1 Berwick, Donald M., Continuous Improvement as an Ideal in Health Care, 320 New Eng. J. Med. 53 (1989)Google Scholar; Avedis, Donabedian, A Primer of Quality Assurance and Monitoring in Medical Care, 20 Toledo L. Rev. 401 (1989)Google Scholar.

2 Avedis Donabedian, The Definition of Quality and Approaches to its Assessment 1 (1980) [hereinafter Donabedian, the Definition of Quality]; Institute of Medicine, Medicare: A Strategy for Quality Assurance (Kathleen N. Lohr ed., 1990).

3 Eddy, David M., Designing a Practice Policy: Standards, Guidelines and Options, 263 JAMA 3077 (1990)Google Scholar; Eddy, David M., Practice Policies—What Are They?, 263 JAMA 877, 878 (1990)Google Scholar. Although there is no standardized terminology, “standards” tend to be the most specific and prescriptive, with “policies” and “guidelines” offering more flexible criteria, and “options” being primarily descriptive without recommendations.

4 Wennberg, John E., Dealing with Medical Practice Variations: A Proposal for Action, Health Aff., Summer 1984, at 6Google Scholar [hereinafter Wennberg, Dealing with Medical Practice Variations].

5 The Pepper Commission estimated that 10 to 20% of the medical services currently used have been studied in randomized clinical trials. United States Bipartisan Commission on Comprehensive Health Care, The Pepper Commission, A Call for Action: Final Report 41 (1990).

6 Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301-394 (1993). Most devices are marketed after submission of a premarket notification (Section 510(k) notification). A device that is not substantially equivalent to a predicate device (marketed before May 28, 1976) must obtain premarket approval based on a demonstration that the device is safe and effective for its intended use.

7 Mulley, Albert G., Jr. & Eagle, Kim A., What Is Inappropriate Care?, 260 JAMA 540 (1988)Google Scholar; Avedis, Donabedian, The Quality of Care: How Can It Be Assessed?, 243 JAMA 1743 (1988)Google Scholar. On defining and measuring quality, see generally, Avedis Donabedian, The Methods and Findings of Quality Assessment and Monitoring: An Illustrated Analysis (1985); Avedis Donabedian, Criteria and Standards of Quality (1982); Donabedian, The Definition of Quality, supra note 2.

8 Harris quotes a Harvard researcher as saying that 1912 was “the first time in human history … a random patient with a random disease consulting a doctor chosen at random stood better than a 50-50 chance of benefiting from the encounter.” Richard Harris, A Sacred Trust 5 (1966).

9 Richard, Epstein et al., Effect of Parenterally Administered Gold Therapy on the Course of Adult Rheumatoid Arthritis, 114 Annals Internal Med. 437 (1991).Google Scholar

10 Park, Rolla E. et al., Physician Ratings of Appropriate Indications for Three Procedures: Theoretical Indications vs. Indications Used in Practice, 79 Am. J. Pub. Health 445 (1989)Google Scholar; Mark, Chassin et al., Does Inappropriate Use Explain Geographic Variations in the Use of Health Care Services?, 258 JAMA 2533, 2536 (1987)Google Scholar (between 17 and 32 percent of three Medicare procedures were found to be performed for inappropriate indications, but procedures performed appropriately were performed at widely different rates in different geographic areas).

11 Chassin et al., supra note 10; John, Dawson, Practice Variations: A Challenge for Physicians, 258 JAMA 2570 (1987)Google Scholar; Park et al., supra note 10; John, Wennberg & Alan, Gittelshon, Small Area Variations in Health Care Delivery, 182 Science 1102–1108 (1973)Google Scholar; John Wennberg et al., Are Hospital Services Rationed in New Haven or Over-Utilized in Boston?, Lancet, May 1987, at 1185; Wennberg, Dealing with Medical Practice Variations, supra note 4.

12 James, Perrin et al., Variations in Rates of Hospitalization of Children in Three Urban Communities, 320 New Eng. J. Med. 1183 (1989)Google Scholar (suggesting that low income families’ lack of access to primary care may contribute to increased hospitalization of children in certain geographic areas); John Wennberg, AHCPR and The Strategy for Health Care Reform, Health Aff., Winter 1992, at 67-71; Wennberg, Dealing with Medical Practice Variations, supra note 4 (noting that when physicians were told that rates of tonsillectomies and hysterectomies varied in different geographic areas, the higher use areas dropped their rates substantially without any obvious adverse effects on patient outcomes). But see John Brook et al., Geographic Variations in the Use of Services: Do They Have Any Clinical Significance?, Health Aff., Summer 1984, at 63.

13 Wennberg, Dealing with Medical Practice Variations, supra note 4, at 78.

14 Omnibus Budget Reconciliation Act of 1989, 42 U.S.C. § 201 (Supp. 1992).

15 AHCPR replaced the National Center for Health Services Research and Health Care Technology Assessment. See Bradford Gray, The Legislative Battle Over Health Services Research, 11 Health Aff., Winter 1992, at 38-66. About one-third of AHCPR's budget has funded outcomes research. Efforts to analyze existing hospital and insurance data as a less expensive alternative to prospective clinical trials have met with some controversy. Christopher, Anderson, Measuring What Works in Health Care, 263 Science 1080 (1994)Google Scholar.

16 See, e.g., Darling v. Charleston Community Memorial Hosp., 211 N.E.2d 253 (111. 1965), cert, denied, 383 U.S. 946 (1966); Arthur F. Southwick, The Law of Hospital and Health Care Administration 554-580 (2d ed. 1988).

17 Barry, Furrow, The Changing Role of the Law in Promoting Quality in Health Care: From Sanctioning Outlaws to Managing Outcomes, 26 Hous. L. Rev. 147 (1989)Google Scholar.

18 42 U.S.C.A. § 11,135 (Supp. 1988).

19 Rubin, Haya R. et al., Watching the Doctor-Watchers: How Well Do Peer Review Organization Methods Detect Hospital Care Quality Problems), 267 JAMA 2349 (1992)Google Scholar.

20 See The Legitimacy of Practice Policies, infra part X.

21 See Individual Care and Payment Determinations, infra part VIII.

22 Blum, John D., Economic Credentialing: A New Twist In Hospital Physician Appraisal Processes, 12 J. Legal Med. 427, 428-29 (1991)Google Scholar; Hershey, , Applying Utilization Review Findings in Medical Staff Appointment and Reappointment Decisions, 1 Quality Assurance & Utilization Rev. 109 (1986)Google Scholar. Other examples are discussed in Individual Care and Patient Determinations, infra part VIII, and Medical Malpractice Litigation infra part IX.

23 Mehlman, Maxwell J., Health Care Cost Containment and Medical Technology: A Critique of Waste Theory, 36 Case W. Res. L. Rev. 778, 784-94 (1986)Google Scholar.

24 For example, lung surfactants appear to help save the lives of newborns with premature lungs. Some of these newborns who would have died several years ago now survive with other severe medical conditions that require costly medical and social services.

25 Antibiotics, for example, can cure a bacterial infection like pneumonia, but have no effect on a viral illness that produces similar symptoms. Diagnostic tests can pinpoint the cause of illness and whether an antibiotic should be used. This should benefit the patient because inappropriate antibiotic use can sometimes create resistance. However, the cost of the diagnostic tests may exceed the cost of the inappropriate use of antibiotics.

26 Canterbury v. Spence, 464 F.2d 772, 783 (D.C. Cir. 1972); Cobbs v. Grant, 502 P.2d 1, 7 (Cal. 1972); RUTH, FADEN & BEAUCHAMP, THOMAS L., A History and Theory of Informed Consent (1986)Google Scholar.

27 Murphy, Donald J. et al., The Influence of the Probability of Survival on Patients’ Preferences Regarding Cardiopulmonary Resuscitation, 330 New Enc. J. Med. 545 (1994)Google Scholar; Schneider, et al., In-Hospital Cardiopulmonary Resuscitation: A 30-Year Review, 6 J. Am. Board Fam. Prac. 91 (1993)Google Scholar (meta-analysis of 98 studies of CPR outcomes reported that, on average, 15% of resuscitations were successful, with success rates varying by age, diagnosis and other factors; many successfully resuscitated patients died before leaving the hospital; see also Cohen, Todd H. et al., A Comparison of Active Compression-Decompression Cardiopulmonary Resuscitation for Cardiac Arrests Occurring in the Hospital, 329 New Eng. J. Med. 1918 (1993)Google Scholar (with a new CPR devise two of 29 patients survived CPR to leave the hospital; none of 33 patients survived standard CPR to leave the hospital).

28 See, e.g., Mass. Gen. Laws Ann., ch. 201D, § 2 (West Supp. 1993). In Cruzan v. Director, Mo. Dep't of Health, 497 U.S. 261 (1990), Justice O'Connor suggested that the Constitution should protect a patient's designation of a surrogate decision maker (as by durable power of attorney) to make binding decisions on her behalf after she becomes incompetent to do so herself.

29 McNeil, Barbara J. et al., Fallacy of the Five-Year Survival in Lung Cancer, 299 New Enc. J. Med. 1397 (1978)Google Scholar.

30 McNeil, Barbara J. et al., Speech and Survival: Tradeoffs Between Quality and Quantity of Life in Laryngeal Cancer, 305 New Eng. J. Med. 982 (1981)Google Scholar.

31 Patient refusals of treatment, even at the end of life, of course, cannot be expected to save substantial sums for the health care system. Emanuel, Ezekial J. & Emanuel, Linda L., The Economics of Dying: The Illusion of Cost Savings at the End of Life, 330 New Eng. J. Med. 540 (1994)Google Scholar.

32 United States General Accounting Office, Medicare: Physician Incentive Payments by Prepaid Health Plans Could Lower Quality of Care (1988).

33 Marc A. Rodwin, Medicine, Money and Morals 135-51 (1993) [hereinafter Rodwin, Medicine Money and Morals].

34 Moore v. Regents of Univ. of Cal., 793 P.2d 479 (Cal. 1990), discussed in George J. Annas, the Standard of Care: The Law of American Bioethics 167-77 (1993).

35 Rodwin, Marc A., Physicians’ Conflicts of Interest: The Limitations of Disclosure, 321 New Eng. J. Med. 1405 (1989)Google Scholar.

36 See generally Rodwin, Medicine, Money and Morals, supra note 33, at 216-20.

37 Susan, Abramowitz et al., Analyzing Patient Satisfaction: A Multianalytic Approach, 13 Quality Rev. Bull. 122 (April 1987)Google Scholar; Cleary, Paul D. et al., Patients Evaluate Their Hospital Care: A National Survey, Health Aff., Winter 1991, at 254Google Scholar; Cleary, Paul D. & McNeil, Barbara J., Patient Satisfaction as an Indicator of Quality of Care, 25 Inquiry 25 (1988)Google Scholar; Patient Judgments of Hospital Quality: Report of Pilot Study, Med. Care, at S1 (Mark Meterko et al. eds., Supp. Sept. 1990).

38 The ability to communicate with a physician or other provider can make possible the identification of critical information about the patient's medical history or preferences that affect diagnostic and treatment choices.

39 Outcomes assessment may be used in disputes to decide whether particular services are or were medically necessary on a case-by-case basis. This is discussed in Individual Care and Payment Determinations, infra part VIII.

40 Hall, Mark A. & Anderson, Gerard F., Health Insurers'Assessment of Medical Necessity, 140 U. Pa. L. Rev. 1637, 1637-38 (1992)CrossRefGoogle Scholar.

41 Congress of the United States, Office of Technology Assessment, Evaluation of the Oregon Medicaid Proposal, 102d Cong., 2d Sess. (1992).

42 448 U.S. 297 (1980).

43 469 U.S. 287 (1985).

44 29 U.S.C. §§ 701-796 (1988).

45 The number of medical procedures covered by mandated benefit laws is increasing, perhaps because patients see such laws as their only avenue to obtain specific services that private insurers would not otherwise cover. A recent example is mandated benefit laws requiring coverage of bone marrow transplants to treat metastatic breast cancer, which many women see as their last chance for survival, but which remains investigational. See, e.g., Mass. Gen. L., ch. 175, § 47m (1994).

46 29 U.S.C. § 1144(a) (1988).

47 Mariner, Wendy K., Problems with Employer-Provided Insurance—The Employee Retirement Income Security Act and Health Care Reform, 327 New Eng. J. Med. 1682, 1683 (1992).Google Scholar

48 42 U.S.C. § 139d(l)-(5) (1988) (inpatient hospital, outpatient hospital, other laboratory and x-ray, skilled nursing facilities, periodic screening and diagnosis, family planning, and physician services). States may fund additional services on their own initiative. The preamble to the Medicaid legislation states that its purpose is to enable the states, “as far as practicable,” to furnish medical care to those “whose income and resources are insufficient to meet the cost of necessary medical services… . “ 43 U.S.C. § 1396. This language identifies the individuals who are (subject to additional requirements) eligible for Medicaid, and does not necessarily entitle them to all services that are medically necessary. Neither the federal statute nor regulations defines medically necessary services.

49 Rush v. Parham, 625 F.2d 1150, 1156-57 (5th Cir. 1980).

50 Frederich v. Secretary of Health and Human Services, 894 F.2d 829 (6th Cir.), cert, denied, 111 S. Ct. 59 (1990); McLaughlin v. Williams, 801 F. Supp. 633 (S.D. Fla. 1992) (even if a therapy is novel or investigational, it should be covered as non-experimental if authoritative evidence shows it be safe and effective).

51 Beal v. Doe, 432 U.S. 438, 444 (1988) (quoting 42 U.S.C. § 1396(a)(17)).

52 42 C.F.R. § 440.230(c) (1992).

53 States may limit services “based on such criteria as medical necessity or utilization control procedures.” 42 C.F.R. § 440.230(d); see also Rush v. Parham, 625 F.2d 1150 (5th Cir. 1980); Cowan v. Meyers, 232 Cal. Rptr. 299 (Cal.), cert, denied, 484 U.S. 846 (1986).

54 Weaver v. Reagan, 886 F.2d 194 (8th Cir. 1989); Pinneke v. Preisser, 623 F.2d 546 (8th Cir. 1980).

55 42 U.S.C. § 1395y(a)(l)(A).

56 Goodman v. Sullivan, 891 F.2d 449 (2d Cir. 1989). Guidelines issued to Medicare intermediaries define an experimental service as one that has not become generally accepted by the professional medical community as an effective and proven treatment for the condition for which it is being used, or one that is rarely used, novel or relatively unknown. If a service is not generally accepted, it can be deemed medically necessary if “authoritative evidence” demonstrates that it is safe and effective.

57 Hall & Anderson, Models of Rationing. Analogous disputes arise over excluding a service because it is “cosmetic” as opposed to “reconstructive” surgery, “custodial” as opposed to “skilled” care, or intended to treat “mental” as opposed to “physical” illness.

58 Marilyn, Chase, Medical Quandary: Breast-Cancer Patients Seeking New Therapy Face Tough Obstacles, Wall ST. J., Feb. 17, 1993, at Al.Google Scholar

59 Bucci v. Blue Cross and Blue Shield of Conn., 764 F. Supp. 728 (D. Conn. 1991); Adams v. Blue Cross and Blue Shield, 757 F. Supp. 661 (D. Md. 1991); Pirozzi v. Blue Cross and Blue Shield of Va., 741 F. Supp. 586 (E.D. Va. 1990). In Fox v. Health Net of California, No. 210692 (Cal. Sup. Ct., Dec. 28, 1993), an unreported jury decision awarded a woman's estate $12.1 million in compensatory damages and $77 million in punitive damages for an HMO's refusal to pay for an autologous bone marrow transplant for metastatic breast cancer. Michael, Meyer & Andrew, Murr, Not My Health Care, Newsweek, Jan. 19, 1994, at 36Google Scholar.

60 Curt, Suplee, Blue Cross Agrees to Fund Breast Cancer Experiment: Women to Undergo Bone-Marrow Transplants, Wash. Post, Nov. 13, 1990, at Al, A8.Google Scholar

61 James, Frank P., The Experimental Exclusion Clause: A Tool for Silent Rationing of Health Care?, 12 J. Legal Med. 359, 403 (1991).Google Scholar

62 Anderson, Gerard F. et al., Medical Technology Assessment and Practice Guidelines: Their Day in Court, 83 Am. J. Pub. Health 1635, 1638 (1993)Google Scholar.

63 Ponder v. Blue Cross, 193 Cal. Rptr. 632 (Ct. App. 1983).

64 Hughes v. Blue Cross of North. Cal., 263 Cal. Rptr. 810 (Ct. App. 1989); VanVactor v. Blue Cross Ass'n, 365 N.E.2d 638 (111. App. Ct. 1977).

65 This conflict of interest is lessened where insurers provide only claims administration services (as by contract to self-insured employers, for example) for which they receive a fixed fee and are not at risk for payment of the benefits. However, to the extent that the insurer's income depends upon maintaining its contract fees, it has an incentive to minimize the benefits its clients have to pay.

66 Anderson et al., supra note 62, at 1636-37.

67 FMC Corp. v. Holliday, 111 S. Ct. 403, 409 (1990).

68 Cathey v. Dow Chem. Medical Care Program, 907 F.2d 554, 558-59 (5th Cir. 1990). The language conferring such authority has itself been construed as ambiguous, however. Adams v. Blue Cross & Blue Shield of Md., 757 F. Supp. 661 (D. Md. 1991).

69 Firestone Tire & Rubber v. Bruch, 489 U.S. 101, 112-15 (1989).

70 Institute of Medicine, Controlling Costs and Changing Patient Care: The Role of Utilization Management (Bradford H. Gray & Marilyn J. Field eds., 1989) [hereinafter Institute of Medicine, Controlling Costs].

71 Wickline v. State of Cal., 228 Cal. Rptr. 661 (Cal. App. 1986), appeal dismissed, (741 P.2d 613 Cal. 1987).

72 In Wickline, Lois Wickline claimed that California's Medi-Cal program had wrongfully denied her extra days in the hospital which resulted in the amputation of her leg. Id. at 662. The court made clear that her physicians retained primary responsibility for patient care decisions. Since Wickline's physicians decided to discharge her without protesting or appealing Medi-Cal's refusal to pay for an additional hospital stay, Medi-Cal was not liable for her loss. Id. at 670-71. Medi-Cal made a decision on payment only. However, the court hinted, in dictum, that third party payors “can be held legally accountable when medically inappropriate decisions result from defects in the design or implementation of cost-containment mechanisms ….” Id. at 670.

73 Corcoran v. United Healthcare, Inc., 965 F.2d 1321 (5th Cir. 1992) (ERISA preempted malpractice action brought against company performing prospective review for employee health plan).

74 Pilot Life Ins. Co. v. Dedeaux, 481 U.S. 41 (1987); John, Blum, An Analysis of Legal Liability in Health Care Utilization Review and Case Management, 26 Hous. L. Rev. 191 (1989)Google Scholar. Some Congressmen have proposed amending ERISA to overrule Pilot Life to allow employees to pursue rights of action under state statutory and common law, such as those for fraud and bad faith in withholding insurance benefits. See, e.g., S.794, 102d Cong., 1st Sess. (1991) (entitled The ERISA Preemption Amendments of 1991); H.R. 6147, 102d Cong., 2d Sess. (1992) (entitled Group Health Plan Nondiscrimination Act of 1992).

75 ERISA also permits injunctive relief which might ensure that necessary care be provided in the future, but may come too late to help a patient who has already been denied care.

76 Ingersoll-Rand Co. v. McClendon, 498 U.S. 133, 145 (1990) (noting that relief requested by employee was “well within the power of the federal courts to provide“).

77 Compare United Automobile, Aerospace & Agricultural Implement Workers v. Midland Steel Prods. Co., 771 F. Supp. 860 (N.D. Ohio 1991) and Haywood v. Russell Corp., 584 So. 2d 1291 (Ala. 1991), with Novak v. Anderson Corp., 962 F.2d 757 (8th Cir. 1992), McRae v. Seafarer's Welfare Plan, 920 F.2d 819 (11th Cir. 1991) and Harsh v. Eisenberg, 956 F.2d 651 (7th Cir. 1991).

78 See supra note 45 and accompanying text.

79 Competing insurers or hospitals might collaborate to develop more consistent practice policies, but in so doing might be accused of engaging in a combination or conspiracy in restraint of trade in violation of the antitrust laws. To the extent that such practices are considered part of the business of insurance, they may be exempt from antitrust challenge. In practice, institutions that make independent judgments face little likelihood of antitrust complaints. Havighurst, Clark C., Applying Antitrust Law to Collaboration in the Production of Information: The Case of Medical Technology Assessment, LAW & CONTEMP. PROBS., Winter 1988 at 341Google Scholar; Martin, Rose & Leibenluft, Robert F., Antitrust Implications of Medical Technology Assessment, 314 NEW ENG. J. MED. 1490, 1493 (1986).Google Scholar

80 Institute of Medicine, Controlling Costs, supra note 70.

81 Such standards have been held not binding on a patient where the private insurance contract did not expressly specify the entity or standard. Pirozzi v. Blue Cross and Blue Shield of Va., 741 F. Supp. 586, 588-89 (E.D. Va. 1990).

82 Anderson et al., supra note 62.

83 It also creates an incentive for physicians and patients to characterize recommended services as services that are covered by the plan, which may produce fraudulent claims. Dennis, Novak et al., Physicians'Attitudes Toward Using Deception to Resolve Difficult Ethical Problems, 261 JAMA 2980, 2981-84 (1989)Google Scholar.

84 This is the practice in Canada, where the government pays physicians on a fee-for-service basis, with fees negotiated with government by medical societies. Total fees are reviewed annually and adjusted prospectively if necessary to keep within provincial budget limits.

85 This is the approach adopted in President Clinton's Health Security Act, S. 1757, H.R. 3600, 139 Cong. Rec. S16.788 (daily ed. Nov. 20, 1993). The single payer alternative sponsored by Senator Wellstone and Representative McDermott and others would also establish a uniform minimum benefit package, but would not require the involvement of insurers.

86 Mandatory uniform benefit plans would preclude people from being able to buy a very cheap health insurance policy, being misled into foregoing important benefits, or remaining uninsured or “underinsured” while healthy. Although some economists might consider this an encroachment on individual freedom, it is no more of a limitation than the restrictions on available products imposed by drug regulation, environmental protection standards, and other consumer safety laws.

87 Hall, Mark A., The Defensive Effect of Medical Practice Policies in Malpractice Litigation, 54 Law & Contemp. Probs. 119, 126-34 (1991)Google Scholar.

88 Havighurst, Clark C., Practice Guidelines as Legal Standards Governing Physician Liability, 54 Law & Contemp. Probs. 87, 94–95 (1991)Google Scholar.

89 The plaintiff must provide expert evidence, usually in the form of testimony by a physician-witness, of what a reasonably skilled physician would do for a patient in similar circumstances. The same principle applies to other practitioners, such as nurses, dentists, and hospital administrators, who are held to the level of skill exercised by a competent practitioner in the same field. The defendant may, and does, offer opposing expert testimony that a different standard of care applies, and that whatever the defendant did or did not do satisfied the applicable standard of care or at least a respectable minority position within the medical community.

90 Edward, Felsenthal, Cookbook Care: Maine Limits Liability for Doctors Who Meet Treatment Guidelines, Wall ST. J., May 3, 1993, at Al, A9.Google Scholar

91 Deborah, Garnick, Can Practice Guidelines Reduce the Number and Costs of Malpractice Claims?, 266 JAMA 2856 (1991)Google Scholar; Edward, Hirshfeld, Should Practice Parameters Be the Standard of Care in Malpractice Litigation?, 266 JAMA 2886 (1991)Google Scholar.

92 Current examples include controversies over the relative effectiveness of TPA and streptokinase in limiting the damage resulting from a heart attack; the association between cholesterol levels and heart disease; and whether AZT improves survival of people with AIDS.

93 Swazey, Judith P., Ethical Problems in Academic Research, 81 Am. Scientist 542, 552 (1993)Google Scholar.

94 Wortman, Paul M., Do Consensus Conferences Work? A Process Evaluation of the NIH Consensus Development Program, 13 J. Health Pol., Pol'v & L. 469, 489 (1988)Google Scholar.

95 Drummond, Rennie, Consensus Statements, 304 New Eng. J. Med. 665-66 (1981).CrossRefGoogle Scholar

96 Annas, George J. et al., American Health Law 365 (1990).Google Scholar