Gene Therapy Casgevy denied for missing prior authorization by Humana?

Humana's specific coverage criteria for gene therapy casgevy 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 Humana Requires Prior Authorization for Casgevy

Humana requires prior authorization (PA) for Casgevy because it is a high-cost, specialized gene therapy administered in a limited-access treatment center setting. The PA process is Humana's mechanism for confirming that clinical eligibility criteria are met before the treatment begins. A denial at this stage means either that the initial PA submission was incomplete or that the clinical information provided did not satisfy each criterion in Humana's coverage policy. This is not a final "no" — it is the starting point for a structured appeal.

## Why This Denial Is Appealable

Under ACA §2719 and ERISA §503, any adverse benefit determination — including a PA denial — triggers full internal appeal and external review rights. The external-review window is approximately four months from the denial notice. Expedited review is available when a standard timeline would seriously jeopardize health or the ability to complete treatment within a clinically required window.

## Federal Appeal Framework

• Peer-to-peer review (pre-appeal): Before filing a formal appeal, your hematologist can request a peer-to-peer discussion with Humana's medical director. This often resolves PA denials without formal escalation.
• Internal appeal: Submit within the timeframe on the denial notice. Include all documentation the original PA lacked.
• External review: Request IRO review if the internal appeal is denied. The IRO applies clinical — not administrative — standards.
• Expedited track: If treatment timing is clinically critical (e.g., the patient is enrolled in a treatment center protocol with scheduling constraints), request expedited review.

## Documentation to Gather

1. Complete PA packet: Verify that the original submission included every document listed in Humana's PA requirements for Casgevy (obtain the requirement checklist from Humana's provider portal or member services). 2. Diagnosis confirmation: Genetic and laboratory records confirming the qualifying diagnosis. 3. Disease severity documentation: Hospitalizations, transfusion logs, organ-involvement records, and clinical notes quantifying disease burden. 4. Prior therapy history: Chronological documentation of every prior disease-modifying treatment with dates and outcomes. 5. Prescriber letter: A comprehensive medical-necessity letter from your hematologist addressing each PA criterion individually. 6. Treatment center qualification: Documentation that the administering center meets any site-of-care requirements Humana specifies.

## Criteria-Mapping Strategy

Obtain Humana's PA criteria for Casgevy. Then construct a table: left column lists each PA criterion verbatim; right column cites the specific chart document and date that satisfies it. Attach the FDA-approved prescribing label to anchor the on-label argument. The goal is to make it impossible for a reviewer to identify an unmet requirement — every box should be checked with a direct citation.