By Counterforce Health Team in Hemgenix (etranacogene dezaparvovec) —

How to Get Hemgenix Covered by UnitedHealthcare in Ohio: ICD-10, HCPCS Codes, and Appeal Guide

Answer Box: Getting Hemgenix Covered by UnitedHealthcare in Ohio

Hemgenix (etranacogene dezaparvovec) requires prior authorization from UnitedHealthcare OptumRx for Ohio residents. Use ICD-10 code D67 (hereditary factor IX deficiency) and HCPCS code J1411 for billing. Submit PA requests through the UnitedHealthcare Provider Portal or call 888-397-8129. If denied, you have 180 days for internal appeals, then external review through Ohio's Department of Insurance. Start today: Gather your hemophilia B diagnosis documentation, prior treatment records, and current factor IX levels.

Table of Contents

  1. Understanding Medical vs. Pharmacy Benefit Coverage
  2. ICD-10 Coding for Hemophilia B
  3. HCPCS, J-Codes, and NDC Requirements
  4. Prior Authorization Request Anatomy
  5. Common Billing Pitfalls to Avoid
  6. Verifying Codes with UnitedHealthcare
  7. Pre-Submission Audit Checklist
  8. Appeals Process in Ohio
  9. FAQ: Common Questions

Understanding Medical vs. Pharmacy Benefit Coverage

Hemgenix is covered under the medical benefit, not pharmacy benefit, because it's administered intravenously in a clinical setting. This means:

  • Claims go through UnitedHealthcare's medical claims processing, not OptumRx pharmacy claims
  • Prior authorization is managed through medical benefit PA processes
  • The therapy is billed using medical HCPCS codes (J-codes) rather than NDC-only billing
  • Administration must occur at qualified treatment centers with appropriate monitoring capabilities
Note: While OptumRx manages some specialty drug prior authorizations for UnitedHealthcare, gene therapies like Hemgenix typically require medical benefit review due to their specialized administration requirements.

ICD-10 Coding for Hemophilia B

Primary Diagnosis Code

ICD-10 Code D67: Hereditary factor IX deficiency is the correct primary diagnosis code for Hemophilia B patients receiving Hemgenix. This code covers:

  • Hemophilia B
  • Christmas disease
  • Plasma thromboplastin component (PTC) deficiency
  • Factor IX deficiency (hereditary)

Documentation Requirements

Your medical records must clearly establish:

  • Hereditary nature of the condition (family history or genetic testing)
  • Severity level (mild, moderate, or severe based on factor IX activity levels)
  • Clinical manifestations (bleeding episodes, joint damage, or prophylaxis needs)
  • Laboratory confirmation with factor IX activity levels <40% of normal
Tip: The word "hereditary" must appear in your documentation. ICD-10 coding guidelines require explicit confirmation that the factor IX deficiency is inherited, not acquired.

HCPCS, J-Codes, and NDC Requirements

Primary Billing Code

HCPCS Code J1411 is specifically assigned for Hemgenix (etranacogene dezaparvovec-drlb). This code replaced the temporary J3590 (unclassified biologics) code that was initially used.

Dosing and Unit Calculations

Hemgenix dosing is 2 mL per kilogram of body weight (2 x 10^13 genome copies per kg):

  • Step 1: Calculate total dose = Patient weight (kg) × 2 mL
  • Step 2: Determine vials needed = Total dose ÷ 10 mL per vial (round up)
  • Step 3: Bill units based on actual vials used

Example: 70 kg patient needs 140 mL total dose = 14 vials

NDC and Modifier Requirements

Include the 11-digit NDC preceded by modifier N4, followed by the quantity of kits dispensed. The Hemgenix billing guide provides specific NDC numbers that vary by kit size and lot.

Prior Authorization Request Anatomy

Required Clinical Information

Your PA request must include:

Patient Demographics:

  • Full name, DOB, UnitedHealthcare member ID
  • Weight in kilograms (for dosing calculation)
  • Prescribing physician and treatment center information

Clinical Justification:

  • ICD-10 code D67 with supporting documentation
  • Factor IX activity levels (baseline and recent)
  • Bleeding history and current prophylaxis regimen
  • Previous factor IX concentrate usage and outcomes

Treatment Plan:

  • Planned administration date and location
  • Pre- and post-infusion monitoring plan
  • Long-term follow-up schedule

Submission Methods

Submit PA requests through:

  • Online: UnitedHealthcare Provider Portal using the Prior Authorization tool
  • Phone: 888-397-8129 for OptumRx specialty pharmacy questions
  • Specialty Pharmacy Transactions: Use the dedicated tile on the Provider Portal Dashboard
Important: As of January 1, 2025, Optum Rx manages prior authorization requests using UnitedHealthcare clinical criteria for eligible plans.

Common Billing Pitfalls to Avoid

Unit Conversion Errors

  • Wrong: Billing by mL instead of vials
  • Right: Bill actual number of 10 mL vials used
  • Wrong: Rounding down vial quantities
  • Right: Always round up to next whole vial

Code Mismatches

  • Wrong: Using J3590 (unclassified) instead of J1411
  • Wrong: Mixing pharmacy NDC-only billing with medical benefit claims
  • Right: Use J1411 with appropriate NDC modifier N4

Missing Documentation

  • Wrong: Generic "hemophilia" without specifying hereditary factor IX deficiency
  • Right: Clear documentation of hereditary factor IX deficiency with lab values
  • Wrong: Missing baseline factor IX levels
  • Right: Include recent factor IX activity percentage

Verifying Codes with UnitedHealthcare

Pre-Authorization Verification

Before submitting your request:

  1. Check formulary status: Log into the UnitedHealthcare Provider Portal to verify current coverage policies
  2. Confirm PA requirements: Review the advance notification requirements for your patient's specific plan
  3. Validate codes: Cross-reference J1411 and D67 in UnitedHealthcare's coding resources

Contact Resources

  • Provider Services: Call the number on the back of the patient's insurance card
  • Prior Authorization Support: 888-397-8129
  • Clinical Questions: Request peer-to-peer review if initial PA is denied

Pre-Submission Audit Checklist

Clinical Documentation ✓

  • ICD-10 code D67 documented with "hereditary" qualifier
  • Factor IX activity levels <40% documented
  • Bleeding history or prophylaxis needs recorded
  • Patient weight in kilograms for dosing

Billing Information ✓

  • HCPCS code J1411 selected
  • NDC with N4 modifier included
  • Vial quantity calculated correctly (round up)
  • Treatment center and administration plan specified

Authorization Status ✓

  • PA submitted through correct portal/method
  • All required attachments included
  • Follow-up date scheduled for PA decision

Appeals Process in Ohio

Internal Appeals with UnitedHealthcare

Level 1 Internal Appeal:

  • Timeline: 180 days from denial notice
  • Method: Submit through UnitedHealthcare Provider Portal or mail
  • Required: Original denial letter, additional clinical documentation, medical necessity letter

Expedited Appeals:

  • Qualifying situations: Urgent medical need where delay could harm patient
  • Timeline: 72 hours or less for decision
  • Same submission methods as standard appeals

External Review in Ohio

After exhausting UnitedHealthcare's internal appeals:

Ohio External Review Process:

External Review Decision:

  • Standard timeline: 45 days maximum
  • Expedited: 72 hours for urgent cases
  • Binding: Decision is legally binding on UnitedHealthcare
Ohio-Specific Advantage: Even if UnitedHealthcare claims your case isn't eligible for external review, the Ohio Department of Insurance can independently determine eligibility.

When to Contact Ohio Regulators

Ohio Department of Insurance Consumer Services:

  • Phone: 1-800-686-1526
  • Use for: Questions about external review process, filing complaints about improper denials
  • Website: insurance.ohio.gov

Counterforce Health helps patients and clinicians navigate complex prior authorization and appeals processes for specialty medications like Hemgenix. Our platform analyzes denial letters and creates targeted, evidence-backed appeals that address specific payer requirements. Learn more about our services for turning insurance denials into approvals.

FAQ: Common Questions

How long does UnitedHealthcare prior authorization take for Hemgenix? Standard PA decisions typically take 5-14 business days. Urgent cases may qualify for expedited review within 72 hours if delay could harm the patient.

What if Hemgenix is listed as non-formulary? Non-formulary status doesn't automatically mean denial. Submit a medical exception request with strong clinical justification showing medical necessity and lack of suitable alternatives.

Can I request peer-to-peer review if initially denied? Yes, request a peer-to-peer review where your prescribing physician can discuss the case directly with UnitedHealthcare's medical director.

Does step therapy apply to Hemgenix in Ohio? Gene therapy typically bypasses standard step therapy, but you may need to document prior factor IX concentrate use and outcomes to establish medical necessity.

What happens if my patient has a self-funded employer plan? Self-funded ERISA plans follow federal rules rather than Ohio's external review process, but many voluntarily use similar independent review procedures.

How much does Hemgenix cost without insurance? The list price is approximately $3.5 million per dose. CSL Behring offers patient assistance programs - contact them directly for eligibility requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance company for specific coverage questions. For additional help with Ohio health insurance appeals, contact the Ohio Department of Insurance at 1-800-686-1526.

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