MolDX: Envisia™, Veracyte™, Idiopathic Pulmonary Fibrosis Diagnostic Test

Summary of Evidence Analysis of Evidence General Information Associated Information Sources of Information Bibliography Revision History Information Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Public Versions Keywords Local Coverage Determination (LCD) MolDX: Envisia™, Veracyte™, Idiopathic Pulmonary Fibrosis Diagnostic Test L37857 Expand All | Collapse All  Email Document  Download  Add to basket Contractor Information Contractor Name Contract Type Contract Number Jurisdiction States LCD Information Document Information LCD ID L37857 LCD Title MolDX: Envisia™, Veracyte™, Idiopathic Pulmonary Fibrosis Diagnostic Test Proposed LCD in Comment Period N/A Source Proposed LCD DL37857 Original Effective Date For services performed on or after 04/01/2019 Revision Effective Date For services performed on or after 06/29/2023 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 02/14/2019 Notice Period End Date 03/31/2019 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee sched

This is a laboratory test which will assist physicians caring for patients who have developed pulmonary (lung) scarring. This policy provides limited coverage for the Envisia™ Genomic Classifier (Veracyte™, Inc., South San Francisco, CA), a tissue based multi-analyte assay with algorithm analysis test (hereafter called Envisia™) for interstitial lung disease (ILD) patients who are suspected of having idiopathic pulmonary fibrosis (IPF) and who do not have a definitive usual interstitial pneumonia (UIP) pattern by high resolution computed tomography (HRCT) or other known cause of ILD. IPF suspicion increases significantly in patients greater than 60 years of age when HRCT is not definitive, and comorbidities in this population make clinicians reluctant to perform surgical lung biopsy to obtain a diagnosis due to significant procedure morbidity and mortality. Envisia™ testing is performed on less-invasive bronchoscopy transbronchial biopsy (TBB) samples and is intended to provide a categorical UIP or non-UIP result that along with clinical and radiographic information may guide treatment without the need or risk of surgical lung biopsy.