By Counterforce Health Team in Defitelio (defibrotide) —

How to Get Defitelio (Defibrotide) Covered by Humana in New York: PA Requirements, Appeals, and State Protections

Answer Box: Getting Defitelio (Defibrotide) Covered by Humana in New York

Defitelio (defibrotide) requires prior authorization from Humana Medicare Advantage plans for hepatic veno-occlusive disease (VOD/SOS) with organ dysfunction post-HSCT. Coverage is limited to FDA-approved indication only. Fastest path to approval: Have your transplant physician submit PA request with complete HSCT documentation, organ dysfunction evidence, and ICD-10 code K76.5. If denied, New York offers expedited external appeals with 24-hour decisions for urgent specialty drugs through the Department of Financial Services. Start today by contacting your prescriber to initiate the PA process and register with CenterWell Specialty Pharmacy.

Table of Contents

  1. Understanding the Denial: Decode Your Letter
  2. Humana's Coverage Requirements for Defitelio
  3. First-Level Appeal Strategy
  4. Peer-to-Peer Review Preparation
  5. New York External Appeal Process
  6. Appeal Templates and Scripts
  7. Tracking Your Case
  8. Clinical Evidence and Guidelines
  9. Cost Assistance Options
  10. FAQ

Understanding the Denial: Decode Your Letter

When Humana denies Defitelio coverage, the denial letter will specify one of several reasons. Understanding the exact denial code helps you craft a targeted response.

Common Denial Reasons for Defitelio:

  • Off-label use: Using defibrotide for SOS prophylaxis (prevention) rather than treatment
  • Insufficient documentation: Missing HSCT records or organ dysfunction evidence
  • Site of care: Requesting outpatient administration without proper justification
  • Medical necessity: Lack of clear diagnosis or severity documentation
Tip: Look for the denial code (often alphanumeric) in your letter and reference it in all appeals. This helps Humana route your case correctly.

Extract Key Information:

  • Appeal deadline (typically 65 days for Medicare Advantage)
  • Reference/case number
  • Specific documentation requested
  • Whether this is a pharmacy or medical benefit denial

Humana's Coverage Requirements for Defitelio

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all plans Humana PA List
Approved Indication Hepatic VOD/SOS with organ dysfunction post-HSCT FDA Label
Specialty Pharmacy CenterWell Specialty Pharmacy required Humana Member Services
Step Therapy Not required (no alternatives) Humana Policy
Site of Care Outpatient preferred; inpatient needs justification Coverage Policy

Medical Necessity Criteria

Humana requires documentation of:

  • Confirmed hepatic VOD/SOS diagnosis (ICD-10: K76.5)
  • Evidence of renal OR pulmonary dysfunction
  • History of hematopoietic stem cell transplantation
  • Clinical rationale for defibrotide as only suitable therapy
  • Proposed dosing plan (6.25 mg/kg IV every 6 hours)

Key Documentation Needed:

  • Transplant records and conditioning regimen details
  • Laboratory evidence of organ dysfunction
  • Clinical notes supporting diagnosis
  • Prescriber attestation of medical necessity

First-Level Appeal Strategy

Step-by-Step: Fastest Path to Approval

  1. Gather Complete Medical Records (Patient/Family)
    • HSCT documentation and dates
    • Laboratory results showing organ dysfunction
    • Clinical notes from transplant team
    • Timeline: 1-2 business days
  2. Request Prescriber Letter (Clinic Staff)
    • Medical necessity justification
    • Prior treatment history
    • Clinical guidelines citation
    • Timeline: 2-3 business days
  3. Submit Internal Appeal (Patient/Prescriber)
    • Use Humana's standard appeal form
    • Include all supporting documentation
    • Submit via member portal or fax
    • Timeline: Same day submission
  4. Track Your Case (Patient)
    • Note confirmation number
    • Set calendar reminder for response deadline
    • Timeline: Ongoing monitoring

Internal Appeal Deadlines:

  • Standard review: 30 days maximum
  • Expedited review: 72 hours (if delay could jeopardize health)
Note: For life-threatening conditions like severe VOD/SOS, always request expedited review and provide clinical justification for urgency.

Peer-to-Peer Review Preparation

Clinician Corner: Medical Necessity Letter Checklist

Essential Elements to Include:

  • Problem Statement: Hepatic VOD/SOS with documented organ dysfunction
  • Prior Treatments: Any supportive care measures attempted
  • Clinical Rationale: Why defibrotide is medically necessary
  • Guideline Citations: ASBMT/EBMT treatment recommendations
  • Dosing Plan: Standard FDA-approved regimen
  • Monitoring Plan: Safety and efficacy assessments

Key Talking Points for Peer-to-Peer:

  • Defibrotide is the only FDA-approved treatment for severe VOD/SOS
  • Time-sensitive condition: Delays increase mortality risk
  • No effective alternatives exist for this indication
  • Standard of care per transplant society guidelines
From our advocates: We've seen successful peer-to-peer calls where transplant physicians emphasize the urgent, life-threatening nature of untreated VOD/SOS and cite the >80% mortality rate in severe cases. Having specific lab values and timeline documentation ready strengthens the medical necessity argument.

New York External Appeal Process

New York offers robust patient protections through the Department of Financial Services (DFS) external appeal system.

When to File External Appeal

  • After receiving final adverse determination from Humana
  • Within 4 months of the final denial
  • When internal appeals are exhausted or waived

Timeline for Specialty Drug Appeals

  • Expedited review: 24 hours for urgent cases
  • Standard review: 72 hours for non-urgent cases
  • Filing fee: $25 (waived for financial hardship)

Required Documentation

  • Final denial letter from Humana
  • Complete medical records supporting necessity
  • Prescriber attestation for urgency (if requesting expedited review)
  • Evidence of prior treatment attempts

How to File:

Tip: Community Health Advocates (888-614-5400) provides free assistance with New York external appeals and can help you gather the right documentation.

Appeal Templates and Scripts

Patient Phone Script for Humana

"Hello, I'm calling about a prior authorization denial for Defitelio. My member ID is [NUMBER]. I received a denial letter dated [DATE] with reference number [REF]. I need to understand the specific reason for denial and how to file an internal appeal. Can you transfer me to the appeals department and provide the required forms?"

Medical Necessity Letter Template

Opening: "I am writing to request coverage for Defitelio (defibrotide) for my patient [NAME] who has developed hepatic veno-occlusive disease with organ dysfunction following hematopoietic stem cell transplantation."

Clinical Justification:

  • Diagnosis with ICD-10 code K76.5
  • Specific organ dysfunction evidence
  • HSCT details and timeline
  • Why alternatives are not appropriate

Supporting Evidence:

  • Clinical guidelines (ASBMT/EBMT)
  • FDA approval for this exact indication
  • Urgency of treatment initiation

Closing: "Given the life-threatening nature of untreated VOD/SOS and the lack of alternative therapies, I respectfully request immediate approval for Defitelio coverage."

Clinical Evidence and Guidelines

Professional Society Recommendations

ASBMT/ASTCT Guidelines:

  • Defibrotide is first-line therapy for severe VOD/SOS
  • Early initiation improves outcomes
  • Standard dose: 6.25 mg/kg IV every 6 hours for minimum 21 days

EBMT 2023 Criteria:

  • Updated diagnostic criteria emphasize early recognition
  • Severity grading guides treatment decisions
  • Defibrotide recommended for all severe cases with organ dysfunction

Key Clinical Evidence Points

  • Only FDA-approved treatment for VOD/SOS with organ dysfunction
  • Proven survival benefit in phase 3 trials
  • Time-sensitive efficacy: Early treatment associated with better outcomes
  • No equally effective alternatives exist

When Counterforce Health reviews Defitelio denials, we consistently see that appeals succeed when they emphasize the urgent, life-threatening nature of VOD/SOS and the absence of treatment alternatives. The clinical evidence strongly supports defibrotide as standard of care for this indication.

Cost Assistance Options

Financial Support Programs

JazzCares Patient Assistance:

  • Income-based assistance for eligible patients
  • Copay support programs
  • Application available through prescriber

Hospital Financial Counseling:

  • Most transplant centers have dedicated financial counselors
  • Can help navigate insurance appeals
  • May offer payment plans or charity care

Disease-Specific Foundations:

  • National Marrow Donor Program
  • Be The Match financial assistance
  • Leukemia & Lymphoma Society copay assistance
Note: Since Defitelio is typically administered in hospital settings, work with your transplant center's financial team to explore all available options.

Tracking Your Case

Appeal Timeline Tracking

Step Timeline Action Required Status
Submit Appeal Day 0 Complete forms, attach docs □
Humana Review 30 days (standard) / 72 hours (expedited) Monitor for decision □
External Appeal Within 4 months of denial File with NY DFS if denied □
Final Decision 24-72 hours (NY external) Implement coverage □

When to Escalate to Regulators:

  • Humana misses response deadlines
  • Procedural violations in appeal process
  • Pattern of inappropriate denials

New York Complaint Resources:

  • Department of Financial Services: 1-800-342-3736
  • Online complaint portal available
  • Document all communications for complaint file

FAQ

How long does Humana prior authorization take for Defitelio in New York? Standard PA requests receive response within 30 days. Expedited requests (for urgent cases) must be decided within 72 hours per Medicare regulations.

What if Defitelio is non-formulary on my Humana plan? You can request a formulary exception with medical necessity documentation. Since there are no therapeutic alternatives, exception requests often succeed with proper clinical justification.

Can I request an expedited appeal for Defitelio? Yes, if waiting for standard review could jeopardize your health. VOD/SOS with organ dysfunction typically qualifies for expedited review given its life-threatening nature.

Does step therapy apply if I haven't tried other treatments? No, step therapy is not required for Defitelio since no FDA-approved alternatives exist for treating VOD/SOS with organ dysfunction.

What happens if my Humana appeal fails? New York residents can file an external appeal with the Department of Financial Services within 4 months of the final denial. External reviewers make binding decisions on medical necessity.

How much does Defitelio cost without insurance? As a hospital-administered specialty medication, costs vary by institution and are typically negotiated through ASP-plus contracts. Work with your transplant center's financial counselors for specific pricing.

Counterforce Health specializes in turning insurance denials into successful appeals by identifying the specific denial basis and crafting targeted, evidence-backed responses. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeal processes for medications like Defitelio.

For additional support with your Defitelio appeal, consider working with Counterforce Health to ensure your case includes all necessary clinical documentation and follows payer-specific workflows for optimal approval chances.

Sources & Further Reading

This guide provides general information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare providers about treatment decisions and work with qualified professionals for insurance appeals. For specific questions about your coverage, contact Humana member services directly.

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