CMS denies Exact Sciences coverage
This article was originally published in The Gray Sheet
Executive Summary
Medicare agency will not cover Exact Sciences' PreGen-Plus stool-based DNA assay as an alternative to screening colonoscopy because it is not FDA-approved, the agency says April 28, confirming its earlier proposal. Other payers, including those represented by trade group America's Health Insurance Plans, support CMS' decision. FDA dealt Exact Sciences a warning letter in October stating that the test needed to undergo regulatory review and could no longer be provided out of laboratory partner LabCorp. Although stool-based DNA testing was recently added to American Cancer Society guidelines as a recommended screening test for colorectal cancer, Exact Sciences said in March it was pursuing strategic alternatives including a possible sale of the company (1"The Gray Sheet" March 24, 2008, In Brief)
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