By Counterforce Health Team in Hemgenix (etranacogene dezaparvovec) —

Getting Hemgenix (Etranacogene Dezaparvovec) Covered by Humana in Illinois: Complete Prior Authorization Guide with ICD-10 Codes and Appeal Steps

Answer Box: Getting Hemgenix Covered by Humana in Illinois

Hemgenix (etranacogene dezaparvovec) requires prior authorization from Humana Medicare Advantage in Illinois. You'll need ICD-10 code D67 (hereditary factor IX deficiency), documentation of severe hemophilia B with ≤2% factor IX activity, and treatment at a CSL Behring-approved center of excellence. First step: Have your hematologist submit a complete prior authorization packet through Humana's provider portal within 5-14 business days. If denied, you have 65 days to file an internal appeal, then 30 days for external review through the Illinois Department of Insurance. Contact Humana Member Services to start the process.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for Hemophilia B
  3. Product Coding: HCPCS J-Code and NDC
  4. Clean Prior Authorization Request
  5. Common Coding Pitfalls
  6. Verification with Humana Resources
  7. Quick Audit Checklist
  8. Appeals Process in Illinois
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Hemgenix follows the medical benefit pathway under Humana Medicare Advantage plans. Unlike oral medications that go through pharmacy benefits, gene therapies are administered in clinical settings and billed as medical procedures.

Key distinctions:

  • Medical benefit: Requires prior authorization through medical management, not pharmacy
  • Site of care: Must be administered at CSL Behring-approved centers of excellence
  • Billing: Uses HCPCS J-codes rather than NDC-only submissions
  • Coverage determination: Based on medical necessity criteria, not formulary placement
Note: Some Humana plans may have "carved out" arrangements where high-cost gene therapies are processed fee-for-service even for managed care members.

ICD-10 Mapping for Hemophilia B

The primary diagnosis code for Hemgenix coverage is ICD-10 D67 (Hereditary factor IX deficiency).

Documentation Requirements for D67

Your medical records must clearly establish:

  • Confirmed hereditary factor IX deficiency (not acquired)
  • Laboratory evidence showing factor IX activity ≤2% of normal
  • Clinical bleeding history consistent with severe hemophilia B
  • Family history supporting hereditary status (when available)

Supporting codes you may also see:

  • Z14.02: Genetic carrier status (if applicable to family members)
  • D68.311: Acquired hemophilia (use only if acquired deficiency is also present)
Important: Never use D66 (hemophilia A) or other coagulation disorder codes unless they're also clinically present. Claims processors audit for code accuracy and incorrect coding can trigger denials.

Product Coding: HCPCS J-Code and NDC

HCPCS J-Code: J1411

Hemgenix uses HCPCS J1411 ("Injection, etranacogene dezaparvovec-drlb, per therapeutic dose") for all billing scenarios.

Key billing requirements:

  • J1411 covers the complete therapeutic dose (single lifetime treatment)
  • Must include corresponding NDC number on all claims
  • Bill through medical benefit, not pharmacy
  • Requires supporting documentation of prior authorization approval

NDC Requirements

The National Drug Code must be included on every claim. The specific NDC varies by kit size—refer to the product labeling at time of service. Failure to include NDC will result in claim denial under most Humana plans.

Units and Dosing

Hemgenix is dosed as a single therapeutic dose per lifetime. The J1411 code is designed for "per therapeutic dose" billing, so typical claims will show:

  • Units: 1
  • HCPCS: J1411
  • NDC: [Product-specific code from kit]

Clean Prior Authorization Request

A complete Humana prior authorization for Hemgenix must include:

Required Clinical Documentation

Requirement Documentation Needed Source
Age verification Patient 18+ years old Demographics/ID
Diagnosis confirmation ICD-10 D67 with clinical notes Medical records
Severity documentation Factor IX activity ≤2% off prophylaxis Recent lab results
Inhibitor status Negative Factor IX inhibitor test (≤30 days) Laboratory report
Exposure history ≥150 documented Factor IX exposure days Treatment center logs
Liver function ALT, AST, ALP, bilirubin, imaging Recent labs/ultrasound
No prior gene therapy Claims history verification Medical records
Approved facility CSL Behring center of excellence confirmation Facility verification

Submission Process

  1. Submit through Humana provider portal for fastest processing
  2. Include all documents simultaneously—incomplete submissions cause delays
  3. Typical review timeline: 5-14 business days
  4. Expedited review available for urgent clinical situations
Tip: Contact your hemophilia treatment center early to gather comprehensive exposure day records—this is often the most time-consuming requirement.

Common Coding Pitfalls

Frequent Errors to Avoid

Wrong diagnosis codes:

  • Using D66 (hemophilia A) instead of D67 (hemophilia B)
  • Missing the hereditary nature of the condition
  • Using acquired hemophilia codes for hereditary disease

Billing mistakes:

  • Submitting through pharmacy benefit instead of medical
  • Missing NDC number on J1411 claims
  • Incorrect unit calculations (should be 1 unit per therapeutic dose)

Documentation gaps:

  • Insufficient exposure day records
  • Missing recent inhibitor testing
  • Outdated liver function assessments
  • No facility approval verification

Quick Fixes

  • Double-check ICD-10 code: Confirm D67 matches clinical documentation
  • Verify facility status: Ensure treatment site is CSL Behring-approved
  • Update lab work: All required tests within 30-day window
  • Complete exposure logs: Include home infusions and emergency treatments

Verification with Humana Resources

Before submitting your prior authorization:

  1. Check current prior authorization list: Verify Hemgenix remains on Humana's PA list
  2. Confirm facility network status: Ensure your chosen center is both CSL Behring-approved and Humana in-network
  3. Review medical necessity criteria: Check for any recent policy updates
  4. Validate submission method: Confirm current portal or fax requirements

Quick Audit Checklist

Before submitting your Hemgenix prior authorization:

☐ ICD-10 D67 properly documented with hereditary factor IX deficiency
☐ Patient age 18+ verified
☐ Factor IX activity ≤2% documented within appropriate timeframe
☐ Negative inhibitor test within 30 days
☐ ≥150 exposure days comprehensively documented
☐ Recent liver function tests and imaging completed
☐ No prior gene therapy verified in medical history
☐ CSL Behring-approved center confirmed
☐ All supporting documents attached to single submission
☐ HCPCS J1411 and NDC ready for billing

Appeals Process in Illinois

If Humana denies your Hemgenix prior authorization, Illinois provides strong appeal rights with specific timelines.

Internal Appeal (First Step)

  • Deadline to file: 65 days from denial notice
  • Humana response time: 30 days for standard review, 72 hours for expedited
  • How to file: Humana member portal or written submission
  • Required documents: Original denial letter, additional clinical evidence, physician letter of medical necessity

External Review (If Internal Appeal Denied)

Illinois provides independent external review through the Illinois Department of Insurance:

  • Deadline to file: 30 days after internal appeal denial (shorter than most states)
  • Decision timeline: 5 business days for standard, 72 hours for expedited
  • Cost: No fee to members
  • Process: Independent physician reviewer with hemophilia expertise
  • Binding decision: If approved, Humana must provide coverage

Contact for external review: Illinois Department of Insurance at (877) 527-9431

Illinois-specific advantage: The state's external review timeline is faster than federal requirements, with decisions in 5 business days vs. up to 30 days in other states.

When to Request Expedited Review

Request expedited appeals when:

  • Active bleeding episodes requiring immediate treatment
  • Scheduled gene therapy appointment at risk of cancellation
  • Clinical deterioration documented by treating physician

Getting expert help with your appeal: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform ingests denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, pulling the right clinical citations and procedural details that payers expect for complex therapies like Hemgenix.

FAQ

How long does Humana prior authorization take for Hemgenix in Illinois?
Standard review is 5-14 business days after complete submission. Expedited review (for urgent cases) is completed within 72 hours.

What if Hemgenix is not on Humana's formulary?
Gene therapies like Hemgenix typically require prior authorization regardless of formulary status. Coverage is based on medical necessity criteria rather than formulary placement.

Can I appeal if I've tried factor IX replacement outside Illinois?
Yes, document all prior therapies regardless of where they were administered. Include comprehensive treatment records and outcomes from all providers.

Does step therapy apply to Hemgenix?
Most Humana plans require documentation of prior factor IX prophylaxis or serious bleeding history, but specific step therapy requirements vary by plan.

What happens if the CSL Behring-approved center isn't in Humana's network?
Humana may provide out-of-network coverage for specialized treatments when no in-network alternative exists. Request a network adequacy review.

How do I find CSL Behring-approved centers in Illinois?
Contact CSL Behring directly or check the Hemgenix provider portal for current approved facilities.

What if I need Hemgenix urgently?
Request expedited prior authorization and appeals at every stage. Have your physician document the urgency and potential health consequences of delay.

Are there financial assistance programs for Hemgenix?
CSL Behring offers patient support programs. Check the Hemgenix patient services page for current eligibility requirements.

If you need additional support with your Humana appeal in Illinois, Counterforce Health's platform can help draft evidence-backed appeals that address specific payer requirements and increase approval chances for complex gene therapies.

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Coverage policies and appeal processes may change. Always verify current requirements with Humana and consult healthcare professionals for medical decisions. For personalized assistance with insurance appeals, contact qualified patient advocates or legal professionals.

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