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.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0591UCPTProprietary Laboratory AnalysesMiCheck ProstatePSA testingHE4prostate cancer risklaboratory analytics

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.
`22`	Increased procedural services	Use when work required to obtain and process the specimen or additional documentation significantly increases complexity beyond typical expectations.
`52`	Reduced services	Use when the test was partially reduced or not completed as described in the full protocol.
`53`	Discontinued procedure	Use when specimen collection or testing was started but discontinued for patient safety reasons.
`59`	Distinct procedural service	Use when this laboratory analysis is distinct from other procedures billed on the same date (note: exercise caution with PLA rules and laboratory bundling).
`26`	Professional component	Use if a separate professional interpretation component is billed by a physician or qualified professional (rare for PLA codes but included for completeness).
`TC`	Technical component	Use if the billing separates technical activity (lab processing) from professional component; typically used by the performing laboratory.
`90`	Reference (outside) laboratory	Use when the performing laboratory is an outside independent reference lab under arrangement.
`QW`	CLIA-waived test	Not typically applicable to PLA but used when a waived test is performed at point-of-care; include only if test status changes.
`XE`	Separate encounter	Use when this service is distinct by encounter from other services on the same date.

Taxonomy Code	Specialty	Notes
`208800000X`	Urology	Urologists commonly order and interpret prostate risk assays and manage subsequent biopsy decisions.
`207Q00000X`	Pathology	Anatomic and clinical pathologists direct laboratory testing programs and may oversee assay performance in reference labs.
`207L00000X`	Clinical Laboratory	Clinical laboratory directors and specialists oversee specimen processing and reporting for proprietary assays.
`363A00000X`	Radiology - Diagnostic	Radiologists involved in prostate imaging (mpMRI) collaborate in overall diagnostic pathways alongside biomarker results.
`261QM0800X`	Family Medicine	Primary care physicians often initiate PSA testing and refer patients for specialized biomarker testing and urology consultation.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`R97.2`	Elevated prostate specific antigen [PSA]	Direct indication for ordering prostate biomarker assays to stratify cancer risk.
`N40`	Benign prostatic hyperplasia	BPH can elevate PSA and is part of the differential when interpreting assay results.
`N45.1`	Orchitis and epididymitis	Inflammatory conditions that can alter PSA levels and affect test interpretation.
`N41.9`	Prostatitis, unspecified	Active or recent prostatitis may raise PSA and influence timing and interpretation of the MiCheck® Prostate assay.
`C61`	Malignant neoplasm of prostate	Used when prostate cancer is suspected or confirmed; the assay provides risk estimation for clinically significant cancer.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0591U`	MiCheck® Prostate – quantifies total PSA, free PSA, and HE4 and reports an algorithmic percentage risk for clinically significant prostate cancer	Primary PLA code for the proprietary assay; report when MiCheck® Prostate is performed.
`84153`	Prostate specific antigen (PSA); total	Commonly ordered before or alongside advanced assays to document baseline total PSA values and for longitudinal comparison.
`84152`	Prostate specific antigen (PSA); free	Free PSA measurement may be ordered in conjunction with total PSA; components are integrated into many risk algorithms.
`83520`	Assay of tumor marker, immunoassay technique; quantitative, each analyte	General laboratory analyte code sometimes used in laboratory billing workflows; not used to replace PLA reporting for proprietary tests.
`88305`	Level IV surgical pathology, gross and microscopic examination	If prostate biopsy is performed following risk stratification, this is a common pathology code for biopsy specimen interpretation.