Billing and Coding: MolDX: Molecular Testing for Solid Organ Allograft Rejection

The information in this article contains billing, coding or other guidelines that complement the Local Coverage Determination (LCD) for MolDX: Molecular Testing for Solid Organ Allograft Rejection L38568. Billing information -Different Z-Code identifiers must be used for protocol vs for-cause testing. This will allow this contractor to better understand the intended use of the test. To report a service, please submit the following claim information: Select CPT ® code Enter 1 unit of service (UOS) 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 Select the appropriate ICD-10-CM code While all covered services can be identified on the DEX registry ( dexzcodes.com ), below is a list of tests covered under this policy. Solid Organ Allograft Rejection Tests that meet coverage criteria of policy L38568 The tests below have completed a MolDx technical assessment and are deemed compliant with policy. However, the tests must be billed in accordance with the specific required indications/coverage criteria outlined in the policy. Test (Manufacturer) Methodology Specimen Source Analyte(s) and Principle of Test Transplant Type(s) Allomap ® (CareDX) GEP (qRT-PCR) Blood GEP is used to calculate a score associated with the level of immune quiescence and probability of AR Heart Allosure ® (CareDX) NGS (targeting 266 SNPs) Blood % dd-cfDNA is measured to identify graft injury and AR Kidney Heart Lung HeartCare (CareDX) AlloSure Heart + AlloMap Heart performed on the same patient sample Blood See AlloSure Heart and AlloMap Heart Heart Prospera™ (Natera™) mmPCR-NGS (targeting 13,926 SNPs) Blood % dd-cfDNA is measured to identify graft injury and AR Kidney Heart Lung QSant™ (NephroSant) Multianalyte assay with algorithmic analysis Urine The concentrations of 6 urinary biomarkers (cell- free DNA (cfDNA), methylated cfDNA (m-cfDNA), CXCL10, clusterin, total protein and creatinine) are incorporated into an algorithm to calculate a composite score (Q-score), to demonstrate the probability of rejection risk. Kidney Tutivia™ (Verici DX) NGS (RNA Seq) with algorithm Blood Analyzes the gene expression of 17 RNA biomarkers to produce a risk score for transplant rejection. Kidney TruGraf ® (Eurofins-Transplant Genomics) GEP (RT-PCR) Blood GEP signatures identify patients that are adequately immunosuppressed Kidney Viracor TRAC™ (Transplant Rejection Allograft Check) (Eurofins) Low-coverage whole genome sequencing (WGS) querying >100,000 SNPs Blood % dd-cfDNA is measured to identify AR Kidney VitaGraft/GraftAssureCore (Insight Molecular Diagnostics Inc.) droplet digital PCR (ddPCR) Blood % dd-cfDNA is measured to identify graft injury and AR Kidney AR: acute rejection; dd-cfDNA: donor-derived cell-free DNA; GEP: gene expression profile; NGS: next generation sequencing; PCR: polymerase chain reaction; WGS: whole genome sequencing