CPT 0440U PrecisionCHD Reimbursement & Policy | OpenPayer

Summary & Overview

CPT 0440U: PrecisionCHD Proprietary Molecular Diagnostic Assay for CHD

Headline: New PLA Code for PrecisionCHD™ Flags Proprietary Molecular Test for Coronary Heart Disease

Lead: CPT code 0440U designates a proprietary laboratory assay — PrecisionCHD™ from Cardio Diagnostics Inc. — that uses whole‑blood qPCR and digital PCR to evaluate 10 SNPs and six DNA methylation markers and reports an algorithmic result of detected or not detected for coronary heart disease. The code formalizes billing for this single‑manufacturer test and has implications for laboratory reimbursement, payer coverage policies, and clinical adoption.

Why it matters nationally: Proprietary laboratory analyses increasingly shape precision medicine pathways; a unique CPT code like 0440U allows clearer identification of utilization and reimbursement for a specific commercial CHD risk test across payers. Stakeholders will monitor coverage decisions and claims coding consistency as adoption evolves.

Key payers covered: Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.

What readers will learn: This publication provides benchmarks for payer coverage and reimbursement practices, summarizes clinical context for a genomic/epigenetic CHD assay, outlines coding and billing considerations associated with a PLA code, and highlights policy and utilization questions payers and providers may address. Data not available in the input will be noted where applicable.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0440UCPTProprietary Laboratory AnalysisPrecisionCHDMolecular DiagnosticqPCRdigital PCRcoronary heart diseasegenetic testing

Billing Code Overview

CPT code 0440U is a Proprietary Laboratory Analyses (PLA) code that applies only to a single, manufacturer-specific test: PrecisionCHD™ from Cardio Diagnostics Inc. The test analyzes a whole‑blood sample using quantitative polymerase chain reaction (qPCR) and digital PCR to assess 10 single‑nucleotide polymorphisms (SNPs) and six DNA methylation markers in specified genes. An algorithmic analysis generates a result reported as detected or not detected for coronary heart disease (CHD).

Service type: Genetic/epigenetic molecular diagnostic test (proprietary laboratory assay)

Typical site of service: Clinical laboratory or reference laboratory using whole‑blood collection

Data not available in the input.

Clinical & Coding Specifications

Clinical Context

A 55-year-old patient with intermediate clinical risk factors for coronary heart disease (CHD) presents to a primary care clinic concerned about future cardiovascular risk. The clinician performs a cardiovascular risk assessment and, after discussion of testing options, orders the PrecisionCHD™ test (0440U) to refine risk stratification. A whole-blood sample is collected in the outpatient clinic or a specimen collection center and sent to the performing laboratory. The lab performs quantitative polymerase chain reaction (qPCR) and digital PCR analysis of 10 single–nucleotide polymorphisms and six DNA methylation markers, then applies the proprietary algorithm to generate a detected/not detected result for CHD. The lab report is returned electronically to the ordering clinician, who documents the result in the medical record, incorporates it into the patient’s risk profile, and communicates findings and follow-up plans to the patient. Typical sites of service include outpatient physician offices, ambulatory collection centers, and clinical laboratories. Common payer interactions include prior authorization review and claims submission under the Proprietary Laboratory Analyses (PLA) code 0440U with applicable modifiers such as 00, 22, 52, or 53 when appropriate.

Coding Specifications

Modifier	Description

CPT 0184U: Navigator DO Sequencing for Dombrock Blood Group Typing

CPT-0559U-MAMMOCHECK-BF9-ELISA-BREAST-CANCER-SERUM-ASSAY

CPT 0559U: MammoCheck BF9 Antigen ELISA for Breast Cancer Monitoring

CPT-0271U-CONGENITAL-NEUTROPENIA-NGS-PANEL

CPT 0271U: Congenital Neutropenia Panel, 24-gene NGS

CPT-0239U-FOUNDATIONONE-LIQUID-CDX-NGS-LIQUID-BIOPSY

CPT 0239U: FoundationOne Liquid CDx NGS Liquid Biopsy Panel

CPT-0038U-SENSIEVA-25-OH-VITAMIN-D2-D3-LC-MSMS

CPT 0038U: Sensieva Droplet 25‑OH Vitamin D2/D3 LC–MS/MS Assay

CPT-0320U-TUTEVA-TRANSCRIPTOME-REJECTION-RISK-ASSAY

CPT 0320U: Tuteva™ NGS Transcriptome Assay for Kidney Transplant Rejection

CPT-0554U-SMART-PGT-SR-EMBRYO-CHROMOSOMAL-ANALYSIS

CPT 0554U: Smart PGT–SR 24-Chromosome Embryo Analysis

CPT-0518U-SYNCVIEW-PAIN-PLASMA-LC-MSMS-PANEL

CPT 0518U: SyncView Pain Plasma LC–MS/MS Drug Panel

CPT-0260U-OPTICAL-GENOME-MAPPING-AUGUSTA-OGM

CPT 0260U: Optical Genome Mapping for Chromosomal Structural Variant Detection

CPT-0598U-INFOODS-IBS-IGG-MICROARRAY-IMMUNOASSAY

CPT 0598U: inFoods® IBS IgG Food Antibody Microarray Test

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Taxonomy Code	Specialty	Notes
207RC0000X	Clinical Pathology	Laboratory directors and clinical pathologists who oversee molecular diagnostic testing.
207RP1001X	Molecular Genetic Pathology	Specialists who validate and interpret molecular assays like qPCR/digital PCR.
207L00000X	Clinical Laboratory	Technologists and laboratories performing high-complexity testing.
208D00000X	Cardiovascular Disease	Ordering cardiologists who use results for CHD risk stratification.
207Q00000X	Medical Genetics	Geneticists who may be involved in interpretation of SNP and methylation marker panels.

ICD-10 Code	Description	Clinical Relevance
Data not available in the input.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Often performed immediately prior to `0440U` for obtaining the whole-blood specimen.
`81025`	Urinalysis, non-automated, with microscopy	May be ordered in the same preventive or diagnostic visit for cardiovascular risk evaluation when metabolic assessment is done concurrently.
`80061`	Lipid panel (cholesterol, LDL, HDL, triglycerides)	Commonly ordered alongside `0440U` to provide standard cardiovascular risk markers.
`82570`	Creatinine; blood	Frequently performed with cardiac risk workups to assess renal function influencing cardiovascular risk and medication decisions.
`83036`	Hemoglobin A1c	Often obtained with CHD risk assessment to evaluate glycemic control and cardiometabolic risk factors.

`00`	No modifier — standard reporting	Use when submitting the routine technical and professional components as applicable without special circumstances.
`22`	Increased procedural services	Use when the laboratory documents significantly greater effort or complexity in test performance or interpretation beyond typical workflow.
`52`	Reduced services	Use when the test is partially reduced or only a subset of the standard test was performed.
`53`	Discontinued procedure	Use when specimen processing or testing was started but discontinued for valid clinical reasons.
`59`	Distinct procedural service	Use when another unrelated laboratory or clinical service is reported on the same date and needs to be identified as distinct.
`76`	Repeat procedure by same provider	Use when the same laboratory repeats the `0440U` testing on the same patient for the same reason.
`77`	Repeat procedure by another provider	Use when a different lab repeats the testing on the same patient for the same reason.
`RT`	Right side	Rarely applicable; generally not used for this blood-based test but included for completeness where laterality reporting systems require it.
`LT`	Left side	Rarely applicable; generally not used for this blood-based test but included for completeness where laterality reporting systems require it.
`26`	Professional component	Use when billing for the professional interpretation component separately from the performing lab’s technical component, if applicable.
`TC`	Technical component	Use when billing only for the technical component of the test performed by the laboratory.
`Q0`	Investigational clinical service FDA clinical trial	Use when the test is part of an FDA-regulated clinical trial and meets `Q0` criteria.
`Q2`	Billing arrangement requires use of modifier for laboratory	Use when payer contract or billing guidance requires reporting this modifier for proprietary laboratory analyses.

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