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

Coverage is provided for hereditary germline cancer testing (including LDTs and NGS) when the patient has any cancer diagnosis, a documented clinical indication and risk factor for inherited cancer, has not previously been tested for the same germline content, and the specific test has a completed MolDX Technical Assessment and contains the minimum guideline-based genetic content required for clinical decision making. NGS tests must meet NCD 90.2 conditions. Tests are denied if duplicative, used instead of a targeted test for known familial or somatic variants, lack a satisfactory TA, or fall outside the policy scope (e.g., ctDNA, somatic tumor tests, polygenic risk scores).

"Patient has any cancer diagnosis and is a candidate for hereditary (germline) testing."

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