Germline BRCA1/2 variant analysis for individuals with metastatic castrate-resistant prostate cancer (mCRPC) to select treatment with FDA-approved targeted therapies may be considered medically necessary.
All other uses of germline BRCA1/2 variant analysis to guide prostate cancer targeted therapy are considered investigational.
Somatic testing using tissue biopsy for homologous recombination repair (HRR) gene alterations (BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, and RAD54L) to select treatment for mCRPC with FDA-approved targeted therapies may be considered medically necessary.
All other uses of somatic testing using tissue biopsy for HRR gene alterations to guide prostate cancer targeted therapy are considered investigational.
Somatic testing using circulating tumor DNA testing (liquid biopsy) for BRCA1, BRCA2, and ATM alterations to select treatment for mCRPC with FDA-approved targeted therapies may be considered medically necessary.
All other uses of somatic testing using circulating tumor DNA testing (liquid biopsy) to guide prostate cancer targeted therapy are considered investigational.
Simultaneous testing using liquid and tumor biopsies (outside of paired or concurrent somatic-germline testing) to guide treatment in individuals with prostate cancer is considered investigational (see Policy Guidelines).
Testing for other variants may become available between policy updates.
