Billing and Coding: MolDX: FDA-Approved KRAS Tests

Two tests have met the Food and Drug Administration (FDA) criteria for KRAS genetic testing: Effective 07/06/2012 therascreen ® KRAS to detect somatic mutations in the human KRAS oncogene was developed to aid in the identification of colorectal cancer (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). Labs may either use the SV101-7 or SV202-7 (preferred) or the NTE field to submit this required information. Enter the assigned 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 Submit the assigned Z-Code™ Identifier on an attachment to the claim form 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: 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 TM : 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.