CMS has finalized its rejection of Epigenomics' blood-based colorectal cancer screening test, depriving the company of the chance to sell the liquid biopsy for Medicare beneficiaries.
Epigenomics is considering an appeal or litigation after CMS published a final decision memo on Tuesday that hewed closely to the draft it released for consultation last year. The core finding that the company's Epi proColon does not meet the coverage criteria remains unchanged.
CMS also tweaked the path to Medicare coverage for other colorectal cancer screening tests in development at companies including Exact Sciences, Guardant Health and Freenome.
The draft decision memo released by CMS last year stated Medicare would only cover a blood-based screening test if it was FDA approved, had sensitivity of 74% or greater, specificity of at least 90% and was recommended by a professional society guideline, consensus statement or the U.S. Preventive Services Task Force. Epi proColon fell short of those barriers to coverage.
CMS revised the criteria in finalizing the decision memo, dropping the requirement for a test to be recommended by a professional society or USPSTF. The conclusion regarding Epi proColon remained the same, though.
The agency's decision looks unlikely to end the matter. Epigenomics said it is "evaluating options for an appeal, litigation and/or other alternatives to achieve Medicare coverage." CEO Greg Hamilton previously called aspects of the draft rejection "unexplainable" and expressed hope that CMS may change its final decision in light of microsimulation studies.
While CMS retained its original position, it did add an explanation of its decision not to include the microsimulation studies in the evidence section of the draft decision. The agency said the studies, which simulate disease incidence and mortality using observed data, did not meet its internal technology assessment criteria and expressed reservations about their utility.
"There are challenges when considering the usefulness and applicability of modeling studies," CMS wrote. "For instance, it is unclear if modeling results should be considered on par with empiric evidence generated from studies on humans."
Other changes include the rewording of CMS' statement on the evidence in support of Epi proColon. The revised section states "the test performance of the Epi proColon test does not meet sensitivity and specificity levels established by prior evidence at which the benefits of using the screening test outweigh harms to Medicare patients."
That conclusion is a blow to Epigenomics, which generated sales of €541,000 ($656,000) over the first nine months of 2020, but the rest of the document offers encouragement to other companies. Upon seeing the draft memo, analysts called the criteria "low and within reach" and "somewhat more favorable than we would have expected." Since then, CMS has removed one of the criteria a test needs to meet to secure Medicare coverage.