Multianalyte Assays with Algorithmic Analysis for the Evaluation and Monitoring of Patients with Chronic Liver Disease

By September 1, 2026: Billing team must update claim denial logic and documentation templates to classify all claims for HCV FibroSURE™ (FibroTest™), ASH FibroSURE™ (ASH Test), NASH FibroSURE™ (NASH Test), Elasto-FibroTest®, FibroSpect II, LiverFASt™ Test, and OWLiver® as investigational and non-covered. Providers must be instructed to: (1) Obtain signed Advanced Beneficiary Notice (ABN) or equivalent financial responsibility form from patients BEFORE ordering these tests, informing them the services are investigational and not covered; (2) Bill patients directly, not the insurance plan; (3) Update encounter documentation to reference the patient's informed consent. Update billing system to automatically deny any submitted claims for these specific tests with denial reason code for investigational services. Train all clinical and billing staff on the non-covered status. Failure to obtain prior patient consent and notification will result in provider liability for patient refund obligations and potential compliance violations.