CARC 114 Active

OA-114: Procedure/Product Not FDA Approved

TL;DR

Adjustment in a COB or secondary payer context. Review the coordination of benefits details to determine the responsible party.

Action
Review & Decide
Who Pays
Depends
Appeal
No
Patient Impact
Indirect
Disclaimer
This content is for informational purposes only and does not constitute professional billing advice. Always verify information against your payer contracts and current coding guidelines. Consult a certified billing specialist for specific claim issues.

What Does OA-114 Mean?

When paired with Group Code OA, CARC 114 (Procedure/Product Not FDA Approved) is processed as an adjustment outside the standard CO/PR classifications. This typically occurs in secondary payer or coordination of benefits scenarios. Review the remittance details and the COB arrangement to determine financial responsibility and appropriate next steps.

CARC 114 indicates procedure/product not fda approved. The payer determined that the service or a portion of it does not meet coverage criteria under the patient's current plan benefits or the applicable coverage rules.

Common scenarios that trigger this adjustment include: the billed product, device, or drug does not have FDA approval for the specific indication or use that was billed, making it non-covered under the patient's plan; The product is FDA-approved for a different indication, but the off-label use is not covered by the payer's policy; The procedure is classified as experimental or investigational by the payer because it has not completed the FDA approval process. The group code paired with CARC 114 determines who bears the financial responsibility — CO places it on the provider as a contractual obligation, PR shifts it to the patient, OA indicates a coordination of benefits or other payer adjustment.

How to Resolve

  1. Review the coordination of benefits Examine the OA-114 adjustment to understand how it fits within the primary/secondary payer relationship or other multi-payer context.
  2. Verify primary payer adjudication Review the primary payer's EOB to understand the basis for the secondary payer's OA adjustment.
  3. Determine the responsible party Based on the COB review, identify whether the adjustment should be absorbed, billed to another payer, or if additional documentation is needed.
  4. Appeal or resubmit if needed If the OA adjustment appears incorrect based on the COB arrangement, submit an appeal or corrected claim with the appropriate documentation.
  5. Follow up Monitor the claim status and take additional action as needed based on the COB determination.
Do Not Appeal This Code

Procedure/Product Not FDA Approved grouped under OA is an Other Adjustment that doesn't fall into the standard contractual write-off or patient responsibility categories. Whether action is needed depends on the specific reason — review any accompanying RARC codes and payer guidance to decide whether this is a final adjustment to accept or an issue to resolve through resubmission.

How to Prevent OA-114

Also Filed As

The same CARC 114 may appear with different Group Codes:

CO-114 PR-114

Related Denial Codes

OA-74 — Indirect Medical Education Adjustment OA-75 — Direct Medical Education Adjustment OA-76 — Disproportionate Share Adjustment OA-85 — Patient Interest Adjustment OA-89 — Professional Fees Removed from Charges

Sources

  1. https://www.cms.gov/medicare/coverage/coverage-general-information
  2. https://www.aapc.com/resources/claim-adjustment-reason-code-carc
  3. https://www.mdclarity.com/denial-code/114
  4. Codes maintained by X12. Visit x12.org for official definitions.