Tafamidis ATTR denied as not FDA-approved for this use by Humana?

Humana's specific coverage criteria for tafamidis attr 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 Tafamidis (ATTR Amyloidosis) as Not FDA-Approved — and Why You Can Appeal

This denial is almost certainly an administrative misclassification. Tafamidis received FDA approval specifically for transthyretin-mediated amyloidosis (ATTR), including both the wild-type and hereditary forms. When a plan asserts the drug is "not FDA-approved," the denial is often triggered by a formulary code mismatch, an incorrect indication listed on the prior-authorization request, or a plan system that has not yet updated its drug database to reflect the approval. All of these errors are correctable on appeal.

## Your Federal Appeal Rights

You have layered federal protections:

• Internal appeal (ACA §2719 / ERISA §503): You may file a formal internal appeal with Humana. For most plans this must be decided within a defined timeframe after submission. Request the specific deadlines in writing from Humana.
• External review: If the internal appeal is denied, you have the right to an independent external review by an accredited Independent Review Organization (IRO). Federal law grants approximately four months from the date of the adverse determination to request external review. If your condition requires urgent access, request expedited external review, which carries a much shorter decision deadline.
• Expedited internal appeal: If waiting for a standard review would seriously jeopardize your health, request an expedited internal appeal simultaneously.

## Documentation to Gather Before You File

1. FDA approval confirmation — print the current FDA label and approval letter for tafamidis directly from the FDA website (drugs.fda.gov). Highlight the approved indication and confirm your diagnosis matches it exactly. 2. Diagnosis documentation — cardiology or neurology records confirming ATTR amyloidosis, including the diagnostic method (e.g., biopsy, nuclear imaging, genetic testing). 3. Prescriber medical-necessity letter — your cardiologist or specialist should write a letter stating the diagnosis, the disease subtype (wild-type vs. hereditary), and why tafamidis is medically necessary, citing the FDA-approved indication. 4. Applicable guideline support — ask your prescriber to reference the relevant ACC/AHA or applicable cardiology guideline organization's recommendations for ATTR amyloidosis treatment, without citing specific numbers.

## Criteria-Mapping Structure for Your Appeal Letter

Organize your appeal around a direct rebuttal of the denial reason:

| Denial Claim | Your Response | |---|---| | Drug is not FDA-approved | Attach FDA approval documentation; state the exact indication; confirm patient diagnosis matches | | Indication on claim did not match | Attach corrected diagnosis codes from chart; have prescriber certify the indication |

Close the letter by requesting that Humana identify the exact regulatory or policy basis for the "not-FDA-approved" classification and respond to each attached document individually. Keep a timestamped copy of everything you submit.