MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS) today announced that the Centers for Medicare and Medicaid Services (CMS) Advisory Panel on Clinical Diagnostic Laboratory Tests voted unanimously to maintain Medicare’s current crosswalk pricing ($492.72) for Cologuard. The 11-0 vote, including one abstention, came after the Clinical Lab Fee Schedule’s July 16, 2015 public meeting. Exact Sciences’ Chairman and CEO Kevin Conroy presented a proposal at the July 16th meeting to crosswalk Cologuard from its current G-code to a CPT code. Following today’s vote, Conroy issued this statement:
“We’re very pleased with the panel’s unanimous vote in favor of maintaining the current Medicare reimbursement for rate for Cologuard. CMS will post a preliminary determination after considering the July meeting comments, today’s panel vote, and other written comments. A final determination is expected to be released in the November timeframe and will be effective January 1, 2016.”
The Advisory Panel on Clinical Diagnostic Laboratory Tests is a new panel established under the 2014 Protecting Access to Medicare Act (PAMA), which directs the Secretary of Health and Human Services to consult with an expert outside advisory panel on establishing payment rates for new clinical diagnostic laboratory tests, including whether to use crosswalking or gapfilling processes to determine payment for new clinical laboratory tests and the factors used in determining coverage and payment processes for new clinical diagnostic laboratory tests. PAMA requires the panel to be established by the secretary and composed of an appropriate selection of individuals with expertise in issues related to clinical diagnostic laboratory tests. The panel may include representatives of clinical laboratories, molecular pathologists, clinical laboratory researchers and individuals with expertise in clinical laboratory science or health economics. Today’s meeting was the first for the panel.
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 colorectal cancer screening guidelines of the American Cancer Society and stool DNA is listed in the screening guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer.
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
Exact Sciences Corp. (NASDAQ: EXAS) is a molecular diagnostics company focused on the early detection and prevention of colorectal cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. For more information, please visit the company's website at www.exactsciences.com, follow us on Twitter @ExactSciences or find us on Facebook.
Certain statements made in this news release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and 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 press 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 future CMS actions regarding Cologuard pricing or reimbursement, expected future operating results, anticipated results of our sales and marketing efforts, expectations concerning other 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; the acceptance of our products by patients and health care providers; the amount and nature of competition from other cancer screening products and procedures; our ability to maintain regulatory approvals and comply with applicable regulations; our success establishing and maintaining collaborative and licensing arrangements; our ability to successfully develop new products; 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.