On May 16, 2018, the Centers for Medicare & Medicaid Services (CMS) opened a national coverage determination (NCD) analysis on Chimeric Antigen Receptor (CAR) T-cell therapy for Medicare beneficiaries with advanced cancer. As part of this NCD analysis, the
Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) will review the evidence specific to patient reported outcomes (PROs). We are seeking recommendations from the MEDCAC panel regarding how existing PRO assessment tools should be incorporated into future clinical studies, including future clinical studies on CAR T-cell therapy. The MEDCAC will focus on specific PRO assessment tools and important characteristics of a PRO assessment tool.
The MEDCAC panel will assess whether scientific evidence supports a specific number of outcome assessments, study design characteristics, study duration, and suitable controls for applying PROs to health outcomes research. This meeting will also explore the challenges regarding the validity, reliability, and generalizability of existing PRO assessments. MEDCAC panels do not make coverage determinations, but CMS benefits from their advice.