CO-114Contractual ObligationMedical Necessity
CO-114 Denial Code: Procedure/product not FDA approved
The payer denies because the drug, device, or procedure lacks FDA approval (or was used outside an approved pathway).
Why CO-114 happens
- ●Investigational device or drug billed to a payer that excludes them
- ●Compounded or imported product without approval status
How to fix a CO-114 denial
- 1
If the product is approved, appeal with the FDA listing and product documentation
- 2
For trial-related services, bill per the clinical-trial coverage rules (Q0/Q1 modifiers, trial registry number)
How to prevent it
Verify approval/coverage status before furnishing novel products to insured patients.
Drowning in CO-114 denials?
OakClaim works every denial within 48 hours and builds prevention rules so they stop recurring.