Summary & Overview
CPT 0458U: Auria® Tear‑Fluid ELISA for S100A8/S100A9 Risk Score
CPT code 0458U is a Proprietary Laboratory Analyses (PLA) code that identifies Auria®, a tear‑fluid ELISA from Namida Lab Inc. measuring proteins S100A8 and S100A9 and producing an algorithmic risk score for potential breast cancer. As a PLA code, 0458U is specific to a single manufacturer's test and signals the use of a proprietary biomarker plus computational analysis in clinical decision support. Nationally, such PLA codes matter because they represent precision diagnostics that can influence screening and diagnostic pathways and raise questions about coverage policies, clinical utility evidence, and laboratory billing practices.
Key payers discussed include Aetna, Blue Cross Blue Shield plans, Cigna, UnitedHealthcare, and Medicare. Readers will find a concise overview of the code's clinical context, typical service setting, and payer landscape. The publication outlines benchmarks and coverage considerations relevant to proprietary biomarker tests, summarizes policy and reimbursement themes commonly applied by major payers, and situates the test within current diagnostic workflows for breast cancer risk evaluation. Data not available in the input will be noted where specific coverage or utilization figures would normally appear.
Billing Code Overview
CPT code 0458U is a Proprietary Laboratory Analyses (PLA) code that applies to a single, specific laboratory test: Auria® from Namida Lab Inc. The test is an enzyme–linked immunosorbent assay (ELISA) performed on a tear‑fluid specimen to evaluate the proteins S100A8 and S100A9. An algorithmic analysis of those protein measurements produces a risk score intended to inform decisions about whether to pursue further diagnostic evaluation for breast cancer.
Service type: Proprietary laboratory diagnostic test (PLA), biomarker assay with algorithmic risk scoring.
Typical site of service: Clinical laboratory or reference laboratory setting; specimen collection can occur in outpatient clinics or specialty offices capable of tear‑fluid sampling.
Clinical & Coding Specifications
Clinical Context
A 52-year-old woman presents to a specialty breast clinic for risk stratification after an equivocal screening mammogram and a family history of breast cancer. She is asymptomatic but requests additional, noninvasive testing to help guide shared decision-making about whether to proceed with diagnostic imaging (diagnostic mammography, ultrasound) or short-interval follow-up. The clinic collects a tear-fluid specimen in the outpatient clinic during the visit. The specimen is sent to Namida Lab Inc. for analysis by the proprietary Auria® assay, which uses an ELISA to measure S100A8 and S100A9 levels and an algorithm to generate a risk score indicating likelihood of underlying breast malignancy. The test report is returned to the ordering clinician who incorporates the risk score into the diagnostic plan; additional procedures (imaging, biopsy) are ordered as indicated by the score and clinical judgment.
Typical service type: Proprietary Laboratory Analysis (PLA) of a biologic specimen using an immunoassay with algorithmic risk scoring.
Typical site of service: Outpatient clinic or ambulatory specialty clinic (specimen collection) with testing performed at the manufacturer’s or reference laboratory.
Typical patient workflow: patient encounter and consent → tear-fluid collection by clinic staff → specimen shipping → laboratory ELISA and algorithmic analysis → result transmitted to ordering clinician → care plan adjusted (imaging, biopsy, surveillance) based on risk score.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Modifier not recognized for standard CMS use (placeholder) | Rarely used; do not apply unless payer-specific guidance requires an explicit placeholder. |
22 | Increased procedural services | Use when work, time, or complexity substantially exceeds typical for specimen collection or reporting when documented.
26 | Professional component | Use when billing only the professional interpretation/analysis portion if separate technical component is billed by the laboratory (rare for PLA codes; use per payer rules).
52 | Reduced services | Use when testing is partially reduced or limited (e.g., incomplete specimen) with documentation.
53 | Discontinued procedure | Use if specimen collection was attempted but discontinued for documented clinical reasons.
54 | Surgical care only | Not typically applicable; include only if a surgeon bills for a component of the encounter separate from the lab service.
55 | Postoperative management only | Not typically applicable for PLA testing; use only if billing relates solely to post-op care.
62 | Two surgeons | Uncommon for this procedure; include only per payer policy in complex multidisciplinary billing scenarios.
80 | Assistant surgeon | Uncommon for this outpatient collection; use only if an assistant performed a billable portion of the encounter per payer rules.
82 | Assistant surgeon (when qualified resident unavailable) | As above, rarely applicable.
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services for assistant at surgery | Not typical for PLA testing; include only under special billing scenarios.
TC | Technical component | Use when billing only the laboratory (technical) component of the test; common when the performing lab bills separately from the ordering provider.
QK | Medical direction of two, three, or four concurrent anesthesia procedures | Not applicable to this test; included in list but not commonly used.
QX | CRNA service with medical direction | Not applicable to this test.
Associated provider taxonomies
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207Q00000X | Clinical Laboratory Scientist/Technologist | Performs or oversees laboratory testing and ELISA operations. |
208D00000X | Pathology | Pathologists may interpret complex laboratory results and oversee algorithmic risk reporting.
207L00000X | Medical Laboratory Technologist | Responsible for specimen handling and assay execution in the performing laboratory.
363LP0800X | Breast Surgery | Ordering clinicians who may use the risk score to determine need for biopsy or surgical consultation.
207P00000X | Oncology | Medical oncologists who may use risk stratification data when evaluating patients with suspected or known breast disease.
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
R92.8 | Other abnormal and inconclusive findings on diagnostic imaging of breast | Used when imaging is indeterminate and additional noninvasive risk stratification is sought. |
R92.1 | Nonspecific abnormal results of breast imaging, screening mammogram | Applicable when screening mammography yields a non-definitive finding prompting adjunctive testing.
Z80.3 | Family history of malignant neoplasm of breast | Relevant for patients seeking additional risk assessment due to family history.
N63 | Unspecified lump or mass in breast | Used when a palpable abnormality exists and adjunctive biomarkers may inform further diagnostic steps.
Z12.31 | Encounter for screening mammogram for malignant neoplasm of breast | May be used when risk stratification is performed in the context of screening follow-up.
C50.919 | Malignant neoplasm of unspecified site of breast, female | Relevant when confirmed malignancy is part of the differential and risk scoring contributes to evaluation decisions.
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0458U | Auria® (Namida Lab Inc.) tear-fluid ELISA for S100A8 and S100A9 with algorithmic risk score for breast cancer | Primary PLA code describing the proprietary assay and report; billed by the performing laboratory. |
36415 | Collection of venous blood by venipuncture | Commonly performed for concurrent laboratory tests or additional biomarkers ordered at the same visit; not a replacement for tear-fluid collection.
99000 | Handling and/or conveyance of specimen for transfer from the patient to the laboratory | Used per payer policy when specific specimen handling fees are billable for nonstandard specimen transport (check payer rules).
99070 | Supplies and materials provided by the physician over and above those usually included with the office visit | May be used by the ordering clinic if special collection kits or supplies are billed separately under payer policy.
85025 | Complete blood count (CBC) with automated differential | Example of routine laboratory testing that may be ordered alongside risk stratification in the diagnostic workup of a patient with suspected malignancy.