How to Get Soliris (Eculizumab) Covered by Blue Cross Blue Shield in California: Complete Prior Authorization and Appeal Guide
Quick Answer: Getting Soliris Covered by Blue Cross Blue Shield in California
Blue Cross Blue Shield requires prior authorization for Soliris (eculizumab) for all covered conditions including PNH, aHUS, myasthenia gravis, and NMOSD. First step: Gather diagnosis documentation, lab results (LDH levels for PNH, ADAMTS 13 for aHUS), and proof of meningococcal vaccination. Submit through your plan's provider portal or CoverMyMeds. If denied, California's Independent Medical Review (IMR) through DMHC has a 68.6% success rate for overturning denials. The process takes 30-45 days for standard reviews, 3 days for expedited cases.
Table of Contents
- Understanding Blue Cross Blue Shield's Soliris Requirements
- Step-by-Step: Fastest Path to Approval
- Required Documentation Checklist
- Common Denial Reasons & How to Fix Them
- California Appeals Process: Your Rights Under DMHC
- Scripts and Templates
- When to Escalate to External Review
- Cost Assistance Options
- Frequently Asked Questions
Understanding Blue Cross Blue Shield's Soliris Requirements
Blue Cross Blue Shield plans in California follow specific prior authorization criteria for Soliris that vary by condition. The medication requires strict clinical documentation and safety monitoring due to its life-threatening meningococcal infection risk.
Coverage at a Glance
| Requirement | Details | Where to Find | Timeline |
|---|---|---|---|
| Prior Authorization | Required for all conditions | Blue Shield Provider Portal | 72 hours standard |
| REMS Enrollment | Prescriber must be certified | UltSolREMS.com | Before first dose |
| Meningococcal Vaccination | Required ≥2 weeks before treatment | ACIP guidelines | 2+ weeks pre-treatment |
| Specialty Prescriber | Hematologist/neurologist required for some conditions | Plan policy | Varies by condition |
Step-by-Step: Fastest Path to Approval
1. Verify Coverage and Benefits
Who does it: Patient or clinic staff
Document needed: Insurance card, member ID
How to submit: Call member services or check online portal
Timeline: Same day
Source: Blue Shield Member Portal
2. Confirm Diagnosis and Lab Requirements
Who does it: Prescribing physician
Documents needed:
- PNH: LDH >1.5x upper limit, flow cytometry results
- aHUS: ADAMTS 13 levels documented
- gMG: MG-ADL score ≥6, anti-AChR antibody positive
- NMOSD: AQP4 antibody status
Timeline: 1-3 days for lab results
Source: Blue Shield Clinical Criteria
3. Complete REMS Enrollment
Who does it: Prescribing physician
Document needed: REMS certification
How to submit: Online at UltSolREMS.com
Timeline: 24-48 hours
Source: FDA REMS Requirements
4. Ensure Vaccination Compliance
Who does it: Patient with physician guidance
Document needed: Proof of meningococcal vaccination (A, C, W, Y, B)
Timeline: Must be ≥2 weeks before first dose
Note: If urgent therapy needed, 2 weeks antibacterial prophylaxis required
5. Submit Prior Authorization
Who does it: Prescriber or clinic staff
Documents needed: Complete PA packet (see checklist below)
How to submit: Blue Shield Provider Portal or CoverMyMeds
Timeline: 72 hours for standard review
6. Track Decision and Prepare for Appeals
Who does it: Patient and clinic
Expected timeline: 3 business days for determination
Next step: If denied, immediately request internal appeal
Required Documentation Checklist
Clinician Corner: Medical Necessity Letter Essentials
Your letter of medical necessity should include: (1) specific diagnosis with ICD-10 codes, (2) documentation of prior treatment failures or contraindications, (3) current lab values supporting severity, (4) FDA-approved dosing regimen, and (5) monitoring plan for meningococcal risk. Reference FDA labeling and relevant specialty society guidelines.
Essential Documents:
- Completed prior authorization form
- Letter of medical necessity from prescriber
- Lab results (condition-specific)
- Documentation of prior therapy failures
- REMS enrollment confirmation
- Vaccination records
- Chart notes supporting diagnosis
- Insurance card and member information
Condition-Specific Requirements:
- PNH: Flow cytometry results, transfusion history, LDH levels
- aHUS: ADAMTS 13 levels, nephrology consultation notes
- gMG: MG-ADL scores, anti-AChR antibody results, prior IST documentation
- NMOSD: AQP4 antibody status, attack frequency documentation
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn | Required Evidence |
|---|---|---|
| Insufficient lab documentation | Submit complete lab panel | Condition-specific values per Blue Shield criteria |
| Missing vaccination proof | Provide immunization records | CDC vaccination card or provider records |
| REMS enrollment not verified | Submit REMS confirmation | Certificate from UltSolREMS.com |
| Step therapy not completed | Document contraindications or failures | Medical records showing prior therapy outcomes |
| Not medically necessary | Strengthen clinical justification | Peer-reviewed literature, specialty guidelines |
California Appeals Process: Your Rights Under DMHC
California offers robust appeal rights through the Department of Managed Health Care (DMHC). Success rates are encouraging: recent data shows Anthem had only a 20.1% success rate in upholding denials, with 68.6% of decisions overturned by independent medical review.
Internal Appeal (First Level)
- Timeline: Must be filed within 180 days of denial
- Decision deadline: 30 days (3 days for expedited)
- How to submit: Through your plan's grievance process
- Required: Written statement from prescriber supporting medical necessity
Independent Medical Review (IMR)
- When to use: After internal appeal denial or for experimental/investigational denials
- Timeline: 30 days for standard, 3 days for expedited
- Cost: Free to patients
- Success rate: 55.3% of medical necessity denials overturned statewide
- How to apply: DMHC online portal
From our advocates: We've seen several Soliris denials successfully overturned through California's IMR process when the initial request lacked complete lab documentation. The key was submitting comprehensive flow cytometry results and detailed prior therapy records that clearly demonstrated medical necessity according to FDA labeling criteria.
Scripts and Templates
Patient Phone Script for Blue Cross Blue Shield
"Hi, I'm calling about a prior authorization request for Soliris that was submitted on [date]. My member ID is [number]. Can you tell me the current status and what additional information might be needed? If it was denied, I'd like to understand the specific reason and start an internal appeal."
Clinic Staff Peer-to-Peer Request Script
"I'm requesting a peer-to-peer review for [patient name] regarding the Soliris denial. The treating physician is Dr. [name], a [specialty] with expertise in [condition]. We have additional clinical information that wasn't included in the initial submission, including [specific evidence]. When can we schedule the review?"
When to Escalate to External Review
Contact the DMHC if:
- Your internal appeal is denied
- Blue Cross Blue Shield fails to respond within required timeframes
- You need help navigating the appeals process
DMHC Help Center: (888) 466-2219
Online IMR Application: HealthHelp.ca.gov
For plans regulated by the California Department of Insurance (some PPO plans), contact the CDI Consumer Hotline: (800) 927-4357.
Cost Assistance Options
While pursuing coverage, explore these support programs:
- Alexion OneSource: Patient support program offering case management and financial assistance screening
- Soliris Co-pay Program: May reduce out-of-pocket costs for eligible patients
- State Pharmaceutical Assistance: California may have programs for rare disease medications
- Foundation Grants: Organizations like the HealthWell Foundation offer assistance for specialty medications
Note: Verify current program availability and eligibility requirements, as these change frequently.
Frequently Asked Questions
How long does Blue Cross Blue Shield prior authorization take in California?
Standard prior authorization decisions are made within 72 hours of receiving complete documentation. Expedited requests (for urgent medical situations) are processed within 24 hours.
What if Soliris is non-formulary on my plan?
You can request a formulary exception through your plan's standard process. If denied, this becomes grounds for appeal through California's IMR system.
Can I request an expedited appeal if I'm already on Soliris?
Yes, if there's an immediate threat to your health from treatment interruption. Your physician must provide written documentation of the urgent medical need.
Does step therapy apply if I've tried other treatments outside California?
Medical records from any state should be accepted as documentation of prior therapy failures, but you may need to provide complete records and ensure they meet Blue Cross Blue Shield's specific criteria.
What happens if my prescriber isn't REMS certified?
Soliris cannot be prescribed without REMS certification. Your prescriber must complete the enrollment process at UltSolREMS.com before submitting any authorization requests.
How do I know if my Blue Cross Blue Shield plan is regulated by DMHC or CDI?
Most HMO and managed care plans are under DMHC jurisdiction. Check your member handbook or call member services to confirm which regulatory body oversees your specific plan.
About Counterforce Health
Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical evidence to create targeted, evidence-backed rebuttal letters. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeals processes for medications like Soliris.
Sources & Further Reading
- Blue Shield of California Soliris Policy (PDF)
- California DMHC Independent Medical Review Process
- FDA Soliris Prescribing Information
- Soliris REMS Program
- Blue Shield Provider Authorization Forms
- DMHC Appeal Success Rate Data
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances, plan benefits, and clinical factors. Always consult with your healthcare provider and insurance plan for specific guidance. For assistance with appeals in California, contact the DMHC Help Center at (888) 466-2219.
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