Summary & Overview
CPT 0284U: Versiti VWD Type 2N Binding ELISA Test
CPT code 0284U designates a proprietary laboratory analysis for the Versiti™ VWD Type 2N Binding test, a specialized plasma-based ELISA used to distinguish type 2N von Willebrand disease from mild hemophilia A. As a PLA code, 0284U applies to a single manufacturer’s or laboratory’s unique assay and is important for precise lab reporting, utilization tracking, and payer adjudication for high-specificity coagulation diagnostics.
Key payers in the national context include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Coverage policies for PLA assays can differ across payers, affecting prior authorization, medical necessity criteria, and allowed sites of service for specialized coagulation testing.
This publication provides a concise reference on clinical context, typical use of the assay, and what readers can expect regarding benchmarks and policy-relevant information. Readers will find: a clear description of the service and site of service, common modifiers associated with laboratory billing, guidance on documentation elements typically relevant to payer review, and discussion of implications for lab reporting and coding integrity. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0284U is a Proprietary Laboratory Analyses (PLA) code for the Versiti™ VWD Type 2N Binding test performed by Versiti™ Diagnostic Laboratories. The test uses a plasma specimen and an enzyme–linked immunosorbent assay (ELISA) to help distinguish type 2N von Willebrand disease (VWD) from mild hemophilia A.
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Service type: Laboratory diagnostic test (proprietary PLA assay)
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Typical site of service: Reference or specialty diagnostic laboratory (Versiti™ Diagnostic Laboratories)
Clinical & Coding Specifications
Clinical Context
A 28-year-old female with a history of lifelong mucocutaneous bleeding and prolonged bleeding after dental extraction is referred to a hematology specialty laboratory to distinguish von Willebrand disease (VWD) type 2N from mild hemophilia A. Prior screening tests show a borderline low factor VIII activity and abnormal von Willebrand factor antigen-to-activity ratio. The clinician orders the Versiti™ VWD Type 2N Binding test (0284U) performed on a plasma specimen using an ELISA assay at Versiti™ Diagnostic Laboratories.
Specimen collection is via standard venipuncture into sodium citrate tube, processed to platelet-poor plasma, and shipped per laboratory instructions. Results help determine whether reduced factor VIII levels are due to defective VWF binding (type 2N VWD) versus intrinsic factor VIII deficiency (hemophilia A), guiding genetic testing and treatment planning. Typical sites of service include outpatient specialty clinics, hospital outpatient laboratories, and reference laboratory facilities where proprietary PLA testing is performed.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
90 | Reference (Outside) Laboratory | Use when testing is performed by an external reference laboratory (e.g., Versiti™ Diagnostic Laboratories). |