SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: FDA-Approved KRAS Tests

A54688

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Draft Article
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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To see the currently-in-effect version of this document, go to the section.

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Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A54688
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: FDA-Approved KRAS Tests
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
02/02/2023
Revision Ending Date
11/15/2023
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Article Guidance

Article Text

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 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 adjacent to the CPT® code in the comment/narrative field for the following Part B claim field/types:
    • Loop 2400 or SV101-7 for the 5010A1 837P
    • Box 19 for paper claim
  • Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for the following Part A claim field/types:
    • Line SV202-7 for 837I electronic claim
    • Block 80 for the UB04 claim form
  • Select the appropriate ICD-10-CM diagnosis.


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 DEXTM 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.

 

Response To Comments

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Coding Information

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CPT/HCPCS Codes

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(3 Codes)
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Group 1 Codes
Code Description
81275 Kras gene variants exon 2
81276 Kras gene addl variants
81479 Unlisted molecular pathology
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ICD-10-CM Codes that Support Medical Necessity

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(37 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
C79.63 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
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ICD-10-CM Codes that DO NOT Support Medical Necessity

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ICD-10-PCS Codes

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Additional ICD-10 Information

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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 article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Code Description
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Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

Code Description
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Other Coding Information

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
02/02/2023 R15

Revision Effective date: 02/02/2023
Revision Explanation: Annual review, no changes.

07/14/2022 R14

Revision Effective date: 07/14/2022
Revision Explanation: Under Article Text revised verbiage regarding instructions on how to submit claims information. Under CPT/HCPCS Codes Group1: Codes added 81479 and 81276.

03/03/2022 R13

Revision Effective date: 03/03/2022
Revision Explanation: 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 R12

Revision Effective date: 10/01/2021
Revision Explanation: 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 10/1/21.

10/31/2019 R11

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

10/31/2019 R10

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

10/31/2019 R9

Revision Effective date: 10/31/2019
Revision Explanation: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. 
CPT® was inserted throughout the article where applicable.

10/03/2019 R8

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

12/22/2017 R7

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

12/22/2017 R6

Revision Effective date: 12/22/2017
Revision Explanation: Removed 22 modifier from text as this is no longer valid.

10/01/2015 R5

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

10/01/2015 R4 Revision Effective date: N/A
Revision Explanation: Annual review no changes made.
10/01/2015 R3 R3
Revision Effective:10/01/2015
Revision Explanation: Added information that diagnosis listed for both tests and add information that this is FDA indications .
10/01/2015 R2 Revision Effective: 10/01/2015
Revision explanation: Changed MolDX ID field to SV101-7 and Z-code to ZCode™ Identifier.
10/01/2015 R1 Revision Effective: N/A
Revision Explanation: Annual review no changes made.
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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)
Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Public Versions
Updated On Effective Dates Status
11/08/2023 11/16/2023 - N/A Currently in Effect View
01/27/2023 02/02/2023 - 11/15/2023 Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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