LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: FDA-Approved EGFR Tests

A55193

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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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Source Article ID
N/A
Article ID
A55193
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: MolDX: FDA-Approved EGFR Tests
Article Type
Billing and Coding
Original Effective Date
02/16/2017
Revision Effective Date
05/30/2024
Revision Ending Date
N/A
Retirement Date
N/A

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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 EGFR genetic testing:

    1. Effective 6/01/16

      cobas EGFR Mutation Test is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anticoagulated peripheral whole blood.

      The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in the Table below in accordance with the approved therapeutic product labeling:
      Drug FFPET Plama
      TARCEVA ®
      (erlotinib)
      Exon 19 deletions
      and L858R
      Exon 19 deletions and
      L858R
      TAGRISSO ™
      (osimertinib)
      T790M  

      Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of EGFR exon 19 deletions or L858R mutations are eligible for treatment with TARCEVA® (erlotinib). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.

            2.  Effective 7/12/13

therascreen EGFR RGQ PCR kit for the detection of the epidermal growth factor receptor (EGFR) gene for non-small cell lung cancer (NSCLC) tumor tissue to help select patients with NSCLC for whom GILOTRIF™ (afatinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated.

To report an FDA approved or laboratory developed test (LDT) EGFR test kit service, please submit the following claim information.

  • CPT code: 81235
  • 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
    • Submit the assigned Z-Code™ Identifier on an attachment to the claim form 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 correct ICD-10-CM diagnosis code(s).

NOTE: MolDX will apply NPI to ID editing on FDA approved EGFR kits. All labs that submit claims for an EGFR 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.

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ICD-10-CM Codes that Support Medical Necessity

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Group 1 Codes
Code Description
C34.00 Malignant neoplasm of unspecified main bronchus
C34.01 Malignant neoplasm of right main bronchus
C34.02 Malignant neoplasm of left main bronchus
C34.11 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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Revenue Codes

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Coding Table Information

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Non-Excluded CPT/HCPCS Ended Codes - Table Format
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
05/30/2024 R6

Posted 06/27/2024 Under Article Text revised 2nd and 5th bullets to remove “DEX Z-Code™” and replaced with “DEX Z-Code®”. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added C34.00, C34.01, and C34.02. Formatting was corrected throughout the article.

03/31/2022 R5

Posted 03/31/2022- Under Article Text number 2, revised sentence to read, “To report an FDA approved or laboratory developed test (LDT) EGFR test kit service, please submit the following claim information. Review completed 02/17/2022.

10/28/2021 R4

10/28/2021-Review completed 09/20/2021- updated CMS National Coverage Policy Section.

11/01/2019 R3

Content moved to the new template. Review completed 11/18/2019.

02/01/2018 R2

02/01/2018- Removed modifier 22 EGFR, common variant and “For lab developed tests (LDT) or tests that modify an EGFR test, CPT code 81235 and NO modifier should be reported and submitted with the assigned LDT test ID.” Replaced McKesson Diagnostics ExchangeTM: with DEX Diagnostics Exchange TM. Annual review completed 01/11/2018.

03/01/2017 R1 03/01/2017- Annual Review completed 02/02/2017. Added Part A claims submission information & expanded on EGFR mutation testing and added TAGRISSO ™ (osimertinib).
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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
L36807 - MolDX: Molecular Diagnostic Tests (MDT)
Related National Coverage Documents
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Updated On Effective Dates Status
06/18/2024 05/30/2024 - N/A Currently in Effect You are here
03/22/2022 03/31/2022 - 05/29/2024 Superseded View
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