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Parallel Review Progress: FDA Approves, CMS Assesses Cologuard Cancer Test

CMS opened a national coverage determination for Exact Sciences Cologuard, the first stool-based colorectal cancer screening test on the same day FDA approved the test. This is the first simultaneous approval/coverage determination under FDA and CMS’ joint parallel review program.

FDA’s approval of Exact Sciences Corp.’s PMA for the Cologuard stool-based colorectal screening teston August 11, the same day CMS proposed national coverage for the unique non-invasive cancer test, marks an important milestone for the agencies’ parallel-review program.

Cologuard is the first product to complete parallel FDA-CMS review under the pilot parallel review program, a voluntarily pilot open to certain PMAs within the scope of Medicare Part A or Part B. It is intended to bring new technology to patients faster than the traditional process of waiting for FDA approval to begin the coverage determination process

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