Alert detail
FDA Approval: ISEMBYLD (APITEGROMAB-MSTN) — Type 1 - New Molecular Entity
Policy ID: FDA-BLA761463Specialty: NeurologyAdded: 9/17/2026Effective: September 11, 2026billing update
What changed
New orphan injectable; Part B pathway, permanent J-code pending.
Who’s affected: Neurology billing teams · Effective: September 11, 2026
Primary source: View the official CMS/MAC document ↗
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