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IMPORTANT: THIS DOCUMENT CONTAINS OUTDATED INFORMATION.
Content provided on this page contains outdated information and instruction and should not be considered current. CGS is providing this archived information for research purposes only. This archived section contains previously issued instructions that have since been updated or are no longer applicable for Medicare billing purposes.

October 12, 2015 - Updated: 01.04.18

FDA-Approved KRAS Tests (CM00027, V2)

Two tests have met the FDA criteria for KRAS genetic testing:

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).

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 KRAS, codon 12 and 13 test kit service, please submit the following claim information:

  • Enter CPT code 81275
  • Enter the appropriate DEX=Z-Code™ identifier in the comment/narrative field for the following claim field/types:
    • Loop SV202-7 for Part A or Loop 2400/ SV101 - 7 for the 5010A1 837P for Part B
    • Block 80 for Part A or Box 19 for Part B

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
  • C79.32 - 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: MolDX 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 DEX Diagnostics Exchange™External Website.

This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.

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