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CPT 0415U: Vascular Inflammation Biomarker Panel with 5-Year ACS Risk Score

CPT code 0415U is a Proprietary Laboratory Analyses (PLA) code assigned to SmartHealth Vascular Dx™ from Morningstar Laboratories LLC. The assay measures seven vascular inflammation biomarkers in a blood specimen and applies an algorithm that integrates biomarker levels with clinical factors to produce a five‑year acute coronary syndrome (ACS) risk score. As a PLA code, 0415U represents a single, manufacturer‑specific test and is relevant for labs, payers, and clinicians managing cardiovascular risk assessment.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication provides national context on clinical utility, coding and billing considerations for PLA tests, typical sites of service, and payer policies affecting access.

Readers will learn the clinical purpose of the test, service type and typical site of service, payer coverage landscape, and common billing modifiers associated with molecular and lab-based services. The summary highlights where data is available and notes when specific inputs are not provided. This information supports coding accuracy, claims submission, and stakeholder understanding of how a proprietary, algorithm‑driven vascular inflammation panel is represented in billing systems.

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Billing Code Overview

CPT code 0415U is a Proprietary Laboratory Analyses (PLA) code specific to a single manufacturer's test. Report 0415U only for SmartHealth Vascular Dx™ from Morningstar Laboratories LLC. The test analyzes a blood specimen to measure seven biomarkers of vascular inflammation and combines those results with patient clinical factors using an algorithm to generate a five‑year risk score for acute coronary syndrome (ACS).

Service type: Proprietary laboratory molecular/biomarker panel with algorithmic risk scoring.

Typical site of service: Clinical laboratory or reference laboratory setting where blood specimens are collected in outpatient or ambulatory settings and processed by Morningstar Laboratories LLC.

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CPT 0415U: Vascular Inflammation Biomarker Panel with 5-Year ACS Risk Score

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Billing Code Overview

Service type: Proprietary laboratory molecular/biomarker panel with algorithmic risk scoring.

Clinical & Coding Specifications

Clinical Context

A 58-year-old male with multiple cardiovascular risk factors (hypertension, hyperlipidemia, and a family history of premature coronary artery disease) presents to his primary care physician for cardiovascular risk stratification. The clinician orders the SmartHealth Vascular Dx™ test (0415U) to assess vascular inflammation markers from a venous blood specimen. The patient has blood drawn in an outpatient phlebotomy suite; the specimen is processed and sent to Morningstar Laboratories LLC. The laboratory performs biomarker assays for seven inflammatory proteins, runs the proprietary algorithm combining biomarker levels with documented clinical factors (age, sex, known risk conditions), and returns a five-year acute coronary syndrome (ACS) risk score to the ordering provider. The provider reviews the report during a follow-up visit or via the electronic health record, integrates the risk score into the broader clinical assessment, and documents the test order, specimen collection, laboratory result, and clinical interpretation in the medical record.

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use when reporting only the professional interpretation portion if separate from the laboratory technical component and permitted by the payor.
`TC`	Technical component	Use when reporting only the laboratory technical component (assay processing) if separated from professional component.
`QK`	CLIA waived test performed by a non-laboratory practitioner	Use if qualifying conditions apply and the performer meets the CLIA requirements for the waived test (rare for PLA tests).
`QX`	CLIA moderate complexity testing performed by a non-laboratory practitioner	Use if a moderate complexity portion is performed and meets CLIA rules for personnel.
`QY`	CLIA high complexity testing performed by a non-laboratory practitioner	Use only if high-complexity testing personnel rules apply (generally not applicable to proprietary reference lab testing).
`62`	Two surgeons	Use if two physicians of different specialties share performance responsibilities when applicable to specimen collection procedures requiring separate surgical services.
`78`	Unplanned return to the operating/procedure room for a related procedure during the postoperative period	Use only when a related procedural re-entry occurs; rarely applicable for diagnostic lab testing but included for completeness.
`80`	Assistant surgeon	Use when an assistant surgeon is documented for an associated procedure requiring assistance (rare for blood specimen collection).
`82`	Assistant surgeon (when qualified resident not available)	Use as above when a qualified resident is not available.
`52`	Reduced services	Use when the laboratory or provider documents that services were reduced or partially performed.
`53`	Discontinued procedure	Use when specimen collection or test processing was discontinued and properly documented.
`22`	Increased procedural services	Use when substantially greater work is documented for the service (uncommon for standardized lab assays).
`23`	Unusual anesthesia	Use when unusual anesthesia is required for a related procedure; not typical for routine blood draws.
`55`	Separation of physician/surgeon services	Use when another physician assumes postoperative management for a related procedure.

Taxonomy Code	Specialty	Notes
`207Q00000X`	Cardiovascular Disease (Cardiologist)	Ordering and interpreting cardiovascular risk biomarker testing.
`207L00000X`	Clinical Pathology (Pathologist/Lab Director)	Oversees laboratory testing quality and result validation at reference lab.
`207K00000X`	Family Medicine	Primary care ordering test for preventive risk stratification.
`207M00000X`	Internal Medicine	Primary care or internist ordering for chronic disease risk assessment.
`263QM0800X`	Clinical Laboratory Technician/Technologist	Performs specimen processing and assay testing in the laboratory.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Venous blood draw required to obtain the sample for `0415U`.
`99000`	Handling and/or conveyance of specimen for transfer from the physician's office to a laboratory	Use when specimen shipping or handling services are billed related to sending the sample to the reference lab.
`G0423`	Hospital outpatient clinic visit for observation or evaluation (example code for related outpatient services)	Represents typical outpatient visit services where ordering and follow-up for `0415U` may occur.
`93000`	Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report	Often performed alongside risk evaluation for cardiac symptoms or risk stratification.
`80061`	Lipid panel	Common laboratory panel ordered in conjunction with vascular inflammation biomarker testing to assess cardiovascular risk.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`I25.10`	Atherosclerotic heart disease of native coronary artery without angina pectoris	Common indication for vascular inflammation testing to refine risk assessment.
`I10`	Essential (primary) hypertension	Hypertension is a cardiovascular risk factor incorporated into risk interpretation.
`E78.5`	Hyperlipidemia, unspecified	Dyslipidemia commonly coexists and influences ACS risk scoring.
`Z13.6`	Encounter for screening for cardiovascular disorders	Use when ordered as part of preventive cardiovascular screening.
`R07.9`	Chest pain, unspecified	Symptom that may prompt more aggressive risk evaluation including biomarker testing.

CPT 0001U: PreciseType HEA Multiplex Erythrocyte Antigen Assay

CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

CPT 0002U: Urine Metabolomic Polyp Risk Assay (PolypDX™)

CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

CPT 0003U: Overa™ (OVA1 Next Generation) Ovarian Cancer Risk Assay

CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

CPT 0005U: ExosomeDx Prostate (IntelliScore) Urine Gene Expression Risk Test

CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

CPT 0007U: ToxProtect Urine Drug Screen with DNA Authentication

CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

CPT 0008U: H. pylori Antibiotic Resistance Panel, Gene Sequence Analysis

CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

CPT 0011U: Cordant CORE™ Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcript Testing

Showing 1–10 of 536

Frequently Asked Questions

References

1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.

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Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

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Clinical & Coding Specifications

Clinical Context

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use when reporting only the professional interpretation portion if separate from the laboratory technical component and permitted by the payor.
`TC`	Technical component	Use when reporting only the laboratory technical component (assay processing) if separated from professional component.
`QK`	CLIA waived test performed by a non-laboratory practitioner	Use if qualifying conditions apply and the performer meets the CLIA requirements for the waived test (rare for PLA tests).
`QX`	CLIA moderate complexity testing performed by a non-laboratory practitioner	Use if a moderate complexity portion is performed and meets CLIA rules for personnel.
`QY`	CLIA high complexity testing performed by a non-laboratory practitioner	Use only if high-complexity testing personnel rules apply (generally not applicable to proprietary reference lab testing).
`62`	Two surgeons	Use if two physicians of different specialties share performance responsibilities when applicable to specimen collection procedures requiring separate surgical services.
`78`	Unplanned return to the operating/procedure room for a related procedure during the postoperative period	Use only when a related procedural re-entry occurs; rarely applicable for diagnostic lab testing but included for completeness.
`80`	Assistant surgeon	Use when an assistant surgeon is documented for an associated procedure requiring assistance (rare for blood specimen collection).
`82`	Assistant surgeon (when qualified resident not available)	Use as above when a qualified resident is not available.
`52`	Reduced services	Use when the laboratory or provider documents that services were reduced or partially performed.
`53`	Discontinued procedure	Use when specimen collection or test processing was discontinued and properly documented.
`22`	Increased procedural services	Use when substantially greater work is documented for the service (uncommon for standardized lab assays).
`23`	Unusual anesthesia	Use when unusual anesthesia is required for a related procedure; not typical for routine blood draws.
`55`	Separation of physician/surgeon services	Use when another physician assumes postoperative management for a related procedure.

Taxonomy Code	Specialty	Notes
`207Q00000X`	Cardiovascular Disease (Cardiologist)	Ordering and interpreting cardiovascular risk biomarker testing.
`207L00000X`	Clinical Pathology (Pathologist/Lab Director)	Oversees laboratory testing quality and result validation at reference lab.
`207K00000X`	Family Medicine	Primary care ordering test for preventive risk stratification.
`207M00000X`	Internal Medicine	Primary care or internist ordering for chronic disease risk assessment.
`263QM0800X`	Clinical Laboratory Technician/Technologist	Performs specimen processing and assay testing in the laboratory.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Venous blood draw required to obtain the sample for `0415U`.
`99000`	Handling and/or conveyance of specimen for transfer from the physician's office to a laboratory	Use when specimen shipping or handling services are billed related to sending the sample to the reference lab.
`G0423`	Hospital outpatient clinic visit for observation or evaluation (example code for related outpatient services)	Represents typical outpatient visit services where ordering and follow-up for `0415U` may occur.
`93000`	Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report	Often performed alongside risk evaluation for cardiac symptoms or risk stratification.
`80061`	Lipid panel	Common laboratory panel ordered in conjunction with vascular inflammation biomarker testing to assess cardiovascular risk.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`I25.10`	Atherosclerotic heart disease of native coronary artery without angina pectoris	Common indication for vascular inflammation testing to refine risk assessment.
`I10`	Essential (primary) hypertension	Hypertension is a cardiovascular risk factor incorporated into risk interpretation.
`E78.5`	Hyperlipidemia, unspecified	Dyslipidemia commonly coexists and influences ACS risk scoring.
`Z13.6`	Encounter for screening for cardiovascular disorders	Use when ordered as part of preventive cardiovascular screening.
`R07.9`	Chest pain, unspecified	Symptom that may prompt more aggressive risk evaluation including biomarker testing.

CPT 0001U: PreciseType HEA Multiplex Erythrocyte Antigen Assay

CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

CPT 0002U: Urine Metabolomic Polyp Risk Assay (PolypDX™)

CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

CPT 0003U: Overa™ (OVA1 Next Generation) Ovarian Cancer Risk Assay

CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

CPT 0005U: ExosomeDx Prostate (IntelliScore) Urine Gene Expression Risk Test

CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

CPT 0007U: ToxProtect Urine Drug Screen with DNA Authentication

CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

CPT 0008U: H. pylori Antibiotic Resistance Panel, Gene Sequence Analysis

CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

CPT 0011U: Cordant CORE™ Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcript Testing

Showing 1–10 of 536

Frequently Asked Questions

References

1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.

Published by

Trek Health powers OpenPayer with a leading commercial payer intelligence platform, seamlessly converting fragmented payer data into actionable insights for provider organizations.

OpenPayer

CPT 0415U: Vascular Inflammation Biomarker Panel with 5-Year ACS Risk Score

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Billing Code Overview

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CPT 0415U: Vascular Inflammation Biomarker Panel with 5-Year ACS Risk Score

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Billing Code Overview

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Related CPT Codes

Related Diagnoses

Related Codes

References

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Related CPT Codes

Related Diagnoses

Related Codes

References

CPT 0415U: Vascular Inflammation Biomarker Panel with 5-Year ACS Risk Score

Sign up for cpt 0415U policy alerts

Billing Code Overview

CPT 0415U: Vascular Inflammation Biomarker Panel with 5-Year ACS Risk Score

Sign up for cpt 0415U policy alerts

Billing Code Overview

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Related CPT Codes

Related Diagnoses

Related Codes

What does CPT 0415U represent and when should it be reported?

Where is the test performed and which ancillary CPT codes are typically associated with the service?

Which billing modifiers are applicable to 0415U?

For which diagnoses or clinical contexts is 0415U commonly used and what documentation is expected?

Is 0415U covered by major payers and where can I find reimbursement or coverage specifics?

References

Clinical & Coding Specifications

Clinical Context

Coding Specifications

Related CPT Codes

Related Diagnoses

Related Codes

What does CPT 0415U represent and when should it be reported?

Where is the test performed and which ancillary CPT codes are typically associated with the service?

Which billing modifiers are applicable to 0415U?

For which diagnoses or clinical contexts is 0415U commonly used and what documentation is expected?

Is 0415U covered by major payers and where can I find reimbursement or coverage specifics?

References