MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer

MolDX provides limited coverage for molecular DNA/RNA prostate biomarker tests to risk-stratify men being considered for initial or repeat prostate biopsy when multiple conditions are met, including no established prostate cancer, candidacy for biopsy per consensus guidelines, and meeting PSA thresholds (men ≤75: PSA >3 ng/mL; men >75: PSA ≥4 ng/mL). Tests must be validated for the intended population with demonstrated clinical validity/utility, performed in CLIA/FDA-compliant laboratories, ordered by a prostate specialist (with limited geographic exceptions), and limited to one biomarker per clinical indication unless a justified adjunct test is documented.

"Molecular DNA/RNA biomarker testing is covered to inform the decision to perform an initial prostate biopsy (pre-biopsy)."

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