Summary & Overview
CPT 0407U: Plasma Immunoassay and Algorithmic Risk Score for Early Diabetic Kidney Disease
Headline: New PLA CPT code 0407U identifies a proprietary plasma immunoassay and algorithm that scores risk of progressive kidney decline in early-stage diabetic kidney disease.
Lead: CPT code 0407U designates the IntelxDKD™ test from Renalytix Inc., a Proprietary Laboratory Analyses (PLA) assay that measures three plasma biomarkers and integrates those results with clinical factors through an algorithm to produce a risk score for progressive kidney function decline in patients with early-stage chronic diabetic kidney disease. The code matters nationally as it codifies a specific manufacturers' test that influences clinical decision-making for a growing population of patients with diabetes and early CKD.
Key payers covered: Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare are the primary payers discussed in the analysis.
What readers will learn: This publication provides benchmarks and context for the clinical utility and coding of CPT code 0407U, outlines typical sites of service and service type, and summarizes payer coverage patterns and policy considerations pertinent to a PLA-level diagnostic with algorithmic scoring. The content addresses implications for billing workflows and laboratory reporting for outpatient kidney disease management and highlights where standardization and documentation are likely to affect reimbursement and clinical adoption.
Additional context: Data not available in the input for associated taxonomies, specific ICD-10 diagnoses, or related codes.
Billing Code Overview
CPT code 0407U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the IntelxDKD™ test from Renalytix Inc. The assay uses a plasma specimen in an immunoassay to detect three specific biomarkers and combines those laboratory results with clinical factors through an algorithmic analysis to report a risk score for progressive kidney function decline in patients with early-stage chronic diabetic kidney disease.
Service type: Proprietary laboratory diagnostic test with algorithmic risk scoring
Typical site of service: Specialty clinical laboratories or reference labs processing plasma immunoassays; results reported to ordering clinicians for use in outpatient chronic kidney disease management.
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with type 2 diabetes mellitus and stage 2 chronic kidney disease (estimated glomerular filtration rate 60–89 mL/min/1.73 m2) presents for routine nephrology follow-up. The clinician orders the IntelxDKD™ proprietary plasma immunoassay to stratify risk for progressive kidney function decline using measured biomarkers and an algorithmic risk score. A phlebotomy appointment is scheduled at an outpatient laboratory or hospital outpatient phlebotomy station. A plasma specimen is collected by venipuncture, labeled with patient identifiers and test requisition for Renalytix Inc., and sent to the performing laboratory. The lab performs the immunoassay measuring the three biomarkers, runs the manufacturer-specific algorithm combining biomarker values with clinical variables, and generates a risk score report indicating low, intermediate, or high risk for progressive diabetic kidney disease. The ordering provider (nephrologist or endocrinologist) receives the result and incorporates the risk score into ongoing management decisions such as monitoring interval, medication review, and care coordination with primary care.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when billing only the professional interpretation component if applicable under split-bill arrangements. |
TC |