Summary & Overview
CPT 0309U: HART CVE Plasma Protein Cardiovascular Risk Score
CPT code 0309U designates a Proprietary Laboratory Analyses (PLA) test specific to Prevencio Inc.'s HART CVE®, which measures four plasma proteins and applies an algorithm to produce a risk score for major adverse cardiovascular events, including myocardial infarction and stroke. Nationally, PLA codes like 0309U matter because they identify single-source diagnostics with unique clinical utility that can influence patient management and payer coverage decisions. Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find succinct benchmarks and clinical context for the test, a summary of payer coverage considerations, and notes on typical sites of service and service classification. The publication highlights how the test is reported in claims using CPT code 0309U, describes its intended clinical application—cardiovascular risk stratification from a plasma sample—and outlines where the service is typically performed (clinical laboratory with outpatient specimen collection). Data not available in the input is noted where applicable. This overview equips payers, providers, and policy analysts with the information needed to interpret the code's purpose, potential impact on care pathways, and the landscape of payer engagement at a national level.
Billing Code Overview
CPT code 0309U is a Proprietary Laboratory Analyses (PLA) code that applies only to a single, manufacturer- or laboratory-specific test: HART CVE® from Prevencio Inc. The test analyzes a plasma specimen for the level of four specific proteins and uses an algorithmic analysis of those results to produce a risk score for major adverse cardiovascular events, such as heart attack or stroke. This risk score is intended to inform clinical decision-making about cardiovascular risk management.
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Service type: Laboratory assay with algorithmic risk scoring
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Typical site of service: Clinical laboratory or outpatient phlebotomy collection with laboratory processing
Clinical & Coding Specifications
Clinical Context
A 62-year-old outpatient with established coronary artery disease and recent symptoms of exertional chest discomfort presents to a cardiology clinic for risk stratification. The treating cardiologist orders the HART CVE® test (0309U) from Prevencio Inc. to quantify a plasma biomarker panel of four proteins and generate an algorithm-derived risk score for major adverse cardiovascular events (MACE). A peripheral blood draw is performed in the clinic or an associated phlebotomy site; the specimen is processed per the laboratory’s instructions and shipped to the performing laboratory. Results are returned to the ordering provider and incorporated into the patient’s longitudinal care plan to inform intensity of preventive therapies and monitoring. Typical sites of service are outpatient physician offices, cardiology clinics, hospital outpatient laboratories, and independent clinical reference laboratories. The procedure is a laboratory-based, algorithmic proprietary assay reported only with 0309U and does not include specimen collection or interpretation CPT codes unless separately reported by qualifying providers using appropriate codes and modifiers.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when a physician or qualified professional interprets and bills separately for the test result interpretation distinct from the laboratory technical component |