CMS to emphasize clinical utility of prognostic cancer tests

At Tuesday's meeting of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to discuss prognostic tests for cancer, CMS's James Rollins said the agency will rely more heavily on clinical utility, in addition to analytical and clinical validity, when evaluating coverage of molecular pathology tests. Rollins is director of CMS's division of items and devices.

CMS convened the panel to discuss 10 types of molecular pathology tests for the prognosis of adenocarcinoma of the colon and rectum, invasive breast cancer and non-small cell lung cancer (NSCLC). The committee expressed "intermediate confidence" that existing evidence is sufficient to support clinical utility of the Oncotype DX breast cancer assay from Genomic Health Inc. (NASDAQ:GHDX). The average vote of the 8-member panel was 2.9 on a scale of 1-5, where 1 is "low confidence" and 5 is "high confidence." ...