Speech Therapy Pediatric denied as not FDA-approved for this use by Cigna?

Cigna's specific coverage criteria for speech therapy pediatric 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 Pediatric Speech Therapy as "Not FDA-Approved" — and Why That Is Appealable

Speech therapy is not a drug and is not subject to FDA approval in the way medications are. When Cigna uses a "not FDA-approved" denial code against a pediatric speech therapy claim, the denial is almost always a misapplication of the review criteria — the services provided should have been evaluated under medical necessity or habilitative/rehabilitative benefit standards, not a drug-approval framework. This creates a strong procedural basis for reversal.

## Why This Denial Is Appealable

Federal law provides multiple layers of protection. Under the ACA (§2719) and ERISA (§503), your plan must offer a full internal appeal, followed by an independent external review if the internal appeal fails. The external review must generally be initiated within approximately four months of the adverse determination notice — check your Explanation of Benefits for the exact deadline. An expedited review is also available when the standard timeline would seriously jeopardize the child's health or ability to function.

Additionally, the Mental Health Parity and Addiction Equity Act (MHPAEA) and the ACA's habilitative services mandate may require Cigna to cover medically necessary pediatric speech therapy at parity with comparable medical or surgical benefits.

## The Concrete Appeal Process

1. Request the denial rationale in writing — Cigna must supply the specific criteria used. If the denial says "not FDA-approved," demand the exact coverage policy language that applies to therapy services. 2. File a Level 1 internal appeal — typically within 180 days of the denial; confirm your plan's deadline on the EOB. 3. Request an Independent Medical Review / External Review if the Level 1 is upheld. 4. File a complaint with your state insurance commissioner and, for self-funded ERISA plans, with the U.S. Department of Labor Employee Benefits Security Administration (EBSA).

## Documentation to Gather

• Diagnosis confirmation: Speech-language pathology evaluation establishing the diagnosed communication disorder (e.g., expressive/receptive language delay, childhood apraxia of speech, dysarthria).
• Medical necessity letter: A signed letter from the treating speech-language pathologist and the child's pediatrician or specialist explaining why ongoing therapy is medically necessary at the prescribed frequency.
• Progress notes: Session notes documenting measurable functional progress, updated treatment goals, and the risk of regression without continued treatment.
• Prior treatment history: Dates of service, frequency, provider credentials, and outcomes of all prior speech therapy, demonstrating the clinical trajectory.
• Applicable guideline reference: Cite the relevant guidelines from the American Speech-Language-Hearing Association (ASHA) without invoking specific numeric thresholds; ask your provider to reference these in their letter.

## Criteria-Mapping Structure

Copy each stated requirement from Cigna's published coverage policy for habilitative and rehabilitative therapy services. For each requirement, document the exact chart fact that satisfies it. For example: if the policy requires a formal diagnosis, attach the SLP evaluation report. If it requires evidence of functional progress, attach dated session notes with goal-tracking data. A point-by-point response to the denial rationale — rather than a general appeal — is the most effective format.