MolDX: Gene Expression Profile Tests for Decision-Making in Castration Resistant and Metastatic Prostate Cancers

Gene expression profile tests are covered for men actively managed for castration-resistant or metastatic prostate cancer when the patient matches the validated population, has not had an equivalent prior test, and testing would inform a choice among multiple management options or predict response to specific therapies per nationally recognized guidelines or FDA labeling. Coverage requires demonstrated analytical validity, clinical validity, and clinical utility (with peer-reviewed evidence and independent algorithm validation if applicable), testing in a CLIA/FDA-accredited lab, and successful completion of the MolDX Technical Assessment; tests using NGS-based CGP or single-biomarker analyses are excluded.

"Beneficiary is being actively managed for prostate cancer that is castration-resistant or metastatic (including hormone-sensitive or castration-resistant metastatic disease)."