Summary & Overview

CPT 0047U: Genomic Prostate Score (GPS) Test

CPT code 0047U identifies the Genomic Prostate Score® (GPS) Test from MDxHealth Inc., a proprietary molecular diagnostic assay that uses RT–PCR to profile mRNA expression of 17 genes and combines results with patient data in an algorithm to estimate mortality and postprostatectomy recurrence risk. As a PLA code, 0047U applies to a single manufacturer's unique test, making it significant for coding, laboratory billing, and payer coverage policies nationally. Commercial and public payers have distinct approaches to molecular diagnostic PLA codes, so clarity on coding and clinical utility affects access and reimbursement for genomic-guided prostate cancer care.

Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise synthesis of what 0047U represents clinically, typical sites of service, and the commercial and Medicare payer landscape as covered in this analysis. The publication summarizes coverage themes, common billing modifiers and operational considerations, and clinical context for use of the GPS test in prostate cancer risk stratification. It also highlights where input data was not provided: associated taxonomies, ICD-10 diagnoses, related codes, and specific payer policy details are noted as unavailable in the input.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0047UCPTProprietary Laboratory AnalysesGenomic Prostate Scoremolecular diagnosticsRT-PCRprostate cancerlaboratory billingPLA code

Billing Code Overview

CPT code 0047U is a Proprietary Laboratory Analyses (PLA) code for the Genomic Prostate Score® (GPS) Test from MDxHealth Inc. The test uses real–time polymerase chain reaction (RT–PCR) to measure mRNA expression for 17 genes and combines those results with patient data in a proprietary algorithm to generate a genomic score that helps predict mortality risk and risk of postprostatectomy recurrence.

Service Type: Laboratory — molecular diagnostic, gene expression profiling

Typical Site of Service: Clinical laboratory or reference laboratory (specimen collected in outpatient or ambulatory settings and sent to the performing laboratory)

Clinical & Coding Specifications

Clinical Context

A typical patient is a man diagnosed with clinically localized prostate cancer or an elevated prostate‑specific antigen (PSA) with biopsy-proven prostate adenocarcinoma who and his treating urologist or oncologist is evaluating individualized postoperative or treatment decision-making. The Genomic Prostate Score® (GPS) Test 0047U is ordered after diagnostic prostate needle biopsy or at time of prostatectomy tissue availability to assess mRNA expression of 17 genes by real‑time PCR and integrate results with clinical features. The workflow: the clinician obtains informed consent, submits formalin‑fixed paraffin‑embedded (FFPE) biopsy or prostatectomy tissue and relevant clinical data to the testing laboratory; the lab performs RNA extraction, RT‑PCR expression profiling and applies the proprietary algorithm to generate a GPS result; the laboratory reports the score to the ordering provider, who uses the score alongside PSA, Gleason grade group, tumor stage and patient preferences to inform prognosis and decisions about active surveillance, definitive therapy intensification, or adjuvant treatment consideration. Typical site of service is an independent or hospital-based clinical molecular pathology laboratory performing the high-complexity molecular test; specimen collection occurs in an ambulatory surgery center, outpatient clinic, or hospital operating room for biopsy or prostatectomy, with the laboratory component reported using 0047U.

Coding Specifications

Modifier	Description	When to Use

26

Taxonomy Code	Specialty	Notes
`2080P0208X`	Urology	Urologists commonly order GPS testing after biopsy or prostatectomy to guide management.
`207L00000X`	Pathology	Anatomic/clinical pathologists provide specimen evaluation, triage, and may coordinate molecular testing.
`2084P0800X`	Medical Oncology	Medical oncologists may use GPS results when considering adjuvant systemic therapy or surveillance strategies.
`363A00000X`	Clinical Laboratory	Clinical laboratory personnel and molecular pathologists perform and report the `0047U` assay.
`207K00000X`	Radiation Oncology	Radiation oncologists may use GPS results to inform decisions about adjuvant radiotherapy.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C61`	Malignant neoplasm of prostate	Primary indication for GPS testing to assess tumor biology and inform prognosis and treatment decisions.
`N40.0`	Benign prostatic hyperplasia with lower urinary tract symptoms	May appear in clinical history but not a direct indication for GPS testing; relevant when differentiating causes of PSA elevation.
`R97.20`	Elevated prostate specific antigen [PSA] without diagnosis of neoplasm	Common clinical scenario prompting biopsy and potential subsequent GPS testing if cancer is diagnosed.
`Z85.46`	Personal history of malignant neoplasm of prostate	Relevant in surveillance or consideration of recurrent disease and may prompt molecular assessment if new lesions arise.
`D07.5`	Carcinoma in situ of prostate	Rare precursor diagnosis; molecular profiling may be considered in select diagnostic or research contexts.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`88305`	Level IV surgical pathology, gross and microscopic examination	Often performed on prostate biopsy or radical prostatectomy specimens before or concurrently with molecular testing to establish histologic diagnosis and provide tumor content assessment required for GPS testing.
`88172`	Cytopathology, cell block specimen, preparation	May be used if specimen processing requires cell block preparation prior to molecular analysis (occasionally applicable for limited tissue scenarios).
`81479`	Unlisted molecular pathology procedure	Historically used for novel molecular tests prior to PLA assignment; replaced by PLA `0047U` for this specific GPS test but may appear in legacy workflows.
`88342`	Immunohistochemistry for single or multiple antigens (per slide)	Used in tumor characterization and to help determine eligibility or adequacy of tissue for molecular profiling.
`84999`	Unlisted chemistry procedure	Rare; may be used in ancillary laboratory billing for nonstandard sample preparation or ancillary testing related to sample quality control.
`99000`	Handling and/or conveyance of specimen for transfer to another lab	Used when specimens are transported to an external reference laboratory performing `0047U` testing; documents specimen handling logistics and may be required by some billing systems.