By Counterforce Health Team in Elfabrio (pegunigalsidase alfa-iwxj) —

How to Get Elfabrio Approved by Blue Cross Blue Shield in Virginia: Step-by-Step Guide with Appeal Forms

Quick Answer: Getting Elfabrio Covered by Blue Cross Blue Shield in Virginia

Yes, Blue Cross Blue Shield covers Elfabrio (pegunigalsidase alfa-iwxj) in Virginia with prior authorization. Anthem Blue Cross Blue Shield Virginia requires PA as of June 2024. Your fastest path: (1) Have your doctor submit a prior authorization request through Anthem's Availity portal with confirmed Fabry disease diagnosis and clinical documentation, (2) If denied, file an internal appeal within 180 days, then (3) Request external review through Virginia's Bureau of Insurance within 120 days using Form 216-A. Start today by calling your doctor's office to initiate the PA process.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timeline and Urgency
  4. Medical Necessity Criteria
  5. Cost Considerations
  6. Denials and Appeals
  7. Specialty Pharmacy Requirements
  8. When to Escalate
  9. FAQ: Common Questions

Coverage Basics

Is Elfabrio Covered by Blue Cross Blue Shield in Virginia?

Yes, but with requirements. Anthem Blue Cross Blue Shield Virginia covers Elfabrio for adults with confirmed Fabry disease, but requires prior authorization as part of their expanded specialty pharmacy precertification list effective June 2024.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Doctor must get approval before prescribing Anthem Provider Portal Anthem VA Newsletter
Age Restriction Adults only (18+) FDA prescribing information Elfabrio Dosing Guide
Confirmed Diagnosis Fabry disease with genetic/enzyme testing Medical policy requirements BCBS Medical Policies
Specialty Pharmacy Must use in-network specialty pharmacy Anthem Specialty Network Anthem Specialty Info
No Step Therapy No requirement to try other ERTs first BCBS ERT policies BCBS ERT Policy

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient/Family)
    • Insurance card and member ID
    • Genetic testing results confirming Fabry disease
    • Previous treatment records (if any)
    • Timeline: 1-2 days
  2. Doctor Submits PA Request (Healthcare Provider)
    • Submit through Anthem's Availity portal
    • Include diagnosis codes, clinical history, and treatment plan
    • Timeline: Same day submission possible
  3. Include Required Clinical Information (Healthcare Provider)
    • Confirmed Fabry disease diagnosis with ICD-10 code
    • Documentation of symptoms or organ involvement
    • Planned dosing (1 mg/kg every 2 weeks)
    • Timeline: Part of initial submission
  4. Anthem Reviews Request (Insurance Company)
    • Medical necessity review against internal criteria
    • May request additional information
    • Timeline: 5-15 business days for standard review
  5. Receive Decision (Patient/Provider)
    • Approval: Begin treatment coordination
    • Denial: Proceed to appeals process
    • Timeline: Decision communicated within review period
Clinician Corner: When writing the medical necessity letter, include: (1) confirmed genetic testing results, (2) clinical manifestations of Fabry disease, (3) specific dosing rationale based on patient weight, and (4) monitoring plan for infusion reactions. Reference the FDA prescribing information and include relevant clinical guidelines.

Timeline and Urgency

Standard Review Times

  • Initial PA Decision: 5-15 business days
  • Expedited Review: 72 hours (if urgent medical need)
  • Internal Appeal: 30 days for decision
  • External Review: 45 days for decision

When to Request Expedited Review

Your doctor can request expedited review if waiting could seriously jeopardize your health. This requires physician certification and may be appropriate if:

  • You're experiencing severe Fabry disease symptoms
  • You're switching from another ERT that's no longer available
  • You have documented clinical deterioration

Medical Necessity Criteria

What Blue Cross Blue Shield Looks For

Required Documentation:

  • Confirmed Fabry disease diagnosis (genetic testing or enzyme assay)
  • Age 18 or older
  • Clinical evidence of disease manifestations
  • Appropriate specialist involvement (nephrologist, cardiologist, or geneticist)
  • Proper dosing plan (1 mg/kg every 2 weeks)

Common Approval Factors:

  • Clear diagnostic confirmation
  • Specialist management
  • Appropriate dosing based on body weight
  • Plan for monitoring and follow-up
Note: Unlike some other conditions, Fabry disease ERTs typically don't require step therapy between different enzyme replacement options like Elfabrio and Fabrazyme.

Cost Considerations

Understanding Your Out-of-Pocket Costs

Typical Cost Structure:

  • Specialty Tier: Usually highest copay/coinsurance tier
  • Medical vs. Pharmacy Benefit: May be covered under medical benefit if administered in clinic
  • Deductible: May apply before copay/coinsurance kicks in

Financial Assistance Options

Manufacturer Support:

  • Chiesi's patient assistance programs
  • Copay cards for eligible commercially insured patients
  • Contact specialty pharmacy to check eligibility

Additional Resources:

  • State pharmaceutical assistance programs
  • Non-profit patient assistance foundations
  • Hospital financial assistance programs
Important: Manufacturer copay cards typically cannot be used with Medicare, Medicaid, or other government insurance programs.

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Lack of medical necessity Provide comprehensive clinical documentation Genetic testing, symptom documentation, specialist notes
Missing prior authorization Resubmit with complete PA form All required clinical information
Age restriction Confirm patient is 18+ Birth certificate or ID
Incorrect dosing Adjust to FDA-approved dosing Weight-based calculation (1 mg/kg q2weeks)
Missing specialist involvement Add specialist to treatment team Referral to appropriate specialist

Virginia Appeals Process

Internal Appeals (Blue Cross Blue Shield):

  1. Timeline: File within 180 days of denial
  2. Process: Submit appeal through member portal or mail
  3. Decision: 30 days for non-urgent, 72 hours for urgent

External Review (Virginia Bureau of Insurance):

  1. Timeline: File within 120 days of final internal denial
  2. Form: Form 216-A (External Review Request)
  3. Decision: 45 days for standard, 72 hours for expedited
  4. Contact: [email protected] or (804) 371-9915
From our advocates: We've seen patients succeed in external review by including a detailed timeline of their Fabry disease progression, documentation of failed previous treatments, and a strong letter from their specialist explaining why Elfabrio is medically necessary. The key is thorough documentation and persistence through the process.

Specialty Pharmacy Requirements

Why Specialty Pharmacy is Required

Elfabrio must be dispensed through Anthem's in-network specialty pharmacies due to:

  • Temperature-sensitive storage requirements
  • Complex dosing calculations
  • Need for patient monitoring and support
  • Prior authorization coordination

Virginia Blue Cross Blue Shield Specialty Network

Common In-Network Options:

  • CVS Specialty
  • BioPlus Specialty Pharmacy
  • CenterWell Pharmacy

Services Provided:

  • Insurance benefit verification
  • Prior authorization support
  • Copay assistance program enrollment
  • Temperature-controlled shipping
  • Clinical monitoring and support

Contact Anthem's specialty pharmacy network to confirm current options and coordinate care.

When working with patients seeking coverage for expensive specialty medications, Counterforce Health helps turn insurance denials into successful appeals by analyzing denial letters and crafting evidence-backed rebuttals that address specific payer criteria. The platform streamlines the complex appeals process by identifying denial reasons and generating targeted responses with the right clinical documentation and regulatory citations.

When to Escalate

Contact Virginia Insurance Regulators

If you've exhausted Blue Cross Blue Shield's internal appeals and external review, contact:

Virginia State Corporation Commission Bureau of Insurance

When to Contact:

  • Plan not following Virginia law
  • Missed deadlines or procedural violations
  • Need help understanding your rights
  • External review decision not being honored

Additional Virginia Resources

Virginia Managed Care Ombudsman

  • Part of the State Corporation Commission
  • Helps with HMO and managed care issues
  • Same contact information as Bureau of Insurance

FAQ: Common Questions

Q: How long does Anthem Blue Cross Blue Shield prior authorization take in Virginia? A: Standard PA decisions are made within 5-15 business days. Expedited reviews (with physician certification of urgency) are decided within 72 hours.

Q: What if Elfabrio is not on my formulary? A: You can request a formulary exception through the same prior authorization process. Include documentation of medical necessity and why other covered options aren't appropriate.

Q: Can I get expedited appeal if my current ERT is being discontinued? A: Yes, if your doctor certifies that waiting could jeopardize your health. Submit expedited appeal request with physician certification using Form 216-C.

Q: Does step therapy apply between different Fabry disease treatments? A: No, current Blue Cross Blue Shield policies don't require step therapy between ERTs like Elfabrio and Fabrazyme for confirmed Fabry disease.

Q: What if I need home infusion instead of clinic administration? A: Home infusion may be covered but requires additional documentation of medical necessity and appropriate monitoring capabilities. Discuss with your specialty pharmacy and healthcare team.

Q: How do I check my appeal status? A: Log into your Anthem member portal or call the customer service number on your insurance card. For external reviews, contact the Virginia Bureau of Insurance.

Q: What happens if external review upholds the denial? A: The decision is final and binding. You may still have options through employer appeals (if applicable) or legal consultation, but the insurance requirement to cover is concluded.

For patients navigating complex prior authorization requirements and appeals, Counterforce Health provides specialized support by analyzing insurance policies and crafting targeted appeals that address specific denial reasons with appropriate clinical evidence and regulatory citations.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on your specific plan benefits and clinical circumstances. Always consult with your healthcare provider and insurance plan for personalized guidance. For official information about Virginia insurance regulations and appeals, contact the Virginia State Corporation Commission Bureau of Insurance.

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