LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: FDA-Approved EGFR Tests

A54021

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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
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Article ID
A54021
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
10/01/2015
Revision Effective Date
05/30/2024
Revision Ending Date
N/A
Retirement Date
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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 anti-coagulated 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 Plasma
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
    • 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
  • ICD-10-CM codes

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.

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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(12 Codes)
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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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Revision History Information

Revision History Date Revision History Number Revision History Explanation
05/30/2024 R12

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.

03/03/2022 R11

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 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.” This revision is effective on 03/03/2022. 

10/24/2019 R10

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 Article Text created another bullet for verbiage, “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”. Under CPT/HCPCS Codes Group 1: Codes added CPT® code 81235. Formatting, punctuation and typographical errors were corrected throughout the Article. CPT® was inserted throughout the article where applicable.

02/26/2018 R9 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
01/29/2018 R8 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
12/14/2017 R7

Removed 22 modified references and McKesson Diagnostics Exchange reference. Corrected bulleting issues.

01/26/2017 R6 Annual review completed, updated article with 2016 info, part a clm submission instructions and added new trademark for McKesson Z-code ID.
02/24/2016 R5 Added statement that MolDX will approve all future FDA-approved indications to the end of article.
01/14/2016 R4 Annual review completed, no changes needed.
12/10/2015 R3 Reverted back to SV101-7 and for trade mark purposes, replaced ID/MolDX identifier/Z-Code to read Z-Code™ Identifier
11/19/2015 R2 Replaced SV101-7 with MID, and removed 2014 coding references
10/01/2015 R1 Removed ICD-9 and ICD-10 codes from the article text.
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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
L35025 - MolDX: Molecular Diagnostic Tests (MDT)
Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
05/24/2024 05/30/2024 - N/A Currently in Effect You are here
02/25/2022 03/03/2022 - 05/29/2024 Superseded View
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