NEW YORK – The Centers for Medicare & Medicaid Services is soliciting public input on Epigenomics' request for a national coverage determination for its Epi proColon blood test for colorectal cancer screening.
The PCR-based Epi proColon test detects methylated Septin9 and was approved by the US Food and Drug Administration in 2016 as a blood-based colorectal cancer screening option for average-risk patients who choose not to undergo screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests.
Epigenomics sent CMS a letter last April formally requesting a national coverage determination for its test. In its NCD request letter, the firm noted that its test fills an unmet medical need since colorectal cancer screening participation is suboptimal in the general population and among Medicare beneficiaries.
"As the Epi proColon test is not a fecal occult blood assay, a screening flexible sigmoidoscopy, or a screening colonoscopy, it is not currently a covered colorectal cancer screening test," the company added in the letter. "The Administrator of the Center for Medicare and Medicaid Services has the authority to provide coverage for other test procedures."
CMS accepted Epigenomics' NCD request on Feb. 28 and initiated a review. In its document seeking public comment on national coverage for Epi proColon, CMS said it is particularly interested in input on the scientific evidence underlying the test and feedback on the characteristics colorectal cancer screening tests should have.
Members of the public have until March 29 to submit comments, and CMS expects to issue a draft national coverage determination on Aug. 28.
CMS granted Exact Sciences' stool-based colon cancer screening test Cologuard national coverage in 2014.