US CMS Opens Medicare National Coverage Analysis For NGS Germline Mutation Tests
The CMS opened a national coverage analysis tracking sheet on 29 April to reconsider evidence for next-generation sequencing tests of germline mutations. These assays identify beneficiaries with hereditary cancer who may benefit from targeted treatments based on the tests’ conclusions about carcinogenic genetic mutations passed on by patients’ parents.
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There is sufficient evidence to expand coverage of next-generation sequencing (NGS) as a diagnostic test for ovarian, breast or other advanced cancers if certain criteria are met, the Centers for Medicare and Medicaid Services wrote in a 30 October proposed decision memo.
The US Centers for Medicare and Medicaid Services said on March 16 that it will cover next-generation sequencing diagnostic laboratory tests for advanced cancers, broadening its final determination to cover use in relapsed, refractory and stage III cancers, while dropping "coverage with evidence development" conditions.
While device firms that create lab test kits, clinical laboratories and cancer medicine groups supported US Centers for Medicare and Medicaid Services' proposed national coverage determination for use of next generation sequencing (NGS) for advanced cancer tests in recent comments, they want the agency to modify its approach to the NCD in one way or another and, in many cases, expand it. A final coverage decision is imminent.