CARC 114 Active

PR-114: Procedure/Product Not FDA Approved

TL;DR

The patient is responsible for this adjustment amount. Verify the balance and collect from the patient.

Action
Collect from Patient
Who Pays
Patient
Appeal
No
Patient Impact
Direct Financial
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 PR-114 Mean?

With PR (Patient Responsibility), the amount adjusted under CARC 114 is owed by the patient. The payer determined that this portion — related to procedure/product not fda approved — falls under the patient's financial obligation per their plan benefits.

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.

Common Causes

Cause Frequency
Patient elected non-FDA-approved treatment with informed consent The patient was informed that the procedure or product is not FDA-approved and chose to proceed, accepting financial responsibility Most Common

How to Resolve

  1. Verify the adjusted amount Cross-reference the adjusted amount against the patient's benefits summary or eligibility response to confirm the adjustment amount was applied correctly per plan terms.
  2. Confirm plan benefit details Use the payer portal or eligibility tool to verify the patient's current benefit status and confirm the adjustment aligns with plan terms.
  3. Generate a patient statement Prepare a clear statement showing the service rendered, the allowed amount, the adjustment amount, and the balance the patient owes.
  4. Collect from the patient Send the statement and follow your practice's collection workflow. Offer payment plan options for substantial balances.
  5. Track and follow up Record payments received, update the account balance, and follow up on outstanding amounts per your collection policy.
Do Not Appeal This Code

The patient accepted financial responsibility for a non-FDA-approved procedure or product. Collect from the patient.

How to Prevent PR-114

Also Filed As

The same CARC 114 may appear with different Group Codes:

CO-114 OA-114

Related Denial Codes

PR-26 — Expenses Incurred Prior to Coverage PR-27 — Expenses Incurred After Coverage Terminated PR-32 — Patient Not Eligible Dependent PR-33 — Insured Has No Dependent Coverage PR-34 — No Coverage for Newborns

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.