Exact Sciences Announces Inclusion of Cologuard® in HEDIS Quality Measures

"Cologuard's inclusion in the preeminent quality measures and its standing as an A-graded service in a leading screening guideline are critical steps toward becoming a standard of care for colon cancer screening," said Kevin Conroy, chairman and CEO of Exact Sciences. "Quality measures rate health care providers, systems and payers on metrics, including colon cancer screening compliance and patient satisfaction. These quality scores influence the level of reimbursement providers receive under value-based health care structures. Providers can now receive quality credit when their patients are screened using Cologuard, and Exact Sciences' comprehensive compliance program encourages completion of screening following a physician's prescription."

The HEDIS quality measures promote evidence-based health care and quality service to patients by assessing the performance of health plans on multiple measures. Colorectal cancer screening compliance and patient satisfaction are two measures that are evaluated to generate an overall quality score.  Cologuard continues to achieve a nearly 70-percent compliance rate¹ and survey data shows that 88 percent of patients have a very positive experience² using Cologuard and engaging Exact Sciences' compliance program.  Conversely, colonoscopy and fecal blood testing compliance rates are typically much lower. 

"Including Cologuard in HEDIS creates incentives for health plans and providers to adopt the test by helping them achieve compensation goals and establish marketing opportunities," Conroy said. "We also believe that because patients like using Cologuard, they are more likely to rate their experience with their prescribing health care provider favorably."

Cologuard's inclusion in HEDIS with a three-year interval provides payers, health systems, and providers quality credit for a three-year lookback period during HEDIS audits. The 2016 HEDIS audit will give credit for Cologuard tests completed beginning in 2014, when Cologuard received FDA approval and was made available to patients.

"The fact that Cologuard is now accounted for in your HEDIS measures is huge for health plans," said Troy Caraway, chief executive officer of Physicians Plus Insurance Corporation. "If one or two early-stage cancers are detected because more people have a Cologuard test, we are far ahead as a health plan."

"With Cologuard, the scientific evidence is there, the compliance service is there, and now it counts toward our colon cancer screening quality credit," said Anas Daghestani, M.D., CEO of Austin Regional Clinic (ARC) and medical director for ARC's Population Health and Clinical Quality.  "Adopting a test like Cologuard allows me to push my screening rate for colon cancer very high, very quickly without investing a lot of internal resources."

The HEDIS measures directly impact the CMS Star Ratings, which use HEDIS as the primary data source to guide quality measures for Medicare Advantage plans. The public comment period for the 2018 Star Ratings is expected to be announced in November 2016.  The updated Star Ratings are expected to be published in February 2017.

NCQA's update to the colorectal cancer screening measure aligns HEDIS with the preeminent colorectal cancer screening guidelines, including those of the U.S. Preventive Services Task Force, American Cancer Society, National Comprehensive Cancer Network and the American College of Gastroenterology.  

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 recommendations of the U.S. Preventive Services Task Force (2016) and the American Cancer Society's (2014) colorectal cancer screening guidelines.  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), the American College of Gastroenterology guidelines (2009) and the National Comprehensive Cancer Network (2016). 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.

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, which are based on certain assumptions and describe our future plans, strategies and expectations, 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 the potential inclusion of Cologuard in CMS's Five-Star Quality Rating System, or other quality measures, the potential impact of using Cologuard on a given HEDIS score, 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 healthcare 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 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; 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 Report(s) 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.

¹Cologuard's patient compliance rate is derived from the number of valid tests reported divided by the number of collection kits shipped to patients during the 12-month period ending 60 days prior to June 30, 2016.
² Exact Sciences Laboratories patient satisfaction survey data is cumulative; n = 2,799

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CONTACT: JP Fielder, [email protected], 608-210-5220

SOURCE EXACT SCIENCES CORP

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