Tumor Genomic Profiling denied for failing step therapy by Cigna?

Cigna'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 Cigna Applies Step Therapy to Tumor Genomic Profiling — and How to Appeal

Tumor genomic profiling — including comprehensive genomic sequencing and large multi-gene molecular panels — provides oncologists with a broad view of the mutations in a patient's cancer. Cigna may apply a step-therapy or diagnostic-sequencing requirement, mandating that narrower molecular tests (such as single-gene assays or limited hotspot panels) be performed first before comprehensive genomic profiling is authorized.

### Why This Denial Happens

Cigna's step-therapy logic for genomic testing is typically written into its medical coverage policy for specific cancer types and test codes. The policy may require that a targeted single-gene or small panel test be attempted first, on the premise that it is less costly and sufficient for the most common clinical decisions. A step-therapy denial occurs when the clinical record does not clearly demonstrate that the prior step was completed and found inadequate, or that it is clinically inappropriate for this patient's specific situation. The denial is often as much a documentation problem as a clinical one.

### Why It Is Appealable

Step-therapy requirements are designed for situations where the simpler prior step is genuinely equivalent to the comprehensive approach. For many patients — including those with rare histologies, tumors of unknown primary, cancers that have progressed on standard therapy, or situations where treatment selection requires knowledge of multiple concurrent alterations — a limited test cannot answer the clinical question. When the ordering oncologist can clearly articulate why the required prior step is clinically inadequate or inappropriate for this patient, the step-therapy denial is directly refutable.

### Federal Appeal Framework

• Internal appeal: File within the timeframe on your denial notice (typically 180 days for ACA-compliant plans). Cigna must respond within 30 days for pre-service or 60 days for post-service appeals.
• External review (ACA §2719): After an adverse internal decision, you have approximately four months to request independent external review by an IRO. The IRO's decision is binding on Cigna.
• ERISA §503: Employer-plan enrollees are entitled to full-and-fair review and may request the complete administrative record, including the criteria applied and the reviewing physician's rationale.
• Expedited review: Available when delay would seriously jeopardize health; decisions are generally required within 72 hours.

### Documentation to Gather

1. Diagnosis and histology documentation — current pathology report confirming the cancer type, histology, and any features that make a limited panel clinically insufficient. 2. Clinical rationale for bypassing the prior step — chart notes or a letter from the ordering oncologist explaining specifically why the required prior step (e.g., a single-gene test) would not provide the information needed for this patient's treatment decision. 3. Treatment history — records of prior systemic therapies, responses, and progression, establishing the clinical context for why comprehensive profiling is needed now. 4. Ordering oncologist's medical-necessity letter — a signed, detailed letter explaining what actionable information only a comprehensive panel can provide, and why targeted testing is insufficient for this patient's clinical scenario. 5. Applicable guideline reference — citation of the relevant NCCN guideline category or equivalent professional society recommendation supporting comprehensive genomic profiling in this clinical situation, including any guideline language endorsing broad panel testing for this cancer type.

### Criteria-Mapping Structure

Download the current Cigna medical coverage policy for the specific test code and cancer indication at cigna.com. Identify the exact step-therapy requirements and any stated exceptions. Build a two-column table: each policy criterion on the left, the corresponding chart documentation on the right. For the step-therapy criterion, address whether the prior step was completed (and what it showed) or explain specifically why it was clinically inappropriate or insufficient. Submit this mapping as a structured cover document so the reviewer must engage with each criterion individually.