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

This policy provides limited coverage for molecular DNA/RNA biomarker tests to risk‑stratify men being considered for initial or repeat prostate biopsy when all specified criteria are met. Coverage requires no established prostate cancer diagnosis, biopsy candidacy per consensus guidelines, specified PSA thresholds by age (≤75: PSA>3 ng/mL; >75: PSA≥4 ng/mL), appropriate prior testing (repeat PSA/DRE as indicated), validated test use in the intended population, laboratory accreditation, and sufficient peer‑reviewed evidence that the test changes management to improve outcomes.

"Molecular DNA/RNA biomarker testing is covered to risk-stratify men being considered for an initial (pre-biopsy) prostate biopsy when all other policy criteria are met."

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