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.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0407UCPTProprietary Laboratory AnalysesPLArenal biomarkerdiabetic kidney diseaseplasma immunoassayalgorithmic risk scorelaboratory testing

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`	Technical component	Use when billing only the technical component (laboratory processing) of the test.
`59`	Data not available in the input.	Data not available in the input.
`52`	Reduced services	Use when the laboratory test is partially reduced or not performed in full for documented clinical reasons.
`53`	Discontinued procedure	Use when specimen collection or testing was started but discontinued for documented clinical reasons.
`62`	Two surgeons — Data not available in the input.	Data not available in the input.
`QK`	Medical direction of two, three, or four technicians by a physician — Data not available in the input.	Data not available in the input.
`QX`	Modifier for modifier pair — Data not available in the input.	Data not available in the input.
`QY`	Attending physician not meeting teaching physician requirements — Data not available in the input.	Data not available in the input.
`AS`	Physician assistant, nurse practitioner, or clinical nurse specialist services for miners or other specific settings — Data not available in the input.	Data not available in the input.
`SH`	Diagnostic/therapeutic service ordered by another physician — Use when another physician orders and documents the test for the treating provider.
`SJ`	Service performed by an unlicensed individual — Use when institutional policy requires identification of non-licensed personnel performing specimen handling (rare).
`TG`	Via an alternative payment system — Use when billing under an alternative payment arrangement that requires this modifier.

Taxonomy Code	Specialty	Notes
207RH0000X	Nephrology	Ordering and interpreting specialists for kidney disease risk stratification.
207L00000X	Endocrinology	Common ordering specialty for patients with diabetic kidney disease.
208000000X	Family Medicine	Primary care clinicians who may order the test for population risk assessment and ongoing management.
207VP0208X	Clinical Pathology	Laboratory medical directors who oversee test performance and reporting.
208D00000X	Internal Medicine	Hospital- and clinic-based internists who manage diabetes and CKD and may order the test.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`E11.21`	Type 2 diabetes mellitus with diabetic nephropathy	Direct indication for risk stratification of progressive diabetic kidney disease using the IntelxDKD™ assay.
`N18.2`	Chronic kidney disease, stage 2 (mild)	Early-stage CKD is the target population for prognostic testing to predict progression risk.
`N18.3`	Chronic kidney disease, stage 3 (moderate)	Useful in patients with moderate impairment where progression risk informs monitoring and therapy.
`E11.22`	Type 2 diabetes mellitus with diabetic chronic kidney disease	Specifies diabetic chronic kidney disease and supports medical necessity for risk assessment testing.
`R79.89`	Other specified abnormal findings of blood chemistry	May be used when abnormal renal-related biomarkers prompt additional prognostic testing.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`80053`	Comprehensive metabolic panel	Frequently ordered at the same visit to assess serum chemistries and baseline kidney function alongside the plasma biomarker test.
`82565`	Creatinine; measurement	Serum creatinine measurement is paired with the proprietary assay results to calculate eGFR and monitor kidney function.
`81002`	Urinalysis, non-automated, without microscopy	Urine testing for albumin or protein may be performed concurrently to assess albuminuria in diabetic kidney disease evaluation.
`84460`	Assay of insulin	Metabolic markers such as insulin or other metabolic labs are sometimes ordered in comprehensive diabetes management that accompanies kidney risk testing.
`80305`	Drug test, presumptive, any method	Not routinely linked but sometimes performed in comprehensive outpatient assessments; included here as an occasionally co-billed laboratory service.