How to Get Lumizyme (Alglucosidase Alfa) Covered by Blue Cross Blue Shield in Pennsylvania: Forms, Appeals, and Success Strategies
Quick Answer: Getting Lumizyme Covered by Blue Cross Blue Shield in Pennsylvania
Lumizyme (alglucosidase alfa) requires prior authorization from all Blue Cross Blue Shield plans in Pennsylvania. Your fastest path to approval: 1) Have your specialist submit the PA request through the electronic portal (Availity for Highmark, online forms for Independence Blue Cross), 2) Include complete Pompe disease diagnosis documentation with enzyme/genetic testing results, and 3) If denied, file an internal appeal within 180 days, then use Pennsylvania's new external review program within 4 months. Pennsylvania's external review program overturns about 50% of appealed denials.
First step today: Contact your Blue Cross Blue Shield plan to verify which forms are required and confirm your specialty pharmacy network options.
Table of Contents
- Start Here: Verify Your Plan and Find Forms
- Prior Authorization Forms and Requirements
- Submission Portals and Electronic Filing
- Specialty Pharmacy Network Enrollment
- Appeals Process: Internal and External Review
- Support Lines and Contact Information
- Pennsylvania Consumer Assistance Resources
- Common Denial Reasons and Solutions
- Frequently Asked Questions
Start Here: Verify Your Plan and Find Forms
Pennsylvania has two major Blue Cross Blue Shield plans with different requirements for Lumizyme coverage:
Highmark Blue Shield (Western PA, including Pittsburgh):
- Covers approximately 31% of Pennsylvania's commercial insurance market
- Requires electronic submission through Availity provider portal
- Uses clinical policy I-58-035 for Lumizyme coverage criteria
- No longer accepts fax or paper forms as of 2024
Independence Blue Cross (Philadelphia region):
- Serves the southeastern Pennsylvania market
- Accepts formulary exception requests via fax to 1-888-671-5285
- Uses Select Formulary Exception Prior Authorization Request Form
- Requires documentation of failed formulary alternatives
Tip: Call the member services number on your insurance card to confirm which Blue Cross Blue Shield plan you have and get the most current forms.
Prior Authorization Forms and Requirements
Coverage Requirements Table
| Requirement | Highmark Blue Shield | Independence Blue Cross | Source |
|---|---|---|---|
| PA Required | Yes, all requests | Yes, all requests | Highmark Policy |
| Submission Method | Electronic only (Availity) | Fax: 1-888-671-5285 | Highmark Forms |
| Authorization Period | 12 months initial | Varies by plan | IBX Prior Auth |
| Step Therapy | May apply | 3+ formulary alternatives required | IBX Exception Form |
Required Documentation for All Plans
Your healthcare provider must include:
- Diagnosis confirmation: Pompe disease with ICD-10 codes
- Enzyme testing results: GAA deficiency laboratory evidence
- Clinical summary: Disease progression and functional status
- Prior treatment history: Failed therapies or contraindications
- Dosing rationale: 20 mg/kg every 2 weeks per FDA labeling
- Prescriber credentials: Specialist qualification (genetics, neurology, etc.)
Submission Portals and Electronic Filing
Highmark Blue Shield Electronic Process
- Provider Registration: Register for Availity portal access
- Form Selection: Use the electronic PA request within Availity
- Document Upload: Attach clinical notes, lab results, and genetic testing
- Submission Timeline: Allow 2-3 business days for initial review
- Status Tracking: Monitor approval status through the portal
Independence Blue Cross Fax Process
- Form Download: Get current Select Formulary Exception form
- Complete Documentation: Fill all required fields with clinical rationale
- Fax Submission: Send to 1-888-671-5285
- Follow-up: Call 1-888-678-7012 if no response within 2 business days
Note: Always use the most current form version. Outdated forms may cause processing delays.
Specialty Pharmacy Network Enrollment
Lumizyme is a limited distribution specialty drug that must be obtained through approved specialty pharmacies. Both major Pennsylvania Blue Cross Blue Shield plans contract with:
Approved Specialty Pharmacy Network
- Accredo Health Group: 1-888-608-9010
- CVS/Caremark Specialty: 1-800-237-2767
- AllianceRx Walgreens Prime: 1-877-627-6337
Enrollment Process
- Prior Authorization First: Ensure PA approval before pharmacy enrollment
- Contact Specialty Pharmacy: Call your chosen in-network pharmacy
- Provide Consent: Authorize transfer of medical records if switching pharmacies
- Coordinate Delivery: Schedule infusion site delivery or patient pickup
- Insurance Verification: Pharmacy will verify coverage and copay responsibility
Counterforce Health's platform can help streamline this process by identifying the right specialty pharmacy partners and ensuring all documentation meets payer requirements for seamless enrollment and medication access.
Appeals Process: Internal and External Review
Internal Appeals Timeline
| Appeal Level | Deadline to File | Decision Timeline | How to Submit |
|---|---|---|---|
| Internal Appeal | 180 days from denial | 30 days standard, 72 hours expedited | Provider portal or written request |
| External Review | 4 months from final denial | 45 days standard, 72 hours expedited | PA.gov external review portal |
Pennsylvania External Review Success
Pennsylvania launched its Independent External Review Program in 2024, providing a powerful tool for overturning insurance denials. In the program's first year, approximately 50% of appealed denials were overturned, with 259 Pennsylvanians successfully getting coverage for treatments initially denied by their insurers.
How to File an External Review
- Complete Internal Appeals: Obtain Final Adverse Benefit Determination letter
- File Within 4 Months: Submit request through PA.gov portal
- No Cost to Patient: The insurer pays for the independent review
- Binding Decision: If approved, insurer must provide coverage immediately
Important: External review is only available for fully-insured plans. Self-funded employer plans follow federal procedures.
Support Lines and Contact Information
Blue Cross Blue Shield Pennsylvania Contacts
Highmark Blue Shield:
- Member Services: 1-800-ASK-BLUE (1-800-275-2583)
- Provider Services: Contact through Availity portal
- Pharmacy Benefits: 1-888-678-7012
Independence Blue Cross:
- Member Services: 1-800-ASK-BLUE (1-800-275-2583)
- Prior Authorization: 1-888-671-5285 (fax)
- Pharmacy Support: 1-888-678-7012
What to Ask When You Call
- "What specific clinical criteria must be met for Lumizyme coverage?"
- "Which specialty pharmacies are in-network for my plan?"
- "What documentation is needed if I'm transferring from another state?"
- "Can I request an expedited review for urgent medical needs?"
Pennsylvania Consumer Assistance Resources
Free Help with Appeals
Pennsylvania Health Law Project (PHLP)
- Toll-Free Helpline: 1-800-274-3258
- Email: [email protected]
- Services: Free legal assistance with insurance appeals, including rare disease medications
Pennsylvania Insurance Department
- Consumer Services: 1-877-881-6388
- External Review Portal: Available at PA.gov
- Email: [email protected]
When to Seek Help
Contact these resources if you experience:
- Repeated denials despite meeting coverage criteria
- Processing delays beyond stated timelines
- Difficulty understanding appeal procedures
- Language or accessibility barriers
Common Denial Reasons and Solutions
Denial Reasons and Fixes
| Denial Reason | Solution Strategy | Required Documentation |
|---|---|---|
| Lack of genetic/enzyme testing | Submit GAA deficiency lab results | Enzyme assay, genetic testing report |
| Non-specialist prescriber | Transfer care to genetics/neurology specialist | Specialist consultation notes |
| Insufficient prior therapy trials | Document contraindications or disease severity | Chart notes explaining why alternatives unsuitable |
| Dosing exceeds policy limits | Provide weight-based calculation rationale | Patient weight, BSA, FDA dosing guidelines |
| "Experimental" designation | Submit FDA approval documentation | FDA label, clinical guidelines, peer-reviewed studies |
Medical Necessity Letter Checklist
Your specialist's medical necessity letter should include:
- Confirmed Pompe disease diagnosis with genetic/enzymatic evidence
- Current functional status and disease progression
- Prior treatments attempted and outcomes/intolerances
- Clinical rationale for Lumizyme specifically
- Dosing calculation based on patient weight (20 mg/kg every 2 weeks)
- Monitoring plan and expected outcomes
- References to FDA labeling and clinical guidelines
Frequently Asked Questions
How long does Blue Cross Blue Shield prior authorization take in Pennsylvania? Standard PA decisions are made within 14 days of receiving complete documentation. Expedited requests for urgent cases are decided within 72 hours.
What if Lumizyme is non-formulary on my plan? You can request a formulary exception by documenting medical necessity and failed trials of formulary alternatives. Independence Blue Cross requires trying at least 3 formulary options when available.
Can I request an expedited appeal if my treatment is urgent? Yes, both internal appeals and Pennsylvania's external review offer expedited processes for urgent medical situations, with decisions within 72 hours.
Does step therapy apply if I've been on Lumizyme in another state? Prior therapy documentation from other states is generally accepted. Provide complete treatment records showing current therapy effectiveness and any failed alternatives.
How much will Lumizyme cost with Blue Cross Blue Shield coverage? Costs vary by plan. Specialty tier copays typically range from $100-500 per month. Contact your plan for specific cost-sharing details and ask about manufacturer copay assistance programs.
What happens if my external review is approved? The insurer must provide coverage immediately, including retroactive coverage if you paid out-of-pocket during the appeal process.
For patients and providers navigating complex prior authorization requirements, Counterforce Health transforms insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to create point-by-point rebuttals with the right clinical evidence and procedural requirements, helping get life-saving treatments like Lumizyme approved faster.
Sources & Further Reading
- Highmark Clinical Policy I-58-035 (Lumizyme)
- Independence Blue Cross Formulary Exception Form
- Pennsylvania External Review Program
- Pennsylvania Health Law Project Consumer Assistance
- Lumizyme FDA Prescribing Information
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may change. Always consult with your healthcare provider and insurance plan for the most current requirements and to discuss the best treatment options for your specific situation.
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