CARC 188CO · Contractual Obligation

The payer only covers this product or procedure when it's used consistent with its FDA-approved indication, and this claim didn't meet that criteria.

Common causes
The product or drug was used off-label or outside the dosing or indication approved by the FDA.
Suggested fix
Confirm the usage matches FDA-approved labeling; if it was medically necessary off-label use, submit supporting literature and documentation on appeal.

Related Contractual Obligation codes

Frequently asked questions

What does CARC 188 mean?

The payer only covers this product or procedure when it's used consistent with its FDA-approved indication, and this claim didn't meet that criteria.

How do I resolve CARC 188?

Confirm the usage matches FDA-approved labeling; if it was medically necessary off-label use, submit supporting literature and documentation on appeal.

Why does CARC 188 happen?

The product or drug was used off-label or outside the dosing or indication approved by the FDA.

CARC codes maintained by X12 (x12.org). Descriptions on this site are original reference interpretations. Always verify codes with authoritative sources before making billing decisions.