By Counterforce Health Team in Hemgenix (etranacogene dezaparvovec) —

Coding That Helps Get Hemgenix (etranacogene dezaparvovec) Approved by Humana in Pennsylvania: ICD-10, HCPCS, and Billing Guide

Answer Box: Getting Hemgenix Covered by Humana in Pennsylvania

Hemgenix (etranacogene dezaparvovec) requires prior authorization from Humana and bills under your medical benefit using HCPCS code J1411. Key steps: (1) Use ICD-10 code D67 for hemophilia B with documented factor IX levels ≤5 IU/dL, (2) Submit PA through Humana's provider portal with bleeding history and current prophylaxis records, (3) Bill as buy-and-bill therapy at qualified hemophilia treatment centers. Pennsylvania residents have strong appeal rights through the state's Independent External Review Program if initially denied. Start by gathering your complete bleeding history and factor IX lab results today.

Table of Contents

  1. Medical vs. Pharmacy Benefit: Why Coding Matters
  2. ICD-10 Coding for Hemophilia B
  3. HCPCS, J-Codes, and NDC Requirements
  4. Clean Prior Authorization Anatomy
  5. Frequent Coding Pitfalls to Avoid
  6. Verification with Humana Resources
  7. Pre-Submission Audit Checklist
  8. Pennsylvania Appeals Process
  9. FAQ

Medical vs. Pharmacy Benefit: Why Coding Matters

Understanding how Hemgenix is covered makes the difference between approval and denial. This $3.5 million gene therapy bills under your medical benefit (Medicare Part B), not your pharmacy benefit (Part D).

Coverage Type Hemgenix Status What This Means
Medical Benefit (Part B) ✅ Primary pathway IV infusion at qualified centers; HCPCS billing; PA required
Pharmacy Benefit (Part D) ❌ Not applicable Self-administered drugs only; Hemgenix doesn't qualify

For Humana Medicare Advantage members in Pennsylvania: Your plan follows Humana's 2026 Medicare Prior Authorization List, which includes Hemgenix with an effective date of April 16, 2025.

Note: Buy-and-bill therapies like Hemgenix require your treatment center to purchase the medication upfront, then bill Humana for reimbursement. This is why proper coding is essential—billing errors can delay reimbursement for months.

ICD-10 Coding for Hemophilia B

Primary diagnosis code: D67 (Hereditary factor IX deficiency)

This is your foundation code for all Hemgenix prior authorization requests. However, documentation supporting this diagnosis is what makes or breaks your case.

Essential Documentation Words That Support D67 Coding

Your medical records should include these specific terms:

  • Factor IX activity level (must be ≤5 IU/dL for severe hemophilia B)
  • Bleeding phenotype (spontaneous joint bleeds, muscle bleeds, or life-threatening episodes)
  • Current prophylaxis regimen (what factor IX products you're using and how often)
  • Breakthrough bleeding episodes with dates, locations, and severity

Additional ICD-10 Codes to Consider

Code Description When to Use
D68.311 Acquired hemophilia If you have factor IX inhibitors
M25.0- Hemarthrosis codes For joint bleeding episodes
K92.2 Gastrointestinal hemorrhage For GI bleeding history
Tip: Counterforce Health helps providers identify the exact ICD-10 combinations that strengthen prior authorization requests by analyzing payer-specific requirements and clinical documentation.

HCPCS, J-Codes, and NDC Requirements

Primary billing code: J1411 (Injection, etranacogene dezaparvovec-drlb, per therapeutic dose)

This HCPCS code became effective April 1, 2023, and is specifically designed for Hemgenix billing.

Complete Billing Code Set

Code Type Code Description Units
HCPCS J1411 Hemgenix injection 1 per therapeutic dose
Administration 96365 IV infusion, initial hour 1
Administration 96366 IV infusion, additional hour(s) As needed
NDC Verify current Product identifier Required on claim
Important: NDC numbers can change with manufacturing lots. Always verify the current NDC with your pharmacy or Humana's formulary database before billing.

Units Calculation

Hemgenix is dosed as a single therapeutic dose regardless of patient weight. This means:

  • J1411 units = 1 (always)
  • No weight-based calculations needed
  • One-time administration only

Clean Prior Authorization Anatomy

Here's what a complete Humana PA request looks like for Hemgenix:

Section 1: Patient Demographics

Patient Name: [Full name]
Humana ID: [Member ID from insurance card]
DOB: [Date of birth]
Diagnosis: D67 - Hereditary factor IX deficiency

Section 2: Clinical Justification

Required elements:

  • Factor IX activity level (lab result ≤5 IU/dL)
  • Bleeding history with specific dates and locations
  • Current prophylaxis regimen and frequency
  • Breakthrough bleeding episodes despite treatment
  • Treatment goals and expected outcomes

Section 3: Provider Information

  • Prescribing physician (must be hematologist or hemophilia specialist)
  • Treatment center certification (must be qualified for gene therapy administration)
  • Contact information for peer-to-peer review

Section 4: Supporting Documentation

  • Complete bleeding diary (minimum 6 months)
  • Factor IX level labs
  • Current medication list
  • Previous treatment failures or inadequate response
From our advocates: We've seen PA approvals happen fastest when providers include a one-page timeline showing the patient's bleeding pattern before and during current prophylaxis. This visual documentation often eliminates the need for additional information requests.

Frequent Coding Pitfalls to Avoid

Pitfall #1: Wrong Benefit Category

Problem: Billing Hemgenix under pharmacy benefit (Part D) Fix: Always bill under medical benefit using HCPCS J1411

Pitfall #2: Missing NDC Numbers

Problem: Claims rejected for incomplete product identification Fix: Include current NDC on all J1411 claims; verify with manufacturer

Pitfall #3: Incorrect Units

Problem: Billing multiple units of J1411 for single dose Fix: Always use 1 unit for therapeutic dose, regardless of patient size

Pitfall #4: Inadequate Diagnosis Support

Problem: Using D67 without supporting documentation Fix: Include factor IX levels, bleeding phenotype, and severity markers

Pitfall #5: Wrong Administration Codes

Problem: Using inappropriate infusion codes for gene therapy Fix: Use CPT 96365/96366 for IV infusion administration

Verification with Humana Resources

Before submitting any Hemgenix request, verify current requirements through these official Humana channels:

Provider Resources

Coverage Verification Steps

  1. Check formulary status - Confirm Hemgenix is covered under medical benefit
  2. Review PA requirements - Download current criteria from policy portal
  3. Verify treatment center - Ensure your facility is qualified for gene therapy
  4. Confirm coding - Double-check J1411 and NDC requirements
Note: Humana's policies can update quarterly. Always verify current requirements before submitting requests, especially for high-cost therapies like Hemgenix.

Pre-Submission Audit Checklist

Use this checklist before submitting any Hemgenix prior authorization to Humana:

Clinical Documentation ✓

  • ICD-10 D67 with supporting factor IX levels
  • Bleeding history with dates, locations, severity
  • Current prophylaxis regimen and outcomes
  • Treatment center qualification verified
  • Prescriber specialty confirmed (hematology/hemophilia)

Coding Accuracy ✓

  • HCPCS J1411 for therapeutic dose
  • Current NDC number included
  • Administration codes (96365/96366) as appropriate
  • Units = 1 for single therapeutic dose
  • Medical benefit pathway confirmed

Submission Requirements ✓

  • Complete PA form with all sections
  • Supporting clinical documentation attached
  • Provider contact info for peer-to-peer
  • Patient consent and authorization forms
  • Treatment timeline and monitoring plan

Pennsylvania Appeals Process

If Humana denies your Hemgenix request, Pennsylvania offers strong appeal rights, though the process differs for Medicare Advantage plans.

Medicare Advantage Appeals (Humana Plans)

Important: Pennsylvania's Independent External Review Program does not cover Medicare Advantage plans. Your appeals follow federal Medicare processes.

Timeline for Humana Medicare Advantage:

  1. Internal Appeal - 65 days from denial notice
  2. Medicare External Review - Contact Medicare.gov for independent review
  3. Administrative Law Judge - For claims over $180 (2024 threshold)

Required Documents for Appeals

  • Final Adverse Benefit Determination letter from Humana
  • Complete medical records supporting medical necessity
  • Updated clinical information if available
  • Provider letter explaining why Hemgenix is medically necessary
Tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each payer's specific policies.

When to Escalate Further

If Medicare appeals are unsuccessful, contact:

  • Medicare Rights Center - Free counseling for Medicare appeals
  • Pennsylvania APPRISE - State Health Insurance Assistance Program
  • Office of Inspector General - For inappropriate denials or delays

FAQ

Q: How long does Humana prior authorization take for Hemgenix in Pennsylvania? A: Standard PA decisions are typically made within 14 business days. Expedited requests (for urgent medical situations) are decided within 72 hours.

Q: What if Hemgenix is non-formulary on my Humana plan? A: Hemgenix appears on Humana's coverage policies with an effective date of April 16, 2025. If listed as non-formulary, request a formulary exception with medical necessity documentation.

Q: Can I request an expedited appeal if denied? A: Yes, if your condition poses an immediate health threat. Submit expedited appeal requests with documentation showing urgent medical need.

Q: Does step therapy apply to Hemgenix in Pennsylvania? A: Some insurers require trial of other gene therapies first, but Medicare Advantage plans may have different requirements. Check your specific plan's medical policy.

Q: What counts as medical necessity for Hemgenix? A: Moderate to severe hemophilia B (≤5 IU/dL factor IX), documented bleeding episodes, current prophylaxis use, and appropriate candidate status per FDA labeling.

Q: How do I find qualified treatment centers in Pennsylvania? A: Contact the Hemgenix patient services program for a list of certified infusion centers in Pennsylvania.

Q: What if I've already paid out-of-pocket during appeals? A: If your appeal is successful, Humana must provide retroactive coverage for approved treatments, including reimbursement for out-of-pocket expenses.

Q: Are there financial assistance programs for Hemgenix? A: CSL Behring offers patient support programs. Contact their patient services team to discuss eligibility and application processes.

This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For official Pennsylvania insurance information, visit pa.gov/services/insurance.

Sources & Further Reading

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