CMS Widens NGS Test Coverage for Inherited Breast, Ovarian Cancers

Under the decision, patients will qualify if they have ovarian or breast cancer; if they have a clinical indication for germline testing for hereditary ovarian or breast cancer; or if they have a risk for germline ovarian or breast cancer, and have not been previously tested with the same germline test using NGS for the same germline genetic content, CMS said.

The “finalized document no longer requires that hereditary breast and ovarian tests have FDA approval (PMA) or FDA clearance (510k) to ensure coverage. This update is clearly a positive for [Invitae], since the company’s current tests are neither FDA approved or cleared,” Cowen analyst Doug Schenkel wrote in a note Monday.

“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,” the agency said Monday.

Source: https://www.medtechdive.com/news/cms-widens-ngs-test-coverage-for-inherited-breast-ovarian-cancers/571176/