Of “Cures and Coverage”: December 2016 Marks Significant Progress in the Fight Against Cancer

The passage of the 21st Century Cures Act on December 7th was a milestone for America’s Precision Medicine initiative. The landmark bill includes $4.8 billion over the coming years for Vice President Biden’s Moonshot Program and, specifically, to advance programs at NIH, NCI and FDA.

Further advancing the precision medicine mantle, today, Palmetto GBA, Foundation Medicine’s Medicare administrative contractor (MAC) in North Carolina, published three draft local coverage determinations (LCD) outlining guidelines for coverage of well-validated comprehensive genomic profiles (CGPs), such as FoundationOne®, in several tumor types.

The draft coverage policies for melanoma, as well as colorectal, peritoneal, fallopian and ovarian cancers, represent significant progress advancing access to personalized cancer treatments for Medicare beneficiaries. In January 2015, Palmetto published an LCD for coverage of CGP tests in a subset of patients diagnosed with metastatic non-small cell lung cancer (NSCLC) that was expanded in September 2016 to include all Stage IIIb/IV NSCLC individuals regardless of smoking history. In recent months, Foundation Medicine has submitted evidence to support the clinical utility of CGP testing of these additional tumor types.

These most recent draft LCDs are based on evidence to support coverage of FoundationOne, a CGP test offered commercially since 2012. Similar to the already final LCD for NSCLC, these draft LCDs cover CGP for patients with advanced and/or metastatic diseases and, importantly, at initial diagnosis. They also reiterate the importance of high standards for analytic validation and differentiated CGP assays to ensure patient safety and physician confidence.

The LCDs also spotlight the important benefits of CGP compared to hotspot-based testing. By its nature, hotspot testing fails to comprehensively analyze entire coding regions of cancer genes and to detect all four classes of genomic alterations, thereby potentially missing clinically relevant targeted therapy options for patients with advanced cancer.

Many physicians and insurers understand that innovative technologies and access to molecular information will positively address the current cancer care model. We’re proud to be a part of the efforts by Palmetto and other stakeholders to advance cancer care in a data driven manner, and to increase patient access to important advanced assays for even more indications.

There will be a 45-day public comment period and discussions of the three draft LCDs at the Palmetto Coverage Advisory Committee (CAC) meetings in February 2017.