Tecartus denied as not FDA-approved for this use by Blue Cross Blue Shield?

Blue Cross Blue Shield's specific coverage criteria for tecartus 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 BCBS May Issue a "Not FDA-Approved" Denial for Tecartus

Tecartus (brexucabtagene autoleucel) is a CAR-T cell therapy manufactured by Kite Pharma. BCBS reviewers sometimes generate a "not FDA-approved" denial code in error — typically because the automated review system flags the indication on the claim, not the drug itself. Tecartus carries FDA approval for specific hematologic malignancies; a denial on this basis is often a coding or classification error that is very frequently overturned on appeal.

## Federal Appeal Rights

Because CAR-T therapy is expensive and time-sensitive, understanding your full appeal rights is essential:

• Internal appeal (Level 1): You have the right under ACA §2719 and ERISA §503 to a full-and-fair internal review. Submit within the deadline shown on your denial letter (typically 180 days).
• External review: After exhausting internal appeal — or if BCBS fails to meet its own deadlines — you may request independent external review. The ACA guarantees this right for most plans, and the reviewer is not employed by BCBS. The external review window is generally available for up to approximately four months after final internal denial.
• Expedited review: If your oncologist certifies that standard timelines would seriously jeopardize your health or your ability to regain maximum function, request expedited review — decisions are legally required within 72 hours.

## What to Include in Your Appeal

1. FDA approval documentation: Pull the current FDA label for Tecartus from DailyMed (dailymed.nlm.nih.gov) and include the approved indications verbatim. Match your diagnosis code to the labeled indication precisely. 2. Diagnosis confirmation: Pathology reports, flow cytometry, bone marrow biopsy, or other diagnostic records that confirm your specific diagnosis and disease classification. 3. Prior treatment history: A dated list of every prior line of therapy, including start/stop dates and response or lack of response, demonstrating that your case fits the labeled treatment context. 4. Prescriber medical-necessity letter: Your treating hematologist-oncologist should state in writing why Tecartus is medically necessary for your specific diagnosis and why alternative treatments are not appropriate. 5. Criteria-mapping table: List each requirement in the FDA label and in BCBS's own published CAR-T coverage policy side-by-side with the specific chart evidence that satisfies it.

## Criteria-Mapping Structure

For each coverage criterion BCBS lists, document the answer from your chart:

| Coverage Criterion (from FDA label and BCBS policy) | Your Chart Evidence | |---|---| | Specific diagnosis and histology per label | Pathology report, date | | Line-of-therapy requirement per label | Treatment history summary | | Performance status requirement | Oncology note, date | | Treating center certification requirement | Center credentials |

## Next Step

Obtain BCBS's published CAR-T / Tecartus medical policy directly from bcbs.com or by calling the member services number on your card. Compare each listed criterion against your records before submitting.