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 met a lower bar, getting Class II clearance that falls short of demonstrating benefit, CMS would have paid for coverage contingent on “evidence development.”

The diagnostic laboratory test using NGS is covered under CED only when they met a long list of criteria.

The CED provision was crossed out of the final decision memorandum.

In the final memo, CMS offers … Continue reading How CMS intends to pay for next generation sequencing

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