Alert detail

FDA Approval: NDA 221443 — Type 4 - New Combination

Policy ID: FDA-NDA221443Specialty: Multi-specialtyAdded: 9/3/2026Effective: August 27, 2026federal register

Low

What changed

Gilead combo drug approved; billing pathway pending FDA label.

Who’s affected: Multi-specialty billing teams · Effective: August 27, 2026

Primary source: View the official CMS/MAC document ↗

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