By Counterforce Health Team in Soliris (eculizumab) —

The Requirements Checklist to Get Soliris (eculizumab) Covered by Blue Cross Blue Shield in Pennsylvania

Quick Answer: Your Path to Soliris Approval

Getting Soliris (eculizumab) covered by Blue Cross Blue Shield in Pennsylvania requires meeting strict clinical criteria including confirmed diagnosis (PNH, aHUS, gMG, or NMOSD), proof of meningococcal vaccination at least 2 weeks before treatment, and documentation of failed standard therapies. Submit your prior authorization through your specific Blue Cross plan's provider portal with complete medical records. If denied, Pennsylvania's new Independent External Review program has overturned roughly 50% of denials in 2024. Start today by verifying your exact Blue Cross plan and gathering vaccination records.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Requirements
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Common Denial Pitfalls & Prevention
  10. Pennsylvania Appeals Process
  11. Quick Reference Checklist

Who Should Use This Checklist

This guide is for patients, caregivers, and healthcare providers seeking Soliris (eculizumab) coverage through Blue Cross Blue Shield plans in Pennsylvania. Use this if you're dealing with:

  • Initial prior authorization requests for PNH, atypical HUS, generalized myasthenia gravis, or NMOSD
  • Coverage denials that need systematic appeal preparation
  • Renewal authorizations requiring updated clinical documentation
  • Plan changes where previous Soliris approval needs transfer

Expected outcome: Following this checklist systematically improves approval odds by ensuring complete documentation and compliance with Pennsylvania-specific requirements.

From our advocates: We've seen cases where patients spent months fighting denials simply because vaccination dates weren't properly documented or the wrong Blue Cross entity was contacted. Taking time upfront to verify your exact plan and gather complete records typically resolves issues in weeks rather than months.

Member & Plan Basics

Verify Your Exact Blue Cross Plan

Pennsylvania has multiple Blue Cross entities with different policies:

  • Independence Blue Cross (Philadelphia region)
  • Highmark Blue Shield (western/central PA)
  • Anthem Blue Cross (if applicable)

Action steps:

  1. Check your member ID card for the exact plan name
  2. Verify coverage is active through the member portal
  3. Confirm whether Soliris falls under medical or pharmacy benefits
  4. Check your deductible status and specialty drug copay structure

Coverage Basics for Soliris

Requirement Details Verification Method
Prior Authorization Required for all Blue Cross PA plans Check formulary or call member services
Formulary Status Typically Tier 4/5 specialty Review current formulary document
Site of Care Often restricted to designated infusion centers Check medical policy
Quantity Limits Dosing must match FDA labeling Review PA criteria

Clinical Criteria Requirements

FDA-Approved Indications

Soliris requires documented diagnosis for one of these conditions:

Paroxysmal Nocturnal Hemoglobinuria (PNH)

  • ICD-10: D59.5
  • Flow cytometry showing ≥2 GPI deficiencies in 2 cell lines
  • Transfusion-dependent (within last 12 months) OR anemia/thrombocytopenia
  • Elevated LDH levels

Atypical Hemolytic Uremic Syndrome (aHUS)

  • ICD-10: D59.3 or D59.39
  • Microangiopathic hemolytic anemia, thrombocytopenia, renal impairment
  • Exclusion of Shiga toxin E. coli
  • Prescribed by hematologist, oncologist, or nephrologist

Generalized Myasthenia Gravis (gMG)

  • ICD-10: G70.00 or G70.01
  • Anti-AChR antibody positive
  • MG-ADL score ≥6
  • Failed ≥2 immunosuppressants (≥1 year each) OR 1 with chronic plasmapheresis

Neuromyelitis Optica Spectrum Disorder (NMOSD)

  • ICD-10: G36.0
  • AQP4-IgG positive
  • Recurrent attacks despite standard therapy

Vaccination Requirements

Mandatory meningococcal vaccination at least 2 weeks before first dose:

  • MenACWY (e.g., Menactra, Menveo)
  • MenB (e.g., Bexsero or Trumenba)

Recommended additional vaccines:

  • Pneumococcal (PCV13 + PPSV23)
  • Haemophilus influenzae type b (Hib)
Critical: If vaccination is delayed, antimicrobial prophylaxis is required (penicillin VK 250 mg BID for adults).

Coding and Billing Requirements

HCPCS J-Codes (Date Sensitive)

Through March 31, 2025:

  • J1300 (Injection, eculizumab, 10 mg)
  • 1 unit = 10 mg

April 1, 2025 and after:

  • J1299 (Injection, eculizumab, 2 mg)
  • 1 unit = 2 mg
  • Example: 900 mg dose = 450 units

Required Modifiers

  • RE: REMS compliance (often required)
  • JZ: Zero drug amount discarded
  • TB: 340B-acquired drug (if applicable)

NDC Reporting

Include 11-digit HIPAA NDC format:

  • 300 mg/30 mL vial: 25682-0001-xx (converted to 11-digit)

Documentation Packet Essentials

Provider Note Requirements

Your specialist's documentation must include:

Clinical History:

  • Exact diagnosis with supporting criteria met
  • Symptom onset, severity, and progression
  • Impact on daily activities and quality of life

Prior Treatments:

  • Specific medications tried, dosages, duration
  • Reasons for discontinuation (failure, intolerance, contraindications)
  • Response to each therapy with objective measures

Current Status:

  • Recent lab values with reference ranges and dates
  • Functional assessments (e.g., MG-ADL scores for gMG)
  • Treatment goals and monitoring plan

Medical Necessity Letter Components

Include these elements in your letter of medical necessity:

  1. Patient identification and diagnosis with ICD-10 code
  2. Clinical rationale for Soliris specifically
  3. Evidence base from FDA labeling or peer-reviewed studies
  4. Failed alternatives with specific details and timeframes
  5. Safety considerations including vaccination status
  6. Dosing rationale aligned with FDA labeling
  7. Monitoring plan and expected outcomes

Required Attachments

  • Flow cytometry report (PNH) or relevant diagnostic labs
  • Anti-AChR antibody results (gMG) or AQP4-IgG (NMOSD)
  • Vaccination records with dates
  • Prior therapy documentation and failure rationale
  • Recent clinic notes (within 30 days)
  • Insurance card copy and demographics

Submission Process

Prior Authorization Submission

For Independence Blue Cross:

  1. Access the IBC provider portal at provcomm.ibx.com
  2. Complete PA request with all required fields
  3. Upload supporting documentation
  4. Submit at least 2 weeks before planned start date

For Highmark Blue Shield:

  1. Use Highmark provider portal or fax submission
  2. Include REMS enrollment attestation
  3. Verify specialty pharmacy requirements

Timeline Expectations

  • Standard review: 72 hours for urgent cases, 15 business days for routine
  • Expedited review: Available for urgent medical situations
  • Emergency supply: 72-hour supply may be available during review

Specialty Pharmacy Requirements

Designated Medical Specialty Pharmacy (DMSP)

Many Blue Cross plans require Soliris to be obtained through specific specialty pharmacies:

Common designated vendors:

  • Accredo Health Group (Express Scripts)
  • CVS Specialty Pharmacy
  • Plan-specific regional specialty pharmacies

Verification Steps

  1. Call member services to confirm required specialty pharmacy
  2. Check current DMSP drug list for your Blue Cross plan
  3. Establish account with designated vendor before approval
  4. Coordinate delivery to infusion site
Note: Using non-designated specialty pharmacies may result in claim denials or out-of-network penalties.

After Submission: What to Expect

Tracking Your Request

  • Record confirmation number from submission
  • Check status weekly through provider portal
  • Document all communications with dates and reference numbers

Approval Timeline

If approved:

  • Authorization letter with specific approval duration
  • Coordinate with specialty pharmacy for drug delivery
  • Schedule infusion appointments

If additional information requested:

  • Respond within specified timeframe (typically 10-15 days)
  • Submit exactly what's requested without additional materials
  • Follow up to confirm receipt

Common Denial Pitfalls & Prevention

Top 5 Denial Reasons and Solutions

Denial Reason Prevention Strategy Required Documentation
Missing vaccination proof Submit dated vaccination records CDC vaccination record or provider note
Insufficient prior therapy Document specific failures with timeframes Detailed treatment history with outcomes
Wrong diagnostic criteria Include complete lab workup Flow cytometry, antibody tests, imaging
Incorrect coding Verify J-code for service date Use J1299 after 4/1/2025
Site of care restrictions Confirm approved infusion locations Pre-verify infusion center network status

Quality Check Before Submission

  • Diagnosis matches approved indications exactly
  • All required labs are current (within 3 months)
  • Vaccination dates are ≥2 weeks before planned start
  • Prior therapies are documented with specific failure reasons
  • Dosing matches FDA labeling precisely
  • Provider is enrolled in REMS program

Pennsylvania Appeals Process

Internal Appeal Process

First-level appeal:

  • Submit within 180 days of denial
  • Include additional clinical evidence
  • Request peer-to-peer review if available

Final adverse determination:

  • Required before external review
  • Document all internal appeal attempts

Pennsylvania Independent External Review

Pennsylvania's new external review program offers strong patient protections:

Eligibility:

  • Must complete internal appeals first
  • Request within 4 months of final denial
  • Applies to medical necessity and experimental treatment denials

Process:

  • Submit online at pa.gov external review portal
  • Independent Review Organization (IRO) assigned within 1 business day
  • 15-day period to submit additional evidence
  • Decision within 45 days (72 hours for urgent cases)

Success rates: Approximately 50% of appeals were overturned in 2024, resulting in coverage for initially denied treatments.

Counterforce Health specializes in transforming insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Our platform helps patients and providers navigate complex prior authorization requirements and appeal processes, particularly for high-cost specialty medications like Soliris.

When to Escalate

Contact Pennsylvania Insurance Department if:

  • Blue Cross violates appeal timelines
  • Procedural violations occur during review
  • Additional regulatory intervention needed

Contact: Pennsylvania Insurance Department Consumer Services Website: insurance.pa.gov Phone: Available on state website

Quick Reference Checklist

Before Starting

  • Verify exact Blue Cross plan and coverage status
  • Confirm Soliris indication matches FDA-approved uses
  • Obtain current vaccination records
  • Document all prior therapy failures

Clinical Documentation

  • Complete diagnostic workup with current labs
  • Specialist evaluation within 30 days
  • Medical necessity letter addressing all criteria
  • REMS enrollment completed

Submission Preparation

  • Correct ICD-10 and J-code for service date
  • All required modifiers included
  • Specialty pharmacy requirements verified
  • Complete documentation packet assembled

Post-Submission

  • Confirmation number recorded
  • Status tracking schedule established
  • Appeal timeline documented if needed
  • Specialty pharmacy coordination confirmed

For complex cases or repeated denials, consider working with Counterforce Health to develop a comprehensive appeal strategy that addresses your specific Blue Cross plan's requirements and Pennsylvania's regulatory framework.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with your specific Blue Cross Blue Shield plan and consult with healthcare providers for medical decisions.

Sources & Further Reading

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