By Counterforce Health Team in Hemgenix (etranacogene dezaparvovec) —

How to Get Hemgenix (Etranacogene Dezaparvovec) Covered by UnitedHealthcare in California: ICD-10, HCPCS Codes, and Appeals Guide

Answer Box: Getting Hemgenix Covered in California

UnitedHealthcare requires prior authorization for Hemgenix (etranacogene dezaparvovec) in California. The fastest path: (1) Submit PA through UHC provider portal with complete clinical documentation including ICD-10 D67, baseline Factor IX activity ≤2%, and negative inhibitor testing, (2) Ensure treatment at an approved hemophilia treatment center, and (3) If denied, file internal appeal within 180 days, then request California DMHC Independent Medical Review. Success rates for specialty drug IMRs exceed 50% statewide. Start today by verifying your plan's gene therapy coverage policy and gathering baseline labs from the past 30 days.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for Hemophilia B
  3. Product Coding: HCPCS, J-Codes, and NDC
  4. Clean Request Anatomy
  5. Frequent Pitfalls
  6. Verification Steps
  7. Quick Audit Checklist
  8. Appeals Playbook for California
  9. Common Denial Reasons & Fixes
  10. FAQ

Coding Basics: Medical vs. Pharmacy Benefit

Hemgenix is billed as a medical benefit drug, not through standard pharmacy channels. This one-time IV gene therapy is administered at specialized centers and coded using HCPCS J-codes with accompanying NDC information.

Key distinction: Unlike oral medications filled at pharmacies, Hemgenix follows a "buy-and-bill" model where the treatment facility purchases the drug and bills UnitedHealthcare using medical claims (UB-04 or CMS-1500 forms).

Tip: Always verify with UnitedHealthcare whether your specific plan covers gene therapy under medical benefits. Some self-funded employer plans may have different structures.

ICD-10 Mapping for Hemophilia B

The primary diagnosis code for Hemgenix coverage is D67 – Hereditary factor IX deficiency. This covers both hemophilia B and factor IX deficiency with functional defects.

Documentation Requirements

Your medical records must clearly support the D67 diagnosis with:

  • Confirmed congenital hemophilia B (not acquired)
  • Baseline Factor IX activity level showing severe (≤1%) or moderately severe (>1-≤2%) disease
  • Family history of bleeding disorders when available
  • Prolonged aPTT corrected by mixing studies

Supporting codes (when applicable):

  • D68.2 – Hereditary deficiency of other clotting factors (if multiple deficiencies exist)
  • Z87.2 – Personal history of diseases of blood and blood-forming organs (for bleeding history)

Product Coding: HCPCS, J-Codes, and NDC

Primary Billing Code

HCPCS J1411 – Injection, etranacogene dezaparvovec-drlb, per therapeutic dose

Critical billing rules:

  • Bill 1 unit of J1411 per complete treatment (not per vial or mL)
  • Each patient receives one therapeutic dose regardless of weight
  • Never use legacy codes like J3590 or J7199

NDC Requirements

Hemgenix has 39 unique kit NDCs in 10-digit format (0053-XXXX-XX). For billing:

  1. Convert to 11-digit format: 00053-XXXX-XX (add leading zero)
  2. Use modifier N4
  3. Report UN1 (1 unit) for quantity
  4. Example: N400053-XXXX-XX UN1

Dosing Calculation

  • Labeled dose: 2 mL/kg IV (single treatment)
  • Total volume needed: Patient weight (kg) × 2 mL/kg
  • Vials required: Total volume ÷ 10 mL per vial (round up)
  • Billing: Always 1 unit of J1411 regardless of vials used

Clean Request Anatomy

Complete Prior Authorization Packet

1. UnitedHealthcare PA Form

  • Patient demographics and UHC member ID
  • ICD-10: D67 (Hereditary factor IX deficiency)
  • HCPCS: J1411 with appropriate NDC
  • Prescriber NPI and treatment facility information

2. Clinical Documentation

  • Hematology consult note with complete bleeding history
  • Laboratory results (within 30 days):
    • Factor IX activity level (≤2% required)
    • Factor IX inhibitor screen (must be negative)
    • Complete liver panel (ALT, AST, bilirubin, alkaline phosphatase)
    • Hepatitis B/C and HIV serologies
  • Treatment history showing ≥50 exposure days to Factor IX products
  • Bleeding log documenting annualized bleeding rate

3. Medical Necessity Letter Must address each UHC criterion:

  • Confirmed congenital hemophilia B diagnosis
  • Severity justification (Factor IX ≤2%)
  • Current prophylaxis regimen and outcomes
  • Negative inhibitor status
  • Center of excellence qualification
  • Long-term monitoring plan

Frequent Pitfalls

Coding Errors

  • Wrong units: Billing multiple units of J1411 instead of 1 unit per dose
  • Missing NDC: Failing to include 11-digit NDC with N4 modifier
  • Incorrect format: Using 10-digit NDC instead of required 11-digit format

Documentation Gaps

  • Outdated labs: Using Factor IX levels or inhibitor testing older than 3 months
  • Incomplete bleeding history: Vague descriptions like "frequent bleeds" without specific dates, locations, or severity
  • Missing exposure days: Inadequate documentation of ≥50 Factor IX product exposures

Site of Care Issues

  • Non-approved center: Attempting treatment at facilities not designated as hemophilia treatment centers
  • Out-of-network: Using centers not contracted with UnitedHealthcare for gene therapy

Verification Steps

Before Submission

  1. Confirm plan coverage: Call UnitedHealthcare member services (number on ID card) to verify gene therapy benefits
  2. Check center status: Ensure treatment facility is in-network and approved for Hemgenix administration
  3. Review policy: Request current UnitedHealthcare gene therapy coverage policy

During Review Process

  • Track PA status through UHC provider portal
  • Respond promptly to requests for additional information
  • Document all communications with UnitedHealthcare representatives

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals. Their platform identifies specific denial reasons and drafts point-by-point rebuttals aligned with each payer's own rules, significantly improving approval odds for high-cost specialty therapies like Hemgenix.

Quick Audit Checklist

Before submitting your PA:

  • ICD-10 D67 used consistently across all forms
  • J1411 coded as 1 unit per therapeutic dose
  • 11-digit NDC with N4 modifier included
  • Factor IX activity ≤2% documented within 30 days
  • Negative inhibitor screen within 30 days
  • Complete liver panel within 30 days
  • ≥50 exposure days to Factor IX products documented
  • Treatment center confirmed as UHC-approved COE
  • Medical necessity letter addresses all policy criteria
  • All required signatures and dates present

Appeals Playbook for California

Internal Appeals (UnitedHealthcare)

Timeline: Must file within 180 days of denial Process: Submit through UHC provider portal or mail/fax Decision time:

  • Standard: 30 days
  • Expedited (urgent): 72 hours

Required documents:

  • Original denial letter
  • Updated medical necessity letter addressing denial reasons
  • Additional clinical evidence or lab results
  • Peer-reviewed studies supporting Hemgenix use

California Independent Medical Review (IMR)

If UnitedHealthcare upholds the denial, California residents can request IMR through the Department of Managed Health Care (DMHC).

Eligibility: DMHC-regulated plans (most HMOs and PPOs) Timeline: File within 6 months of final internal denial Cost: Free to patients Decision time: 30-45 days (expedited: 3-7 days for urgent cases)

Success rates: California IMR data shows approximately 50-60% of specialty drug denials are overturned, with higher rates for "experimental/investigational" and "medical necessity" categories.

How to file:

  1. Complete DMHC IMR application online or by mail
  2. Include denial letter and supporting medical records
  3. Submit clinical evidence showing Hemgenix meets standard of care

DMHC Help Center: 888-466-2219 for assistance with filing

Common Denial Reasons & Fixes

Denial Reason Fix Strategy Required Documentation
Insufficient bleeding history Quantify bleeding episodes Detailed bleeding log with dates, sites, severity
Missing inhibitor testing Submit recent results Negative Factor IX inhibitor screen ≤30 days
Non-approved center Transfer to qualified facility Confirmation of HTC/COE status
Inadequate severity documentation Provide baseline labs Factor IX activity ≤2% from certified lab
Missing prior treatment history Document exposure days Pharmacy records, infusion logs, clinic notes
Liver function concerns Address underlying conditions Treated hepatitis status, acceptable LFTs
From our advocates: We've seen cases where patients were initially denied for "insufficient documentation," but after submitting a comprehensive bleeding log spanning two years with specific dates and treatment interventions, the same plan approved the request within days. The key is quantifying rather than qualifying the clinical need.

FAQ

How long does UnitedHealthcare prior authorization take for Hemgenix in California? Standard review takes 5-14 business days after complete submission. Expedited reviews for urgent cases are typically decided within 72 hours.

What if Hemgenix is listed as non-formulary on my plan? Gene therapies like Hemgenix often require special authorization even when not on standard formularies. Submit a PA with medical necessity documentation - many "non-formulary" denials are overturned with proper clinical justification.

Can I request an expedited appeal if my condition is worsening? Yes. If you're experiencing frequent severe bleeding episodes or have developed target joints, request expedited review citing urgent medical need. Document any recent hospitalizations or emergency department visits.

Does California's step therapy law apply to Hemgenix? California has step therapy override protections. If UnitedHealthcare requires trying other Factor IX products first, your doctor can request an override if those treatments are contraindicated, likely to cause adverse reactions, or medically inappropriate.

What happens if both internal appeals and IMR are denied? While IMR decisions are binding on health plans, you may have additional options including filing complaints with California insurance regulators or seeking legal counsel, particularly if the denial appears to violate state coverage requirements.

How much does Hemgenix cost without insurance coverage? The list price is approximately $3.5 million per dose. However, CSL Behring offers patient assistance programs and copay support for eligible patients. Don't let cost concerns prevent you from pursuing coverage - most denials can be successfully appealed with proper documentation.

For additional support navigating the prior authorization and appeals process, Counterforce Health specializes in turning insurance denials into successful approvals by creating evidence-backed appeals that address each payer's specific requirements and medical policies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and are subject to change. Always consult with your healthcare provider and insurance plan for the most current requirements. For assistance with insurance issues, contact the California Department of Managed Health Care at 888-466-2219 or visit healthhelp.ca.gov.

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