CO-114 denial code
Procedure or product not approved by the Food and Drug Administration
How to fix it
Confirm the product and indication. Appeal where approval exists for the use billed.
How to prevent it
Check FDA status and payer policy before administering high-cost drugs or devices.
In practice
A practice administers a biologic for an indication outside its approved labelling. The plan returns CO-114, stating the product is not approved for the use billed.
Off-label prescribing is lawful and often clinically appropriate, but coverage is a separate question. Plans generally cover approved indications and treat everything else as a matter for their own policy, which may or may not accommodate it.
The appeal depends on what the plan's policy says about off-label use. Many recognise compendia listings or published evidence as sufficient, and where the indication appears in a recognised compendium, citing it directly is usually the strongest available argument.
What sits behind it
The distinction between the product and the indication is what most appeals get wrong. The drug is approved; the use billed is not within the approved labelling. Arguing that the product has FDA approval misses the point the denial is making and will be answered with the same code again.
Compendia carry real weight in this area. Several drug compendia are recognised for coverage purposes, and a listing in one frequently establishes an off-label use as supported without needing to litigate the underlying literature. Checking them before treatment is faster than appealing after.
Because these products are expensive and the exposure is large, the useful control is upstream. Verifying coverage for the specific indication before administration, and obtaining authorisation where available, prevents a denial that can run to five figures on a single claim.
Related codes
Terms used here — Medical Necessity · Prior Authorization · Appeal
How we handle it — Prior Authorization · Denial Management · Medical Coding
Primary sources
The rules behind CO-114, at the bodies that publish them.
- Medicare Coverage Database (LCD/NCD) (opens in a new tab)
Centers for Medicare & Medicaid Services — Searchable national and local coverage determinations. The direct answer to whether a diagnosis supports medical necessity for a given procedure.
- Medicare Benefit Policy Manual (opens in a new tab)
Centers for Medicare & Medicaid Services — What Medicare covers and under what conditions, as distinct from how a claim is processed. The starting point for any coverage or medical necessity question.
- Advance Beneficiary Notice of Noncoverage (ABN) (opens in a new tab)
Centers for Medicare & Medicaid Services — The form and the rules for issuing it. Whether a non-covered service can be billed to the patient usually turns on whether a valid ABN was obtained beforehand.
Looking for a different code? Search all 190 CARC and RARC codes
Questions about CO-114
No. Many plans cover off-label indications supported by recognised drug compendia or published evidence, and their medical policy usually states which sources they accept. Checking that policy before administration is considerably cheaper than appealing a high-cost claim afterwards.
A listing for the indication in a compendium the plan recognises, cited directly. That establishes support without requiring the reviewer to weigh the primary literature, and it addresses the actual question — whether the use is supported — rather than restating that the product is approved.
CO-114 says the product lacks approval for the indication billed. CO-188 says the product is covered only when used according to FDA recommendations, which reaches dosing, route and administration conditions as well as indication. Both turn on conformity to labelling but at different points.
Find out what your denials are costing you
A free billing audit reviews your denial rate, AR aging and clean claim rate against industry benchmarks. Takes about two minutes to request. No sales pitch.
No setup fees · You pay when we collect · Pricing from 3% of net collections