Medicare to cover genomic testing for advanced cancer patients

Medicare-eligible patients with advanced cancers will have access to genomic tests under a national coverage determination CMS finalized March 16.

The determination covers next-generation sequencing diagnostic laboratory tests for patients with recurrent, metastatic, relapsed, refractory, or stage III or stage IV cancers. CMS's decision follows the FDA's approval of Foundation Medicine's cancer genomic test, FoundationOne CDx, in November.

F1CDx is an in vitro diagnostic test that uses next-generation sequencing to identify genetic mutations in 324 genes and two genomic signatures in any solid tumor. The test detects genetic mutations to determine whether patients may benefit from 15 different targeted cancer therapies.

In addition to F1CDx, CMS will cover other FDA-approved and FDA-cleared in vitro diagnostics that provide results to the patient's treating physician. Tests that the FDA approves or clears as in vitro companion diagnostics will automatically receive full coverage under the determination.

CMS released the national coverage determination to assist patients and oncologists in making more informed treatment decisions, according to a March 16 agency statement. Officials noted genomic test results may help determine a patient's eligibility for cancer clinical trials, as well.

"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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