CARC 114: Procedure/Product Not FDA Approved

What it means

The payer denied this claim because the procedure, device, drug, or product billed is not approved by the FDA. Payers generally will not reimburse for items or services that lack FDA approval, are experimental/investigational, or are being used off-label in a way not recognized by the payer's coverage policy.

Common causes

Billing for a drug, device, or biologic that has not received FDA approval
Use of a product under an FDA investigational designation (e.g., IDE/IND) without proper billing modifiers or documentation
Off-label use of an FDA-approved drug/device for a condition or indication the payer does not recognize as covered
Incorrect or outdated HCPCS/CPT code that maps to a non-approved or experimental product
Missing documentation showing FDA approval status or clinical trial enrollment
Product still in clinical trial phase and billed as a standard covered service

How to fix it

Verify the FDA approval status of the exact product/procedure billed, including approved indications
Check whether the item was used under an approved clinical trial (may require different billing rules, such as modifier Q0/Q1 or specific ICD-10 codes for trial participation)
Confirm the correct HCPCS/CPT/NDC code was used and matches the FDA-approved product
Review the payer's medical policy for coverage of investigational or off-label uses
If billed in error, correct the code/product information and resubmit the claim
If the product is FDA-approved but was miscoded, submit a corrected claim with supporting documentation (FDA approval letter, package insert, etc.)
If part of a clinical trial with payer-approved coverage, submit required trial documentation and coding per payer/CMS clinical trial policy

Appeal / resubmit

If you believe the denial is incorrect, gather documentation proving FDA approval status (e.g., FDA approval letter, 510(k) clearance, or package insert) and the approved indication for use. If the service was part of a qualifying clinical trial, include trial protocol information and any payer-specific clinical trial coverage forms. Submit an appeal with a clear explanation and supporting records; note that inherently investigational or non-approved items typically are not covered regardless of appeal, so confirm approval status before proceeding.

Related codes

Frequently asked

Does this mean the procedure is unsafe?

No. This denial code strictly reflects the payer's rule that FDA-approved status is required for reimbursement; it does not comment on the clinical safety or efficacy of the product itself.

Can off-label use ever be billed successfully?

Some payers cover off-label use of FDA-approved drugs/devices if supported by clinical guidelines or compendia, but this varies by payer and policy. Check the specific payer's medical policy for off-label use criteria.

What if the product is part of an FDA clinical trial?

Clinical trial items may be billable under specific coding and modifier requirements per CMS or payer clinical trial policies. Documentation of trial enrollment is typically required.

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This content is informational only and does not constitute billing or legal advice. Coverage and appeal outcomes depend on payer-specific policies and documentation.