CO-188Contractual ObligationMedical Necessity
CO-188 Denial Code: Product covered only per FDA recommendations
The product/procedure is covered only when used consistent with FDA-approved indications — this use wasn't.
Why CO-188 happens
- ●Off-label use billed to a plan that restricts to FDA labeling
How to fix a CO-188 denial
- 1
Appeal with compendia support if the off-label use is recognized (many plans accept compendium-listed uses)
- 2
Otherwise handle as non-covered with appropriate patient notice
How to prevent it
Check payer off-label policies before furnishing high-cost drugs for non-labeled indications.
Drowning in CO-188 denials?
OakClaim works every denial within 48 hours and builds prevention rules so they stop recurring.