Summary & Overview

CPT 0624U: TruD MDS NASH DNA Methylation Blood Test

CPT code 0624U is a Proprietary Laboratory Analyses (PLA) code designated for the TruD MDS NASH assay from TruDiagnostic™ Inc., a whole-blood molecular test that evaluates DNA methylation at 5,000 sites and reports a binary risk result for nonalcoholic steatohepatitis (NASH). PLA codes identify single-source, manufacturer- or lab-specific tests and are important for payers and providers because they signal proprietary assays with unique clinical and coverage considerations. Nationally, PLA codes like 0624U matter for access to advanced molecular diagnostics, lab reimbursement policy, and payer coverage pathways.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical purpose of the test, typical service setting, and what payers commonly consider when evaluating coverage for single-source molecular diagnostics. The publication also outlines expected benchmarking topics and policy issues readers can expect to see in deeper sections, including coverage criteria, coding guidance, billing nuances for PLA tests, and implications for hepatology practice. Data not available in the input is noted where payer-specific coverage determinations, common modifiers, associated taxonomies, ICD-10 mappings, related billing codes, and service line details are not provided.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0624UCPTProprietary Laboratory AnalysesNASHDNA methylationMolecular diagnosticTruDiagnosticHepatologyLaboratory testing

Billing Code Overview

CPT code 0624U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the TruD MDS NASH test from TruDiagnostic™ Inc. The test analyzes DNA methylation at 5,000 sites using a whole blood sample and reports results via an algorithm as a positive or negative risk for nonalcoholic steatohepatitis (NASH).

Service Type: Laboratory — Molecular/Genetic Diagnostic Test (proprietary PLA)

Typical Site of Service: Clinical laboratory or reference lab using whole blood specimens

Data not available in the input.

Clinical & Coding Specifications

Clinical Context

A typical patient is an adult with obesity, type 2 diabetes, metabolic syndrome, or unexplained elevated liver enzymes who is being evaluated for risk of nonalcoholic steatohepatitis (NASH). A primary care physician, hepatologist, or metabolic specialist orders the proprietary TruD MDS NASH test (0624U) when noninvasive assessment of NASH risk is desired to guide monitoring or referral decisions. The workflow: the clinician documents clinical history and indications, obtains a whole blood sample in the laboratory or clinic setting, sends the specimen to TruDiagnostic™ Inc. under the laboratory’s ordering and shipping procedures, and receives a report indicating a positive or negative risk result based on DNA methylation at ~5,000 sites. Results are reviewed in follow-up visit or via secure portal; positive risk results may prompt further noninvasive testing (imaging elastography, fibrosis biomarkers) or referral to hepatology, while negative results can support routine monitoring. Typical site of service is an outpatient clinic, physician office, ambulatory laboratory, or hospital outpatient lab where phlebotomy is performed and specimens are shipped to the performing lab.

Coding Specifications

Modifier	Description	When to Use
`26`	Professional component	Use if billing only the physician interpretation when applicable for lab consults (rare for PLA tests).

Taxonomy Code	Specialty	Notes
207Q00000X	Family Medicine	Primary care clinicians who commonly order NASH risk testing and supervise specimen collection.
207R00000X	Internal Medicine	Internists managing metabolic disease and liver-related risk assessment.
207L00000X	Gastroenterology	Gastroenterologists/hepatologists who interpret results and determine liver-specific follow-up.
208100000X	Clinical Pathology	Pathologists or laboratory medicine physicians overseeing testing, quality, and reporting.
363L00000X	Phlebotomy/Lab Technologist	Clinical laboratory personnel performing specimen collection and processing logistics.

ICD-10 Code	Description	Clinical Relevance
`K76.0`	Fatty (change of) liver, not elsewhere classified	Common indication for NASH risk assessment and monitoring.
`K75.81`	Nonalcoholic steatohepatitis (NASH)	Directly related diagnosis the test aims to detect risk for clinically.
`E11.9`	Type 2 diabetes mellitus without complications	Diabetes is a major risk factor for NAFLD/NASH and commonly co-diagnosed.
`E66.9`	Obesity, unspecified	Obesity increases risk for NAFLD/NASH and frequently prompts testing.
`R74.0`	Nonspecific elevation of transaminase and lactic dehydrogenase	Abnormal liver enzymes often trigger further evaluation including molecular risk testing.

CPT Code	Description	Relationship to This Procedure
`80061`	Lipid panel	Common laboratory test ordered in metabolic evaluation alongside NASH risk assessment.
`84439`	Assay of insulin or insulin resistance markers (insulin)	Ordered when assessing metabolic contributors to fatty liver disease.
`82172`	Alpha-fetoprotein (AFP)	Used in hepatology workups when liver disease is suspected; may be part of broader testing.
`91200`	Hepatic elastography (FibroScan)	Noninvasive imaging for liver stiffness often used following a positive molecular NASH risk test.
`83036`	Hemoglobin A1c	Assessed concurrently to evaluate glycemic control related to NASH risk.

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