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.
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 | When to Use |
|---|---|---|
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). |
| 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. |