Tumor Genomic Profiling denied due to quantity / dose limits 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 Due to Quantity Limits

A quantity-limit denial for tumor genomic profiling typically means Humana's policy restricts coverage to a defined number of tests per diagnosis, per line of therapy, or within a specific time period — and the requested test exceeds that limit. This most often arises when a patient has already had one profiling test and their oncologist is requesting additional profiling due to disease progression, a new biopsy site, or the need to assess treatment resistance.

Quantity limits for genomic profiling can be legitimately challenged when the clinical rationale for re-testing is distinct from prior testing. Disease progression, evolution of tumor biology, development of resistance mutations, or a new metastatic site can all create genuine clinical need for additional profiling that was not addressed by prior results. The appeal must demonstrate that the new test is not duplicative but clinically necessary given changes in disease state.

## Federal Appeal Framework

Under ACA Section 2719, quantity-limit denials are fully appealable through internal review and, if needed, independent external review. File your internal appeal within 180 days of the denial. External review must typically be requested within approximately 4 months of the final internal decision. If treatment planning is time-sensitive, expedited review is available and should be requested explicitly. ERISA employer plans carry equivalent rights under Section 503.

## Concrete Appeal Steps

1. Obtain the specific quantity-limit language from Humana's coverage policy for tumor genomic profiling. 2. Identify the prior test(s) Humana is counting against the limit — confirm dates, assay names, and gene scope. 3. Have your oncologist document the change in clinical status that necessitates additional testing. 4. Frame the appeal around clinical distinction from prior testing, not simply the number of tests. 5. Submit with a complete clinical package and escalate to external review if needed.

## Documentation to Gather

• Prior test records: Reports for all prior genomic profiling tests, including assay names, genes assessed, dates, and clinical results.
• Disease progression documentation: Imaging, pathology, or clinical notes documenting disease progression, new biopsy sites, or treatment failure since prior testing.
• Resistance or evolution rationale: If resistance mutations or tumor evolution are the clinical reason for re-testing, oncologist documentation of this specific concern.
• Oncologist medical-necessity letter: Directly addresses why prior test results are no longer sufficient to guide current treatment decisions.
• Diagnosis and staging update: Current status relative to prior test date — documenting that clinical circumstances have materially changed.

## Criteria-Mapping Structure

List the quantity-limit criteria from Humana's policy. For each exception pathway the policy offers, map the corresponding clinical fact from your record: date of progression, nature of clinical change, and oncologist attestation. A quantity-limit appeal lives or dies on demonstrating that clinical circumstances have materially changed since the prior test — build the record around that narrative.