Skip to main content
Premium Trial:

Request an Annual Quote

And Now Coverage

The US Centers for Medicare & Medicaid Services has announced that it would cover next-generation sequencing-based cancer panel tests for Medicare patients with advanced disease, as 360Dx has reported.

According to a new national coverage determination, CMS will cover Food and Drug Administration-approved or -cleared companion in vitro diagnostics if they have an approved or cleared use for patients' cancers and if the results are given to a physician to help guide treatment. 360Dx adds that this includes Foundation Medicine's FoundationOne CDx test, Illumina's Praxis Extended RAS Panel, and Thermo Fisher Scientific's Oncomine Dx Target Test, among others. Reuters notes that this decision will help match patients to therapies from which they are more likely to benefit.

Wired adds that this may also affect people who are not yet eligible for Medicare in the US, as private insurers typically follow CMS' lead in what to cover. "Which means that genetic testing just became routine care for patients with advanced cancers," it adds. "And that means precision medicine has finally broken into the mainstream."

360Dx notes in a separate article that laboratory-developed NGS cancer tests that haven't sought FDA approval may still be covered if the lab seeks local coverage determinations through a CMS' Medicare Administrative Contractors.