Summary & Overview
CPT 0403U: MyProstateScore 2.0 Urine-Based Molecular Prostate Cancer Risk Test
CPT code 0403U designates the MyProstateScore 2.0 proprietary laboratory test from LynxDX, a urine-based molecular assay that measures expression of 18 genes and generates an algorithmic probability score for clinically significant prostate cancer. This PLA code identifies a specific commercial test and is relevant nationally as molecular diagnostics become more integrated into prostate cancer risk assessment and biopsy decision-making. Payers commonly evaluated include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
Readers will find benchmarks and coverage context for molecular prostate diagnostics, clinical context on test purpose and specimen collection, and a summary of payer approaches to similar PLA and molecular pathology codes. The publication outlines the clinical utility of a first-catch urine specimen assay for triaging patients at risk of clinically significant prostate cancer and summarizes how payers are positioning coverage and coding for unique proprietary tests. Data not available in the input is noted where applicable, and the focus remains on national policy, coding, and clinical placement of this CPT PLA code.
Billing Code Overview
CPT code 0403U is a Proprietary Laboratory Analyses (PLA) code for the MyProstateScore 2.0 test from LynxDX. The assay uses a first–catch urine specimen to evaluate the activity (gene expression) of 18 genes and applies an algorithm to report a probability score for the likelihood of clinically significant prostate cancer.
Service Type: Molecular diagnostic urine test for prostate cancer risk stratification
Typical Site of Service: Clinical laboratory or outpatient specimen collection site (first-catch urine specimen)
Clinical & Coding Specifications
Clinical Context
A typical patient is an adult male aged 50–75 years referred by a urologist or primary care physician for molecular risk stratification after an elevated prostate-specific antigen (PSA) level, abnormal digital rectal exam, or prior negative prostate biopsy with persistent clinical concern. The clinician orders MyProstateScore 2.0 (0403U) performed on a first-catch urine specimen collected after a standardized prostate massage or post–digital rectal exam to enrich prostate-derived cells. The specimen is sent to the performing laboratory (Lynx Diagnostics) which runs a proprietary 18-gene expression panel and returns an algorithm-derived probability score indicating likelihood of clinically significant prostate cancer. Results are reviewed by the ordering clinician to inform shared decision-making regarding the need for prostate biopsy, active surveillance, or additional imaging (for example, multiparametric MRI). Typical sites of service include outpatient urology clinics, ambulatory surgical centers for pre-procedure evaluation, and external reference laboratories that perform PLA testing.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Unspecified modifier | Rarely used; applies when no other modifier is appropriate per payor rules |
22 | Increased procedural services | When additional work is required by the laboratory or ordering clinician beyond usual effort for interpretation or reporting that may warrant increased payment |
26 | Professional component | When billing only the professional component of a service (interpretation) is applicable for ancillary testing components |
52 | Reduced services | If the laboratory or ordering clinician performs a reduced portion of the full service |
53 | Discontinued procedure | If specimen collection or processing is discontinued for reasons beyond control (uses are limited for lab tests) |
62 | Two surgeons | When two providers with separate taxonomies share responsibility for clinical interpretation or combined reporting activities |
80 | Assistant surgeon | Rare for lab testing; used if an assistant provider contributes to the clinical sampling process in procedural settings |
82 | Assistant surgeon (when qualified resident surgeon not available) | As above, specific to assistant roles when a resident is not available |
QK | Medical direction of two or more qualified individuals | When the ordering provider medically directs multiple individuals involved in specimen collection or preanalytic procedures |
QX | Ordered and documented modifier to indicate modifier requirements for certain lab services | Applied when specific payor rules require modifier linkage to lab ordering or ownership arrangements |
QY | Medical direction of one qualified individual by a physician | When a physician directs a single qualified individual performing specimen collection or testing-related activities |
TC | Technical component | When billing only the technical component (laboratory analysis) of the PLA test |
SH | Diagnostic supply and device-specific modifier | When supply or device considerations apply to this proprietary assay per payor guidance |
SJ | Clinical consultation modifier used in some lab scenarios | When an additional clinical consultation is furnished related to test results |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 2086S0001X | Urology | Urologists commonly order and interpret prostate molecular testing |
| 208D00000X | Diagnostic Laboratory | Clinical laboratories performing high-complexity molecular diagnostic testing |
| 207RC0000X | Family Medicine | Primary care physicians who screen for prostate cancer and refer for molecular testing |
| 207RH0000X | Internal Medicine | Internists who manage elevated PSA and coordinate specialty referral |
| 363L00000X | Pathology | Anatomic and clinical pathologists who may oversee molecular test validation and reporting |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
N40.0 | Enlarged prostate with lower urinary tract symptoms | Elevated PSA and LUTS often prompt prostate cancer risk evaluation with molecular urine testing |
R97.20 | Elevated prostate specific antigen [PSA] without diagnosis of prostate cancer | Primary clinical trigger for ordering 0403U to stratify cancer risk before biopsy |
N41.9 | Prostatitis, unspecified | Inflammatory conditions can raise PSA and affect interpretation of molecular test results |
Z12.5 | Encounter for screening for malignant neoplasm of prostate | Screening context where molecular risk stratification may be used adjunctively |
C61 | Malignant neoplasm of prostate | Used when assessing risk of clinically significant prostate cancer or for staging considerations |
Z80.42 | Family history of malignant neoplasm of prostate | Family history increases pretest probability and may influence use of molecular assays |
Z09 | Encounter for follow-up examination after completed treatment for conditions other than malignant neoplasm | Used when monitoring men with prior prostate cancer where molecular testing may inform surveillance |
N42.0 | Cystitis and urethritis | Lower urinary tract infection can confound PSA and urine-based molecular testing interpretations |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0403U | MyProstateScore 2.0; 18-gene expression panel using first-catch urine, algorithmic probability of clinically significant prostate cancer | Proprietary laboratory analysis code for the assay itself; primary billed test |
88172 | Molecular cytopathology; slide review for interpretation by pathologist with ancillary testing | May be billed for cytologic review when urine sediment or cytology is performed in conjunction with molecular testing |
88185 | Cytopathology, gross and microscopic, each specimen; manual screening and review | Used when additional cytologic processing of urine specimens is performed prior to molecular analysis |
88360 | Morphometric analysis; for quantitative immunohistochemistry or image analysis | Performed when adjunctive tissue-based quantitative analyses inform correlation with molecular urine results |
88184 | Immunocytochemistry on smears, quantitative or semiquantitative | Occasionally used for complementary cellular analyses when urine cell preparations are evaluated alongside the PLA assay |