CMS proposes guidelines for biomarker tests for CRC screening

Oct. 28, 2020

The Centers for Medicare & Medicaid Services (CMS) proposed guidelines outlining when it will cover blood-based biomarkers tests for colorectal cancer screening, but it did not approve coverage for an available test, according to a proposed decision memo.

In the memo, the agency said it would cover a blood-based biomarker test for colorectal cancer screening test once every three years – or at another interval as indicated by the U.S. Food and Drug Administration (FDA) – when performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory and when ordered by a treating physician.

CMS said the test would be appropriate only if a patient is between 50-85 years of age, asymptomatic and at average risk of developing colorectal cancer.

In addition, the blood-based biomarker test must meet the following criteria:

·        FDA market authorization with an indication for colorectal cancer screening

·         Proven test performance characteristics for a blood-based screening test with both 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 the recognized standard (accepted as colonoscopy at this time), based on the pivotal studies included in the FDA labeling

·         Inclusion as a recommended routine colorectal cancer screening test in at least one professional society guideline or consensus statement or United States Preventive Services Task Force (USPSTF) recommendation.

CMS said it would not cover Epi proColon because the test does not meet the proposed criteria for an appropriate blood-based biomarker CRC screening test.

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