About this policy
CMS evidence review | evidence_type=Technology Assessment | record_type=technology_assessment | document_id=52 | year=2007
Coverage indications
CMS covers colorectal cancer screening for average risk individuals age 50 years and older using fecal occult blood testing, sigmoidoscopy, colonoscopy, and barium enema (42 CFR 410.37). On June 12, 2007, the Centers for Medicare & Medicaid Services (CMS) received a formal request from EXACT Sciences Corporation asking that we initiate a national coverage determination (NCD) on the use of a screening DNA stool test (the PreGen-Plus test, version 1.1) for average risk individuals. The requestor asks CMS to cover their test every 5 years as an alternative to a screening colonoscopy that may be covered every 10 years or as an alternative to a screening flexible sigmoidoscopy that may be covered every 4 years for such individuals as provided in 42 CFR 410.37 (e) and (g). Neither the law nor the regulations identify the screening DNA stool test as a possible coverage option under the colorectal cancer screening benefit. However, under 42 CFR 410.37 (a)(1), CMS is allowed to use the NCD process to determine coverage of other types of colorectal cancer screening tests that are not specifically identified in the law or regulations as it determines to be appropriate, in consultation with appropriate organizations.
Documentation requirements
Associated Nca: Original Consideration for Screening DNA Stool Test for Colorectal Cancer (CAG-00144N) Issue: CMS covers colorectal cancer screening for average risk individuals age 50 years and older using fecal occult blood testing, sigmoidoscopy, colonoscopy, and barium enema (42 CFR 410.37). On June 12, 2007, the Centers for Medicare & Medicaid Services (CMS) received a formal request from EXACT Sciences Corporation asking that we initiate a national coverage determination (NCD) on the use of a screening DNA stool test (the PreGen-Plus test, version 1.1) for average risk individuals. The requestor asks CMS to cover their test every 5 years as an alternative to a screening colonoscopy that may be covered every 10 years or as an alternative to a screening flexible sigmoidoscopy that may be covered every 4 years for such individuals as provided in 42 CFR 410.37 (e) and (g). Neither the law nor the regulations identify the screening DNA stool test as a possible coverage option under the colorectal cancer screening benefit. However, under 42 CFR 410.37 (a)(1), CMS is allowed to use the NCD process to determine coverage of other types of colorectal cancer screening tests that are not specifically identified in the law or regulations as it determines to be appropriate, in consultation with appropriate organizations. Other Material: Other Material 1 Questions: Questions Technology Assessment: Download Technology Assessment [PDF, 729KB].
Codes in this policy
Code numbers and each code’s status as the policy records it. CPT code descriptions are left out of this page, as are the passages that cite CPT codes; the official document has them.
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