By Counterforce Health Team in Lumizyme (alglucosidase alfa) —

How to Get Lumizyme (alglucosidase alfa) Covered by Blue Cross Blue Shield of Michigan: Complete Prior Authorization and Appeal Guide

Quick Answer: Getting Lumizyme Covered by BCBS Michigan

Blue Cross Blue Shield of Michigan requires prior authorization for Lumizyme (alglucosidase alfa) with strict clinical criteria. Submit through their electronic portal with genetic testing confirmation, specialist evaluation, and FDA-compliant dosing documentation. If denied, you have 60 days for internal appeal, then 127 days for Michigan DIFS external review. First step today: Contact your prescribing specialist to gather enzyme assay results and genetic testing confirming Pompe disease diagnosis.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Mandatory before starting therapy BCBSM Provider Portal BCBSM Policy
Genetic Testing GAA gene mutation confirmation required Order through genetics lab FDA Label Requirements
Specialist Evaluation Metabolic, genetics, or neurology specialist must recommend Specialist referral needed BCBSM Clinical Criteria
FDA Dosing 20 mg/kg every 2 weeks for patients ≥8 years FDA Prescribing Information FDA Label
Site of Care Lower-cost setting preferred (office/infusion center) Document in PA request BCBSM Utilization Management
Quantity Limits New 2025 restrictions on ERT drugs Check current plan documents BCBSM Alert 2024

Step-by-Step: Fastest Path to Approval

1. Confirm Pompe Disease Diagnosis

Who does it: Your specialist
Documents needed: Enzyme assay showing reduced GAA activity + genetic testing confirming GAA mutations
Timeline: 1-2 weeks for results
Key point: Both tests are typically required—enzyme testing alone may not be sufficient for coverage approval.

2. Gather Clinical Documentation

Who does it: Healthcare team
Documents needed:

  • Specialist evaluation and recommendation
  • Prior treatment history (if any)
  • Current clinical status and functional assessments
  • Dosing calculations based on patient weight

3. Complete BCBSM Prior Authorization Form

Who does it: Prescribing provider
Form: Medication Authorization Request Form (MARF)
Submission: Electronic portal via Availity or BCBSM provider portal
Timeline: Submit complete package to avoid delays

4. Submit Supporting Evidence

Required attachments:

  • Genetic testing results
  • Enzyme assay results
  • Specialist consultation notes
  • Treatment plan with site of care justification
  • Patient weight and dosing calculations

5. Track Your Request

Timeline: BCBSM typically responds within 14 days for standard requests
Follow-up: Use provider portal for real-time status updates
Contact: Call provider services if no response within timeframe

6. Prepare for Potential Denial

Common issues: Missing documentation, non-specialist prescriber, dosing questions
Next step: Internal appeal within 60 days if denied

7. Appeal if Necessary

Internal appeal: 60-day deadline from denial letter
External review: 127-day deadline through Michigan DIFS

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Key Documents
"Diagnosis not confirmed" Submit both enzyme assay AND genetic testing GAA gene sequencing results
"Non-specialist prescriber" Get evaluation from metabolic/genetics specialist Specialist consultation note
"Dosing exceeds guidelines" Provide FDA label justification for weight-based dosing FDA prescribing information
"Site of care not justified" Document why hospital setting is medically necessary Clinical notes supporting infusion site
"Medical necessity unclear" Comprehensive letter addressing functional decline Functional assessments, quality of life measures

Appeals Playbook for Michigan Patients

Internal Appeal with BCBSM

  • Deadline: 60 days from denial letter
  • How to file: Use BCBSM appeal forms or write detailed letter
  • Timeline: 30 days for decision on preservice appeals
  • Required: Original denial letter, new medical evidence, prescriber support

External Review with Michigan DIFS

  • Deadline: 127 days from final internal denial
  • How to file: DIFS External Review Portal
  • Timeline: 56 days for standard review, 72 hours for expedited
  • Cost: Free to patients
  • Decision: Binding on BCBSM
Tip: For urgent cases, request expedited external review with physician letter stating delay would "seriously jeopardize" health.

Clinician Corner: Medical Necessity Documentation

Essential Elements for Approval

Diagnosis Confirmation:

  • GAA enzyme activity results (blood or tissue)
  • Genetic testing showing pathogenic GAA mutations
  • Clinical presentation consistent with Pompe disease

Treatment Justification:

  • Current functional status and decline
  • Impact on respiratory function (if applicable)
  • Mobility and quality of life measures
  • Goals of therapy and expected outcomes

Dosing and Administration:

  • Weight-based calculation: patient weight × 20 mg/kg
  • Infusion site justification (office vs. hospital)
  • Monitoring plan for infusion reactions

Key Clinical Guidelines to Reference

  • FDA approved labeling for dosing and administration
  • American College of Medical Genetics guidelines for genetic testing
  • Pompe disease management consensus statements
From our advocates: We've seen the strongest approvals when providers include both the enzyme assay AND genetic testing results upfront, along with a detailed letter explaining how Pompe disease specifically impacts this patient's daily function. Don't assume the reviewer understands the progressive nature of this condition—spell it out clearly.

Cost Savings and Patient Support

Manufacturer Support Programs

Sanofi Patient Assistance:

  • Copay assistance for eligible commercial insurance patients
  • Patient access programs for uninsured/underinsured
  • Contact: Sanofi patient support (verify current programs)

Foundation Resources

  • National Organization for Rare Disorders (NORD) patient assistance
  • Pompe disease-specific foundations and support groups
  • State pharmaceutical assistance programs in Michigan

Healthcare Coverage Advocacy

For complex cases requiring additional support with prior authorizations and appeals, Counterforce Health specializes in turning insurance denials into evidence-backed appeals. Their platform helps patients and clinicians navigate payer-specific requirements and build stronger cases for coverage approval.

FAQ: Your Top Questions Answered

How long does BCBSM prior authorization take for Lumizyme?
Standard requests typically take 14 days, but complex cases may take up to 30 days. Submit complete documentation upfront to avoid delays.

What if Lumizyme isn't on my BCBSM formulary?
You can request a formulary exception with medical necessity documentation. Emphasize lack of therapeutic alternatives for Pompe disease.

Can I get an expedited review in Michigan?
Yes, both BCBSM and Michigan DIFS offer expedited reviews for urgent medical situations with physician support.

Does step therapy apply to Lumizyme?
Typically no, as Lumizyme is the primary FDA-approved treatment for late-onset Pompe disease in patients ≥8 years.

What happens if BCBSM denies my appeal?
You can file for external review with Michigan DIFS within 127 days. This independent review is binding on BCBSM.

Do I need genetic testing if enzyme levels are low?
Yes, most insurers including BCBSM require both enzyme testing AND genetic confirmation of GAA mutations for coverage approval.

Can my primary care doctor prescribe Lumizyme?
BCBSM typically requires evaluation by a specialist (metabolic, genetics, or neurology) familiar with Pompe disease management.

What if I'm under 8 years old?
Lumizyme is not FDA-approved for pediatric patients under 8. Your specialist may need to request coverage for off-label use with additional justification.

When to Contact Michigan Regulators

If you've exhausted internal appeals and external review options, or if you believe BCBSM is not following proper procedures, contact:

Michigan Department of Insurance and Financial Services (DIFS)

  • Phone: 877-999-6442
  • Online: File a complaint
  • Services: External review coordination, insurance complaint investigation

For additional support with complex coverage challenges, organizations like Counterforce Health can help build comprehensive appeals that address payer-specific requirements and leverage the strongest medical evidence for your case.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently—always verify current requirements with your specific BCBSM plan and healthcare providers. For personalized guidance on your coverage situation, consult with your healthcare team and insurance representatives.

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