National Coverage Determination

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Dear LabPulse Member,

February 10, 2020

CMS broadens coverage for NGS tests in breast, ovarian cancers

In a decision memo issued January 27, CMS announced that it will be covering NGS tests that are cleared or approved by the U.S. Food and Drug Administration (FDA) for some patients. The agency explained that its coverage determination applies to patients who have breast or ovarian cancer, as long as the patient has a risk factor or clinical indication for germline (inherited) breast or ovarian cancer and has not been previously tested with the same test for the same germline genetic content.

January 26, 2020

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Dear LabPulse Member,

November 4, 2019

CMS plans broader coverage for NGS in breast, ovarian cancer

The agency's review and terms and conditions on the matter were published on October 29 in a proposed national coverage determination (NCD). The agency advised coverage for next-generation sequencing with physician-ordered companion diagnostic tests approved or cleared by the U.S. Food and Drug Administration (FDA) and performed in a CLIA-certified lab. Patients must meet a range of conditions, according to CMS. They must have ovarian or breast cancer, have clinical indications for testing for hereditary cancer, and have never received a prior NGS test. Results will be provided to the treating physician.

October 29, 2019

CMS opens review of NGS testing for hereditary cancer

CMS announced that it has begun a national coverage analysis (NCA) of next-generation sequencing for Medicare beneficiaries with advanced cancer. The NCA announcement triggers a 30-day comment period that will expire on May 29. The agency expects to issue a proposed decision memo on the topic by October 2019, with completion of the review in January 2020.

April 28, 2019

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