Healthcare Stakeholders Ask CMS Not to Limit Access to NGS Hereditary Cancer Risk Tests

A group of 60 diverse healthcare companies and organizations has written to the Centers for Medicare & Medicaid Services, requesting the agency change its decision to restrict coverage of next-generation sequencing-based testing for hereditary cancer risk.

In early January, Medicare contractor Palmetto updated a local coverage decision for BRCA1 and BRCA2 testing to align with CMS’ national coverage determination for NGS testing for advanced cancer. That NCD was triggered by Foundation Medicine’s bid to garner regulatory approval and national coverage for FoundationOne CDx, an NGS test that analyzes tumor samples for mutations in hundreds of genes in order to personalize cancer treatment. CMS agreed to cover this and similar tests for patients with recurrent, relapsed, refractory, metastatic, or advanced stage III or IV disease who are seeking treatment. 

Initially, only Palmetto incorporated language in an LCD to restrict germline NGS testing coverage for early-stage cancer patients. But since then, at least one other Medicare contractor, Noridian, has included similar language in an updated LCD for BRCA1/2 testing. 

Also adding their names to the letter are large reference labs, including the Laboratory Corporation of America, Quest Diagnostics, BioReference Laboratories; NGS platform providers Illumina and Thermo Fisher Scientific; genetic testing providers Myriad Genetics, Invitae, and Ambry Genetics; and personalized medicine-focused healthcare providers, such as Intermountain Precision Genomics and Columbia University Irving Medical Center. 

Source: https://www.genomeweb.com/cancer/healthcare-stakeholders-ask-cms-not-limit-access-ngs-hereditary-cancer-risk-tests