The federal government and medical technology: Crossing policy and management thresholds

Abstract

This paper reviews the changes in federal government involvement in medical technology in the pastdecade, from prior reliance upon non-governmental decision-making about development, diffusion, anduse, to increasingly centralized decision-making. The case of end-stage renal disease offers contrastsbetween the past and present. The cases of Karen Ann Quinlan and CT scanning indicate the source ofpresent scepticism about benefits and costs of medical technology. Current federal involvement in medicaltechnology decision-making, through health planning, medical device regulation, and increased formalanalysis of safety, effectiveness, and cost-effectiveness, is described. Though increased federal involvementin medical technology stems from a desire to compensate for failures of the medical marketplace, theimmediate effect is to place greater decision-making reliance upon formal analysis, bureaucracy, legalprocedure, and politics. It is unclear whether the result of increased federal involvement will producebeneficial outcomes.