Alert detail

FDA Approval: REZZAYO (REZAFUNGIN) — Type 1 - New Molecular Entity

Policy ID: FDA-NDA217417Specialty: Infectious DiseaseAdded: 7/23/2026Effective: March 22, 2023billing update

Critical

What changed

New FDA drug approval. Coverage and billing pathway depend on the FDA label and applicable Medicare LCDs/NCDs — for very recent approvals the label may not be posted yet. Verify against the FDA label and current coverage policy before billing.

Who’s affected: Infectious Disease billing teams · Effective: March 22, 2023

Primary source: View the official CMS/MAC document ↗

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