Effective date: April 28, 2008

Implementation date: August 25, 2008

Following an external request for reconsideration of the current national coverage determination (NCD) at Publication 100-03, NCD Manual, section 210.3, for colorectal cancer screening, the Centers for Medicare & Medicaid Services (CMS) proposes not to expand the colorectal cancer screening benefit to include coverage of PreGen-Plus™, a commercially available screening DNA (deoxyribonucleic acid) stool test, as an alternative to a screening colonoscopy or a screening flexible sigmoidoscopy.

The Food and Drug Administration (FDA) determines that this test is a medical device that requires pre-market review and approval prior to marketing, which, to date, has not been obtained. In the absence of an FDA determination, CMS believes that there may be unresolved questions regarding the safety and effectiveness of the stool DNA test, and therefore does not believe that identification of stool DNA mutations is an appropriate colorectal cancer screening test at this time. A subsequent request for reconsideration will be considered once FDA approval is obtained.

Additional information is available on the CMS Web site. Here is the link to the MLN Matters article MM6145 .

The official instruction for CR 6145, issued to carriers, FIs, A/B MACs, and DME MACs regarding this change, is reflected in two transmittals, one for the Medicare Benefit Policy Manual and one for the National Coverage Determinations Manual. These are at transmittal 93 and transmittal 92 respectively, on the CMS Web site. (Note: the original transmittal for the NCD manual, transmittal 89, was rescinded and replaced with transmittal 92.)