CurrentCareSourcePolicy N/A

Breast Cancer Index (BCI) testing for managing early-stage breast cancer

Defines medical necessity criteria for use of the Breast Cancer Index (BCI) genomic test to inform adjuvant chemotherapy decisions at diagnosis and extended adjuvant endocrine therapy decisions during treatment for members with invasive hormone-receptor positive, HER2-negative early-stage breast cancer.

Policy Summary

PayerCareSource

PolicyBreast Cancer Index (BCI) testing for managing early-stage breast cancer

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document ER/PR and HER2 status, nodal status, timing of diagnosis, and that testing will use FFPE primary tumor tissue prior to adjuvant treatment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

11genes analyzed by BCI

≤6 motesting timeframe (new dx)

0–3allowed node status

ER+/HER2-required receptor status

oncetesting frequency

Coverage Criteria for Breast Cancer Index (BCI)

inv-01: Newly diagnosed (diagnosis pathway)

Covered when ALL of the following are met for a newly diagnosed member:

Newly diagnosed BCI coverage: Member is newly diagnosed (within the last 6 months)

Newly diagnosed BCI coverage - disease extent: No distant metastases

Newly diagnosed BCI coverage - nodal status: Lymph node negative or 1-3 positive ipsilateral axillary lymph nodes

Newly diagnosed BCI coverage - receptors: Estrogen receptor positive (ER+) or progesterone receptor positive (PR+) or both AND HER2 receptor negative

Policy Summary

PayerCareSource

PolicyBreast Cancer Index (BCI) testing for managing early-stage breast cancer

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document ER/PR and HER2 status, nodal status, timing of diagnosis, and that testing will use FFPE primary tumor tissue prior to adjuvant treatment.

SourceLink

On This Page

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inv-02: On adjuvant hormonal therapy (extension decision pathway)

Covered when ALL of the following are met for a member currently receiving adjuvant hormonal therapy:

On-treatment BCI coverage - receptor status: Member is hormone receptor-positive (ER+ and/or PR+)

On-treatment BCI coverage - HER2: HER2 receptor negative

On-treatment BCI coverage - clinician–patient discussion: The member and treating physician have had a discussion prior to testing regarding the potential results of the test and use of the results to guide a decision regarding extended adjuvant hormonal therapy

BCI predictive result reported as yes/no for benefit from 5 additional years

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required when requesting Breast Cancer Index (BCI) testing to confirm the member meets the coverage criteria listed in this policy. Submit an authorization request with supporting clinical documentation showing the member meets all applicable inclusion criteria (e.g., timing of diagnosis, hormone receptor and HER2 status, lymph node status, absence of distant metastases).

Applies to initial BCI test (one lifetime per patient).
Include pathology report indicating FFPE primary tumor specimen and date of diagnosis (newly diagnosed within last 6 months for initial-use criteria).
Document prior discussion between member and treating physician regarding potential test results and use of results to guide extended adjuvant hormonal therapy when member is currently receiving adjuvant hormonal therapy.

Step Therapy

No Step Therapy Requirements

No step therapy requirements are specified in this policy for BCI testing.

Denial Risk

Not Covered Indications

BCI testing is considered not medically necessary (not covered) when performed outside the specified indications in this policy. Examples of unproven or not covered indications include, but are not limited to, testing for ductal carcinoma in situ (DCIS) or any other use not meeting the stated inclusion criteria.

Testing for DCIS is specifically considered unproven and not medically necessary.
Any gene expression profiling for indications not described under Section D.I (A or B) is considered unproven and not medically necessary.

Background

Hormone‑receptor positive (HR+) early‑stage invasive breast cancer is commonly managed with adjuvant anti‑estrogen therapy such as tamoxifen or aromatase inhibitors. Key clinical decisions include whether to add adjuvant chemotherapy at the initial treatment decision and whether to extend endocrine therapy beyond five years because of the risk of late recurrence.

The Breast Cancer Index (BCI) is a gene expression test that analyzes 11 genes and reports prognostic estimates of late recurrence plus a predictive result for likely benefit from extended endocrine therapy. CareSource covers BCI when used either at the initial adjuvant chemotherapy decision (for members newly diagnosed within 6 months with specified receptor and nodal status) or during ongoing adjuvant hormonal therapy to inform decisions about extending endocrine therapy, provided the policy’s documentation and authorization requirements are met.

Definitions

inv-12: Adjuvant Therapy

DefinitionAdjuvant therapy: primary adjuvant hormone treatment for ER-positive early-stage breast cancer (e.g., tamoxifen or aromatase inhibitors).

Examples - TamoxifenTamoxifen is FDA approved for adjuvant hormone treatment of premenopausal and postmenopausal women (and men) with ER-positive early-stage breast cancer.

Examples - Aromatase inhibitorsAromatase inhibitors include anastrozole, letrozole, and exemestane, approved for adjuvant use in postmenopausal women.

inv-13: Gene Expression Testing

DefinitionGene expression testing: a laboratory test that analyzes mRNA patterns to determine gene activity, used by assays such as the Breast Cancer Index to evaluate prognostic and predictive features.

MethodologyAnalyzes activity of specific genes (BCI evaluates 11 genes) using mRNA expression patterns to generate prognostic and predictive results.

PurposeUsed to assess tumor biology (prognosis and potential benefit from extended endocrine therapy) beyond standard clinicopathologic factors.

inv-14: Predictive Molecular Marker

DefinitionPredictive molecular marker: a biomarker used to evaluate the likelihood of benefit from a specific clinical intervention; BCI predictive result is reported as yes/no for likely benefit from 5 additional years of hormonal therapy.

Use caseGuides decision-making about extended adjuvant hormonal therapy for patients currently on adjuvant endocrine treatment.

inv-15: Prognostic Molecular Marker

DefinitionPrognostic molecular marker: a biological characteristic used to predict disease course; BCI prognostic result estimates risk of cancer recurrence 5–10 years after diagnosis and is reported as a percentage.

BCI roleBCI provides a prognostic percentage estimate of late recurrence risk (example: 2.2% risk of recurrence 5–10 years after diagnosis).

Clinical applicationUsed to inform risk of late distant recurrence and guide adjuvant treatment intensity decisions at diagnosis and follow-up.

Line of Therapy

inv-16: first-line

Adjuvant treatment decision: BCI used at initial adjuvant decision point (newly diagnosed within 6 months) to inform chemotherapy decisions

Tested on FFPE primary tumor prior to adjuvant treatment

inv-17: continuation

Extended endocrine therapy decision: BCI used during ongoing adjuvant hormonal therapy to inform decision about extending endocrine therapy for an additional 5 years

Predictive result reported as yes/no

Biomarker Requirements

inv-18: ER/PR

RequirementEstrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) — hormone receptor positivity is required for coverage.

ContextRequired for both the newly diagnosed (diagnosis pathway) and on-treatment (extension decision) coverage criteria.

DocumentationProviders must document hormone receptor status when requesting BCI testing.

inv-19: HER2

RequirementHER2 receptor must be negative for BCI coverage.

ContextHER2-negative status is required for both newly diagnosed and on-treatment coverage pathways.

DocumentationProviders must document HER2 negative status when requesting BCI testing.

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