Following up on its earlier draft, Palmetto GBA, a Medicare administrative contractor (MAC) and thought leader in molecular diagnostics reimbursement through its innovative Molecular Diagnostics (MolDx) Program, has published a final Local Coverage Determination (LCD) outlining MolDx guidelines for coverage of well-validated comprehensive genomic profiles (CGPs) for cancer, such as FoundationOne®. These guidelines address the reimbursement of CGPs in an initial subset of patients diagnosed with non-small cell lung cancer (NSCLC).

We believe this coverage decision is a critical advancement toward eventual broader coverage as evidence continues to build across multiple cancers. We applaud Palmetto and other stakeholders that are embracing science, advancing cancer care and enabling precision medicine by giving cancer patients access to innovative testing technologies that identify potentially impactful, targeted therapies.

Palmetto’s announcement today and its continued focus in this area, coupled with industry developments such as MED-C and ASCO’s CancerLinQ, are examples of initiatives that can have a significant impact in shaping the future reimbursement landscape for molecular diagnostics. While Palmetto GBA’s decision is an important step, it cannot be the only step to provide cancer patients with access to potentially life-saving therapies identified by comprehensive genomic profiling.

Based on direct feedback from Palmetto, it is our understanding that FoundationOne, a CGP developed and offered commercially by Foundation Medicine since 2012, meets the standards necessary to be covered under this LCD, if it is adopted by National Government Services (NGS), our designated MAC. Importantly, the LCD also highlights the critical distinctions between hotspot-based testing and CGPs, given the inherent limitations of hotspot testing in failing to comprehensively analyze the entire coding regions of cancer genes and detect all four classes of genomic alterations, thereby missing targeted therapy options that are often clinically relevant for treatment of advanced cancer. Additionally, the LCD also highlights the requirement to meet Palmetto’s recently released standards for analytic validation and the absolute necessity for testing of tumor tissue only, which reflects an acknowledgment that tissue is the gold standard sample type. We will continue to work with NGS until adoption is achieved and Medicare patients have access to this important component of cancer care.