Summary & Overview
CPT 0108U: TissueCypher Barrett’s Esophagus Risk Assay
CPT code 0108U designates the TissueCypher® Barrett’s Esophagus Assay, a Proprietary Laboratory Analyses (PLA) test from Cernostics Lab that assists pathologists in interpreting esophageal biopsies and predicting risk of progression to high‑grade dysplasia or esophageal cancer. As a PLA code, 0108U maps to a single manufacturer‑specific test and is used in claims to identify this proprietary prognostic assay. Nationally, such PLA codes are important for tracking uptake of advanced diagnostics and for payer coverage and coding clarity in precision pathology.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of coverage and billing context for 0108U, benchmark considerations for laboratory pathology services, and the clinical context for use in patients with Barrett’s esophagus. The publication also summarizes common modifiers and notes when data are unavailable.
This summary equips policy, coding, and revenue teams with the clinical purpose of the assay, the billing identifier to use on claims, and the national payer landscape to consider when assessing coverage and reimbursement for this laboratory prognostic test.
Billing Code Overview
CPT code 0108U is a Proprietary Laboratory Analyses (PLA) code for the TissueCypher® Barrett’s Esophagus Assay produced by Cernostics Lab. The assay is used to help pathologists interpret esophageal biopsy specimens and to predict risk for high‑grade dysplasia or esophageal cancer in patients with Barrett’s esophagus.
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Service type: Laboratory pathology assay providing prognostic risk stratification for Barrett’s esophagus.
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Typical site of service: Clinical laboratory processing esophageal biopsy specimens; test ordered by pathologists or treating clinicians and performed offsite at the manufacturer's laboratory.
Clinical & Coding Specifications
Clinical Context
A 62-year-old male with a history of chronic gastroesophageal reflux disease and known Barrett’s esophagus undergoes routine surveillance upper endoscopy with biopsies. The endoscopist submits formalin-fixed esophageal biopsy specimens to the pathology laboratory. The pathologist performs routine histopathology and requests the TissueCypher® Barrett’s Esophagus Assay to provide objective risk stratification for progression to high-grade dysplasia or esophageal adenocarcinoma. The laboratory processes the proprietary TissueCypher assay (reportable under CPT 0108U), integrates the assay result with the histologic interpretation, and issues a combined pathology report to the treating gastroenterologist. Typical sites of service include outpatient hospitals, ambulatory surgery centers, and commercial clinical reference laboratories. The typical clinical workflow: endoscopy with biopsy → histology processing and review → reflex or requested molecular assay (0108U) by the reference lab → molecular result returned to pathologist and ordering clinician to inform surveillance interval or management discussions.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Standard technical and professional components | Rarely used; default when no component split applies |
11 | Professional component | When only the professional interpretation component of the test is billed separately
26 | Professional component | When reporting only the physician's interpretation of the laboratory assay
TC | Technical component | When only the laboratory processing (technical) component is billed
52 | Reduced services | When the assay is performed but with reduced services compared to the full test
53 | Discontinued procedure | If the specimen or testing was started but discontinued for documented clinical reasons
59 | Data not available in the input. | Data not available in the input.
QK | Clinical diagnostic laboratory fee schedule (CDLFS) modifier for CLIA-waived labs | Use when applicable to lab billing rules (commercial payer-specific)
QX | Ordering physician is CLIA-exempt performing lab personnel modifier | Use per payer rules when ordering/performing lab relationships apply
QY | Ordering provider certification modifier | Use per payer policies for lab-provider relationships
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RC0000X | Gastroenterology | Ordering clinicians who perform endoscopy and biopsy |
207L00000X | Anatomic Pathology | Pathologists who interpret biopsies and order the assay
261QM0800X | Clinical Laboratory | Laboratory professionals and reference lab billing for the technical component
2085R0201X | Surgical Pathology | Pathologists with surgical pathology focus who integrate assay results
207V00000X | General Internal Medicine | Primary care physicians who may order surveillance testing
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
K22.7 | Barrett esophagus | Primary indication for the TissueCypher assay to risk-stratify progression |
K21.9 | Gastro-esophageal reflux disease without esophagitis | Common underlying condition associated with Barrett’s esophagus and surveillance testing
R19.7 | Diarrhea, unspecified | Data not available in the input.
D37.9 | Neoplasm of uncertain or unknown behavior of digestive system | Data not available in the input.
C15.9 | Malignant neoplasm of esophagus, unspecified | Relevant for patients with known progression to cancer; used in differential when assay indicates high risk
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
43239 | Esophagogastroduodenoscopy, flexible, transoral; with biopsy, single or multiple | Endoscopic procedure that yields the biopsy specimen tested by the TissueCypher assay |
88305 | Level IV surgical pathology, gross and microscopic examination | Histopathologic evaluation of esophageal biopsy specimens that accompanies ordering of the molecular assay
88367 | Immunohistochemistry, per single antigen-antibody stain; initial single stain | Ancillary stain sometimes performed on biopsy tissue as part of diagnostic workup alongside molecular testing
0003U | Molecular pathology test (example PLA code) | Other proprietary laboratory analyses that may be ordered in conjunction with or instead of 0108U depending on clinical context
81002 | Urinalysis, by dip stick or tablet reagent for bilirubin, etc.; without microscopy | Data not available in the input.
0108U | TissueCypher® Barrett’s Esophagus Assay | The specific PLA code reported for the proprietary assay performed by Cernostics Lab to stratify risk of progression in Barrett’s esophagus