Alert detail
FDA Approval: ISOVUE READI (IOPAMIDOL) — Type 5 - New Formulation or New Manufacturer
Policy ID: FDA-NDA220583Specialty: RadiologyAdded: 10/17/2026Effective: October 9, 2026federal register
What changed
Oral iopamidol reformulation follows Part D, not Part B injectable path.
Who’s affected: Radiology billing teams · Effective: October 9, 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.