The Centers for Medicare & Medicaid Services (CMS) recently announced that patients with germline ovarian or breast cancer would be covered for diagnostic testing that uses next-generation sequencing (NGS).1,2

“The evidence for cancers of the breast and ovary suggests that the use of NGS can identify germline mutations which will lead to better treatment and health outcomes for patients with inherited cancers of the breast and ovary,” CMS explained in their decision memo.

To be covered by CMS, the patient must have ovarian or breast cancer and have a clinical indication to receive germline testing for germline breast or ovarian cancer as well as have a risk factor for germline breast or ovarian cancer. In addition, the patient cannot have previously undergone testing with the same germline test that uses NGS for the same germline alteration.

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CMS also requires the diagnostic laboratory that is carrying out the test to be approved or cleared by the US Food and Drug Administration. In addition, the results provided by the diagnostic laboratory to the physician must use a report template that lays out treatment options.

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During the comment period, CMS received submissions suggesting that in addition to germline breast and ovarian cancer, other germline cancers be nationally covered, such as male breast cancer, colorectal cancer, lung cancer, pancreatic cancer and prostate cancer.

According to CMS, there is “insufficient evidence” regarding the clinical utility of diagnostic tests that use NGS for these other cancer types. However, CMS does acknowledge that the evidence on clinical utility for other cancer types is “rapidly developing and accumulating.” As a result, CMS will leave assessments of clinical utility and coverage decisions for patients with germline cancers other than breast or ovarian cancer up to the discretion of Medicare Administrative Contractors.


  1. CMS expands coverage of next generation sequencing as a diagnostic tool for patients with breast and ovarian cancer [news release]. Centers for Medicare & Medicaid Services; January 27, 2020. Accessed February 4, 2020.
  2. Centers for Medicare & Medicaid Services. Decision memo for next generation sequencing (NGS) for Medicare beneficiaries with advanced cancer (CAG-00450R). Published January 27, 2020. Accessed February 4, 2020.