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. |
22 | Increased procedural services | Use when unusually complex pre-analytic or analytic work beyond typical processing is documented and supported, such as extraordinary specimen handling or reflex testing requiring substantial additional resources. |
52 | Reduced services | Use when the test is partially performed or results are limited due to inadequate specimen volume or other documented partial performance. |
53 | Discontinued procedure | Use when specimen collection or testing was started but discontinued for documented clinical or technical reasons prior to completion. |
26 | Professional component | Use only if billing entity separates professional interpretation from technical laboratory work and the professional component is being reported separately (note: PLA codes are generally reported by the performing lab). |
TC | Technical component | Use only if billing entity reports the technical component separately from interpretation and the technical portion was performed by the billing laboratory. |
90 | Reference (outside) lab | Use when this test is performed by an outside independent reference laboratory and the billing arrangement requires this modifier per payer rules. |
91 | Repeat clinical diagnostic laboratory test performed on the same day to obtain subsequent result | Use when a repeat specimen is processed the same day for verification or discordant results as documented. |
59 | Distinct procedural service | Use when separately identifiable tests or services are performed the same day and documentation supports separate reporting (payer policies vary for PLA codes). |
23 | Unusual anesthesia | Not typically applicable to this lab test; include only if unusual anesthesia was required for specimen collection, which is rare. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
2080S00000X | Transplant Hepatology | Ordering and clinical interpretation of transplant surveillance testing. |
207LH0000X | Gastroenterology | Management of post-liver-transplant patients and ordering surveillance tests. |
207L00000X | Internal Medicine | Primary transplant care and coordination of surveillance in outpatient settings. |
363L00000X | Clinical Laboratory | Performing and reporting specialized molecular assays and PLA testing. |
2084P0800X | Clinical Pathology | Laboratory oversight, result interpretation, and reporting of molecular diagnostic tests. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
Z94.4 | Liver transplant status | Directly relevant as routine surveillance for allograft rejection applies to patients with a history of liver transplant. |
T86.40 | Unspecified complication of liver transplant | Coded when a transplant recipient develops graft-related complications prompting rejection risk assessment with 0576U. |
T86.41 | Acute rejection of liver transplant | Indicates suspected acute rejection where 0576U can aid noninvasive risk assessment prior to invasive biopsy. |
K83.0 | Cholangitis | Biliary complications can cause abnormal liver tests; 0576U may be used to help differentiate rejection from biliary causes when clinical context requires. |
K72.90 | Hepatic failure, unspecified without coma | In transplant recipients with graft dysfunction or failure concerns, molecular rejection risk testing can contribute to diagnostic evaluation. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0260U | Measurement of donor-derived cell-free DNA (dd-cfDNA) in plasma by next-generation sequencing, quantitative | May be used in clinical workflows when dd-cfDNA is reported separately or when facilities perform cfDNA-only assays alongside or as an alternative to combined PLA testing; complements 0576U components. |
0549U | Gene expression profiling by real-time PCR for transplant rejection risk (example PLA) | Represents other PLA-style molecular expression assays; similar methodology to the gene expression component of 0576U and may appear on formularies as comparator tests. |
88305 | Level IV surgical pathology, gross and microscopic examination | Performed when 0576U results and clinical assessment lead to a diagnostic liver biopsy; used to provide histologic confirmation of rejection. |
36415 | Collection of venous blood by venipuncture | Typical specimen collection code used by clinics or phlebotomy services when obtaining the plasma and whole-blood samples required for 0576U. |
80076 | Hepatic function panel (e.g., total protein, albumin, bilirubin, ALT, AST, alkaline phosphatase) | Common laboratory tests ordered concurrently for transplant surveillance to correlate with molecular risk assessment provided by 0576U. |