By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

How to Get Breyanzi Covered by Blue Cross Blue Shield in Florida: Appeals, Forms & Timelines

Answer Box: Blue Cross Blue Shield of Florida requires prior authorization for Breyanzi (lisocabtagene maraleucel) with strict clinical criteria. If denied, you have 60 days to file an internal appeal, followed by external review through Florida's Department of Financial Services. Success requires complete documentation of diagnosis, failed prior therapies (≥2 lines for LBCL; BTK and BCL-2 inhibitors for CLL), and medical necessity. Start with your provider submitting a PA request with comprehensive clinical records.

Table of Contents

  1. Understanding Blue Cross Blue Shield Coverage for Breyanzi
  2. Prior Authorization Requirements
  3. Common Denial Reasons and How to Fix Them
  4. Step-by-Step Appeals Process in Florida
  5. Medical Necessity Letter Essentials
  6. External Review and State Resources
  7. Cost Support and Patient Assistance
  8. FAQ

Understanding Blue Cross Blue Shield Coverage for Breyanzi

Breyanzi (lisocabtagene maraleucel) is a CAR-T cell therapy approved for specific blood cancers, with a list price around $477,000-$487,000 per treatment course. Florida Blue (Blue Cross Blue Shield of Florida) covers Breyanzi under the medical benefit (not pharmacy) for FDA-approved indications, but requires extensive prior authorization.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required Must get approval before treatment Florida Blue Provider Portal Florida Blue PA Requirements
Medical Benefit Only Billed through medical claims, not pharmacy Provider billing department BCBS Medical Drug Lists
Single Course Limit Authorization covers one treatment (1-4 vials) PA approval letter Florida Blue Coverage Policies
REMS-Certified Site Must be administered at qualified facility FDA REMS database FDA Safety Requirements
Specific Diagnoses LBCL, CLL/SLL, FL, MCL per FDA label Medical records with ICD-10 codes FDA Prescribing Information

Prior Authorization Requirements

Florida Blue requires comprehensive clinical documentation before approving Breyanzi. The process typically takes 5-10 business days for standard reviews, or 72 hours for expedited cases.

Required Documentation Checklist

Clinical History:

  • Confirmed diagnosis with pathology report
  • ICD-10 codes (C83.3 for DLBCL, C91.1 for CLL)
  • Documentation of ≥2 prior therapy lines with dates and outcomes
  • For CLL/SLL: proof of BTK inhibitor AND BCL-2 inhibitor failure
  • Performance status and organ function assessments

Administrative Requirements:

  • HCPCS code Q2054 for billing
  • REMS program enrollment confirmation
  • Site-of-care certification documentation
  • Patient consent for CAR-T therapy
Tip: Submit PA requests through the Florida Blue provider portal with all documents attached as a single submission to avoid delays from missing information requests.

Common Denial Reasons and How to Fix Them

Based on Counterforce Health's analysis of Blue Cross Blue Shield denials, these are the most frequent issues and solutions:

Denial Reason How to Fix Required Documentation
"Insufficient prior therapy documentation" Provide detailed treatment history with dates, doses, duration, and reason for discontinuation Medical records, infusion logs, progress notes
"Not meeting line of therapy requirements" Clearly document each prior regimen as separate "lines" per NCCN definitions Treatment timeline with NCCN guideline citations
"Missing BTK/BCL-2 inhibitor history" (CLL) Document specific agents tried and outcomes Pharmacy records, treatment summaries
"Non-formulary drug" Request formulary exception with medical necessity justification Exception request form, clinical rationale
"Incorrect billing code/benefit" Ensure billing under medical benefit with Q2054 code Corrected claim submission

Step-by-Step Appeals Process in Florida

If your Breyanzi prior authorization is denied, Florida law provides multiple appeal levels with specific timelines.

Internal Appeal (First Level)

Timeline: Must file within 60 days of denial notice Decision deadline: 30 days for pre-service, 60 days for post-service How to submit: Florida Blue Appeals Portal or fax to number on denial letter

Required elements:

  1. Completed appeal form with patient information
  2. Copy of original denial letter
  3. Medical necessity letter from prescribing physician
  4. Supporting clinical documentation
  5. Relevant clinical guidelines (NCCN, FDA label)

Expedited Appeal

For urgent cases where delays could harm your health, request an expedited appeal:

  • Decision timeline: 72 hours
  • Qualification: Treatment delay would seriously jeopardize health
  • How to request: Mark "URGENT" on appeal form and provide clinical justification

External Review (Independent Review)

If the internal appeal is denied, you can request external review through Florida's Department of Financial Services.

Timeline: Must request within 120 days of final internal denial Decision deadline: 45 days (standard), 72 hours (expedited) How to request: Contact Florida DFS Consumer Services at 1-877-MY-FL-CFO (1-877-693-5236)

The external reviewer will evaluate whether the denial was appropriate based on medical evidence and policy terms. Their decision is binding on Florida Blue.

Medical Necessity Letter Essentials

A strong medical necessity letter is crucial for appeal success. Here's what to include:

Letter Structure

Patient Summary:

  • Age, diagnosis with ICD-10 code
  • Disease stage and prognostic factors
  • Current performance status

Treatment History:

  • Chronological list of all prior therapies
  • Specific agents, doses, duration, and outcomes
  • Reasons for discontinuation (progression, toxicity, intolerance)
  • Documentation of BTK and BCL-2 inhibitor use for CLL/SLL

Clinical Rationale:

  • Why Breyanzi is medically necessary now
  • Why alternative treatments are inappropriate
  • Urgency of treatment need
  • Expected clinical benefit

Guideline Support:

  • NCCN Guidelines recommendations for patient's specific situation
  • FDA-approved indications alignment
  • Published clinical trial data supporting use
Clinician Corner: Include specific NCCN guideline version numbers and page references. For LBCL, cite NCCN B-Cell Lymphomas guidelines; for CLL/SLL, reference NCCN CLL/SLL guidelines. This demonstrates thorough clinical evaluation and strengthens the appeal.

External Review and State Resources

Florida has strengthened patient protections for specialty drug appeals through the Patient Timely Access to Healthcare Act (effective October 2024).

Key Protections

  • 30-day standard appeal resolution (reduced from previous timelines)
  • 24-hour review for concurrent treatment decisions
  • Seven-day operations requirement (insurers can't exclude weekends)
  • Expedited external review for urgent cases

State Support Resources

Florida Department of Financial Services Consumer Help:

  • Phone: 1-877-MY-FL-CFO (1-877-693-5236)
  • Online: Submit service requests
  • Specialty drug delays hotline: 1-800-FL-HEALTH

Florida Office of Insurance Regulation:

  • Phone: (850) 413-3140
  • Role: Oversees insurer compliance with state regulations

Cost Support and Patient Assistance

Even with insurance coverage, out-of-pocket costs for Breyanzi can be substantial. Several programs can help:

Bristol Myers Squibb Patient Support

  • Breyanzi Access Support: Provides coverage navigation and financial assistance
  • Eligibility: Varies by program; some income restrictions apply
  • Contact: Through your treatment center or BMS patient support

Foundation Resources

  • Leukemia & Lymphoma Society: Financial assistance for blood cancer patients
  • Patient Advocate Foundation: Copay relief and insurance appeals support
  • CancerCare: Financial assistance and case management

State Programs

Florida residents may qualify for additional support through state pharmaceutical assistance programs. Contact the Florida Department of Health for current program information.

Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed, policy-specific rebuttals. Their platform analyzes denial letters and payer policies to draft targeted appeals that address each denial reason with appropriate clinical evidence and procedural requirements.

FAQ

How long does Florida Blue prior authorization take for Breyanzi? Standard PA reviews take 5-10 business days. Expedited reviews for urgent cases are completed within 72 hours. Submit complete documentation to avoid delays from information requests.

What if Breyanzi isn't on my Florida Blue formulary? Request a formulary exception through the Coverage Exception Process. Florida Blue must respond within 72 hours and provide expedited reviews for urgent clinical needs.

Can I appeal if I'm on Medicare Advantage with Florida Blue? Yes, but Medicare Advantage appeals follow federal timelines: 60 days to file, with decisions within 30 days for pre-service requests. External review is available through the Medicare appeals process.

What happens if I miss the appeal deadline? Contact Florida Blue immediately to request deadline extension based on "good cause" (such as not receiving proper notice). Florida DFS can also assist with procedural issues.

Does step therapy apply to Breyanzi? Yes, you must demonstrate failure of appropriate prior therapies. For LBCL, this means ≥2 lines of therapy. For CLL/SLL, you need documented failure of both BTK and BCL-2 inhibitors.

How successful are Breyanzi appeals in Florida? Success rates vary, but appeals with complete clinical documentation and proper medical necessity justification have significantly higher approval rates. External reviews overturn approximately 40-50% of specialty drug denials when thorough evidence is provided.

Can my doctor request a peer-to-peer review? Yes, physicians can request peer-to-peer discussions with Florida Blue medical directors. This often resolves coverage issues faster than formal appeals and should be requested early in the process.

What if treatment is urgent and I can't wait for appeals? Request expedited internal and external appeals simultaneously. For life-threatening situations, Florida allows concurrent external review. Contact Florida DFS at 1-800-FL-HEALTH for immediate assistance with urgent cases.

Sources & Further Reading

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Treatment decisions should be made in consultation with qualified healthcare providers. Insurance coverage varies by plan and individual circumstances. Always verify current requirements with your specific insurer and healthcare team.

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