By Counterforce Health Team in Lumizyme (alglucosidase alfa) —

How to Get Lumizyme (Alglucosidase Alfa) Covered by Blue Cross Blue Shield in New York: Appeals Guide and Templates

Answer Box: Getting Lumizyme Covered by Blue Cross Blue Shield in New York

Blue Cross Blue Shield requires prior authorization for Lumizyme (alglucosidase alfa) in New York. To get approved: (1) Ensure your prescriber is a metabolic specialist, neurologist, or geneticist, (2) Submit GAA enzyme test results and genetic confirmation of Pompe disease, and (3) Include baseline pulmonary function tests and 6-minute walk test results. If denied, you have 4 months to file an external appeal through New York's Department of Financial Services. Start with your provider's prior authorization submission today—most approvals take 24-72 hours with complete documentation.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Reading Your Denial Letter
  4. Common Denial Reasons & How to Fix Them
  5. First-Level Appeal Process
  6. Peer-to-Peer Review Strategy
  7. External Appeals in New York
  8. Medical Necessity Letter Template
  9. Costs & Financial Assistance
  10. When to Escalate
  11. Frequently Asked Questions

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Lumizyme prescriptions BCBS NY Provider Portal
Specialist Prescriber Metabolic specialist, geneticist, or neurologist BCBS medical policy documents
Diagnosis Confirmation GAA enzyme assay or genetic testing Lab results required in PA submission
Baseline Testing PFT and 6MWT for patients ≥12 years Clinical documentation
Authorization Duration 12 months initial, renewable annually Policy renewal criteria
Appeal Deadline 4 months from final denial NY DFS External Appeals

Step-by-Step: Fastest Path to Approval

1. Confirm Your Prescriber Qualifications

Who does it: Patient/family
What's needed: Verify your doctor is a metabolic specialist, geneticist, or neurologist
Timeline: Same day
Why it matters: BCBS requires specialist oversight for Lumizyme approval

2. Gather Diagnostic Documentation

Who does it: Healthcare team
What's needed: GAA enzyme assay results and/or genetic testing confirming Pompe disease
Timeline: May take 1-2 weeks if tests need to be ordered
Submit to: Your prescribing physician's office

3. Complete Baseline Assessments

Who does it: Healthcare team
What's needed: Pulmonary function tests (PFT) and 6-minute walk test (6MWT) for patients 12 years and older
Timeline: 1-2 clinic visits
Documentation: Results must show baseline percent predicted forced vital capacity (FVC)

4. Submit Prior Authorization

Who does it: Prescriber's office
How to submit: BCBS NY provider portal or fax
Expected timeline: 24-72 hours for complete submissions
Required forms: BCBS prior authorization form with all supporting documentation

5. Monitor Authorization Status

Who does it: Patient and provider office
How to check: Provider portal or member services phone line
Follow-up: If no response within 72 hours, call to confirm receipt

6. If Denied, Request Peer-to-Peer Review

Who does it: Prescriber
Timeline: Must request within appeal deadline
Preparation: Have clinical rationale and guidelines ready for discussion

7. File External Appeal if Needed

Who does it: Patient or provider
Where: New York Department of Financial Services
Deadline: 4 months from final denial
Forms: NY External Appeal Application

Reading Your Denial Letter

When you receive a denial, look for these key elements:

Denial Reason Codes: Common codes include "not medically necessary," "experimental/investigational," or "non-formulary drug."

Appeal Deadlines: BCBS typically gives you 180 days for internal appeals, but New York's external appeal deadline is 4 months from the final denial.

Required Documentation: The letter should specify what additional information might support approval.

Benefit Type: Determine if the denial is under your medical benefit (for infusions) or pharmacy benefit (for home administration).

Tip: Keep all denial letters and correspondence. You'll need these for appeals and external review.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
Missing enzyme/genetic testing Submit GAA enzyme assay or genetic test confirming Pompe disease
Non-specialist prescriber Transfer care to metabolic specialist, geneticist, or neurologist
Incomplete baseline assessments Provide PFT and 6MWT results for patients ≥12 years
Dosing concerns Justify dosing based on FDA labeling (20 mg/kg every 2 weeks)
Step therapy requirement Document failure/intolerance of required alternatives
Not medically necessary Submit comprehensive medical necessity letter with clinical evidence

First-Level Appeal Process

Internal Appeal Requirements

  1. Submit within deadline: 180 days for most BCBS plans
  2. Include all documentation: Original denial letter, medical records, prescriber letter
  3. Use proper channels: Submit via provider portal, fax, or certified mail
  4. Request expedited review: If urgent medical need exists (physician must certify)

Key Components of Your Appeal

  • Clinical summary: Patient's diagnosis, symptoms, and functional limitations
  • Treatment history: Previous therapies tried and outcomes
  • Medical necessity rationale: Why Lumizyme is specifically needed
  • Supporting literature: FDA labeling, clinical guidelines, peer-reviewed studies
  • Specialist endorsement: Letter from qualified prescriber

Peer-to-Peer Review Strategy

Scheduling the Call

Contact BCBS medical management to request a peer-to-peer review. Your prescriber will speak directly with the plan's medical director.

Preparation Checklist

  • Patient summary: Concise overview of diagnosis and current status
  • Treatment rationale: Why Lumizyme is medically necessary
  • Guidelines ready: FDA labeling and relevant clinical guidelines
  • Outcome measures: How you'll monitor treatment effectiveness
  • Alternative discussion: Why other options aren't suitable

Key Talking Points

  1. Confirmed Pompe disease diagnosis with GAA deficiency
  2. Patient's functional limitations and disease progression
  3. Lumizyme's FDA approval for this indication
  4. Monitoring plan for safety and efficacy
  5. Expected clinical outcomes

External Appeals in New York

New York offers one of the most robust external appeal processes in the country through the Department of Financial Services (DFS).

Eligibility

  • Available for state-regulated health plans (commercial, Medicaid managed care)
  • Must complete internal appeals first
  • File within 4 months of final denial

Process Overview

  1. Complete application: NY External Appeal Form
  2. Submit documentation: All medical records, denial letters, and supporting literature
  3. Independent review: Medical expert reviews case
  4. Binding decision: Insurer must comply with favorable decisions

Timeline

  • Standard appeals: 30 days for decision
  • Expedited appeals: 72 hours (24 hours for urgent drug denials)
  • Cost: $25 fee (waived for financial hardship or Medicaid enrollees)
Note: The DFS maintains a searchable database of past external appeal decisions that can help strengthen your case.

Medical Necessity Letter Template

[Date]

[Insurance Company]
Medical Director
[Address]

Re: Medical Necessity Appeal - Lumizyme (alglucosidase alfa)
Member: [Name, DOB, ID#]
Diagnosis: Pompe Disease (ICD-10: E74.02)

Dear Medical Director,

I am writing to appeal the denial of Lumizyme (alglucosidase alfa) for [Patient Name], who has confirmed Pompe disease.

CLINICAL SUMMARY:
[Patient] is a [age]-year-old with [infantile-onset/late-onset] Pompe disease confirmed by [GAA enzyme assay showing X% of normal activity / genetic testing revealing pathogenic GAA mutations]. Current symptoms include [progressive muscle weakness, respiratory compromise, etc.].

DIAGNOSTIC CONFIRMATION:
- GAA enzyme activity: [specific results and date]
- Genetic testing: [specific mutations identified, if applicable]
- Baseline assessments: FVC [%predicted], 6MWT [distance/time]

MEDICAL NECESSITY:
Lumizyme is FDA-approved for Pompe disease and represents standard of care per [cite relevant guidelines]. Without enzyme replacement therapy, patients experience progressive muscle weakness, respiratory failure, and significant morbidity.

TREATMENT PLAN:
- Dosing: 20 mg/kg IV every 2 weeks per FDA labeling
- Monitoring: Regular PFTs, functional assessments, and antibody testing
- Prescriber: [Name], [specialty] with expertise in lysosomal storage disorders

REQUEST:
I respectfully request approval of Lumizyme for this patient with confirmed Pompe disease. This treatment is medically necessary, FDA-approved for this indication, and represents standard care.

Sincerely,
[Prescriber Name, Credentials]
[Contact Information]

Attachments: Lab results, genetic testing, clinical notes, baseline assessments

Costs & Financial Assistance

Manufacturer Support

Sanofi Genzyme Support: Lumizyme costs approximately $993 per 50mg vial, with typical dosing requiring multiple vials per infusion. Sanofi offers patient assistance programs for eligible patients.

Additional Resources

  • State programs: New York Medicaid may cover Lumizyme for eligible patients
  • Foundation grants: National Organization for Rare Disorders (NORD) and other rare disease foundations
  • Clinical trials: May provide access to treatment while contributing to research

When to Escalate

File a Complaint

If you encounter delays, improper denials, or procedural violations, contact:

New York Department of Financial Services
Consumer Helpline: 1-800-342-3736
File a complaint online

Get Help

Community Health Advocates
Helpline: 888-614-5400
Free assistance with insurance appeals and denials for New York residents

For complex cases involving rare diseases like Pompe disease, specialized support can make a significant difference. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each payer's specific requirements.

Frequently Asked Questions

How long does BCBS prior authorization take for Lumizyme in New York?
With complete documentation, most prior authorizations are processed within 24-72 hours. Incomplete submissions may take 7-14 days.

What if Lumizyme is non-formulary on my BCBS plan?
You can request a formulary exception with medical necessity documentation from your specialist. Success rates improve with comprehensive clinical justification.

Can I request an expedited appeal?
Yes, if your physician certifies urgent medical need. Expedited appeals are decided within 72 hours, or 24 hours for urgent drug denials in New York's external appeal process.

Does step therapy apply if I've tried other treatments outside New York?
Previous treatment history from other states should count toward step therapy requirements. Provide complete documentation of prior therapies and outcomes.

What happens if my external appeal is successful?
The insurer must cover the treatment and may refund your appeal filing fee. The decision is binding on both you and the insurance company.

Can family members help with the appeals process?
Yes, but you may need to complete authorization forms allowing them to speak with your insurance company and access your medical information.

How do I find past external appeal decisions for Lumizyme?
Search the New York DFS external appeals database for "Lumizyme" or "Pompe disease" to see how similar cases were decided.

What if I'm on Medicaid managed care through BCBS?
You have the option of either an external appeal through DFS or requesting a state Fair Hearing through the Department of Health.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific guidance on your situation.

Sources & Further Reading

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