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Exact Sciences nails coveted Medicare coverage for colon cancer DNA test

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Exact Sciences CEO Kevin Conroy

Exact Sciences ($EXAS) now has something that diagnostics companies find increasingly hard to win: Medicare coverage, obtained for its new cutting-edge colorectal cancer-screening test.

Specifically, the Centers for Medicare & Medicaid Services issued what is known as a final National Coverage Determination for the Wisconsin company's Cologuard test. The milestone makes Cologuard the first and only FDA-approved stool DNA test to help spot colorectal cancer and precancer to have Medicare coverage, something Exact Sciences was quick to crow about. As well, CMS issued a preliminary payment decision for the test--$502--and processing of results.

"CMS's decision to cover Cologuard will provide Medicare's 50 million patients with access to this accurate screening option," Exact Sciences President and CEO Kevin Conroy said in a statement. "Colorectal cancer is often considered the most preventable, yet least prevented cancer due to the lack of patient compliance with screening."

Exact Sciences/Cologuard was also the first company and product to successfully complete the FDA/CMS parallel review pilot program, which is designed to reduce the time between the FDA's approval of a device and the obtaining of Medicare coverage. FDA premarket approval for Cologuard came through in August, as did a CMS coverage recommendation.

To gain approval, Exact Sciences ran a clinical trial that screened more than 10,000 patients. Cologuard did extremely well at polyp detection, but the FDA noted that the test wasn't as accurate as the traditional fecal immunochemical test (which detects blood in the stool) in identifying subjects negative for colorectal cancer or advanced adenomas. In trials, Cologuard found 92% of colorectal cancers in average risk patients with 87% specificity. It is the first noninvasive screening test for colorectal cancer that analyzes stool-based DNA and blood biomarkers to detect cancer and precancer, and does not require medication, dietary restrictions or bowel preparation prior to testing, the company noted.

CMS said in its decision that it would cover Cologuard patient testing through Medicare Part B once every three years, for patients aged 50 to 85 years who are asymptomatic and at average risk of developing colorectal cancer.

While Medicare coverage is now official, private insurance reimbursement remains a work in progress. A spokesperson told FierceDiagnostics via email: "We are working with private insurance companies right now to have Cologuard covered as soon as possible. In the meantime, we encourage patients to call their insurance company directly if they have questions about specific benefits."

- read the release
- here's the CMS natonal coverage determination

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