Tumor Genomic Profiling denied as non-formulary by Humana?

Humana's specific coverage criteria for tumor genomic profiling 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 Tumor Genomic Profiling as Non-Formulary

A non-formulary denial for a diagnostic test like tumor genomic profiling reflects that the specific assay or platform requested is not listed on Humana's approved test coverage schedule or preferred laboratory list. Unlike drug formulary denials, this can affect which laboratory performs the test, which specific panel is used, or whether a comprehensive profiling platform is covered versus a more limited targeted panel.

This denial is often appealable on two grounds. First, if no formulary alternative exists that would yield clinically equivalent information for your cancer type, the non-formulary option may be the only medically appropriate choice. Second, if your oncologist has a specific clinical rationale for the requested assay — such as a particular gene set, sensitivity threshold, or tumor fraction requirement — that distinguishes it from available formulary alternatives, that rationale supports a medical-necessity exception.

## Federal Appeal Framework

Under ACA Section 2719, you are entitled to internal appeal and then independent external review for non-formulary denials when they intersect with medical necessity. File internally within 180 days of your denial notice. External review is available within approximately 4 months of a final internal denial. Expedited review applies when clinical urgency prevents waiting for the standard timeline. ERISA-governed employer plans provide equivalent protections under Section 503.

## Concrete Appeal Steps

1. Identify the specific laboratory and assay name that was denied, and confirm whether Humana has a formulary or preferred alternative. 2. If a formulary alternative exists, have your oncologist document in writing why it is clinically inadequate for your specific situation. 3. If no formulary alternative covers the required clinical information, document that gap explicitly. 4. Request a formulary exception in writing from your oncologist, addressed to Humana's coverage review department. 5. Escalate to external review if the internal exception is denied.

## Documentation to Gather

• Diagnosis and indication: Pathology, cancer type, stage, and the specific clinical question the test is meant to answer.
• Formulary alternative assessment: Written statement from your oncologist comparing the requested assay to any Humana-preferred alternative and explaining clinical insufficiency of alternatives.
• Medical-necessity letter: Oncologist letter linking the specific assay's capabilities to your treatment decision needs.
• Guideline support: Applicable NCCN or equivalent guideline recommending genomic profiling for your cancer type — your oncologist should confirm your case meets those criteria.
• Prior authorization records: Any documentation from the ordering provider showing the original request and rationale.

## Criteria-Mapping Structure

Request Humana's formulary exception policy alongside the coverage policy for genomic profiling. Map each exception criterion to a document in your record. Pay particular attention to the "no adequate formulary alternative" criterion — this is the pivot point for most non-formulary genomic testing appeals, and a strong oncologist letter directly addressing it is the most important document you can provide.