OA-188: Product/Procedure Not Covered Unless FDA-Recommended

What Does OA-188 Mean?

With OA (Other Adjustments), the FDA-approved use issue was identified during coordination of benefits. Different payers may have different policies on off-label use coverage. Review each payer's policy to determine coverage.

CARC 188 indicates that the drug, device, or product billed on the claim was used for a purpose or indication that the FDA has not approved, and the payer's coverage policy requires FDA-recommended use. Many payers restrict coverage to FDA-approved indications to ensure they are paying for evidence-based treatments.

However, off-label use is not always uncoverable. Medicare and many commercial payers recognize off-label uses that are supported by approved medical compendia (such as NCCN Drugs & Biologics Compendium, Micromedex DrugDex, or AHFS Drug Information). If the off-label use has compendium support, it may be covered through an appeal with proper documentation.

How to Resolve

1. Review each payer's off-label policy Determine whether each payer in the COB chain covers compendium-supported off-label uses.
2. Submit to the payer with the most favorable policy If one payer covers compendium-supported uses, submit documentation to that payer.
3. Appeal with compendium citations Provide compendium documentation to the payer that denied the claim.

How to Prevent OA-188

• Verify off-label use coverage with all payers before treatment
• Obtain prior authorization for off-label uses from each payer as needed

Also Filed As

The same CARC 188 may appear with different Group Codes:

Related Denial Codes