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 without an established prostate cancer diagnosis for pre-biopsy decision-making or to refine risk after a non-diagnostic biopsy, provided all policy criteria are met. Key criteria include age-specific PSA thresholds for biopsy candidacy, prior biopsy status (no prior biopsy or prior negative/abnormal non-malignant pathology), demonstrated clinical validity and utility in peer-reviewed literature, testing in CLIA/FDA-accredited laboratories, algorithm validation in independent cohorts, and ordering by a prostate cancer specialist (with narrow geographic exceptions).

"Molecular DNA/RNA biomarker tests are indicated to risk-stratify men without an established prostate cancer diagnosis to inform the decision to perform an initial biopsy (pre-biopsy) or to refine r..."

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