Implantable cardioverter defibrillators: an excellent case study

Numerous randomized controlled trials have shown that implantable cardioverter defibrillators (ICDs) reduce mortality from sudden cardiac death. Evidence-based medicine can elucidate the benefits of treatment and inform Medicare policy when applied in a consistent and nonselective manner. The use of cost-effectiveness data to determine Medicare coverage-and therefore access to a therapy-involves many practical challenges. Cost-effectiveness analysis may be more useful as a tool to guide marketplace decision making than as a regulatory mechanism. Medicare coverage does not mandate use of a therapy; it allows the discussion to occur between a patient and his or her doctor.