This document addresses BRCA genetic testing (DNA testing) for individuals who are at higher than average risk for the development of cancer. Genetic tests addressed in this document include BRCA1 and BRCA2 mutations and large genomic rearrangements of DNA in the BRCA1 and BRCA2 genes (BRACAnalysis^® Rearrangement Test [BART]).

Note: For additional information on genetic testing for malignant conditions, please refer to:

• CG-GENE-14 Gene Mutation Testing for Cancer Susceptibility and Management
• CG-GENE-15 Genetic Testing for Lynch Syndrome, Familial Adenomatous Polyposis (FAP), Attenuated FAP and MYH-associated Polyposis

This document does not address panel testing. Please refer to:

• GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling

Clinical Indications

Medically Necessary:

Genetic testing to detect BRCA (BRCA1 and/or BRCA2) mutations and/or large genomic rearrangements is considered medically necessary when any one of the criteria A, B, or C and all of the criteria in D are met:

1. For women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer that suggests an inherited cancer susceptibility as determined by a validated BRCA1 or BRCA2 mutation assessment tool, including any of the following (Ontario Family History Assessment Tool; Manchester Scoring System; Referral Screening Tool; Pedigree Assessment Tool; 7-Question Family History Screening Tool; International Breast Cancer Intervention Study Instrument [Tyrer-Cuzick]; BRCAPRO [brief version]); or
2. For individuals who meet one or more BRCA1 or BRCA2 testing criteria established by the National Comprehensive Cancer Network (NCCN); or
3. For individuals who require confirmatory testing for a BRCA1 or BRCA2 mutation(s) detected by a Food and Drug Administration (FDA)-authorized direct-to-consumer (DTC) test report; and
4. Genetic counseling, which encompasses all of the following components, has been performed:
   1. Interpretation of family and medical histories to assess the probability of disease occurrence or recurrence; and
   2. Education about inheritance, genetic testing, disease management, prevention and resources; and
   3. Counseling to promote informed choices and adaptation to the risk or presence of a genetic condition; and
   4. Counseling for the psychological aspects of genetic testing.

Note: The NCCN testing criteria and BRCA1 or BRCA2 mutation assessment tools are listed below in the Discussion/General Information section.

Genetic testing to detect BRCA (BRCA1 and/or BRCA2) mutations with or without analysis of homologous recombination deficiency (HRD) pathways is considered medically necessary when an individual is a candidate for poly (ADP-ribose) polymerase (PARP) inhibitor therapy.

Not Medically Necessary:

Genetic testing to detect BRCA (BRCA1 and/or BRCA2) mutations and/or large genomic rearrangements is considered not medically necessary in individuals not meeting any of the criteria above.