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Blue Shield of CaliforniaAll Plans · Coverage · Genetic Testing · CA · Oncology, PathologyMedium impact

Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer (2.04.36)

Effective date
Nov 1, 2026
Identified
Oct 31, 2026

Summary

Blue Shield of California medical policy 2.04.36, on assays of genetic expression in tumor tissue to determine prognosis in patients with breast cancer, has an effective date of November 1, 2026. The policy history lists that date as an annual review in which the policy statement and literature were updated. The policy addresses Oncotype DX, EndoPredict, Breast Cancer Index, MammaPrint and Prosigna, lists the criteria under which these tests may be considered medically necessary for adjuvant chemotherapy decisions, and states that all other indications are investigational.

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What to do

Action · 6 steps
01Already effective 2026-11-01: Check the policy's current applicability before acting on it, and read Appendix A to see the policy statement changes from the previous version.
02Tell providers that Oncotype DX, EndoPredict, Breast Cancer Index, MammaPrint and Prosigna should only be ordered on a tissue specimen obtained during surgical removal of the tumor, after pathology examination is complete, and not on a preliminary core biopsy.
03For multiple ipsilateral primary tumors, a specimen from the tumor with the most aggressive histologic characteristics should be submitted.
04Providers should order these tests in the context of a physician-patient discussion regarding risk preferences when the result will aid chemotherapy decisions.
05Billing team: have ready the documentation the policy lists for clinical review, which is history and physical and/or consultation notes covering the reason for the test and whether it will guide the chemotherapy decision, tumor size and classification, node status, differentiation and/or unfavorable features, HER2 status, and hormone receptor status, plus breast surgery operative report(s) and pathology report(s).
06For post-service review, also include previous pertinent laboratory results.

Codes mentioned

815188151981520815218152281523S3854

Original notice

Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer (2.04.36)
blueshieldca.com · Always check the source before changing claims.
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