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

Complete Guide to Getting Berinert (C1-Esterase Inhibitor, IV) Covered by Aetna CVS Health in Pennsylvania: Prior Authorization, Appeals, and Forms

Answer Box: Getting Berinert Covered by Aetna CVS Health in Pennsylvania

Fastest path to approval: Aetna requires step therapy with Ruconest first, then allows Berinert coverage with documented failure/intolerance. Submit prior authorization via Aetna's provider portal with HAE diagnosis (ICD-10: D84.1), C1-INH lab values, and specialist prescription. If denied, Pennsylvania's new external review program has a 50% overturn rate. Start today: Verify active coverage, gather lab results showing C1-INH deficiency, and contact your HAE specialist to document any Ruconest trial or contraindications.

Table of Contents

Who Should Use This Guide

This guide is for Pennsylvania residents with hereditary angioedema (HAE) who need Berinert (C1-esterase inhibitor, IV) covered by Aetna CVS Health plans. You'll find this helpful if:

  • Your doctor prescribed Berinert for acute HAE attacks
  • You received a prior authorization denial
  • You're preparing your first coverage request
  • You need to appeal an Aetna decision

Expected outcome: Following this process typically results in approval within 30-45 days for standard requests, or 72 hours for expedited appeals when properly documented.

Member & Plan Basics

Coverage Requirements

  • Active Aetna CVS Health coverage (commercial, Medicare Advantage, or Medicaid)
  • Specialty pharmacy benefit through CVS Caremark/CVS Specialty
  • Prior authorization required for all C1-esterase inhibitor products

Plan Type Considerations

  • Commercial plans: Standard 30-45 day review timeline
  • Medicare Advantage: 72-hour expedited option for urgent requests
  • Medicaid (Aetna Better Health PA): May have additional state-specific requirements
Note: Verify your specific plan's formulary status, as Berinert may be on different tiers depending on your employer or individual plan design.

Clinical Criteria Requirements

Primary Indication

Berinert is FDA-approved for treatment of acute abdominal, facial, or laryngeal HAE attacks in adults and pediatric patients.

Step Therapy Protocol

Aetna requires step therapy with Ruconest (recombinant C1-INH) before covering Berinert, unless you have:

  • Documented failure of Ruconest (typically 1-month trial)
  • Contraindication to Ruconest (e.g., rabbit allergy)
  • Intolerance with adverse reactions

Required Documentation

  • HAE diagnosis confirmation with lab values:
    • C1-INH functional assay (decreased)
    • C1-INH antigen levels (low in Type I, normal in Type II)
    • C4 complement levels (typically low)
  • Prescription by HAE specialist (immunologist or allergist)
  • Attack history documenting frequency and severity

Coding and Billing Information

Essential Codes

Code Type Code Description
ICD-10 D84.1 Hereditary angioedema (primary)
ICD-10 T78.3XXA Angioedema, initial encounter (secondary)
HCPCS J0597 Injection, C-1 esterase inhibitor (human), Berinert, 10 units
NDC 63833-0835-xx Berinert vial (verify current with pharmacy)

Dosing Parameters

  • Standard dose: 20 IU/kg per attack
  • Quantity limits: Up to 1,100 billable units per 28 days
  • Administration: IV infusion over 30 minutes

Documentation Packet Essentials

Medical Necessity Letter Components

Your HAE specialist should include:

  1. Patient demographics and Aetna member ID
  2. HAE diagnosis with supporting lab values and dates
  3. Attack history including emergency department visits
  4. Prior therapy documentation:
    • Ruconest trial dates and outcomes
    • Reason for discontinuation (ineffective/adverse effects)
    • Other HAE treatments attempted
  5. Clinical rationale for Berinert specifically
  6. Proposed treatment plan including dosing and administration setting

Required Attachments

  • Recent clinic notes confirming HAE diagnosis
  • Laboratory reports (C1-INH functional/antigen, C4 levels)
  • Records of prior treatment failures
  • Emergency department records for severe attacks (if applicable)
Clinician Corner: Reference the FDA prescribing information and include specific lab values with reference ranges. Document any thrombotic risk factors, as Berinert carries a boxed warning for off-label use at high doses.

Submission Process

Step-by-Step Submission

  1. Verify current PA form - Use Aetna's most recent Berinert precertification request form
  2. Complete all required fields - Missing information is the #1 cause of delays
  3. Submit via provider portal - Faster processing than fax
  4. Include all attachments - Submit as single PDF when possible
  5. Request confirmation number - Document for tracking purposes

Common Form Locations

  • Provider portal: Aetna provider website (verify current link)
  • Fax submissions: Check current fax number on member's insurance card
  • Phone support: Aetna provider services for urgent requests

Specialty Pharmacy Routing

CVS Specialty Network

Berinert distribution typically routes through:

  • CVS Specialty Pharmacy (primary)
  • Coram CVS Specialty Infusion Services (for home infusion)

Transfer Process

  1. PA approval required before specialty pharmacy enrollment
  2. Patient enrollment with CVS Specialty
  3. Prescription transfer from retail to specialty
  4. Delivery coordination for home administration or clinic pickup
Important: Verify site-of-care restrictions with your specific plan, as some require administration in approved clinical settings.

After Submission: Tracking Your Request

Timeline Expectations

  • Standard review: 30-45 business days
  • Expedited review: 72 hours (with clinical urgency documentation)
  • Status updates: Available via provider portal

What to Record

  • Confirmation number
  • Submission date
  • Review timeline
  • Case manager contact (if assigned)

Follow-Up Schedule

  • Day 3: Confirm receipt
  • Day 15: Status check for standard requests
  • Day 30: Escalate if no decision

Common Denial Prevention Tips

Top 5 Pitfalls and Solutions

Common Issue How to Prevent
Missing step therapy documentation Include detailed Ruconest trial records or contraindication rationale
Incomplete lab values Submit full C1-INH functional/antigen results with reference ranges
Non-specialist prescription Ensure prescription comes from immunologist or allergist
Inadequate attack documentation Include frequency, severity, and impact on daily activities
Wrong diagnosis code Use primary ICD-10 D84.1 (hereditary angioedema)

Appeals Playbook for Pennsylvania

Internal Appeal Process

  1. Level 1: Standard internal review (30 days)
  2. Level 2: Peer-to-peer review with medical director
  3. Expedited option: 72 hours for urgent medical situations

Pennsylvania External Review

Pennsylvania's new Independent External Review Program offers significant advantages:

  • 50% overturn rate in first year (2024)
  • 45-day standard timeline (72 hours expedited)
  • State-supervised process through Pennsylvania Insurance Department

How to File External Review

  1. Complete internal appeals first
  2. Submit within 4 months of final denial
  3. Use PID online portal or mail/fax forms
  4. Include additional documentation within 15 days of assignment
Pennsylvania Resource: Contact the Pennsylvania Insurance Department Consumer Services for free assistance with appeals.

Printable Requirements Checklist

Before You Start:

  • Active Aetna CVS Health coverage verified
  • HAE diagnosis confirmed with specialist
  • C1-INH lab values available
  • Prior therapy records gathered

Clinical Documentation:

  • ICD-10 D84.1 diagnosis code
  • Specialist prescription (immunologist/allergist)
  • Step therapy documentation (Ruconest trial or contraindication)
  • Attack frequency and severity records

Submission Requirements:

  • Current PA form completed
  • Medical necessity letter attached
  • Lab reports included
  • Confirmation number obtained

After Submission:

  • Status tracking scheduled
  • Appeal timeline noted (if needed)
  • Pennsylvania external review option available

FAQ

How long does Aetna CVS Health prior authorization take in Pennsylvania? Standard requests: 30-45 business days. Expedited requests (with clinical urgency): 72 hours.

What if Berinert is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Step therapy requirements still apply.

Can I request an expedited appeal for HAE attacks? Yes, if you have clinical documentation of urgent medical need, including risk of airway compromise.

Does step therapy apply if I failed Ruconest outside Pennsylvania? Yes, but you must provide documentation of the trial and failure/intolerance from your previous provider.

What's the cost difference between Berinert and alternatives? Berinert vials typically cost in five figures pre-insurance. Check manufacturer copay assistance programs and foundation grants.

How do I contact Pennsylvania's external review program? Visit the Pennsylvania Insurance Department website or call their consumer services line for forms and assistance.

At Counterforce Health, we help patients and clinicians navigate complex prior authorization requirements by turning insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals aligned with each payer's specific requirements, including Aetna's step therapy protocols and Pennsylvania's appeal procedures.

When facing coverage challenges for specialty medications like Berinert, having the right documentation and understanding payer-specific workflows can make the difference between approval and denial. Counterforce Health streamlines this process by providing templates that meet procedural requirements while tracking deadlines and required attachments.

From our advocates: We've seen cases where patients received Berinert approval after initially being denied, simply by providing better documentation of Ruconest contraindications and including specific C1-INH lab values with reference ranges. The key is often in the details of prior therapy documentation and ensuring the medical necessity letter addresses Aetna's specific step therapy requirements.

Sources & Further Reading

Disclaimer: This guide is for informational purposes only and does not constitute medical advice. Coverage decisions depend on your specific plan and clinical circumstances. Always consult your healthcare provider and insurance plan directly for personalized guidance. For additional help with Pennsylvania insurance appeals, contact the Pennsylvania Insurance Department's Office of Consumer Services.

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