By Counterforce Health Team in Hemgenix (etranacogene dezaparvovec) —

How to Get Hemgenix (etranacogene dezaparvovec) Covered by Humana in Washington: Complete Requirements Guide

Answer Box: Get Hemgenix (etranacogene dezaparvovec) Covered by Humana in Washington

Fastest path to approval: Hemgenix requires prior authorization from Humana with documented severe hemophilia B (Factor IX ≤2%), current Factor IX prophylaxis with breakthrough bleeding, and submission through CenterWell Specialty Pharmacy. First step today: Gather your hemophilia treatment records from the past 6 months and contact your Humana-contracted hemophilia treatment center to initiate the prior authorization process via Humana's provider portal.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Essentials
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission: Timeline & Tracking
  9. Common Denial Prevention
  10. Appeals Process for Washington
  11. Costs & Financial Support
  12. FAQ

Who Should Use This Guide

This guide helps Washington residents with Humana Medicare Advantage or Humana commercial plans who need Hemgenix (etranacogene dezaparvovec) for hemophilia B. You'll find the exact requirements, forms, and timelines to get this $3.5 million gene therapy approved.

Expected outcome: With complete documentation and proper submission, most prior authorizations for qualifying patients receive approval within 1-5 business days. If initially denied, appeals have strong success rates—Medicare Advantage appeals overturn 81.7% of denials when properly documented.

Member & Plan Basics

Coverage Verification

Before starting, confirm your plan details:

  • Medicare Advantage: Hemgenix is covered under Part B (office-administered therapy)
  • Commercial plans: Check your formulary tier via Humana's drug list search
  • Deductible status: Verify if you've met your annual deductible, as this affects out-of-pocket costs

Prior Authorization Required

All Humana plans require prior authorization for Hemgenix through their Clinical Pharmacy Review (HCPR) process. No exceptions apply, including Humana's "gold card" program launching in 2026.

Clinical Criteria Requirements

Coverage at a Glance

Requirement What It Means Where to Find It Source
Age ≥18 years Adult patients only Medical records FDA label
Severe/moderate hemophilia B Factor IX activity ≤2% Lab results Humana PA requirements
Current prophylaxis On Factor IX therapy ≥2 months Treatment records Payer policies
Breakthrough bleeding Despite prophylaxis Clinical documentation Medical necessity
No active inhibitors <0.6 Bethesda Units Lab screening FDA contraindications
One-time treatment Lifetime limit Provider attestation All payer policies

Step Therapy Requirements

Humana requires documentation of:

  1. Current Factor IX prophylaxis for ≥2 months with 50-150 exposure days
  2. Treatment failure: Continued bleeding episodes despite adequate prophylaxis
  3. Hemophilia Treatment Center management: Ongoing care at an accredited HTC

Exclusion Criteria

Your medical record must document absence of:

  • Active Factor IX inhibitors (>0.6 Bethesda Units)
  • AAV5 neutralizing antibodies (>1:3212 titer)
  • Active hepatitis B or uncontrolled hepatitis C
  • Severe liver disease or cirrhosis
  • Uncontrolled HIV (CD4+ ≤200/μL)
  • Prior gene therapy treatment

Coding & Billing Essentials

HCPCS and Diagnosis Codes

  • HCPCS: J1411 (Injection, etranacogene dezaparvovec-drlb, per therapeutic dose)
  • Units: 1 unit = 1 complete therapeutic dose/kit
  • ICD-10: D67 (Hereditary factor IX deficiency) or appropriate hemophilia B code
  • Administration: 96365 (Initial IV infusion, up to 1 hour) plus add-on codes as needed

NDC Information

Include the 11-digit NDC for the specific kit dispensed. Verify current NDC with CenterWell Specialty Pharmacy at time of ordering.

Documentation Packet

Provider Note Elements

Your hemophilia specialist must document:

Clinical History:

  • Confirmed hemophilia B diagnosis with genetic testing
  • Baseline Factor IX activity level (≤2%)
  • Current prophylaxis regimen and duration
  • Annualized bleeding rate and severity
  • Prior treatment failures or complications

Laboratory Results (within 3 months):

  • Factor IX activity assay
  • Inhibitor screen (Bethesda assay)
  • AAV5 neutralizing antibody test
  • Liver function tests (ALT, AST, bilirubin)
  • Complete blood count

Treatment Goals:

  • Expected reduction in bleeding episodes
  • Potential for prophylaxis discontinuation
  • Long-term monitoring plan

Medical Necessity Letter Components

Clinician Corner: Your letter of medical necessity should address these key points:
  1. Problem statement: Severe hemophilia B with breakthrough bleeding despite optimal prophylaxis
  2. Prior treatments: Specific Factor IX products used, dosing, duration, and outcomes
  3. Clinical rationale: Why Hemgenix is medically necessary over continued prophylaxis
  4. Guideline support: Reference FDA labeling and hemophilia treatment guidelines
  5. Monitoring plan: Post-treatment surveillance for liver enzymes and immune responses

Required Attachments

  • Complete hemophilia treatment history
  • Recent laboratory results
  • Genetic testing confirmation
  • HTC consultation notes
  • Informed consent documentation

Submission Process

Step-by-Step: Fastest Path to Approval

  1. Provider initiates PA via Humana Provider Portal (Timeline: Same day)
  2. Clinical documentation upload using PA search tool for etranacogene dezaparvovec (Timeline: 1-2 days to compile)
  3. Humana clinical review by HCPR team (Timeline: 1-5 business days for electronic submissions)
  4. Determination letter mailed to member and provider (Timeline: Within 24 hours of decision)
  5. If approved, specialty pharmacy coordination through CenterWell (Timeline: 2-3 days for drug procurement)
  6. Treatment scheduling at approved infusion center (Timeline: 1-2 weeks for scheduling)
  7. Administration and monitoring per protocol (Timeline: Single infusion day plus follow-up)

Submission Requirements

Use Humana's Prior Authorization Search Tool to:

  • Search "etranacogene dezaparvovec" or "Hemgenix"
  • Access current PA form
  • Verify required clinical criteria
  • Submit electronically for fastest processing

Specialty Pharmacy Routing

CenterWell Specialty Pharmacy

Humana steers Hemgenix through CenterWell Specialty Pharmacy, their owned specialty division:

  • Coverage: In-network for 96% of specialty drugs including limited distribution therapies
  • Process: White-bagging to approved infusion centers
  • Contact: Use CenterWell prescriber portal or fax provider forms

Transfer Steps

  1. PA approval triggers automatic CenterWell notification
  2. Prescription routing from HTC to CenterWell
  3. Drug procurement and cold-chain verification
  4. Shipment coordination to Washington infusion center
  5. Administration scheduling with patient and facility

Verification Points

Confirm with CenterWell:

  • Drug availability and lead time
  • Shipping requirements and timeline
  • Backup plans for delays
  • Emergency contact information

After Submission: Timeline & Tracking

Status Monitoring

  • Electronic submissions: 95% processed within 1 business day (improving to 95% by January 2026)
  • Standard timeline: Up to 5 business days for complex cases
  • Tracking: Use Humana provider portal or call provider services

What to Record

Keep documentation of:

  • PA submission confirmation number
  • All correspondence with Humana
  • Clinical reviewer contact information
  • Approval/denial letters
  • Appeal deadlines if denied

Common Denial Prevention

Five Pitfalls and Solutions

Common Issue Prevention Strategy
Incomplete lab work Submit all required tests within 3-month window
Missing step therapy Document adequate Factor IX prophylaxis trial
Wrong facility Ensure HTC or approved center submits request
Insufficient bleeding history Provide detailed annualized bleeding rates
Outdated forms Use current PA form from Humana portal
Tip: Contact Humana's Clinical Pharmacy Review team directly if you have questions about specific requirements before submitting.

Appeals Process for Washington

Internal Appeals Timeline

For Medicare Advantage (Part C):

  • Filing deadline: 65 days from denial notice
  • Standard appeal: 30 days for pre-service decisions
  • Expedited appeal: 72 hours if delay could harm health

For Part D (if applicable):

  • Filing deadline: 65 days from denial
  • Standard redetermination: 7 days
  • Expedited review: 72 hours maximum

External Review in Washington

While Medicare Advantage follows federal appeal rules, Washington residents can also contact:

  • Washington Office of the Insurance Commissioner: 1-800-562-6900 for assistance
  • SHIBA (State Health Insurance Benefits Advisors): Free one-on-one Medicare appeal help
  • Independent Review Entity (IRE): Automatic escalation after Humana's internal denial

Appeal Documentation

Include with your appeal:

  • Copy of original denial letter
  • Updated medical necessity letter
  • Any new clinical evidence
  • Peer-reviewed studies supporting Hemgenix use
  • Treatment center attestation
From our advocates: We've seen successful appeals when providers include specific bleeding episode documentation and emphasize the one-time nature of gene therapy versus lifetime prophylaxis costs. Most appeals succeed when clinical criteria are clearly met but initial documentation was incomplete.

Costs & Financial Support

Out-of-Pocket Estimates

  • Medicare Advantage: Typically 20% coinsurance after deductible
  • Annual out-of-pocket maximum: Varies by plan, often $3,000-8,000
  • Commercial plans: Check your specific benefit design

Financial Assistance

  • CSL Behring patient support: Contact manufacturer for copay assistance programs
  • Medicare Extra Help: Low-income subsidy for prescription costs
  • Washington state programs: Apple Health (Medicaid) coordination

Counterforce Health specializes in turning insurance denials into successful appeals for complex therapies like Hemgenix. Their platform analyzes denial letters and creates evidence-backed appeals that align with payer policies, helping patients access life-changing treatments through proper documentation and strategic appeals.

FAQ

How long does Humana PA take for Hemgenix in Washington? Electronic submissions typically receive decisions within 1-5 business days. Complex cases may take the full standard timeline of 30 days for Part C or 7 days for Part D.

What if Hemgenix is non-formulary on my plan? Submit a formulary exception request with your PA. Document medical necessity and why formulary alternatives are inappropriate for your specific case.

Can I request an expedited appeal if denied? Yes, if waiting for a standard decision could seriously harm your health. Your prescriber must support the expedited request in writing.

Does step therapy apply if I failed treatments outside Washington? Yes, document all prior Factor IX prophylaxis regardless of where treatment occurred. Include complete records and outcomes.

What happens if CenterWell Specialty Pharmacy can't obtain Hemgenix? Humana may approve alternative specialty pharmacies in the manufacturer's limited distribution network. Work with your HTC to identify approved alternatives.

How do I file a complaint about delays or denials? Contact the Washington Office of the Insurance Commissioner at 1-800-562-6900 or file online at their consumer portal.

Are there alternatives if Humana continues to deny coverage? Consider switching plans during open enrollment, exploring clinical trials, or working with Counterforce Health for advanced appeal strategies.

What monitoring is required after Hemgenix treatment? Regular liver function monitoring per FDA labeling, typically monthly for the first few months, then quarterly. Your HTC will coordinate this surveillance.

Printable Checklist

Before You Start:

  • Confirm Humana plan type and benefits
  • Verify HTC is Humana-contracted
  • Gather 6 months of treatment records
  • Complete required laboratory tests

Documentation Required:

  • Factor IX activity ≤2%
  • Negative inhibitor screen
  • Current prophylaxis records
  • Bleeding episode documentation
  • Genetic testing confirmation

Submission Steps:

  • Provider accesses Humana portal
  • Complete current PA form
  • Upload all supporting documents
  • Submit electronically
  • Record confirmation number

After Submission:

  • Monitor status via portal
  • Coordinate with CenterWell if approved
  • Schedule treatment at approved center
  • Prepare appeal documents if denied

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical advice. Coverage decisions depend on individual medical circumstances and plan benefits. Consult your healthcare provider and insurance plan for guidance specific to your situation.

Sources & Further Reading

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