CMS finalizes National Coverage Determination for Next Generation Sequencing Tests for advanced cancer

​On Friday, March 16, Centers for Medicare & Medicaid Services (CMS) finalized its National Coverage Determination (NCD) for Next Generation Sequencing (NGS) tests for Medicare beneficiaries with advanced cancer.

In the draft NCD issued in November 2017, CMS had proposed national coverage of NGS tests only if they had Food and Drug Administration (FDA) approval as companion diagnostics, and would have covered other tests only if they met stringent requirements for Coverage with Evidence Development (CED). In the final NCD, however, CMS backed away from its CED proposal, and will allow Medicare Administrative Contractors (MACs) to continue developing Local Coverage Determinations (LCDs) for NGS tests that aren't FDA cleared or approved as companion diagnostics. In addition, CMS expanded its national coverage to certain tests that are FDA cleared (via a 510(k)) as well as those approved (via a premarket approval); testing for patients with Stage III, rather than just Stage IV, cancer; and repeat testing with the same NGS test if a new primary cancer is diagnosed.

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