MolDX: Lab-Developed Tests for Inherited Cancer Syndromes in Patients with Cancer

Coverage is provided for hereditary germline cancer testing (including LDTs, FDA-cleared, and FDA-approved tests) when the patient has a cancer diagnosis, a clinical indication and risk factors for inherited cancer, has not previously been tested for the same genetic content, and the test has a satisfactory MolDX Technical Assessment and includes the minimum guideline-based gene/variant content. NGS tests must also meet all NCD 90.2 conditions; tests are non-covered if duplicative of prior testing, if a targeted test would identify or confirm a known familial or somatic variant, or if a satisfactory TA is not completed by the required date.

"Patient has any cancer diagnosis."

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