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Cost Containment and Reproductive Autonomy: Prenatal Genetic Screening and the American Health Security Act of 1993

Published online by Cambridge University Press:  24 February 2021

David T. Morris
David T. Morris*
Affiliation:
University of California, Berkeley; Boston University School of Law
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Extract

Prenatal genetic diagnosis represents one of the most important recent advances in the field of clinical genetics. Each year in the United States, a significant number of children are born with some type of hereditary genetic defect that can be diagnosed in utero. Of the over 4000 genetic traits which have been distinguished to date, more than 300 are identifiable via prenatal genetic testing. With increasing frequency, various diagnostic procedures are being used to evaluate the probability that a fetus will be born with a serious physical or mental handicap caused by a genetic abnormality. These procedures identify disabling or potentially fatal genetic disorders, including cystic fibrosis, trisomy 21 (Down syndrome), P-Thalassemia, and neural tube defects (NTDs).

Prenatal diagnosis may be achieved by utilizing one or more techniques from three basic methods of testing. The most commonly performed means, amniocentesis, is a procedure in which a small sample of the fluid surrounding the developing fetus is extracted from the amniotic sac.

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Notes and Comments
Information
American Journal of Law & Medicine , Volume 20 , Issue 3 , 1994 , pp. 295 - 316
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1994

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References

1 In utero literally means “within the womb.” Stedman's Medical Dictionary 798 (25th ed. 1990). Approximately 20,000 infants are born with some sort of chromosomal abnormality every year in the United States. Aubrey Milunsky, Prenatal Genetic Diagnosis and the Law, in Genetics and the Law II 61, 67 (Aubrey Milunsky & George J. Annas eds., 1980). Cf. California Study Offers First Complete Estimate of Lifelong Birth Defect Costs, 2 Health Care Pol'y Rep. (BNA) 1555 (August 29, 1994) (estimating that in California alone, approximately 17,000 of the 600,000 babies delivered every year (one in every thirty-three) are born with some sort of structural defect).

2 Mary Sue Henifin et al., Prenatal Screening, in Reproductive Laws for the 1990s 155, 158 (Sherrill Cohen & Nadine Taub eds., 1989). For a brief, but informative overview of recent progress in human genetic research see Antonarakis, Stylianos E., Diagnosis of Genetic Disorders at the DNA Level, 320 New Eng. J. Med. 153 (1989)Google Scholar.

3 Cystic fibrosis (CF) is an autosomal recessive genetic disorder most prevalent among Caucasians of European descent. Garber, Alan M. & Fenerty, Joseph P., Costs and Benefits of Prenatal Screening for Cystic Fibrosis, 29 Med. Care 473, 473 (1991)Google Scholar. Autosomal recessive means that a copy of the gene which causes the disease must be inherited from each parent. As a result, one out of every four children born to parents who are both carriers of the CF gene will have the disease. Id. Cystic fibrosis is characterized by chronic obstructive pulmonary disease and pancreatic insufficiency and usually results in death before the age thirty. Id See also Mary Alice, Donati et al., Prospective Controlled Study of Home and Hospital Therapy of Cystic Fibrosis Cardiopulmonary Disease, 111 J. Pediatr. 28 (1987)Google Scholar; M.C. Goodchild & J.A. Dodge, Cystic Fibrosis: Manual of Diagnosis and Management (2nd Ed. 1985). The incidence of Cystic Fibrosis has been estimated to be between one in 1700 to one in 2,500 live births. Wilfond, Benjamin S. & Norman, Fost, The Introduction of Cystic Fibrosis Carrier Screening into Clinical Practice: Policy Considerations, 70 Milbank Q, 629, 631 (1992)Google Scholar.

4 Trisomy-21, commonly referred to as Down syndrome, the most common cause of moderate to severe mental retardation, occurs with an estimated frequency of once in every 750 live births. The second most common form, X-linked mental retardation, is estimated to occur once in every 1,500 live births. See Hall, Judith G., Medical Genetics, 254 JAMA 2296, 2297 (1985)Google Scholar.

5 [β-Thalassemia, one of the most predominant inherited lethal diseases in the world, is characterized by deficient production of normal hemoglobin. Scriver, Charles R. et al., β-Thalassemia Disease Prevention: Genetic Medicine Applied, 36 Am. J. Hum. Genetics 1024, 1025 (1984)Google Scholar. The disease leads to impaired development, infertility, and reduced longevity. Id. [β-Thalassemia is prevalent among persons of Mediterranean origin. See Schmidt's Attorney's Dictionary of Medicine T-58 (1994).

6 Neural tube defects (NTDs) include disorders such as anencephaly and spina bifida. Anencephaly is a condition in which the affected child is born without flat bones in the cranium and without part or all of the cerebrum and cerebellum. Schmidt's Attorney's Dictionary Of Medicine A-237 (1994). Spina bifida is marked by a defect in the development of the spinal column which leaves part of the spinal canal exposed. Id at S-l 69. NTDs occur in one of every 590 live births. Rowley, Peter T., Genetic Screening: Marvel or Menace, 225 SCIENCE 138, 140 (1984)Google Scholar.

7 See generally, Committee on Genetics, American Academy of Pediatrics, Prenatal Diagnosis for Pediatricians, 84 Pediatrics 741 (1989) [hereinafter Committee on Genetics]. The three techniques are fetal tissue sampling, maternal alpha-fetoprotein sampling, and fetal visualization. Only the first two techniques involve genetic diagnosis. The third, commonly performed by means of ultrasound, merely allows visualization of anatomic abnormalities. Id.

8 See Ann Tabor et al., Randomised Controlled Trial of Genetic Amniocentesis in 4606 Lew-risk Women, Lancet, June 7, 1986, at 1287; Hanson, F.W. et al., Amniocentesis before 15 Weeks’ Gestation: Outcome, Risks, and Technical Problems, 156 J. Obstet. Gynecol., 1524 (1986)Google Scholar.

9 Committee on Genetics, supra note 7, at 741. Under the current standards of medical practice, fetal tissue sampling is medically indicated for women of advanced maternal age (35 years of age or older), when a chromosomal abnormality is know to exist in either parent, or where either parent has a family history of genetic abnormalities. Id. Amniocentesis is most commonly offered to women who are 35 years of age or older. It is at this age that the risk of giving birth to an infant with a genetic abnormality is greater than that of suffering a miscarriage due to the procedure. Esther B. Fein, Fetal Test Focuses the Health-Care Debate, N.Y. Times, Feb. 5, 1994, at Al. However, an increasing number of younger women, concerned about the emotional and financial costs of bearing a genetically disabled child, are requesting amniocentesis during pregnancy. Id. at A24.

10 Committee on Genetics, supra note 7, at 742.

11 Chorionic Villus Sampling: A Reassessment, 263 JAMA 305, 305 (Helene M. Cole ed., 1990).

12 Committee on Genetics, supra note 7, at 742.

13 Id.

14 Id.

15 Chorionic Villus Sampling: A Reassessment, supra note 11, at 305.

16 Id.

17 See generally, Committee on Genetics, American Academy of Pediatrics, Alpha-fetoprotein Screening, 80 Pediatrics 444 (1987) [hereinafter Alpha-fetoprotein Screening].

18 Alpha-fetoprotein is a type of fetal protein found normally in the amniotic fluid and abnormally in the bloodstream of the mother. Stedman's Medical Dictionary, supra note 1, at 573.

19 Alpha-fetoprotein Screening, supra note 17, at 444.

20 Committee on Genetics, supra note 7, at 741. The usefulness of alpha-fetoprotein sampling is underscored by the fact that nine out of ten neural tube defects occur in families without any prior history of such disease. See Robert Steinbrook, Birth Defects Screening Plan Outlined by State; Voluntary Program Offers Blood Tests to Detect Malformed Fetuses, Includes Advice for Mothers, L.A. Times, Dec. 21, 1985, at Al. Furthermore, neural tube defects cannot be diagnosed prenatally by CVS. Hall, supra note 4, at 2296.

21 “For every 1,000 women screened, 50 will show an abnormally high reading, although only one of those women is likely to be carrying an affected fetus.” Henifin et al., supra note 2, at 163. The follow-up tests may include amniocentesis, CVS, or ultrasound. Committee on Genetics, supra note 7, at 741. See also Sherman Elias et al., Carrier Screening for Cystic Fibrosis: A Case Study in Setting Standards of Medical Malpractice, in Gene Mapping: Using Law and Ethics as Guides, 186, 195-96 (George J. Annas & Sherman Elias eds., 1992).

22 Motulsky, Arno G., Governmental Responsibilities in Genetic Disease, in Genetics and the Law II, supra note 1, at 237, 239Google Scholar.

23 Meaney, F. John & Chang, Susan P., Incorporation of Clinical Genetic Services into the Public Health Arena: Educational Strategies, in 28 Birth Defects: Original Article Series 82Google Scholar (Anver Kuliev et al. eds., 1992). See also Milunsky, supra note 1, at 62 (concluding that in 1978, fewer than 10% of women for whom amniocentesis was medically indicated because of advanced maternal age had undergone the procedure for prenatal chromosomal analysis).

24 Milunsky, supra note 1, at 83.

25 Pub. L. No. 94-278, 90 Stat. 407 (1976). The primary objective of the National Genetic Disease Act was to deliver genetic disease information and to provide education, testing, counseling services, and medical referral for all persons who were suspected of having or transmitting a genetic disorder. Federal funds made available under the Act allowed 43 states to establish genetic screening programs, most of which now face the continual threat of even further budget reductions. See Meaney & Chang, supra note 23, at 82.

26 Jo Merrill, Genetic Services, Research, and Insurance: Tracing the Legislative History, in 28 Birth Defects: Original Article Series, supra note 23, at 163, 164. Even before the Act was repealed, it was criticized as being insufficient to accommodate the genetic health care needs of the country. Such criticism centered on the apparent misallocation of funds to states, which, unlike the large academic medical centers where most genetic screening and testing were conducted, lacked the necessary expertise to efficiently provide genetic services to the general population. See Motulsky, supra note 22, at 243.

27 King, Patricia A., The Past as Prologue: Race, Class, and Gene Discrimination, in Gene Mapping: Using Law and Ethics as Guides, supra note 21, at 94, 103Google Scholar; Motulsky, supra note 22, at 241; Milunsky, supra note 1, at 67.

28 Uninsured Figure Exceeds 38 Million, Small Firms Lead Decline, EBRI Reports, 1 Health Care Pol'y Rep. (BNA) 1773 (Dec. 20, 1993). See also Pyeritz, Reed E., Common Themes Among Different Types of Insurance, in 26 Birth Defects: Original Article Series 121, 124Google Scholar (Natalie Paul et al. eds., 1989) Twelve million of these uninsured persons are women of working age. Poll Shows Support for Abortion Coverage, 2 Health Care Pol'y Rep. (BNA) 52 (May 12, 1994) [hereinafter Abortion Coverage].

29 The Employee Benefit Research Institute (EBRI) reported regional variances as low as 8.1% in Hawaii (a state with its own universal health care system) and as high as 25.5% in the West South Central Region of the country. Uninsured Figure Exceeds 38 Million, Small Firms Lead Decline, EBRI Reports, supra note 28, at 1773.

30 Pyeritz, supra note 28, at 123.

31 H.R. 3600, 103d Cong., 1st Sess. (1993).

32 Among the those bills receiving a considerable amount of attention are H.R. 3222, 103d Cong., 1st Sess. (1993) (a less regulatory managed competition plan introduced by Rep. James Cooper); H.R. 3704, 103d Cong., 1st Sess. (1993) and its counterpart S. 1770, 103d Cong., 1st Sess. (1993) (introduced by Rep. Bill Thomas, and Sen. John Chafee, respectively); H.R. 1200, 103d Cong., 1st Sess. (1993) (a single payor reform package introduced by Rep. Jim McDermott); and S. 2560, 103d Cong., 2d Sess. (1994) (introduced by Sen. George Mitchell).

33 H.R. 3704, 103d Cong., 1st Sess. (1993).

34 S. 2560, 103d Cong., 2d Sess. (1994).

35 As of the time this Note went to press, efforts to pass reform legislation of any type before the end of the legislative year had failed. See Mitchell Abandons Health Reform For This Year; Blames Republicans, 1 Health Care Pol'y Rep. (BNA) 1683 (Oct. 10, 1994) (acknowledging the “bittersweet ending of the health care debate,” but suggesting that comprehensive health care reform is certain to be enacted next year).

36 Clinton Administration Description of President's Health Care Reform Plan, “American Health Security Act of 1993”, 176 Daily Lab. Rep. (BNA) D-37 (Special Supp. Sept. 14, 1993) [hereinafter Administration Description﹜.

37 H.R. 3600, § 3(1). See also H.R. 3704, §§ 1001, 1501; S. 2560, § 1002.

38 H.R. 3600, §3(3).

39 Id § 3(4). See also S. 2560, § 1003. H.R. 3704 does not appear to include any explicit provision respecting individual choice.

40 H.R. 3600, § 3(5). See also H.R. 3704, §§ 1119, 3001-7; S. 2560, §§ 1122, 5001-13.

41 Administration Description, supra note 36, at 5. Rep. Mitchell's proposal protects choice to the extent that it does not preclude a consumer from “purchasing any health care services” or from “obtaining (at the expense of the individual) health care from any health care provider of such individual's choice.” S. 2560, § 1003(1),(5) (emphasis added).

42 See, e.g., Robertson, John A., Procreative Liberty and Human Genetics, 39 EMORY LJ. 697 (1990)Google Scholar.

43 This Note uses the terms “individual” and “woman” interchangeably in an attempt to recognize that reproductive decision-making, while ultimately the domain of the woman, may also involve a partner or spouse.

44 Although a significant number of Americans are opposed to abortion, “overwhelming majorities” believe it should be available in cases of severe genetic abnormality. Annas, George J., The Supreme Court, Privacy, and Abortion, 321 New Eng. J. Med. 1200, 1200 (1989)Google Scholar. See also Rowley, supra note 6, at 140 (“Many parents who find abortion unacceptable in other circumstances do choose to terminate a pregnancy in which the fetus is proved to have a serious birth defect“).

45 These costs can be overwhelming. See infra notes 52-55 and accompanying text.

46 Rowley, supra note 6, at 140.

47 For example, Hasidic Jews, who share a high risk of bearing a child with Tay-Sachs, a particularly painful and crippling disease which usually results in an early death, have embraced genetic screening and prenatal diagnostic testing. See Gina Kolata, Nightmare or Dream of a New Era in Genetics*, N.Y. Times, Dec. 7, 1993, at Al. See also Scriver et al., supra note 5, at 1031 (100% of recessive carriers in [β-thalassemia study indicated that they would not have another pregnancy in absence of prenatal diagnosis).

48 Rowley, supra note 6, at 143.

49 Scriver et al., supra note 5, at 1034.

50 See Rowley, supra note 6, at 140. Use of the term “pro-life” is not intended to imply that prenatal genetic screening is widely accepted by individuals who oppose abortion. However, it does suggest that even among people who oppose abortion, diagnostic screening may lend such reassurances as will allow risk-averse people to procreate with less apprehension of the feared consequences.

51 See H.R. 3600, 103d Cong., 1st Sess. §§ 2(2) (F), 3(3) (1993). The Clinton reform package has been simply described as “managed competition within a global budget.” Clinton Unveils Reform Plan Tofoint Session of Congress, 1 Health Care Pol'y Rep. (BNA) S-3, S-3 (Special Supp. Sept. 27, 1993). The centerpiece of the plan is the development of state-based health insurance purchasing cooperatives known as regional alliances. These alliances are expected to promote competition among insurers and providers of care by negotiating premiums and contracting with health plans on behalf of large groups of consumers. Id. It is expected that increased competition will lead most health plans to operate under some form of managed care arrangement. Id. See also infra note 63 for a brief discussion of managed care. In the event that competition does not serve to slow the growing rate of health care costs, the plan provides for a national health care budget which limits average premium increases to a figure corresponding with the overall rate of inflation. Clinton Unveils Reform Plan To Joint Session of Congress, supra, at S-3, S-5. In addition, budget targets developed by a national health board are established for each regional purchasing cooperative. Id.

52 Colten, Harvey R., Screening for Cystic Fibrosis: Public Policy and Personal Choices, 322 New Eng. J. Med. 328 (1990)Google Scholar. See also Edward R.B. McCabe et al., A Study of Medical Costs Associated With Selected Genetic Disorders in Texas, in 26 Birth Defects: Original Article Series 132 (Natalie Paul et al. eds., 1990) (noting that patients with selected genetic diseases found to show high ratio of payment per Medicaid claim).

53 Colten, supra note 52, at 328.

54 Steinbrook, supra note 20, at A39.

55 Milunsky, supra note 1, at 67. Assuming that 5,000 children are afflicted with Down syndrome each year, society can expect to spend over five billion dollars each year for their care. Id.

56 Fein, supra note 9, at Al. Similarly, the costs of undergoing CVS and CF testing are approximately $1200. Wilfond & Fost, supra note 3, at 642. A single alpha-fetoprotein sampling costs approximately $40. Steinbrook, supra note 20, at Al.

57 See generally Garber & Fenerty, supra note 3, at 473; Chappie, J.C. et al., The New Genetics: Will it Pay Its Way?, LANCET, May 23, 1987, at 1189Google Scholar; Scriver et al., supra note 5, at 1024.

58 See President's Commission For the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Screening and Counseling For Genetic Conditions: A Report on the Ethical, Social, and Legal Implications of Genetic Screening, Counseung, and Education Programs at 84 (1983) [Hereinafter President's Commission].

59 Id. at 8.

60 Id. at 85.

61 The degree to which personal autonomy is suppressed by such a cost-conscious approach is suggested by possible methods of measuring the program's quality or effectiveness. It is by no means inconceivable that such programs might measure success by the number of terminations effected. See Chadwick, Ruth F., What Counts as Success in Genetic Counseling?, 19 J. Med. Ethics 43 (1993)Google Scholar.

62 Administration Description, supra note 36, at 67.

63 See Eddy, David M. et al., Three Battles to Watch in the 1990s, 270 JAMA 520, 520 (1993)Google Scholar (“The changes in structures and incentives that are being proposed … are designed to create incentives to force health plan administrators, medical directors, and practitioners to solve the cost problem.“) Indeed, this is the crux of the debate over the utility of managed care. Managed care represents an effort to integrate the financing and delivery of medical care in such a fashion as to reduce utilization and costs. Iglehart, John K., The American Health Care System: Managed Care, 327 New Eng. J. Med. 742, 742 (1992)Google Scholar. Under the typical managed care plan, an insurer, usually an HMO, agrees to provide or arrange for the provision of a comprehensive set of health care services to a defined patient population for a predetermined annual or monthly premium. Id. The existence of a prepaid premium places the insurer at financial risk of losing money should the cost of providing care to that population exceed the fee payments. In an effort to avoid such uncertainty, managed care plans will usually shift the financial risk on the individual who is best able to avoid the risk—the provider. See id. By enforcing utilization and quality control measures in conjunction with capitated payment schedules, managed care entities provide explicit incentives for physicians to limit costly medical services. Id. See also Hillman, Alan L. et al., How Do Financial Incentives Affect Physicians’ Clinical Decisions and the Financial Performance of Health Maintenance Organizations?, 321 New Eng. J. Med. 86 (1989)Google Scholar; Levinson, Douglas F., Toward Full Disclosure of Referral Restrictions and Financial Incentives by Prepaid Health Plans, 317 New Eng. J. Med. 1729 (1987)Google Scholar; Robert A. Berenson, In a Doctor's Wallet: Financial Confessions of a Sawbones, New Republic, May 18, 1987, at 11. Cf Morreim, E. Haavi, Redefining Quality by Reassigning Responsibility, 20 AM. J. L. & Med. 79 (1994)Google Scholar (suggesting that patients must actively participate in making cost-value tradeoffs in a changing health care environment).

64 See generally, Eddy et al., supra note 63, at 520 (suggesting that current forces in health care reform will increase provider control over decisions regarding patients’ treatment). The control exerted by providers under such circumstances may take the form of explicit directives to patients, or it may manifest itself in the type or quality of information the provider makes available to the patient in an effort to obtain informed consent. See discussion infra part IV.

65 See generally H.R. 3600, 103d Cong., 1st Sess., Title III (proposing funding for a series of public health initiatives design to promote health and disease prevention).

66 Under the reform legislation, new funding for health research is channelled to “provid[e] foundations for prevention efforts across a range of diseases and disorders … encompassing genetics.” Administration Description, supra note 36, at 68. See H.R 3600, supra note 65, at § 3311 (outlining the core functions of public health programs to be funded under the Act). In addition, “priority areas for prevention research” under the Act encompass child and reproductive health, “including birth defects.” Id at § 3201(2).

The Mitchell reform package also introduces national initiatives focusing on preventive health. See S. 2560, 103d Cong., 1st Sess. § 3311 (1993). The plan makes special grant money available for specific programs administered by the Centers for Disease Control and Prevention, including the Preventive Health Services Block Grant under section 1903 of the Public Health Service Act, and the birth defects data program under section 317C of the Public Health Service Act. S. 2560, § 3318(b)(1),(9). While the Thomas plan does not specifically earmark funds for prevention-oriented research programs, the bill does emphasize preventive care as it relates to maternal and infant care coordination. H.R. 3704, § 5201.

67 Rowley, supra note 6, at 140; see also Wilfond & Fost, supra note 3, at 629.

68 Hall, supra note 4, at 2296.

69 Rowley, supra note 6, at 140; Wilfond & Fost, supra note 3, at 629; Raeburn, J.A., Delivery of Genetic Screening Services, in 28 Birth Defects: Original Article SeriesGoogle Scholar, supra note 23, at 60, 62. Cf. Scriver et al., supra note 5, at 1024; Garber & Fenerty, supra note 3, at 473.

70 In fact, the Human Genome Project, the source of most recent information regarding human genetics, has been primarily justified on the grounds that it will provide the knowledge and skill necessary to eliminate or prevent genetic disease. See Proctor, Robert N., Genomics and Eugenics: How Fair is the Comparison?, in Gene Mapping: Using Law and Ethics as Guides, supra note 21, at 57, 58Google Scholar. The project, formally initiated by the U.S. Department of Energy and the Department of Health and Human Services in 1990, is designed to last fifteen years at a cost of over $3 billion. Id at 57.

71 Cf. President's Commission, supra note 58, at 1 (finding “that advances in genetics have greatly enhanced health and well-being“). But see, Henifin et al., supra, note 2, at 158 n.12. (suggesting that because many genetic diseases are recessive in character, it would be medically and financially impossible to screen for all carriers of genetic diseases).

72 Abby, Lippman, Prenatal Genetic Testing and Screening: Constructing Needs and Reinforcing Inequities, 17 AM. J.L. & MED. 15, 22 (1991)Google Scholar. Lippman characterizes arguments based on the technology's ability to prevent genetic illness as belonging to the “public health” model, and those emphasizing the expansion of reproductive choices as belonging to the “reproductive autonomy” model. Id

73 Henifin et al., supra note 2, at 156. At least one commentator believes the likelihood that such “prenatal cures” will be developed is diminished under a model which promotes prevention and elimination of genetic disease. See Lippman, supra note 72, at 23 n.40.

74 A recent analysis of over one hundred public opinion surveys concerning abortion conducted over the past thirty years indicates that Americans are evenly divided over the question whether abortion is morally wrong. Blendon, Robert J. et al., The Public Controversy Over Abortion, 270 JAMA 2871, 2873 (1993)Google Scholar. Notwithstanding their moral views on abortion, a majority of Americans favor legalized abortion under certain circumstances, particularly when there is a “strong chance of serious defects in the baby.” Id. at 2872. Even more importantly for the present discussion, 78% of Americans believe that the decision to have an abortion is “a choice to be made only by the woman herself,” and should not be interfered with by the government. Id.

75 These may be concerns specific to a woman's financial situation, career goals, or personal or family relationships. See Adrienne, Asch, Reproductive Technology and Disability, in Reproductive Laws for the 1990s, supra note 2, at 69, 82Google Scholar (“What differentiates abortion after prenatal diagnosis (and abortion for sex selection) from all other abortions is that the abortion is a response to the characteristics of the fetus and would-be child and not to the situation of the woman.“).

76 Pub. L. 97-377, § 204, 96 Stat. 1884, 1894 (1982).

77 The courts, of course, have not found that such financial limitations place an undue restriction on a woman's right to have an abortion. See Beal v. Doe, 432 U.S. 438 (1977) (holding that Title XIX of the Social Security Act does not require states to fund nontheraputic abortions as a precondition to receiving funds in a joint federal-state medical assistance program); Maher v. Roe, 432 U.S. 464 (1977) (holding that refusal of state to pay for nontheraputic abortions does not violate equal protection clause even where Medicaid support is provided to cover the expenses of childbirth). The Hyde Amendment has been said to place no obstacle in the path of a woman who desires to terminate her pregnancy, but rather, “by means of unequal subsidization of abortion and other medical services, encourages alternative activity deemed in the public interest.” Harris v. McRea, 448 U.S. 297, 315 (1980) (emphasis added). The impact of this sort of reasoning as it relates to the issue of autonomy is addressed infra part III.b.

78 For an interesting discussion regarding the ambiguity inherent in genetic screening, see Proctor, supra note 70, at 75-81 (criticizing biological determinism—the view that human abilities and disabilities are grounded solely in our genes).

79 Wilfond & Fost, supra note 3, at 631; see also Colten, supra note 52, at 328. (” [O] ne third of the more than 15,000 patients listed in the registry of the North American National Cystic Fibrosis Foundation are older than 21 years.“).

80 It is interesting to note that diagnostic ambiguity results not only from an inability to determine what the eventual outcome of a particular genetic anomaly may be, but also the fact that the severity of some diseases (i.e., cancer) to which some people have a genetic predisposition may vary according to external factors such as occupation, diet, and socioeconomic status. See Proctor, supra note 70, at 75-81.

81 See generally, Asch, supra note 75.

82 Caplan, Arthur L., If Gene Therapy Is the Cure, What Is the Disease?, in Gene Mapping: Usinc Law and Ethics as Guides, supra note 15, at 128, 136Google Scholar; see also Asch, supra note 75, at 73-74; Motulsky, Arno G., Impact of Genetic Manipulation on Society and Medicine, 219 Science 135, 136 (1983)Google Scholar (“[The] characteristic of human genetic traits as beneficial or harmful depends entirely on the [social] environment in which the trait or traits operate.“).

83 A National Institute of Health group has warned that the opportunities provided by genetic screening “ ‘could open doors to psychological anguish, stigmatization, and discrimination’ for people who carry diseased genes.” Proctor, supra note 70, at 59. Given the fact that access to genetic screening services has been limited to white, middle class individuals (see sources cited supra note 18), “[t]he ‘biologic underclass’ may turn out to be composed of minority groups and the poor.” King, supra note 27, at 100. Thus, it is not entirely unreasonable to believe that any societal intolerance for those with genetic disease will be directed primarily at these groups.

84 Asch, supra note 75, at 74.

85 This is so for two reasons. First, it is medically and financially unfeasible to screen for all carriers of recessive genetic disease. Second, even if such screening programs were feasible, many genetic mutations are caused by environmental factors which may not be detected through parental screening programs. See also, Steinbrook, supra note 20, at A39.

86 Asch, supra note 75, at 70.

87 President's Commission, supra note 58, at 7.

88 See, e.g., Proctor, supra note 70, at 68-70. “Access to medical services in the United States is already profoundly unequal; one can imagine a situation where the well-to-do avail themselves of genetic services while the poor suffer the burden of genetic disease untreated.” Id. at 69-70; see also sources cited supra note 18.

89 King, supra note 27, at 107.

90 Although the discussion which follows applies to all individuals, many of the issues involved are of particular importance to women whose access to health care will, due to their own financial limitations, be wholly defined by the minimum benefits package. Women with higher incomes will be able to purchase additional insurance to cover those health care needs which are not provided for within the basic benefit package. See H.R. 3600, § 1003; S. 2560, § 1003; H.R. 3704, § 1113(c). The importance of this distinction is particularly significant with respect to funding for abortion. See infra part III.B.

91 Henifin et al., supra note 2, at 156.

92 Pyeritz, supra note 28, at 124. A recent background paper released by the Office of Technology Assessment indicated that “health insurers rarely reimburse individuals for [cystic fibrosis] carrier tests in the absence of a family history,” notwithstanding the fact that 80% of newborns diagnosed with CF are born to parents with no prior family history of the disease. Consumers Have Difficulties Obtaining or Retaining Health Insurance After Genetic Tests—OTA Survey, F-T-C Reports, the Blue Sheet, Oct. 14, 1992, at 8.

93 This might be particularly distressing to parents with reason to believe they are at risk of bearing a child with a hereditary defect. See supra notes 32-34, and accompanying text. In fact, a task force sponsored by the Human Genome Project's Ethical, Legal, and Social Issues (ELSI) program specifically noted that “the existence of genetic risk information in medical records can also make it more difficult for both individuals and their relatives to acquire the health care financing and services they need…. [A]s new genetic risk factors are described, the number of people caught in this dilemma could eventually reach a substantial proportion of the population, leading to an even more severe American health care crisis.” Genetic Data Should Not Be Used to Determine Cost of Basic Health Care Package—ELSI Task Force, F-T-C Reports, the Blue Sheet, Feb. 10, 1993, at 4 [hereinafterELSI Task Force].

94 See discussion supra notes 62-64 and accompanying text.

95 See Wilfond & Fost, supra note 3, at 639; Jecker, Nancy S., Genetic Testing and the Social Responsibility of Private Health Insurance Companies, 21 J. Law Med. & Ethics 109, 110 (1993)Google Scholar (“One preliminary study of genetic discrimination revealed several cases in which HMOs considered withdrawal of or limitations on health care coverage for pregnancy, post partum and pediatric care for children diagnosed prenatally with a genetic disease“); ELSI Task Force, supra note 93, at 4 (estimating the number of cases of genetic discrimination to be upwards of 10,000, the majority of which “involve incidents related to insurance matters“). Cf Colten, supra note 52, at 329 (development of screening programs carry economic risk that “managed health care systems and insurance companies [may not] cover the costs of caring for children with cystic fibrosis who are born to known carriers“); Pyeritz, supra note 28, at 124 (“Prospective subscribers to HMOs need to be certain that the needs of genetically affected individuals will be attended to satisfactorily before signing a contract.“).

96 Motulsky, supra note 22, at 238.

97 See Pyeritz, supra note 28, at 124-26 (summarizing some of the problems individuals with a genetic disease have in obtaining health care insurance that covers their condition).

98 In fact, a parent may have to consider that she will one day be forced to renounce financial responsibility for her child so that the child may meet the poverty guidelines for state assistance eligibility. See Pyeritz, supra note 28, at 125.

99 Genome Information Task Force Says No One Should Be Denied Insurance, Biotechnology Newswatch, June 7, 1993, at 10.

100 The Act classifies the services to be covered under the comprehensive benefit package. Coverage for prenatal genetic screening programs could theoretically fall within “Clinical Preventive Services,” “Family Planning Services and Services for Pregnant Women,” or “Outpatient Laboratory, Radiology, and Diagnostic Services.” See H.R.3600, §§ 1114, 1116, 1121.

101 Presumably, legislators are hesitant to involve themselves in a national debate over the content of the benefits package to be provided under each bill. Such a debate would likely be highly charged and politically dangerous, and would tend to distract from the overall goal of national reform.

102 See H.R. 3600, §§ 1501-1506 (providing for the creation of the National Health Board and generally outlining its membership, responsibilities, and powers). The Board, which acts under the supervision of the Executive Branch, is also responsible for developing standards relating to the eligibility of individuals for coverage and methodologies for the risk-adjustment of premium payments, and for overseeing the cost containment provisions of the Act. Id. §§ 1501, 1503. With respect to clinical preventive services, the Board is responsible not only for defining the content of such services, but also for defining “high risk populations” which are entitled to such services. Id §§ 1114, 1153. Board members are selected by the President “on the basis of their expertise in relevant subjects.” Id. § 1502(b).

Under the Mitchell reform plan, the entity responsible for undertaking this task is known as the “National Health Benefits Board.” SeeS. 2560, § 1211-17. The Health Benefits Board is given specific power under the bill to “promulgate such regulations or establish such guidelines as may be necessary to clarify and refine the items and services” described in the standard benefits package. Id. § 1213(a) (1). The composition of the Health Benefits Board is virtually identical to its counterpart under the Clinton reform bill. See id, § 1211(b).

The Thomas plan provides for the creation of a “Benefits Commission.” See H.R. 3704, §§ 1311-15. The Commission is responsible for submitting to Congress, within six months from the date of the bill's enactment, a proposal for legislation which clarifies the items and services provided under the Standard and Catastrophic Benefits packages. Id § 1312(a)(1). In its proposed legislation the Commission may not specify particular procedures or treatments which are to be provided. Id § 1312(a)(1)(C). However, it may eliminate any category of items or services which are proposed within the Thomas reform bill. Id § 1312(a)(1)(A).

As their responsibilities suggest, each of these entities wields significant power in determining who is entitled to what type of care.

103 “This pattern can be repeated, with the responsibility for developing specific criteria being passed to states, to insurance purchasing cooperatives, or to health plans themselves.” Eddy et al., supra note 63, at 524

104 See generally Fein, supra note 9 (noting that many women “are challenging the notion that the emotional and financial costs of having to raise a seriously disabled child are in any way comparable to the costs of losing a pregnancy“).

105 Of course, the economic costs of screening all pregnant women for all imaginable genetic defects would, in all likelihood, militate against such a policy choice. For the purposes of the present discussion, however, the impact on autonomy would be equally severe if mandatory screening was required only of those women who are at risk due to advanced maternal age or a family history of genetic abnormality.

106 Administration Description, supra note 36, at 11 (emphasis added).

107 The possible justifications for a woman's choice to submit to the procedures involved in obtaining a prenatal diagnosis are many and varied. These may include concern about advanced maternal age, a family history of genetic anomalies, or the simple need to be reassured during pregnancy. Acceptance of prenatal screening among younger women, as noted supra note 8, is most concentrated among educated, professional women “whose lives revolve around control and information,” though the trend is visible among women of all socio-economic classes. Fein, supra note 9, atA24.

108 The initial decision not to seek prenatal screening may, for many individuals, be based on a desire to completely avoid the difficult and highly personal dilemma posed by abortion.

109 Cf. President's Commission, supra note 58, at 47-59 (finding a strong presumption in favor of autonomy and concluding that under no circumstances, other than one in which voluntary testing would fail to prevent avoidable, serious injury to persons who are unable to protect themselves, may compulsory screening be justified).

110 See supra note 91 and accompanying text.

111 H.R. 3600, § 1111.

112 Id. § 1113.

113 Id. §1124.

114 The Mitchell bill provides for “hospital services;” “home health care” as an alternative to inpatient treatment; “extended care services” if required by virtue of a “disorder, or other health condition;” “outpatient rehabilitation services” including physical and respiratory therapy and speech-language pathology services; and “durable medical equipment and prosthetic and orthotic devices.” S. 2560, § 1202(1),(3),(8),(9),(13),(14). The Thomas bill is relatively limited in its description of services to be provided under the standard package of benefits. The bill does, however, indicate that “medical and surgical services” and “medical equipment” will be included in the package. H.R. 3704, §1301 (b)(1),(2).

115 See supra note 102 and accompanying text.

116 H.R. 3600, § 1402(b) (l)-(3).

117 Id. at § 1402(a)(1).

118 Id. § 1101(b).

119 S. 2560, §§ 1002(1), 1114(a), 1121(a), 1602; H.R. 3704, § 1112.

120 Under the Mitchell reform package, a health plan may not discriminate on the basis of a “genetic predisposition to medical conditions.” S. 2560, § 1002(1). Additionally, the bill specifically prohibits health plans from “terminating], restrict[ing], or limiting] coverage or established premiums based on … disability [or] genetic predisposition to medical conditions.” Id. at § 1114(a). See also id §§ 1121(a), 1602.

121 H.R. 3600, § 1141(a)(1),(2); S. 2560, § 1002(3); H.R. 3704, § 1301(b).

122 See supra note 47.

123 Cf. Gina Kolata, Baby's Painful 2 Years of Life Highlight the Cost of Futile Medical Care, N.Y. Times, Oct. 6, 1993, at B7 (suggesting that the President's proposal for health care reform would implicitly discourage care in situations where treatment has little reasonable probability of providing a satisfactory quality of life).

124 “Even those most apprehensive about the anti-disability sentiment in prenatal diagnosis would probably tolerate or welcome abortions after diagnosis of Tay-Sachs disease and other degenerative conditions that cause extreme pain, loss of awareness of self and others, and death in early childhood.” Asch, supra note 75, at 87.

125 See supra notes 63-68 and accompanying text.

126 Asch, supra note 75, at 88.

127 Annas, supra note 44, at 1200.

128 H.R. 3600, § 1116. Similarly, the Mitchell bill provides for “family planning services and services for pregnant women,” but does not define the content of these services. S. 2560, § 1201. The Thomas bill provides only for coordination of existing maternal and infant care programs. H.R. 3704, § 5201. 129 J u d y Foreman, Mrs. Clinton Touts Benefits of Health Package for Women, Boston Globe, Oct. 6, 1993, at 8, see also Maintain Status Quo on Coverage to Ensure Passage of Reform This Year, 2 Health Care Pol'y Rep. (BNA) 15 (Aug. 1, 1994) [hereinafter Status Quol Melinda Beck et al., The President's Tough Choice, Newsweek, J a n. 24, 1994, at 30.

130 Status Quo, supra note 129, at 1.

131 Of course, such a plan would require that Medicaid funds and/or federal income tax subsidies be used to fund abortions, and would therefore require a repeal of the Hyde amendment. Although it is not the intent of this Note to focus on abortion as an issue in and of itself, it is interesting to note that such a repeal may be politically disastrous to the eventual success of the Health Security Act. See Catholic Bishops to Fight Coverage, 70 House Members Reiterate Support, 2 Health Care Pol'y Rep. (BNA) 1286 (July 18, 1994) (“Broad support for health care reform evaporates when linked to abortion mandates“); Status Quo, supra note 129, at 15 (“Maintaining the status quo on abortion is the only way to ensure passage of comprehensive health reform without provoking a divisive, damaging debate.“). But cf. Abortion Coverage, supra note 28, at 52 (seventy two percent of Americans polled agree that standard coverage should include abortions that are medically necessary or appropriate).

132 The number of women affected should abortion coverage be excluded from the comprehensive benefit package extends beyond merely those women who rely upon federal and state funding for their health care needs. Assuming that insurers will charge additional premiums for services above and beyond the basic benefits package, “stripping abortion from the plan would be a major reduction in benefits for women [in general], since many private insurance plans offer it now.” Beck et al., supra note 129, at 30.

133 This result follows from the Hyde Amendment limitations to federal funding of abortions. See supra note 57 and accompanying text.

134 See generally H.R. 3600, §§ 5301-12; S. 2560, §§ 5401-12; H.R. 3740, §§ 4001-27.

135 H.R. 3600, § 5312(a); S. 2560, § 5411. The Thomas bill, rather than allowing states to establish pilot programs utilizing “practice guidelines,” mandates that each state develop a set of specialty clinical practice guidelines. H.R. 3740, § 4025(a)(1).

136 H.R. 3600, § 5312(b)(1). Similarly, under the Mitchell reform plan, the law of the state adopting such practice guidelines must assure that “compliance or non-compliance with an applicable guideline shall be admissible by either party at trial as presumptive evidence of nonliability or liability for medical negligence.” S. 2560, § 5411(b)(1) (emphasis added). Service rendered in accordance with guidelines developed by each state under the Thomas plan, “if introduced, shall establish a rebuttable presumption that the service prescribed by the guidelines is the appropriate standard of care.” H.R. 3740, § 4025(a)(2)(B) (emphasis added).

137 See Elias et al., supra note 21, at 186.

138 Asch, supra note 75, at 83.

139 See supra note 9.

140 See Committee on Genetics, supra note 7, at 741 (“Fetal chromosome analysis should be offered [to women of] advanced maternal age.“); Rowley, supra note 6, at 140 (“The commonest indication for fetal screening is a maternal age of 35 or greater because of the increased risk for an offspring with a chromosomal anomaly.“). 141 See Call v. Kezerian, 185 Cal. Rptr. 103 (1982); Berman v. Allen, 404 A.2d 8 (N.H. 1978); Becker v. Schwartz, 386 N.E.2d 807 (N.Y. 1978); Karlsons v. Guerinot, 57 AD.2d 73 (N.Y. App. Div. 1977).

142 Lippman, supra note 72, at 26-33.

143 See Elias et al., supra note 21, at 186 (suggesting that the structure of medical practice itself, including cost-containment efforts and risk-management programs, may be equally, if not more, responsible for determining a physician's practice than are the standards of the medical profession); see also Milunsky, supra note 1, at 64 (concluding that obstetricians may have been led to practice defensive medicine by the increased pressure applied by patients desirous to know “about the risks of birth defects and genetic disease and the increasing opportunities for prevention.“).

144 Henifin et al., supra note 2, at 175; see also Wilfond & Fost, supra note 3, at 645 (“Physicians’ perceptions of legal liability may be an impetus for screening.“).

145 See, e.g., Turpin v. Sortini, 643 P.2d 954 (Cal. 1982); Schroeder v. Perkel, 432 A.2d 834 (N.J. 1981); Berman, supra note 76.

146 Asch, supra note 75, at 93 (“Commitment to access and choice commits us to support those women who believe that they were denied testing or adequate counseling and, thus, bore a child with a disability whom they would have aborted had they known…. [S]uch suits … may be one of the few ways to compel the medical profession to inform and care for women responsibly during pregnancy.“).

147 Id. at 90.

148 Wilfond & Fost, supra note 3, at 649-52. “[P]hysicians all too readily, in order to obtain patients’ assent, render ‘medical’ opinions that on inspection turn out to be a hodgepodge of personal, interpersonal, emotional, philosophical, social, aesthetic, religious, and medical judgments.” Jay Katz, Disclosure and Consent: In Search of Their Roots, in Genetics and the Law II, supra note 1, at 121, 122.