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  • Washington Highlights

    CMS Finalizes Coverage of Next Generation Sequencing Tests

    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel

    The Centers for Medicare and Medicaid Services (CMS) March 16 announced it will cover Next Generation Sequencing (NGS) tests for patients with advanced cancer. The decision finalizes many aspects of the proposed National Coverage Decision (NCD) issued Nov. 30. The AAMC submitted comments to CMS on the Proposed NCD Jan. 17 [see Washington Highlights, Jan. 19].

    In its comments to CMS, the AAMC argues that limiting coverage for patients to those tests approved or cleared by the Food and Drug Administration (FDA) could impede innovation, increase the use of older or outdated technology, result in Medicare beneficiaries receiving lower quality diagnostic testing, and drive institutions to see FDA approval for diagnostic tests when approval is not required. The NCD finalized by CMS does not limit reimbursement to FDA covered tests, but rather allows for coverage determinations for other diagnostic laboratory tests to be made by local Medicare Administrative Contractors (MAC). Tests that do receive FDA approval will automatically receive full coverage, provided additional criteria are met.

    In a press release announcing the decision, CMS Administrator Seema Verma states, “We want cancer patients to have enhanced access and expanded coverage when it comes to innovative diagnostics that can help them in new and better ways. That is why we are establishing clear pathways to coverage, while at the same time supporting laboratories that currently furnish tests to the people we serve.”