114Denial Code (CARC)Active
CO 114 Denial Code: FDA Approval Issues & Fixes
Code 114 indicates that the procedure or product billed is not approved by the Food and Drug Administration (FDA). This means the payer has denied payment because the service or item is not FDA-approved, which is a requirement for coverage by many insurance plans.
Who Pays: Group Code Liability
For code 114, the group code is typically CO, meaning the provider must write off the charge as a contractual obligation, and the patient cannot be billed for this service or item.
Why Claims Get Code 114
- Billing for a drug or device that has not received FDA approval.
- Using an FDA-approved drug or device for an off-label use that is not covered by the payer.
- Submitting a claim for a procedure that is experimental and not FDA-approved.
- Incorrectly coding a service that suggests it is not FDA-approved when it is.
- Claiming for a service that is FDA-approved but lacks necessary documentation to prove it.
How to Fix & Resubmit
- Verify if the billed procedure or product has FDA approval. Check documentation and FDA status.
- Review the payer's policy to confirm if off-label use is covered under any circumstances.
- Ensure that the service was coded correctly and matches an FDA-approved indication.
- If the procedure or product is FDA-approved, gather supporting documentation and submit a corrected claim.
- If the service is genuinely not FDA-approved, write off the charge per contractual obligation.
Corrected Claim or Appeal?
Submit a corrected claim if the procedure or product is FDA-approved and was denied in error. Appeal only if you have documentation supporting FDA approval or covered off-label use. If the denial is valid (non-FDA approved), no appeal is possible.
Preventing Future 114 Denials
- Verify FDA approval status of procedures and products before billing.
- Ensure documentation clearly supports FDA-approved use cases.
- Train staff on payer policies regarding FDA approval and off-label uses.
- Regularly update billing systems with current FDA approval information.