MADISON, Wis., Aug. 15, 2016 /PRNewswire/ — Exact Sciences Corp. (Nasdaq: EXAS) announced that the Centers for Medicare and Medicaid Services (CMS) issued an updated Evidence of Coverage notice for Medicare Advantage plans that affirms such plans must include coverage of Cologuard every three years without patient coinsurance, copayments or deductibles.
"The CMS update assures patients and physicians that Cologuard is covered by Medicare Advantage plans without any out-of-pocket costs," said Kevin Conroy, chairman and CEO of Exact Sciences. "The update is also significant because it reflects CMS' recognition that Cologuard is an A-graded preventive service under the recently updated USPSTF colorectal cancer screening recommendations. CMS requires Medicare Advantage plans to cover A-graded services without patient cost sharing."
CMS recently issued its 2017 model Evidence of Coverage notice for Medicare Advantage Organizations and included stool DNA-based colorectal cancer screening for first time. In 2016, 17.6 million Americans were enrolled in Medicare Advantage plans. This represents 31 percent of Medicare beneficiaries.
Cologuard was approved by the FDA in August 2014 and results from Exact Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society's (2014) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016). Stool DNA is included in the combined screening guidelines of the American Cancer Society/U.S. Multi-Society Task Force/American College of Radiology (2008) and the American College of Gastroenterology guidelines (2009). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit www.CologuardTest.com. Rx Only.
About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences or find Exact Sciences on Facebook.
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Senior Director, Corporate Communications
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