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IMPORTANT: THIS DOCUMENT CONTAINS OUTDATED INFORMATION.

Content provided on this page contains outdated information and instruction and should not be considered current. CGS is providing this archived information for research purposes only. This archived section contains previously issued instructions that have since been updated or are no longer applicable for Medicare billing purposes.

December 22, 2015 - Updated 01.04.18

FDA-Approved EGFR Tests (CM00092, Vol 3)

Two tests have met the FDA criteria for EGFR genetic testing:

Effective 06/01/2016:

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.

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 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 claim field/types:
- Part A: SV202-7 (electronic claim); Form Locator 80 (paper claim)
- Part B: Loop 2400 or SV101-7 (electronic claim); Item 19 (paper claim)
ICD-10-CM codes
- 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: 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.

License for Use of "Physicians' Current Procedural Terminology", (CPT) Fourth Edition

AMA Disclaimer of Warranties and Liabilities.

CMS Disclaimer

POINT AND CLICK LICENSE FOR USE OF "CURRENT DENTAL TERMINOLOGY", ("CDT")

FDA-Approved EGFR Tests (CM00092, Vol 3)

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