NEW YORK – 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.
The agency reiterated that Epi proColon does not meet these criteria and it will not cover the assay for Medicare-eligible patients.
In a note to investors, BTIG's Mark Massaro wrote that he remains surprised at the relatively low "sensitivity bar" CMS has set given the performance of the existing stool-based screening test, Exact Science's Cologuard, which is 92 percent sensitive and 87 percent specific.
Blood-based tests shouldn't be expected to compete meaningfully with Cologuard for the next 2-4 years, he predicted, but if firms like Guardant and Freenome are successful in obtaining FDA approval, they are poised to become significant competitors given the performance data they have shown so far.
According to Vijay Kumar from Evercore, commenters to the draft memo had expressed notable concern that inclusion into guidelines or the USPSTF recommendations takes significant time and is often a lengthy process. Some also noted that Cologuard was not included in a guidelines when it received Medicare coverage.
Kumar called the removal of the requirement a "big win" for companies developing these tests and said it should allow for faster adoption.