MolDX: Minimal Residual Disease Testing for Cancer

This contractor provides limited coverage for molecular MRD tests (DNA/RNA; PCR or sequencing) for patients with a personal history of cancer when the test is analytically and clinically validated for the intended population, the result would prompt a guideline-recommended change in management, and performance (sensitivity/specificity) is comparable or superior to standard-of-care monitoring. NGS-based tests must meet NCD90.2 conditions when applicable and non–FDA-approved tests must complete a technical assessment demonstrating analytical validity, clinical validity, and clinical utility; established single-gene PCR MRD tests are covered per national/society guideline schedules.

"Coverage is provided for minimally invasive molecular DNA/RNA tests that detect minimal residual disease (MRD) in patients with a personal history of cancer when all policy criteria are met."