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    MolDx
    therascreen KRAS PCR Kit Billing/Coding Guidelines (M00030)

    Palmetto GBA has determined the FDA approved, therascreen KRAS kit (P110030) meets the reasonable and necessary criteria for Medicare reimbursement. The therascreen kit intended 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).

    To report a therascreen service, please submit the following claim information:

    • Claims received prior to 10/1/2014: CPT code 81479– unlisted molecular pathology procedure
    • Claims received on and after 10/1/2014: 81275-22— KRAS codons 12,13
    • Enter 'ZBT98' in the comment/narrative field for the following claim field/types:
      • Loop 2400or SV101-7 for the 5010A1 837P
      • Submit 'ZBT98' on an attachment to the claim form for paper claim
    • Select at least one diagnosis from the following:
      • 196.0 – Secondary and unspecified malignant neoplasms of lymph nodes of head, face, and neck
      • 196.1 – Intrathoracic lymph nodes
      • 196.2 - Intra-abdominal lymph nodes
      • 196.3 - Lymph nodes of axilla and upper limb
      • 196.5 - Lymph nodes of inguinal region and lower limb
      • 196.6 - Intrapelvic lymph nodes
      • 196.8 - Lymph nodes of multiple sites
      • 196.9 - Site unspecified
      • 197.0 - Lung
      • 197.1 - Mediastinum
      • 197.2 - Pleura
      • 197.3 - Other respiratory organs
      • 197.4 -Small intestine, including duodenum
      • 197.5 - Large intestine and rectum
      • 197.6 - Retroperitoneum and peritoneum
      • 197.7 - Liver, specified as secondary
      • 197.8 - Other digestive organs and spleen
      • 198.0 - Kidney
      • 198.1 - Other urinary organs
      • 198.2 - Skin
      • 198.3 - Brain and spinal cord
      • 198.4 - Other parts of nervous system
      • 198.5 - Bone and bone marrow
      • 198.6 - Ovary
      • 198.7 - Adrenal gland
      • 198.8 - Other specified sites
      • 198.81 - Breast
      • 198.82 - Genital organs
      • 198.89 – Other
    • Proposed ICD-10-CM codes:
      • 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: At present the Qiagen therascreen test is the only FDA approved KRAS test. Labs that perform KRAS testing as an LDT and/or modify the therascreen kit must use the following CPT codes as per the CPT description:

    • CPT code 81275 to report KRAS variants in codons 12 and 13
    • CPT code 81403 to report KRAS analysis in exon 3
    • CPT code 81405 to report KRAS full gene sequencing

    Palmetto GBA may request a technical assessment on variations of KRAS testing that does not match the CPT descriptions. 

     

    last updated on 09/25/2014
    ver 1.0.0