By Counterforce Health Team in Hemlibra (emicizumab-kxwh) —

The Requirements Checklist to Get Hemlibra (emicizumab-kxwh) Covered by Aetna (CVS Health) in Ohio

Answer Box: Getting Hemlibra Covered by Aetna in Ohio

Hemlibra (emicizumab-kxwh) requires prior authorization from Aetna (CVS Health) for hemophilia A prophylaxis. You must be prescribed by a hematologist, document failure of factor VIII prophylaxis (step therapy), and provide weight-based dosing plans. The fastest path: gather bleeding history, factor VIII trial records, and submit via Aetna's provider portal. If denied, Ohio allows two internal appeals plus external review through the Ohio Department of Insurance within 180 days. First step today: contact your hematologist to document prior therapy failures and initiate the PA request.

Table of Contents

Who Should Use This Checklist

This checklist is for Ohio patients with hemophilia A who need Hemlibra (emicizumab-kxwh) covered by Aetna (CVS Health), along with their healthcare providers and caregivers. Use this if you're:

  • Starting Hemlibra for the first time
  • Transferring from another insurance plan
  • Facing a denial that needs appeal
  • Switching from another specialty pharmacy

Expected outcome: Following this checklist increases your chances of first-time approval and helps avoid common denial reasons. If denied, you'll have the documentation needed for a successful appeal.

Member & Plan Basics

Coverage Requirements

  • Active Aetna coverage with prescription drug benefits
  • Plan type matters: Commercial, Medicare, and Medicaid plans have slightly different criteria
  • Deductible status: High-deductible plans may require meeting deductible first
  • Prior authorization: Always required for Hemlibra across all Aetna plan types

Key Plan Information to Gather

  • Member ID number
  • Group number (if employer-sponsored)
  • Prescription drug coverage details
  • Current deductible status
  • Specialty pharmacy network requirements
Tip: Call the member services number on your insurance card to confirm your specialty drug coverage and any specific requirements for hemophilia medications.

Clinical Criteria Requirements

FDA-Approved Indication

Hemlibra must be prescribed for routine prophylaxis to prevent or reduce bleeding episodes in hemophilia A patients with or without factor VIII inhibitors. All other uses are considered investigational and not covered by Aetna.

Prescriber Requirements

  • Must be prescribed by a hematologist or in consultation with one
  • Prescriber must have valid NPI, DEA, and state license
  • Hand-written signature required (no stamps)

Disease Severity Documentation

For mild hemophilia A:

  • Document inadequate response to desmopressin, OR
  • Provide clinical reason for not using desmopressin (allergy, contraindication)

For moderate/severe hemophilia A:

  • Document factor VIII activity levels
  • Record bleeding episode history
  • Include severity classification

Step Therapy Requirements

Critical requirement: Patients must first try and fail prophylactic factor VIII concentrates before Hemlibra approval. Document:

  • Specific factor VIII products tried (e.g., Advate, Eloctate, Kovaltry)
  • Duration of therapy attempted
  • Reasons for failure: breakthrough bleeds, adverse reactions, or inadequate response
  • Clinical notes supporting inability to maintain therapeutic levels
Note: Factor VIII prophylaxis must be discontinued after the first week of Hemlibra therapy per Aetna policy.

Coding & Billing Requirements

ICD-10 Diagnosis Code

  • Primary code: D66 (Hereditary factor VIII deficiency - hemophilia A)
  • Use for all Hemlibra claims regardless of inhibitor status

HCPCS J-Code

  • J7170: Injection, emicizumab-kxwh, 0.5 mg (2 units = 1 mg)
  • Modifier JZ: Required by CMS as of 2024 if zero drug wastage
  • Alternative: Some payers may still use J3590 (verify with Aetna)

NDC Requirements

Include 11-digit NDC codes for specific vial strengths used:

  • 30 mg/mL: 50242-0920-01
  • 60 mg/0.4 mL: 50242-0921-01
  • 105 mg/0.7 mL: 50242-0922-01
  • 150 mg/mL: 50242-0923-01

Administration Billing

  • CPT 96372: May be required for subcutaneous injection administration
  • Document injection site and administration details

Documentation Packet

Provider Clinical Notes Must Include:

  • Confirmed hemophilia A diagnosis with factor levels
  • Bleeding episode history and frequency
  • Prior factor VIII therapies tried and outcomes
  • Current weight for dosing calculations
  • Treatment goals and expected outcomes
  • Contraindications to other therapies

Letter of Medical Necessity Components:

  1. Patient demographics and insurance information
  2. Diagnosis: Hemophilia A with/without inhibitors
  3. Clinical justification for prophylactic therapy
  4. Prior therapy failures with specific documentation
  5. Weight-based dosing plan:
    • Loading: 3 mg/kg weekly × 4 weeks
    • Maintenance: 1.5 mg/kg weekly, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks
  6. Safety acknowledgment of boxed warnings
  7. Request for coverage duration (typically 12 months)

Required Attachments:

  • Chart notes from hematologist
  • Factor VIII activity levels and inhibitor titers
  • Documentation of prior therapy failures
  • Bleeding episode records
  • Weight documentation for dosing
Clinician Corner: Use Hemlibra's manufacturer-provided Letter of Medical Necessity template available at hemlibra-hcp.com to ensure all required elements are included.

Submission Process

Submission Methods

  1. Aetna Provider Portal (preferred method)
  2. Availity® Portal for electronic submission
  3. Fax: Check current fax number with Aetna (changes periodically)
  4. Electronic Medical Records integration where available

Required Form Elements

  • Complete patient demographics
  • Prescriber information with NPI
  • Medication details: name, strength, dose, directions
  • Clinical justification narrative
  • All supporting documentation attached
  • Hand-written prescriber signature

Common Rejection Reasons to Avoid:

  • Incomplete patient information
  • Missing prescriber signature
  • Inadequate clinical justification
  • Missing step therapy documentation
  • Incorrect dosing calculations
Tip: Submit PA requests at least 2 weeks before medication is needed to allow processing time.

Specialty Pharmacy Routing

CVS Specialty Pharmacy Enrollment

Since Aetna uses CVS Caremark, most Hemlibra prescriptions route through CVS Specialty:

  1. Download enrollment forms:
  2. Complete required sections:
    • Patient demographics and insurance
    • Prescriber information and signature
    • Medication details and dosing
    • Consent for communication methods
  3. Submit completed forms:
    • Fax: 1-800-323-2445
    • Phone: 1-800-237-2767 for questions

PA Transfer Process

If transferring from another pharmacy:

  • Coordinate with previous pharmacy to obtain PA documentation
  • Submit existing PA approval with enrollment forms
  • Verify transfer completion before discontinuing previous pharmacy

After Submission

Track Your Request

  • Record confirmation number from submission
  • Note submission date and method used
  • Set calendar reminder for follow-up

Expected Timelines

  • Standard PA decision: 30-45 days
  • Expedited/urgent requests: ≤72 hours (requires clinical urgency documentation)
  • Status check schedule: Call every 7-10 business days if no response

What to Document

  • All communication dates and representatives spoken with
  • Reference numbers for each interaction
  • Any additional documentation requested
  • Decision notification method (phone, mail, portal)

Common Denial Prevention Tips

Five Most Common Pitfalls and How to Avoid Them:

  1. Missing Step Therapy Documentation
    • Fix: Provide detailed records of factor VIII prophylaxis trials, including specific products, duration, and reasons for discontinuation
  2. Inadequate Clinical Justification
    • Fix: Include bleeding frequency, severity, and impact on quality of life with specific examples and dates
  3. Wrong Prescriber Type
    • Fix: Ensure prescription comes from hematologist or includes hematology consultation documentation
  4. Incomplete Dosing Information
    • Fix: Provide current weight, calculated doses for loading and maintenance phases, and administration schedule
  5. Missing Safety Documentation
    • Fix: Acknowledge boxed warnings and include monitoring plan for thrombotic events
From Our Advocates: In our experience helping families navigate hemophilia coverage, the most successful Hemlibra approvals include a comprehensive bleeding diary showing frequency and severity of episodes, along with detailed documentation of why factor VIII prophylaxis was inadequate. This clinical picture helps medical reviewers understand the necessity for this specialized therapy.

Appeals Process in Ohio

If your Hemlibra request is denied, Ohio provides multiple appeal levels:

Internal Appeals with Aetna

  1. First Internal Appeal:
    • Deadline: 180 days from denial notice
    • Method: Submit via Aetna member portal or written request
    • Timeline: ~30-45 days for decision
  2. Second Internal Appeal:
    • Deadline: 180 days from first appeal denial
    • Method: Same as first appeal
    • Timeline: ~30-45 days for decision

External Review in Ohio

After exhausting internal appeals:

  • Deadline: 180 days from final internal denial
  • Process: File with your health plan, which notifies Ohio Department of Insurance
  • Review body: Independent Review Organization (IRO)
  • Timeline: 30 days standard, 72 hours expedited
  • Decision: Binding on insurer if overturned

Getting Help in Ohio

  • Ohio Department of Insurance Consumer Services: 1-800-686-1526
  • Online resources: insurance.ohio.gov
  • UHCAN Ohio: Nonprofit advocacy for health coverage issues
Note: Self-funded employer plans follow federal ERISA rules, not Ohio state external review, but many voluntarily provide similar processes.

Printable Checklist

Before Starting:

  • Active Aetna coverage confirmed
  • Hematologist identified as prescriber
  • Factor VIII failure documentation gathered
  • Current weight documented
  • Bleeding history compiled

Clinical Documentation:

  • ICD-10 code D66 confirmed
  • Step therapy failure documented
  • Weight-based dosing calculated
  • Safety monitoring plan included
  • Letter of medical necessity completed

Submission Package:

  • PA form completed with all required fields
  • Hand-written prescriber signature obtained
  • All supporting documents attached
  • Submission method confirmed (portal/fax)
  • Confirmation number recorded

After Submission:

  • Follow-up schedule set
  • Status tracking system in place
  • Appeal deadlines noted (180 days)
  • Ohio external review process understood

Getting Additional Support

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Hemlibra. Their platform analyzes denial letters, identifies specific coverage gaps, and creates evidence-backed appeals tailored to each payer's requirements. For patients facing repeated denials or complex coverage issues, professional appeal assistance can significantly improve approval rates while reducing the burden on families and healthcare providers.

If you need additional support navigating this process, Counterforce Health can help streamline your appeal with payer-specific documentation and evidence-based rebuttals that address Aetna's exact coverage criteria.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and specific plan terms. Always consult with your healthcare provider and insurance plan directly for personalized guidance. Appeal rights and timelines may vary by plan type and state regulations.

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