By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

How to Get Breyanzi Covered by Humana in North Carolina: Appeals Guide & Templates

Answer Box: Getting Breyanzi Covered by Humana in North Carolina

Fastest path to approval: Submit prior authorization to Humana's Transplant Network (fax: 502-508-9300) with complete clinical documentation showing you meet FDA-approved indications for large B-cell lymphoma or CLL after ≥2 prior therapies. If denied, you have 65 days to appeal internally, then 120 days for North Carolina's external review through Smart NC. First step today: Contact your oncologist to gather treatment history and initiate the PA request with Humana's required forms.

Table of Contents

  1. Understanding Humana's Coverage Requirements
  2. Read Your Denial Letter
  3. Common Fixable Issues
  4. First-Level Appeal Strategy
  5. Peer-to-Peer Review Process
  6. North Carolina External Review
  7. Appeal Templates & Scripts
  8. Financial Support Options
  9. When to Escalate
  10. FAQ

Understanding Humana's Coverage Requirements

Breyanzi (lisocabtagene maraleucel) is a CAR-T cell therapy that requires prior authorization from Humana's National Transplant Network. The therapy is covered under Medicare Advantage as a medical benefit (Part B), not pharmacy coverage.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all CAR-T therapies Humana PA List
FDA Indications Only Must meet labeled uses for LBCL or CLL FDA Breyanzi Label
Certified Center Treatment at REMS-approved facility Cell Therapy 360
Medical Necessity Prior therapy failures documented Humana Medical Policy
Appeals Deadline 65 days from denial notice Medicare regulations

Read Your Denial Letter

Your denial letter contains critical information that determines your appeal strategy. Look for these key elements:

Denial reason codes typically fall into these categories:

  • Not medically necessary: Insurer questions clinical appropriateness
  • Prior authorization missing: PA wasn't submitted or approved
  • Non-formulary: Drug isn't on preferred list (less common for CAR-T)
  • Step therapy: Requirement to try other treatments first
  • Facility requirements: Treatment center not certified
Tip: Medicare Advantage denials must specify the exact reason and your appeal rights. If this information is missing, contact Humana member services immediately.

Common Fixable Issues

Before filing an appeal, check if your denial stems from these correctable problems:

Missing Documentation

  • Prior therapy records: Complete history of failed treatments with dates and outcomes
  • Pathology reports: Confirming eligible lymphoma subtype or CLL diagnosis
  • Performance status: ECOG or Karnofsky scores showing fitness for treatment
  • Lab values: Recent CBC, comprehensive metabolic panel, hepatitis screening

Coding Mismatches

CAR-T therapy should be billed under medical benefit using appropriate HCPCS codes. If your claim was processed through pharmacy benefit (Part D), request rebilling under Part B.

Facility Certification

Breyanzi must be administered at a REMS-certified center. Verify your treatment facility meets this requirement.

First-Level Appeal Strategy

Humana Medicare Advantage members have 65 days from the denial date to file an internal appeal. Submit your appeal with these components:

Medical Necessity Letter Checklist

Your oncologist should include:

  • Diagnosis confirmation: Specific lymphoma subtype with ICD-10 codes
  • Prior treatment failures: Detailed history of ≥2 systemic therapies with dates, responses, and reasons for discontinuation
  • Clinical rationale: Why CAR-T is appropriate now based on FDA labeling and guidelines
  • Contraindication review: Confirmation patient meets safety criteria
  • Treatment plan: Proposed monitoring and supportive care

Required Documentation

  • Complete medical records from past 12 months
  • Pathology and cytogenetics reports
  • Prior therapy summary with response assessments
  • Current imaging and lab results
  • Prescriber attestation of medical necessity

Submit via:

Peer-to-Peer Review Process

If your written appeal is denied, request a peer-to-peer review where your oncologist speaks directly with Humana's medical director.

Preparation Checklist

  • Case summary: One-page overview of diagnosis, prior treatments, and current status
  • Guideline references: NCCN Guidelines supporting CAR-T use in your situation
  • FDA label excerpts: Relevant sections confirming indication
  • Clinical studies: Key publications supporting efficacy in similar patients

Key Talking Points

  1. FDA indication met: Patient has relapsed/refractory disease after appropriate prior therapies
  2. Standard of care: CAR-T is established treatment per national guidelines
  3. No alternatives: Other curative options exhausted or contraindicated
  4. Facility readiness: Treatment center certified and experienced

North Carolina External Review

If Humana denies your internal appeals, North Carolina's external review through Smart NC offers an independent assessment.

Timeline & Process

  • Deadline: 120 days from final internal denial
  • Standard review: 45-day decision timeline
  • Expedited review: 72 hours for urgent cases
  • Cost: Free to patients

How to Request

  1. Complete the external review request form
  2. Submit within 120 days of Humana's final denial
  3. Include all medical records and supporting documentation
  4. Smart NC assigns to independent medical reviewer
Note: External review decisions are binding on Humana. If approved, coverage must begin within 3 business days.

Contact Smart NC:

Appeal Templates & Scripts

Patient Phone Script for Humana

"I'm calling about a denial for Breyanzi CAR-T therapy. My member ID is [number]. I'd like to understand the specific denial reason and request information about filing an appeal. Can you transfer me to someone who handles prior authorizations for specialty therapies?"

Medical Necessity Letter Template

[Date]

To: Humana Medical Review
Re: [Patient Name], DOB: [date], Member ID: [number]
Request for: Breyanzi (lisocabtagene maraleucel) CAR-T therapy

Dear Medical Director,

I am writing to request coverage for Breyanzi CAR-T therapy for my patient with relapsed/refractory [specific diagnosis]. This treatment is medically necessary based on the following:

1. DIAGNOSIS: [Patient] has [specific lymphoma subtype] confirmed by [pathology details]

2. PRIOR TREATMENTS: [Patient] has failed the following therapies:
   - [Treatment 1]: [dates, response, reason for discontinuation]
   - [Treatment 2]: [dates, response, reason for discontinuation]

3. FDA INDICATION: This request aligns with FDA-approved labeling for Breyanzi in [indication]

4. CLINICAL RATIONALE: CAR-T therapy represents the standard of care per NCCN Guidelines for patients in this clinical scenario.

Supporting documentation attached. I am available for peer-to-peer discussion.

Sincerely,
[Physician name and credentials]

Financial Support Options

For Medicare Patients

Unfortunately, Bristol Myers Squibb copay assistance excludes Medicare beneficiaries due to federal regulations. However, alternatives exist:

  • Independent foundations: BMS Access Support (1-800-861-0048) can refer you to charitable organizations
  • Hospital financial assistance: Many cancer centers offer need-based support programs
  • Medicare Supplement plans: May reduce out-of-pocket costs

For Commercial Insurance

When to Escalate

Contact these North Carolina regulators if Humana isn't following proper procedures:

Smart NC Consumer Assistance

  • Phone: 1-855-408-1212
  • Purpose: Help with insurance appeals and external review
  • Services: Free advocacy and guidance through the appeals process

NC Department of Insurance

  • Website: ncdoi.gov
  • File complaints: For procedural violations or unfair claim practices

FAQ

Q: How long does Humana prior authorization take in North Carolina? A: Standard PA decisions are typically made within 30 days for Medicare Advantage plans. Expedited reviews (for urgent cases) are processed within 72 hours.

Q: What if Breyanzi is considered experimental by Humana? A: CAR-T therapy is FDA-approved and covered under Medicare NCD 110.24. Reference this coverage determination in your appeal.

Q: Can I request an expedited appeal? A: Yes, if delay would seriously jeopardize your health. Both Humana internal appeals and North Carolina external review offer expedited timelines.

Q: Does step therapy apply if I've failed treatments outside North Carolina? A: Prior treatment failures from any location count toward meeting step therapy requirements, provided they're properly documented.

Q: What happens if the external review denies coverage? A: External review decisions are final for the administrative process. You may have limited legal options to pursue in court.

Q: How much does Breyanzi cost without insurance? A: The wholesale acquisition cost (WAC) is approximately $447,000-$487,000, with total treatment costs potentially higher when including facility fees and monitoring.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payers' own rules, pulling the right clinical evidence and citations to support medical necessity arguments.

For additional support navigating complex prior authorization and appeals processes, Counterforce Health provides tools and expertise to help patients access necessary treatments like Breyanzi.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. Appeal processes and requirements may change; verify current procedures with official sources.

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