Summary & Overview
CPT 0228U: PanGIA Prostate Urine Molecular Diagnostic
CPT code 0228U designates PanGIA Prostate, a proprietary urine-based molecular diagnostic developed by Genetics Institute of America (Entopsis LLC). The test captures and algorithmically analyzes biomolecules in urine to report whether findings are consistent with prostate cancer, and is billed as a PLA code tied to a single manufacturer’s assay. Nationally, PLA codes like 0228U matter because they identify uniquely branded laboratory tests, inform coverage determinations, and affect pricing and utilization tracking for emerging diagnostics.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will learn the clinical context for use of the assay, typical sites of service, and the scope of billing considerations tied to a PLA-coded test. The publication provides benchmarks and policy context relevant to proprietary laboratory analyses, explains common billing modifiers and their typical application, and summarizes payer coverage patterns where available. It also outlines potential implications for laboratory services, outpatient specimen collection workflows, and coding accuracy for tests that utilize specialized analytic algorithms.
Data not available in the input will be noted explicitly where relevant.
Billing Code Overview
CPT code 0228U is a Proprietary Laboratory Analyses (PLA) code for PanGIA Prostate, produced by Genetics Institute of America from Entopsis LLC. The test uses capture and algorithmic analysis of biomolecules in a patient urine specimen to report findings that are consistent or not consistent with men who have prostate cancer.
Service type: Laboratory / Proprietary molecular diagnostic test
Typical site of service: Clinical laboratory or outpatient specimen collection site (urine specimen collection)
Data not available in the input.
Clinical & Coding Specifications
Clinical Context
A 64-year-old male with elevated prostate-specific antigen (PSA) and/or abnormal digital rectal exam is evaluated for risk of prostate cancer. The treating urologist orders the proprietary urine-based molecular assay 0228U (PanGIA Prostate, Genetics Institute of America from Entopsis LLC) to help stratify the likelihood that the patient has clinically significant prostate cancer. Urine is collected after a standardized prostate massage or attentive collection protocol in an outpatient urology clinic or specimen collection center. The specimen is shipped to the performing laboratory under chain-of-custody and temperature-controlled conditions. The laboratory performs biomolecule capture and algorithmic analysis and issues a report indicating results consistent or not consistent with prostate cancer. Results are integrated into the clinical decision-making workflow for determining the need for prostate biopsy, imaging (e.g., multiparametric MRI), or active surveillance planning. Typical sites of service include outpatient urology clinics, ambulatory surgical centers for specimen collection, and commercial reference laboratories that perform the PLA test.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when billing only the professional interpretation portion if applicable and the lab separates components. |
52 | Reduced services | Use when the test was partially completed or a reduced service was furnished. |
53 | Discontinued procedure | Use when specimen collection or testing was started but discontinued for clinical reasons. |
59 | Data not available in the input. | Data not available in the input. |
62 | Data not available in the input. | Data not available in the input. |
78 | Data not available in the input. | Data not available in the input. |
80 | Data not available in the input. | Data not available in the input. |
AS | Data not available in the input. | Data not available in the input. |
TC | Technical component | Use when billing only the technical processing of the laboratory test by the performing lab. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207VG0300X | Urology | Urologists order and interpret results to guide prostate cancer workup. |
| 207Q00000X | Pathology | Pathologists may consult on molecular test interpretation and reporting. |
| 374JP0800X | Clinical Laboratory | Clinical laboratory directors and molecular diagnostics specialists oversee testing and quality control. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
N40.0 | Benign prostatic hyperplasia with lower urinary tract symptoms | Common alternative diagnosis in men evaluated for elevated PSA; test helps differentiate BPH from cancer risk. |
R97.20 | Elevated prostate specific antigen [PSA], unspecified | Direct indication for molecular urine testing to stratify prostate cancer risk. |
R97.21 | Elevated prostate specific antigen [PSA], first noted during clinical encounter | Supports ordering 0228U to clarify cancer risk prior to invasive procedures. |
D40.0 | Neoplasm of uncertain behavior of prostate | Used when lesion is suspected but malignancy not confirmed; test informs further diagnostic steps. |
C61 | Malignant neoplasm of prostate | Applied when used as part of evaluation for suspected prostate cancer or risk stratification before biopsy. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0232U | Data not available in the input. | Data not available in the input. |
88199 | Data not available in the input. | Data not available in the input. |
88360 | Data not available in the input. | Data not available in the input. |
84999 | Data not available in the input. | Data not available in the input. |
0000U | Data not available in the input. | Data not available in the input. |