CMS agrees to pay for DNA colon-cancer screening test

Despite concerns over its accuracy, the CMS has granted national coverage for a new screening test for colon cancer that uses a patient's DNA to detect molecular alterations associated with the disease.

The Cologuard test is made by Wisconsin-based Exact Sciences. The CMS is agreeing to pay for the test once every three years for beneficiaries ages 50 to 85 who are asymptomatic and at average risk of developing colorectal cancer.

Colorectal cancer is the fourth most common cancer and the second-leading cause of cancer deaths in the U.S. About 140,000 new cases of colon and rectum cancer were diagnosed last year, and it caused more than 50,000 deaths, according to the National Institutes of Health.

Providers typically spot tumors by testing blood found in stool.

The CMS made clear that the coverage determination only applies to Cologuard. Other DNA tests not otherwise specified above remain uncovered.

Some in the medical community have expressed concern about false-positives from the Cologuard test—studies have shown that rate to be 13%, compared with less than 5% for blood-based stool tests.

The CMS acknowledged that concern but also noted the advantages of the new test.

“For a new non-invasive screening test, screening with stool DNA provides an option with increased sensitivity that has not been previously available,” the agency said. “As with other stool-based screening tests, positive results should be followed with the gold standard test, colonoscopy, which remains the definitive test.”

The U.S. Preventive Services Task Force has not endorsed DNA screening for colorectal cancer.

The Cologuard kit retails for $600 per patient, compared with $25 for the traditional stool-blood exam. The FDA approved the test in August.

Follow Virgil Dickson on Twitter: @MHvdickson