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

Gene expression profile tests for decision-making in castration-resistant or metastatic prostate cancer are covered when performed on patients actively managed for metastatic or castration-resistant disease who fall within the test's validated population and when the result will inform a choice among multiple guideline-based management options or predict response to therapy per guidelines/FDA labeling. Tests must demonstrate AV, CV (peer-reviewed for intended use), and CU, be performed in CLIA/FDA-accredited labs, and complete the MolDX Technical Assessment; tests after pelvic radiation or ADT or previously performed identical tests are excluded except for narrow exceptions. Targeted/CGP NGS tests and single-biomarker assays are out of scope and not covered under this policy.

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