By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

Getting Breyanzi (Lisocabtagene Maraleucel) Covered by Blue Cross Blue Shield Ohio: Prior Authorization, Appeals, and State Review Process

Answer Box: How to Get Breyanzi Covered by BCBS Ohio

Blue Cross Blue Shield Ohio requires prior authorization for Breyanzi (lisocabtagene maraleucel) with strict medical necessity criteria. Treatment must occur at a Blue Distinction Center for Cellular Immunotherapy. First step: Verify your plan type (HMO requires PCP referral) and confirm the treatment center is in-network. Submit PA with complete documentation of prior failed therapies, ECOG performance status 0-1, and viral screenings. If denied, you have 180 days to appeal internally, then 180 days for external review through Ohio Department of Insurance. Call ODI Consumer Services at 1-800-686-1526 for assistance.

Table of Contents

  1. Plan Types & Network Requirements
  2. Prior Authorization Requirements
  3. Medical Necessity Criteria
  4. Specialty Center Requirements
  5. Appeals Process in Ohio
  6. External Review Through ODI
  7. Required Forms and Documentation
  8. Common Denial Reasons
  9. Cost Considerations
  10. When to Escalate
  11. FAQ

Plan Types & Network Requirements

Blue Cross Blue Shield Ohio offers three main plan types, each with different requirements for accessing Breyanzi:

HMO Plans: Require a primary care physician (PCP) referral to see oncology specialists. You must use in-network providers only. Start by getting a referral from your PCP to a hematologist/oncologist at a qualified CAR-T center.

PPO Plans: Allow direct access to specialists without referrals, but out-of-network care costs significantly more. All Breyanzi treatment must occur at designated centers, so verify network status before proceeding.

EPO Plans: Cover only in-network providers with no out-of-network benefits. Referrals typically aren't required, but all care must be within the network.

Important: Regardless of plan type, Breyanzi is only covered at Blue Distinction Centers for Cellular Immunotherapy that meet specific quality and safety criteria.

Prior Authorization Requirements

All BCBS Ohio plans require prior authorization for Breyanzi before treatment begins. The PA process involves several steps:

  1. Initial Assessment: Your oncologist evaluates whether you meet FDA-approved indications
  2. Documentation Gathering: Complete medical records, prior therapy history, and current labs
  3. PA Submission: Provider submits request through BCBS portal or designated channels
  4. Review Timeline: BCBS has 10 days for standard review, 48-72 hours for urgent requests

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before treatment Provider portal/denial letter BCBS Ohio Policy
Blue Distinction Center Treatment at qualified facility only Provider directory BCBS Center Locator
Medical Necessity Must meet specific clinical criteria Plan policy documents Clinical Criteria
ECOG Status Performance status 0 or 1 required Medical records FDA Label
Viral Screening HBV, HCV, HIV testing required Lab reports PA Criteria

Medical Necessity Criteria

BCBS Ohio follows strict medical necessity criteria for Breyanzi coverage:

Large B-Cell Lymphoma (LBCL)

  • Age ≥18 years
  • Documented eligible LBCL subtype per FDA labeling
  • Failed ≥2 prior lines of systemic therapy
  • ECOG performance status 0 or 1
  • No prior CAR-T or genetically modified T-cell therapy
  • No primary CNS lymphoma
  • Completed viral screenings (HBV, HCV, HIV)

Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

  • Age ≥18 years
  • Failed ≥2 prior lines including:
    • BTK inhibitor therapy
    • BCL-2 inhibitor therapy
  • ECOG performance status 0 or 1
  • Same exclusions and screening requirements as LBCL
Clinician Corner: Medical necessity letters should explicitly address each criterion with supporting documentation. Include specific prior therapies with dates, reasons for discontinuation, and current disease status with imaging or lab evidence.

Specialty Center Requirements

Breyanzi can only be administered at facilities meeting Blue Distinction Center criteria:

  • FACT Immune Effector Cell Program accreditation
  • Multidisciplinary team including oncology, nursing, palliative care, radiology, pathology
  • REMS program enrollment and certification
  • 24/7 monitoring capabilities for toxicity management
  • Coordinated care planning across all treatment phases

Find qualified centers using the BCBS provider directory or verify with your local BCBS Ohio member services.

Appeals Process in Ohio

If your prior authorization is denied, Ohio law provides multiple appeal levels:

Internal Appeals (BCBS Ohio)

First Internal Appeal:

  • Timeline: 180 days from denial notice to file
  • Response Time: 10-30 days standard, 48-72 hours urgent
  • Required: Complete medical records, denial letter, new supporting evidence

Second Internal Appeal (if available):

  • Timeline: 60 days from first appeal denial
  • Response Time: 30 days standard, 72 hours urgent
  • Strategy: Include additional clinical evidence or peer-reviewed literature
Important: If BCBS doesn't respond within statutory deadlines, your PA may be automatically approved under Ohio law.

Step-by-Step Appeal Process

  1. Gather Documentation: Denial letter, complete medical records, lab results, imaging
  2. Write Appeal Letter: Address each denial reason with clinical evidence
  3. Submit Within Deadline: Use method specified in denial letter
  4. Track Timeline: Document submission date and follow up if no response
  5. Prepare for Next Level: If denied, immediately prepare external review request

External Review Through ODI

After exhausting internal appeals, you can request external review through the Ohio Department of Insurance:

Timeline: 180 days from final internal denial to request external review

Process:

  1. File request with BCBS Ohio (they forward to ODI)
  2. ODI assigns Independent Review Organization (IRO)
  3. IRO conducts impartial medical review
  4. Decision is binding on BCBS Ohio

Response Times:

  • Standard review: 30 days
  • Expedited review: 72 hours (for urgent medical situations)

Contact ODI Consumer Services: 1-800-686-1526

Note: IRO external reviews overturn specialty drug denials in approximately 40-60% of cases when strong clinical evidence is presented.

Required Forms and Documentation

Essential Documents for PA Submission

Clinical Documentation:

  • Complete medical history and physical exam
  • Pathology reports confirming diagnosis
  • Prior therapy records with dates and outcomes
  • Current labs including CBC, comprehensive metabolic panel
  • Viral screening results (HBV, HCV, HIV)
  • ECOG performance status assessment

Administrative Forms:

  • BCBS Ohio prior authorization form (obtain from provider portal)
  • Provider attestation of medical necessity
  • Facility certification documents

Appeal Documentation Checklist

  • Original denial letter
  • Complete medical records
  • Peer-reviewed literature supporting treatment
  • Clinical guidelines references (NCCN, FDA label)
  • Second opinion letter (if available)
  • Patient impact statement

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Insufficient prior therapies Document all prior treatments with dates, doses, outcomes Pharmacy records, infusion logs, progress notes
Performance status not documented Obtain formal ECOG assessment Oncologist evaluation with specific ECOG score
Missing viral screening Complete required testing Lab reports for HBV, HCV, HIV
Non-eligible lymphoma subtype Confirm pathology meets FDA criteria Updated pathology review, immunohistochemistry
Center not qualified Transfer to Blue Distinction Center Facility accreditation documentation

Cost Considerations

Breyanzi List Price: Approximately $447,000-$487,000 per dose (2024-2025 estimates)

Total Treatment Costs: Can exceed $500,000+ including:

  • Pre-treatment workup and staging
  • Lymphodepletion chemotherapy
  • Inpatient monitoring (typically 2-4 weeks)
  • Toxicity management
  • Long-term follow-up care

Financial Assistance Options:

  • Bristol Myers Squibb patient assistance programs
  • Hospital charity care programs
  • State pharmaceutical assistance programs
  • Nonprofit foundation grants
Tip: Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed, payer-specific appeals that address each denial reason with targeted clinical documentation and regulatory requirements.

When to Escalate

Contact Ohio Department of Insurance if:

  • BCBS doesn't respond within statutory timelines
  • You're told external review isn't available (ODI can independently determine eligibility)
  • Insurer requests inappropriate documentation
  • You need help navigating the appeals process

ODI Consumer Services: 1-800-686-1526 Website: insurance.ohio.gov

Consider legal consultation if:

  • External review is denied inappropriately
  • Treatment delays cause medical harm
  • Plan appears to violate state or federal coverage requirements

FAQ

How long does BCBS Ohio prior authorization take? Standard PA requests: 10 days. Urgent requests: 48-72 hours. If they don't respond within these timeframes, the PA may be automatically approved under Ohio law.

What if Breyanzi isn't on my plan's formulary? Breyanzi requires prior authorization regardless of formulary status. Focus on meeting medical necessity criteria rather than formulary placement.

Can I request expedited appeals? Yes, if delays would seriously jeopardize your health. Both internal appeals and external reviews offer expedited timelines (48-72 hours).

Do I need to try other CAR-T therapies first? No, BCBS Ohio doesn't require step therapy between different CAR-T products. However, you must have failed conventional therapies per FDA labeling.

What if I have an ERISA self-funded plan? Self-funded plans may not follow Ohio's external review process but often offer voluntary external review. Check your plan documents or contact HR.

How do I find a Blue Distinction Center in Ohio? Use the BCBS provider directory or call member services to verify which Ohio facilities are designated for CAR-T therapy.

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned to each payer's specific requirements, significantly improving approval rates for complex therapies like CAR-T.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by individual plan. Always consult your healthcare provider and insurance plan documents for specific coverage details. For assistance with insurance appeals in Ohio, contact the Ohio Department of Insurance Consumer Services at 1-800-686-1526.

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