CMS Outlines Coverage of Next Generation Sequencing for Cancer

FoundationOne CDx is the first-of-a-kind comprehensive companion diagnostic test for solid tumors.

CMS has finalized a National Coverage Determination (NCD) that covers diagnostic laboratory tests that use Next Generation Sequencing (NGS) for patients with advanced cancer, according to a press release.

According to the release, when the tests are used as a companion diagnostic to identify patients with certain genetic mutations who can potentially benefit from FDA-approved therapies, they can assist patients and their physicians in making more informed treatment decisions. When there is no available treatment for a cancer mutation, the results from the diagnostic lab test, using NGS, can help determine a patient’s candidacy for cancer clinical trials.

“We want cancer patients to have enhanced access and expanded coverage when it comes to innovative diagnostics that can help them in new and better ways,” said CMS Administrator Seema Verma. “That is why we are establishing clear pathways to coverage, while at the same time supporting laboratories that currently furnish tests to the people we serve.”

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