MolDX: Inivata™, InVisionFirst, Liquid Biopsy for Patients with Lung Cancer

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: Inivata™, InVisionFirst®, Liquid Biopsy for Patients with Lung Cancer L37870 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 L37870 LCD Title MolDX: Inivata™, InVisionFirst®, Liquid Biopsy for Patients with Lung Cancer Proposed LCD in Comment Period N/A Source Proposed LCD DL37870 Original Effective Date For services performed on or after 04/08/2019 Revision Effective Date For services performed on or after 10/14/2021 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date N/A Notice Period End Date N/A CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, re

This test is a “liquid biopsy". It is intended to assist physicians caring for patients who suffer from a common form of lung cancer and who have advanced disease. This policy provides limited coverage for InvisionFirst ® - Lung (Inivata ™ , Research Triangle Park, NC) (hereafter InVision ® ) a plasma-based, somatic comprehensive genomic profiling (CGP) test for patients with advanced (Stage IIIB/IV) non-small cell lung cancer (NSCLC): At diagnosis When results for EGFR single nucleotide variants (SNVs) and insertions and deletions (indels); rearrangements in ALK and ROS1; and SNVs for BRAF are not available AND when tissue-based CGP is infeasible [i.e., quantity not sufficient (QNS) for tissue-based CGP or invasive biopsy is medically contraindicated], or At progression For patients progressing on or after chemotherapy or immunotherapy who have not been tested for EGFR SNVs and indels; rearrangements in ALK and ROS1; and SNVs for BRAFs, and for whom tissue-based CGP is infeasible; or For patients progressing on EGFR tyrosine kinase inhibitors (TKIs). If no genetic alteration is detected by InVision ® or if circulating tumor DNA (ctDNA) is insufficient/not detected, tissue-based genotyping should be considered.