By Counterforce Health Team in Aldurazyme (laronidase) —

The Requirements Checklist to Get Aldurazyme (Laronidase) Covered by Cigna in Texas

Quick Answer: Getting Aldurazyme Covered by Cigna in Texas

Eligibility: Patients with confirmed mucopolysaccharidosis I (MPS I) via genetic/biochemical testing. Fastest approval path: Submit complete prior authorization with genetic confirmation, baseline assessments, and specialist attestation through Cigna's provider portal or Express Scripts/Accredo. First step today: Contact your prescriber to initiate the Cigna Aldurazyme Prior Authorization Form and verify specialty pharmacy enrollment with Accredo (800-803-2423 for Texas state plans).

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Requirements
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Setup
  8. After Submission: Tracking Your Request
  9. Common Denial Prevention Tips
  10. Appeals Process in Texas
  11. Quick Reference Checklist
  12. FAQ

Who Should Use This Guide

This checklist is designed for patients with mucopolysaccharidosis I (MPS I) and their healthcare providers seeking Aldurazyme (laronidase) coverage through Cigna plans in Texas. You'll need this if:

  • Your doctor has prescribed Aldurazyme for confirmed MPS I (Hurler, Hurler-Scheie, or Scheie syndrome)
  • You're facing a prior authorization requirement or denial
  • You're switching from another insurer or specialty pharmacy
  • You need to appeal a coverage decision

Expected outcome: With complete documentation meeting Cigna's criteria, approval typically occurs within 72 hours for standard requests or 24 hours for expedited cases where delays could harm your health.

Member & Plan Basics

Verify Active Coverage

Before starting the authorization process:

  • Confirm your Cigna plan is active through myCigna.com or call member services at 1-800-244-6224
  • Check if your plan requires specialty drugs to be filled through Express Scripts/Accredo
  • Verify your deductible status and specialty tier copay/coinsurance

Plan Type Considerations

  • Commercial plans: Standard prior authorization through Cigna
  • Medicare Advantage: May have additional step therapy requirements
  • Texas state employee plans (TRS-Care/HealthSelect): Must use Accredo specialty pharmacy
Note: Self-funded employer plans follow federal ERISA rules for appeals, not Texas state regulations.

Clinical Criteria Requirements

Primary Requirements

Cigna requires documentation of all the following for Aldurazyme approval:

Confirmed MPS I Diagnosis

  • Laboratory evidence of deficient alpha-L-iduronidase activity in leukocytes, fibroblasts, plasma, or serum
  • OR molecular genetic testing confirming biallelic pathogenic variants in the IDUA gene
  • ICD-10 codes: E76.01 (Hurler), E76.02 (Hurler-Scheie), E76.03 (Scheie)

Baseline Disease Severity Assessment

  • Pulmonary function tests
  • Hepatosplenomegaly evaluation
  • Joint mobility assessment
  • Growth parameters (for pediatric patients)

Specialist Involvement

  • Prescription by or consultation with a geneticist, metabolic disorder specialist, endocrinologist, or physician specializing in lysosomal storage disorders

Dosing Requirements

  • Standard dose: 0.58 mg/kg intravenously weekly
  • Infusion duration: Approximately 3-4 hours
  • Administration site: Infusion center, physician office, or approved home setting

Coding & Billing Requirements

Essential Codes

Code Type Code Description Units
HCPCS J1931 Injection, laronidase, 0.1 mg 1 unit = 0.1 mg
NDC 58468-0070-01 Aldurazyme 2.9 mg/5 mL vial As prescribed
CPT 96365 IV infusion, initial hour 1
CPT 96366 Each additional hour As needed

ICD-10 Diagnosis Codes

  • E76.01: Mucopolysaccharidosis type I, Hurler's syndrome
  • E76.02: Mucopolysaccharidosis type I, Hurler-Scheie's syndrome
  • E76.03: Mucopolysaccharidosis type I, Scheie's syndrome

Unit Calculation Example

For a 50 kg patient:

  • Dose = 50 kg × 0.58 mg/kg = 29 mg
  • Units to bill = 29 mg ÷ 0.1 mg = 290 units of J1931
Tip: Use modifier JW for any drug discarded from single-use vials and document the amount.

Documentation Packet

Provider Note Requirements

Your prescriber's clinical note must include:

  • Confirmed MPS I diagnosis with supporting lab results
  • Patient's current clinical status and symptoms
  • Previous treatments attempted (if any)
  • Rationale for Aldurazyme therapy
  • Baseline assessments completed
  • Monitoring plan for infusion reactions

Medical Necessity Letter Components

A comprehensive letter should address:

  1. Patient background: Age, weight, MPS I subtype
  2. Diagnostic confirmation: Enzyme activity levels or genetic test results
  3. Clinical presentation: Current symptoms and functional limitations
  4. Treatment rationale: Why enzyme replacement therapy is necessary
  5. Expected outcomes: Goals for treatment response
  6. Monitoring plan: Safety assessments and efficacy measures

Required Attachments

  • Genetic test results or enzyme activity assay
  • Baseline pulmonary function tests
  • Imaging studies (if available)
  • Growth charts (pediatric patients)
  • Specialist consultation notes

Submission Process

Electronic Submission (Preferred)

  1. Provider Portal: Log into Cigna's provider portal
  2. CoverMyMeds: Complete prior authorization through integrated platform
  3. Express Scripts: Use specialty pharmacy portal for dual submission

Required Forms

Common Rejection Causes

  • Incomplete patient information
  • Missing genetic/biochemical confirmation
  • Unsigned forms
  • Incorrect ICD-10 codes
  • Missing baseline assessments
From our advocates: "We've seen approvals delayed by weeks simply because the genetic test results weren't clearly labeled or the enzyme activity levels weren't included. Double-check that every required field is completed before submission."

Specialty Pharmacy Setup

Accredo Enrollment Process

Most Cigna plans require Aldurazyme to be dispensed through Accredo Specialty Pharmacy:

  1. Prescriber completes: Accredo referral form
  2. Fax to: 888-302-1028
  3. Patient enrollment: Accredo contacts patient within 24-48 hours
  4. Insurance verification: Accredo handles prior authorization coordination

Texas State Plan Considerations

  • TRS-Care members: Call 800-803-2423 for specialty pharmacy transfers
  • HealthSelect members: Specialty drugs must go through Accredo
  • Existing prescriptions from other pharmacies must be transferred

Shipment and Administration

  • Aldurazyme requires refrigerated shipping
  • Coordinate delivery with infusion center schedule
  • Verify infusion site has proper handling protocols

After Submission: Tracking Your Request

Timeline Expectations

  • Standard review: 72 hours for prior authorization decision
  • Expedited review: 24 hours when delay could harm health
  • Appeal decisions: 30 days for internal appeals, 20 days for external review

Status Monitoring

  • Confirmation number: Record PA reference number from submission
  • Provider portal: Check status daily during review period
  • Member services: Call 1-800-244-6224 for updates

What to Document

  • Submission date and confirmation number
  • All communication with Cigna or specialty pharmacy
  • Any requests for additional information
  • Decision date and approval/denial details

Common Denial Prevention Tips

Five Critical Pitfalls to Avoid

  1. Incomplete genetic confirmation
    • Fix: Include both enzyme activity levels AND genetic test results when available
  2. Missing baseline assessments
    • Fix: Complete pulmonary function tests, imaging, and specialist evaluation before submission
  3. Inadequate clinical rationale
    • Fix: Clearly document how MPS I symptoms impact daily function and why ERT is medically necessary
  4. Incorrect specialty pharmacy routing
    • Fix: Verify plan requires Accredo and complete enrollment before PA submission
  5. Insufficient monitoring plan
    • Fix: Detail infusion reaction protocols and ongoing efficacy assessments

Appeals Process in Texas

If your initial request is denied, Texas law provides strong appeal rights:

Internal Appeals with Cigna

  • Deadline: 180 days from denial date
  • Decision timeline: 30 days standard, 72 hours expedited
  • Required: Clinical justification for medical necessity

External Review (Independent Review Organization)

  • Eligibility: After final internal denial
  • Deadline: 45 days to 4 months depending on case type
  • Timeline: 20 days standard, 72 hours expedited
  • Form: Texas Form LHL009 through Texas Department of Insurance

Expedited Review Criteria

Request expedited review when:

  • Delay could seriously harm health
  • Treatment interruption risks disease progression
  • Standard timeline could cause irreversible damage

Texas Resources

  • TDI Consumer Help: 1-800-252-3439
  • IRO Information: 1-866-554-4926
  • Office of Public Insurance Counsel: 1-877-611-6742

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters, identifying specific coverage criteria, and drafting targeted appeals with evidence-based clinical rationale. Their platform streamlines the documentation process and improves approval rates for specialty medications like Aldurazyme.

Quick Reference Checklist

Before Submission ✓

  • Active Cigna coverage verified
  • MPS I diagnosis confirmed with genetic/enzyme testing
  • Baseline assessments completed (PFTs, imaging, specialist eval)
  • Accredo specialty pharmacy enrollment initiated
  • All required forms completed and signed

Required Documentation ✓

  • Cigna Aldurazyme Prior Authorization Form
  • Genetic test results or enzyme activity assay
  • ICD-10 code: E76.01, E76.02, or E76.03
  • Specialist consultation notes
  • Medical necessity letter with clinical rationale
  • Baseline pulmonary function tests

Submission Details ✓

  • Submitted via provider portal or CoverMyMeds
  • Confirmation number recorded
  • All attachments included as PDFs
  • Expedited review requested if clinically urgent
  • Follow-up scheduled for 72 hours

After Decision ✓

  • Approval details documented
  • Specialty pharmacy coordination completed
  • First infusion scheduled
  • Appeal process initiated if denied

FAQ

How long does Cigna prior authorization take for Aldurazyme in Texas? Standard review takes 72 hours, expedited review 24 hours. Incomplete submissions may extend timelines.

What if Aldurazyme is non-formulary on my plan? Request a formulary exception with clinical rationale explaining medical necessity and lack of alternatives.

Can I request expedited review for MPS I? Yes, if your physician certifies that delay could seriously harm your health or cause irreversible disease progression.

Does step therapy apply to Aldurazyme? No FDA-approved alternatives exist for laronidase, so step therapy typically doesn't apply. Document this in your request.

What if I'm denied after internal appeal? Texas residents can request external review through an Independent Review Organization (IRO) within 45 days of final denial.

How much will Aldurazyme cost with Cigna coverage? Costs vary by plan. Specialty tier drugs typically have higher copays or coinsurance. Check manufacturer assistance programs and patient foundations.

Can I switch from another specialty pharmacy to Accredo? Yes, most Cigna plans require Accredo. Your prescriber needs to complete transfer paperwork and coordinate with both pharmacies.

What happens if I miss an infusion due to coverage delays? Contact your physician immediately. Document any clinical changes and use this information to request expedited review or appeal.

Sources & Further Reading

Medical Disclaimer: This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider regarding treatment decisions. Coverage policies may vary by plan and are subject to change. For assistance with complex appeals, consider consulting Counterforce Health or other patient advocacy organizations.

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