Summary & Overview
CPT 0384U: NaviDKD Predictive Diagnostic Screening for Kidney Health
Headline: New PLA CPT code 0384U designates NaviDKD™, a lab-developed predictive screening test for diabetic kidney disease risk.
Lead: CPT code 0384U identifies a proprietary laboratory analysis — NaviDKD™ Predictive Diagnostic Screening for Kidney Health from Journey Biosciences Inc. — that combines LC–MS/MS biomarker measurements with HbA1c and estimated glomerular filtration rate to generate a risk score for progression to advanced kidney disease in patients with diabetes. The code formalizes billing for a single-manufacturer diagnostic service with potential implications for care management and coverage policy.
Why it matters: As a PLA CPT code tied to a specific commercial assay, 0384U affects how laboratories, clinicians, and payers document and bill for a novel predictive biomarker panel. Nationally, adoption may influence clinical workflows for diabetes-related kidney disease risk stratification and shape payer coverage determinations for precision diagnostics.
Payers covered: Analysis includes major national payers: Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
What readers will learn: The publication reviews the clinical purpose of the test, typical sites of service, and the coding context for 0384U. It outlines expected use cases for risk stratification, summarizes payer relevance, and identifies areas where policy updates, coverage criteria, and utilization management may be applied. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0384U is a Proprietary Laboratory Analyses (PLA) code specific to a single manufacturer and test: NaviDKD™ Predictive Diagnostic Screening for Kidney Health from Journey Biosciences Inc. The test uses liquid chromatography with tandem mass spectrometry (LC–MS/MS) to measure blood biomarkers linked to kidney complications in patients with diabetes and combines those biomarker results with the patient’s HbA1c and estimated glomerular filtration rate to produce a risk score for progression to high–stage kidney disease.
Service type: Proprietary laboratory diagnostic test (predictive biomarker panel)
Typical site of service: Clinical laboratory or reference laboratory; blood draw may occur in outpatient clinic or phlebotomy site
Clinical & Coding Specifications
Clinical Context
A 58-year-old patient with type 2 diabetes mellitus attends a routine endocrinology visit with complaints of increased fatigue and reports of long-standing hyperglycemia. The clinician orders the NaviDKD™ Predictive Diagnostic Screening for Kidney Health (0384U) to stratify risk of progression to advanced diabetic kidney disease. A blood sample is drawn in an outpatient clinic or phlebotomy lab and sent to the performing laboratory. The laboratory performs liquid chromatography with tandem mass spectrometry (LC–MS/MS) to measure specific biomarkers and combines those results with the patient’s most recent hemoglobin A1c and estimated glomerular filtration rate to generate a risk score. Results are returned to the ordering provider who documents the test result in the patient’s electronic health record and incorporates the risk score into the ongoing management plan for diabetes and kidney disease monitoring.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier applicable (default) | Use when no specific modifier applies to the claim. |
26 | Professional component |