Summary & Overview
CPT 0511U: PARIS 3D Tumor Drug Response Profiling
CPT code 0511U designates a proprietary laboratory test — PARIS from Tempus AI Inc. — that cultures tumor cells in a 3D microenvironment to assess responses to 36 or more drugs and generate drug-specific effectiveness predictions. As a PLA code, 0511U is unique to a single manufacturer’s lab test and is used to identify the PARIS assay in claims and administrative data. This code matters nationally as precision oncology diagnostics and tumor functional profiling increasingly inform therapeutic selection and payer coverage determinations.
Key payers in the coverage landscape include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare and Medicare. Readers will find a concise overview of the clinical method and intended use of the PARIS test, the payer mix relevant to national coverage discussions, and the types of analyses typically reported for PLA codes (coverage benchmarks, reimbursement context, and policy considerations). The publication highlights how 0511U is captured in billing systems, where the test is usually performed, and what stakeholders commonly examine when evaluating novel laboratory assays for clinical utility and coverage.
Billing Code Overview
CPT code 0511U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to a single, manufacturer-specific laboratory test. Report 0511U only for PARIS from Tempus AI Inc. The assay cultures tumor cells in a 3D microenvironment and evaluates their responses to 36 or more anticancer drugs, producing drug-specific effectiveness predictions.
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Service type: Laboratory diagnostic assay using ex vivo 3D tumor cell culture and pharmacologic response profiling.
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Typical site of service: Commercial clinical laboratories or specialized molecular diagnostics laboratories; test is performed on patient tumor specimens sent to the performing laboratory.
Clinical & Coding Specifications
Clinical Context
A typical patient is an adult with a histologically confirmed solid tumor who has progressed on or is intolerant of standard systemic therapies and for whom personalized functional drug-sensitivity data are requested to guide later-line systemic treatment decisions. A treating oncologist obtains a viable tumor specimen (core needle biopsy or surgical resection) which is shipped to the performing laboratory. The laboratory (Tempus AI Inc. for PARIS) cultures patient tumor cells in a 3D microenvironment, exposes them to a panel of 36 or more anticancer agents, and reports predicted sensitivity/resistance for each drug. Results return to the ordering oncologist and are reviewed in a clinical visit or tumor board to inform selection of off-label agents, clinical trial matching, or supportive decision-making. Typical site of service is an outpatient pathology/molecular diagnostics laboratory with specimen collection performed in an outpatient clinic, ambulatory surgery center, or hospital outpatient department. Billing uses PLA code 0511U uniquely for the PARIS test from Tempus AI Inc.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | When billing only the professional interpretation component if separated by the performing laboratory and billing provider |