CO-114: Procedure/Product Not FDA Approved

What Does CO-114 Mean?

CO-114 means the provider must absorb the denied amount because the payer considers the product or procedure non-FDA-approved. If the product is actually approved and the denial was issued in error (coding mistake, payer system not updated), the provider should appeal with FDA documentation. If the product is genuinely not approved, the provider writes off the amount and cannot bill the patient.

CARC 114 fires when a payer denies a claim because the billed procedure, device, drug, or biological product does not have FDA approval or clearance. The payer classifies the item as experimental, investigational, or non-compliant with regulatory standards, making it ineligible for reimbursement under the patient's coverage.

This denial does not always mean the product actually lacks FDA approval. Coding errors are a frequent cause — using a HCPCS, CPT, or NDC code that corresponds to a non-approved product when the product actually used was FDA-approved. Off-label use of an FDA-approved product is another common trigger: the drug or device has FDA approval for a specific indication but was administered for a different purpose that the payer does not cover. Additionally, newly FDA-approved products sometimes trigger CARC 114 because the payer's formulary or coverage system has not been updated to reflect the recent approval.

The Group Code determines the financial outcome. CO-114 means the provider absorbs the denied amount — this is typical when the payer's policy excludes the product regardless of the provider's or patient's actions. PR-114 shifts responsibility to the patient, usually when the patient elected to receive the non-approved treatment after being informed of the coverage risk. A properly executed Advance Beneficiary Notice (ABN) or financial responsibility form is critical in PR scenarios to support the patient billing.

Common Causes

How to Resolve

Verify the FDA approval status of the actual product used, determine if the denial was caused by a coding error or payer system lag, and appeal with FDA documentation or correct and resubmit.

1. Confirm FDA approval status Check the FDA databases (Orange Book for drugs, 510(k) database for devices) to verify the product's current approval status for the billed indication.
2. Check for coding mismatches Verify HCPCS, CPT, and NDC codes correctly represent the FDA-approved product used. A code that maps to an unapproved product will trigger this denial even when the right product was administered.
3. Gather FDA documentation If the product is approved, compile the FDA approval letter, product label, and database listing. For recently approved products, include the approval date to show the payer's system may not have been updated.
4. Support off-label use if applicable For off-label uses, gather compendium citations from AHFS Drug Information, DrugDex, or NCCN Clinical Practice Guidelines, plus peer-reviewed studies supporting the specific use.
5. File a comprehensive appeal Submit the appeal with FDA documentation, corrected codes, medical necessity evidence, and compendium citations. Reference CMS National Coverage Determinations if applicable.

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, devices, and biologicals before use, particularly for newer items or those with limited approved indications
• Maintain a reference database of FDA-approved products used in your practice and update it as new approvals are issued
• Ensure accurate coding that reflects the specific FDA-approved product used — verify HCPCS, NDC, and device codes
• Obtain prior authorization when using products that may be classified as experimental or investigational
• Document the FDA approval status and medical necessity in the clinical record for products that commonly trigger coverage disputes
• Train clinical and billing staff on the distinction between FDA-approved, off-label, and experimental products and their coverage implications

General Prevention

• Verify FDA approval status of all products, devices, and biologicals before use, particularly for newer items or those with limited approval indications
• Maintain a reference database of FDA-approved products commonly used in your practice and update it as new approvals are issued
• Obtain prior authorization from the payer when using products that may be close to the experimental/investigational boundary
• Ensure accurate coding that reflects the specific FDA-approved product used — verify HCPCS, NDC, and device codes match the actual product administered
• Document the medical necessity and FDA approval status clearly in the medical record, particularly for off-label uses
• Train clinical and billing staff on the distinction between FDA-approved, off-label, and experimental/investigational products and how each affects coverage

Also Filed As

The same CARC 114 may appear with different Group Codes:

Related Denial Codes