MolDX: Breast Cancer Assay: Prosigna®

Prosigna® testing is covered only for post-menopausal women with ER-positive early breast cancer who are either node-negative (stage I or II) or node-positive with 1-3 positive nodes (stage II). Claims that do not meet these FDA-indicated criteria (for example, pre-menopausal status, ER-negative tumors, >3 positive nodes, or stages outside I-II) will be denied; documentation of menopausal status, ER status, stage, and nodal count should be available to support the claim.

"Post-menopausal female with estrogen-receptor positive (ER+) breast cancer that is lymph node-negative and stage I or II."

Sign up to see full coverage criteria, indications, and limitations.