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Genetic Predispositions, Prophylactic Treatments and Private Health Insurance: Nothing is Better Than a Good Pair of Genes

Published online by Cambridge University Press:  24 February 2021

Alexandra K. Glazier*
Affiliation:
Ropes & Gray, Boston. Boston University School of Public Health; Boston University School of Law; Biomedical Ethics, Brown University

Extract

Discovering the genetic basis of a particular disease is not only of great interest to the medical community; private health insurers are also anxiously awaiting the results of genetic linkage studies. Apart from the scientific value of DNA studies, the results of genetic linkage research are relevant to health care delivery in two principal ways. First, identifying the genetic origin of a disease may allow doctors to detect the disease earlier. If doctors know that an individual is genetically predisposed to a particular disease, then health care providers can increase screening efforts and watch for early symptoms. Second, if an individual has a genetic predisposition to a particular disease, health care providers may employ preventive or “prophylactic" measures to reduce or eliminate the risk of developing the disease or condition to which the individual is genetically predisposed. Genetic linkage studies will soon allow more individuals to learn of their own genetic predispositions to certain diseases. Currently genetic predisposition tests (both pedigrees of family history and DNA analysis) can indicate that an individual is at high risk for developing a disease.

Type
Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1997

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References

1 However, it is unclear whether early detection actually benefits the patient. Studies measuring the effectiveness of early detection compare the percentages of individuals alive at various time intervals from the time of diagnosis. See HENNEKENS, CHARLES H. & BURING, JULIE E., Epidemiology in Medicine 339-40 (Mayrent, Sherry L. ed., 1987)Google Scholar. Some researchers have begun to question this assessment measure which hides a “lead time bias.” See Ayanian, John Z. et al., The Relationship Between Health Insurance Coverage and Clinical Outcomes Among Women with Breast Cancer, 326 New Eng. J. Med. 326, 329-30 (1993)CrossRefGoogle Scholar (discussing how a lead time bias may affect results measured by outcome); Black, William C. & Welch, H. Gilbert, Advances in Diagnostic Imaging and Overestimations of Disease Prevalence and the Benefits of Therapy, 328 New Eng. J. Med. 1237, 1239 (1993)CrossRefGoogle ScholarPubMed (concluding that advances in diagnostic imaging techniques confuse the public into thinking early diagnosis confers benefit, when for many diseases little or no benefit is gained). Lead time bias, describes the fact that although a greater percentage of individuals whose disease was detected early may be alive five years after diagnosis, they actually live no longer than individuals whose disease was detected later, because the early diagnosis was made earlier in the life of the disease. See Hennekens & Buring, supra, at 341. For example, if the disease progression starts as a small lump and in 10 years causes death, then, if detection occurs at year two of the disease, the individual will live eight years from the time of diagnosis; whereas if detection occurs at year seven of the disease, the individual will live only three years from the time of diagnosis. The individual dies at the same age in either case. Thus, early detection gives individuals a greater number of years of knowing that they are sick and a greater number of years of treatment but does not necessarily extend their lives. Cf. Klemi, P.J. et al., Aggressiveness of Breast Cancers Found with and Without Screening, 304 Brit. Med. J. 467, 469 (1992)CrossRefGoogle ScholarPubMed (finding variation in the aggressiveness of the breast cancer depending on how it was diagnosed).

2 See Weber, Barbara L. et al., Familial Breast Cancer: Approaching the Isolation of a Suscep tibility Gene, 74 Cancer 1013, 1013(1994)3.0.CO;2-#>CrossRefGoogle Scholar.

3 See Capron, Alexander M., Which Ills to Bear?: Reevaluating the “Threat" of Modern Genet ics, 39 Emory L.J. 665, 686-89 (1989)Google Scholar; Weber et al., supra note 2, at 1020 (stating that identifying the defective gene for breast cancer will soon lead to the availability of a simple blood test to screen individuals for the gene); see also Wooster, Richard et al., Localization of a Breast Cancer Suscep tibility Gene, BRCA2, to Chromosome 13q l2-13, 265 Science 2088, 2090 (1994)CrossRefGoogle Scholar (identifying the gene that causes an increased risk of breast cancer).

4 See Miller, Joseph M., Comment, Genetic Testing and Insurance Classification: National Action Can Prevent Discrimination Based on the “Luck of the Genetic Draw,” 93 Dick. L. Rev. 729, 731-36 (1989)Google Scholar (reviewing current genetic testing technologies).

5 Health insurance commonly covers the expense of treatment only for diagnosable diseases. If an individual does not suffer from a disease, treatments are not a covered benefit. For example, if an individual wants a “nose job" (rhinoplastic surgery) for cosmetic reasons, the cost of surgery is not covered because the individual docs not have a disease and the surgery is therefore considered un necessary. See infra text accompanying notes 11-15.

6 In a sense, the treatment would no longer be considered “prophylactic" because the individual has a cognizable disease.

7 A preexisting condition is, simply, a medical condition that the insured had prior to the date of the policy. See Alexander v. Anheuser-Busch Co., 990 F.2d 536, 537-38 (10th Cir. 1993); Eley v. Boeing Co., 945 F.2d 276, 279 (9th Cir, 1991); Bullwinkcl v. New Eng. Life Mut. Ins. Co., No. 92-C-2528, 1993 U.S. Dist. LEXIS 934, at *3 (N.D. III. Jan. 29, 1993).

8 Because genetic composition is determined at the time of conception, nothing could be more “preexisting" than a genetic predisposition based on a deleterious gene.

9 According to a March of Dimes poll conducted in 1992, although 68 percent of Americans know ‘relatively little’ or ‘almost nothing’ about genetic testing .. . 72 percent said they would take genetic tests to determine whether they or their children were at risk for a serious disease. Sixty-five percent of respondents also felt that genetic testing should be offered to everyone, rather than limiting it to people who have reason to believe they arc genetically at risk.

Genetic Screening of Cancer Risk, Cancer Researcher Wkly., June 27, 1994, at 3, 4Google Scholar [hereinafter Genetic Screening].

10 For example, according to the radiology departments at three of the larger hospitals in Bos ton, the cost of a mammogram ranges from $115 to $250. Telephone Interview with radiology department personnel, Massachusetts General Hospital, Brigham and Women’s Hospital and Beth Israel Hospital, Boston, Mass. (Sept. 20, 1996). Paying for early detection tests enhances an insurer’s public image because the media constantly conveys the message that “[c]arly detection is the best shot at surviving cancer.” Brownlec, Shannon & Watson, Traci, Hunting a Killer Gene, U.S. News & World Rep., Sept. 26, 1994, at 76, 77-78.Google Scholar Insurance companies refusing to provide such care risk unfavorable public attention.

11 For example, in one case a prophylactic total abdominal hysterectomy and bilateral salpingo-oophorectomy (removal of uterus, fallopian tubes and ovaries) cost approximately $6,022.57. See Katskee v. Blue Cross Blue Shield of Neb., 515 N.W.2d 645, 647-48 (Neb. 1994).

12 See Mariner, Wendy, Patients’ Rights After Health Care Reform: Who Decides What is Medi cally Necessary?, 84 Am. J. Pub. Health 1515, 1516 (1994)CrossRefGoogle Scholar (noting that insurance companies commonly use the term “medically necessary" to limit coverage).

13 See Hall, Mark A. & Anderson, Gerard F., The Law and Policy of Health Care Rationing: Models and Accountability, 140 U. Pa. L. Rev. 1637, 1647 nn.30-31 (1992)CrossRefGoogle Scholar (detailing the analysis involved in determining what constitutes “medical necessity" as applied to private health insurance contracts).

14 See Annas, George J., When Should Preventive Treatment Be Paid for by Health Insurance?, 331 New Eng. J. Med. 1027, 1028 (1994)CrossRefGoogle ScholarPubMed (the language of most insurance policies limits coverage to “'medically necessary’ treatment of ‘illness'”).

15 See Hall & Anderson, supra note 13, at 1644-51 (detailing how the determination of medical necessity functions to restrict coverage).

16 Although no compilation of private health insurance contracts is available, courts have recognized that standard language exists. See, e.g., Ralston v. Connecticut Gen. Life Ins. Co., 617 So. 2d 1379, 1381 (La. 1993); see also Annas, supra note 14, at 1028 (noting that “the problem of inter preting such language is a nationwide one. ‘Illness,’ ‘disease,’ and ‘sickness’ are used inter changeably in most insurance contracts.”).

17 See infra notes 49-54 and accompanying text.

18 Disputes regarding prophylactic treatments for genetic risk most likely occur more frequently than the case law suggests because settlements may be presumed to happen with some frequency.

19 515 N.W.2d 645, 653 (Neb. 1994) (holding that the plaintiffs genetic predisposition “did constitute an illness within the meaning of the policy”).

20 See id. at 651. Katskee’s risk assessment was based on a method that is currently considered 95% accurate. See Deposition of Henry T. Lynch, M.D., at 17, Katskee (No. 894-336). The general risk of developing ovarian cancer for women in all age categories combined who do not have this genetic predisposition is approximately 1.4%. See Katskee, 515 N.W.2d at 651. The general risk of developing breast cancer during a woman’s life is 11% based on a lifetime of 85 years. See Deposi tion of Larry E. Roffman, M.D., at 20, Katskee, (No. 894-336). However, the risk of developing breast cancer to a woman with the inherited gene is 85%. See Angier, Natalie, Scientists Identify a Mutant Gene Tied to Hereditary Breast Cancer, N.Y. Times, Sept. 15, 1994, at AlGoogle Scholar. Hereditary breast cancer accounts for about one half of the breast cancer cases in women under 30 years old. See Marcus, J.N. et al., Pathology and Heredity of Breast Cancer in Younger Women, 16 J. Nat'l. Cancer Inst. Monogr. 23, 24 (1994)Google Scholar.

The distinction between hereditary and nonhcreditary breast cancer is important. All cancer is “genetic" in the sense that cancers “are caused by mutated genes.” Brownlee & Watson, supra note 10, at 78. Only 5 to 10% of the 180,000 breast cancers diagnosed each year are attributable to an inherited gene. See id. at 76. In the majority of breast cancer cases the mutated gene is “not inherited but instead arises spontaneously during a woman’s life.” Id. at 78.

21 See Katskee, 515 N.W,2d at 647 (noting her family’s history of breast and ovarian cancer).

22 Id. Although Katskee was at risk for developing breast cancer, Dr. Roffman did not recom mend prophylactic mastectomy because he felt that methods for early detection of breast cancer allowed for effective treatment of the disease. See Deposition of Roffman at 22-23, Katskee (No. 894-336) (stating that “[w]ith breast cancer today and with the use of mammograms and exams where patients can examine themselves . . . because of that we have a much higher cure rate”).

23 See Katskee, 515 N.W.2d at 648.

24 See id. at 648-49.

25 See id. at 648.

26 See id. (noting that the district court found no issue of material fact).

27 Id.

28 See id. (stating that Blue Cross Blue Shield reserved the right to determine which treatments were necessary, thereby curtailing judicial inquiry).

29 See id.

30 See id. at 652 (finding that “the recommended surgery is intended to correct [the] morbid state by reducing or eliminating that risk”).

31 See id. (holding that Katskce’s genetic makeup “is a deviation from what is considered a normal, healthy physical state or structure .... The existence of this unhealthy state results in the woman’s being at substantial risk of developing cancer.”).

32 See id. at 653.

33 See Biesccker, Barbara B. et al., Genetic Counseling for Families with Inherited Susceptibil ity to Breast and Ovarian Cancer, 269 JAMA 1970, 1970 (1993)CrossRefGoogle Scholar (stating that testing for genetic predispositions is increasingly based on family pedigrees using genetic markers).

34 See OFFICE OF TECHNOLOGY ASSESSMENT, Mapping Our Genes: Genome Projects: How Big, How Fast? 83 (1988)Google Scholar (discussing the social and ethical implications of the Human Genome initiative; a fifteen-year study in genetics to identify and map all the genes in the human chromo some); see also Hearings Before the Subcomm. on Energy of the House Comm. on Science, Space and Technology, 103d Cong. 41 (1994)Google Scholar [hereinafter Hearings] (testimony of Neil A. Holtzman, M.D., M.P.H., John Hopkins Medical Institutions) (highlighting the implications to the public of “genetic tests made possible by the identification of genes that play a role in human diseases”).

35 See Kimbcrley Nobles, Note, Birthright or Life Sentence: Controlling the Threat of Genetic Testing, 65 S. Cal. L. Rev. 2081, 2090 (1992)Google Scholar.

36 See id.

37 See id.

38 See id.

39 See id. For a discussion and proposal on coping with genetically based insurance discrimi nation, see Miller, supra note 4, at 735-57.

40 See DiCarlo, Steven & Gabel, Jon, Conventional Health Insurance: A Decade Later, 10 Health Care Fin. Rev. 77, 88 (1989)Google ScholarPubMed (discussing the private health insurance industry’s strategies to cut or at least contain costs).

41 See Mariner, supra note 12, at 1517 (arguing that health care reform will not eliminate the difficult question of what treatments and services the benefit package should include).

42 See, e.g., Katskcc v. Blue Cross Blue Shield of Neb., 515 N.W.2d 645, 647 (Neb. 1994).

43 See 4 Williston, Samuel, a Treatise on the Law of Contracts § 600 (Jaeger, Walter H. ed., 3d ed. 1961).Google Scholar

44 See id.

45 Katskee, 515 N.W.2d at 649.

46 See Williston, supra note 43, § 600.

47 Brief for Appellant at 15, Katskee (No. A-92-1022).

48 Katskee, 515 N.W.2d at 648.

49 See id. at 649 (stating that the court’s proper inquiry was “whether the appellant’s condition constituted an illness" and noting the broad definition employed in the contract).

50 See id. (explaining that Blue Cross Blue Shield denied coverage because Katskee did not suffer from an illness and thus the surgery was not medically necessary).

51 See id. at 650.

52 See id. at 651. Courts may be reluctant to find insurance terms ambiguous because defining such terms necessitates lengthy court proceedings in which parole evidence is offered to determine the term’s meaning under the particular circumstances.

53 Id.

54 See, e.g., Witcraft v. Sundstrand Health & Disability Group Benefits Plan, 420 N.W.2d 785, 788 (Iowa 1988) (quoting 45 C.J.S. Insurance § 893 (1946)) (stating that illness and disease are synonymous terms that should be given broad and ordinary meaning, defined as “'a morbid condition of the body, a deviation from the healthy or normal condition of any of the functions or tissues of the body”’); Cheney v. Bell Nat'l Life, 556 A.2d 1135, 1139-40 (Md. 1989) (holding that hemophilia is a “disease" within its ordinary and common meaning); Orman v. Prudential Ins. Co. of Am., 296 N.W.2d 380, 380 (Minn. 1980) (stating that a condition defined as “unhealthy" by the medical community is a disease or sickness as defined in a health insurance policy); see also Silverstein v. Metropolitan Life Ins. Co., 171 N.E. 914, 915 (N.Y. 1930).

A distinction is to be drawn between a morbid or abnormal condition of such quality or degree that in its natural and probable development it may be expected to be a source of mischief, in which event it may fairly be described as a disease or an infirmity, and a condition abnormal or unsound when tested by a standard of perfection, yet so remote in its potential mischief that common speech would call it not disease or infirmity, but at most a predisposing tendency. Id.

55 Katskee. 515 N.W.2d at 651-53.

56 Id. at 652.

57 See id. at 653.

58 456 N.W.2d 281,285 (Neb. 1990). The court held that [a] disease, illness, or condition exists within the meaning of a health insurance policy excluding preexisting conditions only at such time as the disease, condition, or illness is manifest or active or when there is a distinct symptom or condition from which one learned in medicine can with reasonable accuracy diagnose. Id

59 See id. at 283.

60 See id at 285.

61 See id. (stating that the “case law indicates [that this is] a better statement of the rule”).

62 See Katskee, 515 N.W.2d at 652-53 (stating that “reliance on Fuglsang is somewhat misplaced [because it] concerns when an illness exists, not whether the condition itself is an illness”).

63 See id. at 653 (noting that Katskcc’s condition meets the standard “[e]ven assuming argu endo that the rule announced in Fuglsang is a definition of''disease'”).

64 See id.

65 Brief for Appellee at 13-14, Katskee (No. A-92-1022).

66 Katskee, 515 N.W.2d at 652.

67 See id. at 653.

68 See id. at 647.

69 See id. at 657.

70 This is a crucial question to insured individuals because even if it is conceded that an indi vidual with a genetic predisposition has a disease, prophylactic surgery must be medically necessary for the expense to be covered.

71 See Black’s Law Dictionary 1502 (6th ed. 1990) (defining treatment as “all the steps taken to effect a cure of an injury or disease, including examination and diagnosis as well as [the] application of remedies”).

72 A separate question is whether prophylactic surgery is an effective treatment. The answer is unclear. One medical article suggests that prophylactic surgery for women genetically at risk for ovarian cancer is indicated and effective when accompanied by lifelong estrogen therapy. See Nguyen, Hoa N. et al., Ovarian Carcinoma: A Review of the Significance of Familial Risk Factors and the Role of Prophylactic Oophorectomy in Cancer Prevention, 74 Cancer 545, 553 (1994)3.0.CO;2-Q>CrossRefGoogle ScholarPubMed (suggesting that the use of prophylactic oophorectomy should be limited to specific risk groups with a positive family history and individuals who will comply with lifelong estrogen therapy). But other articles warn of documented instances of cancer in women who have undergone prophylactic surgery. See Brownlee & Watson, supra note 10, at 78 (noting that “[d]octors report scattered cases of breast cancer even after prophylactic surgery”); see also Genetic Screening, supra note 9, at 3 (stating that “prophylactic mastectomy doesn't completely eliminate the risk. There are a few documented cases of women who developed breast cancer after a prophylactic mastectomy, as surgery may leave a few arrant breast cancer cells behind.”).

However, Dr. Lynch, an expert on hereditary breast and ovarian cancer, believes that prophylactic surgery is beneficial. See, e.g., Lynch, Henry T. et al., DNA Screening for Breast/Ovarian Cancer Susceptibility Based on Linked Markers, A Family Study, 153 Arch. Intern. Med. 1979, 1983-96 (1993)CrossRefGoogle ScholarPubMed; Lynch, Henry T. et al., Hereditary Ovarian Cancer: Pedigree Studies, Part II, 53 Cancer Genetics Cytogenetics 161, 161 (1991)CrossRefGoogle ScholarPubMed; Lynch, Henry T. et al., Management of Familial Breast Cancer. II. Case Reports, Pedigrees, Genetic Counseling, and Team Concept, 113 Arch. Surg. 1061. 1061 (1978)CrossRefGoogle ScholarPubMed. In total, Dr. Lynch has authored “some hundreds of articles ... in the field of cancer" and has written chapters “in about 20 [medical text] books.” Deposition of Dr. Lynch at 75-76, Katskee, 515 N.W.2d 645 (Neb. 1994) (No. 894-336).

73 See infra notes 74-83 and accompanying text.

74 420 N.W.2d 785 (Iowa 1988).

75 See id. at 787.

76 See id. at 786 (noting that the plaintiffs physician considered the sperm treatment and IVF their “only option" for having a second child).

77 See id. at 788 (holding that IVF does not “encourage healing or reverse the malfunction" and therefore it is not a covered expense).

78 See id. (noting that a failure to be pregnant is not a disease).

79 See id. at 786.

80 See id. (noting that the district court held that the treatment was covered both because of the policy’s broad definition of illness and because of the absence of a specific exclusion for infertility treatments).

81 See id. at 790.

82 There have been no randomized clinical trials involving prophylactic surgery for women genetically at risk for developing breast and ovarian cancer. Although it appears that by removing the potentially affected body part the risk is removed, it is unclear whether that is the case. See Deposition of Dr. Roffman at 25, Katskee, 515 N.W.2d 645 (Neb. 1994) (No. 894-336).

83 See Witcraft, 420 N.W.2d at 788 (stating that the issue “is whether infertility as experienced by this couple is an illness within the meaning of the plan. The district court thought so and so do wc”).

84 See infra Part IV.

85 See Hennekens & Buring, supra note 1.

86 See id.

87 Katskec’s risk was calculated as a 50% lifetime risk based on the fact that her aunt and mother died of ovarian cancer at ages 47 and 48 and her sister had breast cancer at age 35. See Deposition of Dr. Roffman at 19, Katskee (No. 894-336). At the time of Dr. Lynch’s deposition, more accurate diagnostic procedures had become available, such that with gene linkage technology the risk could be assessed as 95%. See Deposition of Dr. Lynch at 17, Katskee (No. 894-336). Katskee was diagnosed only by a family pedigree risk assessment technique which can assess up to a 50% risk. See id. at 26. It is thus possible that Katskee actually faced a 95% lifetime risk of breast or ovarian cancer. See id. at 26.

88 Katskee v. Blue Cross Blue Shield of Nebraska, 515 N.W.2d 645, 652 (Neb. 1994).

89 See Lynch, Henry T. ct al., Psychological Aspects of Monitoring High Risk Women for Breast Cancer, 74 Cancer 1184, 1190 (1994)3.0.CO;2-4>CrossRefGoogle ScholarPubMed (stating that because of mammography’s uncertain efficacy in young women, risk counseling may produce psychological morbidity among these women).

90 Because Katskee did not undergo genetic testing at the micro level, there was a 50% chance that she did not carry the gene that creates the genetic predisposition. See Deposition of Dr. Roffman at 20-21, Katskee (No. 894-336).

91 See Eddy, David, Three Battles to Watch in the 1990s, 270 JAMA 520, 524 (1993)CrossRefGoogle ScholarPubMed (noting the battle over coverage exclusions through the use of terms such as “medical necessity" and that, “depending on how the terms arc defined, billions of dollars worth of treatment will be swept to one side or the other”).

92 See supra notes 74-78 and accompanying text.

93 See Deposition of Dr. Lynch at 26, Katskee (No. 894-336).

94 Genetically at risk individuals are eligible to receive prophylactic treatments regardless of insurance coverage, if their physicians believe that the prophylactic treatments are clinically indicated and are willing to perform the procedure without guaranteed reimbursement. Courts should interpret private health insurance contracts to give fair meaning to the intent and expectations of the parties involved as well as consideration to the public policy issues at hand. As Professor Wendy Mariner frames it, “the fundamental social issue is what kinds of health care services should be covered in any respectable health care system.” Mariner, supra note 12, at 1526. Reimbursement schemes greatly affect treatment patterns and outcomes, because authorization for coverage is often required before procedures and treatments are administered. See Ayanian et at., supra note 1, at 329 (finding that uninsured women are less likely to have surgery and are also more likely to have bad health outcomes).

95 See Annas, supra note 14, at 1029 (suggesting that the court’s logic in Katskee would not distinguish between fetuses, children or adults with the deleterious gene).

96 In a national health insurance system this issue would not arise. Because the purpose of universal coverage is to cover everybody, a national health care plan with that goal would be unlikely to include a preexisting condition exclusion. The health care plan proposed by President Clinton, for example, did not contain a preexisting condition exclusion.

97 See Annas, supra note 14, at 1029 (noting that “[t]o be consistent, the [Katskee] court would have to conclude that a genetic syndrome is a preexisting condition, the treatment of which could be excluded on this basis”).

98 See supra note 8 and accompanying text.

99 The majority of cases discussing preexisting conditions involve workers compensation claims in which the issue of a preexisting condition is crucial to determining causation and extent of harm in order to invoke benefits. See McElveen, Junius C. Jr. & Postol, Lawrence P., Compensating Occupational Disease Victims Under the Longshoremen’s and Harbor Workers’ Compensation Act, 32 Am. U. L. Rev. 717, 765-75 (1983)Google Scholar. Tort litigation suits also raise the issue of a preexisting condition as it affects proximate cause and harm elements. See id. These two types of cases provide useful analogies to preexisting condition litigation in the health insurance context but will not be considered for the purposes of this Article.

Workers compensation cases differ from private health insurance cases, because they are governed statutorily and are administratively enforced. For a thorough discussion of preexisting conditions in workers compensation cases, see McElveen & Postol, supra at 765-75 (detailing how preexisting permanent or partial disability can include “any condition for which a cautious employer might discharge the employee”). Although the statutes do not require actual knowledge, the statutory manifestation requirement can be satisfied only if the preexisting condition “could have been diagnosed from the claimant’s appearance or medical records.” Id. at 769. The preexisting condition also “must have contributed to the claimant’s final disability" for compensation to be limited. Id. at 772.

The tort cases involving preexisting conditions focus narrowly on the issue of causation for the purpose of calculating damages and have evolved into a complex area of law—primarily due to toxic tort litigation. For discussions of how preexisting conditions function in tort claims, see Ashton, David P., Decreasing the Risks Inherent in Claims for Increased Risk of Future Disease, 43 U. Miami L. Rev. 1081, 1086 (1989)Google Scholar (arguing that courts should recognize increased future risk of disease as a valid claim and should impose a remedy of insurance coverage for this risk), King, Joseph H. Jr., Causation, Valuation, and Chance in Personal Injury Torts Involving Preexisting Conditions and Future Consequences, 90 Yale L.J. 1353, 1374-76 (1981)CrossRefGoogle Scholar (discussing different standards for proving the extent of harm when a preexisting condition is involved), and Thompson, Melissa M., Comment, Enhanced Risk of Disease Claims: Limiting Recovery to Compensation for Loss, Not Chance, 72 N.C. L. Rev. 453, 453 (1994)Google Scholar (urging that courts limit recovery under enhanced risk claims to the expenses associated with medical monitoring and emotional distress and not enhanced risk itself as an independent form of damages).

100 See infra notes 101-27 and accompanying text.

101 312 S,W,2d 441 (Ark, 1958).

102 Id. at 442.

103 See id.

104 See, e.g., Karagon v. Aetna Life Ins. Co., 228 N.W.2d 515, 516 (1975) (holding that the preexisting condition exclusion was not triggered because the disease was not manifested with sufficient clarity to allow for a reasonably accurate diagnosis).

105 288 N.E.2d 279, 282 (Ind. Ct. App. 1972).

106 942 F.2d 504, 506 (8th Cir. 1991) (holding that the symptoms for which the plaintiff sought treatment during the relevant time period were the first manifestations of the disease and “under Stamper, therefore, Kirk’s condition was pre-existing”).

107 See id. (stating that the undiagnosed symptoms for which Kirk sought treatment in March stemmed from the disease later diagnosed as bacterial endocarditis, meaning the disease first manifested itself and became active in March).

108 775 F. Supp. 513, 516-17 (D. Conn. 1991) (noting that the plaintiff had received medical advice for symptoms of rectal cancer during the relevant time period although the cancer itself was still undiagnosed).

109 18 F.3d 429, 432 (7th Cir. 1994) (stating that even though the plaintiff did not know that the lump was cancerous, “her visit with the doctor in that month concerning the lump actually concerned cancer. It follows that [the plaintiff] was ‘seen’ and ‘treated’ and incurred medical expenses for her cancer in July" and therefore any “treatment concerning the same condition is not covered.”).

110 See id. at 430.

111 See id.

112 See id. at 432 (holding that the district court reasonably inferred that a lump found to be cancerous at the time of affirmative diagnosis was also cancerous two months previously when plaintiff received “treatment" in the form of a diagnostic exam, therefore affirming the insurance company’s request for summary judgment).

113 33 F.3d 330 (4th Cir. 1994), vacated, reh'g granted, 1994 U.S. App. LEXIS 29089 (4th Cir. Oct. 13, 1994), rev V, 52 F.3d 70 (4th Cir. 1995).

114 The brief filed to petition for an en banc rehearing stressed the national importance of this case to the health insurance reform debate. See Petitioner’s Brief for Rehearing and Suggestion That the Case Be Heard En Banc at 11-12, Hardester, 33 F.3d 330 (No. 94-1172). The petitioner notes that the majority opinion stands for the proposition that health insurers can deny coverage for undetected preexisting conditions. See id. at 4. “The consequences of this opinion are too important to leave a divided panel.” Id. at 12. At the en banc rehearing, the court affirmed the district court’s decision. See Hardester, 52 F.3d at 71.

115 See Hardester, 33 F.3d at 332.

116 See id. Approximately 80-90% of women have this benign condition, but only one-tenth of one percent of women age 40-49 develop breast cancer. See Bullwinkel v. New England Life Mut. Ins. Co., No. 92 C 2528, 1993 U.S. Dist. LEXIS 934, at *2 (N.D. 111. Jan. 29, 1993).

117 See Hardester, 33 F.3d at 331.

118 See id.

119 See id. at 332.

120 See id. at 332-33.

121 Id. at 332.

122 See id at 336.

123 See Hardester v. Lincoln Nat'l Life Ins. Co., 52 F.3d 70, 71 (4th Cir. 1995). Dissenting to the majority of the original Fourth Circuit panel, Judge Hall carefully pointed out that the case was decided “on its own narrow facts" but questioned whether “applying a preexisting condition clause to an undiagnosed condition would violate public policy.” Hardester, 33 F.3d at 339 (Hall, J., dissenting).

124 26 F.3d 264, 269 (1st Cir. 1994).

125 870 F. Supp. 903, 909 (S.D. Ind. 1994).

126 See id. at 914 (noting that the district court dissent in ]Hardester was persuasive).

127 See Negrettc v. Principal Mut. Life Ins. Co., 1995 WL 314711, at *3 (9th Cir. 1995) (holding that plaintiff received treatment for symptoms of undiagnosed cancer during the exclusion period and therefore coverage was properly excluded under the preexisting condition provision); cf. Holman v. Pacific Health & Life Ins. Co., 902 P.2d 106, 109 (Or, Ct. App. 1995) (reversing and remanding the lower court’s judgment notwithstanding the verdict because it was reasonable for the jury to find that a routine breast exam was not treatment for the later diagnosed cancer and therefore the preexisting condition provision did not apply).

128 See Capron, supra note 3, at 686-89.

129 See id. at 692-93 (stating that the “question of insurability is in part a question of employ-ability,” and arguing that the greatest “threat" of modern genetics is not the high tech possibilities but the effects of genetic screening).

130 Paul R. Billings et al., Discrimination as a Consequence of Genetic Testing, 50 Am. J. Hum. Genetics 476, 477 (1992).

131 See Frances H. Miller & Philip A. Huvos, Genetic Blueprints, Employer Cost-Cutting, and the Americans with Disabilities Act, 46 Admin. L. Rev. 369, 377-81 (1994).

132 See id. at 377 (discussing the unresolved issue of whether genetic discrimination in employment is per se unlawful pursuant to the Americans with Disabilities Act); cf. Marne E. Brom, Insurers and Genetic Testing: Shopping for that Perfect Pair of Genes, 40 Drake L. Rev. 121, 133— 36 (1991) (detailing how insurance companies use genetic information to accept insureds, set premium rates and pay out benefits).

133 See Nobles, supra note 35, at 2090 (arguing that it is unfair to allow insurance companies to discriminate based on the random assignment of an individual’s genetic composition). But cf. Richard A. Epstein, The Legal Regulation of Genetic Discrimination: Old Responses to New Technology, 74 B.U. L. Rev. 1, 13 (1994) (arguing that a policy of full disclosure of genetic information to insurance companies should replace the current “don't ask don't tell" policy. This would arguably result in the fairest distribution of burdens and lead to the most efficient mechanism to deal with genetic predispositions.).

134 Obviously, individuals remain at risk for increased premiums and/or flat out denial of insurance, but even if such discrimination is legislatively addressed, the preexisting condition contractual loophole remains. See Cheryl L. Becker, Note, Legal Implications of the G-8 Huntington’s Disease Genetic Marker, 39 Case W. Res. L. Rev. 273, 301-02 (1989) (arguing that insurance companies already assume the risk of a person developing a future disease, and therefore insurance companies should not be allowed to deny coverage simply because technology allows identification of afflicted individuals).

135 See Elcy v. Boeing Co., 945 F.2d 276, 279 (9th Cir. 1991) (concluding that a routine PAP smear is a diagnostic procedure for purposes of satisfying a preexisting condition exclusion even if the results were delivered after the relevant time period had elapsed).

136 See Miller, supra note 4, at 744 (questioning whether insurance companies may be able “to use genetic test results made long after coverage had begun to exclude benefits for disorders that were discovered at a later time”).

137 See Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, 110 Stat. 1936, 1961 (codified at 42 U.S.C. §§ 300gg to gg-92 (Supp. 1996)).

138 See 42 U.S.C.A. § 300gg.

139 See id. § 300gg(b)(1)(A). Because this new law amends ERISA, only those health plans governed by ERISA will be affected. See Health Insurance Portability and Accountability Act of 1996 § 101, 110 Stat. at 1939. All other health plans will continue to be guided by state statutory and case law. See 42 U.S.C. § 300gg.

140 42 U.S.C. §300gg(a).

141 See id.

142 Id.

143 See id.

144 See id. § 300gg(b)(1)(B).

145 See supra text accompanying note 88.

146 The above analysis changes each time a change in our health care delivery system occurs. In spite of the failure to enact national health care reform, the system is evolving at a rapid pace. As Professor George Annas points out, the shift from fee-for-service reimbursement to capitation may “slow the proliferation of new ‘diseases’ and new interventions to address them, and thus the cost of care.” Annas, supra note 14, at 1029.

Under a fee-for-service reimbursement system, insurance companies retroactively pay for any treatment or service the physician rendered which was, in her judgment, medically necessary. The economic incentives under this type of system arguably results in overutilization of services and development of new diseases and treatments. In a capitation system, physicians are given a lump sum for a particular period of time for a defined set of patients. See Miller, Frances H., Foreword: The Promise and Problems of Capitation, 22 Asm J.L. & Med. 167, 167 (1996)Google Scholar. The physician must decide how to allocate and utilize the resources. See id. The capitation system provides incentives to limit ovcrutilization of health care services and procedures because extra tests, procedures and treatments do not generate extra revenue for the physician. See Latham, Stephen R., 22 Am. J.L. & Med. 399, 409-11 (1996)Google Scholar. In this sense, a physician may be less likely to conclude that a genetic risk is a disease requiring prophylactic treatment, because she suffers marginal loss from the extra care. However, it is unlikely that the problem will disappear entirely, because while reimbursement mechanisms may affect physician behavior, they should not control a physician’s clinical judgment. Presumably, a physician will still be held to the established standard of care in a malpractice suit regardless of reimbursement incentives. See id. at 412.

147 Note that family history plus gene linkage results in a 95% accurate diagnosis of an 85% risk. See Deposition of Dr. Lynch at 17, Katskee, 515 N.W.2d 645 (Neb. 1994) (No. 894-336); Angier, supra note 20, at Al.

148 See Deposition of Dr. Lynch at 18, 47, Katskee (No. 894-336). Dr. Lynch states that he is giving an overly simplistic view “of [a] complicated area" to which a lawyer replies, “ I appreciate that, because you would probably lose me in three or four seconds if you got into it real deep.” Id. at 18. Later the lawyer admitted that while reading the articles on genetic linkage in site-specific types of cancer he “felt like [he] was beating [his] head against the wall . . . .” Id. at 47. He further stated, “1 was sitting there with Dorland’s, 1 mean every time 1 found something I would have to flip to Dorland’s to figure out what I was reading.” Id.

149 Of course, a contractual response from health insurance companies is probable. See Anderson, Gerard F. et al., Medical Technology Assessment and Practice Guidelines: Their Day in Court, 83 Am. J. Pub. Health 1635, 1637 (1993)CrossRefGoogle ScholarPubMed (suggesting potential strategics for limiting judicial involvement in policy decisions about insurance coverage by careful contract drafting or the adoption of external guidelines on technology assessment by the courts). If insurance contracts explicitly specify that genetic risk and/or genetic predisposition based on a deleterious gene does not constitute a disease, then courts will be hard pressed to require coverage for prophylactic treatments. See id.; see also Thomas E. Johnson, How to Draft a Defensible Expcrimental/Investigational Exclusion, Address Before the Group Health Association of America, Fifth Annual Managed Care Law Conference, LaQuinta, Cal. (Sept. 8-10, 1993) (offering strategics on how carefully to construct a health insurance contract to avoid ambiguities in the terms medically necessary and experimental). I would urge insurance companies to adopt a similar formula of covering prophylactic treatments for individuals with a genetic defect who have a current risk of greater than Fifty percent.