Quick Explanation
Denial code CO-113 indicates that the payer has rejected the claim because the billed procedure, drug, or medical device lacks official Food and Drug Administration (FDA) approval or clearance. As a result, the insurer classifies the service or product as experimental, investigational, or non-covered under the patient's benefit plan.
Common Causes for CO-113
Denials with code CO-113 typically happen for the following specific reasons:
- Billing for a novel medical device or therapeutic drug that is currently undergoing clinical trials and has not yet received FDA 510(k) clearance or Premarket Approval (PMA).
- Using FDA-approved pharmaceuticals or biologics for off-label indications that are not recognized or supported by standard clinical compendia.
- Submitting claims with unlisted HCPCS codes for newly released products without providing the necessary FDA approval documentation or National Drug Code (NDC) information.
- Omission of required clinical trial identifiers (NCT numbers) or Investigational Device Exemption (IDE) numbers when billing for approved clinical research protocols.
How to Prevent CO-113 Denials
To avoid receiving this denial in the future, implement these specific checks:
- Implement a rigorous pre-service review process to verify FDA approval status and clearance parameters for all high-cost drugs, biologics, and implantable devices.
- Obtain prior authorization and submit comprehensive clinical documentation, including peer-reviewed medical literature, to support off-label drug utilization before billing.
- Accurately append clinical trial modifiers (such as Q0 or Q1) and document the official Category B IDE number on the claim form when participating in approved clinical studies.
- Establish a proactive pre-determination workflow with payers to secure written coverage agreements for newly FDA-approved products before service delivery.
Appeal Letter Template for CO-113
If you believe this claim was denied incorrectly, you can use the following template to submit an appeal.
[Your Practice Header]
[Date]
[Payer Name]
[Appeals Department Address]
RE: Appeal for Claim [Claim Number]
Patient: [Patient Name]
ID: [Patient ID]
Date of Service: [Date]
Denial Code: CO-113 - Procedure/product not approved by the Food and Drug Administration
Dear Appeals Department,
I am writing to appeal the denial of the above-referenced claim, which was denied with code CO-113: "Procedure/product not approved by the Food and Drug Administration".
We are writing to appeal the denial of this claim (Code CO-113) regarding the FDA approval status of the billed procedure/product. The product/device utilized in this patient's treatment possesses active FDA clearance/approval (under PMA/510(k) number or FDA NDA approval, which is attached to this appeal), contrary to the denial determination. Furthermore, in accordance with CMS Medicare Benefit Policy Manual Guidelines and recognized drug compendia, the clinical indication for this treatment is medically necessary, peer-supported, and standard-of-care. Enclosed please find the FDA approval letter, clinical progress notes, and peer-reviewed literature demonstrating safety and efficacy. We request that you overturn this denial and process this claim for immediate payment.
Attached please find:
1. A copy of the original claim.
2. The relevant medical records supporting the service.
3. [Any other supporting documents].
We respectfully request that you reprocess this claim for payment.
Sincerely,
[Your Name]
[Title]
[Practice Name]
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