Article - Billing and Coding: MolDX: therascreen® KRAS PCR Kit Guidelines (A54200)

CMS National Coverage PolicyN/AArticle TextFDA-Approved KRAS TestsTwo 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, 13Enter 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 BSubmit 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 neckC77.1 - Secondary and unspecified malignant neoplasm of intrathoracic lymph nodesC77.2 - Secondary and unspecified malignant neoplasm of intra-abdominal lymph nodesC77.3 - Secondary and unspecified malignant neoplasm of axilla and upper limb lymph nodesC77.4 - Secondary and unspecified malignant neoplasm of inguinal and lower limb lymph nodesC77.5 - Secondary and unspecified malignant neoplasm of intrapelvic lymph nodesC77.8 - Secondary and unspecified malignant neoplasm of lymph nodes of multiple regionsC77.9 - Secondary and unspecified malignant neoplasm of lymph node, unspecifiedC78.01 - Secondary malignant neoplasm of right lungC78.02 - Secondary malignant neoplasm of left lungC78.1 - Secondary malignant neoplasm of mediastinumC78.2 - Secondary malignant neoplasm of pleuraC78.39 - Secondary malignant neoplasm of other respiratory organsC78.4 - Secondary malignant neoplasm of small intestineC78.5 - Secondary malignant neoplasm of large intestine and rectumC78.6 - Secondary malignant neoplasm of retroperitoneum and peritoneumC78.7 - Secondary malignant neoplasm of liver and intrahepatic bile ductC78.80 - Secondary malignant neoplasm of unspecified digestive organC78.89 - Secondary malignant neoplasm of other digestive organsC79.01 - Secondary malignant neoplasm of right kidney and renal pelvisC79.02 - Secondary malignant neoplasm of left kidney and renal pelvisC79.11 - Secondary malignant neoplasm of bladderC79.19 - Secondary malignant neoplasm of other urinary organsC79.2 - Secondary malignant neoplasm of skinC79.31 - Secondary malignant neoplasm of brainC79.49 - Secondary malignant neoplasm of other parts of nervous systemC79.32 - Secondary malignant neoplasm of cerebral meningesC79.49 - Secondary malignant neoplasm of other parts of nervous systemC79.51 - Secondary malignant neoplasm of boneC79.52 - Secondary malignant neoplasm of bone marrowC79.61 - Secondary malignant neoplasm of right ovaryC79.62 - Secondary malignant neoplasm of left ovaryC79.71 - Secondary malignant neoplasm of right adrenal glandC79.72 - Secondary malignant neoplasm of left adrenal glandC79.81 - Secondary malignant neoplasm of breastC79.82 - Secondary malignant neoplasm of genital organsC79.89 - Secondary malignant neoplasm of other specified sitesNOTE: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/#/loginFor 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.