Alert detail
FDA Approval: NDA 221109 — Type 2 - New Active Ingredient
Policy ID: FDA-NDA221109Specialty: NeurologyAdded: 10/2/2026Effective: September 25, 2026federal register
What changed
Oral lamotrigine suspension bills under Part D; no J-code expected.
Who’s affected: Neurology billing teams · Effective: September 25, 2026
Primary source: View the official CMS/MAC document ↗
Get the action steps and full analysis
The full analysis, the revision comparison and the as-of-date version of this policy are what a partner packet carries. The source document above is free and always will be.