Cologuard® Coverage Expands with Updated Policies from HCSC and Florida Blue

Positive medical policies from health plans that collectively insure 18 million people

MADISON, Wis., Aug. 11, 2016 /PRNewswire/  Exact Sciences Corp. (Nasdaq: EXAS) today announced that Health Care Service Corp. (HCSC), the nation's fourth largest health insurer, and Florida Blue recently updated their medical policies to cover Cologuard. With these policy updates, 80 million people are insured by commercial plans with positive medical policies regarding Cologuard. Including Medicare, Cologuard is now covered for 62 percent of its total target population.more

"We are pleased that Cologuard's commercial coverage continues to broaden following its inclusion in the recently-updated U.S. Preventive Services Task Force colorectal cancer screening recommendations," said Kevin Conroy, chairman and CEO of Exact Sciences. "As health plans continue to update their coverage policies to include Cologuard, an increasing number of people have access to an innovative, non-invasive colorectal cancer screening option."

HCSC is the largest customer-owned insurer in the United States.  Its subsidiaries include Blue Cross and Blue Shield plans in Illinois, Texas, Montana, New Mexico and Oklahoma. Under HCSC's updated policy, which is effective Aug. 15, 2016, Cologuard may be considered medically necessary for colorectal cancer screening once every three years for average risk patients who are not up to date with screening. The HCSC policy update states, "In 2016, the USPSTF updated their CRC screening guidelines to recommend the use of gFOBT, FIT, FIT-DNA (multitargeted stool DNA testing), colonoscopy, CT colonography, and flexible sigmoidoscopy for individuals ages 50 years to 75 years at average risk of colorectal cancer." To read HCSC's policy, click here.

According to Florida Blue's updated policy, "The use of an FDA approved fecal DNA test (e.g. Cologuard) meets the definition of medical necessity once every three years as a screening technique for members in whom colorectal cancer preventive screening is indicated (per USPSTF Colorectal Cancer Screening Grade A recommendation)." To read Florida Blue's policy, click here. 

About Cologuard

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 Rx Only.

AboutExact 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 noninvasive, molecular screening technology for the detection of colorectal cancer. For more information, please follow us on Twitter @ExactSciences or find us on Facebook.

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "could," "seek," "intend," "plan," "estimate," "anticipate" or other comparable terms. All statements other than statements of historical facts included in this news release regarding our strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales and marketing efforts, expectations concerning payor reimbursement and the anticipated results of our product development efforts. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and health care providers; the willingness of health insurance companies and other payors to cover Cologuard and reimburse us for our performance of the Cologuard test; the amount and nature of competition from other cancer screening products and services; the effects of any healthcare reforms, including the Affordable Care Act, or changes in healthcare pricing, coverage and reimbursement; recommendations, guidelines and/or quality-of-care metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Cancer Society and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; the impact of our sales and marketing efforts, including our nationwide television advertising campaign; and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

J.P. Fielder
Exact Sciences Corp.

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Topics: Exact Sciences News

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