Art Cabenuva LA denied as not FDA-approved for this use by Humana?

Humana's specific coverage criteria for art cabenuva la 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 Denied Cabenuva (Long-Acting) as Not FDA-Approved

A "not FDA-approved" denial for Cabenuva is factually incorrect as a matter of regulatory record: Cabenuva (cabotegravir + rilpivirine) received FDA approval for the treatment of HIV-1 in adults. This type of denial typically arises from a data-entry error, a stale formulary database, or a reviewer applying an outdated policy that predates the approval. It is one of the clearest-cut denial types to reverse on appeal.

This denial is distinct from an "experimental" denial. An experimental denial argues the evidence is insufficient; a not-FDA-approved denial asserts a factual claim about regulatory status that can be directly rebutted with the FDA's own published records. The denial letter is required to specify the basis for the determination. Request the complete file so you can see exactly what the reviewer relied on.

## Your Federal Appeal Rights

• Internal appeal: Under ACA §2719 and ERISA §503, you are entitled to a full-and-fair internal review. The clinical reviewer on appeal must be different from the original reviewer and must consider the evidence you submit, including FDA documentation.
• External review: After an adverse internal outcome — or if the plan fails to decide within the required timeframe — you may request independent external review. Federal law provides approximately four months from the original denial to file; check your plan documents for the exact window. An IRO, not Humana, makes the binding final decision.
• Expedited review: If delay would jeopardize your health, request expedited external review; turnaround is typically 72 hours.

## What to Gather

1. FDA approval documentation: The FDA drug-approval letter and current prescribing information (label) for Cabenuva. These are publicly available from the FDA's website and constitute direct rebuttal of the denial's factual premise. 2. Prescriber letter: A brief letter from your HIV specialist noting that Cabenuva carries FDA approval for HIV-1 treatment in adults and that the denial's factual basis is incorrect. 3. Your denial letter and complete claim file: Request the full administrative record from Humana so you can identify which policy or database version was applied. 4. Current Humana coverage policy: Obtain the most current version of Humana's policy for HIV antiretroviral therapy; if the policy itself predates FDA approval, that supports your appeal.

## Criteria-Mapping Structure

In your appeal letter, attach the FDA approval documentation as Exhibit A and the current prescribing label as Exhibit B. In the body of the letter, quote the denial's specific basis verbatim, then directly rebut it with the FDA document reference. Keep the letter short and factual: this appeal succeeds by demonstrating a factual error, not by extensive clinical argument. If the internal appeal fails despite this evidence, external review is particularly likely to succeed because independent reviewers apply an objective standard and the FDA record is unambiguous.