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Billing and Coding: MolDX: PIK3CA Gene Tests
A55602
Effective: January 1, 2022
Updated: December 31, 2025
Policy Summary
PIK3CA targeted gene testing is covered when performed with an FDA‑approved assay to identify PIK3CA mutations in postmenopausal women and men with HR‑positive, HER2‑negative advanced or metastatic breast cancer who have progressed on or after endocrine therapy and are candidates for alpelisib (Piqray). Claims must include the appropriate CPT and diagnosis codes and must have the DEX Z‑Code™ entered adjacent to the CPT code in the specified Part A/Part B claim fields; tests that are not FDA‑approved or claims missing required elements may not be accepted.
Coverage Criteria Preview
Key requirements from the full policy
"Coverage is provided for PIK3CA targeted gene sequencing to detect PIK3CA mutations to guide alpelisib (Piqray) therapy in patients with hormone receptor–positive (HR+), HER2‑negative, advanced or ..."
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