By Counterforce Health Team in Kymriah (tisagenlecleucel) —

Getting Kymriah (Tisagenlecleucel) Covered by Humana in New York: Complete Appeal Guide with Forms and Deadlines

Quick Answer: How to Get Kymriah Approved by Humana in New York

If Humana denies Kymriah (tisagenlecleucel), you have strong appeal rights in New York. First step: Request your oncologist submit a medical necessity letter addressing Humana's CAR-T policy criteria within 60 days. If denied again: File a New York State external appeal through the Department of Financial Services within 4 months—their independent reviewers overturn many experimental/investigational denials. For urgent cases: Request expedited review (72-hour decision) if delay threatens health. Start today by gathering your denial letter, treatment history, and FDA indication documentation.

Table of Contents

  1. Understanding Your Denial Letter
  2. Humana's CAR-T Coverage Requirements
  3. Building Your Medical Necessity Case
  4. First-Level Appeal Process
  5. New York External Appeal Rights
  6. Certified CAR-T Centers in New York
  7. Appeal Templates and Scripts
  8. Cost Assistance Options
  9. When to Escalate
  10. Frequently Asked Questions

Understanding Your Denial Letter

When Humana denies Kymriah, the denial letter will specify whether it's processed under Part B medical benefits (most common for CAR-T) or Part D pharmacy benefits. This determines your appeal pathway.

Common Denial Reasons

Denial Reason What It Means How to Fix
Not medically necessary Doesn't meet clinical criteria Submit detailed medical necessity letter with guideline citations
Experimental/investigational Plan considers treatment unproven Cite FDA approval and NCCN Category 2A evidence
Missing prior authorization Treatment wasn't pre-approved Request retroactive review with clinical documentation
Not at certified center Facility lacks CAR-T certification Transfer to REMS-certified facility
Important: Kymriah is processed as a Part B medical service, not a Part D drug benefit, because it's administered in a hospital setting.

Humana's CAR-T Coverage Requirements

Humana follows CMS requirements for CAR-T therapy with additional internal criteria. Coverage requires:

Medical Necessity Criteria

For B-cell ALL (≤25 years):

  • Confirmed B-cell precursor ALL diagnosis
  • Refractory disease or second/later relapse
  • No prior CD19-directed CAR-T therapy
  • Performance status: Karnofsky/Lansky ≥50%

For DLBCL/Large B-cell lymphoma (adults):

  • Relapsed/refractory disease after ≥2 lines of systemic therapy
  • No active CNS lymphoma
  • Adequate organ function
  • Treatment at REMS-certified facility

Required Documentation

  • Pathology confirming CD19+ disease
  • Complete treatment history with response/failure details
  • Performance status assessment
  • Organ function labs (cardiac, hepatic, renal)
  • Planned lymphodepletion regimen

Building Your Medical Necessity Case

Clinician Corner: Medical Necessity Letter Checklist

Your oncologist's letter should address each Humana criterion:

  1. Diagnosis confirmation with ICD-10 codes (C91.0x for ALL; C83.3x for DLBCL)
  2. Prior therapy details including drug names, durations, and reason for discontinuation
  3. FDA indication alignment citing specific approved use
  4. NCCN guideline support (Category 2A for relapsed/refractory disease)
  5. Performance status and functional assessment
  6. Treatment plan including lymphodepletion protocol
  7. Prognosis without treatment and expected benefit
Tip: Reference the NCCN Guidelines for B-ALL or DLBCL by version number and page.

First-Level Appeal Process

Timeline and Submission

  • Deadline: 60 days from denial notice date
  • Method: Humana member portal, fax, or mail
  • Decision timeline: 30 days standard, 72 hours expedited

Required Components

  1. Appeal request form (available on denial notice)
  2. Medical necessity letter from treating oncologist
  3. Clinical documentation supporting each coverage criterion
  4. FDA label excerpts showing approved indication
  5. NCCN guideline citations (with page numbers)

Sample Appeal Script

"I am requesting reconsideration of the denial for Kymriah (tisagenlecleucel) for [patient name], member ID [number]. The attached medical necessity letter demonstrates that this FDA-approved therapy meets all clinical criteria in your CAR-T policy. Per NCCN Guidelines v2.2025, Kymriah is Category 2A for relapsed/refractory [condition] after ≥2 prior lines."

New York External Appeal Rights

If Humana upholds the denial, New York's robust external appeal system provides a second chance through independent medical review.

Eligibility and Timeline

  • Who can appeal: Patient or authorized representative
  • Deadline: 4 months from final adverse determination
  • Fee: Up to $25 (waived for Medicaid or financial hardship)
  • Decision binding: Yes, on both patient and insurer

Filing Process

  1. Complete NY External Appeal Application
  2. Submit physician attestation for experimental/investigational denials
  3. For expedited cases: Call (888) 990-3991 immediately after faxing

Mail or fax to:

New York State Department of Financial Services
99 Washington Avenue, Box 177
Albany, NY 12210

Expedited Review Criteria

Request expedited review (72-hour decision) if:

  • Patient currently hospitalized, OR
  • Physician attests delay would "seriously jeopardize life, health, or ability to regain maximum function"
Success Rate: New York external appeals frequently overturn denials for FDA-approved cancer treatments when proper clinical documentation is provided.

Certified CAR-T Centers in New York

Kymriah must be administered at REMS-certified facilities. Major New York centers include:

Academic Medical Centers

  • NewYork-Presbyterian/Columbia University Irving Medical Center
    • Adult DLBCL and pediatric ALL programs
    • FACT-accredited cellular therapy center
    • Contact: CAR-T program coordinator
  • NYU Langone Transplantation & Cellular Therapy Center
    • Comprehensive CAR-T program
    • Manhattan and Long Island locations
    • Phone: (212) 263-7000
  • Montefiore Einstein Comprehensive Cancer Center
    • FACT Center of Excellence for CAR-T therapy
    • Serves Bronx and surrounding areas
    • Specialized in complex cases

Network Coverage Verification

Call Humana member services with these steps:

  1. Verify each center's in-network status for your specific plan
  2. Ask about center-of-excellence requirements
  3. Request network exception if nearest certified center is out-of-network

Appeal Templates and Scripts

Patient Phone Script for Humana

"I'm calling about a denial for Kymriah CAR-T therapy, member ID [number]. I need to understand the specific clinical criteria not met and request an expedited appeal. Can you transfer me to the medical review department and provide the exact policy number being applied?"

Peer-to-Peer Request Template

"Dr. [Name] is requesting a peer-to-peer review for Kymriah denial, case [number]. Patient has relapsed/refractory [condition] meeting FDA indication and NCCN guidelines. Available [days/times] for clinical discussion with medical director."

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each payer's specific requirements.

Cost Assistance Options

Financial Support Programs

  • Novartis Patient Assistance Program: Income-based coverage for eligible patients
  • Cancer Financial Assistance Coalition: Grants up to $10,000 for treatment costs
  • New York State Cancer Services Program: Additional support for eligible residents

Insurance Navigation

  • Community Health Advocates: Free help with NY appeals at (888) 614-5400
  • Hospital financial counselors: Assistance with prior authorization and appeals
  • Counterforce Health: Professional appeal support turning denials into approvals

When to Escalate

State Regulator Complaints

File a complaint with New York Department of Financial Services if:

  • Humana violates appeal timelines
  • Denies expedited review inappropriately
  • Fails to provide required forms or information

Documentation to Include

  • All denial and appeal correspondence
  • Timeline of delays or violations
  • Clinical evidence supporting medical necessity
  • Copy of external appeal decision (if applicable)

Frequently Asked Questions

How long does Humana prior authorization take in New York? Standard decisions within 30 days; expedited within 72 hours if delay threatens health.

What if Kymriah is considered experimental by Humana? File external appeal citing FDA approval and NCCN Category 2A evidence. NY frequently overturns experimental denials for approved therapies.

Can I appeal if I'm under 26 with ALL? Yes, Kymriah is FDA-approved for B-cell ALL up to age 25. Ensure your appeal emphasizes this specific indication.

Does step therapy apply to CAR-T? Typically no, but you must document failure of ≥2 prior systemic therapies per FDA labeling.

What if the nearest certified center is far away? Request travel/lodging benefits or network exception to use the closest REMS-certified facility.

How much does external appeal cost in New York? Maximum $25, waived for Medicaid enrollees or financial hardship cases.

Can I get expedited review for aggressive disease? Yes, if your oncologist attests that delay would seriously jeopardize your health.

What happens if I win the external appeal? Humana must cover the treatment and refund your appeal fee.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare team and insurance company for guidance specific to your situation. Coverage policies and appeal processes may change; verify current requirements with official sources.

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