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CO-114 Denial Code: Not FDA Approved

CO-114 means the payer denied the service because the procedure, drug, device, or product was not approved by the Food and Drug Administration, or was not used in a way the payer recognizes as approved. Under CO, the provider absorbs the charge unless the patient agreed in advance to pay.

Quick facts

Code
CO-114 (CARC 114)
Status
Active In use since January 1, 1995.
Code set
Claim Adjustment Reason Codes (CARC)
Group codes
  • CO (Contractual Obligation): The provider is liable. The patient generally cannot be billed unless a valid advance notice or waiver was signed before the service.
  • PR (Patient Responsibility): The patient accepted financial responsibility in advance, or the plan treats the exclusion as a member liability. Confirm before billing.
Official description
Procedure/product not approved by the Food and Drug Administration.
X12 Claim Adjustment Reason Codes, retrieved September 25, 2026
Last verified
against the official X12 list.

What CO-114 means

CARC 114 says the procedure/product was not approved by the Food and Drug Administration. Payers generally require drugs, biologics, and devices to have FDA approval or clearance before covering them. When the payer’s policy or records show no approval for what you billed, it denies the claim with CARC 114.

The denial can also occur when an approved product is used with equipment, in a setting, or for a trial period the payer does not accept. Remark codes like M102 or M61 narrow it down.

Example: a practice bills a device that has not received FDA clearance. The payer denies the line with CO-114. Unless the patient signed a financial waiver beforehand, the practice absorbs the cost.

Common causes

  • The product is investigational and has no FDA approval or clearance.
  • The approval number required by the payer was missing or invalid on the claim.
  • The billed HCPCS code or NDC maps to a product the payer’s file shows as unapproved.
  • The service was performed on equipment not approved for that use.
  • A clinical trial’s approval period ended before the date of service.
  • The product was compounded or imported in a way that falls outside FDA approval.

How to fix it

  1. Verify the product’s FDA status and gather the approval or clearance documentation.
  2. Check the claim coding. If the NDC or HCPCS code was wrong, send a corrected claim with resubmission code 7 in box 22 and the right identifiers.
  3. Add a missing approval number if the payer requires one, then resubmit as the payer instructs.
  4. Appeal with documentation if the product is approved and the payer’s determination is wrong.
  5. If the product is not approved, write off the charge under CO, or bill the patient only when a valid advance notice or waiver was signed before the service.

How to prevent it

  • Confirm FDA status and payer coverage before using new drugs or devices, especially recent market entries.
  • Keep NDC-to-HCPCS mappings current so claims identify the approved product.
  • Obtain advance notices when coverage is doubtful, and use the payer’s required modifiers.
  • Review payer medical policies on investigational services. For a framework, see medical claim denials and their preventable causes.

Specialty notes

DME suppliers and practices administering drugs in the office see this most. Make sure the device or drug supplied matches what the payer’s coverage policy lists.

Remark codes that may appear with CO-114

  • MA128 (Missing/incomplete/invalid FDA approval number.): The FDA approval number is missing, incomplete, or invalid on the claim.
  • M102 (Service not performed on equipment approved by the FDA for this purpose.): The service was not performed on equipment approved by the FDA for that purpose.
  • M61 (We cannot pay for this as the approval period for the FDA clinical trial has expired.): The approval period for an FDA clinical trial has expired.
  • CO-55 (Procedure/treatment/drug is deemed experimental/investigational by the payer.): The treatment is considered experimental or investigational by the payer.
  • CO-56 (Procedure/treatment has not been deemed 'proven to be effective' by the payer.): The treatment has not been proven effective by the payer.
  • CO-188 (This product/procedure is only covered when used according to FDA recommendations.): The product is covered only when used according to FDA recommendations, an off-label use issue.
  • CO-96 (Non-covered charge(s).): The general non-covered charge code.

CO-114 FAQ

Does CO-114 apply to off-label drug use?

Payers vary. Off-label use of an FDA-approved drug is often reported with CARC 188 instead. CARC 114 usually means the product or procedure itself lacks FDA approval, or the payer could not confirm it.

Can I appeal CO-114?

Yes, if the product has FDA approval or clearance and the payer's records are wrong. Send proof such as the approval or clearance number and product labeling.

Can I bill the patient after CO-114?

Only if the patient signed a valid advance notice or financial waiver before the service and the group code or your contract permits it.