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New Legislation Would Require CMS Coverage for Blood-Based Colorectal Cancer Screens

NEW YORK (GenomeWeb) – A bipartisan group of Congressional representatives today unveiled a bill that would require Medicare coverage for qualifying US Food and Drug Administration-approved blood-based colorectal cancer screening tests in order to boost screening in traditionally underserved communities.

While the legislation was lauded by Epigenomics, which makes the only FDA-approved blood-based screen for colorectal cancer, Epi proColon, questions remain about the test's effectiveness.

The so-called Donald Payne Sr. Colorectal Cancer Detection Act was introduced by Representative Donald Payne (D-NJ), who co-chairs the Congressional Men's Caucus, and is co-sponsored by Representatives Charlie Dent (R-PA) and John Delaney (D-MD). Named for Payne's father, a former Congressman who died from colorectal cancer in 2012, it would provide Medicare coverage for all FDA-approved blood-based screening tests with available screening methods and authorize equivalent CMS reimbursement.

"Colorectal cancer is one of the most preventable forms of cancer, yet it remains the second leading cause of cancer death in the United States, mainly because one in three Americans do not stay up to date with their screenings," Payne said in a statement.

He added that Epigenomics' recently approved blood-based colorectal cancer test Epi proColon would "enable historically underserved communities to more fully participate in screening," yet the Centers for Medicare & Medicaid Services (CMS) has not yet issued a coverage determination for the test. "For this reason, I have introduced legislation that would include all FDA-approved blood-based screening tests with available screening methods and authorize equivalent CMS reimbursement. By doing so, we can finally close the gap and screen the unscreened."

Notably, the legislation comes amid questions about Epi proColon's efficacy. Despite receiving a positive recommendation from an FDA advisory panel in 2014, the agency issued the test a "not approvable letter" a few months later, citing a lack of data showing that the test would improve compliance to colorectal cancer screening. The FDA again asked Epigenomics for additional data in late 2015, and early this year said that the additional information was sufficient.

More recently, in June the US Preventive Services Task Force issued an updated recommendation report on colorectal cancer screening in which it cited data showing Epi proColon to have low sensitivity for detecting the disease. In a Journal of the American Medical Association Viewpoint that accompanied the release of the task force report, Ravi Parikh of Brigham and Women's Hospital and Vinay Prasad of the Knight Cancer Institute at Oregon Health and Science University outlined many of the shortcomings in the data around Epi proColon, arguing that "allowing blood-based screening tests for colon cancer to have a lower standard than that of other screening tests risks prioritizing convenience over patient safety and health care value."

Epigenomics CEO Greg Hamilton said today in a statement that the company is "very excited to join the mission of Congressman Payne, Jr. and Congressman Dent to fight colorectal cancer in the United States. This new initiative is a unique opportunity to provide millions of unscreened, underserved Americans access to colorectal cancer screening and to ultimately save thousands of lives."

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