Volume of comments delays Foundation coverage decision

After missing the Feb. 28 decision date, the Centers for Medicare & Medicaid Services (CMS) said it will "soon" issue a final National Coverage Determination (NCD) for next-generation sequencing (NGS) cancer diagnostics, including FoundationOne CDx from Foundation Medicine Inc. (NASDAQ:FMI).

FoundationOne was granted a proposed NCD on Nov. 30, 2017, simultaneous with its FDA approval as a universal companion diagnostic for FDA-approved targeted cancer agents. The in vitro test had undergone parallel review by CMS and FDA...