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.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0284UCPTProprietary Laboratory AnalysesVWD Type 2NELISAHemostasis TestingLaboratory MedicineDiagnostic Coding

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.

Service type: Laboratory diagnostic test (proprietary PLA assay)
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).

Taxonomy Code	Specialty	Notes
`207RH0000X`	Hematology	Specialists who diagnose and manage bleeding disorders and order specialized VWD testing.
`208D00000X`	Medical Genetics	Providers who evaluate inherited bleeding disorders and coordinate genetic testing.
`2080P0800X`	Pathology - Clinical	Laboratory directors and clinical pathologists overseeing specialty coagulation assays.
`363E00000X`	Laboratory Director	Clinical laboratory specialists responsible for reference lab testing quality and reporting.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`D68.0`	von Willebrand disease	Primary diagnostic category for which the Versiti™ VWD Type 2N Binding test is ordered to subtype VWD.
`D66`	Hereditary factor VIII deficiency (Hemophilia A)	Important differential diagnosis; test helps distinguish mild hemophilia A from VWD type 2N.
`R58`	Hemorrhage, not elsewhere classified	Symptom code for active bleeding that may prompt coagulation testing including specialized VWD assays.
`R79.82`	Abnormal coagulation studies	Used when screening coagulation results are abnormal and reflex testing to PLA assays is needed.
`Z13.6`	Encounter for screening for disorders of blood and blood-forming organs	Used for targeted screening or family history evaluations leading to specialized VWD testing.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0284U`	Versiti™ VWD Type 2N Binding (proprietary PLA)	The primary proprietary laboratory analysis used to distinguish VWD type 2N from mild hemophilia A.
`85360`	von Willebrand factor antigen assay	Commonly performed earlier in the diagnostic workup to quantify VWF antigen before specialized PLA testing.
`85302`	Factor VIII activity assay (FVIII:C)	Performed to measure factor VIII activity when differentiating between VWD type 2N and hemophilia A.
`86140`	von Willebrand factor activity (ristocetin cofactor or equivalent)	Assesses VWF functional activity and is part of initial VWD evaluation before ordering type 2N binding assays.
`81479`	Unlisted molecular pathology procedure	May be used for genetic testing for VWF or F8 mutations when sequencing or specific molecular tests are ordered following PLA results.
`36415`	Collection of venous blood by venipuncture	The specimen collection procedure required to obtain plasma for the ELISA-based PLA test.