Medicare Gives Green Light to NGS IVDs

摘要

In what is viewed as a step forward for NGS-based clinical testing, the US Centers for Medicare & Medicaid Services (CMS) announced this month a final National Coverage Determination (NCD) for FDA-approved NGS tests for advanced cancer (defined as either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV) patients as long as certain criteria are met. An NCD decides what services will be paid for by the government's national Medicare program. Medicare covers roughly 15% of the US population, according to AARP. The NCD was specifically issued for Foundation Medicine's FoundationOne CDx (Companion Diagnostics) test for solid tumors.