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CPT 0441U: IntelliSep® Sepsis Risk Assessment
CPT code 0441U designates the IntelliSep® Proprietary Laboratory Analyses (PLA) test from Cytovale, a semiquantitative biomechanical assay that uses deformability cytometry on a whole‑blood sample to produce an algorithmic index estimating a patient’s likelihood of developing sepsis. As a PLA code, 0441U is specific to a single manufacturer’s test and is used when reporting this unique diagnostic service. Nationally, such specific PLA codes matter because they enable distinct tracking, reimbursement, and clinical utilization of novel laboratory diagnostics for critical conditions like sepsis.
Key payers addressed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the code’s clinical purpose and service setting, plus benchmarking information where available, payer coverage context, and relevant policy considerations that affect adoption and billing for proprietary assays. The publication summarizes clinical context for sepsis risk assessment, standard reporting expectations for a PLA test, and common billing elements associated with reporting 0441U.
This summary is intended for clinicians, laboratory administrators, and billing managers seeking a clear, national-level understanding of the CPT code 0441U, its clinical application, and its place in payer coverage and policy discussions.
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Billing Code Overview
CPT code 0441U is a Proprietary Laboratory Analyses (PLA) code reported only for the IntelliSep® test from Cytovale®. The test is a semiquantitative biomechanical assessment using deformability cytometry on a whole‑blood sample to generate an algorithmic index that categorizes a patient’s likelihood of developing sepsis.
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Service type: Proprietary laboratory diagnostic test with algorithmic interpretation
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Typical site of service: Clinical laboratory or hospital laboratory performing the IntelliSep® whole‑blood assay