188Denial Code (CARC)Active
CO 188 Denial Code: FDA Recommendation Compliance
Code 188 indicates that the claim was denied because the product or procedure is only covered when used according to FDA recommendations. This means that the payer believes the usage of the product or procedure does not align with those guidelines.
Who Pays: Group Code Liability
Typically, with code 188, the group code CO applies, meaning the provider must write off the charge and cannot bill the patient. However, if the service was not covered due to patient-specific reasons, PR might apply, making it patient responsibility.
Why Claims Get Code 188
- The procedure was performed in a manner not approved by the FDA.
- The product was used off-label, outside of FDA recommendations.
- Documentation did not clearly support FDA-approved use.
- The claim lacked sufficient detail to verify FDA-compliant use.
- The payer's system did not recognize the service as FDA-approved for the condition treated.
How to Fix & Resubmit
- Review the claim and supporting documentation to ensure the procedure aligns with FDA recommendations.
- Verify whether the product or procedure was indeed used according to FDA guidelines.
- If FDA-compliant, gather supporting documentation such as clinical notes or FDA approval letters.
- Contact the payer to verify their interpretation and discuss the denial if the usage was FDA-compliant.
- Submit a corrected claim with additional documentation, or appeal if the usage was appropriate per FDA guidelines.
Corrected Claim or Appeal?
Submit a corrected claim if you can provide evidence that the procedure was used according to FDA recommendations. If the denial was due to a misunderstanding, formally appeal with comprehensive documentation.
Preventing Future 188 Denials
- Ensure all procedures and products are used strictly per FDA recommendations to avoid denials.
- Train staff to document usage according to FDA guidelines thoroughly.
- Regularly review FDA guidelines and payer policies for covered procedures.
- Implement a checklist for FDA compliance before claim submission.