MOUD Naltrexone LA denied as not FDA-approved for this use by Cigna?

Cigna's specific coverage criteria for moud naltrexone la 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 May Deny Long-Acting Naltrexone as 'Not FDA-Approved' — and Why That Denial Is Wrong

Long-acting injectable naltrexone holds FDA approval for both opioid use disorder and alcohol use disorder. A denial coded as 'not FDA-approved' is almost certainly a coding or review error, or it may reflect a misapplication of the approval to the specific indication documented in your claim. Either way, it is directly rebutted with the FDA's own public approval record.

## Why This Denial Is Immediately Appealable

Because the factual premise of the denial — that the drug lacks FDA approval — is incorrect, this appeal has a strong documentary foundation. The FDA approval is a matter of public record and can be cited directly. Insurers may not deny coverage by misstating a drug's regulatory status. If Cigna is actually applying an 'experimental' or 'off-label' code in error, the appeal should address both the accurate approval status and clinical necessity.

## Your Federal Appeal Rights

• Internal appeal (ERISA §503 / ACA §2719): Submit a formal internal appeal immediately. Include the FDA approval reference and the prescriber's documentation of the approved indication.
• External review (ACA §2719): If the internal appeal is denied, request IRO review within approximately four months of the original denial date. Expedited review is available when delay creates serious health risk.

## Appeal Timeline

1. On the denial date, request the full claim file and the specific policy or clinical criteria Cigna used. 2. Submit an internal appeal with the FDA approval documentation and the prescriber's letter confirming the approved indication. 3. If denied, immediately file for external IRO review.

## Documentation to Gather

• FDA approval confirmation: Cite the FDA drug label (publicly available at DailyMed or FDA.gov) confirming the approved indication matching the patient's diagnosis.
• Diagnosis confirmation: Chart documentation linking the patient's ICD-coded diagnosis to the FDA-approved indication.
• Prescriber letter: States clearly that the prescription is for an FDA-approved indication, references the label, and documents clinical necessity from chart findings.
• Denial letter analysis: Identify the exact language Cigna used and rebut each statement with the corresponding FDA record.

## Criteria-Mapping Structure

Build a two-column rebuttal table: left column quotes Cigna's denial language; right column cites the FDA approval record and/or chart fact that directly contradicts it. This structure makes it easy for an internal reviewer or IRO to resolve the dispute on the facts.