Summary & Overview
CPT 0385U: PromarkerD ELISA Plasma Assay for Diabetic Kidney Disease Risk
CPT code 0385U designates the PromarkerD proprietary laboratory test, an ELISA-based plasma assay that quantifies biomarkers linked to diabetic kidney disease and combines those values with age, HDL–cholesterol, and estimated glomerular filtration rate to produce a risk score. As a PLA code, 0385U is specific to PromarkerD by Sonic Reference Laboratory and Proteomics International Pty Ltd, and it identifies a unique commercial laboratory service rather than a generic test.
Key payers included in this analysis are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Coverage and payment policies for PLA codes vary by payer and can influence patient access to specialized diagnostic risk scores at the national level. The use of a proprietary algorithm and single-source test manufacturer are factors that payers and employers evaluate when making coverage determinations.
Readers will find an overview of the clinical context for PromarkerD, a summary of common payer approaches to PLA codes, benchmarks for service type and site of service, and notes on coding mechanics and administrative considerations. Data not available in the input are explicitly noted where applicable. This publication is written for national audiences including payers, clinicians, laboratory administrators, and policy analysts interested in biomarker-based risk assessment for diabetic kidney disease.
Billing Code Overview
CPT code 0385U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the PromarkerD test produced by Sonic Reference Laboratory, Proteomics International Pty Ltd. Using an enzyme–linked immunoassay (ELISA) method on a blood (plasma) sample, the test measures biomarkers associated with diabetic kidney disease and combines those results with the patient’s age, HDL–cholesterol level, and estimated glomerular filtration rate to generate a risk score for developing kidney disease.
Service type: Proprietary laboratory diagnostic test (biomarker risk score for diabetic kidney disease)
Typical site of service: Clinical laboratory or reference laboratory
Clinical & Coding Specifications
Clinical Context
A 58-year-old patient with type 2 diabetes mellitus and mildly reduced kidney function presents to a primary care clinic for routine diabetes management. The clinician orders the PromarkerD test to assess the patient’s risk of developing diabetic kidney disease within the next four years. A phlebotomy draw of plasma is sent to Sonic Reference Laboratory (Proteomics International Pty Ltd) using the manufacturer-specific PromarkerD kit. The lab performs an enzyme–linked immunoassay (ELISA) for the specified biomarkers, combines results with the patient’s age, HDL–cholesterol level, and estimated glomerular filtration rate (eGFR), and returns a risk score. Results are reviewed by the ordering clinician and incorporated into the care plan for monitoring, nephrology referral consideration, or medication management as clinically appropriate.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | Standard reporting when no modifier applies to the PLA service |
26 | Professional component | Use if billing only the professional interpretation component separate from the technical component |
TC | Technical component | Use if billing only the technical component (laboratory performing assay) |
52 | Reduced services | Use when the test is partially reduced or not performed to full extent |
53 | Discontinued procedure | Use if specimen processing started but testing was discontinued for valid clinical reasons |
62 | Two surgeons | Rarely applicable; use when two providers of different specialties share responsibility for service (not typical for this lab test) |
78 | Unplanned return to OR | Not typically applicable; included when relevant to procedure-related complications |
80 | Assistant surgeon | Not typical for lab tests; use only if an assistant surgeon performs an associated interventional procedure |
82 | Assistant surgeon (when qualified resident unavailable) | As above, only if relevant to an associated procedure |
QX | Ordering/servicing laboratory modifier — modifier for CLIA-exempt situations | Use when applicable to designate the appropriate ordering/servicing laboratory responsibilities |
QK | Clinical laboratory fee schedule payments by separate entity | Use when lab billing arrangements require this modifier per payer rules |
QY | Payer-specific ordering/modifier for services furnished by a different entity | Use when indicating a particular billing/performing entity relationship per payer guidance |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207Q00000X | Family Medicine | Primary care clinicians who commonly order diabetes-related risk testing |
| 207R00000X | Internal Medicine | Internists managing diabetes and chronic kidney disease risk |
| 208000000X | Nephrology | Specialists who interpret kidney disease risk scores and manage CKD |
| 207L00000X | Endocrinology | Endocrinologists managing complex diabetes and complications |
| 363LF0000X | Clinical Laboratory | Laboratories performing the PromarkerD assay; includes lab directors and pathologists |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
E11.21 | Type 2 diabetes mellitus with diabetic nephropathy | Directly related to assessing risk for progression of diabetic kidney disease |
E11.22 | Type 2 diabetes mellitus with diabetic chronic kidney disease | Indicates established CKD in diabetes; PromarkerD may inform risk stratification for progression |
E11.9 | Type 2 diabetes mellitus without complications | Baseline diabetes diagnosis where risk assessment for future kidney disease is appropriate |
N18.2 | Chronic kidney disease, stage 2 (mild) | Early CKD stage where predictive testing may alter monitoring frequency |
N18.3 | Chronic kidney disease, stage 3 (moderate) | Moderate CKD where prognostic testing helps guide nephrology referral and treatment decisions |
R79.89 | Other specified abnormal findings of blood chemistry | Abnormal biomarker or lipid findings prompting further risk evaluation including PromarkerD |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
80053 | Comprehensive metabolic panel | Commonly ordered to assess renal function and electrolytes alongside biomarker testing |
82043 | Drug assay, qualitative or semi-quantitative (e.g., immunoassay) | Includes ELISA methods conceptually related to assay methodology; not specific to PromarkerD |
82947 | Glucose; quantitative, blood (except reagent strip) | Routine diabetes monitoring test often ordered with kidney risk assessment |
83876 | Immunoassay for analyte other than infectious agent antibody or toxicology; quantitative | CPT family covering quantitative immunoassay methodology, conceptually related though PromarkerD is reported with PLA code 0385U |
90471 | Immunization administration (per vaccine) | Not directly related to the lab test but commonly billed during diabetes preventive visits where PromarkerD might be ordered |