Retired Local Coverage Article Billing and Coding

Billing and Coding: MolDX: ThermoFisher Oncomine Dx Target Test For Non-Small Cell Lung Cancer

A55888

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Contractor Information

Article Information

General Information

Article ID
A55888
Article Title
Billing and Coding: MolDX: ThermoFisher Oncomine Dx Target Test For Non-Small Cell Lung Cancer
Article Type
Billing and Coding
Original Effective Date
06/22/2017
Revision Effective Date
05/12/2022
Revision Ending Date
10/27/2022
Retirement Date
10/27/2022
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 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.

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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 (SSA) §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim

Article Guidance

Article Text

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

The Oncomine Dx Target Test (Thermo Fisher Scientific, Inc., Waltham, MA) is a 23 gene panel including 3 gene targets approved by the FDA for non-small cell lung cancer from tissue specimens1. The test can simultaneously identify three gene variants that are key to targeted therapy selection:  EGFR, BRAF and ROS1.  

Gene Variant Targeted therapy
BRAF BRAF V600E TAFINLAR®(dabrafenib) in combination with MEKINIST® (trametinib)
ROS1 ROS1 fusions XALKORI® (crizotinib)
EGFR L858R, Exon 19 deletions IRESSA® (gefitinib)

Erlotinib, gefitinib, or afatinib are approved therapies for NSCLC patients with EGFR exon 19 deletions and L858R mutation. The OncomineTM Dx Target is an FDA-approved companion diagnostic test for gefitinib only.

Crizotinib is very effective for NSCLC patients with ROS1 rearrangements. Oncomine DX Target Test is the only FDA approved companion diagnostic test that detects ROS1 fusions.  The assay does not detect ALK fusions.

Dabrafenib in combination with Trametinib is approved therapy for NSCLC patients with a BRAF V600E mutation. Oncomine DX Target Test is the only FDA approved companion diagnostic test that detects BRAF V600E.

To report a Oncomine Dx Target Test service on tissue specimens, submit the following claim information:

  • 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
    • Item 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 for
  • Select the appropriate ICD-10-CM code

https://www.accessdata.fda.gov/cdrh_docs/pdf16/p160045d.pdf

 

Coding Information

CPT/HCPCS Codes

Group 1

(1 Code)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
0022U TARGETED GENOMIC SEQUENCE ANALYSIS PANEL, CHOLANGIOCARCINOMA AND NON-SMALL CELL LUNG NEOPLASIA, DNA AND RNA ANALYSIS, 1-23 GENES, INTERROGATION FOR SEQUENCE VARIANTS AND REARRANGEMENTS, REPORTED AS PRESENCE/ABSENCE OF VARIANTS AND ASSOCIATED THERAPY(IES) TO CONSIDER

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(17 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
C33 Malignant neoplasm of trachea
C34.00 Malignant neoplasm of unspecified main bronchus
C34.01 Malignant neoplasm of right main bronchus
C34.02 Malignant neoplasm of left main bronchus
C34.10 Malignant neoplasm of upper lobe, unspecified bronchus or lung
C34.11 Malignant neoplasm of upper lobe, right bronchus or lung
C34.12 Malignant neoplasm of upper lobe, left bronchus or lung
C34.2 Malignant neoplasm of middle lobe, bronchus or lung
C34.30 Malignant neoplasm of lower lobe, unspecified bronchus or lung
C34.31 Malignant neoplasm of lower lobe, right bronchus or lung
C34.32 Malignant neoplasm of lower lobe, left bronchus or lung
C34.80 Malignant neoplasm of overlapping sites of unspecified bronchus and lung
C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung
C34.82 Malignant neoplasm of overlapping sites of left bronchus and lung
C34.90 Malignant neoplasm of unspecified part of unspecified bronchus or lung
C34.91 Malignant neoplasm of unspecified part of right bronchus or lung
C34.92 Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

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ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

Additional ICD-10 Information

N/A

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.

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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.

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Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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Revision History Information

Revision History DateRevision History NumberRevision History Explanation
11/03/2022 R4

This article is being retired as it is no longer applicable as the test is covered under NCD 90.2.

05/12/2022 R3

Under CPT/HCPCS Codes Group1: Codes the description was revised for 0022U. This revision is due to the Q2 CPT/HCPCS Code Update and is effective for dates of service on or after 4/1/2022.

Under CMS National Coverage Policy added regulation Title XVIII of the Social Security Act (SSA) §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.
This revision is effective 5/12/2022.

11/01/2019 R2

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

10/01/2017 R1

Replaced CPT code 81445 with 0022U, effective 10/1/2017.

Associated Documents

Related Local Coverage Documents
LCDs
L36256 - MolDX: Molecular Diagnostic Tests (MDT)
Related National Coverage Documents
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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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Other URLs
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Public Versions
Updated On Effective Dates Status
11/03/2022 05/12/2022 - 10/27/2022 Retired You are here
05/04/2022 05/12/2022 - N/A Superseded View
10/16/2019 11/01/2019 - 05/11/2022 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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