Summary & Overview
CPT 0344U: OWLiver® Serum Lipid Panel for NASH Risk
CPT code 0344U is a PLA code for the OWLiver® proprietary serum lipid panel from CIMA Sciences LLC. The test measures 28 lipid biomarkers by LC–MS/MS and uses an algorithm to categorize results as not NASH or at risk for NASH. As a PLA code, 0344U identifies a single manufacturer-specific assay, which affects coding, billing transparency, and payer review policies nationally. The code matters because it represents a growing class of algorithm-driven laboratory diagnostics used to stratify patients for nonalcoholic steatohepatitis risk, with implications for diagnostic pathways and utilization.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of national coverage considerations, common billing modifiers, and clinical context for use of the OWLiver® test. The publication summarizes where the service is typically performed, the clinical purpose of the assay, and the implications of PLA coding for prior authorization and claim adjudication workflows. Data not available in the input are noted where applicable. This briefing is intended to inform billing managers, laboratory directors, and policy analysts about the coding and clinical positioning of CPT code 0344U.
Billing Code Overview
CPT code 0344U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the OWLiver® test from CIMA Sciences LLC. The assay analyzes a serum specimen for 28 lipid biomarkers using liquid chromatography with tandem mass spectrometry (LC–MS/MS) and applies an algorithmic interpretation to report results as not nonalcoholic steatohepatitis (NASH) or at risk for NASH.
Service Type: Laboratory diagnostic test — proprietary serum lipid panel with algorithmic interpretation
Typical Site of Service: Clinical laboratory or reference testing laboratory; specimen collected in an outpatient or ambulatory phlebotomy setting
Clinical & Coding Specifications
Clinical Context
A 52-year-old patient with obesity, type 2 diabetes mellitus, and persistently elevated liver enzymes is seen in hepatology clinic for evaluation of suspected nonalcoholic fatty liver disease (NAFLD). The clinician orders the proprietary OWLiver® serum lipidomic test (0344U) from CIMA Sciences LLC to noninvasively assess risk of nonalcoholic steatohepatitis (NASH). A fasting blood specimen is collected at an outpatient laboratory or hospital phlebotomy service (typical site of service: outpatient infusion/clinic or hospital outpatient laboratory). The specimen is processed and shipped per the laboratory’s instructions; testing is performed by LC–MS/MS with algorithmic analysis. Results are reported as either “not NASH” or “at risk for NASH,” which the clinician uses alongside imaging, labs, and clinical assessment to guide further management such as referral for specialty care, consideration of liver biopsy, or serial monitoring.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier (baseline) | Use when no additional reporting modifier applies; report 0344U alone for the OWLiver® test. |
26 | Professional component | Use when reporting only the professional component of the test if the laboratory separates technical and professional components. |
TC | Technical component | Use when reporting only the technical component of the test if billed separately. |
52 | Reduced services | Use when the laboratory performed a limited or partial version of the assay resulting in reduced services. |
53 | Discontinued procedure | Use if testing was started but discontinued for reasons beyond the lab’s control and documentation supports discontinuation. |
59 not provided | Data not available in the input. | Data not available in the input. |
62 | Two surgeons or providers | Use when two qualified providers share responsibility for the test interpretation under allowed circumstances (rare for PLA tests). |
78 | Return to operating room | Use when applicable to a surgical episode; generally not applicable to this lab test but included in list of available modifiers. |
80 | Assistant surgeon | Use when an assistant surgeon is involved; generally not applicable to this lab test. |
82 | Assistant not available | Use when assistant services are performed by another qualified provider; generally not applicable here. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207Q00000X | Gastroenterology | Hepatologists and gastroenterologists commonly order and interpret NASH risk testing. |
| 208000000X | Internal Medicine | Primary care physicians manage metabolic risk factors and order noninvasive liver tests. |
| 207L00000X | Infectious Disease | Infectious disease specialists may be involved when evaluating liver disease differential, although less common. |
| 207K00000X | Family Medicine | Family medicine clinicians frequently order tests for metabolic liver disease in outpatient settings. |
| 261QM2500X | Clinical Pathology | Laboratory physicians and pathologists oversee testing, QA, and result interpretation workflows. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
E66.9 | Obesity, unspecified | Obesity is a major risk factor for NAFLD and NASH; often present in patients tested with 0344U. |
E11.9 | Type 2 diabetes mellitus without complications | Diabetes increases risk of progressive fatty liver disease and is commonly seen in patients evaluated with the OWLiver® assay. |
K76.0 | Fatty (change of) liver, not elsewhere classified | Clinical diagnosis indicating hepatic steatosis; noninvasive tests including 0344U aid risk stratification. |
K75.81 | Nonalcoholic steatohepatitis (NASH) | Target condition for the test; 0344U reports likelihood of NASH to inform further management. |
R74.0 | Nonspecific elevation of levels of transaminase and lactic acid dehydrogenase | Elevated liver enzymes often prompt ordering of NASH risk testing such as 0344U. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
80053 | Comprehensive metabolic panel | Commonly performed before or alongside 0344U to assess liver enzymes and metabolic status. |
82043 | Assay of bile acids (quantitative) | Performed in differential evaluation of liver dysfunction; may be ordered in broader metabolic workup. |
83655 | Lipoprotein, direct measurement, HDL cholesterol | Lipid panel components often ordered concurrently to evaluate metabolic risk that relates to NAFLD/NASH. |
84443 | Assay of thyroid stimulating hormone (TSH) | Thyroid dysfunction is part of metabolic assessment affecting liver disease risk and is often obtained in the workup. |
88305 | Level IV surgical pathology, gross and microscopic examination | If 0344U and other noninvasive testing indicate high risk for NASH, a liver biopsy with pathology coding such as 88305 may follow for definitive histologic diagnosis. |