CO-188: Product/Procedure Not Covered Unless FDA-Recommended
The product was used off-label. Appeal with FDA indication documentation or compendium citations supporting the use.
What Does CO-188 Mean?
With CO (Contractual Obligation), the payer determined the product was not used in accordance with FDA recommendations and the provider bears the contractual cost. Appeal with documentation of the FDA-approved indication or compendium-supported off-label use.
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.
Common Causes
| Cause | Frequency |
|---|---|
| Off-label use of drug or device The product was used in a manner not approved or recommended by the FDA, and the payer requires FDA-approved use for coverage | Most Common |
| Product used for non-FDA-approved indication The drug, device, or product was used to treat a condition or indication that is not among the FDA-approved uses | Most Common |
| Missing documentation of FDA-approved use The claim did not include documentation confirming the product was used in accordance with FDA recommendations | Common |
| Compendium-supported use not recognized by payer The off-label use is supported by an approved compendium but the payer does not recognize this as equivalent to FDA recommendation | Occasional |
How to Resolve
- Verify the indication Confirm whether the product was used for an FDA-approved indication for the patient's diagnosis.
- Gather compendium support If off-label, search approved medical compendia for documentation supporting the use.
- Appeal with evidence Submit FDA-approved indication documentation or compendium citations with the appeal.
- Reference Medicare policy if applicable For Medicare claims, cite the Medicare Benefit Policy Manual provisions for compendium-supported uses.
Appeal with documentation of the FDA-approved indication for which the product was used, or provide compendium citations supporting the off-label use. For Medicare, reference the Medicare Benefit Policy Manual provisions for compendium-supported uses.
Common RARC Pairings
The RARC code tells you exactly what triggered the CO-188:
| RARC | Description |
|---|---|
| N130 | You may need to review plan documents or guidelines Review the payer's policy on FDA-approved use requirements for this product → |
| N381 | Consult your contractual agreement for restrictions Check contract terms regarding off-label use coverage and compendium requirements → |
How to Prevent CO-188
- Verify FDA-approved indications before using products that may have coverage restrictions
- Document the FDA-approved indication on the claim when using products with off-label potential
- Obtain prior authorization for off-label uses that may require compendium support
- Stay current on payer policies regarding off-label use and compendium requirements
- Include appropriate diagnosis codes that align with the FDA-approved indication
Also Filed As
The same CARC 188 may appear with different Group Codes:
Related Denial Codes
Sources
- https://www.mdclarity.com/denial-code-carcs
- https://x12.org/codes/claim-adjustment-reason-codes
- https://portal.ct.gov/-/media/ohs/health-it-advisory-council/apcd-advisory-group/data-submission-guide-workgroup/meeting-materials/6-30-22/carc-codes_final.pdf
- https://medicaid-documents.dhhs.utah.gov/Documents/pdfs/ClaimDenialCodes.pdf
- Codes maintained by X12. Visit x12.org for official definitions.