If it is correct that MCOs have been reluctant to use CEA explicitly, what will be the spark that sets it off? And, once in use, will it make a difference? The spark could come from several sources.
The Courts. First, the courts could signal a willingness to incorporate CEA into the standard of care. As noted above, courts have already signaled their willingness to internalize cost containment strategies, confirmed by the Pegram v. Herdrich decision. As long as the CEA is
conducted according to standard methodologies by qualified experts, admissibility should not be a problem. The crucial issue will be how judges instruct juries on the weight the CEA evidence should be given and whether CEA should set the standard of care. In our view, CEA should be viewed as one piece of evidence for the jury to consider and should not set the standard of care.
An analogy would be how courts have considered (or should consider) clinical practice guidelines, as discussed in Arnold Rosoff's article in this issue. As Rosoff (1995) and others have argued (Brennan 1991), it is unlikely that courts will rely solely on guidelines to set the standard of care but will allow the jury to weigh them as one piece of evidence in determining liability. Given the physician judgment inherent in any
clinical situation, the potential multiplicity of competing and conflicting guidelines, the usual lack of certainty inherent in the guidelines development process, and direct physician testimony, it is improbable that any guideline will suffice to set the standard of care.
The same reasoning holds for CEA. The use of CEA should not be an automatic defense to medical liability; nor, however, should using CEA in and of itself lead to liability. Because there is limited scientific evidence of clinical effectiveness, both sides will use CEA and derive opposite conclusions as to whether the treatment should have been provided. CEA alone will not define the standard of care. The jury should be instructed that CEA is an entirely appropriate method for plans and physicians to use in making clinical decisions, but it is only one factor among many to take into account. Thus, if the jury finds that the CEA was poorly executed, it is free to give other evidence greater weight.
In the alternative, the courts could simply abandon the professional custom standard and switch to the standard of care for nonmedical liability cases, where deference to custom is not as strong. Of the two paths discussed earlier, Helling and Hilbun, the more likely is to incorporate CEA into an evolving standard of care that distinguishes between resource constraints and technical skill. Haavi Morreim (1997) has been a leading proponent of this approach. Morreim argues that both health plans and physicians owe patients the traditional standard of administrative or medical expertise concerning professional knowledge and skill. But since both plans and physicians operate under resource constraints, Morreim would rely on the terms of the contract to set the levels of expected resource use. This provides deference to MCOs in deciding which CEA methods are appropriate and avoids the judicial capacity concerns noted below. As the history of the Helling case suggests, placing judges at the forefront of CEA may not be the best strategy. In any event, the distinction between technical skill and resource utilization is unlikely to be as clear as Morreim maintains.
Institutional Capacity. A question that has received considerable scholarly and judicial attention is the judiciary's capacity for evaluating whether to admit CEA and other complex statistical analyses into evidence. As Daniel W. Shuman argues in his essay, the courts have not aggressively accepted the Supreme Court's invitation to act as a gatekeeper. One possibility is for judges to retain outside expertise to evaluate the qualifications of proposed witnesses and to assess their methodologies for purposes of admissibility only. Then the jury would weigh the evidence once admitted.
MCOs. Second, MCOs could begin more explicit use of CEA. Ideally, the spark should emanate from MCOs rather than courts. Nothing prevents the medical profession from incorporating resource constraints into customary medical practice.
In this case, the role of the courts should not be to force the market to implement any particular cost containment strategy. Rather, the impetus should be among MCOs and other stakeholders to determine when and how CEA should become an integral part of managed care decision making. Then the courts can react on a case-by-case basis to establish whether and how CEA should be incorporated into the standard of care.
Contractual Arrangements. Third, one way to facilitate the goal of applying CEA to clinical decisions is to include explicit authorization for using CEA in managed care contracts. Employers can negotiate with plans over the terms under which CEA would be conducted, and MCOs can include these provisions in the contracts with subscribers. The contract should include how and when CEA will be used, processes for patient appeals, and information explaining the implications to subscribers. Several legal scholars, most prominently Clark Havighurst (1995) and Mark Hall (1997), and economists have advocated the contractual approach (Epstein 1997; Morreim 1997).
The rationale for the primacy of contract is that consumers can directly exercise sovereignty over cost, quality, and service. As an instrument of market arrangements, contract will force health care providers to compete on both price and quality to retain customers. Paul Rubin (1999: 27) notes that purchasers have an incentive to choose an efficient plan, defined as "one that provides all cost-justified care and no more," and that contracts allow individuals to decide how much they desire to spend on health care relative to other commodities. As long as patients understand what benefits will or will not be provided when they get sick, and how costs or CEA will be factored into clinical decisions, patients should be able to select plans providing fewer benefits at lower cost.26 In this way, the market will set the desired benefit-cost levels through a series of contractual arrangements.
Once the spark is ignited, how should the courts set the applicable standard of care? In their otherwise excellent recitation of the barriers to using CEA, Prosser et al. (2000) missed one important problem: how the courts might interpret it. The question is whether MCOs can implement CEA without providing plaintiffs' attorneys with an evidentiary smoking gun. This raises the broader question of what the standard of care should be for MCOs. As a normative proposition, should MCOs be immune from negligence actions based on reasonable cost containment programs? As an empirical proposition, will the imposition of liability unduly constrain the development of cost containment programs? If CEA becomes a standard for clinical decisions, will courts shift from the dominant tort law paradigm to contract law in resolving disputes?
From a conceptual perspective, there is no reason why MCOs should be automatically absolved from the adverse consequences of their economic decisions. One issue is whether the standard should continue to be based in tort or should shift to contract law. Despite the urging of several commentators (Morreim 1995; Havighurst 1995), courts have only hinted at the possibility of shifting to contract-based determinations (see, e.g., Dukes v. U.S. Healthcare, 57 F.3d 350 [3d Cir. 1995]). Numerous commentators have argued in favor of enterprise liability where the MCO would assume legal responsibility for any negligent outcomes. Enterprise liability would further solidify the MCOs's control over medical care but would give them greater flexibility to bargain with employers to include CEA (see, e.g., Havighurst 1997; Abraham and Weiler 1994; Sage 1997).
While a full discussion of potential MCO liability standards is beyond the scope of this article, there is no reason why MCOs should be prevented from arguing that the proper negligence standard should incorporate cost-based decisions.27 In essence, juries should be able to decide whether the MCO has balanced the benefits of preserving assets for the patient population relative to the harm incurred by the individual patient, as in any other industry. In considering the standard of care for MCOs, courts could adopt one of several possibilities.28
First, in 1975, Randy Bovbjerg argued that the liability standard for HMOs should be based on standard practices among similar organizations. Bovbjerg contended that it would not be desirable to hold HMOs to customary standards of the fee-for-service system when HMOs were organized on a different model. Doing so could undermine HMOs's cost control strategies. When this concept was introduced, it really only applied to HMOs. With the expansion of MCO types since then, it might be a more difficult concept to apply. Still, the core idea that the standard of care for MCOs would adjust for cost containment strategies remains attractive and is consistent with the arguments above allowing for the profession to incorporate cost constraints into clinical decisions. The Illinois Supreme Court adopted a similar approach in Jones v. Chicago HMO Ltd. (730 N.E.2d 1119, 1129 [Ill. 2000]), stating that "an HMO must act as would a 'reasonably careful' HMO under the circumstances."
Second, the standard could be based on whether the plan made a reasonable attempt at applying CEA. Similar to the deference standard seen in government regulation cases, courts would accept that MCOs make cost-quality-access trade-offs and would only intervene if the CEA were conducted in an arbitrary and capricious manner. In this sense, the courts' primary role would be to ensure that fair processes were followed.29
Third, courts could reverse their deference to professional custom and resolve liability questions under traditional negligence standards. This would place cost-benefit trade-offs at the core of the judicial inquiry. An advantage is that MCOs could explicitly invoke CEA and other cost containment efforts as a defense. A disadvantage is that the court may second-guess the appropriateness of the methods and impose a higher standard of care, as in Helling v. Carey. Certainly, the potential for liability places a constraint on the extent of cost containment. But in doing so, the courts would simply be playing their traditional role in setting limits and in monitoring private economic relations. By imposing general negligence standards, the courts would not be impeding cost containment initiatives. They would instead be requiring plans to weigh the costs and benefits of implementing cost controls given potential adverse medical outcomes.
Fourth, courts might revert to the physician dominated standard of care seen under fee-for-service litigation where the physician's duty is to treat the individual patient and to increase the probability of a good outcome without worrying about resource constraints. In this approach, CEA would constitute a lower standard of care unless it became part of customary practice.
A fifth possibility is that courts could abandon tort altogether in favor of contract. As noted earlier, this is the preferred solution for many legal scholars and economists. To be viable, the contract would need to clearly specify the use of CEA, how it will be implemented and how patients will be informed about its use. Absent more explicit contractual arrangements between plans and employers, there is no reason to believe that courts will shift to contract on their own (Jacobson and Pomfret 1999). This would change if, over time, plans and subscribers bargained for lower cost plans with lower benefit levels based on explicit CEA or other cost containment strategies. Courts would then be compelled to address the use of CEA from a contractual, as opposed to a tort, perspective.30
Sixth, courts could abandon both tort and contract to develop a standard based on fiduciary duty (Jacobson and Cahill 2000). This standard would force the courts to develop criteria for balancing between individual patient needs and preserving resources for the patient population. Although the Supreme Court has now foreclosed fiduciary challenges under ERISA in Pegram v. Herdrich, nothing prevents state courts from developing a common law of fiduciary duty in managed care litigation that survives an ERISA preemption challenge.
Finally, courts could develop alternative standards that combine tort and contract approaches. Various scholarly strategies for bridging tort and contract are described by Jacobson and N. M. Patil (2000), such as the bifurcate standard of care described earlier.31
Right now, ERISA preemption may limit state court experimentation with different standards of care. But to the extent that state courts hear more managed care cases, it seems likely that variation across states among the above options will emerge. Judges will look to legal scholars and health policy analysts and researchers for guidance on the health care policy and delivery implications of each standard.
Avoiding the Smoking Gun. Even if one accepts this approach, it still leaves unanswered the question of how plans can use CEA without either providing the smoking gun for a jury verdict or engendering a public backlash. In some ways, responding to the backlash may define how the former will be resolved. If plans can develop ways to bring the public into the decision-making process, there is less likelihood that individuals will sue, and less likelihood that juries will punish the use of CEAs.
Suppose courts eventually rule that CEA is admissible as one piece of evidence to determine the standard of care (in the same way that courts seem to be handling guidelines). Can this be introduced without prejudicing the jury against the MCO? As the Ford and GM cases illustrate, juries may have an inherent dislike of CEA when carried out by private parties who are maximizing profits at the expense of lives. The problem is likely to occur on cross-examination. In interviews regarding the cost-effectiveness of contrast agents, physicians who argued in favor of using the more expensive technology worried about being cross-examined as follows: "Dr. X, do you mean to tell me that this patient died (or suffered a severe reaction) because you wouldn't spend $150 to protect the patient's safety?" (Jacobson and Rosenquist 1996). As the GM gas tank case suggests, this is likely to be as much of a problem for MCOs as for physicians, particularly at a time when the public is generally skeptical, if not suspicious, of managed care's economic motives.
One possible approach is for judges to provide explicit instructions to the jury on how to weigh CEA evidence and where CEA fits in setting the standard of care. But this problem will not easily be solved. As Gary Schwartz (1991: 1041) observed in commenting on the Grimshaw case: "It seems sensible to recognize in all of this an instance of the 'two cultures' problem. A culture has developed around public policy analysts that sees the risk-benefit criterion as obviously acceptable; but the culture of public opinion itself tends to regard that criterion as distressing. Indeed, the outcome of the subsequent GM gas tank case suggests that the gulf between the two cultures remains wide."
Another possible approach is to develop a CEA certification process, perhaps under the auspices of the Agency for Healthcare Quality and Research (AHRQ) or the Institute of Medicine (IOM). CEAs certified by the responsible entity would be admissible, while CEAs not certified would be inadmissible.
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In a 1988 article, Jacobson and John Rosenquist (1988: 1589) argued that medical professionals should not be held liable for the failure to use new technologies that were not cost-effective, stating that "nothing prevents the profession from factoring in resource constraints in defining the level of technology that will become customary practice." Surprisingly, the technology discussed in that article, contrast agents, never generated the anticipated litigation, so there was no test of whether the suggested approach would be persuasive in an appropriate case. For that test to occur, CEA needs to be implemented. Sooner or later, the dictates of cost containment will compel more widespread use of CEA. Then the courts can decide whether to defer to the profession or to consider medical liability under general negligence principles that take cost-effectiveness into account.
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a. The authors would like to thank fellow panelists Cynthia D. Mulrow and Daniel W. Shuman along with Wilhelmine Miller and Jacqueline Besteman for valuable comments on the manuscript and throughout the process. We are particularly indebted to Arnold J. Rosoff for astute comments and suggestions for expanding the analysis. Robert Adler, Jeffrey Wasserman, and Philip G. Peters Jr. provided valuable comments on a previous draft, as did two anonymous reviewers. The authors benefited from comments made by panelists convened by the Institute of Medicine and the Agency for Healthcare Research and Quality workshop on medical evidence, "'Evidence': Its Meanings and Uses in Law, Medicine, and Health Care," in Washington, DC, on 10 April 2000. Jacobson appreciates financial support provided by the Agency for Healthcare Research and Quality, the Institute of Medicine, and a Robert Wood Johnson Foundation Investigator Award in Health Policy Research.
1. We define cost containment initiatives as that set of managed care practices designed to reduce the costs of health care by encouraging providers to limit medical treatment. For more detailed consideration, see Gold et al. 1995.
2. Eddy (1996: 653) adds that a clinical intervention "is considered cost-effective if there is no other available intervention that offers a clinically appropriate benefit at a lower cost."
3. Some economists treat CBA and CUA as a variant of CEA. Personal communication with Michael Chernew, 15 August 2000.
4. Although the authors collected data from thirty-four plans and medical groups, the actual number of plan and group staff interviewed is not apparent in the final report, making it difficult to assess the validity of the reported results.
5. This, of course, creates some cognitive dissonance with the public's apparent desire to reduce health care costs. Perhaps it's the health care equivalent of the NIMBY syndrome (not in my backyard).
6. Philip Peters Jr. (2000) postulates that a trend among state courts is to move away from deference to the professional custom standard toward a "reasonable and prudent physician" standard. Even if Peters is correct, it is not clear how the emerging reasonable physician standard differs conceptually from professional custom and whether case outcomes are actually different in jurisdictions switching to the new approach.
7. Restatements of the law are summaries of cases and commentaries on where the law should go prepared by leading scholars under the auspices of the American Law Institute. Many courts adopt the restatements in resolving litigation.
8. The case was subsequently superseded by the Washington state legislature.
9. For example, the test has a high false-positive rate and early detection does not always alter the outcome (Fortess and Kapp 1985). On the other hand, the fact that the physician ignored the plaintiff's repeated complaints suggests a violation of the standard of care regardless of CEA.
10. Haavi Morreim has been an avid proponent of the bifurcated standard of care.
11. Federal medical liability jurisdiction almost always results from diversity of citizenship (litigants residing in different states) rather than from raising a federal question.
12. For more detailed consideration, see Jacobson and Pomfret 2000.
13. En banc decision affirming the three-judge panel, dissenting opinion.
14. The Boren Amendment provided the states with greater flexibility in setting Medicaid reimbursement rates to reduce rising Medicaid costs. The question for the courts is whether the rates set bear a reasonable relationship to the costs of providing the care.
15. Reversed on other grounds in Kawaauhau v. Geiger, 523 U.S. 57 (1998).
16. In their review of 203 judicial decisions involving clinical appropriateness criteria in medical necessity challenges, Anderson, Hall, and Smith (1998) make no mention of cost as a factor in case outcomes.
17. Singer et al. (1999: 66) note that "whether this relates to the tendency to pursue cases only when large amounts of money are at stake or whether disputes over lower cost treatments are settled at an earlier stage is not clear."
18. We thank Arnold Rosoff for this observation.
19. For an excellent analysis of the underlying issues in this case, see Schwartz 1991. For additional case examples, see Viscusi 2000.
20. In commenting on this article, Daniel W. Shuman asked whether it is fair to compare these automobile cases to CEA in health care. Because the auto case memos suggest a clear financial trade-off between the costs safety relative to paying for loss of life, while health care CEA makes trade-offs at the margin regarding net health benefits, the two may be very different. However inexact the analogy, it is a fair comparison. Inappropriately denied care may result in disability or premature mortality, so the practical effect may be similar.
21. Issued by President Clinton on 30 September 1993.
22. Health care, and especially health care financing, would be another expected regulatory use of CEA. However, the HCFA recently backed away from using CEA in its proposed criteria for making coverage decisions. See Federal Register, vol. 65, no. 95, Tuesday, 16 May 2000, pp. 31124-31129.
23. Industrial Union Department v. American Petroleum Institute, 448 U.S. 607 (1980); American Textile Manufacturers Institute v. Donovan, 452 U.S. 490 (1981).
24. See also, International Union, United Auto Workers v. OSHA, 938 F.2d 1310 (D.C. Cir. 1991) (Williams, J., concurring at p. 1326: "And larger incomes enable people to lead safer lives.").
25. Lempert is also skeptical of the "deep pocket" effect, where jurors punish the party with the greatest financial assets. Personal communication, 10 April 2000. Viscusi (2000) conducted a subsequent jury judgment survey using different scenarios. In some scenarios, respondents were asked to react to situations where corporations used CBA; in others, CBA was not used. Mock jurors awarded 50 percent greater damage amounts when CBA was used. However, Peters (2000) echoing Lempert (1999), argues that policy makers should proceed cautiously to enact reform proposals that would systematically favor defendants.
26. As Catherine McLaughlin and Paul Ginsburg (1998) argue, subscribers usually do not negotiate directly over the contractual terms but are represented by employers, and subscribers are usually uninformed about contractual provisions.
27. "There is no theoretical impediment to configuring a medical malpractice standard that is . . . sensitive to available patient resources" (Henderson and Sciciliano 1994: 1395).
28. We are indebted to Arnold Rosoff for suggesting this line of analysis.
29. P. D. Jacobson and M. T. Cahill (2000) have proposed a similar strategy for resolving conflicts of interest under fiduciary duty concepts.
30. In response to this point, Shuman (in this issue) argues that this should be a contracts issue and that our approach essentially allows courts to rewrite contracts under the guise of tort law. From a normative perspective, one of the authors has argued against using a contract regime in health care litigation (Jacobson and Patil 2000). As an empirical proposition, we are not aware of instances where employers have negotiated contracts with MCOs to incorporate CEA. Absent some contractual language about the use of CEA, if an MCO uses CEA to deny care, the subsequent challenge lies in tort, not contract.
31. Jacobson and Cahill (2000) argue that a breach of fiduciary standard is more useful than either tort or contract in the managed care context.
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Cost-Effectiveness Analysis in the Courts:
Recent Trends and Future Prospects. Evidence: Its Meanings in Health Care and in Law. Journal of Health Politics, Policy and Law, 26:2, April 2001. Copyright 2001, Duke University Press. All rights reserved; posted with permission. For information on the journal or to order a hard copy, go to http://www.dukeupress.edu/jhppl/