On March 16, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination (NCD) for Next Generation Sequencing (NGS) as a diagnostic laboratory test for patients with certain advanced stages of cancer. The NCD process was initiated by Foundation Medicine, Inc.’s request for Medicare coverage for its FoundationOne CDx test, the first FDA companion diagnostic that can detect genetic mutations in solid tumors. The NCD provides for Medicare coverage of NGS tests that have been FDA-approved or cleared as a companion diagnostic for patients with certain stage III or IV cancers. In addition, the NCD delegates authority to Medicare Administrative Contractors (MACs) to determine local coverage for tests that do not meet the NCD’s FDA criteria.
Holding a key role in the area of precision medicine, NGS is the second technology, and also the second category of vitro laboratory tests, to have successfully completed the FDA-CMS Parallel Review Program. The first in vitro diagnostic to be approved and covered under the Parallel Review Program was Cologuard®, a multi-target sDNA colorectal cancer screening test for which CMS finalized a NCD in October 2014. The Parallel Program was designed to reduce the time between FDA approvals and Medicare national coverage and, here, CMS issued its proposed NCD determination on November 30, 2017, the same date that FDA extended approval for the FoundationOne CDx test and within six months of the FDA’s receipt of the product application. Continue Reading