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.
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 |
|---|---|---|
00 | Procedure performed as reported (no modifier) | Use when the PLA test is billed without any special circumstances affecting the service. |
22 | Increased procedural services | Use when reporting significant additional work or complexity in specimen handling or documentation beyond typical processing (rare for PLA tests). |
52 | Reduced services | Use if only part of the billed test was completed and a reduced service is reported. |
53 | Discontinued procedure | Use if specimen collection or processing was started but discontinued for documented clinical reasons. |
26 | Professional component | Use if billing for the professional interpretation component separately (uncommon for PLAs, include only if the performing lab separates components). |
TC | Technical component | Use when billing only the technical component (laboratory processing) and the professional component is billed separately by another entity. |
90 | Reference (outside) laboratory | Use when the submitting laboratory refers the specimen to an outside laboratory for performance and reports the result. |
91 | Repeat clinical diagnostic laboratory test | Use when the same test is repeated on the same day for verification or quality control. |
QW | CLIA waived test | Use only if the specific PLA meets CLIA-waived status (generally not applicable to complex PLAs like 0599U). |
59 | Distinct procedural service | Use when another unrelated service is performed on the same day and a distinct service needs delineation (use cautiously with laboratory tests per payer rules). |
| 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. |