BRCA Testing (BRACAnalysis CDx; myChoice CDx) (Myriad)
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Coverage and prior-authorization criteria for Myriad's BRACAnalysis CDx (germline) and myChoice CDx (tumor/somatic) tests for members being considered for specific targeted therapies, including required documentation for prior authorization.
No material clinical or coverage changes in this revision.
Coverage Criteria and Indications
BRACAnalysis_CDx - Covered Indications
BRACAnalysis_CDx will be covered to plan limitations for members 18 years or older who meet ONE of the following clinical scenarios:
Based on II.A.a.i-iii in policy
Based on II.A.b.i-iii in policy
Based on II.A.c in policy
Based on II.A.d in policy
myChoice CDx - Covered Indications
myChoice CDx will be covered to plan limitations for members who meet ALL the following:
Based on II.B.a and II.B.b in policy
Based on II.B.b.i-iii in policy
Specific Covered Indications
Germline BRCA testing (BRACAnalysis CDx) - Covered Indications
Reflects II.A.a-d in policy
Somatic tumor BRCA testing and HRD assessment (myChoice CDx) - Covered Indications
Based on II.B.a and II.B.b in policy
Based on II.B.b.i-iii in policy
CPT / HCPCS Coding
| 81162 | BRCA1, BRCA2 gene analysis; full sequence analysis and full duplication/deletion analysis |
| 0172U | Oncology (solid tumor as indicated by the label), somatic mutation analysis of BRCA1 and BRCA2 and analysis of homologous recombination deficiency pathways, DNA, FFPE tissue, algorithm quantifying tumor genomic instability score |
| 81164 | BRCA1, BRCA2 gene analysis; full duplication/deletion analysis (detection of large gene rearrangements) |
| 81166 | BRCA1 gene analysis; full duplication/deletion analysis (detection of large gene rearrangements) |
| 81167 | BRCA2 gene analysis; full duplication/deletion analysis (detection of large gene rearrangements) |
Prior Authorization, Documentation, and Denial Risks
Prior authorization required for BRCA/myChoice testing
Prior authorization is required for BRACAnalysis CDx (germline) and myChoice CDx (tumor) testing; requests must be limited to the clinical indications listed in the policy tied to consideration of targeted therapies (e.g., Lynparza, Rubraca, Talzenna, Niraparib).
Step-therapy: none specified
No step-therapy sequencing or additional step requirements are specified in the policy for BRACAnalysis CDx or myChoice CDx.
Required documentation for prior authorization
Required documentation must be submitted with the prior authorization request: chart notes, previous treatments, and the treatment plan.
- Include documentation that supports the member meets the specific clinical indication tied to consideration of the named targeted therapy.
- Attach prior treatment history (e.g., number and type of chemotherapy lines or response to platinum-based therapy) as applicable to the indication.
Denial risk if clinical criteria are not met
Testing requests that do not meet the coverage criteria (the specific clinical scenarios and therapy considerations in Section II) may be denied.
- Verify member age (18+) and the exact therapy-related conditions listed for BRACAnalysis_CDx or myChoice CDx before submitting authorization.
Eligibility Requirements
Determine member eligibility by confirming the member is 18 years or older and that the clinical situation meets the policy’s specified indications for either BRACAnalysis CDx (germline testing tied to consideration of PARP inhibitor therapy) or myChoice CDx (tumor testing and homologous recombination deficiency assessment tied to niraparib or olaparib/bevacizumab decisions). Prior testing status (e.g., no previous BRCA testing where required) and the specific therapy-related criteria listed for each indication must be documented.
Definitions
Background
BRACAnalysis CDx is Myriad’s germline BRCA1/2 assay performed on blood DNA to detect single nucleotide variants, small insertions/deletions, and large rearrangements to identify patients eligible for PARP inhibitor therapy. myChoice CDx is an FDA-authorized tumor-based NGS assay performed on FFPE tissue that assesses BRCA1/2 variants and computes a Genomic Instability Score (GIS) — an algorithmic measure of loss of heterozygosity, telomeric allelic imbalance, and large-scale state transitions — to identify ovarian cancer patients who may be eligible for niraparib or olaparib plus bevacizumab as indicated.
Not Covered
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