The following coding and billing guidance is to be used with its associated Local coverage determination.
The Oncomine Dx Target Test (Thermo Fisher Scientific, Inc., Waltham, MA) is a 23 gene panel including 3 gene targets approved by the FDA for non-small cell lung cancer from tissue specimens1. The test can simultaneously identify three gene variants that are key to targeted therapy selection: EGFR, BRAF and ROS1.
||TAFINLAR®(dabrafenib) in combination with MEKINIST® (trametinib)
||L858R, Exon 19 deletions
Erlotinib, gefitinib, or afatinib are approved therapies for NSCLC patients with EGFR exon 19 deletions and L858R mutation. The OncomineTM Dx Target is an FDA-approved companion diagnostic test for gefitinib only.
Crizotinib is very effective for NSCLC patients with ROS1 rearrangements. Oncomine DX Target Test is the only FDA approved companion diagnostic test that detects ROS1 fusions. The assay does not detect ALK fusions.
Dabrafenib in combination with Trametinib is approved therapy for NSCLC patients with a BRAF V600E mutation. Oncomine DX Target Test is the only FDA approved companion diagnostic test that detects BRAF V600E.
To report a Oncomine Dx Target Test service on tissue specimens, submit the following claim information:
- Enter 1 unit of service (UOS);
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
- Loop 2400 or SV101-7 for the 5010A1 837P
- Item 19 for paper claim
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
- Line SV202-7 for 837I electronic claim
- Block 80 for the UB04 claim for
- Select the appropriate ICD-10-CM code