Tafamidis ATTR denied as not medically necessary 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 Denies Tafamidis on Medical-Necessity Grounds — and How to Appeal

Humana's medical-necessity standard requires that a drug be appropriate for the patient's diagnosis, consistent with the standard of care, and supported by clinical documentation in the medical record. For tafamidis in ATTR cardiomyopathy, denials typically occur when the submitted records do not clearly establish the confirmed ATTR-CM diagnosis, do not document functional severity, or do not address how the patient meets the criteria in Humana's coverage policy. The disease is underdiagnosed and the documentation requirements are specific — gaps in records are the primary driver of these denials.

## Your Federal Appeal Rights

• ACA §2719 External Review: After Humana's internal review process is exhausted, independent external review by a certified IRO is available. The window is generally approximately four months from the final internal denial — confirm the exact date on your denial notice.
• ERISA §503: Employer-plan members are entitled to a written explanation of the specific medical-necessity criteria not met, and to a full-and-fair review with the ability to submit additional evidence.
• Expedited Review: If delay poses a serious health risk, request expedited simultaneous internal and external review — typically resolved within 72 hours.

## Concrete Appeal Steps and Timeline

1. Request Humana's denial letter and its coverage criteria for tafamidis — the letter must cite the specific requirements the patient allegedly did not meet. 2. Obtain Humana's published coverage policy and read each criterion carefully. 3. Work with the treating cardiologist to gather records that directly address each unmet criterion. 4. File a Level 1 internal appeal within the deadline on the denial notice (confirm the exact date — do not rely on a default assumption). 5. Request a peer-to-peer review between the prescriber and Humana's medical director — this step resolves many medical-necessity denials without further escalation. 6. If the Level 1 appeal is denied, file Level 2 and then external review within the deadline.

## Documentation to Gather

• Confirmed ATTR-CM diagnosis: Scintigraphy report, biopsy pathology, or genetic testing results with interpretation by the treating or consulting cardiologist.
• Disease subtype: Wild-type vs. hereditary variant documentation — Humana's criteria may differentiate.
• Functional and clinical severity: Echocardiogram reports, functional classification per the treating cardiologist's chart notes, symptom trajectory, relevant laboratory trends.
• Prior treatment history: All cardiac therapies previously tried, with start/stop dates and documented outcomes or reasons for inadequacy.
• Prescriber letter of medical necessity: Explicitly maps the patient's clinical findings to each of Humana's stated criteria; should reference applicable ACC/AHA or HFSA guideline recommendations generically without fabricating statistics.

## Criteria-Mapping Structure

Obtain Humana's coverage policy before drafting the appeal. Create a structured table: column one lists each criterion verbatim from Humana's policy; column two provides the specific chart evidence satisfying that criterion (test name, date, result, and treating physician's conclusion). Submit this map as the appeal cover sheet. Reviewers can confirm compliance at a glance, reducing the likelihood of a second denial and shortening resolution time.