CO 114 denial code

Claim adjustment reason code 114. Often reported as CO 114 or PR 114.

Not approved by the FDA

Unofficial reference. This is our own plain-English explanation, not the official code text. Payer rules differ. Verify with the payer and the official X12 code list. AlphaPrefix is not affiliated with X12, CMS or any payer. Data last updated Nov 11, 2026.

What 114 means

The payer did not cover the procedure or product because it lacks the needed FDA approval.

The payer is saying the drug, device or procedure has not been approved by the FDA, or not for the way it was used. Many plans exclude unapproved items.

Off-label use and items under clinical trial rules can be handled differently. Check the payer's policy and whether any exceptions apply before you appeal.

Group codes seen with 114

On a remittance, 114 comes after a group code. These are the ones it is most often reported with:

• CO 114 (Contractual Obligation): The provider's side of the ledger. The reduction comes from the payer contract or a rule the provider has to follow, and the patient normally cannot be billed for it.
• PR 114 (Patient Responsibility): The amount is assigned to the patient. Deductibles, coinsurance and copays are the everyday examples. Whether you can collect it still depends on your contract and the patient's plan.

The payer chooses the group code for each adjustment, so the same reason code can appear with another group code on your remittance. Read the two together. More about group codes.

Common causes

• The device or drug used does not have FDA approval or clearance.
• The item was used for a purpose outside its approved labeling and the payer does not cover that use.
• The service was part of a clinical study and was not billed under the payer's study rules.

What to do next

1. Confirm the approval status of the drug or device for the use billed.
2. Check the payer's coverage policy for off-label or investigational use.
3. Appeal with approval documentation if the item is in fact approved for the indication.

Related codes

• 96 (reason code) Service not covered by the plan
• 50 (reason code) Not medically necessary per the payer