Tyvaso Inhaled denied for missing prior authorization by Cigna?

Cigna's specific coverage criteria for tyvaso inhaled 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 Requires Prior Authorization for Tyvaso (Inhaled Treprostinil)

Cigna categorizes Tyvaso (inhaled treprostinil) as a specialty drug requiring prior authorization before dispensing. This is a standard gating mechanism for high-cost specialty therapies — it is not a clinical judgment that the drug is inappropriate. A prior-auth denial means the submitted request was incomplete, the documentation did not satisfy Cigna's review criteria, or the request was not submitted before the drug was dispensed.

Prior-auth denials are among the most frequently overturned on appeal precisely because the underlying clinical case is often strong — the paperwork simply needs to be complete and well-organized.

## Your Federal Appeal Rights

• Internal appeal (ACA §2719 / ERISA §503): You must exhaust internal appeal before proceeding to external review. File within the deadline on the denial notice.
• Expedited prior-auth review: If the patient is currently hospitalized or faces urgent clinical need, request expedited review — the insurer must respond within hours to days rather than weeks.
• External review: After an internal denial, request IRO review within approximately four months. External reviewers regularly overturn prior-auth denials when clinical documentation is complete.
• Retrospective appeal: If the drug was dispensed without authorization in an emergency, a retrospective appeal may be available — check the denial notice for this option.

## Documentation to Gather

1. Specialist diagnosis and workup: Records from the treating pulmonologist or cardiologist establishing the diagnosis of PAH or PH-ILD, including diagnostic test results. 2. Functional status: Documented WHO/NYHA functional classification and clinical severity from chart notes. 3. Step-therapy / prior treatment history: Dates, drug names, doses attempted, and outcomes for all prior PAH therapies — demonstrating the patient has completed any required prior treatment steps. 4. Prescriber letter of medical necessity: A detailed letter addressing each of Cigna's prior-authorization criteria point by point. The prescriber should reference the FDA-approved prescribing information and applicable clinical guideline organizations. 5. Cigna's PA criteria checklist: Obtain the exact current prior-authorization criteria from Cigna (call the provider line or pull from Cigna's coverage policy library) and ensure every line item is addressed in the submission.

## Criteria-Mapping Strategy

Request Cigna's current prior-authorization criteria document for inhaled treprostinil. Lay each criterion out as a numbered list. For each criterion, insert the specific chart entry, test result date, or clinical note that satisfies it. Submit this as an exhibit to the appeal letter. This format makes it impossible for a reviewer to overlook a satisfied criterion and is the single most effective tool for PA appeal success.