Colon Cancer Screening Test Gets FDA Approval, Proposed Medicare Coverage

The Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) concurrently issued decisions Aug. 11 aimed at providing access to the first noninvasive DNA screening test for colon cancer. The FDA approved Cologuard, a stool-based DNA screening test used to detect abnormalities that may indicate colon cancer. The test is manufactured by Exact Sciences Corp. of Madison, Wis. The FDA’s Molecular and Clinical Genetics Panel March 27 voted 10-0 in favor of approval for the Cologuard test. Cologuard was approved under a pilot program involving the FDA and CMS conducting a parallel review. The agencies first announced the parallel review program in October 2011. The FDA’s approval coincided with CMS Aug. 11 issuing a proposed coverage decision (CAG-000440N) for Cologuard. The coverage decision said the “CMS proposes to cover the Cologuard screening once every three years for beneficiaries who meet” specified criteria. The colon cancer screening test is the first product approved under the parallel review pilot. Exact Sciences requested that CMS consider a national coverage determination for Cologuard. Comments regarding the proposed coverage decision are due Sept. 10. Eligibility Criteria To fulfill the eligibility coverage for the Cologuard test, the proposed coverage decision said beneficiaries must meet the following conditions:

• Be 50 to 85 years old;
• Be asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test); and
• Be at average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn’s disease and ulcerative colitis and no family history of colorectal cancers or an adenomatous polyp, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).

The coverage decision also said Cologuard would be covered under Medicare Part B, which pays for medically needed services and supplies and preventive care. It noted that other colon cancer screening procedures are covered by CMS. However, “Since Cologuard cannot be classified in any existing” colon cancer screening category, the agency said it needed to create a new category specifically for tests screening stool or examining fecal DNA. CMS’s proposed coverage decision is available at www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=277. The FDA announcement is available at www.fda.gov/newsevents/newsroom/pressannouncements/ucm409021.htm.