Billing and Coding: MolDX: FDA-Approved KRAS Tests (A54498)


Related Local Coverage Determination (LCD)
L35160-MolDX: Molecular Diagnostic Tests (MDT)


Contractor NameContract NumberStates
Noridian Healthcare Solutions, LLC 01111 - A and B MAC California - Entire State
01112 - A and B MAC California - Northern
01182 - A and B MAC California - Southern
01211 - A and B MAC American Samoa
Guam
Hawaii
Northern Mariana Islands
01212 - A and B MAC American Samoa
Guam
Hawaii
Northern Mariana Islands
01311 - A and B MAC Nevada
01312 - A and B MAC Nevada
01911 - A and B MAC American Samoa
California - Entire State
Guam
Hawaii
Nevada
Northern Mariana Islands

Article Information

Article ID Number: A54498 Status: A-Approved

Article Title: Billing and Coding: MolDX: FDA-Approved KRAS Tests

Original Article Effective Date: 10/01/2015

Revision Effective Date: 07/14/2022

Article Text:

The following coding and billing guidance is to be used with its associated Local coverage determination.

Two tests have met the Food and Drug Administration (FDA) criteria for KRAS genetic testing:

1. Effective 7/06/2012

therascreen® KRAS to detect 7 somatic mutations in the human KRAS oncogene was developed to aid in the identification of colorectal cancer (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 an FDA approved or laboratory developed test (LDT) KRAS, service, please submit the following claim information.

  • Select the appropriate CPT code
  • Enter 1 unit of Service (UOS)
  • Enter the appropriate DEX Z-Code™ Identifier in the comment/narrative field for the following Part B claim field/types:
    • Loop 2400 or SV101-7 for the 5010A1 837P
    • Item 19 for paper claim
  • Enter the appropriate DEX Z-Code™ Identifier in the comment/narrative field for the following Part A claim field/types:
    • Line SV202-7 for the 837I electronic claim
    • Block 80 for the UB04 claim form
  • Select the appropriate ICD-10-CM diagnosis.

NOTE: MolDX will apply National Provider Identifier (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: https://app.dexzcodes.com/login.

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

Coding Information
Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.


CPT/HCPCS Codes:

Group 1 Paragraph:

N/A



Group 1 CPT Codes:
81275 KRAS (KIRSTEN RAT SARCOMA VIRAL ONCOGENE HOMOLOG) (EG, CARCINOMA) GENE ANALYSIS; VARIANTS IN EXON 2 (EG, CODONS 12 AND 13)
81276 KRAS (KIRSTEN RAT SARCOMA VIRAL ONCOGENE HOMOLOG) (EG, CARCINOMA) GENE ANALYSIS; ADDITIONAL VARIANT(S) (EG, CODON 61, CODON 146)
81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE


ICD-10 Codes That Are Covered

N/A

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
C79.63 Secondary malignant neoplasm of bilateral ovaries
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
ICD-10 Codes That Are Not Covered

N/A


Revision History Information
Revision History DateRevision History NumberRevision History Explanation
07/14/2022
R8

Updated to indicate this article is an LCD Reference Article.

07/14/2022
R7

Under Article Test revised verbiage regarding instructions on how to submit claims information. 

Under CPT/HCPCS Code Group 1: Codes added 81479 and 81276. 

This revision is effective on 07/14/2022.

03/03/2022
R6

Rev 13. Under CMS National Coverage Policy added regulation, Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim. Under Article Text, revised sentence to read, “To report an FDA approved or laboratory developed test (LDT) KRAS, codon 12 and 13 test kit service, please submit the following claim information.” This revision is effective on 03/03/2022.

10/01/2021
R5

Under Article Text corrected hyperlink for DEX webpage. Acronyms were defined and inserted where appropriate throughout the article. Formatting was corrected throughout the article. This revision is effective 10/1/2021.

Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C79.63. This revision is due to the Annual ICD-10 update and will become effective on 10/1/2021.

11/01/2019
R4

11/01/2019: This article is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into related Billing and Coding Articles.

Under CPT/HCPCS Codes Group 1: Codes added CPT® code 81275.

CPT® was inserted throughout the article where applicable.

11/01/2019
R3

As required by CR 10901 article is converted to a formal billing and coding type article. There is no change in coverage.

12/14/2017
R2

Article is updated to remove modifier 22 instruction, add Part A claim filing instructions and correct reference to and website address for DEX™ Diagnostics Exchange.

Article number A54497 for Jurisdiction E Part A (JEA) was retired on January 24, 2018, and combined into Jurisdiction E Part B (JEB) article number A54498.  JEA and JEB contract numbers will have the same final MCD article number.

 

01/01/2016
R1
Article is revised to change the title from "MolDX: therascreen® KRAS PCR Kit Billing/Coding Guidelines" to "MolDX: FDA-Approved KRAS" Tests and the following diagnoses were removed to be consistent with the MolDX Contractor coverage article: C78.00, C78.30, C79.00, C79.10, C79.40, C79.60, C79.70 and C79.9.