MADISON, Wis.—(BUSINESS WIRE)— Exact Sciences Corp. (Nasdaq: EXAS) today announced that the Centers for Medicare and Medicaid Services (CMS) issued a preliminary determination maintaining the current reimbursement rate for Cologuard, the company's non-invasive, stool DNA-based colon cancer screening test.
CMS considered reimbursement for a new CPT billing code for Cologuard (81528), as well as a request for reconsideration of Cologuard's current reimbursement rate. In its determination, CMS approved a crosswalk of the new CPT code for Cologuard to three existing codes, which yield a current reimbursement rate of $492.72. The new CPT code replaces the G code assigned to Cologuard as part of CMS' national coverage determination from October, 2014.
"We are pleased with CMS' preliminary determination regarding Cologuard's reimbursement rate and coding," said Kevin T. Conroy, Exact Sciences' chairman and chief executive. "Both Medicare and commercial payors are accustomed to using CPT codes and they facilitate the smooth processing of claims. We have worked cooperatively with CMS and appreciate their continued support of Cologuard as a valuable non-invasive screening option for patients and providers."
After a period of public comment, CMS' decision will be finalized in November and will become effective on Jan. 1, 2016.
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 Corp.
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of some of the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is included in the guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please follow us on Twitter @ExactSciences or find us on Facebook.
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Cara Tucker, 614-302-5622
Source: Exact Sciences Corp.