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

How to Get Berinert (C1-Esterase Inhibitor) Covered by Aetna CVS Health in Virginia: Complete PA Guide with Appeal Scripts

Answer Box: Fast Track to Berinert Coverage

Yes, Berinert requires prior authorization from Aetna CVS Health in Virginia. To get approved: (1) Have your allergist/immunologist submit a PA request through Availity portal with HAE diagnosis confirmation, attack documentation, and medical necessity letter; (2) Include lab results (low C1-INH, low C4) and clinical notes showing acute abdominal/facial/laryngeal attacks; (3) If denied, file internal appeal within 60 days, then Virginia external review through the State Corporation Commission within 120 days. Start the PA process at least 14 days before needed treatment.

Table of Contents

  1. Eligibility Quick Check
  2. Required Documentation Checklist
  3. Step-by-Step Submission Process
  4. Common Denial Reasons & Solutions
  5. Virginia Appeals Process
  6. Cost Assistance Options
  7. When to Escalate
  8. FAQ

Eligibility Quick Check

Likely Eligible if you have:

  • Confirmed HAE diagnosis (Type I or II)
  • History of acute abdominal, facial, or laryngeal attacks
  • Prescription from allergist/immunologist or HAE specialist
  • Lab confirmation: low C1-INH functional level and/or low C4
  • Age 6 years or older

Possibly Eligible if you have:

  • Family history of HAE but incomplete testing
  • Recurrent angioedema without hives
  • Some attack documentation but missing specialist evaluation

Not Yet Eligible if you have:

  • No confirmed HAE diagnosis
  • Seeking prophylaxis use (not FDA-approved for Berinert)
  • Only mild symptoms without documented attacks
Note: Berinert is FDA-approved only for treating acute HAE attacks, not for prevention. If you need prophylaxis, discuss alternatives like lanadelumab or berotralstat with your doctor.

Required Documentation Checklist

Medical Records

  • HAE diagnosis confirmation with ICD-10 code T78.3
  • Lab results: C1-INH functional assay (low), C4 level (low)
  • Genetic testing results (if available)
  • Family history documentation (if genetic testing unavailable)

Clinical Documentation

  • Attack frequency and severity records
  • Location of attacks (abdominal, facial, laryngeal)
  • Response to previous treatments
  • Contraindications to alternative therapies

Prescriber Requirements

  • Prescription from allergist/immunologist or HAE specialist
  • Medical necessity letter addressing FDA indication
  • Treatment plan including dosing and administration site

Counterforce Health helps streamline this documentation process by automatically identifying what's missing from your prior authorization package and ensuring all payer-specific requirements are met, potentially reducing approval time from weeks to days.

Step-by-Step Submission Process

Step 1: Gather Documentation (Patient + Clinic)

Timeline: 3-5 business days
Action: Collect all items from checklist above
Submit to: Your prescribing physician's office

Step 2: Prescriber Submits PA Request

Timeline: 1-2 business days
Method: Availity provider portal (preferred) or fax to 1-855-330-1716
Include: Complete PA form, medical necessity letter, all supporting documentation

Step 3: Aetna Review Process

Timeline: 24-72 hours for complete submissions
Contact: 1-888-632-3862 for commercial plans, 1-800-624-0756 for Medicare
Expedited: Available if delay could harm health (24-hour decision)

Step 4: Decision Notification

Timeline: Within 72 hours
Method: Written notice to patient and prescriber
Next Steps: If approved, coordinate with specialty pharmacy; if denied, proceed to appeals

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
"Not medically necessary" Submit detailed attack history and specialist letter Clinical notes showing attack severity, frequency, impact on daily life
"Use for prophylaxis" Clarify acute treatment indication Letter stating "for treatment of acute HAE attacks only" per FDA labeling
"Missing HAE documentation" Provide complete diagnostic workup Lab results, genetic testing, or family history documentation
"Quantity limits exceeded" Justify dosing based on weight/attack severity Weight-based dosing calculation, attack response data
"Site of care restriction" Document medical necessity for specific setting Letter explaining why hospital/clinic administration required

Virginia Appeals Process

Internal Appeal (First Level)

Deadline: 60 days from denial notice
Method: Call 1-888-632-3862 or submit written appeal
Timeline: 30 days for standard, 72 hours for expedited
Include: Original denial letter, additional medical records, updated necessity letter

Peer-to-Peer Review

When: After initial denial, before or during internal appeal
Request: Have prescriber call Aetna medical director
Benefit: Real-time clinical discussion can resolve coverage issues immediately

Virginia External Review

Deadline: 120 days after final internal denial
Authority: Virginia State Corporation Commission Bureau of Insurance
Process: Submit written request; SCC assigns independent review organization
Timeline: 45 days for standard, 72 hours for expedited
Cost: Free to consumers

Virginia External Review Contact:
State Corporation Commission
Bureau of Insurance
Life & Health Consumer Services
Phone: 1-877-310-6560

From our advocates: We've seen Virginia external reviews succeed when the clinical documentation clearly shows HAE attacks meet FDA criteria and alternative treatments aren't appropriate. The key is submitting a comprehensive medical necessity narrative that directly addresses the original denial reason.

Cost Assistance Options

Manufacturer Support

  • CSL Behring Patient Assistance: Income-based free drug program
  • Copay Card: May reduce out-of-pocket costs for commercially insured patients
  • Contact: Visit manufacturer website or call patient support line

Foundation Grants

  • Patient Access Network (PAN) Foundation: HAE-specific grants
  • National Organization for Rare Disorders (NORD): Emergency assistance
  • HealthWell Foundation: Copay assistance for qualifying patients

Virginia Resources

  • Virginia Medicaid: May cover if eligible (expanded in 2019)
  • Pharmaceutical Assistance Programs: State-sponsored options for qualifying residents

When to Escalate

Contact Virginia regulators if:

  • Aetna fails to meet decision timelines
  • Required forms or processes aren't honored
  • You suspect discrimination based on condition

Virginia State Corporation Commission
Bureau of Insurance Consumer Services
Phone: 1-877-310-6560
File complaint online

When facing complex appeals or multiple denials, Counterforce Health's platform can analyze your specific case against Aetna's policies and Virginia regulations, helping identify the strongest arguments for coverage approval.

FAQ

How long does Aetna prior authorization take in Virginia?
Standard PA decisions within 72 hours of complete submission. Expedited requests (when delay could harm health) decided within 24 hours.

What if Berinert isn't on Aetna's formulary?
Request a formulary exception with clinical justification. Emphasize FDA approval for HAE and lack of therapeutic alternatives for acute attacks.

Can I request expedited appeal in Virginia?
Yes, if your doctor certifies that waiting could seriously harm your health. Virginia expedited external reviews decided within 72 hours.

Does step therapy apply to Berinert?
Possibly. Aetna may require trying other HAE treatments first. Document failures or contraindications to preferred agents.

What happens after Virginia external review approval?
Aetna must authorize coverage within 24-72 hours. The decision is binding on both you and the insurer.

Can I get Berinert for prevention?
No, Berinert is FDA-approved only for acute attack treatment. For prophylaxis, discuss lanadelumab (Takhzyro) or berotralstat (Orladeyo) with your doctor.

Who can prescribe Berinert in Virginia?
Any licensed physician, but Aetna typically requires prescription by or consultation with an allergist/immunologist or HAE specialist.

What if I need Berinert while traveling?
Contact Aetna member services for temporary coverage authorization. Emergency use may be covered with proper documentation.

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 plan terms. Always consult your healthcare provider and insurance plan documents for specific guidance. For assistance with Virginia insurance appeals, contact the State Corporation Commission Bureau of Insurance at 1-877-310-6560.

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