Summary & Overview
CPT 0343U: miR Sentinel Prostate Cancer Urine Molecular Test
CPT code 0343U designates a proprietary laboratory test — the miR Sentinel™ Prostate Cancer Test from miR Scientific LLC — that analyzes small RNA fragments from urine to classify and monitor prostate cancer risk noninvasively. As a PLA code, 0343U applies only to this single, manufacturer-specific assay and is relevant for payers, laboratories, and clinicians evaluating noninvasive alternatives to biopsy-based diagnostics. Nationally, PLA codes like 0343U matter because they enable distinct tracking, reimbursement discussions, and policy decisions for novel, single-source diagnostics.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical context and service delivery (urine-based molecular diagnostic performed in a clinical laboratory), payer coverage considerations and common modifiers used in billing, and practical information on how the code is reported. The publication summarizes benchmarking and policy updates where available, clarifies typical sites of service, and identifies areas where input data was not provided. Data not available in the input is noted explicitly to avoid assumptions.
Billing Code Overview
CPT code 0343U is a Proprietary Laboratory Analyses (PLA) code reported for the miR Sentinel™ Prostate Cancer Test from miR Scientific LLC. The test extracts and analyzes relevant small RNA segments from a urine specimen and uses an algorithmic analysis to classify and monitor prostate cancer risk without invasive procedures such as biopsy.
Service type: Laboratory molecular diagnostic assay (proprietary PLA)
Typical site of service: Clinical laboratory or outpatient specimen collection site (urine specimen collection with laboratory analysis)
Clinical & Coding Specifications
Clinical Context
A 64-year-old man with a rising prostate-specific antigen (PSA) level and prior negative biopsy presents for noninvasive risk stratification for clinically significant prostate cancer. The clinician orders the miR Sentinel™ Prostate Cancer Test (0343U) to analyze urinary small RNA signatures. A midstream or post–digital rectal exam urine specimen is collected in clinic or at a designated phlebotomy/laboratory draw site and sent to the performing laboratory (miR Scientific LLC). The laboratory extracts small RNAs, runs the proprietary assay and algorithm, and issues a report classifying risk of clinically significant prostate cancer to inform shared decision-making about surveillance, imaging (such as multiparametric prostate MRI), or the need for targeted or systematic biopsy. Typical sites of service include outpatient urology clinics, ambulatory care centers, and commercial reference laboratories.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default/standard — no modifier | Use when no special circumstances apply to the billed service |
26 | Professional component | Use if reporting a professional interpretation component separately when applicable |
52 | Reduced services | Use if the laboratory performed a reduced version of the test or specimen was inadequate but partial testing completed |
53 | Discontinued procedure | Use if testing was started but discontinued for documented clinical reasons |
62 | Two surgeons | Rare for this lab test; would apply when multiple providers share responsibility for preanalytic specimen acquisition in complex settings |
78 | Unplanned return to the operating/procedure room | Not typically applicable but available if return affects billing in a combined encounter involving procedures |
80 | Assistant surgeon | Not typically applicable to a lab-based test but included when an assistant performs specimen procurement in the operative setting |
82 | Assistant surgeon (when qualified resident unavailable) | See 80; applies only if assistant billing is appropriate for specimen procurement |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services for surgical procedures | Use when an advanced practice clinician performs specimen collection under appropriate rules |
QK | Medical direction of two, three, or four concurrent anesthesia procedures | Not applicable to the lab test itself; included among common modifiers for institutional billing contexts |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 208500000X | Urology | Urologists commonly order the test for prostate cancer risk stratification |
| 207Q00000X | Pathology | Pathologists or laboratory medicine specialists oversee testing interpretation and QA |
| 363L00000X | Clinical Laboratory | Clinical laboratory director/chemistry specialty responsible for assay performance |
| 208D00000X | Internal Medicine | Primary care physicians/internists may order the test when managing elevated PSA |
| 208M00000X | Family Medicine | Family physicians who evaluate prostate cancer risk and coordinate referral |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
R97.2 | Elevated prostate specific antigen [PSA] | Common indication to order a noninvasive urine-based molecular risk test |
N40.1 | Benign prostatic hyperplasia with lower urinary tract symptoms | BPH is a common comorbid prostate condition; PSA and molecular tests help differentiate benign from malignant risk |
N45.2 | Chronic prostatitis | Inflammatory conditions can affect PSA and influence decision to use molecular testing for risk clarification |
C61 | Malignant neoplasm of prostate | Used when assessing known prostate cancer for monitoring or risk classification where noninvasive testing may inform management |
Z12.5 | Encounter for screening for malignant neoplasm of prostate | Screening encounter where a clinician may order reflex or adjunct molecular testing based on PSA or clinical concern |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0343U | miR Sentinel™ Prostate Cancer Test — Proprietary Laboratory Analyses (PLA) code | Primary PLA code describing extraction and algorithmic analysis of urinary small RNA for prostate cancer risk classification |
84153 | Prostate specific antigen (PSA); total | Often performed as an initial screening test that may lead to ordering the urine miR Sentinel assay |
80502 | Oncology (proprietary molecular pathology) quantitative, single analyte; each additional analyte (deprecated in many contexts) | Related conceptually as molecular diagnostic testing; not used instead of the PLA code but represents other molecular assays that may be ordered in prostate cancer evaluation |
88342 | Immunohistochemistry; per specimen; first antibody stain | Performed on biopsy specimens if biopsy proceeds following a positive or high-risk urine test |
72197 | Magnetic resonance imaging, pelvis; without and with contrast, followed by subtraction (multiparametric prostate MRI coded under body-region MRI) | Multiparametric prostate MRI commonly performed after noninvasive risk stratification to localize lesions prior to targeted biopsy |