Alert detail

FDA Approval: BIXLENVO (BICTEGRAVIR/LENACAPAVIR) — Type 4 - New Combination

Policy ID: FDA-NDA221104Specialty: Infectious DiseaseAdded: 9/3/2026Effective: August 27, 2026federal register

Low

What changed

Oral HIV combo BIXLENVO routes through Part D; no J-code needed.

Who’s affected: Infectious Disease billing teams · Effective: August 27, 2026

Primary source: View the official CMS/MAC document ↗

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