CO-114: Procedure/Product Not FDA Approved

What Does CO-114 Mean?

With CO (Contractual Obligation), the CARC 114 adjustment is the provider's responsibility. The payer denied or reduced payment because of the billed product, device, or drug does not have FDA approval for the specific indication or use that was billed, making it non-covered under the patient's plan. The patient is not liable for this amount. If the denial is in error, the provider can correct and resubmit the claim or file an appeal with supporting documentation.

CARC 114 indicates procedure/product not fda approved. The payer determined that the service or a portion of it does not meet coverage criteria under the patient's current plan benefits or the applicable coverage rules.

Common scenarios that trigger this adjustment include: the billed product, device, or drug does not have FDA approval for the specific indication or use that was billed, making it non-covered under the patient's plan; The product is FDA-approved for a different indication, but the off-label use is not covered by the payer's policy; The procedure is classified as experimental or investigational by the payer because it has not completed the FDA approval process. The group code paired with CARC 114 determines who bears the financial responsibility — CO places it on the provider as a contractual obligation, PR shifts it to the patient, OA indicates a coordination of benefits or other payer adjustment.

Common Causes

How to Resolve

1. Review the remittance details Examine the CO-114 adjustment and any accompanying RARC codes to identify the specific reason for the denial.
2. Identify the root cause Determine which issue applies: product or device not FDA approved for billed indication, off-label use of FDA-approved product without coverage, experimental or investigational procedure, among others.
3. Correct the claim Address the identified issue — update the claim data in your billing system to resolve the procedure/product not fda approved problem.
4. Resubmit the corrected claim Submit the corrected claim following the payer's resubmission guidelines. Include any supporting documentation that addresses the denial reason.
5. Appeal if the original claim was correct Appeal with FDA clearance documentation (510(k), PMA, or NDA approval letter) for the product and indication. If the use is off-label, provide compendium support (NCCN, DrugDex, etc.) and clinical evidence supporting the use. Include the correct product code and medical necessity documentation.

Common RARC Pairings

The RARC code tells you exactly what triggered the CO-114:

How to Prevent CO-114

• Verify FDA approval status of all products and devices before use and billing
• Maintain a reference list of FDA-approved products used in your practice with their approved indications
• Use correct HCPCS and NDC codes that accurately identify the FDA-approved product
• Check payer policies for off-label use coverage when planning non-standard treatments
• Obtain informed consent and ABN documentation before using non-FDA-approved products or off-label treatments

Also Filed As

The same CARC 114 may appear with different Group Codes:

Related Denial Codes