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Christopher Fleming

Evidence-Based Medicine Should Focus On Evidence Of Value, Not Just Evidence Of Benefit, Say David Eddy And Sean Tunis

 Eddy And Tunis Say The American Health Care System Should Explicitly Consider Costs; Tunis Explains How Cost Considerations May Implicitly Affect Medicare Coverage Decisions

Bethesda, MD – Evidence-based medicine (EBM) represents a major advance in medical decision making, but it will not achieve its full potential to improve quality and save money unless it is combined with explicit consideration of costs.

That conclusion emerges strongly from a conversation between Sean Tunis and David Eddy, published today as a Health Affairs Web Exclusive. What’s more, say the two experts on EBM, when costs are not considered explicitly they tend to creep into coverage decisions in less visible ways. This happened, Tunis suggests, when the Centers for Medicare and Medicaid Services (CMS) reconsidered its coverage policy for implantable cardioverter-defibrillators (ICDs).

Tunis is the founder and director of the Center for Medical Technology Policy, a nonprofit that provides a neutral forum where patients, clinicians, payers, manufacturers, and researchers collaborate on design and implementation of prospective, real-world studies of promising technologies.  He was instrumental in reforming the national coverage process at the CMS to explicitly incorporate principles of EBM, and was extensively involved in decision making about coverage for ICDs as the chief medical officer at the CMS. Eddy has made seminal contributions to evidence-based medicine, coining the term “evidence based” and applying it to guidelines, coverage policies, and performance measures. He is the founder and medical director of the Archimedes Project, which is designed to improve the quality and efficiency of health care through realistic simulation models of physiology, disease, and health care systems. You can read the conversation between Tunis and Eddy at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.26.4.w500

Analyzing The Evidence Is Only The First Step
In Medical Decision Making; Weighing Preferences Is The Second Half

Eddy defines EBM as “a set of principles and methods intended to ensure that, to the greatest extent possible, population-based policies and individual medical decisions are consistent with evidence of effectiveness and benefit.” He describes medical decisions as occurring in two “boxes” representing separate decision-making steps. EBM happens in the first box, in which the decisionmaker must “evaluate the information at hand and determine the consequences or outcomes of each of the options.”

However, both individual and population-based health care decisions also require a second box that does not depend on evidence, but instead is governed by the particular weights that the relevant individual or organization attaches to particular benefits, harms, and costs, Eddy explains. He gives the example of Nancy Reagan, who made a well-informed choice to have her breast cancer treated with a radical mastectomy. “A lot of people criticized her and her physician, saying that she was overtreated,” but “there is no evidence about whether a simple mastectomy is more or less desirable to Nancy Reagan than a radical mastectomy. That determination is personal and can be made only by her,” Eddy states.

Even though EBM is thus relevant to only the first half of medical decisions, its contribution is still extremely important, according to Eddy. “In the relatively recent past,” he says, decisions about the appropriateness of a medical technologies such as ICDs “would likely have been based on whatever the chairman of surgery said should be done (authority), or whatever the majority of practitioners were doing (‘standard and accepted practice’), or on nonevidentiary factors such as ‘This is the patient’s last hope,” or even ‘I’m a surgeon, and surgeons recommend surgery.’”

If Costs Are Not Considered Explicitly And Transparently,
They Can Influence Decisions In Less Visible Ways

“I believe that our failure to explicitly consider costs in medical decision making is the single greatest flaw in our health care system,” Eddy declares. “To have any hope of maximizing quality within a budget or of minimizing the cost of achieving any specified level of quality, we have to determine the value of each activity and give priority to activities with the highest value. But if we are not allowed to consider cost, there is no way to determine the value of any activity.”

Tunis explains how cost considerations might have made their way into Medicare’s ICD reconsideration, even though the program does not formally consider costs in such determinations, and has stated that it does not do so. In light of a study showing that many additional beneficiaries might benefit from ICDs, the CMS expanded coverage, but not initially by as much as a joint American College of Cardiology/American Heart Association committee had recommended.

“The potential impact on Medicare spending or cost-effectiveness of ICDs was really not discussed much within the agency or within the Department of Health and Human Services when the decision was made,” Tunis says. “At the same time, it was well understood by me and others at CMS that ICDs were expensive and that there were a lot of additional people who might be eligible for an ICD, and that added up to a large amount of money. So what does that cause us to do differently than for decisions with less potential financial impact? It causes us to look extremely carefully at data on safety and effectiveness. You might think of this as an upside-down or inside-out variation of a cost-effectiveness analysis in which the evidence threshold for coverage is implicitly adjusted based on a qualitative judgment about the economic impact of the decision.”

Tunis adds, “My view is that Medicare decisionmakers didn’t consider costs any more or any less than the members of the ACC/AHA guideline committee did, but I think that our implicit level of concern about costs was different and perhaps influenced the analysis of evidence and the conclusions drawn by each organization.”

Eddy says that the same phenomenon occurs in the private sector as well. “For example, an insurer or managed care organization might say that their coverage, guidelines or performance measures are based solely on evidence of effectiveness and are not affected by costs. But at the same time, they can ratchet up on the requirements for evidence … this is taking the value judgment about cost out of the second box but inserting it implicitly into the first box by raising the bar for the evidence.”

Both Tunis and Eddy agree that public reporting of quality measures and pay-for-performance programs will not save money without explicit consideration of costs. To save money, “we have to make certain that performance measures and P4P formulas are based on value, not just evidence of benefit,” Eddy says. “Second, we need to create measures and incentives that turn low-value things off, not just high-value things on. That is, we need to add some pay-for-nonperformance to the pay-for-performance, if you will.”


Health Affairs, published by Project HOPE, is the leading journal of health policy. The peer-reviewed journal appears bimonthly in print with additional online-only papers published weekly as Health Affairs Web Exclusives at www.healthaffairs.org.


©2007 Project HOPE–The People-to-People Health Foundation, Inc.