publication date: Feb. 2, 2018

Dear CMS, Here’s what I think about your NGS policy… Agency draft memo garners 315 comments

By Paul Goldberg

The range of opinions reflected in the 315 comments CMS received on its proposal for Medicare payment for Next Generation Sequencing reflects the extent of controversy over the test.

By statute, CMS now has to sift through the comments and produce the final National Coverage Analysis memo by Feb. 28.

The CMS plan predicates payment on FDA approval, thereby placing the company that has the highest and broadest approvals into the top-tier position, a move that, according to some, would make it difficult for other players, including cancer centers that have their own sequencing programs, to catch up.

If a test has FDA approval—i.e. if it has cleared the agency’s highest bar, obtaining a Class III approval, by demonstrating clinical utility—it will be paid for by Medicare, provided that two additional conditions are met:

First, the patient has to (1) have recurrent, metastatic, or advanced stage IV cancer; (2) have not been previously tested using the same NGS test; and (3) have decided to seek further cancer treatment (e.g., therapeutic chemotherapy).

Second, the diagnostic laboratory test using NGS meets all the following criteria: (1) the test is an FDA-approved companion in vitro diagnostic; (2) the … Continue reading Dear CMS, Here’s what I think about your NGS policy… Agency draft memo garners 315 comments

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