publication date: Mar. 23, 2018

How CMS intends to pay for next generation sequencing

By Paul Goldberg

Centers for Medicare and Medicaid Services March 16 published the final National Coverage Determination that will pay for next generation sequencing in a broad range of cancers.

The document is posted here. To qualify for coverage under the NCD, laboratories must meet three conditions:

FDA approval or clearance as a companion in vitro diagnostic;

An FDA approved or cleared indication for use in that patient’s cancer; and

Results provided to the treating physician for management of the patient using a report template to specify treatment options.

Labs that don’t have FDA approval or clearance may ask to see coverage from Medicare Administrative Contractors. MACs are usually reticent to provide such coverage. Foundation Medicine Inc. clearly stands to win the most from the NCD.

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). It was FMI that requested the NCD.

The final NCD differs significantly from the preliminary decision memorandum that was posted last November (The Cancer Letter, Feb. 2).

In the preliminary decision, tests that have … Continue reading How CMS intends to pay for next generation sequencing

To access this members-only content, please log in.
If you're not a subscriber why not join today?
If you believe you should be able to view this area but cannot log in, then please contact us and we will try to rectify this issue as soon as possible.
To gain access to the members only content click here to subscribe.
You will be given immediate access to premium content on the site.
Click here to join.

Copyright (c) 2018 The Cancer Letter Inc.