How to Get Breyanzi (lisocabtagene maraleucel) Covered by UnitedHealthcare in Georgia: Prior Authorization Guide and Appeals Process
Answer Box: Getting Breyanzi Covered by UnitedHealthcare in Georgia
UnitedHealthcare requires prior authorization for Breyanzi (lisocabtagene maraleucel) CAR-T therapy through OptumRx. Submit via the UHC Provider Portal with diagnosis documentation, prior therapy failures, and medical necessity justification. If denied, you have 180 days for internal appeals and 60 days for Georgia's external review through the Department of Insurance. Start by gathering your clinical records and verifying your specific plan's formulary coverage today.
Table of Contents
- Why Georgia State Rules Matter
- UnitedHealthcare Prior Authorization Requirements
- Step Therapy Protections and Medical Exceptions
- Appeals Process: Internal and External Review
- Coverage at a Glance
- Common Denial Reasons and How to Fix Them
- Costs and Patient Assistance Options
- When to Contact Georgia Regulators
- FAQ
Why Georgia State Rules Matter
Georgia's insurance laws provide important protections that work alongside UnitedHealthcare's policies. While UnitedHealthcare follows national coverage guidelines, Georgia residents benefit from specific state protections for appeals and external reviews.
Key Georgia protections include:
- 60-day external review deadline after final denial
- Expedited reviews within 72 hours for urgent medical situations
- Binding external review decisions that insurers must honor
- No-cost external review process through the Georgia Department of Insurance
Understanding these rights is crucial because CAR-T therapies like Breyanzi often face initial denials due to their high cost (~$447,000-$487,000) and complex approval criteria.
UnitedHealthcare Prior Authorization Requirements
UnitedHealthcare requires prior authorization for Breyanzi through OptumRx for all plan types—commercial, Medicare Advantage, and state employee plans in Georgia.
Coverage Details by Plan Type
Medicare Advantage Plans:
- Covered under autologous stem cell transplantation benefits
- Subject to OptumHealth Transplant Solutions criteria
- May require step therapy unless medically contraindicated
Commercial Plans:
- Treated as injectable oncology medication
- Requires PA through the UHC Provider Portal
- Subject to medical necessity review
Required Documentation
Your healthcare team must submit:
- Diagnosis verification with ICD-10 codes
- Prior therapy documentation showing failure or intolerance
- Performance status assessment
- Organ function tests and infection screening
- Treatment center certification for CAR-T administration
Clinician Corner: Medical Necessity Checklist
Include these elements in your prior authorization request:Specific lymphoma subtype (LBCL, CLL/SLL) with pathology confirmationDocumentation of ≥2 prior therapy lines with dates and outcomesFor CLL/SLL: evidence of prior BTK inhibitor and BCL2 inhibitor useCurrent disease status and imaging resultsPatient's ECOG performance statusCertified CAR-T treatment center confirmation
Step Therapy Protections and Medical Exceptions
Georgia law requires insurers to provide medical exceptions to step therapy when clinically appropriate. For Breyanzi, this is particularly important given its use after multiple prior therapies.
When to Request Step Therapy Exceptions
- Treatment failure: Prior therapies caused disease progression
- Medical contraindications: Patient cannot tolerate required step therapies
- Clinical urgency: Delay would cause serious harm
- Unique patient factors: Age, comorbidities, or drug interactions
How to Document Medical Necessity
Use specific language in your appeal:
"Based on the patient's refractory large B-cell lymphoma after failure of [specific regimens with dates], Breyanzi is medically necessary as the appropriate next-line therapy per FDA labeling and NCCN guidelines. Step therapy with [alternative] would delay appropriate care and potentially worsen outcomes."
Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to create point-by-point rebuttals. Their platform helps identify the specific denial basis and drafts appeals aligned to each payer's requirements, which can be particularly valuable for complex CAR-T therapy cases.
Appeals Process: Internal and External Review
Internal Appeals with UnitedHealthcare
Standard Timeline: 30 days for non-urgent requests Expedited Timeline: 72 hours for urgent medical situations
How to File:
- Submit through the UHC Provider Portal
- Include all supporting clinical documentation
- Request peer-to-peer review if needed
- Follow up within 15 days if no response
Georgia External Review Process
If UnitedHealthcare denies your internal appeal, Georgia law provides a powerful backup option.
Timeline: You have 60 days from the final denial letter to file Decision: External reviewer has 30 business days to decide Cost: Free to consumers
Required Documents:
- UnitedHealthcare's final denial letter
- External review application form
- Complete medical records
- Prescriber's medical necessity statement
Contact Information: Georgia Department of Insurance Consumer Services
- Phone: 1-800-656-2298
- Email: [email protected]
- Address: 2 Martin Luther King Jr. Dr. SE, Suite 704 West Tower, Atlanta, GA 30334
From Our Advocates
In our experience, external reviews for CAR-T therapies often succeed when the clinical documentation clearly shows the patient meets FDA labeling criteria and has exhausted appropriate prior therapies. Independent medical reviewers understand the complexity of these cases and focus on clinical appropriateness rather than cost considerations.
Coverage at a Glance
| Requirement | What It Means | Where to Find It |
|---|---|---|
| Prior Authorization | Required for all UHC plans | UHC Provider Portal |
| Medical Necessity | Must meet FDA-approved indications | FDA Breyanzi Label |
| Treatment Center | Certified CAR-T facility required | Contact your oncology team |
| Internal Appeal Deadline | 180 days from denial | UHC denial letter |
| External Review Deadline | 60 days from final denial | Georgia DOI website |
Common Denial Reasons and How to Fix Them
| Denial Reason | How to Overturn |
|---|---|
| "Not meeting line of therapy" | Submit detailed treatment history with dates and outcomes |
| "Insufficient prior therapy documentation" | Request complete medical records from all treating facilities |
| "Treatment center not certified" | Confirm CAR-T certification and include facility credentials |
| "Not medically necessary" | Provide peer-reviewed literature supporting CAR-T use in your situation |
| "Experimental/investigational" | Cite FDA approval and Medicare NCD 110.24 coverage |
Costs and Patient Assistance Options
List Price: Approximately $447,000-$487,000 per treatment Total Cost: Often exceeds $500,000 including hospitalization and monitoring
Financial Assistance Programs
Bristol Myers Squibb Patient Assistance:
- Access Support Hub: 1-888-423-5436
- May provide free drug for eligible uninsured patients
- Copay assistance for commercially insured patients
Independent Foundations:
- The Leukemia & Lymphoma Society
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation
Tip: Apply for patient assistance programs while pursuing insurance coverage. These programs can serve as backup options if appeals are unsuccessful.
When to Contact Georgia Regulators
Contact the Georgia Department of Insurance if:
- UnitedHealthcare fails to respond within required timeframes
- You need help understanding your appeal rights
- You believe the insurer violated Georgia insurance law
- You want to file a formal complaint
Georgia DOI Consumer Services:
- Phone: 404-656-2070 or 1-800-656-2298
- Online: File complaints at oci.georgia.gov
The Consumer Services Division can informally contact insurers to ensure proper handling of your case and provide guidance on the external review process.
FAQ
How long does UnitedHealthcare prior authorization take in Georgia? Standard PA decisions are made within 14 days. Expedited requests for urgent situations must be decided within 72 hours per Georgia law.
What if Breyanzi is not on my UnitedHealthcare formulary? Non-formulary drugs can still be covered through the medical exception process. Your doctor must demonstrate medical necessity and that formulary alternatives are inappropriate.
Can I request an expedited appeal in Georgia? Yes, if waiting for a standard appeal would seriously jeopardize your health. Both UnitedHealthcare internal appeals and Georgia external reviews offer expedited options.
Does step therapy apply if I've already failed therapies outside Georgia? Yes, prior therapy failures from other states count toward step therapy requirements. Ensure all medical records are included in your PA request.
How much will I pay out-of-pocket for Breyanzi? This depends on your specific plan. Medicare Advantage plans typically have annual out-of-pocket maximums. Commercial plans vary widely in their cost-sharing for specialty drugs.
What happens if the external review supports coverage? Georgia law requires UnitedHealthcare to cover the treatment if the external reviewer approves it. The decision is binding on the insurer.
Can I appeal a quantity limit for Breyanzi? Breyanzi is typically a one-time treatment, so quantity limits are rare. If imposed, they can be appealed through the same process as coverage denials.
Should I continue other treatments while appealing? Work with your oncology team to determine the best approach. Some patients may need bridge therapy while pursuing CAR-T approval.
Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters and creating evidence-backed appeals tailored to each payer's specific policies. Their platform is designed to turn insurance obstacles into successful coverage outcomes for life-saving treatments like Breyanzi.
Sources & Further Reading
- UnitedHealthcare Provider Portal
- Georgia Department of Insurance Consumer Services
- FDA Breyanzi Prescribing Information
- UHC Commercial Prior Authorization Requirements (PDF)
- UHC Medicare Advantage Drug Coverage Policy (PDF)
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and state laws may change. Always consult with your healthcare team and insurance plan for the most current requirements. For specific legal questions about insurance denials, consider consulting with a qualified attorney familiar with Georgia insurance law.
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