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 |
TC | Technical component | Use when billing only the laboratory processing and reporting portion of the test performed by the laboratory |
QK | Performance and payment of a commercially available laboratory test (PI) | Use when the performing laboratory provides the proprietary test under applicable laboratory reporting rules (per payer guidance) |
QX | Ordering/Referring/Prescribing physician NPI not enrolled in program | Use per payer policy where applicable for laboratory services requiring special ordering provider enrollment; follow payer-specific rules |
QY | Ordering/Referring/Prescribing physician enrolled in program | Use where payer requires enrollment attestation for ordering providers for lab benefit payment |
00 | Default/No modifier | Use when no specific modifier applies; standard reporting of the PLA code |
62 | Two surgeons or practitioners | Rarely used; apply only if two physicians from different groups share responsibility for interpretation under payer rules |
78 | Unplanned return to OR by same physician following initial procedure | Generally not applicable to laboratory testing; include only if an associated procedure triggers this modifier per payer guidance |
80 | Assistant surgeon | Not typically applicable to laboratory tests; include only if an associated procedure involves an assistant surgeon |
52 | Reduced service | Use if the laboratory test is performed but with significantly reduced components compared to the full validated assay and payer allows reduced service reporting |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 2084P0800X | Cardiology | Ordering providers commonly include cardiologists managing ischemic heart disease and risk stratification |
| 207RC0000X | Internal Medicine | Primary care physicians and internists frequently order cardiovascular risk stratification tests |
| 363L00000X | Phlebotomy/Diagnostic Laboratory | Specimen collection and laboratory technical work are performed by clinical laboratory personnel/phlebotomists in reference labs or hospital labs |
| 207RC0001X | Preventive Medicine | Providers focusing on cardiovascular prevention may order this assay for risk-guided management |
| 261QM0700X | Clinical Pathology | Laboratory directors and pathologists oversee analytic validity and reporting of proprietary assays |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
I25.10 | Atherosclerotic heart disease of native coronary artery without angina pectoris | Common indication for MACE risk stratification where the HART CVE® score may inform preventive therapy intensity |
I20.9 | Angina pectoris, unspecified | Patients with chest pain syndromes may receive this assay to refine near-term event risk |
I48.91 | Unspecified atrial fibrillation | Patients with atrial arrhythmias have elevated stroke risk; biomarker-based cardiovascular risk assessment can influence management decisions |
I10 | Essential (primary) hypertension | Hypertension is a major cardiovascular risk factor and often coexists with patients undergoing advanced risk testing |
E11.9 | Type 2 diabetes mellitus without complications | Diabetes significantly increases MACE risk; clinicians commonly order biomarker-based risk stratification in this population |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
36415 | Collection of venous blood by venipuncture | Often performed immediately prior to 0309U to obtain the plasma specimen for the HART CVE® assay |
81002 | Urinalysis, non-automated, without microscopy | Occasionally performed as part of pre-testing labs or concurrent risk evaluation but not required for the assay |
80061 | Lipid panel | Commonly ordered alongside 0309U to assess traditional cardiovascular risk markers and inform comprehensive risk assessment |
83036 | Hemoglobin A1c | Frequently ordered with cardiovascular risk testing to evaluate glycemic control, a key risk modifier for MACE |
93000 | Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report | Performed in the outpatient workflow to document cardiac status and correlate with biomarker risk results |