CMS Seeking Advice Regarding Molecular Pathology Tests Estimating Cancer Prognosis

A panel from CMS’s Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) will meet in March to review evidence concerning molecular pathology tests used to estimate the prognosis of certain cancers: including adeno carcinoma of the colon and rectum, invasive breast cancer and non small cell lung cancer. MEDCAC “was established to provide independent guidance and expert advice to CMS on specific clinical topics” giving “unbiased and current deliberation of ‘state of the art’ technology and science,” according to CMS’s webpage regarding MEDCAC. This panel will consider outcomes (good and bad) from anti-tumor treatments that were selected based on specific molecular pathology tests’ predictions for the cancer patient’s prognosis. That panel will then advise CMS “about the extent to which it may wish to use existing evidence as the basis for any future determinations about coverage for tests that estimate cancer prognosis.” These are not coverage determinations but merely advice. Questions under consideration address whether existing evidence: demonstrates the analytical and clinical validity of the test to estimate the prognosis for Medicare patients with the related cancer shows whether the estimated prognosis “affects health outcomes” for those patients whose treatment is determined based on the test result indicates that the […]