Summary & Overview
CPT 0339U: SelectMDx Urine Gene Expression Test for Prostate Cancer
CPT code 0339U identifies SelectMDx® for Prostate Cancer, a proprietary urine-based molecular diagnostic that measures expression of the genes HOXC6 and DLX1 and produces a probability score for high–grade prostate cancer. As a PLA code tied to a single manufacturer and test, 0339U matters nationally for labs, clinicians, and payers because it standardizes billing for a specific genomic assay used in prostate cancer risk stratification and biopsy decision-making.
Key payers included in this analysis are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Coverage and payment policies for PLA codes can vary by payer and clinical context; PLA designation often leads to individualized medical policy review and separate pricing from cross-lab codes.
Readers will learn: a concise description of the clinical purpose and service type for 0339U; typical sites of service for specimen collection and testing; which major commercial payers and Medicare are referenced in the analysis; and where data gaps exist. The publication provides benchmarking and policy context relevant to adoption of proprietary molecular tests, summarizes payer landscape coverage considerations, and outlines clinical context for use in prostate cancer risk assessment. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0339U is a Proprietary Laboratory Analyses (PLA) code for SelectMDx® for Prostate Cancer from MDxHealth® Inc. The test uses a urine specimen to measure gene expression of HOXC6 and DLX1. An algorithmic analysis of the gene-expression results reports a probability score estimating the likelihood of high–grade prostate cancer.
Service Type: Molecular diagnostic/urine-based gene expression test
Typical Site of Service: Clinical laboratory or outpatient specimen collection site (urine)
Clinical & Coding Specifications
Clinical Context
A 58-year-old man with elevated prostate-specific antigen (PSA) and/or suspicious digital rectal exam is being evaluated to determine the likelihood of clinically significant (high-grade) prostate cancer prior to prostate biopsy. A urine specimen is collected after a prostate massage in the urology clinic and sent to the reference laboratory for the SelectMDx® assay. The laboratory measures expression of HOXC6 and DLX1 and returns an algorithmic probability score indicating the likelihood of high-grade (grade group ≥2) prostate cancer. The result is reviewed by the ordering urologist to inform shared decision-making about proceeding to transrectal or transperineal prostate biopsy.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default/standard code usage | Use when no modifier applies and billing the PLA code as usual. |
22 | Increased procedural services | Use when unusually high complexity in specimen collection or documentation increases work beyond typical for test coordination or counseling. |