Summary & Overview
CPT 0410U: Avantect Pancreatic Cancer Test, 5hmC Profiling and WGS
Headline: New PLA CPT code 0410U designates the Avantect™ Pancreatic Cancer Test, a blood‑based assay using 5‑hydroxymethylcytosine (5hmC) profiling and whole‑genome sequencing to evaluate patients at high risk for pancreatic cancer.
Lead: CPT code 0410U identifies a single‑manufacturer laboratory test—Avantect™ from ClearNote™ Health—that analyzes 5hmC biomarkers and performs whole‑genome sequencing on a blood specimen to aid earlier detection of pancreatic cancer in high‑risk patients. As a Proprietary Laboratory Analyses (PLA) code, 0410U applies only to this specific test.
Why it matters: Early detection of pancreatic cancer remains a national clinical priority due to typically late-stage presentation and poor prognosis. A PLA code such as 0410U provides a clear billing identifier for a novel, manufacturer‑specific diagnostic that may influence coverage policies, prior authorization workflows, and lab reporting.
Payers covered: Analysis highlights national payers including Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
What readers will learn: The publication outlines the clinical purpose of CPT code 0410U, the service context and typical sites of service, payer landscape and potential coverage considerations, and how this PLA code fits into laboratory billing practice. It also summarizes common billing modifiers associated with laboratory procedural reporting. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0410U is a Proprietary Laboratory Analyses (PLA) code assigned to the Avantect™ Pancreatic Cancer Test from ClearNote™ Health. The test profiles 5–hydroxymethylcytosine (5hmC) biomarkers and uses whole–genome sequencing on a patient blood specimen to evaluate individuals at high risk of developing pancreatic cancer. The assay is intended to help identify pancreatic cancer earlier than some common testing methods and to indicate potential follow–up diagnostic pathways.
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Service type: Diagnostic laboratory testing using biomarker profiling and whole–genome sequencing
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Typical site of service: Clinical laboratory or outpatient phlebotomy site
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with a family history of pancreatic cancer and new-onset, unexplained diabetes presents to a gastroenterologist after imaging and routine laboratory tests are inconclusive. The clinician identifies the patient as high risk for pancreatic neoplasm based on age, familial predisposition, and clinical features (weight loss, epigastric pain, or recent diabetes). After counseling about diagnostic options, the clinician orders the Avantect™ Pancreatic Cancer Test (Proprietary Laboratory Analyses code 0410U) to evaluate circulating 5–hydroxymethylcytosine (5hmC) patterns and whole-genome sequencing from a peripheral blood specimen.
The clinical workflow: the outpatient clinic or oncology infusion/lab collection site collects a blood specimen following the test manufacturer’s kit instructions and ships it to ClearNote™ Health. The laboratory performs the proprietary 5hmC biomarker profiling and sequencing, generates a report indicating risk stratification for pancreatic cancer, and returns results to the ordering provider. Based on results, the provider determines next steps such as cross-sectional imaging (CT or MRI), endoscopic ultrasound with possible biopsy, referral to surgical oncology, or routine surveillance.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default; no modifier | Use when no special circumstances apply to the billed service |
22 | Increased procedural services | Use when documentation supports substantially greater work than typical for the lab's procedural component or reporting complexity beyond standard PLA processing |
26 | Professional component | Use if reporting only the professional interpretation component separately from the technical testing (rare for PLA) |
52 | Reduced services | Use when testing was partially reduced or incomplete but a reportable result was generated |
53 | Discontinued service | Use if specimen collection or testing was started but discontinued for clinical reasons prior to completion |
62 | Two surgeons | Use if two qualified labs/providers share significant responsibility for analytic or interpretive components (uncommon for PLA) |
78 | Unplanned return to the operating/procedure room | Generally not applicable; use only if an associated invasive procedure required immediate return due to test-driven intraoperative decision-making |
80 | Assistant surgeon | Generally not applicable; use only if an assistant’s services are separately reportable in an associated procedural encounter |
QK | Medical record documentation electronically signed by non‑physician | Use when a qualified non-physician practitioner signs interpretation documentation per payer rules |
QX | Service performed by a qualified non-physician under physician's billing | Use when a qualified non-physician performs the service under a physician’s supervision per payer policy |
QY | Non-physician practitioner service billing under own NPI | Use when the non-physician practitioner bills for the service under their own identifier per payer rules |
TC | Technical component | Use when billing only the technical component of the test (laboratory processing/sequencing) separate from interpretation |
SH | Diagnostic laboratory or pathology services performed in a hospital by a non‑physician | Use in specific institutional billing arrangements where permitted |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 208000000X | Pathology | Clinical pathology or molecular pathology labs that perform high-complexity testing and interpretive reporting |
| 207RH0000X | Gastroenterology | Ordering and interpreting clinicians who manage patients at high risk for pancreatic cancer |
| 207Q00000X | Hematology/Oncology | Oncology specialists who may order molecular screening tests as part of cancer risk evaluation |
| 363L00000X | Clinical Laboratory | Laboratory director or high-complexity testing laboratory personnel responsible for PLA testing |
| 2084P0800X | Molecular Genetic Pathology | Specialists in molecular diagnostics overseeing sequencing and biomarker profiling |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
R73.09 | Other abnormal glucose | New-onset or worsening diabetes can be an early clinical feature prompting pancreatic cancer evaluation |
R63.4 | Abnormal weight loss | Unintentional weight loss is a concerning symptom associated with pancreatic malignancy and may prompt testing |
R10.11 | Right upper quadrant pain | Abdominal or epigastric pain can be a presenting symptom leading to further pancreatic evaluation |
K86.8 | Other specified diseases of pancreas | Includes non-specific pancreatic disorders that may warrant molecular assessment in context of cancer risk |
Z80.42 | Family history of malignant neoplasm of pancreas | Documented family history increases pre-test probability and clinical justification for the Avantect™ test |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0410U | Avantect™ Pancreatic Cancer Test — 5‑hmC biomarker profiling and whole‑genome sequencing (Pla) | Primary proprietary laboratory analysis code for the test performed by ClearNote™ Health |
88172 | Morphometric analysis (e.g., cytology automated analysis) | May be performed on cytology specimens if follow-up endoscopic ultrasound with FNA is done after a positive blood-based test |
88305 | Surgical pathology, gross and microscopic examination, intermediate complexity | Used if tissue biopsy from pancreatic lesion is obtained for histopathologic diagnosis following a positive screening test |
43238 | Endoscopic ultrasound, with or without fine-needle aspiration; with FNA and/or aspiration of a cystic or solid lesion | Common next-step diagnostic procedure to obtain tissue after a concerning PLA result |
74177 | Computed tomography, abdomen and pelvis with contrast, diagnostic | Cross-sectional imaging often performed before or after the PLA test to localize lesions suggested by risk stratification |
88361 | Immunohistochemistry (per single antibody stain) | May be used on biopsy specimens to characterize tumor markers after tissue diagnosis |