagnosed with IgM-MGUS will have progressed, in 20 years 30 percent will have. For that reason, Dr. Hunter’s health must be regularly monitored for the rest of this life. At present, Dr. Hunter pays co-payments to the VA and travel expenses for his doctor’s visits associated with his IgM-MGUS and its sequelae and secondary conditions.
V. BACKGROUND: THE CURRENT REGULATORY FRAMEWORK
A. The VA’s Provision of Medical Care
Under 38 U.S.C. § 1710, the Secretary “shall furnish” “medical services” that the Secretary determines to be “needed” by several classes of veterans, including those with a service-connected disability, former prisoners of war, veterans of World War I, and all veterans who are unable “to defray the expenses of necessary care,” which include all veterans who qualify for Medicaid, receive a qualifying pension, or meet specified income thresholds. 38 U.S.C. §§ 1710(a)(1)-(2), 1722 (a)(1)-(3). In addition, under § 1710, the Secretary is authorized to provide “needed” “medical services” to all veterans “to the extent resources and facilities are available.” 38 U.S.C. § 1710(a)(3). Thus, all veterans are eligible to receive medically necessary health care, as determined by the Secretary, as long as the VA has the resources to provide or pay for such care. As President Clinton explained in signing the current enabling statute into law, the law “authorizes the Department of Veterans Affairs to furnish comprehensive medical services to all veterans.” Presidential Statement on Signing Veterans Legislation, 32 Weekly Comp. Pres. Doc. 2018 (Oct. 9, 1996).
Veterans who enroll in the VA health care system (as well as certain other veterans meeting other criteria) are entitled to a “medical benefits package” as defined by regulation (the “Medical Benefits Package”). 38 C.F.R. § 17.36. The regulation sets forth a broad and overarching directive for the provision of veterans’ health care: Veterans are meant to receive a given medical treatment “if it is determined by appropriate healthcare professionals that the care is needed to promote, preserve, or restore the health of the individual and is in accord with generally accepted standards of medical practice.” 38 C.F.R. § 17.38(b). Care is deemed “to promote health” if “the care will enhance the quality of life or daily functional level of the veteran.” Id. at 17.38(b)(1). To that end, the regulation broadly covers inpatient and outpatient medical, surgical, and mental health care. See 38 C.F.R. § 17.38(a).
B. Herbicide Agent Exposure
From 1962 to 1971, the U.S. military’s Operation Ranch Hand involved spraying certain herbicide agents over Vietnam to strip the thick jungle canopy that could conceal opposition forces, to destroy crops that those forces might depend on, and to clear tall grasses and bushes from the perimeters of U.S. base camps and outlying fire-support bases. Mixtures of 2,4-dichlorophenoxyacetic acid (2,4-D), 2,4,5-trichlorophenoxyacetic acid (2,4,5-T), picloram, and cacodylic acid made up the bulk of the herbicide agents sprayed. The main chemical mixture sprayed was Agent Orange, a 50:50 mixture of 2,4-D and 2,4,5-T. At the time of the spraying, 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD), the most toxic form of dioxin, was an unintended contaminant generated during the production of 2,4,5-T and so was present in Agent Orange and some other formulations sprayed in Vietnam. The herbicide agents were also used by the U.S. military in Vietnam after 1971 and were used by the U.S. military in Korea and Thailand and in other areas. Veterans who served on land in Vietnam or on a ship operating on the inland waterways of Vietnam between January 9, 1962 and May 7, 1975 are presumed to have been exposed to herbicide agents.
C. Monoclonal Gammopathy of Undetermined Significance
At issue in this petition is the VA’s provision of no-cost medically-necessary health care for Dr. Hunter and other herbicide-agent-exposed veterans at increased risk for or already diagnosed with MGUS. The medical profession uniformly recognizes MGUS as a serious medical condition (International Myeloma Foundation, 2016). Moreover, the protocols for screening for and monitoring of MGUS are well established and generally accepted by the medical community (Rajkumar, 2010). Patients with low-risk IgG-MGUS (approximately 40 percent of all MGUS patients) need limited assessment and infrequent follow-up (Merlini et al., 2012).
MGUS is a condition that impairs the normal functioning of the body, and is, therefore, a disease. MGUS is a pre-malignant condition that precedes a number of malignancies. Three distinct clinical subtypes of MGUS have been defined: non-IgM-MGUS (IgG-MGUS, IgA-MGUS, IgD-MGUS or IgE-MGUS), IgM-MGUS, and light-chain-MGUS (Rajkumar, 2010).
Patients with non-IgM-MGUS have approximately a one percent per year risk of their disease transforming (progressing) into multiple myeloma; however, the risk of transformation is double in patients with IgM-MGUS. IgM-MGUS not only has a higher risk of transformation than non-IgM-MGUS, but also the spectrum of diseases associated with IgM-MGUS transformation is broader than that of non-IgM MGUS. Whereas non-IgM-MGUS can progress into smoldering and active multiple myeloma and AL amyloidosis, IgM-MGUS can transform into Waldenström macroglobulinemia (a type of non-Hodgkin’s lymphoma), AL amyloidosis, and less commonly, IgM smoldering multiple myeloma, or IgM multiple myeloma. For this reason, patients with IgM-MGUS require closer follow-up than patients with non-IgM-MGUS, and from a conceptual perspective, IgM-MGUS can be thought of as a “lymphoproliferative” MGUS while non-IgM-MGUS behaves as a “plasma cell proliferative” MGUS (Mikhael, 2014, updated online in 2016).
MGUS can have serious sequelae and cause secondary conditions. Patients with MGUS can develop severe end-organ damage caused by structural characteristics of the monoclonal protein or may be related to poorly understood paraneoplastic syndromes that are independent of the size and proliferation of the plasma cell clone. These disorders, caused by “dangerous small B-cell clones,” can develop silently during follow-up, are often overlooked by clinicians, and may become manifest when organ function is already irreparably compromised. Disorders include AL amyloidosis and light-chain deposition disease and conditions related to antibody activity of the monoclonal protein, deep vein thrombosis, cryoglobulinemia, cold agglutinin disease, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, acquired Fanconi syndrome, Schnitzler syndrome, and scleromyxedema (Merlini, 2012). Although peripheral neuropathy can occur with all forms of MGUS, it is most commonly associated with IgM-MGUS. AL amyloid is also more commonly associated with IgM-MGUS than other forms of MGUS.
MGUS patients are more than twice as likely as the general population to develop bacterial or viral infections because they have reduced production of polyclonal (normal) immunoglobulins, and therefore have diminished antibody response (Tete et al., 2014). The risk is increased even among MGUS patients with as little as < 0.5 g/dL of monoclonal protein (International Myeloma Foundation, 2016).
Recent research by researchers from the National Institute of Health, Centers for Disease Control and Prevention, and other institutions has determined that the prevalence of MGUS is two-fold higher among Operation Ranch Hand veterans than veterans with similar duties in Southeast Asia during the same period who were not involved in herbicide spray operations (Landgren et al., 2015). Moreover, the researchers observed an apparent excess of IgM-MGUS (Petitioner’s subtype) and light-chain-MGUS in their herbicide-agent-exposed veteran population.
The accepted standard of care after MGUS has been diagnosed is life-long monitoring of the patient to ensure that progression to a malignancy or a related condition is not occurring. In the absence of screening of veterans at higher risk for MGUS, e.g., veterans who have been exposed to herbicide agents, a MGUS diagnosis is unlikely to occur before symptoms of the malignancy or related condition develop. In patients in whom a monoclonal protein has been identified through serum electrophoresis and immunofixation, a few standard investigations are recommended, with additional studies graduated according to the risk (Merlini et al. 2012).
Recent research has also found that patients with multiple myeloma who had a prior diagnosis of MGUS had better multiple myeloma survival, suggesting (but not proving) earlier treatment of multiple myeloma leads to better survival (Sigurdardottir et al., 2015). Causality could not be proven because of the nature of the study design (Kyle et al., 2015). The researchers made the observation that a low monoclonal protein concentration at MGUS diagnosis was associated with poorer multiple myeloma survival and may reflect less frequent clinical follow-up. Their observations stress the importance of life-long clinical follow-up monitoring in patients with MGUS.
D. The VA’s Current Provision of a Screening Exam to Herbicide-Agent-Exposed Veterans
The VA offers eligible Veterans a no-cost Agent Orange Registry health exam for possible long-term health problems related to herbicide exposure. That exam does not include offering blood tests for MGUS diagnosis, e.g., serum protein electrophoresis (SPEP), serum immunofixation electrophoresis (IFE), and serum free-light-chain (FLC) assay.
E. The VA’s Current Provision of Health Care to Veterans Whose MGUS Has Progressed to Presumptive Diseases
The VA recognizes certain cancers and other health problems as presumptive diseases associated with exposure to Agent Orange or other herbicide agents during military service. Among those presumptive diseases, the following result from progression from MGUS:
AL amyloidosis,
Multiple myeloma, and
Non-Hodgkin’s lymphoma.
Notably, MGUS is present in virtually all patients diagnosed with multiple myeloma, years prior to the development of the malignancy (Landgren et al., 2009). Waldenström macroglobulinemia, a type of non-Hodgkin’s lymphoma, is the most common malignant outcome for IgM-MGUS, but patients are also at increased risk to develop other B-cell neoplasms (Goldin et al., 2013).
VI. THE VA SHOULD AMEND ITS REGULATIONS TO PROVIDE NO-COST SCREENING FOR AND MONITORING OF MGUS IN HERBICIDE-AGENT-EXPOSED VETERANS
The VA should offer no-cost screening for and monitoring of MGUS and treatment of the sequelae and secondary conditions of MGUS to herbicide-agent-exposed veterans, first and foremost, because doing so is good policy. The VA may adopt a new policy if it “is permissible under the statute, [] there are good reasons for it, and [] the agency believes it to be better, which the conscious change adequately indicates.” F.C.C. v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009). No-cost screening and monitoring is clearly permissible under 38 U.S.C. § 1710, which broadly authorizes the Secretary to provide “needed” medical care to veterans, and there are good reasons for this policy change: providing this screening and monitoring is consistent with, and mandated by, the VA’s mission, would impose at most only a relatively minor burden on the VA health care system, and would provide medically-necessary that appears to improve the outcomes of those diagnosed with MGUS who progress to cancer. It may be that some herbicide-agent-exposed veterans will opt not to be screened because of the emotional burden a knowledge of on-going MGUS can impose, but after MGUS is discovered, even incidentally, life-time monitoring is the standard of care.
Providing no-cost screening and monitoring is required by the VA’s mission to promote the health of veterans through coverage of medically accepted treatments that enhance the quality of life or daily functional level of veterans. The Secretary is charged with providing hospital care and medical services to veterans. See 38 U.S.C. § 1710. The VA has determined that this mandate includes care that is “needed to promote, preserve, or restore the health of the individual and is consistent with generally accepted standards of medical practice.” 38 C.F.R. § 17.38(b).
Care is deemed “to promote health” if “the care will enhance the quality of life or daily functional level of the veteran,” id. § 17.38(b)(1), and care is deemed to “preserve health” if the care will maintain the current quality of life or daily functional level of the veteran,” including by “extend[ing] lifespan,” id. § 17.38(b)(2).
As was noted above, not all patients with MGUS are asymptomatic. For example, IgM-related disorders are characterized by the aberrant properties of the IgM monoclonal component, such as cryoglobulinemic, anti-red blood cell, anti-platelet, and anti-neural activity, before evidence of lymphoma (Morra et al., 2004). So, IgM-MGUS can cause anemia, low-platelet count, peripheral neuropathy, and osteoporosis (and attendant bone fractures) long before a malignancy occurs (Klein et al., 2011; International Myeloma Foundation, 2016).
Finally, offering no-cost MGUS screening and monitoring and treatment of MGUS sequelae and secondary conditions to herbicide-agent-exposed veterans is the right thing to do. Offering such services to these veterans can be life-extending and can improve their quality of life.
VII. DECIDING NOT TO COVER MGUS WOULD BE ARBITRARY
Under the Administrative Procedure Act, a court may hold unlawful and set aside final agency action, such as a regulation or a denial of a petition for rulemaking or to amend existing rules, that it finds to be, inter alia, “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706. To comply with the requirements of the Act, the agency “must examine the relevant data and articulate a satisfactory explanation for its action.” F.C.C. v. Fox Television Stations, Inc., 556 U.S. 502, 552, (2009) (quoting Motor Vehicles Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42-43 (1983)). That explanation must “includ[e] a rational connection between the facts found and the choice made.” State Farm, 463 U.S. at 42-43. “Normally, an agency rule would be arbitrary and capricious if the agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise[.]” Fox Television, 556 U.S. at 552 (quoting State Farm, 463 U.S. at 42-43). Moreover, “it is well-established that ‘an agency action is arbitrary when the agency offer[s] insufficient reasons for treating similar situations differently.’” SKF USA Inc. v. United States, 263 F.3d 1369, 1382 (Fed. Cir. 2001) (quoting Transactive Corp. v. United States, 91 F.3d 232, 237 (D.C. Cir. 1996)).
Before its mandate ended, the Veterans and Agent Orange (VAO) Committee charged by law to identify presumptive diseases for rule making by the VA stated that “the best measure of potency for the quantification of risk to veterans would be the rate of the outcome in exposed Vietnam veterans compared with the rate in nonexposed veterans, adjusted for the degree to which any other factors that differ between exposed and nonexposed veterans might influence those rates” (Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides-Ninth Biennial Update, 2014) which is exactly how the recently-reported research primarily relied upon by this petition was performed (Landgren et al., 2015). Had Landgren et al.’s research been published in time to be considered by the now-disbanded VAO Committee, this petition would not be necessary.
A denial of this petition would be arbitrary because the VA already recognizes AL amyloidosis, multiple myeloma, and non-Hodgkin’s lymphoma as presumptive diseases and currently provides treatment for these diseases to herbicide-agent-exposed veterans, yet the VA arbitrarily excludes no-cost screening for and monitoring of the precursor condition MGUS and no-cost treatment of its sequelae and secondary conditions from the covered care of these veterans as service-related conditions.
It is the height of arbitrary action to recognize these presumptive diseases as treatable medical conditions and provide treatments for them, while denying no-cost screening for and monitoring of the disease that often progresses to them and no-cost treatment of its sequelae and secondary conditions. That policy is incoherent because it is internally inconsistent, and therefore arbitrary.
For these reasons, a denial of this petition to amend VA regulations to include no-cost screening for and monitoring of herbicide-agent-exposed veterans for MGUS and treatment of its sequelae and secondary conditions in the Medical Benefits Package would constitute unlawful, arbitrary agency action.
Petitioner is confident, however, that, after consideration of the evidence, the Secretary will agree with the recent editorial in the American Medical Association’s JAMA Oncology journal (Munchi, 2015) which concluded: “The study by Landgren et al. now highlights a strong relationship between Agent Orange exposure and plasma cell disorder, including the development of MGUS, suggesting inclusion of such benign conditions in the list of disorders considered to be Agent Orange related.”
VIII. CONCLUSION
For the foregoing reasons, Petitioner respectfully requests the Secretary of Veterans Affairs to amend its regulations by finding that MGUS is positively associated with herbicide agent exposure in accordance with 38 U.S. Code § 1116(a) and 38 CFR 3.307 and adding MGUS to the list of presumptive diseases found in 38 CFR 3.309(e). Furthermore, Petitioner requests that the Secretary of Veterans Affairs amend or promulgate rules and regulations expressly including no-cost medically-necessary health screening for and monitoring of MGUS for veterans who were exposed to certain herbicide agents during their service and no-cost treatment of the sequelae and secondary conditions of MGUS in the medical benefits package provided to veterans under the VA health care system.
Respectfully submitted,
Robert M. Hunter, Ph.D., Petitioner Dated: March 4, 2017
APPENDIX A – EVIDENCE