Yescarta denied as not FDA-approved for this use by UnitedHealthcare?

UnitedHealthcare's specific coverage criteria for yescarta 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 Yescarta as "Not FDA-Approved"

Yescarta (axicabtagene ciloleucel) is an FDA-approved CAR-T cell therapy. A "not FDA-approved" denial for an on-label use of Yescarta is almost always an administrative or coding error — the most common causes are: the ICD-10 diagnosis code submitted did not precisely match the FDA-approved indication, the claim was submitted under an authorization number that referenced a different product, or UHC's policy has not been updated to reflect Yescarta's most recent FDA label expansion.

If the intended use is genuinely off-label (outside the exact approved indications), the analysis shifts: UHC may still cover off-label use for oncology drugs when the use is supported by a recognized compendia such as NCCN, Micromedex, or other CMS-recognized references. Many state laws and UHC's own policies include compendia-based coverage provisions.

## Why This Is Appealable

When Yescarta is being used for an FDA-approved indication, this denial is factually incorrect and should be corrected at the first level of appeal. Your oncologist should provide a direct written statement citing the specific FDA-approved indication and referencing the prescribing label. For off-label uses supported by recognized oncology guidelines, cite the relevant guideline organization's recommendation without referencing version numbers or statistics.

## Federal Appeal Framework

• Internal appeal: File under ACA §2719 / ERISA §503 within the deadline on the denial letter. Expedited review (72-hour decision) is available and appropriate for oncology cases.
• External review: Available within four months of the final internal denial. Expedited external review is available given the life-threatening nature of the diagnosis.

## Documentation to Collect

1. FDA prescribing label — the current full prescribing information for Yescarta, with the applicable approved indication highlighted. 2. Diagnosis records — pathology, flow cytometry, molecular testing, and imaging confirming the specific diagnosis that maps to the approved indication. 3. Authorization and claim records — the original prior-authorization approval (if any), the claim form, and the denial letter to identify any coding discrepancy. 4. Oncologist letter — explicitly stating the FDA-approved indication being treated, quoting the relevant label language, and (if applicable) citing the relevant oncology guideline organization's compendia listing. 5. UHC coverage policy — obtain UHC's current Yescarta medical policy and confirm whether on-label and compendia-supported off-label uses are covered.

## Criteria-Mapping Structure

For an on-label dispute: provide a one-page exhibit with the FDA indication on the left and your diagnosis documentation on the right. For an off-label dispute: provide a three-column table — UHC's coverage criterion, the FDA label text, and the compendia or guideline reference — with your clinical facts mapped to each.