Medicare will cover genetic tests for cancer patients

CANCER DIGEST – Mar. 17, 2018 – The Centers for Medicare & Medicaid Services (CMS) announced on Mar. 16 that Medicare will cover genetic testing needed to match cancer patients with targeted immunotherapies. Specifically Medicare will cover Next Generation Sequencing (NGS) for patients with advanced cancer that has spread or has relapsed or fails to respond to other therapies.

NGS testing identifies genetic mutations of tumors that allows doctors to use a therapy that specifically targets tumors with the mutations identified for a given patient. Advances in identifying specific mutations of a patient’s particular type of cancer has led to so-called "personalized" therapies, which match a biologic treatment to the patient's cancer according to specific genetic mutations.

The CMS’s decision follows FDA approval of NGS-based tests called F1CDx and Cdx, developed by FoundationOne that were approved last November for cancer diagnosis and therapy decision-making. F1CDx and Cdx are first "breakthrough designated" NGS-based diagnostic tests that can be used with 15 targeted therapies and can detect mutations in 324 genes and two genomic signatures, or patterns of mutations, that indicate cancer in any solid tumor.

“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 Seema Verma, CMS Administrator. “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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