Yescarta denied due to quantity / dose limits 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 Limits Yescarta — and Why You Can Appeal

Yescarta (axicabtagene ciloleucel) is a CAR-T cell therapy — a one-time, individualized infusion manufactured from the patient's own T-cells. By its very nature, it is administered once per indication and course of treatment. Despite that biological reality, UnitedHealthcare's coverage policy applies quantity or administration limits that can generate an automatic denial if the claim is coded or submitted in a way the system reads as exceeding those parameters. This type of denial is almost always a clinical documentation or billing mismatch rather than a genuine policy disagreement — and that makes it strongly appealable.

## Why This Is Appealable

CAR-T therapies do not follow the same quantity logic as daily oral medications. A quantity-limit denial on a single-infusion product frequently reflects a coding artifact, a site-of-service discrepancy, or a policy that was written for conventional drugs and misapplied here. Oncology guidelines from organizations such as NCCN address CAR-T administration as a singular treatment event, not a repeating course. Documenting that the infusion is consistent with the FDA-approved labeling and the applicable guideline recommendation undermines the basis for the limit.

## Federal Appeal Framework

• Internal appeal: You have the right to a full-and-fair internal review under ERISA §503 (employer plans) or applicable state law. Submit within the timeframe stated in the denial letter, typically 180 days.
• External review: Under ACA §2719, you may escalate to an independent review organization (IRO) after exhausting internal remedies — or immediately for urgent clinical situations. The external review window is generally up to four months from denial. The IRO's decision is binding on the insurer.
• Expedited review: If delay would seriously jeopardize life or health, request expedited internal and external review simultaneously — decisions are required within days, not weeks.

## Documentation to Gather

1. Diagnosis confirmation — pathology reports, bone marrow biopsy or imaging establishing the specific diagnosis and relapse/refractory status. 2. Prior-treatment history — a dated list of every prior line of therapy, the regimen used, duration, and documented response or progression, demonstrating the patient has met any prior-line requirements the policy specifies. 3. Clinical severity — performance status, disease burden, and any time-sensitivity factors documented in the chart. 4. Prescriber medical-necessity letter — the treating oncologist should state in writing that one administration is the standard, FDA-labeled, guideline-consistent approach and explain why a quantity limit does not apply to a single-infusion cell therapy. 5. FDA-approved prescribing label — cite the label's own administration section showing the authorized quantity and schedule.

## Criteria-Mapping Strategy

Obtain UnitedHealthcare's published Yescarta coverage policy in full. List every requirement. For each requirement, write one sentence citing the exact chart record that satisfies it. Where the policy's quantity language conflicts with the FDA label's single-infusion instruction, quote both side-by-side. An IRO reviewer will see the conflict clearly, and conflicts between insurer policy and FDA labeling routinely resolve in the patient's favor.