Serum Testing for Evidence of Mild Traumatic Brain Injury
Customize your policy alerts
Sign up for Molina Healthcare Policy G2151 alerts
Get alerted when Policy G2151 changes without checking for updates manually.
Monitor payer policy activity
Defines Molina Healthcare's coverage stance on serum (and related fluid) biomarker testing for evaluation of mild traumatic brain injury, including individual markers and panels, and summarizes scientific background and guideline context for clinicians and payers.
Panel testing moved from CC1 into new CC2 for clarity; new CC2 states that panels designed to measure biomarkers of TBI DO NOT MEET COVERAGE CRITERIA.
Added CPT code 0570U (effective date 7/1/2025).
Updated the background, guidelines and recommendations, and evidence-based scientific references.
Coverage Determinations and Criteria
Coverage determinations
Covered when ALL of the following are met:
ALL of the following
- Biomarker testing for evaluation of mild traumatic brain injury (blood, saliva, or CSF)
Measurement of concussion markers (e.g., S100B, GFAP, UCH-L1) does not meet coverage criteria due to insufficient published evidence of clinical benefit.
- Panels designed to measure biomarkers of TBI
Panels (for example: i-STAT TBI Plasma, Alinity® i TBI) do not meet coverage criteria.
- Benefit verification
Application of coverage criteria depends on an individual's benefit coverage at the time of request; Medicare/Medicaid specifications are in the Applicable State and Federal Regulations section.
coverage_stance_and_criteria
Summarizes guideline positions, FDA clearances, and evidence limitations relevant to coverage decisions for serum biomarker testing in mTBI.
ALL of the following
Guideline positions
- Major society guidance notes limited or insufficient evidence for routine biomarker use
ACEP, CDC, VA/DoD, AMSM/other societies state biomarkers are not routinely recommended or should be limited to research/are of low evidence.
- Some guideline pathways acknowledge potential role to reduce CT use in selected adults
Certain bodies (e.g., ACEP, Scandinavian guideline via task force, American College of Surgeons) describe limited scenarios where S100B or GFAP/UCH-L1 may aid ruling out CT when combined with clinical decision rules, but emphasize limited data and unclear incremental value.
Regulatory status
- FDA-cleared assays available
FDA cleared i-STAT TBI Plasma (i-STAT/Alinity system) and Alinity® i TBI for use in adults within specified time windows (intended for aid with imaging decisions).
Evidence limitations
- Insufficient evidence of clinical utility across populations
Published literature is limited by variable sensitivity/specificity, uncertain incremental value over decision rules, limited pediatric data, and lack of consistent guideline incorporation for GFAP/UCH-L1.
ALL of the following
- Tests must be considered in context of individual's benefits
LDTs exist and are regulated under CLIA; FDA clearance is not required for clinical use of LDTs.
- Procedure coding and billing considerations
Referenced procedure codes include 83516, 84999, and CPT 0570U for GFAP/UCH-L1 assays; availability and intended use (e.g., within 12 hours for i-STAT) are noted in device labeling.
Non-covered: TBI biomarker panels (CC2)
Revision history and explicit non-coverage classification for panel testing.
Per policy revision, panels designed to measure biomarkers of TBI (for example: i-STAT TBI Plasma, Alinity® i TBI) DO NOT MEET COVERAGE CRITERIA.
CPT/HCPCS and Assay Coding
| i-STAT Alinity / Alinity i (device/tests referenced) | Platform-level references—Abbott i-STAT/Alinity assays measure UCH-L1 and GFAP; FDA 510(k) clearances noted |
| 83516 | Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method. |
| 84999 | Unlisted chemistry procedure. |
| 0570U | Neurology (traumatic brain injury), analysis of glial fibrillary acidic protein (GFAP) and ubiquitin carboxylterminal hydrolase L1 (UCHL1), immunoassay, whole blood or plasma, individual components reported with the overall result of elevated or non-elevated based on threshold comparison |
| 0570U | Newly added CPT code (effective 7/1/2025) included in policy |
Provider Actions, Billing Rules, and Denial Risk
Verify benefits; blood/saliva/CSF concussion markers not covered
Application of coverage criteria depends on the individual’s benefit coverage at time of request; verify member benefits and any Medicare/Medicaid specifications before ordering testing. Measurement of concussion markers in blood, saliva, or cerebrospinal fluid (e.g., S100B, GFAP, UCH‑L1) does not meet coverage criteria.
- Verify member benefits and applicable state/federal program rules at time of request.
Do not use or bill TBI biomarker panels (i‑STAT TBI Plasma, Alinity® i TBI)
Do not order or bill for panel tests designed to measure TBI biomarkers (examples explicitly named: i‑STAT TBI Plasma, Alinity® i TBI) because these panels do not meet coverage criteria.
- Panels measuring multiple TBI biomarkers are expressly excluded from coverage.
- Abbott i‑STAT/Alinity examples are listed as non‑covered panels.
Bill with appropriate procedure codes (83516, 84999, 0570U)
Use only the listed procedure codes for claims related to biomarker testing and ensure coding reflects the test performed: 83516 (immunoassay), 84999 (unlisted chemistry), and CPT 0570U (GFAP and UCH‑L1 assay).
- 0570U — Neurology (TBI), analysis of GFAP and UCH‑L1, immunoassay, whole blood or plasma, components reported with overall elevated/non‑elevated result.
- 83516 — Immunoassay for analyte other than infectious agent antibody/antigen.
- 84999 — Unlisted chemistry procedure.
- Reference to Abbott i‑STAT/Alinity FDA clearances for context (i‑STAT TBI Plasma; Alinity® i TBI).
Panels measuring TBI biomarkers (CC2) — not covered; expect claim denial
Panels designed to measure biomarkers of TBI are classified as non‑covered (Coverage Category 2); ordering or submitting claims for these panels will be denied per policy.
- Policy revision moved panel testing into CC2 with explicit non‑coverage language.
- Examples cited: i‑STAT TBI Plasma, Alinity® i TBI — DO NOT MEET COVERAGE CRITERIA.
Definitions and Biomarker Descriptions
Policy Revision Timeline
Reviewed and updated background, guidelines, and evidence references; literature review did not change coverage criteria; panels moved into new CC2 with explicit non-coverage language.
Added CPT code 0570U (neurology, GFAP and UCH-L1 assay) effective 2025-07-01 and included in coding section of the policy.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.