By Counterforce Health Team in Aldurazyme (laronidase) —

How to Get Aldurazyme (laronidase) Covered by Cigna in Michigan: Complete Requirements Checklist and Appeals Guide

Answer Box: Getting Aldurazyme Covered by Cigna in Michigan

Who qualifies: Patients with confirmed mucopolysaccharidosis I (MPS I) requiring enzyme replacement therapy, prescribed by a genetics/metabolic specialist.

Fastest path: Submit prior authorization with genetic/enzymatic confirmation, baseline assessments (uGAG, FVC, cardiac), and specialist attestation. If denied, file internal appeal within 180 days, then external review with Michigan DIFS within 127 days.

Start today: Contact your prescribing specialist to gather diagnostic confirmation and baseline clinical measurements for the prior authorization packet.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Information
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Coordination
  8. After Submission: What to Expect
  9. Appeals Process in Michigan
  10. Common Denial Reasons & Solutions
  11. Cost Assistance Options
  12. Frequently Asked Questions

Who Should Use This Checklist

This guide is designed for patients with mucopolysaccharidosis I (MPS I) and their healthcare teams seeking Cigna coverage for Aldurazyme (laronidase) enzyme replacement therapy in Michigan.

Expected outcome: With complete documentation following this checklist, most appropriate candidates receive approval within 72 hours to 30 days. If initially denied, appeals have meaningful success rates when proper clinical evidence is provided, particularly for rare diseases like MPS I.

When to use: Before starting therapy, when switching from another ERT, or if you've received a denial that you believe is incorrect.

Member & Plan Basics

Coverage Verification Checklist

  • Active Cigna coverage confirmed through member portal or customer service (1-800-882-4462)
  • Specialty drug benefits active (Aldurazyme is typically managed through Accredo specialty pharmacy)
  • Prior authorization requirement confirmed (required for most Cigna plans)
  • Deductible status checked (high-deductible plans may require meeting deductible first)

Plan Type Considerations

Commercial plans: Standard prior authorization through Express Scripts/Accredo Medicare Advantage: May have additional step therapy requirements Medicaid managed care: Different appeal pathways apply

Tip: Cigna typically covers Aldurazyme as a medical benefit (not pharmacy benefit) when administered in infusion centers.

Clinical Criteria Requirements

Diagnosis Confirmation Required

  • Confirmed MPS I diagnosis with one of these subtypes:
    • Hurler syndrome (severe)
    • Hurler-Scheie syndrome (intermediate)
    • Scheie syndrome (attenuated)
  • Age requirement: Patient must be ≥6 months old at therapy initiation

Laboratory Evidence

  • Enzymatic confirmation: Deficient α-L-iduronidase enzyme activity in leukocytes, fibroblasts, plasma, or serum
  • Genetic testing: Pathogenic mutations in the IDUA gene (supporting evidence)
  • Baseline urinary glycosaminoglycans (uGAG) measurement

Clinical Baseline Assessments

For patients ≥6 years:

  • Percent predicted forced vital capacity (FVC)
  • 6-minute walk test results
  • Joint range of motion assessment
  • Cardiac evaluation (echocardiogram for left ventricular hypertrophy)
  • Growth measurements

For patients 6 months to <6 years:

  • Cardiac status evaluation
  • Growth velocity documentation
  • Upper airway obstruction assessment
  • Neurodevelopmental status (if applicable)

Specialist Requirement

  • Prescribed by or in consultation with a specialist in:
    • Medical genetics
    • Endocrinology
    • Metabolic diseases
    • Lysosomal storage disorders

Coding and Billing Information

Essential Codes

Code Type Code Description Notes
ICD-10 E76.01 Mucopolysaccharidosis, type I (Hurler) Use most specific
ICD-10 E76.02 Mucopolysaccharidosis, type I (Hurler-Scheie)
ICD-10 E76.03 Mucopolysaccharidosis, type I (Scheie)
HCPCS J1931 Injection, laronidase, 0.1 mg 1 unit = 0.1 mg
CPT 96365 IV infusion, initial hour Administration
CPT 96366 IV infusion, additional hour If needed

Dosing Information

  • Standard dose: 0.58 mg/kg IV weekly
  • Billing units: Calculate total mg dose ÷ 0.1 mg per unit
  • NDC: 58468-0070-xx (verify current NDC with manufacturer)

Documentation Packet Essentials

Provider Note Requirements

Your specialist's documentation should include:

  • Patient demographics and insurance information
  • Detailed MPS I diagnosis with subtype specification
  • Diagnostic test results (enzyme assay, genetic testing)
  • Baseline clinical assessments with specific measurements
  • Treatment rationale referencing FDA indication
  • Dosing plan with frequency and monitoring schedule

Medical Necessity Letter Components

A comprehensive letter should address:

  1. Clinical presentation and symptom severity
  2. Diagnostic confirmation with lab values
  3. Baseline functional assessments
  4. Treatment goals and expected outcomes
  5. Safety monitoring plan
  6. Specialist qualifications and experience with MPS I

Required Attachments

  • Laboratory reports (enzyme activity, uGAG)
  • Genetic testing results (if available)
  • Baseline clinical measurements
  • Specialist consultation notes
  • Any prior therapy documentation
Note: Incomplete documentation is the most common reason for initial denials. Ensure all baseline assessments are current and clearly documented.

Submission Process

Cigna Prior Authorization Pathways

Provider portal submission:

  • Log into Cigna provider portal
  • Complete prior authorization form
  • Upload all supporting documents
  • Submit and record confirmation number

Alternative submission methods:

  • CoverMyMeds platform (if available)
  • Fax to Cigna specialty pharmacy team (verify current fax number)
  • Phone for urgent cases: 1-800-882-4462

Timeline Expectations

  • Standard review: 72 hours for non-urgent requests
  • Urgent review: 24 hours with clinical urgency documentation
  • Complex cases: Up to 30 days (rare disease cases may need additional review)

Specialty Pharmacy Coordination

Accredo Specialty Pharmacy

Cigna typically routes Aldurazyme through Accredo:

  • Enrollment in Accredo patient portal
  • Shipping address confirmation
  • Infusion site coordination (hospital outpatient, infusion center)
  • Insurance benefits verification with Accredo team

Accredo contact: 877-826-7657

Infusion Site Requirements

  • Site approval by Cigna (some plans require specific facilities)
  • Administration training for healthcare staff
  • Emergency protocols in place for infusion reactions

After Submission: What to Expect

Tracking Your Request

  • Confirmation number recorded
  • Status checks scheduled (every 3-5 business days)
  • Contact information for follow-up readily available

Possible Outcomes

Approval: Proceed with specialty pharmacy coordination Partial approval: May approve with restrictions (dose, frequency) Denial: Review denial reason and prepare appeal

Appeals Process in Michigan

When facing a denial, Michigan residents have specific rights under state law.

Internal Appeals with Cigna

Timeline: File within 180 days of denial notice

Process:

  1. Submit written appeal via Cigna member portal or mail
  2. Include all clinical documentation supporting medical necessity
  3. Request peer-to-peer review with specialist if needed
  4. Decision timeline: 30 days (pre-service) or 60 days (post-service)

Michigan DIFS External Review

If Cigna's internal appeal is denied:

Timeline: 127 days from Cigna's final denial to file external review

Process:

  1. Complete DIFS External Review form online
  2. Submit supporting documents: denial letters, clinical records, medical necessity rationale
  3. Decision timeline: 60 days standard, 72 hours expedited (with physician urgency letter)

Contact DIFS: 877-999-6442 for assistance

Important: DIFS external review decisions are binding on Cigna. This provides Michigan patients with strong appeal rights for medically necessary treatments.

Expedited Appeals

For urgent cases where delay could jeopardize health:

  • Physician letter documenting medical urgency
  • Clinical rationale for immediate treatment need
  • Submit to both Cigna (24-hour review) and DIFS (72-hour expedited external review)

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Lack of genetic confirmation Submit IDUA gene testing results Genetic lab report with pathogenic variants
Missing baseline assessments Complete required clinical measurements uGAG, FVC, cardiac eval, growth data
Non-specialist prescriber Transfer care or obtain consultation Genetics/metabolic specialist attestation
Insufficient medical necessity Strengthen clinical rationale Detailed symptom documentation, functional impact
Experimental/investigational Provide FDA approval evidence FDA label, peer-reviewed efficacy studies

Cost Assistance Options

Manufacturer Support

Sanofi Patient Assistance:

  • Copay assistance programs
  • Patient access services
  • Financial hardship programs

Contact: Sanofi patient support website (verify current programs)

Foundation Grants

  • National MPS Society assistance programs
  • HealthWell Foundation rare disease fund
  • Patient Access Network Foundation

State Programs

Michigan residents may qualify for additional state assistance through Healthy Michigan Medicaid or other state programs.

Frequently Asked Questions

Q: How long does Cigna prior authorization take in Michigan? A: Standard reviews take 72 hours; urgent cases are reviewed within 24 hours. Complex rare disease cases may take up to 30 days.

Q: What if Aldurazyme is non-formulary on my plan? A: File a formulary exception request with clinical justification. Cigna typically covers medically necessary treatments for rare diseases even if non-formulary.

Q: Can I request an expedited appeal? A: Yes, both Cigna (24-hour review) and Michigan DIFS (72-hour external review) offer expedited processes with physician documentation of urgency.

Q: Does step therapy apply to Aldurazyme? A: Rarely, as Aldurazyme is the only FDA-approved enzyme replacement therapy for MPS I. However, some plans may require documentation of disease severity first.

Q: What happens if I move from another state to Michigan? A: Prior therapy documentation from other states is typically accepted. Ensure continuity by transferring all clinical records to your Michigan specialist.

Q: How often do I need reauthorization? A: Most plans require annual reauthorization with documentation of continued clinical benefit and absence of significant adverse effects.

From Our Advocates

We've seen many MPS I families successfully navigate the Cigna approval process by working closely with their metabolic specialist to gather comprehensive baseline data before submitting. One key insight: don't wait for a denial to compile your strongest clinical evidence—submit it with the initial request to avoid delays in starting this time-sensitive therapy.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful, evidence-backed appeals. Our platform analyzes denial letters and payer policies to create targeted rebuttals that address specific coverage criteria, pulling the right clinical evidence and regulatory citations to support medical necessity. For complex cases like MPS I enzyme replacement therapy, having the right documentation strategy can make the difference between approval and prolonged delays.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance plan directly for personalized guidance. For assistance with Michigan insurance appeals, contact DIFS at 877-999-6442.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.