WASHINGTON — Patient groups and drug manufacturers say a proposed rule from the Center for Medicare and Medicaid Services would dramatically restrict coverage of genetic tests for patients covered by those programs — a move which may specifically impact patients deciding between various cancer treatments.
The rule, expected to be finalized next week, stipulates that CMS only cover next-generation sequencing (NGS) tests approved by the Food and Drug Administration. That would leave a small subset of existing diagnostic tools — including the FoundationOne, Oncomine Dx, and Illumina — available to Medicare beneficiaries.
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