Alert detail
FDA Approval: OPZELURA (RUXOLITINIB) — Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
Policy ID: FDA-NDA215309Specialty: DermatologyAdded: 7/8/2026Effective: 2021-09-21federal register
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: Dermatology billing teams · Effective: 2021-09-21
Primary source: View the official CMS/MAC document ↗
Get the action steps and full analysis
Subscribers get the recommended action (“what to do”), the full AI analysis, the LCD revision comparison, and related alerts across your specialty and jurisdiction.
Not ready to subscribe?
Get the free weekly reimbursement brief for Dermatology— the week’s changes and deadlines, delivered to your inbox. No account required.