Does CLIA '88 mandate regulation of physician utilization of laboratory testing?

Readers of this issue will find a provocative position put forward by Peddecord and Hammond (Clin Chem 1990;36:2027-35). In their article reviewing the Clinical Laboratory Improvements Act (CLIA) of 1988, they present, within the historical context for laboratory regulation, a comprehensive view of the proposed regulations implementing this law and provide insight into the complex process of making law and implementing law through regulations. Moreover, their article is unique in asserting the concept that the intent, implied or otherwise, of Congress is to regulate the practice of medicine. This extraordinary assertion has implications of immense proportions for the future role of the government in healthcare. If they are correct, the potential for CLIA ‘88 (1) to affect the clinical chemistry and laboratory community at large would be equalled by its impact on clinical medicine. The conventional approach to assessing CLIA ‘88 involves dissection of the numerous specifics that detail the various issues relating to the provision of testing results, the maintenance of appropriate analytical conditions, and the assessment of the product in a conventional focus on the analytical result. Indeed, this occupies the bulk of the presentation in the current paper. However, Peddecord and Hammond go much farther. They state: