CMS issues final coverage decision for NGS cancer tests

CMS issued a final National Coverage Determination (NCD) on Friday for next-generation sequencing (NGS) cancer diagnostics, including FoundationOne CDx from Foundation Medicine Inc. (NASDAQ:FMI), that outlines the criteria under which Medicare providers must cover such tests.

In November, FDA approved FoundationOne CDx as a universal companion diagnostic for FDA-approved targeted cancer agents and CMS simultaneously issued a proposed NCD for the in vitro laboratory-developed test (LDT), along with three other FDA-approved NGS oncology panel tests (see BioCentury Extra, Nov. 30, 2017)...