Thursday, December 21, 2017

CMS Extends Comment Period on NGS/Cancer Proposed NCD

CMS has extended the comment period to January 17, 2017, on the currently debated National Coverage Determination for all uses of next generation sequencing in cancer.   The NCD provides coverage only for PMA-approved tests used on-label in the relevant cancers.   The NCD would cover patients who are part of clinical studies (coverage with evidence developments) for other uses of PMA- or 510(k)-approved NGS tests.

The tracking and dates page is here.   The NCD is here.

Comment deadline has been revised (old, Dec 29, new Jan 17)