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Screening DNA Stool Test for Colorectal Cancer

Following reconsideration of the current national coverage determination (NCD) for colorectal cancer screening, CMS proposes not to expand the colorectal cancer screening benefit to include coverage of PreGen-Plus, a commercially available screening DNA stool test. The FDA determines that this test requires premarket review and approval. A subsequent request for reconsideration will be considered once FDA approval is obtained.

Download the Guidance Document

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: July 25, 2008

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.