Denial Code 114 means that a claim has been denied because the procedure or product billed has not been approved by the Food and Drug Administration (FDA). Below you can find the description, common reasons for denial code 114, next steps, how to avoid it, and examples.
2. Description
Denial Code 114 is a Claim Adjustment Reason Code (CARC) and is described as ‘Procedure/Product Not Approved by FDA’. This code indicates that the insurance company will not make the payment for the billed procedure or product because it has not received approval from the FDA. In other words, the insurance company does not consider the procedure or product to be medically necessary or safe.
2. Common Reasons
The most common reasons for denial code 114 are:
- Lack of FDA Approval: The primary reason for denial code 114 is that the procedure or product being billed has not received approval from the FDA. This could be due to the procedure or product being experimental, investigational, or not meeting the safety and efficacy standards set by the FDA.
- Off-Label Use: Denial code 114 may also occur when a procedure or product is being used for a purpose that is not approved by the FDA. Insurance companies typically only cover procedures and products that are used for their approved indications, and any off-label use may result in denial.
- Documentation Insufficiency: In some cases, denial code 114 may be triggered due to insufficient documentation supporting the medical necessity of the procedure or product. Insurance companies require detailed documentation to justify the use of certain procedures or products, and failure to provide this documentation can lead to denial.
- Policy Exclusions: Some insurance policies may have specific exclusions for certain procedures or products, regardless of FDA approval. If the procedure or product falls under one of these exclusions, denial code 114 may be applied.
3. Next Steps
You can address denial code 114 as follows:
- Review FDA Approval Status: First, verify the FDA approval status of the procedure or product being billed. If it has not received FDA approval, it may be necessary to explore alternative treatment options that are approved and covered by insurance.
- Appeal with Additional Documentation: If you believe that the procedure or product is medically necessary and should be covered by insurance, gather additional documentation to support your case. This may include research studies, clinical guidelines, or expert opinions that demonstrate the safety and efficacy of the procedure or product.
- Consult with the Provider: Engage in a discussion with the healthcare provider who performed or prescribed the procedure or product. They may be able to provide additional information or insights that can help in the appeal process.
- Submit an Appeal: Prepare a formal appeal letter outlining the reasons why you believe the procedure or product should be covered by insurance. Include the additional documentation gathered and any supporting statements from the healthcare provider. Submit the appeal to the insurance company for review.
- Follow Up: Keep track of the status of your appeal and follow up with the insurance company if necessary. Be prepared to provide any additional information or documentation that may be requested during the review process.
4. How To Avoid It
To avoid denial code 114 in the future, consider the following:
- Verify FDA Approval: Before undergoing a procedure or using a specific product, ensure that it has received FDA approval. This can be done by consulting with the healthcare provider or conducting independent research.
- Consult with Insurance: If you are unsure whether a procedure or product is covered by your insurance, contact your insurance provider and inquire about their coverage policies. They can provide information on any specific requirements or restrictions.
- Obtain Prior Authorization: For procedures or products that require prior authorization, make sure to obtain the necessary approval from your insurance company before proceeding. This will help ensure that the procedure or product is covered and minimize the risk of denial.
- Document Medical Necessity: Keep detailed records of your medical condition, treatment plans, and discussions with healthcare providers. This documentation can be useful in demonstrating the medical necessity of a procedure or product if it is ever questioned by the insurance company.
5. Example Cases
Below are two examples of denial code 114:
- Example 1: A patient undergoes a stem cell therapy procedure that has not yet received FDA approval. As a result, the insurance company denies the claim under denial code 114, stating that the procedure is not approved by the FDA.
- Example 2: A patient is prescribed a medication for a condition that is not listed as an approved indication by the FDA. The insurance company denies coverage for the medication, citing denial code 114.
