Cipaglucosidase Alfa-atga (Pombiliti™)

By September 30, 2026: (1) Billing team must implement prior authorization workflow for Pombiliti claims in the billing system. (2) Configure system to flag claims for prior auth review when Pombiliti is billed with Opfolda for late-onset Pompe disease treatment. (3) Providers and clinical staff must validate that prescribers are metabolic disease or lysosomal storage disorder specialists before processing claims. (4) Create authorization request template requiring: enzyme assay results (GAA <40% normal), genetic testing results if available, chart documentation of clinical signs/symptoms (proximal muscle weakness, respiratory insufficiency, cardiomyopathy), and evidence of inadequate response to prior ERT (Lumizyme, Nexviazyme). (5) For reauthorization requests, ensure clinical documentation demonstrates response (improvement, stabilization, or disease progression slowing). (6) Do not process claims without prior authorization—claims lacking required prior auth will be denied. (7) Update patient eligibility screens and denial management protocols to reflect Tennessee-specific requirements per TCA 56-7-2352.