publication date: Feb. 2, 2018

Like it or not, CMS policy aims to change everything in Next generation sequencing

By Paul Goldberg

A policy now in the works at the Centers for Medicare and Medicaid Services will define settings where Medicare will pay for next generation sequencing.

The health care funding agency will use FDA approval of NGS tests to determine whether these tests are covered outright, receive “coverage with evidence development,” or are denied coverage altogether.

Foundation Medicine Inc., a provider of NGS testing based in Cambridge, Mass., emerges as a clear, big winner in this action by CMS. Last November, the company’s FoundationOne CDx test received an FDA approval, and—concurrently—CMS issued a provisional National Coverage Determination defining the settings where Medicare would cover the test (The Cancer Letter, Dec. 1, 2017).

“I think doctors and patients have tremendous confidence in knowing that a test has gone through the scrutiny of FDA review,” Vincent Miller, chief medical officer of Foundation Medicine, said to The Cancer Letter. “It offloads some of the thinking they need to do as they sit there with a patient and there are multiple issues on the table to be addressed in a very short period of time in which to see the patient.

“This becomes, I believe, indispensable to … Continue reading Like it or not, CMS policy aims to change everything in Next generation sequencing

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