CPT 0599U PancreaSure™ Reimbursement & Policy | OpenPayer

Summary & Overview

CPT 0599U: PancreaSure™ Serum Protein Algorithm for Pancreatic Cancer

CPT code 0599U designates PancreaSure™, a Proprietary Laboratory Analyses (PLA) test from Immunovia Inc. that measures five serum proteins and applies a diagnostic algorithm to produce a positive or negative result for markers associated with pancreatic cancer. As a PLA code tied to a single manufacturer test, 0599U matters for clinical laboratories, oncology practices, payers, and health systems evaluating coverage and billing pathways for novel diagnostics.

Key payers in national discussions include Aetna, Blue Cross Blue Shield plans, Cigna Health, UnitedHealthcare, and Medicare. Coverage approaches for PLA codes vary across commercial plans and Medicare, affecting access and claim adjudication for newer proprietary tests.

Readers will find a concise overview of the test purpose and service setting, a summary of payer considerations and common claim modifiers, and context about where this test fits in diagnostic workflows for suspected pancreatic cancer. The publication summarizes available benchmarks, typical billing practices for PLA assays, and policy issues that commonly arise with single-source laboratory diagnostics. Data not available in the input is noted where applicable.

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Billing Code Overview

CPT code 0599U is a Proprietary Laboratory Analyses (PLA) code that applies only to a single commercial test, PancreaSure™ from Immunovia Inc. The test analyzes a blood serum sample to measure five proteins — ICAM1, TIMP1, CTSD, THBS1, and CA 19-9 — that are associated with pancreatic cancer. Results are processed through a diagnostic algorithm that yields a final result of positive or negative.

Service type: Proprietary laboratory diagnostic test (PLA)

Typical site of service: Independent clinical laboratory or hospital outpatient laboratory

Clinical & Coding Specifications

Clinical Context

A typical patient is a 55–75-year-old adult with unexplained weight loss, new-onset or worsening diabetes, persistent upper abdominal pain, or a pancreatic mass identified on imaging. A gastroenterologist or oncologist orders the PancreaSure™ serum protein panel (0599U) when there is clinical suspicion for pancreatic ductal adenocarcinoma to aid diagnostic evaluation. The clinical workflow: the clinician documents history and indication (for example, R63.4 for abnormal weight loss or E11.9 for type 2 diabetes mellitus without complications), orders the Proprietary Laboratory Analysis 0599U in the electronic medical record, and arranges phlebotomy. A serum specimen is collected in an outpatient lab or hospital laboratory, processed, and sent to the performing laboratory. The assay measures five proteins (ICAM1, TIMP1, CTSD, THBS1, and CA 19-9) and an algorithm produces a final binary result (positive/negative). Results are reported to the ordering clinician and are integrated with imaging, histology, and clinical findings to guide further diagnostics such as contrast-enhanced CT, endoscopic ultrasound with biopsy, or referral to surgical oncology. Typical sites of service are outpatient hospital laboratories, independent reference laboratories, and ambulatory clinic-based phlebotomy centers.

Coding Specifications

Modifier	Description	When to Use

CPT 0446U: aiSLE DX Disease Activity Index, SLE Biomarker Panel

CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

CPT-0219U-HIV-1-NGS-GENOTYPING-ASSAY-SENTOSA-SQ

CPT 0219U: Sentosa SQ HIV-1 Genotyping Assay (NGS)

CPT-0555U-PGT-SR-PLUS-PREIMPLANTATION-GENETIC-TESTING-STRUCTURAL-REARRANGEMENTS

CPT 0555U: Preimplantation Genetic Testing for Structural Rearrangements

CPT-0188U-GERBICH-BLOOD-GROUP-NAVIGATOR-GE-SEQUENCING

CPT 0188U: Gerbich Blood Group Sequencing (Navigator GE)

CPT-0462U-SALIVARY-MELATONIN-PROFILE-CIRCADIAN-PHASE-ASSESSMENT

CPT 0462U: Salivary Melatonin Profile (Circadian Phase Assessment)

CPT-0171U-MYMRD-NGS-MRD-PANEL-MYELOID-MALIGNANCIES

CPT 0171U: MyMRD NGS Panel for MRD Detection in Myeloid Malignancies

CPT-0378U-UCGSL-RFC1-REPEAT-EXPANSION-TEST-CANVAS

CPT 0378U: UCGSL RFC1 Repeat Expansion Test for CANVAS

CPT-0312U-AVISE-LUPUS-PROPRIETARY-LAB-ASSAY

CPT 0312U: Avise® Lupus Proprietary Laboratory Assay

CPT-0596U-PRECIVITY-APOE-PROTEOTYPE-LC-MSMS

CPT 0596U: Precivity–ApoE™ APOE Proteotype by LC-MS/MS

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Taxonomy Code	Specialty	Notes
208000000X	Gastroenterology	Ordering providers commonly include gastroenterologists evaluating suspected pancreatic disease.
207RC0000X	Hematology & Oncology	Medical oncologists order tumor biomarker testing during cancer workup.
281M00000X	Clinical Pathology	Pathologists or clinical laboratorians oversee test validation and result interpretation in the lab.
363L00000X	Phlebotomy	Phlebotomists and laboratory collection staff perform specimen collection and handling.
207L00000X	Surgical Oncology	Surgical oncologists may order the test as part of preoperative staging and decision-making.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C25.9`	Malignant neoplasm of pancreas, unspecified	Primary diagnosis of pancreatic cancer; a positive `0599U` result may raise suspicion prompting confirmatory testing.
`R63.4`	Abnormal weight loss	Common presenting symptom leading to evaluation including tumor marker testing.
`R73.9`	Hyperglycemia, unspecified	New-onset or worsening diabetes can be associated with pancreatic neoplasms and prompt biomarker testing.
`R10.11`	Right upper quadrant abdominal pain	Abdominal pain is a frequent symptom when evaluating for pancreatic pathology.
`K86.1`	Other chronic pancreatitis	Chronic pancreatic disease may be in the differential diagnosis when interpreting biomarker results.
`R94.5`	Abnormal results of liver function studies	Abnormal labs may accompany pancreatic disease and lead to expanded diagnostic evaluation.
`Z03.89`	Encounter for observation for other suspected diseases and conditions ruled out	Used when evaluation (including `0599U`) is performed to rule out pancreatic malignancy in symptomatic patients.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`80053`	Comprehensive metabolic panel	Routine blood chemistry panel often ordered concurrently to assess organ function prior to further diagnostic procedures.
`81275`	BRAF gene analysis (interpretive example of molecular testing)	Represents molecular diagnostic testing workflows; molecular or tumor marker tests may be ordered in parallel depending on clinical need (note: this is an example of molecular testing in oncology workflows).
`88305`	Level III surgical pathology, gross and microscopic examination	Performed when tissue biopsy is obtained after positive serum results; provides definitive histologic diagnosis.
`74470`	Computed tomography, abdomen and pelvis; with contrast material	Cross-sectional imaging commonly used after a positive `0599U` result to localize lesions and stage disease.
`43238`	Endoscopic ultrasound, with FNA/biopsy of pancreas	Diagnostic procedure frequently performed to obtain tissue after suspicious imaging or biomarker results.

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