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The changing landscape of medical benefits and risks creates new challenges for all stakeholders in health care. We offer examples of different medical interventions to help illustrate the complexity and diversity of considerations that define the trade-offs between benefits and risks for each patient. As more information becomes available at all stages of a product's life cycle, the Food and Drug Administration (FDA) needs to play a central role as an authoritative voice in communicating drugs' benefits and risks and must have the resources to perform the functions necessary to keep pace with this accelerating rate of change.

Comparative information about different approaches to treating a disease or condition plays a critical role in the success of any competitive, market-based health care system in achieving quality and value. To ensure that effectiveness studies will be used to stimulate development of important advances in care and not lead to limits in coverage and treatment options, a comparative effectiveness center needs to demonstrate independence from payers; operate with transparent processes; and coordinate, not duplicate, the requirements of the relevant federal agencies. A fully independent, quasi-governmental center is most likely to produce credible, broadly acceptable findings.

In 1989, Congress enacted sweeping legislation to require that Medicare pay physicians under a single fee schedule beginning in January 1992. Although the law was detailed in specifying the structure of the fee schedule, it left many difficult policy and operational issues to be resolved. This article discusses how the agency charged with implementing the new law will address those issues and describes some of the key steps that will be taken to put the fee schedule together.