Regenerative Injection denied as not FDA-approved for this use by Cigna?

Cigna's specific coverage criteria for regenerative injection 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 Your Regenerative Injection as Not FDA-Approved

Cigna issues a not-FDA-approved denial when the specific regenerative injection product — for example, a particular platelet-rich plasma preparation, cellular therapy, or biologic concentrate — does not hold FDA approval or clearance for the indication being treated. Many regenerative procedures use autologous (your own) biological material processed in ways that fall outside traditional FDA drug-approval pathways, or they are used for indications that are off-label relative to any existing clearance. Cigna's medical policies typically treat lack of FDA approval as a basis for an investigational or non-covered finding. These denials are legally contestable, particularly when the procedure uses autologous material and has a recognized evidence base in peer-reviewed literature.

## Your Right to Appeal

• Internal appeal: File a written appeal within the deadline on your denial letter. Request the specific policy language Cigna applied and ask whether the denial is based on FDA approval status, insufficient clinical evidence, or both — the distinction matters for how you construct your response.
• External review (ACA §2719): If the internal appeal fails, request IRO external review within approximately four months of the final internal denial. External reviewers evaluate against current clinical standards, not only FDA approval status.
• Expedited review: Available for urgent conditions, with a decision typically required within 72 hours.
• ERISA §503: Employer-sponsored plan members retain full-and-fair review and federal court access.

## Documentation to Gather

1. Regulatory classification clarification: Ask your provider or the facility to document the exact regulatory status of the product and procedure — distinguishing between FDA-cleared devices (e.g., centrifuges), unregulated autologous procedures, and biologics under FDA oversight. Precision here can rebut a blanket "not approved" finding. 2. Clinical evidence: Peer-reviewed studies and relevant society position statements supporting the use of this procedure for your diagnosis. Current evidence from recognized medical organizations carries significant weight with IRO reviewers. 3. Diagnosis and prior treatment records: Full chart documentation of diagnosis, severity, and prior failed treatments. 4. Prescriber medical-necessity letter: A letter from your provider addressing the regulatory classification, citing the applicable guideline organization, and distinguishing Cigna's policy language from the actual regulatory reality.

## Criteria-Mapping Strategy

Many not-FDA-approved denials conflate "not FDA-approved as a drug" with "clinically unacceptable" — these are distinct findings. Obtain the full text of the applicable Cigna medical policy and identify whether the denial is rooted in regulatory status, evidence standards, or both. Address each separately. If the procedure uses autologous material processed at the point of care, the FDA approval framework may not apply in the same way as it does to commercial biologics. Your appeal should make this distinction plainly and back it with your provider's written explanation.