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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

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

Customize your policy alerts

Sign up for cpt 0599U policy alerts

Get alerted when payer policies referencing 0599U are released or updated.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Billing Code Overview

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.

CPT 0001U: PreciseType HEA Multiplex Erythrocyte Antigen Assay

CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

CPT 0002U: Urine Metabolomic Polyp Risk Assay (PolypDX™)

CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

CPT 0003U: Overa™ (OVA1 Next Generation) Ovarian Cancer Risk Assay

CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

CPT 0005U: ExosomeDx Prostate (IntelliScore) Urine Gene Expression Risk Test

CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

CPT 0007U: ToxProtect Urine Drug Screen with DNA Authentication

CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

CPT 0008U: H. pylori Antibiotic Resistance Panel, Gene Sequence Analysis

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

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

CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

CPT 0011U: Cordant CORE™ Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcript Testing

Showing 1–10 of 536

Frequently Asked Questions

References

1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.

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Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

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Clinical & Coding Specifications

Clinical Context

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.

CPT 0001U: PreciseType HEA Multiplex Erythrocyte Antigen Assay

CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

CPT 0002U: Urine Metabolomic Polyp Risk Assay (PolypDX™)

CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

CPT 0003U: Overa™ (OVA1 Next Generation) Ovarian Cancer Risk Assay

CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

CPT 0005U: ExosomeDx Prostate (IntelliScore) Urine Gene Expression Risk Test

CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

CPT 0007U: ToxProtect Urine Drug Screen with DNA Authentication

CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

CPT 0008U: H. pylori Antibiotic Resistance Panel, Gene Sequence Analysis

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

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

CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

CPT 0011U: Cordant CORE™ Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcript Testing

Showing 1–10 of 536

Frequently Asked Questions

References

1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.

Published by

Trek Health powers OpenPayer with a leading commercial payer intelligence platform, seamlessly converting fragmented payer data into actionable insights for provider organizations.

OpenPayer

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

Sign up for cpt 0599U policy alerts

Billing Code Overview

OpenPayer

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

Sign up for cpt 0599U policy alerts

Billing Code Overview

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Related Diagnoses

Related CPT Codes

Related Codes

References

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Related Diagnoses

Related CPT Codes

Related Codes

References

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

Sign up for cpt 0599U policy alerts

Billing Code Overview

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

Sign up for cpt 0599U policy alerts

Billing Code Overview

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Related Diagnoses

Related CPT Codes

Related Codes

What exactly does CPT 0599U represent?

Who orders 0599U and where is the test typically performed?

What other CPT codes or procedures are commonly associated with the PancreaSure™ testing workflow?

Which billing modifiers are applicable to 0599U and when are they used?

Is 0599U covered by major payers and where can I find reimbursement details?

References

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Related Diagnoses

Related CPT Codes

Related Codes

What exactly does CPT 0599U represent?

Who orders 0599U and where is the test typically performed?

What other CPT codes or procedures are commonly associated with the PancreaSure™ testing workflow?

Which billing modifiers are applicable to 0599U and when are they used?

Is 0599U covered by major payers and where can I find reimbursement details?

References