By Counterforce Health Team in Gamifant (emapalumab-lzsg) —

The Requirements Checklist to Get Gamifant (Emapalumab-lzsg) Covered by Humana in New Jersey

Answer Box: To get Gamifant (emapalumab-lzsg) covered by Humana in New Jersey, you need prior authorization with documented HLH diagnosis meeting HLH-2004 criteria, evidence of conventional therapy failure, and specialty pharmacy coordination. Start by gathering diagnostic labs, genetic testing results, and prior treatment records. Submit through Humana's provider portal with complete clinical documentation. If denied, Humana Medicare Advantage follows federal appeals (65 days), while commercial plans may qualify for New Jersey's external review process through Maximus Federal Services.

Table of Contents

Who Should Use This Guide

This guide is for patients, caregivers, and healthcare providers seeking coverage for Gamifant (emapalumab-lzsg) through Humana in New Jersey. You'll find this most helpful if:

  • Your hematologist has recommended Gamifant for primary hemophagocytic lymphohistiocytosis (HLH)
  • You've received a Humana denial for this medication
  • You're preparing a prior authorization request
  • You need to understand the appeals process specific to New Jersey

Expected outcome: Following this checklist improves your chances of approval by ensuring complete documentation and proper submission procedures.

Member & Plan Basics

Coverage Verification

Before starting, confirm these basics:

  • Active Humana coverage with current member ID
  • Plan type: Medicare Advantage, commercial, or Medicaid managed care
  • Deductible status: High-cost specialty drugs may apply to deductible
  • Prior authorization requirement: Gamifant requires PA for all Humana plans due to its high cost and specialty status

Plan-Specific Considerations

  • Medicare Advantage: Follows Medicare Part B/D appeals process (65-day deadline)
  • Commercial plans: May qualify for New Jersey external review through IHCAP
  • Medicaid managed care: State-specific timelines and procedures apply
Note: Humana has committed to streamlining prior authorization, with 95% of electronic requests receiving decisions within one business day by January 2026.

Clinical Criteria

FDA-Approved Indication

Gamifant is approved for primary (familial) HLH in pediatric and adult patients with:

  • Refractory disease
  • Recurrent disease
  • Progressive disease
  • Intolerance to conventional HLH therapy

HLH-2004 Diagnostic Criteria

Documentation must show either:

  1. Confirmed biallelic pathogenic variants in HLH-associated genes, OR
  2. 5 out of 8 clinical criteria:
    • Persistent fever
    • Splenomegaly
    • Cytopenias (≥2 cell lines)
    • Hypertriglyceridemia (≥3.0 mmol/L) and/or hypofibrinogenemia (≤1.5 g/L)
    • Hemophagocytosis in bone marrow, spleen, or lymph nodes
    • Low/absent NK cell activity
    • Ferritin ≥500 µg/L
    • Elevated soluble CD25 (≥2400 U/mL)

Conventional Therapy Requirements

Must document failure, intolerance, or inadequate response to:

  • Dexamethasone
  • Etoposide-based regimens
  • Cyclosporine (when applicable)

Include specific details: medications tried, doses, duration, and reasons for discontinuation.

Coding Requirements

HCPCS and Billing Codes

  • J-code: J9210 (injection, emapalumab-lzsg, 1 mg)
  • Billable unit: 1 mg = 1 unit
  • NDC codes: 66658-501-01 (10mg), 66658-505-01 (50mg), others available
  • Modifier: UD (required for 340B drug pricing claims)

Diagnosis Codes

  • Primary: D76.1 (Hemophagocytic lymphohistiocytosis)
  • Additional: D76.2 (Infection-associated hemophagocytic syndrome, if applicable)

Administration Codes

  • CPT 96365: IV infusion, first hour
  • ICD-10-PCS: XW033MA (peripheral IV) or XW043MA (central IV)

Documentation Packet

Provider Note Elements

Your hematologist's documentation should include:

  1. Diagnosis confirmation:
    • HLH-2004 criteria met (specify which 5+ criteria)
    • Genetic testing results (if available)
    • Laboratory values with dates
  2. Treatment history:
    • Conventional therapies tried
    • Doses and duration
    • Response and reasons for discontinuation
    • Contraindications to alternatives
  3. Clinical rationale:
    • Why Gamifant is medically necessary
    • Treatment goals and expected outcomes
    • Monitoring plan

Medical Necessity Letter Components

Include these key elements:

  • Patient demographics and diagnosis
  • Detailed clinical history
  • Laboratory evidence supporting HLH diagnosis
  • Prior treatment failures with specific details
  • Rationale for Gamifant therapy
  • Dosing plan and monitoring schedule
  • References to FDA labeling and clinical guidelines

Required Attachments

  • Complete medical records
  • Laboratory results (ferritin, soluble CD25, etc.)
  • Genetic testing reports (if available)
  • Prior therapy documentation
  • Imaging studies showing organomegaly
  • Bone marrow biopsy results (if hemophagocytosis documented)

Submission Process

Electronic Submission (Preferred)

  1. Access: Use Humana's provider portal or Availity
  2. Required fields: Complete all mandatory sections to avoid rejection
  3. Attachments: Upload all supporting documents in accepted formats
  4. Confirmation: Save confirmation number for tracking

Alternative Methods

  • Fax: 502-508-9300 (verify current number)
  • Phone: Provider services line for urgent requests
  • Mail: Use certified mail with tracking

Common Rejection Reasons

  • Incomplete clinical documentation
  • Missing prior therapy details
  • Incorrect coding or billing information
  • Unsigned medical necessity letter
Tip: Submit requests electronically when possible for faster processing and better tracking capabilities.

Specialty Pharmacy Routing

Network Requirements

Gamifant is distributed only through Humana's contracted specialty pharmacies and cannot be bought and billed by provider offices.

Coordination Steps

  1. After PA approval: Contact Humana Specialty Pharmacy Provider Line (1-800-486-2668)
  2. Shipment arrangement: Drug ships to designated site of care
  3. Benefit verification: Ongoing verification required for each shipment
  4. Case management: Specialty pharmacy provides clinical support

Administration Requirements

  • Must be combined with dexamethasone
  • Requires infection screening (TB, herpes zoster)
  • Only prescribed by hematologists
  • Administered in appropriate clinical setting

After Submission

Tracking Your Request

  • Confirmation numbers: Record all reference numbers
  • Status checks: Check every 3-5 business days
  • Response timeline: Standard decisions within 15 days, expedited within 72 hours

What to Document

  • Submission date and method
  • Confirmation numbers
  • Follow-up communications
  • Additional requests for information

Next Steps Based on Outcome

  • Approval: Coordinate with specialty pharmacy for shipment
  • Denial: Review reason and prepare appeal
  • More information needed: Respond promptly with requested documentation

Common Pitfalls to Avoid

1. Incomplete HLH Documentation

Problem: Missing key diagnostic criteria or lab values Solution: Ensure all 5+ HLH-2004 criteria are clearly documented with specific values and dates

2. Inadequate Prior Therapy History

Problem: Vague descriptions of previous treatments Solution: Include specific medications, doses, duration, and detailed reasons for failure or intolerance

3. Wrong Submission Route

Problem: Using incorrect portal or outdated forms Solution: Verify current submission requirements through Humana's provider portal

4. Missing Specialist Documentation

Problem: Request submitted without hematologist involvement Solution: Ensure prescribing physician is board-certified in hematology

5. Coding Errors

Problem: Incorrect HCPCS codes or missing modifiers Solution: Use J9210 with appropriate NDC and UD modifier when applicable

Appeals Process for New Jersey

Humana Medicare Advantage

  • Timeline: 65 days from denial notice
  • Process: Follow federal Medicare appeals procedures
  • Levels: Humana reconsideration → Independent Review Entity → Administrative Law Judge
  • Resources: Humana appeals portal

Commercial Plans (Fully-Insured)

For fully-insured commercial Humana plans in New Jersey:

  1. Internal appeals: Complete Humana's internal process first
  2. External review: File with New Jersey IHCAP through Maximus Federal Services
  3. Timeline: 4 months from final denial to file external appeal
  4. Fee: $25 filing fee to NJ Department of Banking and Insurance
  5. Decision: 45 days (standard) or 48 hours (expedited)

Important Distinction

Medicare Advantage plans do NOT qualify for New Jersey's IHCAP external review. They follow federal Medicare appeals only.

From our advocates: "We've seen cases where families spent months trying to file a New Jersey external appeal for their Medicare Advantage denial, only to learn it wasn't eligible. Always confirm your plan type first—it determines which appeals process you'll use."

Quick Reference Checklist

Before You Start

  • Confirm active Humana coverage and plan type
  • Verify prior authorization requirement
  • Gather insurance card and member ID
  • Identify prescribing hematologist

Clinical Documentation

  • HLH-2004 criteria documented (5+ criteria met)
  • Genetic testing results (if available)
  • Complete laboratory values with dates
  • Prior therapy history with specific details
  • Medical necessity letter from hematologist

Coding and Billing

  • Correct HCPCS code (J9210)
  • Appropriate NDC codes
  • ICD-10 diagnosis code (D76.1)
  • UD modifier if applicable

Submission

  • Electronic submission through provider portal
  • All required fields completed
  • Supporting documents attached
  • Confirmation number recorded

Follow-Up

  • Status checked within 3-5 days
  • Response timeline noted
  • Appeal strategy prepared if needed

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and turn insurance denials into successful appeals. Our platform analyzes denial letters, identifies specific policy requirements, and generates evidence-backed appeals tailored to each payer's criteria. When dealing with high-cost specialty medications like Gamifant, having the right documentation and submission strategy can make the difference between approval and denial.

For additional support with your Gamifant prior authorization or appeal, visit www.counterforcehealth.org to learn how our platform can help streamline your approval process.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances, plan details, and clinical factors. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional help with insurance issues in New Jersey, contact the NJ Department of Banking and Insurance Consumer Hotline at 1-800-446-7467.

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