CommercialPrior AuthMedium impact
Bezlotoxumab (Zinplava) (CPB 0914, reviewed 2026-01-07)
Aetna·Infectious Disease, Gastroenterology, Internal Medicine +2 more·Medical Policy
Effective date
Jan 7, 2026
We identified it
Aug 12, 2026
Summary
Aetna has updated its clinical policy for Bezlotoxumab (Zinplava) to establish coverage criteria for reducing recurrence of Clostridium difficile infection (CDI) in high-risk patients aged 1 year and older. The policy requires specific medical necessity criteria including confirmed CDI diagnosis, documentation of high-risk factors, and concurrent use with standard-of-care antibiotics. Repeat administration is considered experimental and not covered.
Action Required
By January 7, 2026: Billing team must implement prior authorization requirements for Bezlotoxumab (HCPCS J0565) when billed with infusion administration codes (CPT 96365-96366). Create a verification checklist requiring documentation of: (1) patient age ≥1 year; (2) confirmed CDI diagnosis with positive stool test within 7 days; (3) evidence of at least one high-risk factor (age ≥65, long-term antibiotics, prior CDI in past 6 months, immunocompromised status, severe CDI per Zar score ≥2, or hypervirulent strain ribotypes 027/078/244); (4) concurrent standard-of-care antibiotic therapy. Update billing software to flag and reject claims for repeat Bezlotoxumab administration as experimental/not covered. Train providers and billing staff that Zinplava is NOT for CDI treatment but only for recurrence prevention. Failure to obtain required documentation and prior authorization will result in claim denials.