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) MolDX: Molecular Testing for Solid Organ Allograft Rejection L40249. Billing information • For a given patient encounter, only 1 molecular service (which may include more than 1 assay) for assessing allograft rejection status (within scope of this policy) may be billed for a given patient indication and encounter. Any additional molecular services billed after the first will be denied. • As noted in the LCD, a molecular test and biopsy should not be billed on the same date of service (DOS) or within a timeframe that will not reasonably allow the results of 1 test to inform the other. However, for the rare case that fulfills the exemption outlined in the LCD, an automated denial will be issued for a molecular test performed on the same DOS as biopsy. This may be appealed to allow for manual review. • 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. Additional information is provided below. • Frequency limits for surveillance testing apply as outlined in the LCD. • As stated in the LCD, surveillance testing will not be reimbursed if for-cause testing has been performed within the prior month. • The medical record must support the services billed. All services must be billed in compliance with the LCD and may be subject to medical review. 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 NOTE: When entering the DEX Z-Code ® on the SV101-7 documentation field for Part B claims please do not add additional characters and/or information on the line. 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 L40249 The tests below have completed a MolDX technical assessment and are deemed compliant with policy only for the specific indications listed; they must be billed in compliance with the policy requirements. The UOS = 1. ADDITIONAL NOTES: To-date, NO test has met policy criteria for surveillance testing past 5 years post-transplantation. Such claims will be denied but may be appealed to allow for manual review. Unless otherwise specified, tests that are comprised only of dd-cfDNA must be performed at least 2 weeks post-transplantation. Test (Manufacturer) Methodology Specimen Source Analyte(s) and Principle of Test Transplant Type(s) Indication(s) AlloMap ® (Care Dx) GEP (qRT- PCR) Blood GEP is used to calculate a score associated with the level of immune quiescence and probability of AR Heart Surveillance (Testing must be performed at least 2 months (≥55 days) post-transplantation) AlloSure ® (Care Dx) NGS (targeting 266 SNPs) Blood % dd-cfDNA is measured to identify graft injury and AR Kidney For-cause & Surveillance Heart For-cause & Surveillance Lung Surveillance in Bilateral Lung Transplants only HeartCare® (Care Dx) Combination of AlloMap and Allosure Blood As above Heart Surveillance >55 days post-transplantation Prospera™ (Natera™) mmPCR-NGS (targeting 13,926 SNPs) Blood % dd-cfDNA is measured to identify graft injury and AR Kidney For-cause & Surveillance Heart For-cause & Surveillance Lung Surveillance (must be at least 28 days post-transplant) 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 For-cause & Surveillance TruGraf ® (Eurofins-Transplant Genomics) GEP (RT-PCR) Blood GEP signatures identify patients that are adequately immunosuppressed Kidney Surveillance Viracor TRAC™ (Transplant Rejection Allograft Check) (Eurofins) Low-coverage WGS querying >100,000 SNPs Blood % dd-cfDNA is measured to identify AR Kidney For-cause & Surveillance GraftAssureCore (Insight Molecular Diagnostics Inc.) droplet digital PCR (ddPCR) Blood % dd-cfDNA is measured to identify graft injury and AR Kidney For-cause & Surveillance (must be at least 12 days post-transplant) 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 For more information regarding the MolDx Technical Assessment process, please visit MolDX - Technical Assessment (palmettogba.com) .