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

How to Get Hemlibra (emicizumab-kxwh) Covered by Cigna in Virginia: Complete Prior Authorization and Appeals Guide

Quick Answer: To get Hemlibra (emicizumab-kxwh) covered by Cigna in Virginia, you need prior authorization with hemophilia A diagnosis, factor VIII inhibitor testing, and bleeding history documentation. Submit through CoverMyMeds or fax to (855) 840-1678. Standard review takes 15-30 days. If denied, file internal appeal within 180 days, then Virginia external review through the State Corporation Commission within 120 days for binding coverage decision.

Table of Contents

Who Should Use This Guide

This guide helps Virginia residents with hemophilia A who need Hemlibra (emicizumab-kxwh) covered by Cigna insurance. You'll find this most useful if you're:

  • Starting Hemlibra prophylaxis for the first time
  • Transferring from another hemophilia treatment
  • Facing a prior authorization denial
  • Working with your clinic to prepare a strong initial request

Expected outcome: With proper documentation and adherence to Cigna's clinical criteria, most medically appropriate Hemlibra requests get approved. Virginia's robust external review process provides additional protection if initial appeals fail.

Member & Plan Basics

Active Coverage Requirements

Verify your Cigna coverage is active and includes prescription benefits. Hemlibra is classified as a Tier 4 specialty drug on most Cigna formularies, meaning higher copays but guaranteed coverage once approved.

Plan Type Considerations

  • Commercial plans: Follow standard prior authorization process
  • Medicare Advantage: May have additional step therapy requirements
  • Medicaid managed care: Check if your specific Virginia Medicaid plan contracts with Cigna

Authorization Requirements

Prior authorization is always required for Hemlibra through Cigna. No exceptions exist for emergency fills or samples transitioning to coverage.

Clinical Criteria Requirements

Primary Indication

Hemlibra must be prescribed for routine prophylaxis to prevent or reduce bleeding episodes in hemophilia A patients. Acute bleeding treatment is not covered.

Patient Age

Patients must be ≥12 years old for initial authorization. Pediatric patients under 12 require individual case review.

Hemophilia A Documentation

Submit recent lab work confirming:

  • Congenital factor VIII deficiency
  • Factor VIII activity level (severe <1%, moderate 1-5%, mild 5-40%)
  • Current factor VIII inhibitor status via Bethesda assay

Inhibitor Status Requirements

For patients WITH inhibitors (≥5 Bethesda Units):

  • Document high-titer inhibitor presence
  • Show inadequate response to bypassing agents (if tried)
  • Provide bleeding frequency despite current prophylaxis

For patients WITHOUT inhibitors:

  • Confirm absence of high-titer inhibitors
  • Document inadequate response to standard factor VIII prophylaxis
  • Show patient is not suitable candidate for shorter half-life Factor VIII products

Prescriber Requirements

Hemlibra must be prescribed by or in consultation with a hematologist experienced in hemophilia care. Community physicians can prescribe with specialist co-management documentation.

Coding and Billing Information

ICD-10 Diagnosis Code

  • D66: Hereditary factor VIII deficiency (required for all hemophilia A cases)

HCPCS Codes

  • J3590: Emicizumab-kxwh injection, for subcutaneous use
  • J7170: Injection, emicizumab-kxwh, 0.5 mg billable unit

Required Modifiers

  • JZ modifier: Must be used as of January 1, 2024, indicating no quantity limits apply

Dosing for Authorization

Loading phase: 3 mg/kg subcutaneously once weekly for 4 weeks Maintenance phase: Choose one of:

  • 1.5 mg/kg once weekly
  • 3 mg/kg every two weeks
  • 6 mg/kg every four weeks

Documentation Packet Essentials

Provider Note Elements

Your hemophilia specialist's note should include:

  1. Confirmed hemophilia A diagnosis with severity classification
  2. Current bleeding pattern with frequency and joint involvement
  3. Prior treatment history with specific products, doses, and outcomes
  4. Factor VIII inhibitor status with recent Bethesda assay results
  5. Weight-based dosing rationale for chosen maintenance schedule
  6. Treatment goals focusing on bleeding prevention and quality of life

Medical Necessity Letter Components

A strong letter of medical necessity addresses:

  • Problem statement: Current bleeding frequency and impact on daily activities
  • Prior therapies: Detailed history of factor VIII products tried, including duration and reasons for discontinuation
  • Clinical rationale: Why Hemlibra is appropriate for this patient's specific situation
  • Guideline support: Reference to FDA labeling and hematology society recommendations
  • Expected outcomes: Realistic goals for bleeding reduction and improved quality of life

Required Attachments

Submit these documents with your prior authorization:

  • Recent lab results (factor VIII level, inhibitor testing)
  • Bleeding logs or clinic documentation of bleeding episodes
  • Prior treatment records from pharmacy or clinic
  • Specialist consultation notes
  • Weight documentation for dosing calculations

Submission Process

Preferred Submission Methods

  1. Online: CoverMyMeds Cigna portal
  2. EHR integration: SureScripts electronic submission
  3. Fax: (855) 840-1678 for standard requests
  4. Phone: (800) 882-4462 for urgent situations requiring expedited review

Common Form Errors

Avoid these frequent submission mistakes:

  • Incomplete patient weight documentation
  • Missing inhibitor test results
  • Unclear prior treatment history
  • Inadequate bleeding frequency documentation
  • Wrong prescriber credentials or missing specialist involvement

Review Timelines

  • Standard review: 15-30 business days
  • Expedited review: 72 hours (requires clinical urgency documentation)
  • Peer-to-peer: Available if initial review raises questions

Specialty Pharmacy Requirements

Mandatory Specialty Network

Hemlibra must be obtained through Accredo Specialty Pharmacy, Cigna's preferred specialty vendor. No exceptions for retail pharmacy dispensing.

Enrollment Process

  1. Contact Accredo: Call 877-826-7657 to initiate enrollment
  2. Complete patient profile: Provide insurance, shipping, and clinical information
  3. Coordinate with prescriber: Ensure prescription is sent directly to Accredo
  4. Verify prior authorization: Confirm approval before first shipment

Transfer from Current Pharmacy

If switching from another specialty pharmacy:

  • Contact current pharmacy to request prescription transfer to Accredo
  • Provide Accredo contact information: 1640 Century Center Pkwy, Memphis, TN 38134-8822
  • Allow 3-5 business days for transfer completion
  • Verify no gap in therapy during transition

After Submission: What to Expect

Confirmation Process

Within 24-48 hours of submission, you should receive:

  • Reference number for tracking your request
  • Estimated review timeline based on standard vs. expedited processing
  • Contact information for status updates

Status Monitoring

Check authorization status weekly through:

  • Cigna provider portal (for clinicians)
  • CoverMyMeds status updates
  • Direct contact with Cigna utilization management at (800) 882-4462

Documentation Requests

Cigna may request additional information during review. Respond within 5 business days to avoid delays:

  • Updated lab results
  • Additional bleeding documentation
  • Specialist clarification letters
  • Pharmacy benefit verification

Common Denial Prevention Tips

Five Critical Pitfalls to Avoid

  1. Insufficient bleeding documentation: Submit detailed logs showing frequency, severity, and impact on function
  2. Missing specialist involvement: Ensure hematologist prescribes or provides consultation documentation
  3. Incomplete prior therapy records: Document specific factor VIII products tried, with doses and clinical outcomes
  4. Wrong indication: Emphasize routine prophylaxis, not acute bleeding treatment
  5. Inadequate inhibitor documentation: Provide current Bethesda assay results, not historical references

Strengthening Your Request

  • Include quality of life assessments showing functional impact
  • Reference FDA labeling for approved indications
  • Provide weight-based dosing calculations
  • Submit recent clinic notes documenting bleeding episodes
  • Ensure all required forms are complete and signed

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps patients and clinicians navigate complex prior authorization requirements by identifying denial reasons and drafting point-by-point rebuttals aligned to each plan's specific rules.

Appeals Process in Virginia

Internal Appeals with Cigna

Timeline: File within 180 days of denial notice

Required documents:

  • Written appeal request
  • Original denial letter
  • Additional clinical documentation addressing denial reasons
  • Updated medical necessity letter from prescriber

Submission: Use Cigna member/provider portal or mail to address listed in denial notice

Virginia External Review Process

If Cigna upholds the denial after internal appeal, Virginia offers robust external review protection through the State Corporation Commission Bureau of Insurance.

Eligibility requirements:

  • Completed Cigna's internal appeal process
  • Virginia-issued insurance plan (or opted-in self-funded plan)
  • Denial based on medical necessity or experimental treatment determination

Timeline: Submit within 120 days of final internal denial

Process:

  1. Contact Bureau first: Call (877) 310-6560 for guidance before submitting
  2. Complete Form 216-A: External Review Request form
  3. Submit supporting documents: Include all clinical records and specialist letters
  4. Independent review: Bureau assigns case to qualified Independent Review Organization (IRO)

Decision timeline:

  • Standard review: 45 days maximum
  • Expedited review: 72 hours for urgent medical situations

Binding decision: If IRO overturns denial, Cigna must provide coverage within 1-3 days

Virginia Consumer Support

Managed Care Ombudsman: Available through SCC Consumer Services at (877) 310-6560 for informal resolution assistance

No cost: Virginia provides external review at no charge to consumers

For complex appeals, organizations like Counterforce Health can help craft compelling medical necessity arguments that address specific payer requirements and increase approval chances.

Frequently Asked Questions

How long does Cigna prior authorization take for Hemlibra in Virginia? Standard review takes 15-30 business days. Expedited review for urgent medical situations is completed within 72 hours.

What if Hemlibra is non-formulary on my Cigna plan? Request a formulary exception by providing medical necessity documentation showing formulary alternatives are ineffective or inappropriate for your specific case.

Can I request expedited appeal if my Hemlibra is denied? Yes, if your doctor certifies that waiting for standard review could seriously jeopardize your health. Virginia allows expedited external review within 72 hours for urgent situations.

Does step therapy apply to Hemlibra in Virginia? Cigna may require documentation of prior factor VIII prophylaxis attempts, but Virginia law allows step therapy appeals for medically inappropriate requirements.

What happens if I miss the appeal deadline? Internal appeals must be filed within 180 days of denial. External review requests must be submitted within 120 days of final internal denial. Missing these deadlines typically forfeits appeal rights.

Who pays for Hemlibra if my appeal succeeds? If Virginia external review overturns Cigna's denial, your insurance must provide coverage according to your plan benefits, including any applicable copays or deductibles.

Can I get Hemlibra while my appeal is pending? Contact HEMLIBRA Access Solutions at (833) 436-5427 for temporary assistance programs during appeals. The Genentech Patient Foundation may provide free medication for eligible uninsured patients.

What if my employer plan is self-funded? Many Virginia-headquartered self-funded plans opt into the state external review process. If not, you may have federal external review rights through HHS. The Bureau of Insurance can help determine your options.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Consult your healthcare provider for medical guidance and contact Virginia's Bureau of Insurance for specific appeals assistance.

Sources & Further Reading:

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