LCDActive
MolDX: Breast Cancer Assay: Prosigna®
L36125
Effective: April 22, 2021
Updated: December 31, 2025
Policy Summary
Prosigna (PAM50) testing is covered only for post-menopausal females 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 all of these FDA-aligned criteria will be denied; the policy does not specify additional frequency limits but requires documentation confirming menopausal status, ER positivity, tumor stage, and lymph node count.
Coverage Criteria Preview
Key requirements from the full policy
"Post-menopausal female with estrogen receptor (ER) positive, node-negative breast cancer, stage I or II."
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