By Counterforce Health Team in Berinert (C1-esterase inhibitor, IV) —

How to Get Berinert (C1-Esterase Inhibitor) Covered by Cigna in North Carolina: Complete PA Guide with Appeal Scripts

Quick Answer: To get Berinert covered by Cigna in North Carolina, you'll need prior authorization with documented HAE diagnosis (low C4 and C1-INH levels), ICD-10 code D84.1, and prescription by an allergist/immunologist. Submit through Cigna's provider portal or Accredo specialty pharmacy. If denied, file internal appeal within 180 days, then pursue external review through North Carolina's Smart NC program. Start by verifying your plan's formulary status and gathering HAE lab results.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Timelines
  6. If You Need More Information
  7. If Your Request Is Denied
  8. Appeals Process: Cigna Internal to Smart NC External Review
  9. Renewal and Re-Authorization
  10. Quick Reference Checklist
  11. 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 (C1-esterase inhibitor, IV) in North Carolina. Berinert is an FDA-approved plasma-derived treatment for acute HAE attacks affecting the abdomen, face, or larynx.

Who this helps:

  • Patients diagnosed with HAE Types I or II needing on-demand treatment
  • Clinicians submitting prior authorization requests
  • Families navigating insurance denials and appeals

Expected outcomes: With proper documentation, most HAE patients meeting clinical criteria receive approval. North Carolina's external review process provides additional protection, with many denials overturned when proper medical evidence is provided.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and drafting point-by-point rebuttals aligned to each plan's specific requirements.

Before You Start: Verify Your Coverage

Check Your Plan Type

Not all Cigna plans are the same. Log into your myCigna portal to confirm:

  • Commercial plan: Standard Cigna coverage with Express Scripts pharmacy benefits
  • Medicare Advantage: Different appeal process with 5 levels
  • Self-funded employer plan: May not be subject to North Carolina insurance laws

Confirm Berinert's Status

Berinert is typically covered under Cigna's pharmacy benefit through Accredo specialty pharmacy, not the medical benefit. Check your plan's:

  • Formulary tier: Usually Tier 5 (specialty)
  • Prior authorization requirement: Required for most plans
  • Quantity limits: Typically 30-day supply, based on attack frequency
Tip: Call Accredo at 877-826-7657 to verify coverage and start the PA process simultaneously.

Gather Required Documentation

Essential HAE Diagnosis Documentation

Cigna requires confirmation of HAE Types I or II with specific lab values:

Laboratory Results (both required):

  • C1-INH functional activity: <50% of normal
  • C4 levels: <50% of normal at baseline
  • C1-INH antigen levels: Often low in Type I HAE
  • C1q levels: Normal (helps distinguish from acquired angioedema)

Clinical Documentation:

  • ICD-10 code: D84.1 (Defects in the complement system)
  • Attack history: Frequency, locations (laryngeal, abdominal, facial), ER visits
  • Family history: HAE in relatives
  • Response to prior treatments: Lack of response to antihistamines, corticosteroids

Provider Requirements

  • Prescription by or consultation with allergist/immunologist or HAE specialist
  • Documentation of medical necessity
  • Weight-based dosing calculation (20 units/kg per attack)

Submit Your Prior Authorization Request

Cigna's PA Process

  1. Download the form: Access Cigna's C1-Esterase Inhibitor PA form (verify current version)
  2. Complete all sections: Include patient demographics, diagnosis, lab results, attack history
  3. Submit via:
    • Cigna provider portal (fastest)
    • Fax to number on PA form
    • Through Accredo specialty pharmacy

Clean Request Packet Checklist

  • ✓ Completed PA form with all required fields
  • ✓ HAE lab results (C1-INH, C4, C1q)
  • ✓ Clinical notes documenting attack history
  • ✓ Prescriber attestation of medical necessity
  • ✓ Weight documentation for dosing calculation

Follow-Up and Timelines

Expected Processing Times

  • Standard review: 1-3 business days for electronic submissions
  • Paper submissions: Up to 15 days
  • Expedited review: 72 hours for urgent cases (laryngeal attacks)

Sample Follow-Up Script

"Hi, I'm calling to check the status of a prior authorization for Berinert for [patient name], DOB [date]. The reference number is [number]. Can you tell me if any additional information is needed?"

Document: Date called, representative name, reference number, outcome

If You Need More Information

Common Medical Necessity Questions

Cigna may request clarification on:

  • Attack frequency: Provide specific dates and symptoms
  • Alternative treatments: Explain why other HAE medications aren't suitable
  • Dosing rationale: Confirm 20 units/kg aligns with FDA labeling

Supporting Literature

Include references to:

If Your Request Is Denied

Common Denial Reasons & Solutions

Denial Reason How to Address Required Documentation
Insufficient HAE documentation Submit complete lab panel C1-INH, C4, C1q with reference ranges
Use for prophylaxis Clarify on-demand use only Attack logs, acute treatment plan
Missing specialist involvement Add consultation note Allergist/immunologist attestation
Quantity limits exceeded Justify based on attack frequency 6-month attack diary

Peer-to-Peer Review Request

If initially denied, request a peer-to-peer review where your prescribing physician can speak directly with Cigna's medical director. This often resolves clinical questions quickly.

Appeals Process: Cigna Internal to Smart NC External Review

Cigna Internal Appeal (Level 1)

Deadline: 180 days from denial notice How to file:

  1. Complete Cigna Appeal Request Form
  2. Include denial letter and supporting documentation
  3. Submit to address on denial notice

Review timeline: 60 days for standard appeals, 72 hours for expedited

North Carolina External Review (Smart NC)

If Cigna's internal appeal is denied, North Carolina residents have strong additional protections.

Eligibility: State-regulated plans (not self-funded employer plans) Process:

  1. Receive Cigna's final denial with external review rights notice
  2. Submit written request to Cigna within 4 months
  3. Cigna forwards to NC Department of Insurance
  4. Independent physician review (binding decision)

Contact Smart NC: 1-855-408-1212 for free advocacy support

From our advocates: We've seen many HAE patients initially denied for Berinert receive approval on appeal, especially when the submission includes complete lab documentation and clear attack history. The key is demonstrating that the patient meets both FDA labeling criteria and clinical guidelines for on-demand C1-INH therapy.

Timeline for External Review

  • Standard: 45 days from Smart NC receipt
  • Expedited: 72 hours for urgent cases
  • Coverage required: Within 3 business days if overturned

The North Carolina Department of Insurance provides detailed guidance on external review rights and processes.

Renewal and Re-Authorization

When to Resubmit

Most Cigna approvals for Berinert last 12 months. Set a calendar reminder 60 days before expiration to begin renewal.

Renewal Documentation

  • Updated attack frequency data
  • Current weight for dosing
  • Continued specialist oversight
  • Response to treatment (attack duration, severity)

Counterforce Health can help streamline renewal submissions by tracking your approval timeline and preparing evidence-backed reauthorization requests before your coverage expires.

Quick Reference Checklist

Before Starting:

  • ✓ Verify Cigna plan type and formulary status
  • ✓ Confirm Accredo specialty pharmacy coverage
  • ✓ Gather HAE lab results (C1-INH, C4, C1q)

For PA Submission:

  • ✓ Complete Cigna PA form
  • ✓ Include attack history and frequency
  • ✓ Prescriber specialty documentation
  • ✓ Weight-based dosing calculation

If Denied:

  • ✓ Request peer-to-peer review
  • ✓ File internal appeal within 180 days
  • ✓ Contact Smart NC for external review guidance

FAQ

How long does Cigna prior authorization take for Berinert in North Carolina? Standard electronic submissions typically process within 1-3 business days. Paper forms may take up to 15 days.

What if Berinert isn't on my Cigna formulary? You can request a formulary exception with medical necessity documentation. Include evidence that preferred alternatives aren't suitable for your specific case.

Can I request an expedited appeal for urgent HAE attacks? Yes. For life-threatening laryngeal attacks, both Cigna and North Carolina's Smart NC program offer expedited reviews within 72 hours.

Does step therapy apply if I've tried other HAE medications outside North Carolina? Document any prior HAE treatments and outcomes. Cigna should consider out-of-state treatment history when evaluating step therapy requirements.

What's the difference between medical and pharmacy benefit coverage for Berinert? Berinert is typically covered under pharmacy benefits through Accredo specialty pharmacy, even when administered in a healthcare facility.

How much does Berinert cost without insurance in North Carolina? Cash prices can reach five figures per vial. Most patients qualify for manufacturer copay assistance or patient foundation support programs.

What happens if Smart NC external review upholds the denial? The external review decision is binding on Cigna. At that point, you may need to explore alternative treatments or legal options.

Can family members help with the appeals process? Yes, you can designate an authorized representative to handle appeals on your behalf using Cigna's authorization forms.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with Cigna and consult your healthcare provider for medical decisions.

Sources & Further Reading

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