Gene Therapy Casgevy denied as not medically necessary 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 Denies Casgevy on Medical-Necessity Grounds

Casgevy (exagamglogene autotemcel) is a one-time CRISPR-based gene therapy approved by the FDA for sickle cell disease and transfusion-dependent beta-thalassemia. Humana's medical-necessity denials for gene therapies like Casgevy typically arise because the plan requires documented evidence that the patient meets every clinical criterion in Humana's own published coverage policy — a high bar that can be cleared with thorough chart documentation.

## Why This Denial Is Appealable

Federal law entitles you to a full internal appeal and, if that is denied, an independent external review. Under ACA §2719, non-grandfathered individual and group plans must provide access to external review. ERISA §503 guarantees a full-and-fair review for employer-sponsored plans. You generally have up to approximately four months from the denial notice to request external review, and expedited review is available when standard timelines would seriously jeopardize your health.

## Federal Appeal Framework

• Level 1 — Internal appeal: Submit within the timeframe stated on the denial notice (typically 180 days). The plan must respond within 30 days (pre-service) or 60 days (post-service).
• Level 2 — External review: If the internal appeal is denied, request independent external review immediately. An accredited Independent Review Organization (IRO) — not affiliated with Humana — will evaluate the clinical evidence.
• Expedited review: If waiting would seriously harm your health, request expedited external review; decisions are issued within 72 hours.

## Documentation to Gather

1. Diagnosis confirmation: Hematology records confirming your diagnosis (sickle cell disease or transfusion-dependent beta-thalassemia), including genetic/lab confirmation. 2. Disease severity: Documentation of disease burden — hospitalization history, pain crisis frequency, transfusion records, organ involvement — exactly as recorded in your chart. 3. Prior treatment history with dates and outcomes: A chronological list of every prior disease-modifying therapy attempted, its duration, and documented reasons for inadequate response or discontinuation. 4. Prescriber medical-necessity letter: A detailed letter from your treating hematologist explaining why Casgevy is medically necessary for you specifically, referencing the applicable clinical guidelines from the relevant professional society (such as ASH — the American Society of Hematology). 5. Relevant specialist records: Any bone marrow transplant evaluation, transfusion medicine notes, or multidisciplinary team assessments.

## Criteria-Mapping Strategy

Obtain a copy of Humana's current published medical policy for Casgevy (request it directly from Humana or locate it on their provider portal). Then, for each listed criterion:

• Copy the exact language of the requirement.
• Identify the specific chart note, lab result, or clinical record that satisfies it.
• Attach that supporting document.

Also obtain and reference the FDA-approved prescribing information for Casgevy, which defines the indicated patient population. Your appeal should show, point by point, that your clinical profile matches both the FDA label's indicated population and every condition in Humana's own policy. A well-organized criteria-mapping table is often the single most persuasive element of a successful gene-therapy appeal.