Summary & Overview
CPT 0376U: ArteraAI Prostate Test, AI Pathology Risk Assessment
CPT code 0376U designates a Proprietary Laboratory Analyses (PLA) test — the ArteraAI Prostate Test from Artera Inc. — that uses artificial intelligence to analyze a digitized prostate pathology slide together with clinical inputs to estimate risks of distant metastasis and prostate cancer mortality and to suggest potential response to androgen deprivation therapy. As a PLA code, 0376U is reportable only for this single manufacturer’s assay, signaling its proprietary clinical utility and unique billing identity. Nationally, PLA codes are important because they provide a standardized mechanism to identify and track utilization of single-source laboratory tests that often involve complex analytic methods.
Key payers considered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The content addresses payer coverage landscapes, coding and billing considerations for proprietary laboratory tests, and the clinical context for use in prostate cancer prognostication and treatment planning.
Readers will learn the clinical purpose and service setting for CPT code 0376U, common billing implications for laboratory and pathology providers, and the types of benchmarks and policy issues to monitor for PLA-designated assays. Data not available in the input will be noted where relevant, and the document focuses on nationally applicable information rather than jurisdiction-specific rules.
Billing Code Overview
CPT code 0376U is a Proprietary Laboratory Analyses (PLA) code specific to a single laboratory test: the ArteraAI Prostate Test from Artera Inc. The test applies an artificial intelligence algorithm to a digitized prostate pathology slide and integrates selected clinical variables to generate algorithmic risk estimates for distant metastasis and prostate cancer–specific mortality, and it may provide information about likely response to androgen deprivation therapy.
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Service type: Laboratory-based, algorithmic diagnostic/prognostic test using digital pathology and clinical data
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Typical site of service: Clinical laboratory or pathology service associated with a diagnostic laboratory; specimen originates from surgical pathology or biopsy processing prior to digital slide analysis
Clinical & Coding Specifications
Clinical Context
A 67-year-old man with a history of intermediate-risk prostate adenocarcinoma (Gleason score 7, clinical stage T2) undergoes radical prostatectomy. Pathology yields a digitized whole-slide image of the tumor. The treating urologist and multidisciplinary tumor board order the 0376U ArteraAI Prostate Test to augment risk stratification. The laboratory performs AI-driven image analysis of the submitted digital pathology slide, integrates select clinical variables (such as Gleason score, pathologic stage, margin status, and preoperative PSA), and generates an algorithmic report estimating the patient’s risk of distant metastases and prostate cancer–specific mortality and potential response to androgen deprivation therapy.
Typical clinical workflow:
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The surgical pathology team prepares and digitizes the prostatectomy slide and submits the de-identified digital slide and required clinical data to Artera Inc. under the laboratory’s ordering protocol.
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The laboratory performs analytic processing and runs the proprietary AI algorithm unique to Artera Inc. to produce a quantitative risk report.
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The pathology report and ArteraAI result are returned to the ordering provider (urologist or oncologist) as an adjunctive prognostic tool to inform postoperative surveillance intensity and consideration of adjuvant therapies.
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Results are archived in the medical record and may be discussed at tumor board to guide shared decision-making about adjuvant radiation or systemic therapy.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | Default when no specific modifier applies |
26 | Professional component | When billing only the interpreting physician’s professional component for the report (if separated from technical component)
TC | Technical component | When billing only the laboratory’s technical component for the test
52 | Reduced services | If the test is partially completed or limited in scope
53 | Discontinued procedure | If testing was started but terminated due to unforeseen circumstances
62 | Two surgeons | Rarely applicable; use when two qualified providers share responsibility for the procedure-related interpretation
78 | Return to operating room | Not typically applicable to laboratory PLA codes but used if test-related complication requires reoperation
80 | Assistant surgeon | Not routinely used for PLA codes; included when surgical assistance impacted specimen acquisition billing context
QK | Anesthesia direction of CRNAs | Not applicable to the lab test itself; occasionally present on the global surgical claim associated with the specimen
QX | CRNA service furnished under supervision of an anesthesiologist | As above, relates to associated operative services, not the PLA code
QY | Medical direction of one CRNA by anesthesiologist | As above, relates to the associated operative claim
SH | Assistant at surgery (physician) | Rarely relevant; pertains to the operative service creating the specimen
SJ | Assistant at surgery (nonphysician) | As above
| Taxonomy Code | Specialty | Notes |
|---|---|---|
208800000X | Anatomic Pathology | Pathologists order, interpret, and coordinate the digital slide submission and correlate AI report with pathology |
207L00000X | Urology | Urologists commonly order the test post-prostatectomy to guide adjuvant therapy decisions
2084P0800X | Medical Oncology | Medical oncologists use the prognostic output to assess systemic therapy considerations
261QM0800X | Radiation Oncology | Radiation oncologists reference risk estimates when considering adjuvant or salvage radiotherapy
363LP0800X | Clinical Informatics | Clinical informaticists and laboratory directors manage digital pathology workflows and data integration
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C61 | Malignant neoplasm of prostate | Primary diagnosis indicating prostate cancer; direct indication for prognostic testing after tissue diagnosis or surgery |
D07.5 | Carcinoma in situ of prostate | When high-risk in situ or atypia prompts further risk stratification; less common but may be contextual
N40 | Benign prostatic hyperplasia | Often present as a comorbidity; not an indication for metastatic risk testing but frequently in the differential
R97.20 | Elevated prostate-specific antigen [PSA] without diagnosis of malignant neoplasm of prostate | May trigger biopsy and subsequent pathology that leads to ordering of prognostic testing once malignancy confirmed
Z85.46 | Personal history of malignant neoplasm of prostate | Relevant for surveillance contexts where prognostic testing informs recurrence/metastasis risk
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
88305 | Level IV pathology examination; surgical pathology, gross and microscopic examination | Represents the standard surgical pathology interpretation of the prostate specimen; the digital slide used by the ArteraAI test is generated as part of this workflow |
88313 | Special stains, each procedure; a single or multiple immunohistochemical stain (per specimen) | Performed on prostate specimens when additional immunostains are required for diagnostic clarification alongside AI analysis
88361 | Morphometric analysis; computer-assisted (e.g., digital image analysis of histologic images) | Related to digital pathology workflows and image analysis; complements proprietary AI algorithm though 0376U is a PLA specific to Artera Inc.
0042U | Molecular pathology (example PLA) — placeholder for other PLA codes | Other Proprietary Laboratory Analyses that may be ordered for prostate cancer prognostication in parallel or comparison to 0376U
G0480 | Computed or digitized pathology slide transmission (telepathology) | Supports the digital slide transmission and storage needed for central laboratory AI analysis