CARC Code
188
FDA Guidelines Not Followed
The claim was denied because the product or procedure was used in a way that does not match the FDA's approved recommendations. Coverage is only provided when the item or service follows FDA guidelines.
contractualHow to resolve this denial
Submit clinical documentation showing FDA-recommended use and appeal
- 1
Obtain the complete medical record documenting the clinical need for the service
- 2
Review the payer's LCD/NCD or coverage policy for the billed procedure
- 3
Prepare a Letter of Medical Necessity from the treating physician
- 4
Submit a formal appeal with clinical records, the letter, and peer-reviewed literature
- 5
Track the appeal and follow up within 30 days
▶✓ Pre-action checklist — verify before contacting the payer
Review the full remittance advice (ERA/EOB) for additional RARC codes that explain the denial.
Verify the claim was submitted with correct patient eligibility and benefit information.
Check if this denial applies to a specific line item or the entire claim.
▶More about CO-188 — stats, related codes, appeal template
35%
Recovery Rate
21-45 days
Avg. Resolution
Hard
Difficulty
Rare
Frequency
Payer-Specific Notes
How major payers handle CARC 188 by specialty.
Blue Cross Blue Shield
BCBS requires appeal submission within 180 days for most plans.
Appeal Letter Template
Generic appeal template for CARC 188 denials.
We are submitting a formal appeal for claim [CLAIM_NUMBER] for patient [PATIENT_NAME], date of service [DOS]. This claim was denied/adjusted with CARC 188 indicating: "Product/service only covered when used according to FDA recommendations.." We have reviewed the claim and are providing the attached documentation to support reconsideration. [SUPPORTING_DOCUMENTATION]. Please reconsider payment per the terms of our contract.
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