MolDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer
L39042
Limited coverage is provided for molecular DNA/RNA biomarker tests to risk‑stratify men at increased risk for prostate cancer in pre‑biopsy or post‑biopsy settings when strict conditions are met: no established prostate cancer diagnosis, eligibility for biopsy per consensus guidelines, age‑specific PSA thresholds (≤75: PSA>3 ng/mL; >75: PSA≥4 ng/mL), appropriate biopsy history, evidence of clinical validity/utility in peer‑reviewed literature, testing in CLIA/FDA‑accredited labs, and ordering by a prostate cancer specialist (with limited‑access exceptions). Additional constraints include a one‑test‑per‑indication limit (unless a validated adjunct is necessary), independent validation of algorithms, and documentation requirements demonstrating medical necessity, validation evidence, and guideline‑recommended prior testing.
"Molecular DNA/RNA biomarker testing is covered to inform the decision to perform an initial (pre‑biopsy) prostate biopsy in men without an established diagnosis of prostate cancer who are candidate..."