Billing and Coding: MolDX: FDA-Approved KRAS Tests

Two tests have met the FDA criteria for KRAS genetic testing: Effective 7/6/2012 therascreen® KRAS to detect seven somatic mutations in the human KRAS oncogene was developed to aid in the identification of CRC patients for treatment with Erbitux® (cetuximab). Effective 5/7/2015 cobas® KRAS to detect mutations in codons 12 and 13 of the KRAS gene was developed to aid in identification of CRC patients for treatment with Erbitux® (cetuximab) or Vectibix® (panitumumab). To report an FDA approved or laboratory developed test (LDT) KRAS, service, please submit the following claim information: Select the appropriate CPT® code 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 Box 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 form Select the appropriate ICD-10-CM diagnosis. NOTE: MolDX will apply NPI to ID editing on FDA approved KRAS kits. All labs that submit claims for a KRAS, codon 12 and 13 test kit MUST register the test and confirm the UNMODIFIED use of the kit. Tests may be registered on the DEX TM Diagnostics Exchange: https://app.dexzcodes.com/login This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.