Zemaira® (alpha-1 proteinase inhibitor) (Revised)

By January 1, 2026: Billing team must implement prior authorization requirement for all Zemaira claims under Medicare and Medicaid (Kentucky and South Carolina) plans. Update billing system to flag Zemaira requests for prior auth review. Create clinical criteria checklist for authorization staff requiring verification of: (1) congenital alpha-1 antitrypsin deficiency diagnosis with clinically evident emphysema, (2) confirmed phenotype (PiZZ, PiZ(null), or Pi(null,null)), and (3) serum alpha-1 antitrypsin levels below 57 mg/dL (nephelometry) or 80 mg/dL (radial immunodiffusion). Ensure pre-authorization screening identifies and excludes IgA-deficient members with anti-IgA antibodies. Train authorization personnel to deny coverage for PiMZ or PiMS phenotypes and experimental/investigational indications not supported by CMS compendia. Route all Zemaira pharmacy billing through prior authorization workflow before claim submission. Coordinate with providers to obtain required baseline phenotype and serum level documentation. Claims submitted without prior authorization approval will be denied. Reference the full policy on Humana's website before processing each claim, as this is a controlled document subject to updates.