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CMS Finalizes Coverage for Next-Generation Sequencing Tests

Jaime Rosenberg
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. The finalization comes a few months after the FDA granted approval to FoundationOne CDx, 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.”

When the FDA granted approval of Foundation Medicine’s FoundationOne CDx last November, CMS simultaneously proposed a NCD for NGS cancer diagnostics. FoundationOne CDx is the first-of-a-kind comprehensive companion diagnostic test for solid tumors. The test searches for genetic mutations in 324 genes known to drive cancer growth and is a companion diagnostic for 15 available targeted therapies, providing physicians with a more complete picture of what's causing tumor growth and potentially actionable information to help guide treatment decisions.

The test also has the potential to open the door to new targeted therapy drugs. In an interview with The American Journal of Managed Care® , Stuart Goldberg, MD, chief scientific officer, Cota, explained that if it’s discovered that many patients have a certain mutation, there’s a possibility that someone will start developing a drug for it.

In addition to covering FoundationOne CDx, CMS is covering FDA-approved or cleared companion in vitro diagnostics when the test has an FDA-approved or cleared indication for use in that patient’s cancer, and results are provided to the treating physician for management of the patient using a report template to specify treatment options, according to the release.

“These tests can help doctors consult with patients about more targeted care or enrollment in a clinical trial,” said Kate Goodrich, MD, CMS' chief medical officer and director, Center for Clinical Standards and Quality. “The expanded coverage in this final NCD now includes additional tests for relapsed, refractory, and earlier stage III cancers to aid in the treatment of these cancer patients.”

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