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CMS Finalizes NGS Test National Coverage Determination, Removes Evidence Development for LDTs

This article has been updated with information about NGS cancer panels with FDA-approved companion diagnostic indications.

NEW YORK (GenomeWeb) – CMS on Friday finalized the draft national coverage determination it issued last year on next-generation sequencing cancer panels, altering the determination to no longer include coverage with evidence development (CED) for tests that haven't been approved by the US Food and Drug Administration.

The final decision also expands automatic coverage for FDA-approved tests to patients with relapsed, refractory, or stage III cancers in addition to stage IV cancers and allows for repeat testing when a patient has a new primary diagnosis.

This decision to issue a broad NCD on NGS panels was made following CMS' parallel review with the FDA, which granted approval of Foundation Medicine's FoundationOne CDx test last November.

In addition to covering the FDA-approved F1CDx, the NCD provides for CMS coverage of other FDA-approved or cleared companion in vitro diagnostics when these tests have an FDA-approved or -cleared indication for use in that patient's cancer and results are provided to the treating physician for management of the patient using a report template to specify treatment options. 

Other commercial NGS cancer panels with FDA-approved CDx indications include FoundationFocus CDxBRCA, Illumina's Praxis Extended RAS Panel, and Thermo Fisher Scientific's Oncomine Dx Target Test.

While the draft NCD also included provisions for tests that are not FDA approved to garner coverage through the CED process, CMS said in its issuance of the revised final determination that it was removing that in response to public comments.

"Many commenters reported that they are already developing or have developed the evidence to demonstrate these [tests] improve health outcomes for Medicare beneficiaries with cancer — or are equipped to conduct their own studies to generate evidence that use of the test guides management and treatment, and improves health outcomes for the Medicare population," CMS wrote in a statement accompanying the NCD. "We strongly encourage continuing and publishing the results of these important studies, especially on the endpoints of overall survival, progression-free survival, objective response, and patient-reported outcomes relevant to the quality of life for Medicare beneficiaries."

Under the final determination, tests that gain FDA approval or clearance as an in vitro companion diagnostic will automatically receive full coverage, while determinations of coverage for laboratory-developed tests that have not been approved or cleared will be left up to local Medicare Administrative Contractors.

In early morning trading, Foundation Medicine's stock price had increased by around 3 percent and was trading at $81.97.