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CARC 114 · CO-114

CARC 114 Denial: Procedure/product not approved by the Food and Drug Administration — How to Fix and Appeal

Reviewed by QuickIntell RCM Editorial Team · Last reviewed

Updated

TL;DR

CARC 114 (X12 Procedure/product not approved by the Food and Drug Administration). CARC 114 denies a procedure/drug that lacks FDA approval for the indication or device.

Official X12 description

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

Source: X12 Claim Adjustment Reason Codes. The X12 External Code Lists are the single authoritative source for every CARC descriptor — always verify against the current release before building a claim-scrub rule.

What CARC 114 actually means

CARC 114 denies a procedure/drug that lacks FDA approval for the indication or device. Usually implies the service is experimental/investigational — similar to CARC 55 for practical purposes.

Common root causes

  • Drug/device off-label or pre-approval.
  • Investigational device/therapy.

Prevention checklist

  • FDA-approval check in the medical-policy workflow before service.

Appeal strategy — step by step

Most CARC 114 denials clear faster with the right remediation than with a formal appeal. Work the steps in order and escalate only when a lower-effort path has been ruled out.

  1. 1Appeal with peer-reviewed literature and FDA filings if approval exists for the indication.
Sample appeal-letter language for CARC 114
[Provider letterhead] Re: Appeal of CARC 114 — Claim #{claim_number} Member: {member_name} · Member ID: {member_id} Date(s) of Service: {dos} On {remittance_date} this claim was adjusted with CARC 114: "Procedure/product not approved by the Food and Drug Administration." We respectfully request reconsideration. The X12 External Code List definition of CARC 114 does not apply to this claim for the following reasons: 1. [Cite the clinical / coding / policy fact that rebuts the adjustment] 2. [Cite the supporting documentation attached — op note, EOB, LCD/NCD citation, NCCI edit indicator, modifier rationale] 3. [Cite the payer's own policy where applicable] Attached: {list supporting documents} Please process payment under the member's benefits. If additional information is required, contact the billing office at {provider_phone} or {provider_email}. Sincerely, {billing_manager_name}, {credentials}

Edit the bracketed fields before sending. This template is a starting point; a payer-specific appeal form may still be required — check the provider portal first.

Payer-specific notes

Payer-specific behavior for CARC 114 publishes here as the QuickIntell anonymized denial ETL ingests sufficient volume. In the meantime, consult the payer directory for the relevant provider manual and appeal form.

How common is CARC 114?

Search demand rank
#136

Out of 306 seeded CARCs, ranked by combined US monthly search volume for "CARC 114", "CO-114 denial", and "denial code 114".

Platform frequency
Pending ETL

Platform frequency ranks publish once the anonymized denial-rate pipeline reaches the publication threshold (strategy §12 Phase 2).

How QuickRCM prevents CARC 114

QuickRCM catches the root causes above before the 837 leaves the clearinghouse:

  • Claim-scrub rules fire on every root cause listed above — the scrub references the same X12 CAS segment logic that drives the denial, so what the payer checks, QuickRCM checks first.
  • When a denial lands, QuickRCM routes it to the correct worker with the documentation bundle already attached (op note, LCD citation, modifier rationale, EOB, primary 835).
  • Appeal templates tuned to each CARC (including this one) pull the supporting facts from the claim and fill the bracketed fields automatically.
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Frequently asked questions — CARC 114

What does CARC 114 mean?

CARC 114 is an X12 Claim Adjustment Reason Code. The official definition is: "Procedure/product not approved by the Food and Drug Administration." In plain English, the payer is telling you cARC 114 denies a procedure/drug that lacks FDA approval for the indication or device. Usually implies the service is experimental/investigational — similar to CARC 55 for practical purposes.

How do I resolve a CARC 114 (CO-114) denial?

Start with the most common root cause: Drug/device off-label or pre-approval. First step: Appeal with peer-reviewed literature and FDA filings if approval exists for the indication. See the full remediation and appeal checklist on this page before filing a formal appeal.

Is CARC 114 patient responsibility?

No — CARC 114 is typically carried under CO (Contractual Obligation) or OA (Other Adjustment), which means it is the provider's responsibility, not the patient's. Do not bill the patient unless the 835 CAS group code is PR.

What does CARC 114 look like on an EOB or 835 remittance?

On the 835 ERA, CARC 114 appears in Loop 2110 CAS segment as "CAS*CO*114*{amount}". On a paper EOB the same code prints in the Adjustment/Denial Reason column with the X12 description: "Procedure/product not approved by the Food and Drug Administration." — usually paired with one or more RARC remark codes in the same remittance line for additional context.

Which RARC is paired with CARC 114?

CARC 114 is commonly observed with RARC N115. The RARC narrows the reason — for example, pointing at a missing modifier, an LCD citation, or a specific policy. Fix the underlying CARC first; the RARC usually clears with the corrected claim.

Disclaimer

This page is operational reference for medical-billing professionals. It is not legal, clinical, or contractual advice. X12 code descriptors are maintained by the X12 External Code Lists; always verify against the current X12 release and the payer's own published policy before submitting or appealing a claim.