LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: Therascreen® EGFR RGQ PCR Kit Guidelines

A54199

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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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Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A54199
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: Therascreen® EGFR RGQ 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
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.

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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

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Article Guidance

Article Text

Effective for dates of service on and after 7/12/13, CGS Administrators and the MolDX Program contractor will cover the FDA approved, therascreen EGFR RGQ PCR kit for the detection of the epidermal growth factor receptor (EGFR) gene from non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used to select patients with NSCLC for whom GILOTRIF™ (afatinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated.

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

    • CPT code 81479 – Unlisted chemistry procedure
    • Enter “ZBZ25” in the comment/narrative field for the following claim field/types:

 

      • Loop 2300 NTE01 for Part A or Loop 2400 NTE02/SV 101-7 for Part B
      • Submit “ZBZ25” 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:
    • 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
    • C34.31-Malignant neoplasm of lower lobe, right bronchus or lung
    • C34.32-Malignant neoplasm of lower lobe, left bronchus or 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
    • C34.91-Malignant neoplasm of unspecified part of right bronchus or lung
    • C34.92-Malignant neoplasm of unspecified part of left bronchus or lung



NOTE: CGS and the MolDX Program will apply NPI to ID editing. All labs that submit claims for the therascreen EGFR kit MUST register the test and confirm the UNMODIFIED use of the kit. For lab developed tests (LDT) or tests that modify the therascreen EGFR kit, CPT code 81235 should be reported and submitted with the assigned LDT test ID.

Response To Comments

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Coding Information

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Revenue Codes

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CPT/HCPCS Codes

Group 1

(1 Code)
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Group 1 Codes
Code Description
81479 Unlisted molecular pathology
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CPT/HCPCS Modifiers

Group 1

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ICD-10-CM Codes that Support Medical Necessity

Group 1

(9 Codes)
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Group 1 Codes
Code Description
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
C34.31 Malignant neoplasm of lower lobe, right bronchus or lung
C34.32 Malignant neoplasm of lower lobe, left bronchus or 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
C34.91 Malignant neoplasm of unspecified part of right bronchus or lung
C34.92 Malignant neoplasm of unspecified part of left bronchus or lung
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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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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
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 R1
Revision Effective:10/01/2015
Revision Explanation: Changed MoPath to MolDX .
10/01/2015 R1 Revision Effective: N/A
Revision Explanation: Added Part A loop information.
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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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Other URLs
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Public Versions
Updated On Effective Dates Status
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
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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