Summary & Overview
CPT 0591U: MiCheck Prostate PSA and HE4 Risk Score
CPT code 0591U designates the MiCheck® Prostate proprietary laboratory assay from Minomic® Inc., which measures total PSA, free PSA, and HE4 in plasma or serum and applies an algorithm incorporating digital rectal exam findings to produce a percentage risk score for clinically significant prostate cancer. As a PLA code, 0591U applies only to a single manufacturer’s test and signals a targeted, proprietary diagnostic offering with implications for clinical decision-making and payer coverage evaluation nationwide. Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
Readers will learn what 0591U represents clinically, the service setting and laboratory workflow contexts where the test is performed, and the factors that typically shape payer coverage and coding implementation for PLA tests. The publication covers national benchmarks and common payer approaches to proprietary molecular diagnostics, summarizes clinical context for prostate cancer risk stratification, and highlights where Data not available in the input prevents detailing associated taxonomies, ICD-10 diagnoses, or related procedure codes. This summary provides a concise reference for billing staff, laboratory managers, and policy analysts evaluating adoption and reimbursement implications of the MiCheck® Prostate assay.
Billing Code Overview
CPT code 0591U is a Proprietary Laboratory Analyses (PLA) code reported only for the MiCheck® Prostate assay from Minomic® Inc. The test quantifies total PSA, free PSA, and HE4 in plasma or serum, and an integrated algorithm combines those protein levels with digital rectal examination findings to generate a percentage risk score for clinically significant prostate cancer.
Service type: Proprietary laboratory test with algorithmic risk scoring
Typical site of service: Clinical laboratory or hospital laboratory with specimen collection performed in outpatient clinic or hospital outpatient setting
Clinical & Coding Specifications
Clinical Context
A 62-year-old man with elevated prostate‑specific antigen (PSA) on routine screening and a suspicious digital rectal examination (DRE) presents for risk stratification. The urologist orders the MiCheck® Prostate assay (0591U), a proprietary laboratory test performed on a serum or plasma sample collected in the outpatient clinic or ambulatory surgical center. The sample is sent to the manufacturer’s laboratory; results return as a percentage risk score for clinically significant prostate cancer based on total PSA, free PSA, HE4 levels, and the recorded DRE finding. The clinician integrates the numeric risk score with clinical history, prior imaging (for example, multiparametric MRI), and patient preferences to decide whether to proceed with prostate biopsy, active surveillance, or continued observation. Typical workflow steps: order test in the electronic medical record, obtain venous blood specimen during the office visit or pre-procedure visit, document DRE result in the chart, ship specimen per manufacturer instructions, receive algorithmic risk percentage in the laboratory report, and document the result and management decision in the patient record.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default/No modifier | Use when no other modifier applies; report the service as performed without special circumstances. |