publication date: Jan. 23, 2015


CMS Opens Door to Coverage of Comprehensive Genomic Sequencing


At first glance, it’s hard to imagine anything as obscure as a policy by a private contracting firm that runs the Medicare program in the Carolinas, Virginia and West Virginia.

But look closer: a “local coverage determination” by Palmetto GBA addresses an urgent, vexing problem of precision oncology: how advanced molecular testing can be used to determine treatment options for individual patients and what insurers will be willing to pay for.

The coverage determination, titled “Comprehensive Genomic Profiling for Non-Small Cell Lung Cancer” popped up on a government website well after close of business Jan. 22. There was no press release; no rollout whatsoever.

Nonetheless, the decision may introduce clarity into the informational pea-soup fog that engulfs molecular testing by spelling out the criteria for opening payment for complex tests and comprehensive genomic assays, which measure multiple markers.

As it stands, the vast majority of assays that cost thousands of dollars and are used to determine treatment for cancer patients are not reviewed by government agencies before they enter the marketplace.

Moreover, Medicare claim forms make it impossible for nearly all payers to determine what the tests are for and how effective they are (The Cancer Letter, Aug. 8, 2014). With more than 11,000 laboratories selling tests that fit under a small number of codes, Medicare administrators and private insurers typically get claims for they-don’t-know-what. And they pay at least some portion of those claims.

Palmetto’s new policy is poised to determine … Continue reading 41-03 CMS Opens Door to Coverage of Comprehensive Genomic Sequencing

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