Medicare coverage of germline next-generation sequencing (NGS) panels for early-stage cancer patient has been a topic of controversy of late. The problem began when the Centers for Medicare and Medicaid Services (CMS) instructed its Medicare Administrative Contractors (MACs) to impose new coverage restrictions on early-stage cancer testing. But after a public outcry, the agency seems to have backed off. Or has it? The NGS Tests at Issue NGS technology enables laboratory testers to read the order of nucleotide molecules on DNA and more effectively provides detailed information on multiple types of genetic alternations simultaneously. The NGS oncology panel tests also facilitate personalization of treatment by giving patients and providers a more comprehensive genetic profile of cancer and information relevant to potential cancer treatments. The NGS testing at issue is germline NGS testing of BRCA1/2 genes. Such testing can be used to direct treatment of poly ADP ribose polymerase (PARP) inhibitors in advanced breast and ovarian cancer patients; but it can also be used at early stages to assess patients for their inherited risks for these and other cancers. Early-stage NGS germline testing results generate risk information that can be determining a patient’s need for preventive screening and surgical interventions. The […]