PR-188: Product/Procedure Not Covered Unless FDA-Recommended

What Does PR-188 Mean?

PR-188 is less common and appears when the patient elected to receive a product or procedure that was used off-label, and the payer considers the non-covered portion to be the patient's financial responsibility. This typically occurs when the patient was informed that the use might not be covered and agreed to proceed.

CARC 188 appears on your remittance when the payer denies coverage for a product, device, medication, or procedure because it was not used in accordance with FDA recommendations. This is a coverage denial tied specifically to FDA compliance — the payer is not questioning whether the patient needed treatment, but whether the specific product or procedure was used for an FDA-approved purpose.

The most common trigger is off-label usage. When a medication, device, or product is used for an indication not listed in its FDA-approved labeling, many payers will deny coverage unless the off-label use is supported by recognized medical compendia or peer-reviewed literature. The second most frequent cause is documentation failure — the product may have been used correctly, but the medical record does not explicitly document the FDA-approved indication, leaving the payer unable to verify compliance.

This code carries significant financial risk because it often applies to high-cost items — specialty drugs, implantable devices, and advanced biological products. The resolution path almost always involves an appeal rather than a simple resubmission, because you need to demonstrate either that the use was FDA-compliant or that the off-label use meets recognized compendium standards. Many payers will cover off-label uses if they are supported by sources like the National Comprehensive Cancer Network (NCCN) compendium or other recognized clinical references.

How to Resolve

Document that the product or procedure was used in accordance with FDA recommendations or recognized compendium standards, and submit a clinical appeal.

1. Verify patient consent was obtained Confirm that the patient was informed about the off-label use and potential non-coverage, and that they signed an Advance Beneficiary Notice (ABN) or similar waiver.
2. Collect from the patient Bill the patient for the denied amount and provide documentation explaining the coverage determination.

How to Prevent PR-188

• Obtain a signed ABN or financial responsibility waiver before providing off-label products or procedures
• Inform patients about potential non-coverage for off-label uses and discuss alternative FDA-approved options

Also Filed As

The same CARC 188 may appear with different Group Codes:

Related Denial Codes