CO-114 Denial: Not FDA Approved

CO-114 fires where a payer concludes a drug, device or procedure lacks FDA approval for the use billed. The commonest real situation is not an unapproved product but an approved product used off-label.

What CO-114 means

Off-label prescribing is lawful and routine, particularly in oncology, and coverage rules recognise it. Medicare and many commercial policies accept support from recognised drug compendia or peer-reviewed literature for off-label indications, which converts the question from what the label says to what the compendia say. Identifying the compendium entry supporting the use is usually the whole appeal.

Why CO-114 fires

An approved product was used for an indication outside its labelling.
A device was used outside its cleared indication.
The payer's policy limits coverage to labelled uses only.
A compendium supporting the use exists and was not cited in the request.

Is CO-114 worth appealing?

Often worth appealing

Distinguish unapproved from off-label. Where the use is off-label and supported by a recognised compendium or the literature, cite the specific entry — that is the standard most policies actually apply.

How to resolve or appeal CO-114

1
Confirm the regulatory status
Approved product used off-label, or genuinely unapproved — the appeals differ entirely.
2
Cite the compendium entry
By name and indication, not as a general assertion of support.
3
Add the clinical rationale
Why this patient, on this evidence, for this indication.

CO-114 — frequently asked

Is off-label use covered?

Often, where a recognised compendium or the peer-reviewed literature supports it. Oncology in particular is governed largely by compendia rather than by labelling.

What if nothing supports it?

Then the denial is likely to stand, and the honest conversation with the patient about that is better had early than after a long appeal.

Sources

Reason-code meanings are paraphrased from the X12 Claim Adjustment Reason Code list for plain-language reference; they are not reproduced verbatim. This is general information, not legal, coding, or medical advice — always confirm against the payer's remittance and policy.

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