Publication Date: January 2006
Publisher: Genetics and Public Policy Center
Author(s): Kathy Hudson; Gail Javitt; Juli Murphy
Research Area: Health
Keywords: Oversight; Public policy; Genetic testing; Clinical Laboratories Improvements Amendments
Coverage: United States
This paper reviews the comments submitted in response to the NOI and identifies areas of consensus as well as areas of concern and opposition. It finds that there was support for key recommendations in the NOI, and recommends that CMS issue a proposed rule that focuses on these key issues, while leaving aside those that were more controversial and arguably less central to ensuring laboratory quality. Before reviewing the comments, however, it is necessary to place the NOI within the overall history and purpose of CLIA and the regulation of laboratory tests more generally.