84431
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Clinical documentation that the member is 'being considered' for the specific drug therapy for which the genetic or biomarker test is intended (e.g., documentation that member is being considered for olaparib, osimertinib, entrectinib, etc.)
- Relevant diagnosis and ICD-10 code that corresponds to the covered indication (policy lists covered ICD-10 codes per test — e.g., C34.00-C34.92 for NSCLC, C50.011-C50.929 for breast cancer, E84.0-E84.9 for cystic fibrosis, etc.)
- When required by the indication, documentation of prior lines of therapy and response status (e.g., BRCA testing for ovarian cancer: 'treated with three or more prior lines of chemotherapy' or 'in complete or partial response to first-line platinum based chemotherapy'; BRCA testing for metastatic pancreatic carcinoma: 'disease has not progressed on first-line platinum treatment'; somatic BRCA for prostate cancer: prior androgen-receptor directed therapy and taxane-based chemotherapy)
Key Coverage Criteria
- ALK gene rearrangement for members who are considering pembrolizumab (Keytruda) for the treatment of NSCLC
- BCR/ABL mutation testing (e.g., MRDx BCR-ABL Test) for members with chronic myeloid leukemia being considered for treatment with nilotinib (Tasigna)
- BRAF and NRAS mutations (e.g., cobas KRAS Mutation Test; therascreen KRAS RGQ PCR Kit, Dako EGFR pharmDx Kit) for members with colorectal cancer being considered for treatment with cetuximab (Erbitux) or panitumumab (Vectibix)
- BRAF gene (V600E or V600K) mutation testing (e.g., the THxID BRAF test, cobas 4800 BRAF V600 mutation test, Qiagen therascreen BRAF V600E RGQ PCR Kit) for members with unresectable or metastatic melanoma being considered for treatment with vemurafenib (Zelboraf), dabrafenib (Tafinlar), trametinib (Mekinist), cobimetinib (Cotellic), binimetinib (Mektovi) or encorafenib (Braftovi)
- BRAF gene (V600E or V600K) mutation testing for members with metastatic colorectal cancer being considered for treatment with encorafenib (Braftovi)
- BRAF gene (V600E or V600K) mutation testing for members with recurrent or metastatic non-small cell lung cancer who are being considered for treatment with dabrafenib (Tafinlar), pembrolizumab (Keytruda), or vemurafenib (Zelboraf)
1 Active Policy
AETNA-CPB-0715 — Pharmacogenetic and Pharmacodynamic Testing
Related Codes
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