PR-114: Procedure/Product Not FDA Approved

What Does PR-114 Mean?

PR-114 means the patient bears financial responsibility for the non-FDA-approved product or procedure. This typically occurs when the patient was informed the service might not be covered (via an ABN or financial responsibility form) and elected to proceed. The provider can bill the patient if proper informed consent and financial responsibility documentation is on file.

CARC 114 fires when a payer denies a claim because the billed procedure, device, drug, or biological product does not have FDA approval or clearance. The payer classifies the item as experimental, investigational, or non-compliant with regulatory standards, making it ineligible for reimbursement under the patient's coverage.

This denial does not always mean the product actually lacks FDA approval. Coding errors are a frequent cause — using a HCPCS, CPT, or NDC code that corresponds to a non-approved product when the product actually used was FDA-approved. Off-label use of an FDA-approved product is another common trigger: the drug or device has FDA approval for a specific indication but was administered for a different purpose that the payer does not cover. Additionally, newly FDA-approved products sometimes trigger CARC 114 because the payer's formulary or coverage system has not been updated to reflect the recent approval.

The Group Code determines the financial outcome. CO-114 means the provider absorbs the denied amount — this is typical when the payer's policy excludes the product regardless of the provider's or patient's actions. PR-114 shifts responsibility to the patient, usually when the patient elected to receive the non-approved treatment after being informed of the coverage risk. A properly executed Advance Beneficiary Notice (ABN) or financial responsibility form is critical in PR scenarios to support the patient billing.

Common Causes

How to Resolve

Verify the FDA approval status of the actual product used, determine if the denial was caused by a coding error or payer system lag, and appeal with FDA documentation or correct and resubmit.

1. Verify the product's actual approval status Before billing the patient, confirm the product truly lacks FDA approval. If it is approved and the denial was a coding error, correct and resubmit the claim.
2. Check financial responsibility documentation Verify the patient signed an ABN or financial responsibility form acknowledging the service may not be covered and accepting responsibility.
3. Bill the patient if documented If the ABN is on file and the product is genuinely non-approved, bill the patient with documentation of their prior consent and explanation of the non-coverage.
4. Absorb cost if no ABN If no financial responsibility form was obtained before the service, the provider may need to absorb the cost. Implement ABN procedures for future non-approved treatments.

How to Prevent PR-114

• Obtain signed ABN or financial responsibility forms before administering non-FDA-approved products or procedures
• Clearly communicate to patients that non-approved products may not be covered and explain their potential financial liability
• Offer FDA-approved alternatives when available and discuss the coverage implications before proceeding

General Prevention

• Obtain signed financial responsibility forms (ABN or equivalent) from patients before administering non-FDA-approved treatments
• Clearly communicate to patients that non-FDA-approved products may not be covered by insurance and explain their potential financial liability
• Offer FDA-approved alternatives when available and discuss the coverage implications with the patient before proceeding

Also Filed As

The same CARC 114 may appear with different Group Codes:

Related Denial Codes