Berinert (C1 esterase inhibitor, human) (Revised)

By December 15, 2024: Billing team must configure billing system to require prior authorization for Berinert (HCPCS J7633) for all Humana Medicare Advantage, Traditional Medicare Part B, Medicaid-Kentucky, and Medicaid-South Carolina claims. Update claim submission templates and provider ordering forms to include documentation fields for: (1) HAE Type 1 or 2 diagnosis, (2) lab values including C4 level, C1INH antigenic or functional level or C1INH mutation documentation, (3) C1q level from lab report, (4) documentation of recurrent angioedema without urticaria, (5) confirmation of specialist treatment (allergist or immunologist), (6) exclusion of medications causing angioedema (ACEIs, ARBs) and other angioedema causes. For Medicare Part B claims: Add requirement to document prior treatment/contraindication/intolerance to generic icatibant or indicate continuation within 365 days (exemption applies). For Medicaid claims: Remove step-therapy requirement for icatibant. Communicate policy changes to all providers and clinical staff who prescribe Berinert. Claims submitted without proper prior authorization and required documentation will be denied. Update internal knowledge base and training materials for billing and authorization staff.