Evidence-based health care coverage for children: proceed with caution.

Making health care coverage depend on the existence of valid, applicable research data and positive cost-effectiveness analyses, as managed care contracts are beginning to do, is particularly problematic for children. Because of research challenges specific to children, there are relatively few pediatric data and analyses required under such evidence-based coverage standards. It is too soon to expect major increases from federal efforts to stimulate pediatric health care research. But absence of requisite evidence would entitle a managed care organization or other decision maker to deny coverage on the basis of unproven, negative assumptions about an intervention. In general, population-based evidence is an incomplete basis for decisions on coverage for individual patients. Cost-effectiveness analyses are not standardized and may be biased. Purchasers of managed care and policy makers should understand the limits of evidence-based coverage standards. Other uses of evidence may contribute more to systemic improvements of health care.