Coverage Criteria vs. Clinical Reality: Navigating Medicaid Barriers to Tirzepatide Access

Abstract: Medicaid beneficiaries often face barriers to accessing evidence-based metabolic therapies, even as U.S. Food and Drug Administration (FDA) indications for agents such as tirzepatide expand. Although tirzepatide is approved for type 2 diabetes (T2D), obstructive sleep apnea (OSA), and obesity, some state Medicaid programs apply diagnosis-based restrictions that do not align with FDA labeling or clinical practice. We describe a 34-year-old woman with obesity, T2D, and OSA who experienced repeated denials for tirzepatide under Ohio Medicaid, despite meeting FDA-approved criteria for multiple indications. Diagnostic silos, contradictory exclusion rules, and inconsistent authorization pathways delayed treatment for six months, requiring multiple appeals, peer-to-peer reviews, and a state hearing before approval. This case illustrates how rigid coverage criteria can override clinical judgment and impede timely treatment. Variation across Medicaid programs limits access to glucagon-like peptide-1 (GLP-1)–based therapies. Aligning coverage with FDA labeling is essential to ensuring equitable, patient-centered care for underserved populations.