The Centers for Medicare & Medicaid Services yesterday issued a national decision to cover diagnostic laboratory tests using next generation sequencing for certain Medicare patients with inherited ovarian or breast cancer. As proposed last October, the test must be approved or cleared by the Food and Drug Administration, ordered by a treating physician for a patient not previously tested using the same NGS test, and performed in a laboratory certified under the Clinical Laboratory Improvement Amendments program, among other requirements. Under the decision, Medicare administrative contractors also could decide to cover the tests for patients with other cancers that may be inherited. NGS tests provide the most comprehensive genetic analysis of a patient’s cancer because they enable simultaneous detection of multiple types of genetic alterations. Medicare began covering the tests in March 2018 for patients with certain advanced cancer.   

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