Tepezza TED denied as not FDA-approved for this use by Aetna?

Aetna's specific coverage criteria for tepezza ted are defined in its own published medical/coverage policy and the FDA-approved prescribing label. A successful appeal documents that your medical records satisfy each criterion those sources list — confirmed diagnosis, any required prior treatments (with dates and outcomes), and clinical severity. If the exact criteria weren't included with your denial, request them in writing; your appeal then maps each requirement to the matching fact in your chart.

## Why Aetna May Issue a "Not FDA-Approved" Denial for Tepezza (Thyroid Eye Disease)

Tepezza (teprotumumab-trbw) carries FDA approval for thyroid eye disease (TED). An Aetna denial on "not FDA-approved" grounds is typically an administrative or coding error — the most common triggers are a diagnosis code mismatch between the ICD-10 code on the claim and the indication in Aetna's coverage policy, or a clinical policy bulletin that has not been updated since Tepezza received approval. This denial type has one of the highest overturn rates on appeal precisely because the factual basis (FDA approval) is publicly verifiable.

## Federal Appeal Rights

• Internal appeal: ACA §2719 and ERISA §503 guarantee a full-and-fair internal review. Respond within the deadline on your denial notice.
• External review: After final internal denial, you may escalate to an independent external reviewer not employed by Aetna. This right is preserved under most ACA-compliant plans for approximately four months after the final internal denial.
• Expedited review: If your ophthalmologist certifies that standard timelines would seriously jeopardize your vision or health, request expedited review — Aetna must respond within 72 hours.

## What to Include in Your Appeal

1. FDA approval letter and current prescribing label: Download both from fda.gov and include them as exhibits. Highlight the approved indication and match it to the patient's documented diagnosis. This is the central exhibit in this appeal type. 2. ICD-10 code verification: Confirm with the billing team that the diagnosis code submitted on the claim correctly maps to TED. A code mismatch is the most common source of a false "not approved" denial and can sometimes be resolved with a corrected claim before a formal appeal is needed. 3. Aetna clinical policy bulletin: Obtain the current version. If it predates FDA approval or is otherwise inconsistent with the current FDA label, cite that discrepancy explicitly in your letter. 4. Ophthalmology and endocrinology records: Documents confirming the TED diagnosis, clinical activity, and the treating specialist's credentials. 5. Prescriber attestation letter: The treating physician should attest that Tepezza is being prescribed for its FDA-approved indication and that the diagnosis code on the claim is accurate.

## Criteria-Mapping Structure

| Aetna Policy Criterion | Your Documentation | |---|---| | FDA-approved indication | FDA label, approval letter | | Diagnosis code matches labeled indication | Billing review, clinical notes | | Prescriber attestation | Prescriber letter | | Aetna policy consistency with FDA status | Policy bulletin dated after FDA approval |

## Next Step

Before filing a formal appeal, ask the treating facility's billing team to verify the ICD-10 code on the claim. If the code is incorrect, a corrected claim may resolve the denial without a formal appeal. If the code is correct, proceed directly to the internal appeal with the FDA documentation package outlined above.