By Counterforce Health Team in Aldurazyme (laronidase) —

How to Get Aldurazyme (Laronidase) Covered by Blue Cross Blue Shield Michigan: Prior Authorization, Appeals, and State Review Process

Quick Answer: Getting Aldurazyme Covered by Blue Cross Blue Shield Michigan

Eligibility: Blue Cross Blue Shield of Michigan covers Aldurazyme (laronidase) for mucopolysaccharidosis type I (MPS I) with prior authorization. Fastest path: Submit PA request through the Medical and Pharmacy Drug PA Portal with genetic/enzymatic confirmation of MPS I diagnosis and specialist documentation. First step today: Contact your prescriber to gather MPS I diagnostic records and initiate the prior authorization process. If denied, Michigan's external review through DIFS provides binding decisions within 60 days (72 hours for urgent cases).

Table of Contents

Why Michigan State Rules Matter for Your Aldurazyme Coverage

Michigan's insurance landscape gives patients strong protections when fighting for rare disease treatments like Aldurazyme. With Blue Cross Blue Shield of Michigan covering about 67% of commercial plan members in the state, understanding how Michigan's Patient's Right to Independent Review Act (PRIRA) works alongside BCBS policies can make the difference between approval and denial.

Unlike many states, Michigan provides a 127-day window for external appeals—longer than the federal standard—and offers expedited 72-hour reviews for urgent medical situations. These state-level protections apply to all commercial insurance plans, including BCBS Michigan, giving you additional leverage when standard prior authorization processes don't work.

Note: Self-funded employer plans (ERISA) may have different appeal processes, though many voluntarily follow state guidelines.

BCBS Michigan Prior Authorization Requirements

Blue Cross Blue Shield of Michigan requires prior authorization for Aldurazyme under its medical benefit drug program. Here's what you need to know:

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required before coverage BCBS PA Portal
Medical Necessity MPS I diagnosis confirmation FDA labeling, genetic testing
Provider Administration Healthcare professional required Medical benefit, not pharmacy
Supporting Documentation Clinical records, treatment history Patient chart, specialist notes

Key Documentation Needed

  • Genetic/enzymatic confirmation of MPS I diagnosis
  • Baseline disease severity assessments (pulmonary function, hepatosplenomegaly, mobility)
  • Specialist attestation from geneticist, metabolic specialist, or pediatric specialist
  • Monitoring plan for infusion reactions and clinical response
  • Treatment history showing medical necessity for enzyme replacement therapy

Step-by-Step: Fastest Path to Approval

1. Gather Essential Documentation (Patient/Family)

  • Insurance card and member ID
  • Complete MPS I diagnostic records (genetic testing, enzyme assays)
  • Previous treatment history and outcomes
  • Timeline: 1-2 days

2. Schedule Specialist Consultation (If Needed)

  • Geneticist, metabolic specialist, or pediatric subspecialist
  • Obtain formal MPS I diagnosis confirmation
  • Timeline: 2-4 weeks (varies by availability)

3. Provider Submits Prior Authorization (Prescriber)

4. BCBS Reviews Request

  • Standard review: up to 15 business days
  • Expedited review: 72 hours (if urgent medical necessity)
  • Timeline: 10-15 business days typically

5. If Approved: Treatment Begins

  • Coordinate with infusion center or hospital
  • Schedule baseline monitoring
  • Timeline: 1-2 weeks after approval

6. If Denied: Begin Appeal Process

  • Request internal appeal within 180 days
  • Gather additional supporting evidence
  • Timeline: Internal appeal decision within 30 days

7. External Review (If Needed)

  • File with Michigan DIFS within 127 days of final denial
  • Independent medical review
  • Timeline: 60 days for standard, 72 hours for expedited

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Key Documents
"Missing genetic confirmation" Provide enzyme assay and/or genetic testing results Lab reports showing α-L-iduronidase deficiency
"Lack of specialist evaluation" Obtain consultation with metabolic/genetic specialist Specialist letter confirming MPS I diagnosis
"Insufficient baseline assessments" Document disease severity and organ involvement Pulmonary function tests, imaging studies, physical exam
"No monitoring plan" Submit detailed infusion protocol and safety monitoring Infusion center protocols, adverse reaction management plan
"Quantity over limits" Justify dosing based on patient weight and FDA labeling Weight-based dosing calculation, FDA prescribing information

Michigan Appeals Process & External Review

When BCBS Michigan denies Aldurazyme coverage, you have structured appeal rights under state law:

Internal Appeals Process

  1. Request internal appeal within 180 days of denial
  2. Submit additional evidence: specialist letters, peer-reviewed studies, FDA labeling
  3. Decision timeline: 30 days for pre-service, 60 days for post-service
  4. Expedited option: 72 hours if urgent medical necessity

External Review Through DIFS

If internal appeals fail, Michigan's Department of Insurance and Financial Services provides independent review:

  • Deadline: 127 days from final internal denial
  • Process: Independent Review Organization (IRO) with medical experts
  • Timeline: 60 days standard, 72 hours expedited
  • Outcome: Binding decision on BCBS Michigan
  • How to file: DIFS External Review Portal or call 877-999-6442
From our advocates: We've seen patients succeed in external review by including comprehensive specialist letters that directly address the plan's denial reasons, along with peer-reviewed evidence showing Aldurazyme's effectiveness for their specific MPS I presentation. The key is making it easy for the IRO to understand why this treatment is medically necessary.

Step Therapy Protections in Michigan

Michigan currently does not have state-level step therapy reform laws specifically protecting rare disease patients. However, you can still request step therapy exceptions from BCBS Michigan based on:

Medical Exception Criteria

  • Prior drug failure or intolerance: Document adverse reactions or lack of efficacy
  • Contraindications: Medical reasons why step therapy drugs are inappropriate
  • Patient stability: Already stable on current therapy
  • FDA labeling concerns: Step therapy drug not approved for your indication

Documentation for Step Therapy Exceptions

  • Detailed medical history showing prior treatment failures
  • Specialist letter explaining why alternatives are inappropriate
  • Clinical evidence supporting Aldurazyme as first-line therapy for your case
  • Any contraindications to alternative treatments

For patients needing help navigating complex step therapy requirements, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by identifying the specific denial basis and crafting point-by-point rebuttals aligned to plan policies.

Continuity of Care & Treatment Transitions

Plan Changes

  • Grace period: BCBS Michigan may provide temporary coverage during plan transitions
  • Prior authorization transfer: Previous approvals don't automatically transfer to new plans
  • Documentation: Keep copies of all approval letters and clinical records

Provider Changes

  • Specialist continuity: Ensure new providers understand MPS I management
  • Infusion site coordination: May need new prior authorization for different treatment locations
  • Medical records transfer: Critical for maintaining treatment approval

When to Escalate: External Review Through DIFS

Contact Michigan DIFS when:

  • BCBS Michigan's internal appeals are exhausted
  • Urgent medical situation requires expedited review
  • Plan fails to meet response deadlines
  • Procedural violations in the appeals process

DIFS Contact Information

  • Phone: 877-999-6442
  • Website: DIFS External Review
  • Mail: Appeals Section, PO Box 30220, Lansing, MI 48909-7720

Cost Assistance and Patient Support

Manufacturer Support

  • Sanofi Genzyme: Patient assistance programs may be available (verify with manufacturer)
  • BioMarin: Check for patient support programs

Michigan-Specific Resources

  • Michigan Medicaid: May cover Aldurazyme for eligible patients
  • State insurance marketplace: Premium tax credits may help with commercial coverage
  • Rare disease foundations: National organizations may provide grants or support

Platforms like Counterforce Health can help identify all available cost assistance options while simultaneously working on insurance approval strategies.

Frequently Asked Questions

How long does BCBS Michigan prior authorization take for Aldurazyme? Standard reviews take up to 15 business days. Expedited reviews for urgent medical necessity are completed within 72 hours.

What if Aldurazyme is non-formulary on my BCBS Michigan plan? Request a formulary exception with medical necessity documentation. Non-formulary status doesn't prevent coverage if medically necessary.

Can I request an expedited appeal in Michigan? Yes, if delay would seriously jeopardize your health or ability to regain function. Your physician must provide supporting documentation of urgency.

Does step therapy apply if I've failed treatments outside Michigan? Treatment history from any location should be considered. Provide complete documentation of prior therapy failures or intolerances.

What happens if DIFS external review overturns the denial? The decision is binding on BCBS Michigan. They must provide coverage as directed by the Independent Review Organization.

How much does Aldurazyme cost without insurance? The manufacturer's wholesale acquisition cost is approximately $1,113.38 per 2.9 mg/5 mL vial as of January 2025. Total treatment costs depend on patient weight and dosing frequency.

Can my doctor file appeals for me? Yes, Michigan law allows physicians or authorized representatives to file appeals with patient consent. This often streamlines the process.

What if my employer plan is self-funded (ERISA)? Self-funded plans may not be subject to Michigan's external review process, but many voluntarily follow similar procedures. Check your plan documents or contact HR.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations may change. Always consult with your healthcare provider and insurance plan for the most current requirements and procedures.

Sources & Further Reading

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