Summary & Overview
CPT 0576U: OmniGraf® Liver Allograft Rejection Risk Assay
CPT code 0576U designates a Proprietary Laboratory Analyses (PLA) test for OmniGraf® Liver (Eurofins Transplant Genomics LLC) that combines donor–derived cell–free DNA (cfDNA) whole genome NGS from plasma with a 56-gene expression profile from whole blood to generate a single algorithmic score estimating liver allograft rejection risk. As a PLA code, 0576U applies exclusively to one manufacturer's test, and it reflects the growing role of multimodal molecular diagnostics in transplant surveillance.
Key national payers considered include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will learn the clinical purpose of the test, typical sites of service where the assay is performed, payer coverage landscape, and how this code is used to bill a combined cfDNA and gene expression assay in transplant care. The publication provides benchmarks and policy context relevant to laboratory billing, coverage terminology, and operational considerations for transplant centers and clinical laboratories. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0576U is a Proprietary Laboratory Analyses (PLA) test reported only for OmniGraf® Liver from Eurofins Transplant Genomics LLC. The assay assesses the risk of liver allograft rejection by combining two lab methods into a single algorithmic score: measurement of donor–derived cell–free DNA (cfDNA) from plasma using whole genome next–generation sequencing (NGS) and gene expression profiling of 56 genes from whole blood via multiplex real–time polymerase chain reaction (PCR).
Service Type
- Service Type: Multimodal molecular diagnostic test combining NGS-based cfDNA analysis and targeted gene expression profiling
Typical Site of Service
- Typical Site of Service: Hospital outpatient laboratories, independent clinical reference laboratories, and transplant clinic-associated lab facilities
Clinical & Coding Specifications
Clinical Context
A 52-year-old patient with a history of orthotopic liver transplantation presents for routine post-transplant surveillance and evaluation for possible allograft dysfunction. The transplant hepatologist orders the OmniGraf® Liver test (0576U) conducted by Eurofins Transplant Genomics LLC to assess rejection risk. Two blood samples are collected during a single outpatient visit: a plasma specimen for donor-derived cell-free DNA (dd-cfDNA) measured by whole genome next-generation sequencing and a whole-blood specimen for a 56-gene expression panel measured by multiplex real-time PCR. The laboratory combines both results into a single algorithmic risk score. Results are returned to the ordering provider and used alongside clinical assessment, liver function tests (e.g., ALT, AST, bilirubin), and imaging; elevated risk may prompt consideration of diagnostic liver biopsy, adjustment of immunosuppression, or closer monitoring. Typical site of service is an outpatient clinic, transplant center, or ambulatory phlebotomy draw station associated with the transplant program.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default single component — full service | Use when submitting the test without any CMS modifier that alters payment or indicates an altered service; report the standard PLA test as intended. |