LCD Reference Article Billing and Coding Article

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

A54200

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Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

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Article ID
A54200
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: therascreen® KRAS PCR Kit Guidelines
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
11/22/2023
Revision Ending Date
N/A
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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.








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Coding Information

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ICD-10-CM Codes that Support Medical Necessity

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(36 Codes)
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Group 1 Codes
Code Description
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
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
11/22/2023 R10

Revision Effective: 11/22/2023
Revision Explanation: Updated LCD Reference Article section.

10/03/2019 R9

Revision Effective: N/A
Revision Explanation: Annual review no changes made.

10/03/2019 R8

Revision Effective date: 10/03/2019
Revision Explanation: Converted article into new billing and coding article format.

10/01/2015 R7

Revision Effective date: N/A
Revision Explanation: Annual review no changes made.

10/01/2015 R6

Revision Effective date: N/A
Revision Explanation: Annual review no changes made

10/01/2015 R5 Revision Effective date: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R4 Revision Effective: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R3 R1
Revision Effective:10/01/2015
Revision Explanation: Changed MoPath to MolDX .
10/01/2015 R2 Revision Effective: N/A
Revision Explanation: Added Part A loop information.
10/01/2015 R1 Revision Effective: 10/01/2015
Revision Explanation: Updated article with additional test for KRAS updated the note concerning registering tests.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L36021 - MolDX: Molecular Diagnostic Tests (MDT)
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11/15/2023 11/22/2023 - N/A Currently in Effect You are here
11/26/2019 10/03/2019 - 11/21/2023 Superseded View
09/27/2019 10/03/2019 - N/A Superseded View
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