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    Friday, May 15, 2009



    The CER (Comparative Effectiveness Program) Debate; Snippets from the May 7, 2009 NEJM & THE May 12 WSJ.

    • One congressman, a physician, sent out an "alert" through the Republican Study Committee, warning that the CER legislation would create "a permanent government rationing board prescribing care instead of doctors and patients." The true intent of the CER provision, he was alleged was "to enable the government to ration care.”

    • George Will states "that with such a system, "Congress could restrict the tax exclusion for private health insurance to `insurance that complies with the Board's recommendation.' The CER, which would dramatically advance government control — and rationing — of health care, should be thoroughly debated, not stealthily created in the name of `stimulus.'"

    • Talk-show host Rush Limbaugh warned that once the stimulus bill "computerizes everybody's health record," a new federal bureaucracy "will monitor treatments to make sure your doctor is doing what the federal government deems appropriate."

    • A single-payer system is fiscally unsustainable without rationing says one pundit-“Why do you think the stimulus package pours $1.1 billion into medical

    "comparative effectiveness research"? It is the perfect setup for medical rationing. Because once you establish what is "best practice" for expensive operations, medical tests and aggressive therapies, you've laid the premise for funding some and denying others,” say opponents.

    So What? What’s all the excitement about?

    Right now, “there is no place that helps you sort through a specific option and how that compares to another,” says the director of the Agency for Healthcare Research and Quality. Under the comparative effectiveness program, the Department of Health and Human Services and two agencies under it —the National Institutes of Health and the Agency for Healthcare Research and Quality — will finance studies that will look at various treatments and will pay for the development of information-gathering tools, like databases of patients being treated for a certain condition.

    The American Reinvestment and Recovery Act gives comparative-effectiveness research (CER) a large boost in funding over the next two years. Despite a consensus that better information about the relative effectiveness of different medical interventions is needed to improve the quality and value of care, some including those quoted above, oppose CER. They have taken the familiar tack that this program will not take adequate account of individual patient differences and may impede the development and adoption of improvements in medical care and "stymie progress in personalized medicine." This is code for medical rationing on a grand scale and withholding of treatments thought best for you by your personal physician.

    But what's wrong with that? asks one debater.

    Even if you want to call it rationing so what? Rationing is not quite as alien to America as we think. We already ration kidneys and hearts for transplant according to survivability criteria as well as by queuing. A nationalized health insurance system would ration everything from MRIs to intensive care by myriad similar criteria.

    It is estimated that a third to a half of one's lifetime health costs are consumed in the last six months of life. Accordingly, Britain's National Health Service can deny treatments it deems not cost-effective -- and if you're old and infirm, the cost-effectiveness of treating you plummets. In Canada, they ration by queuing. You can wait forever for so-called elective procedures like hip replacements.

    The controversy stems in part from a perceived contradiction between the concepts of CER and personalized medicine. In CER, groups of patients are analyzed to compare the effectiveness of alternative medical strategies, with the intent of informing clinical decisions and policies affecting health care. The very name "personalized medicine" suggests an approach to care that is based on individuals rather than groups. The term has been used to describe the consideration of characteristics such as age, coexisting conditions, preferences, and beliefs in crafting an individual management strategy. As the stimulus bill was being debated the opposition to CER found its voice in commentators who claimed that these studies will inevitably lead to government domination of the doctor–patient relationship, "cookbook medicine," and medical rationing. Certainly, important issues do arise in trying to translate CER findings into specific decisions regarding patient care and reimbursement.

    But the most critical question facing CER: Will its results significantly improve the quality and safety of the health care received by the average patient?

    The problem with many current clinical practice guidelines being used to improve quality care is the lack of outcome studies showing proof that the use of process quality measurements or metrics will improve morbidity or mortality in the real world. I have long maintained that P4P "pay-for-performance" is really "pay-for-process."
    Rather than measuring and rewarding improved outcomes, the program which is also being adopted by state and private insurers rewards adherence to practice guidelines. I agree with Groopman that using the current quality guidelines seems like good thinking superficially, but these rigid rules cannot fit the complexity of the human condition. There is little or no evidence the quality measures that comprise the guidelines correlate with improved outcomes. When measuring outcomes be prepared for surprises. As I recalled in III of III fof last week’s articles, the UCLA study of over 5,000 patients at 91 hospitals published in 2007 in the Journal of the American Medical Association found that the application of most federal quality process measures did not change mortality from heart failure.

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