CPT 0342U IMMray PanCan–d Reimbursement | OpenPayer

Summary & Overview

CPT 0342U: IMMray PanCan–d Serum Biomarker Assay for Pancreatic Cancer

CPT code 0342U designates a Proprietary Laboratory Analyses (PLA) test for IMMray® PanCan–d (Immunovia Inc.), a serum-based assay that measures nine biomarkers with two immunoassays and uses an algorithm plus patient data to classify results as positive, negative, or borderline for pancreatic cancer. As a PLA code, 0342U applies only to this specific manufacturer’s test and signals a single-source diagnostic offering with potential implications for access, coverage, and lab practice.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication summarizes payer coverage patterns, reimbursement benchmarks, clinical context for pancreatic cancer biomarker testing, and relevant policy updates that affect how proprietary assays are paid and administered nationally.

Readers will learn the clinical purpose of the assay, typical sites where the service is performed, common billing modifiers, and the implications of PLA designation for coding and claims processing. The report also outlines national payer approaches to novel proprietary tests, summarizes expected documentation and reporting practices, and highlights factors that influence coverage decisions for algorithm-based biomarker assays. Data not available in the input is noted where applicable.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0342UCPTProprietary Laboratory AnalysesPancreatic cancerBiomarker assayLaboratory testAlgorithmic interpretationIMMray PanCan-dClinical diagnostics

Billing Code Overview

CPT code 0342U is a Proprietary Laboratory Analyses (PLA) code for the IMMray® PanCan–d test from Immunovia Inc. The code describes a laboratory procedure performed on a serum specimen that measures nine biomarkers using two different immunoassays, then applies an algorithm combining the assay results and other patient data to report a positive, negative, or borderline result for pancreatic cancer.

Service type: Laboratory-based proprietary biomarker assay with algorithmic interpretation

Typical site of service: Clinical laboratory or reference laboratory

Clinical & Coding Specifications

Clinical Context

A 62-year-old patient with new-onset, unexplained weight loss, vague epigastric discomfort, and a recent episode of painless jaundice is referred by their primary care physician to a specialty clinic for evaluation of possible pancreatic neoplasm. The clinician orders the proprietary IMMray® PanCan–d test (0342U) to assess serum biomarkers that, together with an algorithm incorporating patient age and sex, yield a reported result of positive, negative, or borderline for pancreatic cancer. A serum specimen is collected in an outpatient phlebotomy setting (ambulatory clinic or reference laboratory) and sent to the performing laboratory (Immunovia Inc.).

The testing workflow includes: initial patient encounter and indication documentation; blood draw and specimen labeling; shipment to the performing laboratory under required conditions; laboratory immunoassays for the nine biomarkers listed in the PLA descriptor; algorithmic analysis combining assay results with clinical variables; and a laboratory report communicated to the ordering clinician. Results are used by gastroenterology, oncology, or surgery teams to inform further diagnostic workup such as imaging (contrast-enhanced CT or MRI), endoscopic ultrasound with biopsy, or referral to a multidisciplinary tumor board. Typical sites of service are outpatient clinics, ambulatory phlebotomy centers, and reference laboratory environments. The service type is a proprietary laboratory analytic (PLA) molecular/immunoassay diagnostic test performed by a single manufacturer/laboratory for clinical decision support in evaluating suspected pancreatic cancer.

Coding Specifications

Modifier	Description

CPT 0079U: ToxLok™ Urine Specimen Identity Verification

CPT-0293U-MINDX-BLOOD-TEST-SUICIDALITY-RNA-NGS-RISK-SCORE

CPT 0293U: MindX Blood Test – Suicidality, RNA NGS Gene Expression Risk Score

CPT-0519U-SYNCVIEW-PAINPLUS-LC-MSMS-PLASMA-DRUG-PANEL

CPT 0519U: SyncView® PainPlus LC–MS/MS Plasma Drug Panel

CPT-0501U-QUANTIDNA-COLORECTAL-CANCER-TRIAGE-TEST

CPT 0501U: QuantiDNA™ Colorectal Cancer Triage Test

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

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

CPT-0270U-VERSITI-COAGULATION-DISORDER-PANEL-NGS-20-GENES

CPT 0270U: Versiti Coagulation Disorder Panel, NGS 20-Gene Test

CPT-0390U-PEPREDICTDX-PREECLAMPSIA-RISK-SERUM-IMMUNOASSAY

CPT 0390U: Preeclampsia Risk Score from Serum Immunoassay (PEPredictDx)

CPT-0093U-COMPLYRX-LC-MSMS-URINE-MULTI-DRUG-SCREEN

CPT 0093U: ComplyRX™ LC–MS/MS Urine Multi-Drug Screen

CPT-0314U-DECISIONDX-DIFFDX-MELANOMA-RT-PCR-FFPE

CPT 0314U: DecisionDx DiffDx Melanoma RT–PCR Gene Expression Test

CPT-0332U-EPISWITCH-CIRT-CHECKPOINT-INHIBITOR-RESPONSE-TEST

CPT 0332U: EpiSwitch CiRT Checkpoint‑inhibitor Response Test

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Taxonomy Code	Specialty	Notes
207Q00000X	Medical Oncology	Oncologists who interpret results for cancer diagnostic pathways and treatment planning.
207K00000X	Gastroenterology	Gastroenterologists ordering testing during workup for suspected pancreatic disease.
208000000X	Pathology & Laboratory Medicine	Laboratory directors and pathologists overseeing test validation and reporting.
363L00000X	Phlebotomy/Laboratory Technician	Providers performing specimen collection and handling.
2086S0102X	Diagnostic Radiology	Radiologists integrating results with imaging for staging and follow-up.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C25.9`	Malignant neoplasm of pancreas, unspecified	Primary diagnostic consideration for which this assay is intended to aid detection.
`R19.7`	Unspecified abnormal finding of pancreas	Non-specific pancreatic abnormality where biomarker testing may contribute to diagnostic clarification.
`R17`	Unspecified jaundice	Clinical presentation prompting evaluation for biliary or pancreatic malignancy where the biomarker panel may be ordered.
`R63.4`	Abnormal weight loss	Systemic symptom that can trigger cancer workup including this biomarker assay.
`K86.1`	Other chronic pancreatitis	Differential diagnosis to distinguish inflammatory from neoplastic pancreatic disease; biomarker contextually relevant.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0342U`	IMMray® PanCan–d (Immunovia Inc.), serum immunoassays for nine biomarkers with algorithmic analysis to report positive/negative/borderline for pancreatic cancer	Primary proprietary laboratory analysis code describing the assay and reporting algorithm performed by the manufacturer/laboratory.
`80047`	Basic metabolic panel	Often ordered concurrently to assess baseline metabolic status prior to further diagnostic testing or treatment.
`81479`	Unlisted molecular pathology procedure	May be used for reporting additional, non-standard molecular analyses not covered by a PLA code when needed in the diagnostic workup.
`88305`	Level IV surgical pathology, gross and microscopic examination	May be billed later if tissue diagnosis is obtained via biopsy for histopathologic confirmation.
`43238`	Endoscopic ultrasound with fine needle aspiration (FNA) of pancreatic lesion	Common subsequent procedural diagnostic step when imaging plus biomarker testing raise suspicion for pancreatic cancer.
`74177`	CT abdomen and pelvis with contrast, diagnostic	Cross-sectional imaging commonly performed before or after biomarker testing to identify pancreatic masses or staging.

`26`	Professional component	Use when billing only the professional component of the test if the performing laboratory and reporting clinician separate technical and professional billing.
`TC`	Technical component	Use when billing only the technical component (laboratory processing) of the test.
`QX`	Ordering physician attests to direct supervision by a non-physician practitioner	Use when a qualified non-physician practitioner performs or directly supervises specimen collection under the ordering physician’s supervision as permitted.
`QK`	Clinical laboratory improvement amendments (CLIA) waived test direct supervision by a non-physician practitioner	Use per payer policy when applicable to non-physician practitioner supervision scenarios.
`QY`	Ordering practitioner is a physician; services furnished under general supervision of physician	Use when specimen collection or ancillary services are provided under general supervision of the ordering physician.
`52`	Reduced services	Use when the laboratory or ordering clinician documents that testing was partially performed or limited for documented clinical reasons.
`53`	Discontinued procedure	Use if specimen collection or testing was started but discontinued for patient safety or other documented reasons.
`22`	Increased procedural services	Use when extraordinary work beyond the typical test performance and reporting is documented (rare for standardized lab assays).
`90`	Reference (outside) laboratory	Use when the performing laboratory bills as a reference lab; (note: not in provided list but commonly paired—Data not available in input).
`59`	Distinct procedural service	Use when this test is reported on the same date as an unrelated diagnostic test and payer requires a distinct service modifier (note: not in provided list—Data not available in input).

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