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Mothers and Children Last: The Oregon Medicaid Experiment

Published online by Cambridge University Press:  24 February 2021

Sara Rosenbaum
Sara Rosenbaum*
Affiliation:
Health Division, Children's Defense Fund
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Abstract

“There is always a lofty goal in the research work of medicine but too often it has been the bodies of the poor on … whom the unholy testing is done.“

James Jones, Bad Blood: The Tuskeegee Syphilis Experiment

In 1989 and 1991, the Oregon legislature enacted a series of initiatives to extend health coverage to uninsured state residents. Among these initiatives is an act that seeks to extend a modified set of Medicaid benefits to state residents with family incomes below the federal poverty level. This act also reduces benefits the state is now required to provide to Medicaid-enrolled women of childbearing age and children. This Article explores the legal context in which the Oregon Medicaid experiment must be evaluated. It argues that by reducing the level of coverage to which tens of thousands of exceedingly poor, Medicaid-eligible women and children are entitled, the experiment falls outside the scope of valid research that the United States Department of Health and Human Services may either sanction or fund. The Article also discusses the implications of the Oregon experiment, if approved, for the future direction of the Medicaid program in particular, and for health care reform for the poor, generally.

Type
Articles
Information
American Journal of Law & Medicine , Volume 18 , Issue 1-2: Rationing Health Care: Social, Political and Legal Perspectives , 1992 , pp. 97 - 126
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1992

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References

1 Act effective July 1, 1989, ch. 836, 1989 OR. LAWS 836 (codified as amended in scattered subsections of OR. REV. STAT. § 414 (1989)) (health services); Act effective July 1, 1989, ch. 838, 1989 OR. LAWS 838 (codified as amended in scattered subsections of OR. REV. STAT. § 735 (1989)) (Oregon Medical Insurance Pool); Act effective Oct. 3, 1989, ch. 381, 1989 OR. LAWS 381 (codified as amended in scattered subsections of OR. REV. STAT. § 414 (1989)) (health care); Act effective Jan. 1, 1992, ch. 916, 1991 OR. LAWS 916 (codified as amended in scattered subsections of OR. REV. STAT. §§ 316, 317, 414, 743, 750 (1991)) (health benefit plans); Act effective June 30, 1991, ch. 470, 1989 OR. LAWS 470 (codified as amended in scattered subsections of OR. REV. STAT. §§ 127, 244, 442, 753 (1991)) (health care cost containment); Act effective Aug. 5, 1991, ch. 753, 1991 OR. LAWS 753 (codified as amended in scattered subsections of OR. REV. STAT. § 414 (1991)) (health care).

2 1989 OR. LAWS 836.

3 1989 OR. LAWS 838.

4 1989 OR. LAWS 381.

5 Id.

6 Oregon seeks waivers from the federal Health Care Financing Administration. See OFFICE OF MEDICAL ASSISTANCE PROGRAMS, OREGON DEP't OF HUMAN RESOURCES, OREGON MEDICAID WAIVER APPLICATION 7.1-7.5 (1991) [hereinafter WAIVER APPLICATION].

7 42 U.S.C.A. §§ 1396-1396u (West 1992).

8 Social Security Act, 42 U.S.C.A. §§ 301-1397e (West 1991 & 1992).

9 HEALTH CARE FINANCING ADMIN., MEDICAID RECIPIENT AND EXPENDITURE DATA (Fiscal Year 1990) (unpublished) [hereinafter HCFA MEDICAID DATA].

10 42 U.S.C.A. § 1396b(a)(l) (West 1992).

11 Medicaid has been credited with aiding in the reduction of infant mortality and in achieving overall and dramatic improvements in poor persons’ access to medical care. See, e.g., KAREN, DAVIS & CATHY, SCHOEN, HEALTH AND THE WAR ON POVERTY: A TEN YEAR APPRAISAL (1977)Google Scholar; ROBERT, STEVENS & ROSEMARY, STEVENS, WELFARE MEDICINE IN AMERICA: A CASE STUDY OF MEDICAID (1974).Google Scholar

12 CONGRESSIONAL RESEARCH SERVICE FOR THE SUBCOMM. ON HEALTH AND THE ENVIRONMENT OF THE COMM. ON ENERGY AND COMMERCE, 100TH CONG., 2D SESS., MEDICAID SOURCE BOOK: BACKGROUND DATA AND ANALYSIS 5 (Comm. Print 1988). See ako Timothy, Egan, For Oregon's Health Care System, Triage by A Lawmaker with an M.D., N.Y. TIMES, June 9, 1991, at A18.Google Scholar

13 THE PEPPER COMM'N: U.S. BIPARTISAN COMM'N ON COMPREHENSIVE HEALTH CARE, 101ST CONG., 2D SESS., A CALL FOR ACTION (S. Print 1990) [hereinafter PEPPER COMM'N REPORT].

14 42 U.S.C.A. § 1396a(a)(10)(i)(I) (West 1992).

15 HOUSE COMM. ON WAYS AND MEANS, 101ST CONG., 1ST SESS., BACKGROUND MATERIAL AND DATA ON PROGRAMS WITHIN THE JURISDICTION OF THE COMM. ON WAYS AND MEANS 560 (Comm. Print 1989) [hereinafter WAYS AND MEANS REPORT].

16 42 U.S.C.A. § 1396a(a)(10)(A)(i)(I) (West 1992). WAYS AND MEANS REPORT, supra note 15, at 701. Created in 1974, the SSI program provides cash assistance to approximately 4.4 million persons, a quarter million of whom are children under age 18. Id. at 671.

17 42 U.S.C.A. § 1396a(a)(10)(A)(i)(VI), (VII) (West 1992). See infra text accompanying notes 29-34.

18 42 U.S.C.A. § 1396a(a)(10)(C) (West 1992). The medically needy are persons whose medical care costs exceed their available income and resources. In 1990, approximately 25 million medically needy women of childbearing age and children were served by the program nationally. HCFA MEDICAID DATA, supra note 9.

19 42 U.S.C.A. § 1396a(a)(10)(C)(ii) (West 1992).

20 Id. §§ 1396a(a)(10), 1396(d)(a) (West 1992).

21 Id. § 1396a(a)(10)(A)(ii) (West 1992).

22 id. §§ 1396a(a)(10)(A)(i)(III), 1396d(r) (West 1992). This special coverage mandate applies to all children under age 21 and is known as Early and Periodic Screening, Diagnosis and Treatment (EPSDT). See infra text accompanying note 35.

23 42 U.S.C.A. § 1396a(a)(10)(C)(ii)(II) (West 1992).

24 See generally id. § 1396b (West 1992).

25 [1990] Medicare and Medicaid Guide (CCH) 114,905.

26 For example, New York State provides Medicaid benefits to all poor residents. N.Y. Soc. SERV. LAW § 366 (McKinney 1983 & Supp. 1992). See also Elizabeth, Kolbert, New York Extending Medicaid Eligibility and Shifting Services, N.Y. TIMES, Aug. 25, 1988, at B1Google Scholar. However, federal financial participation is available only for those categories of poor residents (e.g., AFDC and SSI beneficiaries and poor pregnant women and children) listed in the federal statute. See 42 U.S.C.A. § 1396a(a)(10)(A) (West 1992).

27 See, e.g., PEPPER COMM'N REPORT, supra note 13, at 30-32, Ruth, Colker, An Equal Protection Analysis of United States Reproductive Health Policy: Gender, Race, Age, and Class, 1991 DUKE L.J. 324, 346CrossRefGoogle Scholar; L. Rachel, Eisenstein, Prenatal Health Care: Today's Solution to the Future's Loss, 18 FLA. ST. U. L. REV. 467, 475-77 (1991)Google Scholar; Rand E., Rosenblatt, Medicaid Primary Care Case Management, The Doctor-Patient Relationship, and the Politics of Privatization, 36 CASE W. RES. L. REV. 915, 917 & n.6 (1986).Google Scholar

28 CLIFFORD M., JOHNSON ET AL., CHILDREN's DEFENSE FUND, CHILD POVERTY IN AMERICA 9 (1991)Google Scholar; SARA, ROSENBAUM ET AL., SPECIAL REPORT: CHILDREN AND HEALTH INSURANCE 15 (1992).Google Scholar

29 Numerous reports detail the increase in childhood poverty, the loss of insurance and the stagnation and erosion of key maternal and child health indicators, in particular, infant mortality, infant low birthweight and prematurity, poor access to maternity care and declining childhood immunization rates. See, e.g.. CHILDREN's DEFENSE FUND, AMERICAN CHILDREN IN POVERTY, reprinted in Infant Mortality Rates: Failure to Close the Black-White Gap: Hearing Before the Subcomm. on Oversight and Investigations and the Subcomm. on Health and the Environment of the House Comm. on Energy and Commerce, 98th Cong., 2d Sess. 237 (1984) (statement of Sara Rosenbaum, Director, Child Health, Children's Defense Fund); NATIONAL COMM'N TO PREVENT INFANT MORTALITY, DEATH BEFORE LIFE: THE TRAGEDY OF INFANT MORTALITY (1988), reprinted in 134 CONG. REC. 510, 900 (1988); WHITE HOUSE TASK FORCE REPORT ON INFANT MORTALITY IN THE UNITED STATES (1989); NATIONAL COMM'N ON CHILDREN, BEYOND RHETORIC (1991); SARA ROSENBAUM ET AL., CHILDREN's DEFENSE FUND, THE HEALTH OF AMERICA's CHILDREN (1991).

30 The Deficit Reduction Act of 1984, Pub. L. No. 98-369, 98 Stat. 494 (mandatory coverage of all children under age five, all single pregnant women and women in two-parent unemployed families with family incomes below AFDC payment levels (which amounts to approximately 40% of the federal poverty level) and automatic coverage of newborns); The Consolidated Omnibus Budget Reconciliation Act of 1985, Pub. L. No. 99-272, 100 Stat, 82 (mandatory coverage of all pregnant women with family incomes below AFDC eligibility levels); The Omnibus Budget Reconciliation Act of 1986, Pub. L. No. 99-509, Stat. 1874 (permitting states at their option to extend coverage to all pregnant women and children under age five with family incomes below 100% of the federal poverty level and permitting states to extend “presumption” eligibility to pregnant women); The Omnibus Budget Reconciliation Act of 1987, Pub. L. No. 100-203, 101 Stat. 1330 (permitting states at their option to extend coverage to all pregnant women and infants with family incomes below 185% of the federal poverty level and providing mandatory coverage of all children under age eight with family incomes below state AFDC levels, permitting states at their option to cover all poor children under age eight). These reforms, as well as those enacted in 1988, 1989 and 1990, were adopted on a drawn out, incremental basis, both in order to meet spending constraints on new Medicaid entitlements imposed by annual federal budgets and because of the evolutionary nature of health care reform consensus-building in the United States. It took approximately 15 years, from initial attempts by the Carter Administration, key lawmakers, such as Representative Henry Waxman of California, and various advocacy groups and organizations, to convince lawmakers to revise Medicaid at first to permit, and then to require, coverage of low-income pregnant women and children.

31 The Medicare Catastrophic Coverage Act of 1988, Pub. L. No. 100-360, § 301(a), 102 Stat. 683, 748; The Omnibus Budget Reconciliation Act of 1989, Pub. L. No. 101-239, § 6405(b), 103 Stat. 2106, 2265; The Omnibus Budget Reconciliation Act of 1990, Pub. L. No. 101-508, § 4601(a), 104 Stat. 1388, 1388.

32 42 U.S.C.A. 1396a(a)(17) (West 1992) In Medicaid, as in welfare law generally, financial eligibility is determined by comparing an individual's or family's “net” income and resources (i.e., amounts considered available to meet basic needs after certain deductions and exclusions are applied) to program eligibility levels. This “net” income test incorporates, in the case of poor families and children applying for AFDC and/or Medicaid such important deductions and exclusions as child care costs, work-related expenses, and special pregnancy and shelter allowances in certain states. Additionally, in the case of children who apply for Medicaid, certain household income is not counted unless actually contributed to the child's support. Only the income of parents is considered automatically available to children applying for Medicaid. 42 U.S.C.A. § 1396a(a)(17)(D) (West 1992). Thus, the income of other household members, such as grandparents, other relatives or unrelated household members, may not be taken into account, unless actually available to the child. See Reed v. Blinzinger, 816 F.2d 296, 297 (7th Cir. 1987); Vance v. Hegstrom, 793 F.2d 1018, 1026 (9th Cir. 1986); Rosado v. Bowen, 698 F. Supp. 1191, 1202 (D.N.J. 1987); Ward v. Wallace, 652 F. Supp. 301, 304 (M.D. Ala. 1987), afd, 853 F.2d 929 (11th Cir. 1988); Sundberg v. Mansour, 627 F. Supp. 616, 621 (W.D. Mich. 1986).

These deductions, disregards and exclusions are of pivotal importance because of the impact that even a few extra dollars of income can have on a child's eligibility for Medicaid. Where, as in the Medicaid program, permissible income levels are exceedingly low, it takes only a very slight increase in countable income to exclude a pregnant woman or child entirely.

33 In 1991 this amount equalled $11,140 annually for a family of three in the continental United States. Annual Update of the HHS Poverty Income Guidelines, 56 Fed. Reg. 6860 (1991).

34 Coverage of poor children ages six to 19 is phased in on a year-by-year basis, starting with children born after September 30, 1983. AH poor children will be covered by the year 2002. 42 U.S.C.A. § 1396a(l)(l)(D) (West 1992).

35 See supra note 22.

36 42 U.S.C.A. § 1396d(a)(4)(B), 1396d(r) (West 1992). For a review of EPSDT, see Sara, Rosenbaum & Kay, Johnson, Providing Health Care to Low Income Children: Reconciling Child Health Goals to Child Health Financing Realities, 64 MILBANK MEMORIAL FUND Q. 442.Google Scholar

37 Preventive benefits covered through the EPSDT program include comprehensive unclothed physical exams, laboratory services such as lead poisoning testing, nutritional, immunizations and developmental assessments and complete vision, hearing and dental care. 42 U.S.C.A. § 1396d(r) (West 1992). Both basic screening services and all treatment required must be provided at medically appropriate periodic intervals, as well as “interperiodically” (whenever an illness or condition is suspected).

38 See PEPPER COMM'N REPORT, supra note 13, at 31-32; see also supra notes 29-34 and accompanying text.

39 See WAIVER APPLICATION, supra note 6, at 3.8-3.12. It is important to note that under current federal law the state has the option of covering all children within this group whose incomes are at or below state-defined levels. 42 U.S.C.A. § 1396a(a)(10)(A)(ii) (West 1992). Approximately half of the children added through the waiver thus would be eligible for Medicaid under existing law were the state to exercise-its current coverage options.

40 See supra note 20 and accompanying text.

41 WAIVER APPLICATION, supra note 6, at 2.1.

42 Id.

43 Id. at 2.2.

44 Id. at 2.3.

45 Id.

46 Id. at 2.4-2.5.

47 Indeed, the state would not need federal waivers to eliminate coverage of medically unnecessary services, since federal Medicaid law already prohibits states from claiming federal funds for coverage of medically unnecessary, poor quality or ineffective services. 42 U.S.C.A. § 1396a(a)(30)(A) (West 1992).

48 OREGON HEALTH SERVICES COMM'N, PRIORITIZATION OF HEALTH SERVICES: A REPORT TO THE GOVERNOR AND LEGISLATURE (1991).

49 FAMILIES USA, THE OREGON EXPERIMENT — A HOLLOW PROMISE, reprinted in Oregon Medicaid Rationing Experiment: Hearing Before the Subcomm. on Health and the Environment of the House Comm. on Energy and Commerce, 102d Cong., 1st Sess. 37 (1991) [hereinafter Hearings on Oregon Rationing] (statement of Families USA Foundation).

50 See supra note 32.

51 WAIVER APPLICATION, supra note 6, at 7.2-7.3.

52 Id. at 7.3. Retroactive eligibility is mandatory under the statute. 42 U.S.C.A. § 1396a(a)(34) (West 1992). It permits payments to be made on beneficiaries’ behalf even if application for benefits occurred after treatment began. Retroactive eligibility (which can cover a period of three months prior to the date of application) is essential for assuming that health care providers do not refuse to initiate treatment because a patient has not yet applied for benefits.

53 Memorandum from Sara Rosenbaum, Director Health Div., Children's Defense Fund, and Joe Liu, Health Division, Children's Defense Fund to Jill Eden, Office of Technology Assessment, U.S. Congress (Oct. 26, 1991).

54 HCFA MEDICAID DATA, supra note 9.

55 In a 1990 conversation with this author, a key member of the state legislature, acknowledging the exemptions for elderly and disabled persons and the long-term care industry, stated that “you have to pick your political enemies.” For an excellent review of the politics of the Oregon Waiver Legislation see Lawrence D., Brown, The National Politics of Oregon's Rationing Plan, HEALTH AFF., Summer 1991, at 28.Google Scholar

56 SSI provides assistance to persons who are poor and whose disabilities (a) can be expected to last a year or longer; and (b) prevent them from engaging in “substantial gainful activity.” 42 U.S.C.A. § 1382c(a)(3)(A) (West 1992). Thus, SSI reaches only a small proportion of all low-income persons with physical or mental impairments. This is true particularly in the case of children, because of the unlawfully restrictive measures for evaluating children with disabilities that were utilized by the United States Department of Health and Human Services until declared illegal in 1990. Zebley v. Sullivan, 493 U.S. 521 (1990). Measuring disabilities in children, especially young children, also presents more difficulties than in the case of adults because of the subtleties involved in measuring children's development. In other words, far more low-income children have disabilities than receive SSI. For example, it was estimated that about 5% of the nation's 13.4 million poor children under age 18 have an activity-limiting impairment. Yet only 250,000 children (about 30% of the number with impairments) receive SSI.

57 1991 OR. LAWS 836.

58 Interestingly, foster children are exempt under 1991 OR. LAWS 836. This suggests that when the state maintains a parental relationship in a child, it is not willing to subject the child to the experiment.

59 1991 OR. LAWS 836. 1991 OR. LAWS 753 provides for eventually including these excluded groups under the waiver. WAIVER APPLICATION, supra note 6, at 1.11. However, the high cost of adding coverage for currently ineligible elderly persons, as well as the major modification of the prioritization system which would be required, make this expansion unlikely. Moreover, long-term care services, the central and costliest chronic care service used by elderly and disabled persons, would continue to be excluded.

60 WAIVER APPLICATION, supra note 6, at app. I.

61 The listings do not define “end stage” AIDS.

62 WAIVER APPLICATION, supra note 6, at app. I.

63 LAMBDA LEGAL DEFENSE FUND ANALYSIS (1991) (unpublished). Indeed poor people with AIDS probably are far more likely to have “end-stage” AIDS, since their poverty undoubtedly has substantially impaired their access to early care.

64 See Frances H., Miller, Denial of Health Care and Informed Consent in English and American Law, 18 AM. J.L. & MED. 37, 47 (1992)Google Scholar (discussing how AIDS adds a new dimension to the issues of health care rationing).

63 42 C.F.R. § 440.230 (1990).

66 The state estimates the added costs created just by the coverage of new eligibles under the experiment to be slightly more than $100 million over five years. This figure does not include the federal funding needed to continue modified benefits to current eligibles. OFFICE OF MEDICAL ASSISTANCE PROGRAMS, OREGON DEP't OF HUMAN RESOURCES, OREGON MEDICAID DEMONSTRATION: WAIVER COST ESTIMATE Es.l (1991). The Congressional Budget Office has estimated the additional five year costs at approximately $300 million. Hearings on Oregon Rationing, supra note 49, at 214 (testimony of Charles E. Seagrave, Budget Analysis Division, Congressional Budget Office).

67 Other waivers of specific provisions of the statute not reviewed here are also sought. See WAIVER APPLICATION, supra note 6, at 7.1-7.5. For example, the state seeks the right to limit beneficiaries access to only certain health providers and to entirely eliminate coverage for certain benefits. Id. at 7.4.

68 Social Security Act, § 1115 (codified as amended at 42 U.S.C.A. § 1315 (West 1991)).

69 Id. § 1115(a) (codified as amended at 42 U.S.C.A. § 1315(a) (West 1991)).

70 Public Welfare Amendments of 1962, Pub. L. No. 87-543, § 122, 76 Stat. 172, 192 (codified as amended at 42 U.S.C.A. § 1315 (West 1991)).

71 For example, § 1915 of the Social Security Act, 42 U.S.C.A. § 1396n (West 1992), authorizes the Secretary to waive specific provisions of the federal Medicaid statute in order to give states flexibility to modify provisions of the law pertaining to long-term care and the right of beneficiaries to receive care from the qualified provider of their choice.

72 See H.R. REP. NO. 1414, 87th Cong., 2d Sess. 24 (1962); S. REP. NO. 1589, 87th Cong. 2d Sess. 19-20 (1962).

73 See, e.g., Aguyo v. Richardson, 352 F. Supp. 462 (S.D.N.Y. 1972), aff’d, 473 F.2d 1090 (2d Cir.), cert, denied, 414 U.S. 1146 (1973). See also Greater N.Y. Hosp. Ass'n v. Blum, 476 F. Supp. 234 (E.D.N.Y. 1979); Crane v. Mathews, 417 F. Supp. 532 (N.D. Ga. 1972); California Welfare Rights Org. v. Richardson, 348 F. Supp. 491 (N.D. Cal. 1972).

74 Crane, 417 F. Supp. at 539; Aguayo, 352 F. Supp. at 470; Richardson, 348 F. Supp. at 496- 97.

75 Blum, 476 F. Supp. at 243.

76 In 1982, in response to efforts by the Reagan Administration to use § 1115(a) to permit states to impose stringent and otherwise unlawful costsharing obligations on Medicaid recipients, Congress amended the Medicaid statute itself to circumscribe strictly the Secretary's research authority to undertake demonstrations in which benefits are found to outweigh risks and participation is voluntary, or provision is made for assumption of liability for preventable damage to beneficiaries involuntarily subjected to an experiment. Tax Equity and Fiscal Responsibility Act of 1982, Pub. L. No. 97-248, § 131(b), 96 Stat. 324, 367 (codified as amended at 42 U.S.C.A. § 1396o (West 1992)).

77 See supra notes 29-37 and accompanying text.

78 See supra note 29 and accompanying text.

79 See supra note 36 and accompanying text.

80 See supra note 22.

81 Social Security Amendments of 1967, Pub.L. No. 90-248, § 302(a), 81 Stat. 821, 929 (1968) (codified as amended at 42 U.S.C.A. § 1396d(a) (West 1992)).

82 42 U.S.C.A. § 1396d(a)(4)(B), 1396d(r) (West 1992).

83 Id. § 1396d(r)(5) (West 1992).

84 Omnibus Budget Reconciliation Act of 1989, Pub. L. No. 101-239, § 6403, 103 Stat. 2106, 2262.

85 42 U.S.C.A. § 1396d(r)(5) (West 1992). The state specifically seeks a waiver of this requirement.

86 Id. § 1396d(r) (West 1992).

87 Oregon Administrative Rules, Rule 410-125-161, in DEPARTMENT OF HUMAN RESOURCES, OFFICE OF MEDICAL ASSISTANCE PROGRAMS, ADMINISTRATIVE RULES FOR THE OREGON MEDICAL ASSISTANCE PROGRAM, HOSPITAL SERVICES 34 (1991).

88 WAIVER APPLICATION, supra note 6, at app. I.

89 Charles, Marwick, Exploring Causes of Paralysis in Spina Bifida, 261 JAMA 3069, 3069 (1989).Google Scholar

90 Notably, the plan's supporters frequently speak of the additional pregnant women who will be aided by their Medicaid reforms. See Hearings on Oregon Rationing, supra note 49, at 63 (testimony of the following United States Representatives from Oregon: Ron Wyden, Les Aucoin, Peter DeFazio, Robert Smith); id. at 73 (testimony of Barbara Roberts, Governor, State of Oregon); id. at 75 (testimony Jean I. Thome, Director, Office of Medical Assistance Programs, Oregon Department of Human Resources). Yet at 133% of the poverty level and with a net income test, see supra text accompanying notes 33-34, the current Medicaid statute is far more generous than the experimental standard of 100% of the poverty level using a gross income test.

91 42 U.S.C.A. § 1396a(a)(10)(F)(v) (West 1992).

92 See, e.g., COMMITTEE TO STUDY THE PREVENTION OF LOW BIRTHWEIGHT, INSTITUTE OF MEDICINE, PREVENTING Low BIRTHWEIGHT 132-47 (1985); PUBLIC HEALTH SERVICE, DEP't OF HEALTH AND HUMAN SERVICES, HEALTHY PEOPLE 2000: NATIONAL HEALTH PROMOTION AND DISEASE PREVENTION OBJECTIVES 379 (Conference ed. —).

93 See supra text accompanying notes 30-32.

94 Indeed, it is Medicaid's broad maternity related objectives that, in the view of the United States Supreme Court, justified the withholding of federal funding for medically necessary Medicaid abortion services. Harris v. McRae, 448 U.S. 297, 325-26 (1980).

95 Indeed, it is interesting to note that in the mid 1970s, Oregon was given federal experimental waivers under § 1115 to cover all poor residents of Multnomah County. One wonders why this state should be given federal funds now to do what it already did nearly two decades ago.

96 Crane v. Mathews, 417 F. Supp. 532, 546 (N.D. Ga. 1976).

97 National Research Act of 1974, Pub. L. No. 93-348, 88 Stat. 342 (codified as amended in scattered sections of 42 U.S.C.A. (West 1991)).

98 Administrative Procedure Act, 5 U.S.C.A. §§551-559, 701-706, 3105, 3344 (West 1977 & Supp. 1991).

99 42 U.S.C.A. §§ 201 - 300aaa-13 (West 1991).

100 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Act of 1992, Pub. L. No. 102-170, §211, 105 Stat. 1107, 1127 (1991).

101 45 C.F.R. §46.101 (1991).

102 Id. § 46.101(a) (1991).

103 See id. §46.102(i) (1991).

104 See id. § 46.103(a) (1991).

105 Public Health Service Act, 42 U.S.C.A. § 201 (West 1991).

106 45 C.F.R. § 46.101(a) (1991).

107 Id. §46.102(d) (1991).

108 Id. (emphasis added).

109 Crane v. Mathews, 417 F. Supp. 532, 545, 546 (N.D. Ga. 1976).

110 45 C.F.R. § 46.102(f) (1991).

111 See WAIVER APPLICATION, supra note 6, at 1.14-1.17.

112 Id. at 1.14-1.15.

113 Id. at 5.3-5.4. Candidate hypotheses in the area of quality of care/patient health status include the following:

Current eligibles will report no change in the quality of care…. The health status [of new eligibles] will improve…. Pregnancy outcomes will improve … among the newly eligible population…. The incidence of severe untreated conditions among new eligibles will decrease and will show no change for current eligibles…. Mortality rates among new eligibles will be reduced and will show no change for current eligibles.

Id. at 5.11.

114 45 C.F.R. § 46.109 (1991). Reviews of human subjects research by independent IRBs were a key recommendation of the National Commission on the Protection of Human Subjects of Biomedical and Behavioral Research in its report. See NATIONAL COMM'N FOR THE PROTECTION OF HUMAN SUBJECTS OF BIOMEDICAL AND BEHAVIORAL RESEARCH, THE BELMONT REPORT: ETHICAL PRINCIPLES AND GUIDELINES FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH (1978). The report, the central work of the Commission, recommended IRB review of all federally funded research, whether or not conducted under the Public Health Service Act. Id. at 12-3-12-7.

115 See 45 C.F.R. §46.101(b)(l)-(5) (1991).

116 Final Regulations Amending Basic HHS Policy for the Protection of Human Research Subjects, 46 Fed. Reg. 8366 (1981).

117 Exemption of Certain Research and Demonstration Projects from Regulations for Protection of Human Research Subjects, 48 Fed. Reg. 9266 (1983) (codified at 45 C.F.R. §§ 46.101, 46.116 (1991)) [hereinafter Exemption of Research from Regulations]. Rules proposing to broaden the Department's § 1115 research latitude were originally proposed in March 1982. The first rule, published in early March, exempted from IRB protections all § 1115 Medicaid costsharing demonstrations. Waiver of Requirements as Applied to Medicaid Demonstration Projects Involving Cost-Sharing (Copayments, Deductibles, Coinsurance), 47 Fed. Reg. 9208 (1982) (to be codified at 45 C.F.R. Part 46). It was this “emergency” rule, published without notice and opportunity for prior comment, which Congress enjoined in its 1982 Medicaid costsharing demonstration amendments, see supra note 54. Later in March, the Administration published a Notice of Proposed Rulemaking which proposed to withdraw completely from IRB protections all § 1115 demonstrations. Exemption of Certain Research and Demonstration Projects from Regulations for Protection of Human Research Subjects, 47 Fed. Reg. 12276 (1982) (to be codified at 45 C.F.R. §§ 46.101, 46.116) (proposed Mar. 22, 1982). The proposal was made, not on the ground that § 1115 projects do not constitute federally funded research involving human subjects, but on the ground that “these demonstration and service projects are already subject to procedures which provide for extensive review by high level officials in various program administration offices.” Id. This justification is particularly ironic given the fact that the requirement of independent IRB review was established in part to curb the inherent conflict of interest that inevitably arises when officials intimately involved in human subject research are called upon to review its propriety.

It is also worth noting that David Swope, who was HHS Undersecretary at the time of the 1982-1983 revisions, had been a “high level” California welfare official under then Governor Reagan, and had designed the Medicaid costsharing experiment challenged on § 1115 grounds in California Welfare Rights Org. v. Richardson, 348 F. Supp. 491 (N.D. Cal. 1972). Officials in the Reagan Presidency fully understood the impact that the 1981 research rules would have on their latitude to engage welfare experiments and thus sought to avoid any external review.

118 Exemption of Research from Regulations, supra note 119, at 9269.

119 Id. at 9266-67 (emphasis added).

120 Id. at 9270. On November 10, 1988, the Office of Science and Technology, of the Executive Office of the President, proposed a “model rule” governing human subject research conducted by 16 separate federal agencies, including HHS. 53 Fed. Reg. 45,660 (Nov. 10, 1988). The proposed rule was promulgated in final form on June 18, 1991. 56 Fed. Reg. 28,002 (June 18, 1991). The final model rule makes no mention of the 1983 rule, even though there was no change in the appropriations statute restrictions governing HHS-conducted research. It is unclear why the 1983 rule tracking the statute was deleted from the final HHS versions of the model rule, particularly since the special statutory requirement pertaining to HHS research did not change. However, the final HHS version of the model rule makes clear that “compliance with this policy requires compliance with pertinent federal laws … which provide additional protections.” 45 C.F.R. § 46.101(e) (1991).

121 45C.F.R. §46.211 (1991).

122 Id.

123 The Appropriations Act research protections first appeared in 1982. Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations Act of 1982, Pub. L. No. 97-377, § 511, 96 Stat. 1830, 1905.

124 While the experiment exempts providers from sanctions and penalties, certain federal laws prohibiting providers from denying or withdrawing coverage in the case of medical emergencies could not be waived by the Secretary under his § 1115 authority. Hospital Survey and Construction (Hill Burton) Act, 42 U.S.C.A. §§ 291 - 291o-l (West 1991), and the Emergency Medical Treatment and Active Labor Act, 42 U.S.C.A. § 1395dd (West 1992). Both of these laws compel the provision of emergency care regardless of a patient's ability to pay. See Sara, Rosenbaum & Marilyn, Sager, Unlocking the Hospital Doors: Medical Staff Membership and Physicians Who Serve the Poor, 9 YALE L. & POL'Y REV. 46 (1991).Google Scholar

125 WAIVER APPLICATION, supra note 6, at app. I. Coverage of neonatal myasthenia gravis is ranked at number 74, id, well within the prioritization coverage cutoff point. However, the condition remains highly treatable beyond the first 25 days of life. Under the waiver, it would not be covered.

126 Id. at 5.11.

127 Id.

128 See Glen F., Ackerman, Access to Health Care for the Uninsured: The Perspective of the American Academy of Family Physicians, 265 JAMA 2856, 2856 (1991).Google Scholar

129 See Emily, Friedman, The Uninsured: From Dilemma to Crisis, 265 JAMA 2491, 2492 (1991).Google Scholar

130 See Stuart M., Butler, A Tax Reform Strategy to Deal With the Uninsured, 265 JAMA 2541, 2541-42 (1991).Google Scholar

131 Indeed, the nation's Governors recently expressed support for the experiment as part of their 1991 statement on health reform. See Warren, King, Health Care: Focus is on Oregon's Plan, THE SEATTLE TIMES, Aug. 18, 1991, at A10Google Scholar (reporting on the national governors’ conference in Seattle).