By Counterforce Health Team in Lumizyme (alglucosidase alfa) —

How to Get Lumizyme (Alglucosidase Alfa) Covered by Aetna in Michigan: Complete Guide with Forms and Appeal Process

Quick Answer: Getting Lumizyme Covered by Aetna in Michigan

Aetna requires prior authorization for Lumizyme (alglucosidase alfa) with strict documentation requirements. You'll need enzyme assay or genetic testing confirming Pompe disease, prescription from a metabolic specialist, and submission through CVS Caremark specialty pharmacy. If denied, you have 180 days for internal appeals, then 127 days for Michigan DIFS external review. Start today: Download Aetna's Lumizyme precertification form and gather your diagnostic lab results.

Table of Contents

  1. Verify Your Plan and Find the Right Forms
  2. Required Prior Authorization Forms
  3. Specialty Pharmacy Enrollment Process
  4. Submission Portals and Methods
  5. Appeals Process: Internal and External
  6. Support Contacts and Case Management
  7. Michigan Regulatory Assistance
  8. Common Denial Reasons and Solutions
  9. FAQ

1. Verify Your Plan and Find the Right Forms

Before starting your Lumizyme coverage request, confirm your specific Aetna plan type. Michigan residents may have:

  • Aetna commercial plans (employer-sponsored)
  • Aetna Medicare Advantage
  • Aetna Better Health Michigan (Medicaid)

Each uses different forms and fax numbers. Check your member ID card or call the number on your card to verify your plan type.

Note: ERISA employer plans may have different appeal rights than Michigan-regulated plans. Confirm with member services if Michigan DIFS external review applies to your specific plan.

2. Required Prior Authorization Forms

Aetna Lumizyme Precertification Form

Download the current form: Aetna Lumizyme Medication Precertification Request form (verify this is the 2024/2025 version)

Required documentation includes:

  • Patient demographics and insurance information
  • Prescriber details (must be metabolic/lysosomal storage specialist)
  • Diagnosis confirmation: Enzyme assay showing GAA deficiency OR genetic testing consistent with Pompe disease
  • Dosing: 20 mg/kg every 2 weeks via IV infusion
  • Site of care justification (if requesting hospital outpatient vs. home/infusion center)

Coverage Criteria Checklist

Requirement Details Source
Diagnosis proof Enzyme assay OR genetic testing confirming Pompe disease Aetna Policy CPB 0442
Prescriber Metabolic or lysosomal storage disorder specialist Aetna PA form
Prior authorization Required for all Pompe ERTs 2025 Precert List
Continuation criteria Evidence of clinical response/stabilization Aetna Policy CPB 0442

Clinician Corner: Medical Necessity Letter

When completing the PA form, your specialist should include:

  • Diagnosis confirmation: Lab results showing GAA enzyme deficiency levels
  • Clinical presentation: Current symptoms, functional assessments (6MWT, FVC if applicable)
  • Treatment goals: Expected outcomes based on published literature
  • Monitoring plan: How clinical response will be evaluated
  • Site of care rationale: Why specific infusion location is medically necessary

3. Specialty Pharmacy Enrollment Process

Lumizyme must be dispensed through CVS Caremark Specialty Pharmacy. You cannot fill this at regular retail pharmacies.

Step-by-Step Enrollment

  1. Download enrollment form: CVS Specialty Lysosomal Storage Disorders Enrollment Form
  2. Complete all sections:
    • Patient/guardian information
    • Insurance card copies (front and back)
    • Prescriber information with NPI, DEA numbers
    • Clinical documentation
  3. Submit via:
  4. Processing time: 2 business days for standard requests with complete documentation
Tip: CVS Specialty offers 24/7 pharmacist support at 1-800-237-2767. Use this number for urgent questions about enrollment status or medication delivery.

4. Submission Portals and Methods

Fax Numbers (verify current numbers)

  • Commercial plans: 1-888-267-3277
  • Medicare Advantage Part B: 1-844-268-7263

Online Portals

Required Attachments

  • Completed PA form with all signatures
  • Lab reports confirming GAA deficiency
  • Specialist consultation notes
  • Insurance card copies
  • Any prior ERT treatment records

5. Appeals Process: Internal and External

Internal Aetna Appeals

Timeline: File within 180 days of denial Standard review: 30 days for decision Expedited review: 72 hours (requires physician certification of urgency)

How to file:

  • Online through Aetna member portal
  • Phone: Number on your denial letter
  • Written appeal with supporting documentation

Michigan DIFS External Review

If Aetna's internal appeal is denied, Michigan residents can request external review through the Department of Insurance and Financial Services.

Key details:

  • Filing deadline: 127 days from Aetna's final denial
  • Standard review: Up to 60 days
  • Expedited review: 72 hours (requires physician letter stating delay would harm patient)
  • Cost: Free to patients
  • Decision: Binding on Aetna for Michigan-regulated plans

How to file:

  • Online: DIFS External Review Portal
  • Phone: 877-999-6442 for forms and guidance
  • Required documents: Aetna's final denial letter, medical records, physician support letter
From our advocates: We've seen Pompe disease appeals succeed when families include detailed functional assessments showing disease progression alongside genetic confirmation. One family's appeal was approved after submitting 6-minute walk test results and pulmonary function trends that clearly demonstrated medical necessity—though outcomes vary by individual case.

6. Support Contacts and Case Management

Aetna Contact Numbers

  • Specialty Pharmacy Member Services: 1-866-782-2779 (Monday-Friday, 8 AM-7 PM ET)
  • General Pharmacy Services: 1-888-792-3862
  • Specialty Drug Prior Authorization: 1-866-814-5506

CVS Caremark Specialty

  • Patient support: 1-800-237-2767 (24/7)
  • Refills and delivery: Available through patient portal

What to Ask When Calling

  • Current PA status and any missing documentation
  • Expected decision timeline
  • Appeal rights and deadlines
  • Specialty pharmacy enrollment status
  • Case manager assignment (if applicable)

7. Michigan Regulatory Assistance

Michigan Department of Insurance and Financial Services (DIFS)

  • Consumer Hotline: 877-999-6442
  • Hours: Monday-Friday, 8 AM-5 PM
  • Services: External review filing, insurance complaint assistance, consumer education

Additional Resources

  • Michigan Attorney General Consumer Protection: For billing disputes or fraud concerns
  • Patient advocacy organizations: National Organization for Rare Disorders (NORD), Pompe community groups

8. Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
"Not medically necessary" Submit detailed clinical notes showing disease progression Functional assessments, specialist evaluation
"Experimental/investigational" Reference FDA approval and clinical guidelines FDA label, medical society recommendations
"Non-formulary" Request formulary exception Medical necessity letter, alternative therapy failures
"Missing diagnostic confirmation" Provide enzyme assay or genetic testing Lab reports with GAA deficiency levels
"Non-specialist prescriber" Transfer care to metabolic specialist Specialist consultation notes

When navigating complex prior authorization requirements, platforms like Counterforce Health help patients and clinicians turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned with payer policies.

9. FAQ

Q: How long does Aetna prior authorization take for Lumizyme in Michigan? A: Standard PA decisions are made within 14 days of receiving complete documentation. Expedited requests (with physician urgency certification) are decided within 72 hours.

Q: What if Lumizyme isn't on my Aetna formulary? A: Request a formulary exception by demonstrating medical necessity and providing documentation that formulary alternatives aren't appropriate for your condition.

Q: Can I get expedited appeals in Michigan? A: Yes, both Aetna and Michigan DIFS offer expedited appeals (72 hours) when a physician certifies that delay would seriously jeopardize your health.

Q: Does step therapy apply to Lumizyme? A: Aetna may require documentation that other ERTs have failed or aren't appropriate, especially for newer agents like Pombiliti. First-line Lumizyme typically doesn't require step therapy.

Q: What happens if my employer plan isn't Michigan-regulated? A: ERISA plans may not be subject to Michigan DIFS external review. Check with your benefits administrator about your specific appeal rights.

Q: How much does Lumizyme cost without insurance? A: Sanofi's wholesale acquisition cost is approximately $993 per 50-mg vial. Monthly costs can exceed $20,000 depending on weight-based dosing.

Q: Are there patient assistance programs? A: Yes, Sanofi offers patient support programs. Contact their specialty pharmacy team or visit the manufacturer's website for eligibility requirements.

Q: Can I transfer from another specialty pharmacy to CVS Caremark? A: Yes, but you'll need to complete new enrollment paperwork and coordinate the transfer with both pharmacies to avoid treatment delays.

Important Disclaimer: This information is for educational purposes and not medical advice. Coverage decisions depend on your specific plan terms and medical circumstances. Always consult your healthcare provider and verify current forms and procedures with Aetna and Michigan DIFS.

For complex appeals requiring detailed medical evidence, Counterforce Health specializes in helping patients and clinicians navigate insurance denials with targeted, evidence-backed appeal strategies.

Sources & Further Reading

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