Tyvaso Inhaled denied as not FDA-approved for this use 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 Issues a "Not FDA-Approved" Denial for Tyvaso (Inhaled Treprostinil) — and Why It Is Likely Wrong

This denial type for Tyvaso (inhaled treprostinil) is almost always based on a coding, routing, or indication-matching error rather than a genuine approval status issue. Tyvaso DPI and the nebulized form of inhaled treprostinil hold FDA approval for specific pulmonary hypertension indications. If Cigna's system flagged it as "not FDA-approved," the most common causes are:

• The claim was submitted under a diagnosis code that falls outside the exact labeled indication in Cigna's system.
• A generic or alternate product code was used that the system did not recognize.
• The prescriber submitted the request under an off-label indication that is not covered by the approval.

Before appealing on medical grounds, confirm with the prescriber's office that the submitted diagnosis code and drug code precisely match the FDA-approved labeled indication.

## Your Federal Appeal Rights

• Internal appeal (ACA §2719 / ERISA §503): File within the deadline on the denial notice (often 180 days). Attach documentation establishing FDA approval status — specifically, the FDA product label and approval history from the FDA's public Drugs@FDA database.
• Expedited internal review: Available if clinical urgency applies.
• External review: If the internal appeal fails, request IRO review within approximately four months of the internal denial. An IRO reviewing a factual dispute about FDA approval status will typically find in the patient's favor when approval documentation is submitted.

## Documentation to Gather

1. FDA prescribing information: Download the current full prescribing information from FDA.gov (Drugs@FDA) confirming the approved indication(s). 2. FDA approval letter: Also available from Drugs@FDA; attaching this directly removes all ambiguity. 3. Diagnosis and indication match: Chart notes and the prescriber's letter confirming the patient's diagnosis falls within the FDA-approved indication — stated in the exact language of the label. 4. Correct billing codes: Confirm with the prescriber's billing staff that the HCPCS/NDC code and ICD-10 diagnosis code on the claim match what Cigna's system expects.

## Criteria-Mapping Strategy

In the appeal letter, reproduce the exact language of the FDA-approved indication from the prescribing information. Directly alongside it, place the physician's documentation of the patient's diagnosis using matching clinical language. This one-to-one alignment between the label's indication and the patient's diagnosis is typically sufficient to overturn a "not FDA-approved" denial when the underlying approval is genuine.