Who has to pay after a code 114 denial?

Who owes depends on the details. The letters in front of the number matter: CO (contractual obligation) usually means an in-network provider must absorb it, while PR (patient responsibility) means the plan says you owe it.

How long do I have to appeal?

It depends on your coverage: 180 days for most employer and marketplace plans, 120 days for Original Medicare, about 90 days for Medicaid (varies by state), and only 65 days for Medicare Advantage. Set your deadline clock before you do anything else.

Denial code 114 · CO-114 / PR-114 · translated

Denial code 114: what it means — and how to fight it

Denial code 114 (shown on your EOB as CO-114 or PR-114) means: “Procedure/product not approved by the Food and Drug Administration.” In plain English: They're calling the treatment non-FDA-approved. Off-label use of approved drugs is often still coverable — and this denial is frequently wrong about the facts.

high appealability Who owes depends on the details

What they're really saying

“Procedure/product not approved by the Food and Drug Administration.”

They're calling the treatment non-FDA-approved. Off-label use of approved drugs is often still coverable — and this denial is frequently wrong about the facts.

Your odds

Strong — this type of denial has real weaknesses.

Off-label and compendium-supported uses win on external review regularly.

Fewer than 1 in 100 denied claims are ever appealed. When people do appeal, roughly 4 in 10 win the first round — and independent external review overturns 40–50% of what reaches it.

How to appeal a code 114 denial

Decode. You just did — this page is step one.
Set your clock. 180 days for most employer and marketplace plans, 120 for Original Medicare, ~90 for Medicaid, only 65 for Medicare Advantage.
Urgent? If this is care you still need, call and request an expedited appeal — they must decide within 72 hours.
Ask your doctor whether the use is FDA-approved, compendium-listed, or evidence-supported off-label. Verify actual FDA status. For off-label prescriptions: cite drug compendia listings and peer-reviewed support — many states require coverage of compendium-supported off-label uses, especially in cancer care.
Send it certified. Letter plus evidence, keep copies of everything.
Escalate. Denied again? Independent external review — a doctor who doesn't work for your insurer decides.

Do it in minutes, free

The AppealClock tool translates your denial, drafts your appeal letter, computes your exact deadline — and watches the clock so you don't have to. No account. Your medical details never leave your device.

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Common questions

What does denial code 114 mean?: They're calling the treatment non-FDA-approved. Off-label use of approved drugs is often still coverable — and this denial is frequently wrong about the facts.
Can I appeal a CO-114 or PR-114 denial?: Yes. Appealing is free and it is your legal right. For this code the odds are high: Off-label and compendium-supported uses win on external review regularly. Fewer than 1 in 100 denials are ever appealed — insurers count on silence.
Who has to pay after a code 114 denial?: Who owes depends on the details. The letters in front of the number matter: CO (contractual obligation) usually means an in-network provider must absorb it, while PR (patient responsibility) means the plan says you owe it.
How long do I have to appeal?: It depends on your coverage: 180 days for most employer and marketplace plans, 120 days for Original Medicare, about 90 days for Medicaid (varies by state), and only 65 days for Medicare Advantage. Set your deadline clock before you do anything else.