Tafamidis ATTR Cm denied as not FDA-approved for this use by UnitedHealthcare?

UnitedHealthcare's specific coverage criteria for tafamidis attr cm 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 UnitedHealthcare Denied Tafamidis-Attr-Cm as Not FDA-Approved — and Why This Denial Does Not Stand

This denial is almost certainly a system or administrative error. Tafamidis has received full FDA approval for the treatment of ATTR cardiomyopathy (ATTR-CM), covering both wild-type and hereditary forms of the disease. A "not-FDA-approved" denial in this context typically results from: a miscoded indication on the claim or authorization request, a UHC formulary database that has not been updated to reflect the current approval status, a confusion between different tafamidis formulations or NDC codes, or an incorrectly applied coverage policy.

Because the factual premise of this denial is incorrect, it has one of the highest overturn rates of any denial category — particularly at the external review stage, where an IRO applies the objective FDA approval standard rather than UHC's internal classification.

## Your Federal Appeal Rights

• Internal appeal (ACA §2719 / ERISA §503): Request from UHC in writing the specific basis for the "not-FDA-approved" determination, including which indication, NDC, or policy section it relied upon. You are entitled to the full administrative record.
• External review: After the internal appeal, request IRO review. The IRO will look directly at the FDA approval record — not UHC's internal database — and is likely to overturn a factually incorrect classification. Federal law provides approximately four months from the adverse determination to initiate external review. Expedited review is available for urgent clinical situations.

## Documentation to Gather

1. FDA approval documentation — download the current approval letter and prescribing label from drugs.fda.gov. Highlight the approved indication for ATTR-CM (wild-type and hereditary). This is the cornerstone of your appeal. 2. Diagnosis confirmation — cardiology records confirming ATTR-CM diagnosis, including the diagnostic method (nuclear scan, biopsy, genetic testing) and disease subtype. 3. Correct NDC and drug identification — work with your pharmacist to confirm the NDC code submitted on the claim matches the FDA-approved formulation. Attach the pharmacist's attestation. 4. Prescriber rebuttal letter — your cardiologist should directly state that tafamidis is FDA-approved for this patient's confirmed diagnosis and attach the FDA label as a supporting exhibit. 5. UHC's denial basis in writing — request the specific UHC policy or database entry that led to the classification so you can rebut it directly.

## Criteria-Mapping Structure

| UHC Denial Basis | Your Rebuttal Document | |---|---| | Drug not FDA-approved | FDA approval letter + current label (attached) | | Indication mismatch | Patient diagnosis records + FDA label indication highlighted | | NDC or formulation issue | Pharmacist attestation of correct NDC submitted |

This type of denial should be appealed promptly. Attach the FDA label as the first exhibit and lead with it in your appeal letter.