On December 19, 2018 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) reported that the Centers for Medicare & Medicaid Services (CMS) have issued its official 2019 Clinical Lab Fee Schedule (CLFS) on December 14, 2018, including the final reimbursement rate of $192 for Epi proColon, the first and only FDA-approved blood test for colorectal cancer screening (Press release, Epigenomics, DEC 19, 2018, View Source [SID1234532142]). Epigenomics is confident that this new rate, which is a 130% increase from the originally published Medicare rate of $83.67 in 2017, will lead to increased sales in 2019. Epigenomics will provide 2019 guidance on the next earnings call, which will take place on March 27, 2019, on the occasion of the 2018 full-year results. The finalization of the rate increase is another important step for Epigenomics on its way to reimbursement, as per Protecting Access to Medicare Act (PAMA) regulations the rate of $192 per test will remain unchanged for at least three years.
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Epigenomics gives update on the Donald Payne Sr. Colorectal Cancer Detection Act
Furthermore, Epigenomics has briefed the CBO (Congressional Budget Office) on HR 6919, the Donald Payne Sr. Colorectal Cancer Detection Act, and provided additional information about the colorectal screening market. There is no formal estimate on the CBO score at this time, but we will continue to provide updates if new information becomes available.