CMS to Expand Coverage of Next-Generation Sequencing for Ovarian or Breast Cancer
Posted: Monday, February 3, 2020
On January 27, 2020, the Centers for Medicare & Medicaid Services (CMS) took action to cover U.S. Food and Drug Administration–approved or cleared laboratory diagnostic tests using next-generation sequencing for patients with germline (inherited) ovarian or breast cancer.
Over the past several years, CMS has been actively monitoring the rapid innovation of next-generation sequencing tests and the evolution of cancer diagnostic tools. These tests provide the most comprehensive genetic analysis of a patient’s cancer because they enable simultaneous detection of multiple types of genetic alterations. Medicare first began covering laboratory diagnostic tests using next-generation sequencing in March 2018 for Medicare patients with advanced cancer who met specific criteria. As a result of this January 2020 decision, more Medicare patients will have access to next-generation sequencing in managing other types of inherited cancers to reduce mortality and improve health outcomes.
CMS recognizes that innovation is happening quickly, and evidence is moving fast, and the agency wanted to ensure that patients have ready access to this diagnostic test when appropriate. Therefore, CMS is now providing Medicare’s Administrative Contractors with discretion over whether to cover certain other indications.
To read a summary of the CMS decision, visit cms.gov.