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.
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). |
TC | Technical component | Use if billing only the technical component (laboratory performing the test). |
59 | Distinct procedural service | Use if reporting a separately identifiable lab procedure on same day that is unrelated to the PLA test. |
90 | Reference (outside) laboratory | Use when specimen is sent to an outside/reference laboratory for testing. |
91 | Repeat clinical diagnostic laboratory test | Use when same test is repeated on the same day for confirmation per payer policy. |
CG | Item/service delivered electronically, clinical diagnostic laboratory test | Use per payer rules when applicable for electronic delivery of results (payer-specific). |
WC | Workers' compensation | Use when services are related to a workers' compensation claim. |
25 | Significant, separately identifiable E/M service by the same physician on the same day | Use if an E/M visit is separately documented and medically necessary in addition to ordering the test. |
RT | Right side | Use if laterality reporting is required by payer for associated procedures (rare for blood-based tests). |
LT | Left side | Use if laterality reporting is required by payer for associated procedures (rare for blood-based 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. |
Related Diagnoses
| 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. |
Related CPT Codes
| 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. |