Blue Cross & Blue Shield of MississippiAll Plans · Coverage · Medical Policy · Oncology, PathologyMedium impact
Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis and Predict Therapeutic Response in Individuals With Breast Cancer
Effective date
Not stated in the notice
Identified
Sep 29, 2026
Summary
The Blue Cross Blue Shield Association policy on gene expression assays in breast cancer (Oncotype DX, EndoPredict, Breast Cancer Index, MammaPrint and Prosigna) now states that a gene expression assay during workup for women considering preoperative (neoadjuvant) therapy is investigational. A policy update dated 08/25/2026 also changed the title to include predicting therapeutic response and updated the guidance on omitting sentinel lymph node biopsy and neoadjuvant therapy. The assays may be considered medically necessary for the listed node-negative and node-positive criteria, and are investigational for all other indications, including repeat testing, combination testing and length of endocrine therapy.
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01Billing team: For breast cancer workup considering neoadjuvant therapy, the gene expression assay is investigational, and the policy states that no payment is made for services not documented to be medically necessary, so do not bill it as medically necessary for that use.
02For the listed assays, order only on tissue from surgical removal of the tumor after pathology examination is complete, not on a preliminary core biopsy.
03Order the assays within 6 months after diagnosis, in the context of a physician-patient discussion about risk preferences when the result will aid chemotherapy decisions.
04For multiple ipsilateral primary tumors, submit the specimen from the tumor with the most aggressive histologic characteristics.
Codes mentioned
815188151981520815218152281523
Original notice
Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis and Predict Therapeutic Response in Individuals With Breast Cancer
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