![]() The natural history of colorectal neoplasia has been well studied. Primary prevention, early detection and early treatment have contributed to the observed reduction in mortality however, CRC was estimated to account for over 50,000 deaths in 2013, with a median age at death of 74 years (NIH/SEER 2013). Overall mortality rates for CRC have declined over the past decade. In 2013, the National Institutes of Health (NIH) National Cancer Institute (NCI) estimated that there will be over 140,000 new cases of colon and rectum cancer in the United States with a median age at diagnosis of 68 years. It is an important issue for the Medicare population. This decision memorandum does not address the use of stool DNA testing as a diagnostic test to evaluate signs or symptoms of colorectal disease.ĬRC is the fourth most common cancer and the second leading cause of cancer deaths in the United States. We have focused our review on the commercially available Cologuard TM test since the test evaluates specific DNA markers and fecal hemoglobin using a proprietary analytic algorithm. USPSTF – United States Preventive Services Task ForceĬMS initiated this national coverage determination (NCD) to consider coverage for colorectal cancer (CRC) screening using Cologuard TM – a multitarget stool DNA (sDNA) test. USMSTF – United States Multi-Society Task Force SSED – Summary of Safety and Effectiveness Data SEER – Surveillance, Epidemiology, and End Results QuARTS – quantitative allele-specific real-time target and signal amplification MEDCAC – Medicare Evidence Development & Coverage Advisory Committee HIPAA – Health Insurance Portability and Accountability Act Gene names are expressed in italics.ĪCG – American College of GastroenterologyĬLIA – Clinical Laboratory Improvement AmendmentsįDA – United States Food & Drug Administration Additionally, nomenclature for DNA gene markers is used throughout this document. Please find below a list of these acronyms and corresponding full terminology. Throughout this document we use numerous acronyms, some of which are not defined as they are presented in direct quotations. SUBJECT: Final Decision Memorandum for Screening for Colorectal Cancer Using Cologuard TM – A Multitarget Stool DNA TestĪll other screening stool DNA tests not otherwise specified above remain nationally non-covered. ![]()
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