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 7/6/2012  
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).  
  
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 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.