Summary & Overview
CPT 0579U: PromarkerD Predictive Assay for Kidney Function Decline
CPT code 0579U designates Promarker®D, a proprietary laboratory assay that uses ELISA-measured plasma biomarkers (APOA4 and CD5L) combined with estimated GFR and age in an algorithm to predict risk of kidney function decline in patients with diabetic chronic kidney disease. As a PLA code, 0579U applies only to a single manufacturer’s test and is used to identify this specific diagnostic service in claims and coverage discussions. Nationally, PLA codes like 0579U are important for tracking use of commercially developed tests that provide prognostic information supporting disease management and care planning.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical context for using Promarker®D, expected service locations, and the test’s role in predicting progression of diabetic kidney disease. The publication summarizes payer coverage considerations, common claim modifiers, and how this PLA code is reported. It also highlights benchmarks and policy-related updates relevant to laboratory innovation and proprietary tests, plus practical billing and documentation points to support accurate claim submission. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0579U is a Proprietary Laboratory Analyses (PLA) code specific to a single commercial test: Promarker®D from Proteomics International USA and Proteomics International Pty Ltd. The test analyzes a blood plasma sample by enzyme–linked immunosorbent assay (ELISA) to measure levels of apolipoprotein A4 (APOA4) and CD5 antigen–like (CD5L). These biomarker results are combined with the patient's estimated glomerular filtration rate (GFR) and age using a proprietary algorithm to produce a risk score that predicts the likelihood of kidney function decline in individuals with diabetic chronic kidney disease.
Service type: Laboratory diagnostic assay using blood plasma with algorithmic risk scoring.
Typical site of service: Clinical laboratory or reference laboratory processing blood specimens; sample collection typically occurs in outpatient phlebotomy settings or physician offices.
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with type 2 diabetes mellitus and known diabetic chronic kidney disease (CKD) stage 3a is seen in nephrology clinic for risk stratification of progressive kidney function decline. The clinician orders the Promarker®D blood test (0579U) to inform prognosis. A phlebotomy appointment is scheduled at the outpatient lab; a plasma sample is collected in accordance with the manufacturer's instructions and sent to Proteomics International USA (or Proteomics International Pty Ltd) for analysis. The laboratory performs an ELISA to measure apolipoprotein A4 (APOA4) and CD5 antigen–like (CD5L) levels, integrates those protein concentrations with the patient’s estimated glomerular filtration rate (GFR) and age via the proprietary algorithm, and returns a risk score indicating likelihood of kidney function decline. Results are reviewed by the ordering nephrologist or endocrinologist and documented in the outpatient medical record to guide longitudinal monitoring and care planning.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default — no modifier | Use when no special circumstances alter billing or payment; standard reporting for the single proprietary lab test. |
22 | Increased procedural services | Use when additional work or resources beyond the typical test processing are required and documented (e.g., extensive interpretation or reporting beyond routine test report).