How to Get Berinert (C1-Esterase Inhibitor) Approved by Cigna in Virginia: Complete PA Guide with Appeal Scripts
Quick Answer: Getting Berinert Approved by Cigna in Virginia
Cigna requires prior authorization for Berinert (C1-esterase inhibitor, IV) through Express Scripts, with confirmed HAE diagnosis via low C1-INH and C4 levels, specialist prescription, and documented attack history. In Virginia, if denied, you have 180 days to appeal internally, then 120 days for external review through the State Corporation Commission Bureau of Insurance. Start today: Have your HAE specialist gather labs (C1-INH functional/antigenic, C4, C1q) and submit PA via EviCore portal with clinical rationale for acute attacks only.
Table of Contents
- What This Guide Covers
- Before You Start: Verify Your Coverage
- Gather What You Need
- Submit the Prior Authorization Request
- Follow-Up and Tracking
- Typical Timelines in Virginia
- If You're Asked for More Information
- If Denied: Appeals Process
- Virginia External Review Process
- Renewal and Re-Authorization
- Quick Reference Checklist
- FAQ
What This Guide Covers
This guide helps patients with hereditary angioedema (HAE) and their healthcare providers navigate Cigna's prior authorization process for Berinert in Virginia. Whether you're facing your first denial or preparing to submit a new request, we'll walk you through each step to maximize your chances of approval.
Berinert (C1-esterase inhibitor, human) is FDA-approved for treating acute abdominal, facial, or laryngeal HAE attacks. It's a plasma-derived IV medication that costs thousands per vial, making insurance approval critical for most patients.
Note: If you're dealing with insurance denials and need expert help crafting appeals, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for specialty medications like Berinert.
Before You Start: Verify Your Coverage
Check Your Plan Type
Look at your Cigna ID card to identify your plan:
- Commercial plans: Most require PA through Express Scripts
- Medicare Advantage: Different PA process
- Self-funded employer plans: May have modified requirements
Confirm Berinert's Formulary Status
Berinert is excluded from the 2026 Express Scripts National Preferred Formulary, which means you'll likely need both prior authorization and a formulary exception. This actually works in your favor if you have documented medical necessity.
Verify Network Status
Ensure your HAE specialist (allergist/immunologist) is in-network with Cigna to avoid additional coverage complications.
Gather What You Need
Required Documentation
| Document Type | Specific Requirements | Where to Get It |
|---|---|---|
| HAE Diagnosis Labs | C1-INH functional (<50% normal), C1-INH antigenic (low for Type I), C4 (low), C1q (normal) | HAE specialist lab results |
| ICD-10 Code | D84.1 (Deficiency of C1-esterase inhibitor) | Medical records |
| Attack History | Frequency, severity, ED visits, impact on daily life | Clinic notes, ER records |
| Prior Treatments | Ruconest trial/failure documentation (dates, doses, reasons for discontinuation) | Treatment records |
| Prescriber Information | HAE specialist (allergist/immunologist) credentials and signature | Provider office |
Clinical Evidence Checklist
- Confirmed HAE Type I or II diagnosis
- Lab results within 6 months showing characteristic pattern
- Documentation of acute attacks requiring treatment
- Evidence of step therapy completion (Ruconest failure) or contraindication
- Weight-based dosing calculation (20 IU/kg per attack)
- Confirmation of acute use only (not prophylaxis)
Submit the Prior Authorization Request
Primary Submission Route: EviCore Portal
- Access the portal: Use EviCore (Evernorth) electronic prior authorization system
- Select "Pharmacy Drugs (Express Scripts Coverage)"
- Complete all required fields - incomplete submissions face automatic denial
- Upload supporting documents immediately
Tip: Submit during business hours (Monday-Friday) for faster processing.
Alternative Submission Methods
- Provider portal: CignaforHCP.com or Provider.Evernorth.com
- Fax: Use number provided in denial letter (verify current number)
- Phone: 1-800-882-4462 for status updates
Clean Request Packet Components
Your submission should include:
- Completed PA form with all fields filled
- Prescriber attestation letter explaining medical necessity
- Lab results showing HAE diagnosis
- Attack history and treatment records
- Step therapy documentation (Ruconest failure details)
- Patient demographics and insurance information
Follow-Up and Tracking
When to Call
- 5 business days after submission if no confirmation received
- 10 business days for status update
- Day 14 if approaching the 15-day decision deadline
Sample Call Script
"Hi, I'm calling to check the status of a prior authorization request for Berinert submitted on [date]. The patient name is [name], member ID [number], and the request confirmation number is [if available]. Can you provide an update on the review status and expected decision timeline?"
Documentation Tips
- Record all reference numbers
- Note representative names and call times
- Follow up with written requests if promised callbacks don't occur
Typical Timelines in Virginia
Standard Prior Authorization
- Cigna decision deadline: 15 business days from complete submission
- Expedited review: 24 hours for urgent medical needs
- Additional information requests: 5-7 business days to respond
Appeal Timelines
- Internal appeal deadline: 180 days from denial notice
- Internal appeal decision: 60 days (expedited: 72 hours)
- External review filing: 120 days after final internal denial
- External review decision: 45 days (expedited: 72 hours)
If You're Asked for More Information
Common Information Requests
- Additional lab values: Provide complete HAE panel results
- Attack documentation: Submit ER records or detailed clinic notes
- Step therapy details: Include specific dates, doses, and failure reasons for Ruconest
- Dosing rationale: Confirm 20 IU/kg calculation for patient's weight
Medical Necessity Letter Template
Your specialist should address:
- Confirmed HAE diagnosis with supporting labs
- Attack frequency and severity impact
- Prior treatment failures or contraindications
- Why Berinert is medically necessary for acute attacks
- FDA labeling support for proposed use
- Monitoring and safety plan
If Denied: Appeals Process
Internal Appeal (First Level)
Timeline: Submit within 180 days of denial notice
Required documents:
- Cigna appeal form or written letter
- Copy of denial notice/EOB
- Additional clinical evidence
- Prescriber support letter
Submission address: Use address on your denial letter or mail to address provided on Cigna ID card
Peer-to-Peer Review
Request a clinical discussion between your HAE specialist and Cigna's medical director:
Key talking points for your doctor:
- Patient has confirmed HAE with characteristic lab pattern
- Acute attacks documented with ER visits or clinic records
- Step therapy completed or contraindicated
- Berinert is FDA-approved for this exact indication
- Alternative treatments inappropriate per clinical guidelines
Second-Level Internal Appeal
If first appeal is denied, Cigna provides a second internal review with a different reviewer. Same timeline and documentation requirements apply.
Virginia External Review Process
When to Use External Review
After completing Cigna's internal appeals process, Virginia residents can request an independent review through the State Corporation Commission Bureau of Insurance.
Filing Requirements
- Deadline: 120 days after final internal denial
- Form: Submit Form 216-A (External Review Request)
- Supporting documents: All denial letters, medical records, provider recommendations
Process Timeline
- SCC review: 1 business day to forward to Cigna
- Cigna preliminary review: 5 business days to verify eligibility
- Independent reviewer assignment: 1 business day
- Additional information period: 5 business days for patient submissions
- Final decision: 45 days (expedited: 72 hours)
Virginia Contact Information
State Corporation Commission Bureau of Insurance
- Website: scc.virginia.gov (verify current forms and address)
- Consumer Services: 1-877-310-6560
- External review decisions are binding on Cigna
Virginia Advantage: The state provides free external review services and has consumer advocates available to help navigate the process.
Renewal and Re-Authorization
Planning Ahead
- Calendar reminder: Set for 30 days before current authorization expires
- Annual lab updates: Ensure recent C1-INH and C4 levels on file
- Attack documentation: Keep records of Berinert use and effectiveness
- Dosing adjustments: Document any weight changes affecting dose calculation
Renewal Documentation
Include evidence of:
- Continued medical necessity
- Appropriate use (acute attacks only)
- Clinical benefit (reduced attack duration/severity)
- No adverse events or contraindications
- Compliance with quantity limits (up to 4 doses per month)
Quick Reference Checklist
Before Submitting PA:
- HAE diagnosis confirmed with labs (C1-INH, C4, C1q)
- HAE specialist prescriber (allergist/immunologist)
- Step therapy documented (Ruconest failure or contraindication)
- ICD-10 code D84.1 in medical records
- Weight-based dosing calculated (20 IU/kg)
- Attack history documented
Submission:
- Complete PA form via EviCore portal
- Upload all supporting documents
- Request confirmation number
- Set follow-up reminder for day 5
If Denied:
- Review denial reason carefully
- Gather additional evidence addressing specific concerns
- Submit internal appeal within 180 days
- Consider peer-to-peer review request
- Prepare for external review if needed
FAQ
Q: How long does Cigna take to decide on Berinert PA requests in Virginia? A: Standard decisions take up to 15 business days. Expedited reviews for urgent medical needs are completed within 24 hours.
Q: What if Berinert is non-formulary on my Cigna plan? A: You can request a formulary exception alongside your PA, providing clinical rationale for why formulary alternatives are inappropriate for your HAE management.
Q: Can I request an expedited appeal if I'm having frequent attacks? A: Yes, if your doctor certifies that waiting could jeopardize your health. Virginia allows expedited external reviews within 72 hours for urgent cases.
Q: Does step therapy apply if I've never tried Ruconest? A: Most Cigna policies require step therapy with Ruconest first, unless you have documented contraindications or prior failure with that medication.
Q: What's the success rate for Berinert appeals in Virginia? A: While specific statistics aren't publicly available, Virginia's external review process provides independent medical review, and many appeals succeed when proper clinical documentation is provided.
Q: Can I self-administer Berinert at home? A: Yes, Berinert is FDA-approved for self-administration after proper training, though laryngeal attacks require immediate medical follow-up regardless of treatment location.
From our advocates: "We've seen HAE patients succeed by having their specialist write a detailed letter explaining not just the diagnosis, but specifically why the patient's attack pattern and severity require Berinert over alternatives. The more specific the clinical narrative, the stronger the case."
Need expert help with your Berinert appeal? Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements.
Sources & Further Reading
- Cigna HAE C1-Esterase Inhibitor Coverage Policy
- Virginia State Corporation Commission External Review Process
- Berinert FDA Prescribing Information
- Cigna Appeals and Disputes Process
- Virginia Bureau of Insurance Consumer Services
Disclaimer: This guide provides educational information about insurance processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance company directly for coverage determinations. For specific legal questions about insurance coverage, consider consulting with a qualified attorney familiar with Virginia insurance law.
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