By Counterforce Health Team in Kymriah (tisagenlecleucel) —

How to Get Kymriah (tisagenlecleucel) Covered by Humana in North Carolina: Complete Appeals Guide

Answer Box: Getting Kymriah Covered by Humana in North Carolina

Kymriah (tisagenlecleucel) requires prior authorization from Humana Medicare Advantage plans. Submit through Humana's National Transplant Network at 866-421-5663 or [email protected] with CD19 testing, prior therapy documentation, and REMS enrollment proof. If denied, you have 65 days to appeal internally, then 120 days for North Carolina's external review through Smart NC. Treatment must occur at certified centers like Duke, UNC, or Atrium Health. Start today: Verify your provider is enrolled in the KYMRIAH REMS program and confirm network status with Humana.

Table of Contents

  1. Kymriah Coverage Basics with Humana
  2. Prior Authorization Requirements
  3. Step-by-Step Approval Process
  4. Common Denial Reasons & Solutions
  5. Humana Appeals Process
  6. North Carolina External Review
  7. Certified Treatment Centers
  8. Cost Considerations
  9. FAQ
  10. Resources & Next Steps

Kymriah Coverage Basics with Humana

Kymriah (tisagenlecleucel) is a groundbreaking CAR-T cell therapy that Humana Medicare Advantage plans cover for specific blood cancers. This personalized treatment, which costs around $475,000 for pediatric ALL and $373,000 for adult lymphomas, requires careful navigation through Humana's approval process.

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all CAR-T therapies Humana CAR-T Policy
Approved Indications B-cell ALL (≤25 years), DLBCL, FL (adults) FDA Label
Submission Method National Transplant Network Provider Manual
Appeal Deadline 65 days from denial Humana Appeals
External Review 120 days through Smart NC NC DOI

Humana's approval process follows Medicare guidelines and requires demonstration of medical necessity through their established clinical criteria. The good news? Humana has one of the lowest denial rates among major Medicare Advantage plans at approximately 3.5%.

Prior Authorization Requirements

Success with Kymriah approval depends on submitting complete documentation that addresses Humana's specific criteria. Here's what you'll need:

Essential Documentation Checklist

  • CD19 Testing Results: Lab report confirming CD19 positivity on tumor cells
  • Diagnosis Confirmation: Pathology reports with ICD-10 codes
  • Prior Therapy Documentation: Complete treatment history with dates, responses, and failures
  • REMS Program Enrollment: Provider certification in KYMRIAH REMS program
  • Performance Status: Karnofsky/Lansky ≥50 (ALL) or ECOG 0-1 (lymphomas)
  • Conditioning Regimen Plan: Lymphodepleting chemotherapy protocol details
  • Center Certification: Confirmation of treatment at authorized facility

Medical Necessity Criteria

For B-cell ALL patients (≤25 years):

  • Relapsed or refractory disease after ≥2 cycles of chemotherapy
  • Post-transplant relapse (if applicable)
  • For Ph+ ALL: failure of ≥2 tyrosine kinase inhibitors

For adult lymphomas (DLBCL/FL):

  • Relapsed/refractory after ≥2 lines of systemic therapy
  • Ineligible for or failed autologous stem cell transplant
  • CD19-positive disease confirmation

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing payer policies and crafting evidence-backed rebuttals. Their platform can help identify gaps in your initial submission and strengthen your case with the right clinical citations.

Step-by-Step Approval Process

1. Verify Network Status and REMS Enrollment

  • Confirm your treatment center is in-network with Humana
  • Ensure your oncologist is enrolled in the KYMRIAH REMS program
  • Timeline: 1-2 business days

2. Gather Required Documentation

  • Collect all pathology reports, lab results, and treatment records
  • Obtain CD19 testing results
  • Document prior therapy failures with specific dates and outcomes
  • Timeline: 3-5 business days

3. Submit Prior Authorization

  • Contact: Humana National Transplant Network
  • Phone: 866-421-5663
  • Email: [email protected]
  • Fax: 502-508-9300
  • Include all supporting documentation and medical necessity letter
  • Timeline: Same day submission possible

4. Await Initial Decision

  • Standard review: 30 days for pre-service requests
  • Expedited review: 72 hours (requires provider certification of urgency)
  • Track status through provider portal or phone follow-up

5. If Approved: Proceed with Treatment

  • Coordinate leukapheresis collection
  • Schedule conditioning regimen
  • Plan for CAR-T infusion and monitoring

6. If Denied: Initiate Appeals Process

  • Review denial reasoning carefully
  • Gather additional supporting evidence
  • Submit internal appeal within 65 days

Common Denial Reasons & Solutions

Understanding why Kymriah requests get denied helps you strengthen your initial submission or appeal.

Top Denial Reasons and Fixes

Denial Reason Solution Documentation Needed
Missing CD19 positivity Submit flow cytometry or IHC results Lab report with CD19+ confirmation
Insufficient prior therapy Document all treatments with dates/outcomes Complete treatment timeline with response data
Non-certified center Transfer to authorized facility Letter confirming treatment at certified center
REMS non-compliance Complete provider enrollment REMS program certification
Lack of medical necessity Strengthen clinical rationale Updated physician letter with guidelines

Medical Necessity Letter Template Elements

Your oncologist's letter should include:

  • Patient's complete diagnosis with staging
  • Detailed prior treatment history and failures
  • Contraindications to alternative therapies
  • CD19 testing results and interpretation
  • Treatment goals and expected outcomes
  • Citations to relevant clinical guidelines
From our advocates: We've seen denials overturned when providers include specific details about why standard therapies failed—not just that they failed, but the clinical markers that showed lack of response. Quantitative data (blast counts, imaging measurements) strengthens the medical necessity argument significantly.

Humana Appeals Process

If your initial Kymriah request is denied, don't lose hope. Humana's appeals process provides multiple opportunities to present your case.

Internal Appeals Timeline

  • File within: 65 days of denial notice
  • Standard review: 30 days (pre-service), 60 days (post-service)
  • Expedited review: 72 hours with provider certification
  • Submit to: Humana Grievance and Appeal Department

Required Appeal Documentation

  • Original denial notice
  • Additional medical records supporting necessity
  • Updated physician letter addressing denial reasons
  • Peer-reviewed literature supporting off-label use (if applicable)
  • Patient impact statement (optional but helpful)

Contact Information for Appeals

  • Phone: 1-800-233-4013
  • Mail: Humana Grievance and Appeal Department, PO Box 14165, Lexington, KY 40512-4165
  • Fax: 1-920-339-2112

Peer-to-Peer Review Strategy

While not explicitly required, requesting a peer-to-peer review can be effective:

  • Ask your oncologist to request direct physician-to-physician discussion
  • Prepare talking points about unique patient circumstances
  • Have clinical guidelines and recent studies readily available
  • Document the conversation and any commitments made

North Carolina External Review

If Humana's internal appeals are unsuccessful, North Carolina residents have strong external review rights through Smart NC.

Smart NC External Review Process

North Carolina's external review program, managed by the Department of Insurance, provides an independent assessment of coverage denials. This process has helped many patients access expensive cancer treatments, including CAR-T therapies.

Key Advantages of NC External Review:

  • Independent medical experts review your case
  • Decisions are binding on Humana
  • No cost to patients
  • Expedited process for urgent cases
  • Free advocacy support available

How to Request External Review

  1. Complete Humana's internal appeals (required unless urgent)
  2. Submit request within 120 days of final denial
  3. Include physician certification for expedited review if urgent
  4. Attach all relevant medical records and prior correspondence

Timeline and Contacts

  • Standard review: 45 days
  • Expedited review: 72 hours (24-72 hours for urgent drug denials)
  • Smart NC Helpline: 1-855-408-1212
  • Request forms and guidance

The Smart NC team can help you complete the external review request and gather supporting documentation. Their registered nurses understand complex medical cases and can guide you through the process.

Certified Treatment Centers in North Carolina

Kymriah must be administered at certified centers with specialized CAR-T capabilities. North Carolina has several excellent options, though you should verify Humana network participation before proceeding.

Major CAR-T Centers in North Carolina

  • Duke Cancer Institute (Durham): First NC center to offer FDA-approved CAR-T therapies
  • UNC Lineberger Comprehensive Cancer Center (Chapel Hill): Comprehensive cellular immunotherapy program
  • Atrium Health Levine Cancer Institute (Charlotte): Leading manufacturer-authorized center
  • Wake Forest Baptist Comprehensive Cancer Center (Winston-Salem): Full CAR-T accreditation with robust support services
  • Novant Health Cancer Institute: Advanced CAR-T program with streamlined referrals

Verifying Network Status

Before starting the approval process:

  • Call Humana member services to confirm center participation
  • Verify both facility and physician network status
  • Ask about any specific CAR-T network requirements
  • Get confirmation in writing if possible

Cost Considerations

Even with Humana coverage, CAR-T therapy involves significant costs that patients should understand upfront.

Potential Patient Costs

  • Medicare Part B deductible and coinsurance
  • Part D prescription drug costs (if applicable)
  • Hospital copayments for extended stays
  • Travel and lodging for out-of-town treatment

Financial Assistance Options

  • Novartis Patient Assistance: Income-based support programs
  • Leukemia & Lymphoma Society: Copay assistance and travel grants
  • National Foundation for Cancer Research: Emergency financial assistance
  • Hospital financial counseling: Many centers offer payment plans and charity care

Counterforce Health's platform can help identify coverage gaps and appeal any unexpected denials for related services like conditioning chemotherapy or supportive care medications.

FAQ

How long does Humana's Kymriah prior authorization take in North Carolina? Standard reviews take up to 30 days, but expedited reviews (with physician certification of urgency) are completed within 72 hours. Most oncology teams request expedited review given the time-sensitive nature of CAR-T therapy.

What if Kymriah is non-formulary on my Humana plan? Kymriah is typically covered under Medicare Part B as a physician-administered drug rather than Part D formulary. However, if formulary issues arise, you can request an exception with supporting medical necessity documentation.

Can I request an expedited appeal if denied? Yes, if delays would significantly harm your health, you can request expedited appeal processing. Your physician must provide written certification of the urgent medical need.

Does step therapy apply to Kymriah approvals? Step therapy requirements vary by indication. For relapsed/refractory cancers, prior therapy failures typically satisfy step therapy requirements, but documentation of these failures is crucial.

What happens if my treatment center isn't in Humana's network? You can request an out-of-network exception based on medical necessity if no in-network certified centers are available within reasonable distance. This requires additional documentation and may involve higher out-of-pocket costs.

How successful are appeals for CAR-T therapy denials? While specific statistics aren't publicly available, appeals with strong clinical documentation and proper medical necessity justification have good success rates, particularly when denial reasons are clearly addressed.

Resources & Next Steps

Immediate Action Items

  1. Verify your oncologist's REMS program enrollment
  2. Confirm treatment center network status with Humana
  3. Begin gathering required documentation
  4. Schedule consultation at certified CAR-T center

Key Contacts

  • Humana National Transplant Network: 866-421-5663
  • Smart NC Consumer Assistance: 1-855-408-1212
  • Humana Member Services: 888-700-2263
  • KYMRIAH REMS Program: Contact your treatment center

Official Resources

Getting Kymriah covered requires persistence and thorough documentation, but with proper preparation and understanding of the process, many patients successfully navigate Humana's approval system. Don't hesitate to use North Carolina's strong consumer protection resources if you encounter denials.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare team and insurance representatives for guidance specific to your situation. For personalized assistance with insurance appeals and coverage determinations, consider consulting with healthcare coverage advocates or legal professionals specializing in insurance matters.

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