Summary & Overview
CPT 0313U: PancreaSeq® Pancreatic Cyst Genomic Classifier
CPT code 0313U identifies the PancreaSeq® Genomic Classifier, a proprietary molecular diagnostic assay from the University of Pittsburgh Medical Center that analyzes pancreatic cyst fluid using next-generation sequencing of 74 genes plus targeted RNA testing of CEACAM5. The test generates an algorithmic probability score indicating low or high likelihood that a cyst harbors cancer-associated genetic changes, informing risk stratification for patients with pancreatic cysts. Nationally, this PLA code matters because it standardizes reporting for a single-vendor, high-complexity genomic test used in management decisions for pancreatic cystic lesions.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical purpose and laboratory setting for the service, guidance on typical sites of service, and a summary of payer inclusion. The publication also outlines what to expect in benchmarks, coding guidance, and policy considerations for proprietary laboratory analyses without making clinical recommendations.
This resource is intended for health plan analysts, revenue cycle professionals, and clinical laboratory managers seeking a national-level briefing on CPT code 0313U, including clinical context, payer landscape, and the operational setting for test delivery.
Billing Code Overview
CPT code 0313U is a Proprietary Laboratory Analyses (PLA) code for the PancreaSeq® Genomic Classifier developed by the University of Pittsburgh Medical Center Molecular and Genomic Pathology Laboratory. The test analyzes pancreatic cyst fluid obtained via imaging-guided aspiration and uses next-generation sequencing (NGS) of 74 genes together with targeted RNA analysis of CEACAM5 (carcinoembryonic antigen) to assess molecular features associated with neoplastic transformation.
The service type is molecular diagnostic testing / genomic classifier performed on a clinical laboratory specimen. The typical site of service is a clinical laboratory or reference laboratory, with specimen collection occurring in an outpatient imaging or procedural setting (for example, cyst aspiration under endoscopic or radiologic guidance).
The PancreaSeq® assay integrates DNA and RNA sequencing results through an algorithm to produce a probability score indicating low (negative) or high (positive) likelihood that a pancreatic cyst harbors genetic changes that could lead to cancer.
Clinical & Coding Specifications
Clinical Context
A 58-year-old patient is referred to a gastroenterologist after cross-sectional imaging (CT or MRI) identifies a pancreatic cyst. The cyst is asymptomatic but has worrisome features such as a size >2 cm, a solid component, or a dilated main pancreatic duct. Endoscopic ultrasound (EUS) with fine-needle aspiration (FNA) is performed to obtain cyst fluid. Fluid is sent to the University of Pittsburgh Medical Center Molecular and Genomic Pathology Laboratory for the PancreaSeq® Genomic Classifier. The laboratory performs next-generation sequencing (NGS) of 74 genes plus measurement of carcinoembryonic antigen (CEA/CEACAM5) RNA expression and applies an algorithm to generate a probability score indicating low (negative) or high (positive) likelihood that the cyst harbors high-risk molecular alterations. Results are used by the multidisciplinary team (gastroenterology, surgery, and pathology) to support surveillance versus surgical resection decisions. Typical sites of service include outpatient endoscopy centers, hospital-based endoscopy suites, and reference molecular pathology laboratories. Specimen handling includes secure transport of cyst fluid, documented chain-of-custody, and laboratory accessioning under the specific proprietary test name PancreaSeq®.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default/No modifier | Use when no special circumstances apply to the billed test |