Billing and Coding: MolDX: therascreen® KRAS PCR Kit Guidelines

FDA-Approved KRAS Tests Two tests have met the FDA criteria for KRAS genetic testing: 1. Effective 7/6/2012therascreen® 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). 2. Effective 5/7/2015cobas® 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 a FDA approved KRAS, codon 12 and 13 test kit service, please submit the following claim information: CPT code 81275-22 – KRAS codons 12, 13 Enter the assigned MolDx identifier in the comment/narrative field for the following claim field/types: Loop 2300 NTE01 for Part A or Loop 2400 NTE02/SV101-7 for Part B Submit the assigned MolDX identifier on an attachment to the claim form for paper claim(Form locator 80 for Part A or Box 19 for Part B) For dates of service (DOS) on or after 10/01/2015, select the appropriate ICD-10-CM diagnosis from the following list: C77.0 - Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck C77.1 - Secondary and unspecified malignant neoplasm of intrathoracic lymph nodes C77.2 - Secondary and unspecified malignant neoplasm of intra-abdominal lymph nodes C77.3 - Secondary and unspecified malignant neoplasm of axilla and upper limb lymph nodes C77.4 - Secondary and unspecified malignant neoplasm of inguinal and lower limb lymph nodes C77.5 - Secondary and unspecified malignant neoplasm of intrapelvic lymph nodes C77.8 - Secondary and unspecified malignant neoplasm of lymph nodes of multiple regions C77.9 - Secondary and unspecified malignant neoplasm of lymph node, unspecified C78.01 - Secondary malignant neoplasm of right lung C78.02 - Secondary malignant neoplasm of left lung C78.1 - Secondary malignant neoplasm of mediastinum C78.2 - Secondary malignant neoplasm of pleura C78.39 - Secondary malignant neoplasm of other respiratory organs C78.4 - Secondary malignant neoplasm of small intestine C78.5 - Secondary malignant neoplasm of large intestine and rectum C78.6 - Secondary malignant neoplasm of retroperitoneum and peritoneum C78.7 - Secondary malignant neoplasm of liver and intrahepatic bile duct C78.80 - Secondary malignant neoplasm of unspecified digestive organ C78.89 - Secondary malignant neoplasm of other digestive organs C79.01 - Secondary malignant neoplasm of right kidney and renal pelvis C79.02 - Secondary malignant neoplasm of left kidney and renal pelvis C79.11 - Secondary malignant neoplasm of bladder C79.19 - Secondary malignant neoplasm of other urinary organs C79.2 - Secondary malignant neoplasm of skin C79.31 - Secondary malignant neoplasm of brain C79.49 - Secondary malignant neoplasm of other parts of nervous system C79.32 - Secondary malignant neoplasm of cerebral meninges C79.49 - Secondary malignant neoplasm of other parts of nervous system C79.51 - Secondary malignant neoplasm of bone C79.52 - Secondary malignant neoplasm of bone marrow C79.61 - Secondary malignant neoplasm of right ovary C79.62 - Secondary malignant neoplasm of left ovary C79.71 - Secondary malignant neoplasm of right adrenal gland C79.72 - Secondary malignant neoplasm of left adrenal gland C79.81 - Secondary malignant neoplasm of breast C79.82 - Secondary malignant neoplasm of genital organs C79.89 - Secondary malignant neoplasm of other specified sites NOTE: CGS and the MolDX contractor 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 McKesson Diagnostics ExchangeTM: https://app.mckessondex.com/#/login For lab developed tests (LDT) or tests that modify a KRAS, codon 12 and 13 test, CPT code 81275 and NO modifier should be reported and submitted with the assigned LDT test ID.