By Counterforce Health Team in Aldurazyme (laronidase) —

The Requirements Checklist to Get Aldurazyme (laronidase) Covered by UnitedHealthcare in Pennsylvania: Forms, Appeals, and Success Strategies

Answer Box: Getting Aldurazyme Covered by UnitedHealthcare in Pennsylvania

Fastest path to approval: Submit prior authorization through the UnitedHealthcare Provider Portal with confirmed MPS I diagnosis (enzymatic + genetic testing), baseline assessments, and specialist attestation. If denied, Pennsylvania's Independent External Review Program has a 50% overturn rate for specialty drug appeals. First step today: Verify your plan requires PA and gather diagnostic confirmation—enzymatic testing showing reduced IDUA activity plus genetic confirmation of biallelic IDUA pathogenic variants.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Requirements
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Network
  8. After Submission: Tracking Your Request
  9. Common Denial Reasons & How to Fix Them
  10. Appeals Process in Pennsylvania
  11. Cost Support Options
  12. Printable Checklist

Who Should Use This Guide

This guide is designed for patients with mucopolysaccharidosis I (MPS I) and their healthcare teams seeking UnitedHealthcare coverage for Aldurazyme (laronidase) in Pennsylvania. You'll benefit from this checklist if you're:

  • Starting enzyme replacement therapy for confirmed MPS I
  • Facing a UnitedHealthcare prior authorization requirement
  • Dealing with a denial that needs appeal
  • Switching from another insurer to UnitedHealthcare

Expected outcome: Following this systematic approach significantly improves your chances of approval. Pennsylvania's new external review program has overturned approximately 50% of specialty drug denials in 2024, giving you strong appeal options if initially denied.

Member & Plan Basics

Coverage Verification Steps

Before starting the prior authorization process:

  1. Confirm active UnitedHealthcare coverage and verify your member ID
  2. Check your specific plan type (Commercial, Medicare Advantage, or Medicaid)
  3. Verify prior authorization is required for Aldurazyme through your plan documents or member portal
  4. Review your deductible status and specialty drug tier placement
Note: UnitedHealthcare requires prior authorization for Aldurazyme across all plan types, administered through their OptumRx specialty pharmacy benefit.

Plan-Specific Considerations

Plan Type Key Requirements Contact for PA
Commercial Prior auth required; specialty pharmacy network UnitedHealthcare Provider Portal
Medicare Advantage PA required; 24-hour expedited review available OptumRx: 888-397-8129
Medicaid State-specific criteria may apply Verify with Pennsylvania Medicaid

Clinical Criteria Requirements

UnitedHealthcare's medical necessity criteria for Aldurazyme require comprehensive documentation of MPS I diagnosis and clinical need.

Diagnostic Requirements

Primary requirement: Confirmed diagnosis of mucopolysaccharidosis I through:

  1. Enzymatic testing: Reduced or absent alpha-L-iduronidase (IDUA) enzyme activity in leukocytes, serum, or dried blood spots
  2. Genetic confirmation: Biallelic pathogenic variants in the IDUA gene identified through DNA sequencing
  3. Clinical presentation: Documentation consistent with MPS I (Hurler, Hurler-Scheie, or Scheie variants)

Baseline Assessments Required

UnitedHealthcare typically requires these baseline measurements before approving Aldurazyme:

  • Urinary glycosaminoglycans (uGAG) levels
  • Pulmonary function tests (for patients ≥6 years)
  • Six-minute walk test (age-appropriate)
  • Joint range of motion assessments
  • Cardiac evaluation (echocardiogram)
  • Hepatosplenomegaly documentation (imaging)

Age and Dosing Criteria

  • Minimum age: 6 months or older
  • Standard dosing: 0.58 mg/kg body weight weekly via IV infusion
  • Prescriber requirement: Must be prescribed by or in consultation with a specialist experienced in treating lysosomal storage disorders

Coding and Billing Requirements

Essential Billing Codes

Code Type Code Description
HCPCS J-code J1931 Injection, laronidase, 0.1 mg
ICD-10 Diagnosis E76.01 Mucopolysaccharidosis I
NDC Verify current Match to actual dispensed vial

Documentation for Billing

  • Use J1931 for all Aldurazyme billing to UnitedHealthcare
  • Match NDC on claims to the specific product vial dispensed
  • Include primary diagnosis code E76.01 (Mucopolysaccharidosis I)
  • Verify site of care restrictions with your specific UnitedHealthcare plan

Documentation Packet

Medical Necessity Letter Components

Your specialist should include these elements in the medical necessity letter:

  1. Patient identification and confirmed MPS I diagnosis
  2. Diagnostic test results (enzymatic and genetic confirmation)
  3. Clinical presentation and disease severity
  4. Treatment rationale for enzyme replacement therapy
  5. Baseline assessments and monitoring plan
  6. Expected clinical outcomes and monitoring schedule

Required Attachments Checklist

  • Laboratory reports confirming reduced IDUA enzyme activity
  • Genetic testing results showing biallelic IDUA pathogenic variants
  • Baseline uGAG levels
  • Pulmonary function tests (if age-appropriate)
  • Cardiac evaluation results
  • Imaging studies documenting organomegaly
  • Specialist consultation notes
  • Previous treatment history (if applicable)

Submission Process

Prior Authorization Submission

  1. Access the UnitedHealthcare Provider Portal at uhcprovider.com
  2. Navigate to "Specialty Pharmacy Transactions" tile
  3. Complete the prior authorization form with all required clinical information
  4. Upload supporting documentation (all items from checklist above)
  5. Submit and record confirmation number
Tip: For urgent cases, request expedited review. UnitedHealthcare must provide a determination within 24 hours for expedited requests when supporting documentation is complete.

Alternative Submission Methods

If portal access isn't available:

  • Phone: OptumRx at 888-397-8129
  • Fax: Use the fax number provided in your denial letter (verify current number)

Specialty Pharmacy Network

UnitedHealthcare requires Aldurazyme to be sourced through their preferred specialty pharmacy network:

Preferred Specialty Pharmacies

  • Accredo Health Group
  • AllianceRx Walgreens Pharmacy
  • CVS Specialty (Caremark)
  • Option Care Health
  • Optum Specialty Pharmacy
  • Amber Specialty Pharmacy

Coordination Steps

  1. Confirm prior authorization approval before pharmacy coordination
  2. Contact your preferred specialty pharmacy from the approved list
  3. Provide prescription and PA approval information
  4. Arrange delivery to your infusion site or home (as appropriate)
  5. Verify cold-chain shipping requirements are met
Note: Specialty pharmacies handle temperature-controlled shipping and provide patient support services as part of their coordination.

After Submission: Tracking Your Request

Timeline Expectations

Review Type Timeline Next Steps
Standard PA 5-15 business days Check status via provider portal
Expedited PA 24-72 hours Follow up if no response
Appeal (Internal) 30 days Document all communications

Status Tracking

  • Record confirmation numbers from all submissions
  • Check status weekly through the provider portal
  • Document all phone calls with dates, times, and representative names
  • Save all correspondence including emails and fax confirmations

Common Denial Reasons & How to Fix Them

Denial Reason Documentation Fix Source
Missing genetic confirmation Submit complete IDUA gene sequencing results showing biallelic pathogenic variants Mayo Clinic Labs MPS I Testing
Insufficient baseline assessments Provide uGAG levels, pulmonary function, and cardiac evaluation UHC ERT Policy
Non-specialist prescriber Obtain consultation or prescription from MPS specialist Plan policy requirement
Quantity limits exceeded Justify dosing based on weight and FDA labeling FDA Aldurazyme prescribing information

Most Effective Appeal Strategies

  1. Peer-to-peer review: Request direct physician-to-physician discussion
  2. Additional clinical evidence: Submit recent functional assessments showing disease progression
  3. Guideline citations: Reference established MPS treatment guidelines
  4. Economic analysis: Document cost-effectiveness vs. disease progression

Appeals Process in Pennsylvania

Pennsylvania offers one of the strongest external review programs in the nation for patients facing insurance denials.

Internal Appeals (Required First Step)

  1. Submit internal appeal within 180 days of denial
  2. Include all clinical documentation and medical necessity letter
  3. Request peer-to-peer review if available
  4. Await Final Adverse Benefit Determination letter

Pennsylvania External Review Program

If your internal appeal is denied, Pennsylvania's Independent External Review Program offers excellent success rates:

Key advantages:

  • 50% overturn rate for specialty drug appeals in 2024
  • No cost to patients
  • Binding decision on UnitedHealthcare
  • 45-day standard timeline (72 hours for urgent cases)

External Review Process Steps

  1. Complete internal appeals first (required)
  2. Submit external review request within 4 months of final denial
  3. Use Pennsylvania's online portal at pa.gov/reviewmyclaim or mail/fax forms
  4. Submit additional evidence within 15 days of case assignment
  5. Await independent medical review decision
From our advocates: We've seen Pennsylvania's external review program consistently favor patients with well-documented rare disease cases. The key is submitting comprehensive clinical evidence that clearly demonstrates medical necessity according to established treatment guidelines.

For assistance with the external review process, contact the Pennsylvania Insurance Department Consumer Help Center at 1-877-881-6388.

Cost Support Options

Manufacturer Support Programs

  • Sanofi Patient Connection: May provide copay assistance for eligible patients
  • Foundation support: Check rare disease foundations for grant opportunities

Pennsylvania-Specific Resources

  • Pennsylvania CHIP: For eligible children
  • Medicaid coverage: May provide more comprehensive coverage than commercial plans

Printable Checklist

Before You Start

  • Confirm UnitedHealthcare coverage is active
  • Verify prior authorization is required
  • Gather all diagnostic documentation

Clinical Documentation

  • IDUA enzyme activity test results (reduced/absent)
  • Genetic testing showing biallelic IDUA pathogenic variants
  • Baseline uGAG levels
  • Pulmonary function tests (if age ≥6 years)
  • Cardiac evaluation (echocardiogram)
  • Imaging documenting organomegaly
  • Specialist consultation notes

Submission Requirements

  • Complete PA form via UnitedHealthcare Provider Portal
  • Upload all supporting documentation
  • Record confirmation number
  • Set calendar reminder to check status

If Denied

  • Submit internal appeal within 180 days
  • Request peer-to-peer review
  • Consider Pennsylvania external review (within 4 months of final denial)
  • Contact Pennsylvania Insurance Department if needed (1-877-881-6388)

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 plan policies to create targeted rebuttals that align with payer-specific requirements, significantly improving approval rates for complex medications like Aldurazyme.

Sources & Further Reading

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 the most current requirements and procedures. Coverage policies may change, and individual circumstances vary.

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