How To Fix Denial Code 188 | Common Reasons, Next Steps & How To Avoid It

Denial Code 188 means that a claim has been denied because the product or procedure billed is not covered unless it is used according to FDA recommendations. Below you can find the description, common reasons for denial code 188, next steps, how to avoid it, and examples.

2. Description

Denial Code 188 is a Claim Adjustment Reason Code (CARC) and is described as ‘This product/procedure is only covered when used according to FDA recommendations’. This means that the insurance company will not make the payment for the billed product or procedure if it is not used in accordance with the recommendations set by the FDA. In simpler terms, the claim is denied because the product or procedure was not utilized as approved by the FDA.

2. Common Reasons

The most common reasons for denial code 188 are:

1. Off-Label Use: Denial code 188 often occurs when a product or procedure is used for a purpose that is not approved by the FDA. Insurance companies typically only cover products and procedures that are used according to the FDA’s recommendations. If the use of the product or procedure is considered off-label, the claim may be denied under code 188.
2. Lack of Medical Necessity: Another common reason for denial code 188 is a lack of medical necessity. Insurance companies require that products and procedures be medically necessary in order to provide coverage. If the insurer determines that the use of the product or procedure was not medically necessary, the claim may be denied under code 188.
3. Missing or Inadequate Documentation: Claims may be denied under code 188 if there is missing or inadequate documentation to support the use of the product or procedure according to FDA recommendations. Insurers often require detailed documentation to verify that the product or procedure was used appropriately.
4. Non-Compliance with FDA Recommendations: Denial code 188 can also occur if the provider or facility does not comply with the FDA’s recommendations for the use of the product or procedure. This could include using the product or procedure in a manner that is not consistent with the FDA’s approved guidelines.
5. Incorrect Coding and Billing Information: Errors in coding and billing information can also lead to denial code 188. If the product or procedure is not accurately coded or billed, the insurer may deny the claim under code 188.

3. Next Steps

You can address denial code 188 as follows:

1. Review FDA Recommendations: First, review the FDA’s recommendations for the use of the product or procedure in question. Ensure that the product or procedure was utilized in accordance with these guidelines.
2. Evaluate Medical Necessity: Assess the medical necessity of the product or procedure. Determine if there is sufficient documentation to support its use as medically necessary. If necessary, gather additional documentation to strengthen the case for medical necessity.
3. Provide Detailed Documentation: Ensure that all documentation related to the use of the product or procedure is complete and accurate. Include any relevant clinical notes, test results, or other supporting evidence that demonstrates compliance with FDA recommendations.
4. Appeal the Denial: If the claim is denied under code 188, prepare an appeal. Clearly outline the reasons why the product or procedure was used in accordance with FDA recommendations and provide any additional documentation or evidence to support your case. Submit the appeal to the insurance company for reconsideration.
5. Engage in Communication: If there is confusion or disagreement regarding the use of the product or procedure, engage in communication with the insurance company. Discuss the specifics of the claim and provide any necessary clarification or additional information to support your position.
6. Adjust Coding and Billing Practices: Based on the outcome of the denial, consider adjusting coding and billing practices to ensure accurate representation of the product or procedure. This may involve additional training for coding staff or implementing processes to verify compliance with FDA recommendations.

4. How To Avoid It

You can prevent denial code 188 in the future by taking the following steps:

1. Stay Informed: Stay up to date with the FDA’s recommendations for the use of products and procedures. Regularly review any updates or changes to ensure compliance.
2. Educate Providers: Educate providers and staff on the importance of using products and procedures according to FDA recommendations. Provide training on proper utilization and documentation requirements.
3. Document Appropriately: Ensure that all documentation related to the use of products and procedures is complete, accurate, and supports compliance with FDA recommendations. Include detailed clinical notes, test results, and any other relevant information.
4. Verify Medical Necessity: Before utilizing a product or procedure, verify that it is medically necessary for the patient. Document the medical necessity in the patient’s records.
5. Code and Bill Accurately: Ensure that products and procedures are accurately coded and billed. Use the appropriate codes and provide detailed descriptions to accurately represent the utilization of the product or procedure.

5. Example Cases

Below are two examples of denial code 188:

• Example 1: A provider submits a claim for a medication that is typically used to treat one condition but is being used off-label for a different condition. The claim is denied under code 188 because the off-label use is not covered unless it is used according to FDA recommendations.
• Example 2: A facility bills for a surgical procedure that is not considered medically necessary for the patient’s condition. The claim is denied under code 188 because the procedure does not meet the criteria for coverage according to FDA recommendations.

Source: Claim Adjustment Reason Codes