LCD Reference Article Billing and Coding Article

Billing and Coding: MolDX: FDA-Approved EGFR Tests

A54424

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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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General Information

Source Article ID
N/A
Article ID
A54424
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
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 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
    • 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 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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81235

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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Coding Table Information

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Revision History Information

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

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 R5

Updated to indicate this article is an LCD Reference Article.

03/03/2022 R4

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. 

11/01/2019 R3

11/01/2019: 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.

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.

12/14/2017 R1

Article is updated for consistency with the MolDX Contractor: The entire section for cobas EGFR Mutation Test was revised, including effective date; modifier 22 instruction was removed; added Part A claim filing instructions and correct reference to and website address for DEX™ Diagnostics Exchange.

Article number A54423 for Jurisdiction F Part A (JFA) was retired on January 24, 2018, and combined into Jurisdiction F Part B (JFB) article number A54424.  JFA and JFB contract numbers will have the same final MCD article number.

 

 

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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
L36256 - MolDX: Molecular Diagnostic Tests (MDT)
Related National Coverage Documents
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Updated On Effective Dates Status
05/24/2024 05/30/2024 - N/A Currently in Effect You are here
11/22/2023 03/03/2022 - 05/29/2024 Superseded View
02/28/2022 03/03/2022 - N/A Superseded View
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