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 | Use when billing only the professional component of laboratory testing (interpretation or professional work) if the lab separates components. |
52 | Reduced services | Use when the test was performed but with reduced services or scope compared with standard. |
53 | Discontinued procedure | Use when specimen collection or testing was started but discontinued for patient-related or technical reasons. |
62 | Two surgeons | Use when two qualified professionals are required and both share work related to test management in a complex procedural context. |
78 | Unplanned return to operating/procedure room | Rare for this test; use only if specimen collection required an unplanned return to procedure area. |
80 | Assistant surgeon | Use when an assistant surgeon/qualified clinician provided assistance during specimen collection under surgical circumstances. |
82 | Assistant surgeon (when qualified resident unavailable) | Use when an assistant is required and a qualified resident is not available. |
QX | Service furnished with modifier RT/LT under an Advanced Beneficiary Notice (ABN) context for certain lab owners/operators (QX often used for CLIA-waived lab arrangements) | Use when specific private lab billing arrangements require the QX modifier per payer rules. |
QY | CLIA-waived test performed in a certified independent laboratory | Use when lab meets CLIA-waived conditions per payer guidance. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RH0000X | Internal Medicine | Common ordering specialty for diabetes and kidney risk assessment. |
207RN0300X | Endocrinology | Frequent ordering provider for diabetic complications risk stratification. |
207RC0000X | Nephrology | Interprets kidney-risk biomarker results and integrates into CKD management. |
208D00000X | Pathology & Clinical Laboratory | Performs and oversees LC–MS/MS assays and laboratory reporting. |
363L00000X | Clinical Laboratory | Direct laboratory service provision and billing for proprietary lab analyses. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
E11.21 | Type 2 diabetes mellitus with diabetic nephropathy | Primary indication for kidney-risk biomarker testing to assess progression risk. |
E11.22 | Type 2 diabetes mellitus with diabetic chronic kidney disease | Indicates established CKD in diabetes; test refines risk stratification. |
N18.3 | Chronic kidney disease, stage 3 (moderate) | eGFR in this range influences risk calculation and management decisions. |
N18.4 | Chronic kidney disease, stage 4 (severe) | Higher baseline stage increases relevance of predictive risk testing. |
R79.89 | Other specified abnormal findings of blood chemistry | Abnormal biomarker or renal function tests prompting advanced assessment. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
80048 | Basic metabolic panel (Calcium, total) | Common concurrent laboratory panel to assess serum electrolytes and renal function alongside kidney-risk testing. |
83036 | Hemoglobin; glycosylated (A1c) | HbA1c is combined with biomarker results by the test algorithm; often ordered if a recent A1c is not available. |
82607 | Creatinine; serum, plasma or blood (may be reported as part of CMP) | Creatinine is used to calculate estimated glomerular filtration rate (eGFR) which is incorporated into the risk score. |
86336 | Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative | Represents other quantitative biomarker assays that may be performed in parallel or for verification in clinical workflow. |
0001U | Proprietary laboratory analyses (example PLA code) | Other PLA codes are used similarly for proprietary biomarker tests; listed to represent the PLA code category and potential companion assays. |