Summary & Overview
CPT 0513U: Tempus p–Prostate, MSI and HRD Assessment via Digital Pathology
CPT code 0513U designates Tempus p–Prostate, a Proprietary Laboratory Analyses (PLA) test that applies algorithmic analysis to digitized whole-slide images to estimate microsatellite instability (MSI) and homologous recombination deficiency (HRD) in prostate cancer tissue. As a PLA code, 0513U is unique to a single manufacturer's test and signals the growing role of computational pathology in precision oncology. Nationally, this code matters because it supports billing clarity for an emerging class of image-based, algorithm-driven diagnostics that inform targeted therapy decisions, clinical trial eligibility, and tumor profiling strategies.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical context for the test, payer coverage considerations, and typical billing and site-of-service expectations for laboratory-based digital pathology services. The publication summarizes benchmarking and coverage themes for proprietary laboratory tests, highlights coding and billing implications specific to PLA-designated CPT codes, and outlines the clinical utility of MSI and HRD assessment in prostate cancer management. Data not available in the input for specific ICD-10 pairings, associated taxonomies, and payer-specific policy language are noted where applicable.
Billing Code Overview
CPT code 0513U is a Proprietary Laboratory Analyses (PLA) code for Tempus p–Prostate, a laboratory-developed test by Tempus AI Inc. The assay uses algorithmic analysis of digitized whole-slide imaging to estimate the probability of microsatellite instability (MSI) and homologous recombination deficiency (HRD) in prostate cancer tissue.
Service type: Laboratory diagnostic test using digital pathology and algorithmic analysis.
Typical site of service: Clinical pathology laboratory or specialized diagnostic laboratory performing digital whole-slide imaging and computational analysis.
Data not available in the input.
Clinical & Coding Specifications
Clinical Context
A male patient with a history of localized or metastatic prostate adenocarcinoma undergoes surgical resection or core needle biopsy of a prostate lesion. The pathology laboratory digitizes the hematoxylin and eosin whole‑slide images from the formalin‑fixed paraffin‑embedded tissue block. The specimen is submitted to Tempus AI Inc. for the proprietary 0513U test (Tempus p–Prostate), which applies algorithmic analysis of digitized whole‑slide imaging to estimate the probability of microsatellite instability (MSI) and homologous recombination deficiency (HRD). Results are used by the treating oncologist and molecular tumor board to inform molecular profiling, potential eligibility for targeted therapies (e.g., PARP inhibitors for HRD, immune checkpoint inhibitors for MSI‑high), and further confirmatory genetic or genomic testing. Typical workflow steps include: specimen collection (biopsy or prostatectomy), anatomic pathology processing and slide scanning, submission of digital images to the performing laboratory, algorithmic analysis under 0513U, report generation, and clinical interpretation by urology, medical oncology, or pathology teams. Typical site of service: hospital outpatient laboratory, independent clinical laboratory, or pathology department with digital pathology capabilities.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | When billing physician interpretation of the test result separately from the technical component |
TC | Technical component | When billing only the laboratory or device technical component (image processing, algorithm run) |
59 | Distinct procedural service | Data not available in the input. |
52 | Reduced services | When full test cannot be completed and a reduced service is reported |
53 | Discontinued procedure | When testing is started but discontinued due to specimen or technical failure |
62 | Two surgeons | Data not available in the input. |
78 | Return to OR for related procedure by same physician | Data not available in the input. |
80 | Assistant surgeon | Data not available in the input. |
QK | Medical direction of 2 or more CRNAs by physician | Data not available in the input. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207R00000X | Anatomic Pathology | Pathologists oversee specimen processing, slide interpretation, and ordering of PLA tests |
| 208800000X | Urology | Urologists perform biopsies or prostatectomy and order tissue‑based molecular tests |
| 2084P0800X | Medical Oncology | Oncologists use MSI/HRD results to guide systemic therapy selection |
| 2023P0800X | Clinical Laboratory Director | Laboratory directors manage performance and billing of proprietary laboratory analyses |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C61 | Malignant neoplasm of prostate | Primary diagnosis leading to prostate tissue testing and MSI/HRD assessment |
D07.5 | Carcinoma in situ of prostate | In select cases where molecular profiling of high‑risk in situ lesions is considered |
Z85.46 | Personal history of malignant neoplasm of prostate | Relevant for surveillance and molecular characterization of recurrent disease |
R87.8 | Other abnormal findings on cytological and histological examination of prostate | Supports further molecular testing when histology shows atypia |
C79.82 | Secondary malignant neoplasm of genital organs | Used when metastatic disease to pelvic/genitourinary sites prompts molecular evaluation |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88305 | Level IV surgical pathology, gross and microscopic examination | Commonly billed for pathologist evaluation of prostate biopsy or resection slides prior to digital image analysis |
88342 | Immunohistochemistry, per single stain/antibody | May be performed on tissue to evaluate biomarkers complementary to MSI/HRD assessment |
88331 | Pathology consultation during surgery (frozen section) | Performed when intraoperative assessment is needed before definitive procedure; precedes permanent slide processing and digital analysis |
G0452 | Pharmacogenomic/chemotherapy related test (not PLA-specific) | Represents advanced laboratory molecular services sometimes ordered in parallel with PLA results |
810XX | Data not available in the input. | Data not available in the input. |