CPT 0310U: HART KD® Plasma Biomarker Panel for Kawasaki Disease

CPT code 0310U is a Proprietary Laboratory Analyses (PLA) code for the HART KD® test from Prevencio Inc., a laboratory assay that measures three specified plasma biomarkers and uses an algorithmic analysis to generate a risk score to aid in the diagnosis of Kawasaki Disease; service type is laboratory diagnostic testing and the typical site of service is a clinical laboratory or hospital laboratory where a plasma specimen is collected and analyzed.

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CPT 0310U: HART KD® Plasma Biomarker Panel for Kawasaki Disease

Customize your policy alerts

Sign up for cpt 0310U policy alerts

Get alerted when payer policies referencing 0310U are released or updated.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Clinical & Coding Specifications

Clinical Context

A 3-year-old child presents to the pediatric emergency department with 5 days of persistent high fever, conjunctival injection, erythematous cracked lips, swollen hands and feet, and a polymorphous rash. The pediatrician suspects Kawasaki Disease (KD) and orders laboratory evaluation to support diagnosis and risk stratification. A peripheral blood draw is performed; a plasma specimen is sent to the reference laboratory performing the proprietary HART KD® test (Prevencio Inc.). The laboratory measures the three biomarkers specified by the proprietary assay and applies the manufacturer’s algorithm to generate a risk score indicating likelihood of KD and potential coronary artery involvement. Results are returned to the ordering clinician to inform cardiology consultation and decisions about echocardiography, intravenous immunoglobulin (IVIG) therapy, and inpatient monitoring.

Typical site of service: outpatient pediatric clinic, urgent care, emergency department, or hospital laboratory when a plasma sample is drawn and sent to the performing laboratory.

Service type: proprietary laboratory analysis (PLA) — analytic laboratory test performed and reported by the single-source manufacturer/lab for diagnostic risk scoring of Kawasaki Disease.

Typical clinical workflow:

The clinician documents signs and symptoms consistent with suspected KD and places the order for the HART KD® test.
A blood specimen is collected (plasma) and prepared per lab instructions; couriered to the performing laboratory if offsite.
The performing laboratory runs the proprietary assay, applies the algorithm, and issues a report with the KD risk score.
The ordering clinician reviews the report, integrates it with clinical and imaging data (for example, echocardiography), and documents decisions about IVIG therapy, cardiology referral, and follow-up monitoring.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0310U`	HART KD® (Prevencio Inc.) — Proprietary laboratory analysis reporting a risk score for Kawasaki Disease based on three plasma biomarkers and algorithmic analysis	Primary PLA code for the specific proprietary assay performed by the manufacturer or designated laboratory
`80053`	Comprehensive metabolic panel (CMP)	Commonly ordered alongside specialized PLA tests to assess general metabolic status and aid clinical evaluation in febrile pediatric patients
`85025`	Complete blood count (CBC) with automated differential	Routinely ordered in suspected KD to evaluate leukocytosis, anemia, and platelet counts; informs diagnosis and monitoring
`83970`	Cardiac enzyme assay (example: troponin)	May be ordered when there is concern for cardiac involvement; assists in evaluating myocardial injury in severe presentations
`93306`	Echocardiography, transthoracic, real-time with image documentation, complete	Performed to assess coronary artery dimensions and cardiac function in patients with suspected or confirmed KD; often ordered after lab results inform risk stratification
`96372`	Therapeutic injection, subcutaneous or intramuscular (e.g., for IVIG administration preparation may require injections)	Associated with treatment workflows when IVIG or adjunctive therapies are administered after diagnosis; included to reflect related interventional services

Related Modifiers

6 rows

Modifier	Description	When to Use
26	Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…	- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
52	Modifier ‑52 (Reduced Services) indicates that a service or procedure was partially reduced or omitted at the provider’s discretion, allowing reporting of the basic procedure number with a qualifier…	- Use modifier -52 when a physician or qualified health professional electively reduces or omits part of a procedure or service (for example, performing fewer required views or omitting a portion of…
53	Modifier 53 (Discontinued Procedure) signals that a surgical or diagnostic service was begun by the physician but terminated because of extenuating circumstances that threatened the patient’s…	- Use modifier -53 when a physician/qualified healthcare professional has started a surgical or diagnostic procedure (e.g., anesthesia administered, incision or scope insertion) and then discontinues…
62	Modifier 62 indicates that two surgeons function as co‑surgeons, each performing distinct parts of the same primary surgical procedure. It is appended to the primary procedure code (and any…	- Use modifier -62 when two surgeons act as co‑surgeons (both primary surgeons) on a single definitive primary procedure, each performing distinct parts of the same surgical procedure (append -62 to…
78	CPT modifier -78 indicates an unplanned, related return to the operating or procedure room by the same provider during the global postoperative period. It is appended when treatment for a…	- Use modifier -78 when an unplanned, related complication during the original procedure’s global postoperative period requires the patient to return to a formal operating or procedure room and the…
80	CPT® Modifier 80 (Assistant Surgeon) is appended to a surgical CPT code when a physician (MD or DO) provides full, continuous assistance throughout the operative procedure. It is intended only for…	- Use CPT Modifier -80 when a physician (MD or DO) serves as an assistant surgeon and provides full, continuous assistance throughout the entire operative procedure; append -80 to the surgical CPT…

Related Provider Taxonomies

8 rows

Taxonomy Code	Specialty	Notes
208000000X	Pediatrics Physician	A pediatrician is concerned with the physical, emotional and social health of children from birth to young adulthood. Care encompasses a broad spectru…
207Q00000X	Family Medicine Physician	Family Medicine is the medical specialty which is concerned with the total health care of the individual and the family. It is the specialty in breadt…
207L00000X	Anesthesiology Physician	An anesthesiologist is trained to provide pain relief and maintenance, or restoration, of a stable condition during and immediately following an opera…
111NP0017X	Pediatric Chiropractor	The Pediatric Chiropractor is a chiropractor with specialized, advanced training and certification in the evaluation, care and management of health an…
332000000X	Military/U.S. Coast Guard Pharmacy	A Department of Defense (DoD) or U.S. Coast Guard entity whose primary function is to store, prepare and dispense pharmaceuticals and other associated…
273Y00000X	Rehabilitation Hospital Unit	In general, a distinct unit of a general acute care hospital that provides care encompassing a comprehensive array of restoration services for the dis…
207RE0101X	Endocrinology, Diabetes & Metabolism Physician	An internist who concentrates on disorders of the internal (endocrine) glands such as the thyroid and adrenal glands. This specialist also deals with …
2085U0001X	Diagnostic Ultrasound Physician	A Radiology doctor of Osteopathy that specializes in Diagnostic Ultrasound.

Related Payer Policy Updates

Specialty: Genetic & Molecular Testing1 / 3

10 rows

Policy	Payer	Effective Date
RTM Testing of Homocysteine Metabolism-Related Conditions	Oscar Health	2026-10-01
Multimarker Serum Testing Related to Ovarian Cancer	Blue Cross Blue Shield - Rhode Island	2026-09-01
Genomic Profiling for Selecting Targeted Cancer Therapies	Blue Cross Blue Shield - Rhode Island	2026-09-01
Whole Exome and Whole Genome Sequencing for Diagnosis of Genetic Disorders	Blue Cross Blue Shield - Rhode Island	2026-09-01
Biomarker and Genetic/Molecular Testing Coverage and Prior Authorization	Blue Cross Blue Shield - Rhode Island	2026-09-01
Non-Invasive Prenatal Testing (NIPT)	univerahealthcare	2026-08-17
Lumizyme (alglucosidase alfa) — Pompe Disease (acid alpha‑glucosidase deficiency)	Cigna	2026-08-15
Molecular Oncology Testing for Solid Tumor Cancer Diagnosis, Prognosis, and Treatment Decisions	Colorado Rocky Mountain Health Plans	2026-08-01
Molecular Oncology Testing for Hematologic Cancer Diagnosis, Prognosis, and Treatment Decisions	Colorado Rocky Mountain Health Plans	2026-08-01
Carrier Testing Panels for Genetic Diseases	Colorado Rocky Mountain Health Plans	2026-08-01

CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

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

CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

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

CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

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

CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression 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 Gene Panel

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: 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 Transcripts

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.

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

Typical site of service: outpatient pediatric clinic, urgent care, emergency department, or hospital laboratory when a plasma sample is drawn and sent to the performing laboratory.

Service type: proprietary laboratory analysis (PLA) — analytic laboratory test performed and reported by the single-source manufacturer/lab for diagnostic risk scoring of Kawasaki Disease.

Typical clinical workflow:

The clinician documents signs and symptoms consistent with suspected KD and places the order for the HART KD® test.
A blood specimen is collected (plasma) and prepared per lab instructions; couriered to the performing laboratory if offsite.
The performing laboratory runs the proprietary assay, applies the algorithm, and issues a report with the KD risk score.
The ordering clinician reviews the report, integrates it with clinical and imaging data (for example, echocardiography), and documents decisions about IVIG therapy, cardiology referral, and follow-up monitoring.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0310U`	HART KD® (Prevencio Inc.) — Proprietary laboratory analysis reporting a risk score for Kawasaki Disease based on three plasma biomarkers and algorithmic analysis	Primary PLA code for the specific proprietary assay performed by the manufacturer or designated laboratory
`80053`	Comprehensive metabolic panel (CMP)	Commonly ordered alongside specialized PLA tests to assess general metabolic status and aid clinical evaluation in febrile pediatric patients
`85025`	Complete blood count (CBC) with automated differential	Routinely ordered in suspected KD to evaluate leukocytosis, anemia, and platelet counts; informs diagnosis and monitoring
`83970`	Cardiac enzyme assay (example: troponin)	May be ordered when there is concern for cardiac involvement; assists in evaluating myocardial injury in severe presentations
`93306`	Echocardiography, transthoracic, real-time with image documentation, complete	Performed to assess coronary artery dimensions and cardiac function in patients with suspected or confirmed KD; often ordered after lab results inform risk stratification
`96372`	Therapeutic injection, subcutaneous or intramuscular (e.g., for IVIG administration preparation may require injections)	Associated with treatment workflows when IVIG or adjunctive therapies are administered after diagnosis; included to reflect related interventional services

Related Modifiers

6 rows

Modifier	Description	When to Use
26	Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…	- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
52	Modifier ‑52 (Reduced Services) indicates that a service or procedure was partially reduced or omitted at the provider’s discretion, allowing reporting of the basic procedure number with a qualifier…	- Use modifier -52 when a physician or qualified health professional electively reduces or omits part of a procedure or service (for example, performing fewer required views or omitting a portion of…
53	Modifier 53 (Discontinued Procedure) signals that a surgical or diagnostic service was begun by the physician but terminated because of extenuating circumstances that threatened the patient’s…	- Use modifier -53 when a physician/qualified healthcare professional has started a surgical or diagnostic procedure (e.g., anesthesia administered, incision or scope insertion) and then discontinues…
62	Modifier 62 indicates that two surgeons function as co‑surgeons, each performing distinct parts of the same primary surgical procedure. It is appended to the primary procedure code (and any…	- Use modifier -62 when two surgeons act as co‑surgeons (both primary surgeons) on a single definitive primary procedure, each performing distinct parts of the same surgical procedure (append -62 to…
78	CPT modifier -78 indicates an unplanned, related return to the operating or procedure room by the same provider during the global postoperative period. It is appended when treatment for a…	- Use modifier -78 when an unplanned, related complication during the original procedure’s global postoperative period requires the patient to return to a formal operating or procedure room and the…
80	CPT® Modifier 80 (Assistant Surgeon) is appended to a surgical CPT code when a physician (MD or DO) provides full, continuous assistance throughout the operative procedure. It is intended only for…	- Use CPT Modifier -80 when a physician (MD or DO) serves as an assistant surgeon and provides full, continuous assistance throughout the entire operative procedure; append -80 to the surgical CPT…

Related Provider Taxonomies

8 rows

Taxonomy Code	Specialty	Notes
208000000X	Pediatrics Physician	A pediatrician is concerned with the physical, emotional and social health of children from birth to young adulthood. Care encompasses a broad spectru…
207Q00000X	Family Medicine Physician	Family Medicine is the medical specialty which is concerned with the total health care of the individual and the family. It is the specialty in breadt…
207L00000X	Anesthesiology Physician	An anesthesiologist is trained to provide pain relief and maintenance, or restoration, of a stable condition during and immediately following an opera…
111NP0017X	Pediatric Chiropractor	The Pediatric Chiropractor is a chiropractor with specialized, advanced training and certification in the evaluation, care and management of health an…
332000000X	Military/U.S. Coast Guard Pharmacy	A Department of Defense (DoD) or U.S. Coast Guard entity whose primary function is to store, prepare and dispense pharmaceuticals and other associated…
273Y00000X	Rehabilitation Hospital Unit	In general, a distinct unit of a general acute care hospital that provides care encompassing a comprehensive array of restoration services for the dis…
207RE0101X	Endocrinology, Diabetes & Metabolism Physician	An internist who concentrates on disorders of the internal (endocrine) glands such as the thyroid and adrenal glands. This specialist also deals with …
2085U0001X	Diagnostic Ultrasound Physician	A Radiology doctor of Osteopathy that specializes in Diagnostic Ultrasound.

Related Payer Policy Updates

Specialty: Genetic & Molecular Testing1 / 3

10 rows

Policy	Payer	Effective Date
RTM Testing of Homocysteine Metabolism-Related Conditions	Oscar Health	2026-10-01
Multimarker Serum Testing Related to Ovarian Cancer	Blue Cross Blue Shield - Rhode Island	2026-09-01
Genomic Profiling for Selecting Targeted Cancer Therapies	Blue Cross Blue Shield - Rhode Island	2026-09-01
Whole Exome and Whole Genome Sequencing for Diagnosis of Genetic Disorders	Blue Cross Blue Shield - Rhode Island	2026-09-01
Biomarker and Genetic/Molecular Testing Coverage and Prior Authorization	Blue Cross Blue Shield - Rhode Island	2026-09-01
Non-Invasive Prenatal Testing (NIPT)	univerahealthcare	2026-08-17
Lumizyme (alglucosidase alfa) — Pompe Disease (acid alpha‑glucosidase deficiency)	Cigna	2026-08-15
Molecular Oncology Testing for Solid Tumor Cancer Diagnosis, Prognosis, and Treatment Decisions	Colorado Rocky Mountain Health Plans	2026-08-01
Molecular Oncology Testing for Hematologic Cancer Diagnosis, Prognosis, and Treatment Decisions	Colorado Rocky Mountain Health Plans	2026-08-01
Carrier Testing Panels for Genetic Diseases	Colorado Rocky Mountain Health Plans	2026-08-01

CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

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

CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

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

CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

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

CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression 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 Gene Panel

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: 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 Transcripts

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 0310U: HART KD® Plasma Biomarker Panel for Kawasaki Disease

Sign up for cpt 0310U policy alerts

OpenPayer

CPT 0310U: HART KD® Plasma Biomarker Panel for Kawasaki Disease

Sign up for cpt 0310U policy alerts

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Payer Policy Updates

Related Codes

References

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Payer Policy Updates

Related Codes

References

CPT 0310U: HART KD® Plasma Biomarker Panel for Kawasaki Disease

Sign up for cpt 0310U policy alerts

CPT 0310U: HART KD® Plasma Biomarker Panel for Kawasaki Disease

Sign up for cpt 0310U policy alerts

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Payer Policy Updates

Related Codes

What does CPT 0310U represent and which test does it apply to?

Where is the HART KD® test typically performed and what type of service is it?

What is the clinical workflow for ordering and reporting the HART KD® (0310U) test?

Which billing modifiers are relevant for 0310U and when might they be used?

What related CPT and ICD-10 codes are commonly associated with the HART KD® test (0310U)?

References

Clinical & Coding Specifications

Clinical Context

Related CPT Codes

Related Modifiers

Related Provider Taxonomies

Related Payer Policy Updates

Related Codes

What does CPT 0310U represent and which test does it apply to?

Where is the HART KD® test typically performed and what type of service is it?

What is the clinical workflow for ordering and reporting the HART KD® (0310U) test?

Which billing modifiers are relevant for 0310U and when might they be used?

What related CPT and ICD-10 codes are commonly associated with the HART KD® test (0310U)?

References