CARC 188 Active

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

TL;DR

The patient owes for the off-label product use. Verify whether compendium support exists before collecting.

Action
Review & Decide
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-188 Mean?

With PR (Patient Responsibility), the patient is financially responsible for the cost of the product used outside FDA-approved indications. The patient may need to pay out of pocket for the off-label use.

CARC 188 indicates that the drug, device, or product billed on the claim was used for a purpose or indication that the FDA has not approved, and the payer's coverage policy requires FDA-recommended use. Many payers restrict coverage to FDA-approved indications to ensure they are paying for evidence-based treatments.

However, off-label use is not always uncoverable. Medicare and many commercial payers recognize off-label uses that are supported by approved medical compendia (such as NCCN Drugs & Biologics Compendium, Micromedex DrugDex, or AHFS Drug Information). If the off-label use has compendium support, it may be covered through an appeal with proper documentation.

How to Resolve

  1. Check for compendium support Before billing the patient, verify whether the off-label use has compendium support that could reverse the denial.
  2. Appeal if support exists If compendium support is found, appeal on behalf of the patient.
  3. Collect from the patient if no support If the off-label use is not supported, communicate the charges and collect from the patient.
Do Not Appeal This Code

Product/Procedure Not Covered Unless FDA-Recommended reflects a service that falls outside covered benefits, with the patient held responsible. Coverage decisions per plan terms generally aren't appealable in the traditional sense — the appropriate next step is verifying the patient was informed (ABN where applicable) and billing the patient if the determination is correct.

How to Prevent PR-188

Also Filed As

The same CARC 188 may appear with different Group Codes:

CO-188 OA-188

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.mdclarity.com/denial-code-carcs
  2. https://x12.org/codes/claim-adjustment-reason-codes
  3. https://portal.ct.gov/-/media/ohs/health-it-advisory-council/apcd-advisory-group/data-submission-guide-workgroup/meeting-materials/6-30-22/carc-codes_final.pdf
  4. https://medicaid-documents.dhhs.utah.gov/Documents/pdfs/ClaimDenialCodes.pdf
  5. Codes maintained by X12. Visit x12.org for official definitions.