• How comparative effectiveness fails – ctd

    A 1993 JAMA paper by John Furguson, Michael Dubinsky, and Peter Kirsch is a nice complement to my prior post on the challenges that private insurers would (and do) have in making coverage decisions based on comparative effectiveness research (CER).

    Among the numerous reasons for assessing health care technology is the need to provide scientifically reliable information for health care providers and third-party payers so they can make the reasoned decisions necessary for proper health care and cost control.

    The courts often play a pivotal role in assessing new health care technology. We became aware of several cases in which patients successfully recovered incourt from third-party payers for failure to reimburse for various medical procedures or treatments, some of which were widely agreed to be medically unsafe or ineffective. We postulated that the courts—as unscientific arbiters of medical technology—could inadvertently become the true assessors of new technology, and that insurers might reimburse medical claims hastily, without adequate assessments, in order to avoid litigation. One would hope that the judicial system (including attorneys, judges, and jurors), increasingly exposed to issues involving medical science and technology, would rely on scientifically valid, balanced, and unbiased assessments. To the contrary, we found that the judicial system seldom uses, and may avoid, published medical science. […]

    Furthermore, common law interpretations of contracts, which historically have been intended to protect consumers from overreaching by insurance companies, often leave courts little choice but to hold in favor of the insured, even when competent medical evidence demonstrates that the technology in question is either unsafe or ineffective. Court judgments that order reimbursement for unproven technologies potentially spread their use, since reimbursement is known to encourage the use of a new technology, as was demonstrated for magnetic resonance imaging. If abused, these traditional doctrines, which the legal system relies on, would effectively undercut or bypass medical technology assessments, resulting in not only a more expensive health care system, but also one that does not properly respond to changes in medical science.

    Is anyone aware of a more recent paper that covers similar territory? If the legal landscape hasn’t changed, how are private insurers ever to make CER-based coverage decisions without risk of litigation, unless, of course, Medicare provides the cover?


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    • On an unrelated topic, have you done posts on the question of allowing insurers to sell across state lines? Do you have some references to good analyses on both sides of this issue?

    • Austin
      There must be updates.

      I am interested in hearing whether courts, over the decade since the paper was published, ruled in favor MCOs when evidence was presented in cases of dubious distinction. Ten years is a long time and rx and procedures have advanced ($).


      PS–whats with the ellipsis misuse?

    • If the problem is that the law requires any ambiguity in the insurance contract to be interpreted in favor of the insured–a good idea in general–how much of a marketing problem would it be for insurance companies to explicitly say in bold print (1) that they don’t cover procedures that published studies show have a less than X percent chance of producing a better outcome than a placebo. and (2) that they weigh such studies far more highly than anecdotal reports from patients and physicians and “expert” testimony from physicians?
      saying that they don’t cover experimental procedures would probably be way to vague.

      Does the law require that the effectiveness of new technologies tested against placebo and/or existing treatments before they are put on the market or just shown to be safe? What about new procedure not involving new technology? Is there any requirement to test them or is it enough that physicians decide they represent a reasonable approach?

    • I would argue that part of the problem here is the fractured nature of the market. It is not that claims payers do not attempt to apply rational science to their decisions, it is just that we have dozens of payers each going it alone. There is no coordinated effort.

    • What is the FDA doing? Aren’t they supposed to approve of procedures as being safe and effective before they are available? And would that not be a way to regulate this?

      This is a terrible misuse of law and something ought to be done to change it. It is almost unbelievably stupid.

    • This certainly helps to explain why private insurers just pass on costs.


    • I’m personally skeptical of how much comparative effectiveness testing will yield, so let me ask this: are there many examples of therapies which have been shown to be ineffective on the basis of epidemiological research, and on that basis have been eliminated from standard medical practice? I’m wondering if hormone replacement therapy (HRT) might be one such example, but I don’t know — maybe there are still doctors out there who are still recommending this to their patients.

      What I would expect in these situations is that the insurance company has absolutely no interest in getting involved in this dispute, and instead the most sensible policy is to simply agree to cover all available options, and let the doctors take responsibility for making the actual decisions.