Billing and Coding: MolDX: FDA-Approved KRAS Tests

The following coding and billing guidance is to be used with its associated Local coverage determination. Two tests have met the Food and Drug Administration (FDA) criteria for KRAS genetic testing: 1. Effective 7/06/2012 therascreen® KRAS to detect 7 somatic mutations in the human KRAS oncogene was developed to aid in the identification of colorectal cancer (CRC) patients for treatment with Erbitux® (cetuximab). 2. 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 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 in the comment/narrative field for the following Part A claim field/types: Line SV202-7 for the 837I electronic claim Block 80 for the UB04 claim form Select the appropriate ICD-10-CM diagnosis. NOTE: MolDX will apply National Provider Identifier (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™ 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.