CMS Finalizes Blood-Based Colon Cancer Screening NCD with Non-Coverage for Epi ProColon

The US Centers for Medicare and Medicaid Services has finalized the draft national coverage decision memo it issued last October, describing criteria for the coverage of blood-based colorectal cancer screening tests, but denying coverage for Epigenomics’ Epi ProColon assay.

Apart from Epigenomics, the memo stands to impact a number of companies developing genomic and epigenomic blood tests for colorectal cancer including Guardant Health, Freenome, Exact Sciences, and others.

After the draft decision was posted last year, stakeholders were invited to contribute comments. Nevertheless, the finalized memo has retained its main conclusions largely unchanged apart from the removal of a requirement for covered tests to be included in professional society guidelines or recommended by the United States Preventive Services Task Force.

CMS will provide coverage for FDA authorized blood-based CRC screening tests for Medicare beneficiaries when certain requirements are met including that the patient is between 50 and 85 years old, asymptomatic, and at average risk of developing colorectal cancer. In the draft, the timing interval for testing was suggested at every 3 years but left open to change based on FDA labelling. In the final determination, however, a 3-year interval is specified for all tests.

The test used, meanwhile, must have proven sensitivity greater than or equal to 74 percent and specificity greater than or equal to 90 percent in the detection of colorectal cancer compared to colonoscopy.

Source: https://www.genomeweb.com/business-news/cms-finalizes-blood-based-colon-cancer-screening-ncd-non-coverage-epi-procolon