MolDX: Minimal Residual Disease Testing for Cancer

This contractor provides limited coverage for molecular MRD testing (DNA/RNA, PCR or sequencing) in patients with a personal history of cancer when the test is analytically validated for the intended population, has peer‑reviewed clinical validity, is used per intended use, and its results are recognized by guidelines as prompting a definitive change in management. NGS-based tests must meet NCD 90.2 when applicable, non‑FDA MRD assays must complete a technical assessment demonstrating analytical validity/clinical validity/clinical utility, and testing frequency and schedules follow national or society guidelines (with serial assays in known cancer forming a single test).

"Coverage provided for minimally invasive molecular DNA/RNA MRD tests in patients with a personal history of cancer when all policy conditions are met."

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