Linx denied for failing step therapy by Cigna?

Cigna's specific coverage criteria for linx 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 Denied the LINX Device Under Step Therapy

Cigna's step-therapy denial means the coverage policy requires documented failure of one or more specified conservative or less-invasive treatments before the LINX Reflux Management System will be approved. For GERD, this most commonly means Cigna requires a documented adequate trial of proton pump inhibitor (PPI) therapy — and sometimes optimization of lifestyle and dietary measures — before approving a surgical intervention. This denial is not a finding that LINX is inappropriate for you; it is a procedural hurdle that can be cleared by demonstrating that you have already met the required steps.

## Why This Denial Is Appealable

Step-therapy denials are routinely overturned when the clinical record clearly documents a sufficient trial of the required prior therapies. If your chart already contains that documentation but it was not submitted with the initial authorization request, an appeal with the complete records is often sufficient for reversal. Additionally, if the required prior therapy is contraindicated, caused documented intolerable side effects, or is clinically inappropriate for your specific situation, the step-therapy requirement can be waived — many state laws and the federal 21st Century Cures Act include step-therapy exception provisions for exactly this scenario.

## Federal Appeal Framework

• Internal appeal: File within the deadline on your denial notice. Request Cigna's specific step-therapy criteria so you know exactly what prior-treatment documentation is required.
• Step-therapy exception: If you cannot complete the required step (due to contraindication or failure), explicitly invoke the step-therapy exception process under your plan documents and any applicable state step-therapy exception law.
• External review: If the internal appeal fails, escalate to external review under ACA §2719. The standard window is 4 months from the final internal denial; confirm the exact deadline on your denial letter.
• Expedited option: If your condition is urgent, request expedited review.

## Documentation to Gather

1. Step completion evidence — a complete dated log of every required prior therapy (e.g., PPI trials), including the specific agent, duration, adherence, and documented reason for failure or discontinuation. This is the central exhibit. 2. Objective GERD severity records — pH monitoring, impedance study, manometry, and endoscopy results confirming the underlying diagnosis and severity despite prior treatment. 3. Step-therapy exception basis — if any required step is contraindicated or was tried and failed, document the contraindication or failure explicitly in the chart and in the prescriber's letter. 4. Prescriber medical-necessity letter — must walk through each step Cigna requires and confirm completion or documented exception, citing specific chart dates and findings. 5. Applicable guideline references — ask the prescriber to reference the relevant gastroenterology society guidelines (e.g., SAGES, ACG) by organization name to confirm that surgical management is consistent with evidence-based practice after failed medical therapy.

## Criteria-Mapping Structure

Obtain Cigna's step-therapy criteria for LINX. Create a step-by-step checklist: for each required prior treatment, list what Cigna requires, when you tried it (date from chart), for how long, and the documented outcome. If a step was skipped for a documented clinical reason, state that reason and cite the chart note. Submit this checklist as the lead exhibit in your appeal letter.