The Centers for Medicare & Medicaid Services (CMS) has issued its final payment decision for the Cologuard test by Exact Sciences Corp, Madison, Wis, and will reimburse it at $502 per test. Cologuard is the first FDA-approved noninvasive stool DNA colorectal cancer screening test.
The final payment decision follows a comprehensive evaluation by the agency as part of a joint FDA and CMS parallel review pilot program. Cologuard is the first technology to gain approval through this program.
“CMS’s final payment decision represents a major milestone, by providing 50 million Medicare patients access to this noninvasive colorectal cancer screening option,” says Kevin Conroy, president, CEO, and chairman of Exact Sciences. “We thank FDA and CMS for giving Exact Sciences the opportunity to bring this new screening option to patients and physicians.”
Exact Sciences is a molecular diagnostics company focused on the early detection and prevention of colorectal cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer.
Colorectal cancer is highly treatable with early detection through screening. However, 23 million Americans between 50 and 75 are not getting screened as recommended and, as a result, colorectal cancer remains the second-leading cause of cancer-related deaths in the United States.
Available through a healthcare provider by prescription in all 50 states, Cologuard offers people 50 years and older who are at average risk for colorectal cancer an easy-to-use screening test that they can perform in the privacy of their own home. Cologuard does not require medication, dietary restrictions, or bowel preparation, and is included in the American Cancer Society’s national guidelines for colorectal cancer prevention and early detection.
In the pivotal clinical trial that enrolled more than 10,000 patients, the test found 92% of colorectal cancers in average-risk patients, with 87% specificity. For more information, visit Cologuard.