The United States (U.S.) Food and Drug Administration (FDA) has approved several poly ADP-ribose polymerase (PARP) inhibitor treatments indicated for patients with ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer.
BRACAnalysis CDx® is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein-coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR.
Results of the test are used as an aid in identifying patients who are or may become eligible for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.
Table 1: Companion diagnostic indications
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Tumor Type
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Biomarker
|
Therapy
|
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Breast Cancer
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Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes
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Lynparza® (olaparib)
Talzenna® (talzoparib)
|
|
Ovarian Cancer
|
Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes
|
Lynparza® (olaparib)-treatment/maintenance
Rubraca® (rucaparib)
|
|
Pancreatic Cancer
|
Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes
|
Lynparza® (olaparib)
|
|
Prostate Cancer
|
Deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes
|
Lynparza® (olaparib)
|
This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108.
This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for this test.
BRACAnalysis CDx™ is only covered for individuals diagnosed with ovarian cancer, breast cancer, pancreatic cancer or prostate cancer and who have not been previously tested for BRCA mutations.
To report a BRACAnalysis CDx™ service, please submit the following claim information:
- CPT code 81162
- One (1) unit of service
- Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information.
- Assigned DEX Z-Code™ Identifier in the comment/narrative field for the following Part B claim field/types:
- Loop 2400 or SV101-7 for the 5010A1 837P
- Submit the assigned Z-Code™ Identifier on an attachment to the claim form for paper claim
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
- Line SV202-7 for 837I electronic claim
- Block 80 for the UB04 claim form
- Select at least one ICD-10-CM diagnosis code.
Only 1 BRCA testing per beneficiary lifetime will be considered reasonable and necessary. If a patient received BRCA testing prior to PARPi treatment consideration, regardless of the performing lab, additional testing would not be considered a reasonable and necessary service.
BRCA1/BRCA2 genetic testing is not reasonable and necessary, thus it is non-covered, for the following indications:
- Genetic screening in the general population. Such testing is considered screening and is excluded by Medicare statute. An ABN must be obtained for BRCA1 and BRCA2 testing for individuals without signs and symptoms of breast, ovarian, pancreatic, or prostate cancer as indicated in this article.
- Testing of individuals with no personal history of breast, ovarian, fallopian tube, primary peritoneal, pancreatic, or prostate cancer. Such testing is considered screening and is excluded by Medicare statute. An ABN must be obtained for BRCA1 and BRCA2 testing for individuals without signs and symptoms of breast, ovarian or other hereditary cancer syndromes as indicated in this article.
- Testing of individuals under 18 years of age.
