MolDX: Minimal Residual Disease Testing for Cancer
L38835
Limited coverage is provided for molecular MRD (DNA/RNA) tests in patients with a personal history of cancer when the test is analytically and clinically validated for the intended-use population, is expected to change management per established guidelines (e.g., NCCN), and demonstrates detection of molecular recurrence/progression prior to clinical/radiographic evidence with comparable or superior performance to standard monitoring. NGS-based tests must satisfy NCD 90.2 requirements (or be inapplicable) and non-FDA-approved MRD assays must complete a technical assessment demonstrating analytical validity, clinical validity, and clinical utility; single-gene PCR standard-of-care tests (e.g., BCR-ABL1) are covered per guideline schedules.
"Coverage is provided for MRD tests (DNA/RNA) in patients with a personal history of cancer when all policy conditions are met, including analytic and clinical validation for the intended-use popula..."