CMS Proposes New National Coverage Policy for NGS Germline Testing

The government payor now proposes to cover US Food and Drug Administration-approved or -cleared germline NGS testing for breast and ovarian cancer patients who have risk factors that suggest they should receive testing to assess their inherited risk for these cancers. Patients cannot have previously had NGS testing, doctors must order testing, and the lab must perform testing in a CLIA-certified lab. 

Additionally, in order to garner Medicare coverage under the new national policy proposal, the test must be FDA approved or cleared; the patient must be tested for one of the FDA-approved or -cleared indications on the NGS test, and the test results must be furnished to the patient’s doctor and indicate treatment options associated with the genetic test results. 

Under this proposal, CMS would allow its Medicare Administrative Contractors to determine local coverage for physician-ordered NGS tests that are performed in a CLIA-certified lab but aren’t FDA approved. In order to receive local coverage, patients must have breast or ovarian cancer, but they can also have risk factors indicating a need for inherited cancer risk testing for other cancers, and not have previously received an NGS test.

Source: https://www.genomeweb.com/reimbursement-news/cms-proposes-new-national-coverage-policy-ngs-germline-testing