By Counterforce Health Team in Myozyme (alglucosidase alfa) —

How to Get Myozyme (Alglucosidase Alfa) Covered by Cigna in Washington: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Myozyme Covered by Cigna in Washington

Cigna covers Myozyme (alglucosidase alfa) for confirmed Pompe disease with prior authorization. The fastest path: (1) Ensure your prescriber is a metabolic specialist or geneticist, (2) Submit complete diagnostic confirmation (GAA enzyme deficiency or genetic testing) with Cigna's PA form via fax to 1-866-873-8279, and (3) If denied, file an internal appeal within 180 days, then request external review through Washington's Office of the Insurance Commissioner. Most approvals require documented diagnosis, specialist prescribing, and evidence-based dosing (≤20 mg/kg every 2 weeks).

Table of Contents

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

Who Should Use This Guide

This comprehensive guide is designed for Washington state residents with Cigna insurance who need Myozyme (alglucosidase alfa) for Pompe disease treatment. Whether you're facing an initial prior authorization request or appealing a denial, this resource provides the specific requirements, forms, and timelines for success.

Expected outcome: With proper documentation and adherence to Cigna's clinical criteria, most medically necessary requests for confirmed Pompe disease are approved. If initially denied, Washington's robust appeals process—including external review by independent specialists—provides additional pathways to coverage.

Member & Plan Basics

Coverage Requirements

  • Active Cigna coverage: Verify your plan includes specialty drug benefits
  • Prior authorization required: All Myozyme requests need pre-approval
  • Specialty pharmacy mandate: Must use Express Scripts/Accredo for fulfillment
  • Deductible considerations: High-cost specialty drugs may apply to medical or pharmacy deductibles

Plan Types Covered

Cigna covers Myozyme across commercial plans, Medicare Advantage, and employer-sponsored insurance when medical necessity criteria are met. Coverage details may vary by specific plan design.

Clinical Criteria Requirements

Diagnosis Confirmation

Required: Documentation of Pompe disease through either:

  • Laboratory evidence: Deficient acid alpha-glucosidase (GAA) activity in blood, fibroblasts, or muscle tissue
  • Genetic testing: Molecular genetic test results confirming biallelic pathogenic or likely pathogenic GAA gene variants

Prescriber Requirements

The prescription must come from or be in consultation with:

  • Geneticist
  • Neurologist
  • Metabolic disorder subspecialist
  • Physician specializing in lysosomal storage disorders

Dosing Guidelines

  • Maximum dose: 20 mg/kg intravenously
  • Frequency: No more than once every 2 weeks
  • Deviation: Higher doses or different intervals require case-by-case medical director review
Note: According to Cigna's coverage policy, requests outside FDA-approved dosing parameters face additional scrutiny.

Coding and Billing Information

ICD-10 Diagnosis Code

Primary code: E74.02 (Pompe disease)

HCPCS J-Code

J0221: Injection, alglucosidase alfa (Lumizyme), 10 mg

  • Billing units: Each unit represents 10 mg
  • Example: 100 mg dose = 10 units

Additional Codes

Consider including related condition codes when applicable:

  • P94.2 (Congenital hypotonia) for infantile cases
  • I42.9 (Cardiomyopathy, unspecified) when cardiac involvement is present

Documentation Packet Essentials

Required Clinical Information

  1. Complete diagnostic workup:
    • GAA enzyme activity results
    • Genetic testing reports (if applicable)
    • Clinical presentation details
  2. Patient demographics:
    • Full name, date of birth, address
    • Insurance card copies (front and back)
    • Weight and height for dosing calculations
  3. Prescriber information:
    • NPI number and medical license
    • Specialty certification
    • Contact information

Medical Necessity Letter Components

Your prescriber should include:

  • Problem statement: Clear diagnosis with ICD-10 code E74.02
  • Clinical rationale: Disease progression, symptoms, functional impact
  • Treatment history: Previous therapies tried or contraindications
  • Dosing justification: Evidence-based rationale for prescribed regimen
  • Monitoring plan: How treatment response will be assessed
Clinician Corner: Reference FDA labeling and current ACMG guidelines for Pompe disease management to strengthen medical necessity arguments.

Submission Process

Electronic Submission (Fastest)

  • CoverMyMeds: Most efficient pathway
  • ExpressPAth: Cigna's proprietary system
  • EHR integration: Through supported electronic health records

Traditional Methods

  • Fax: 1-866-873-8279
  • Phone: 1-800-882-4462 for assistance
  • Mail: Use address provided on specific PA forms

Required Form Fields

Ensure completion of all sections:

  • Service description
  • Proposed start and end dates
  • Relevant HCPCS codes
  • Clinical history and concurrent medications
  • Site of care details

Specialty Pharmacy Enrollment

Express Scripts/Accredo Process

  1. Provider completes enrollment form: Available at Accredo's prescriber portal
  2. Fax completed form: 888.302.1028
  3. Patient registration: Create account at MyAccredoPatients.com
  4. Coordination: Accredo handles insurance verification and shipment scheduling

Washington State Considerations

No state-level restrictions override Cigna/Express Scripts specialty pharmacy requirements. Ensure compliance with Washington prescription regulations to avoid delays.

At Counterforce Health, we help patients navigate complex prior authorization requirements by turning denials into targeted, evidence-backed appeals. Our platform analyzes payer policies and clinical evidence to draft compelling rebuttal letters that align with each plan's specific criteria.

After Submission: What to Expect

Timeline Expectations

  • Standard review: 72 hours to 14 days
  • Expedited review: 24-72 hours for urgent cases
  • Complex cases: May require peer-to-peer review

Status Tracking

  • Record confirmation numbers
  • Check status through Cigna provider portal
  • Follow up if no response within expected timeframes

Documentation

Maintain copies of:

  • All submitted forms and attachments
  • Confirmation receipts
  • Communication logs with Cigna

Common Denial Reasons & Solutions

Denial Reason Solution Strategy
Insufficient diagnostic confirmation Submit complete GAA enzyme results or genetic testing reports
Non-specialist prescriber Obtain consultation or referral from metabolic specialist
Dosing outside guidelines Provide literature support or adjust to FDA-approved parameters
Lack of medical necessity Strengthen clinical rationale with disease progression documentation
Missing prior authorization Ensure PA approval before therapy initiation

Appeals Process in Washington

Internal Appeals

First level: Submit within 180 days of denial

  • Use Cigna's appeals form
  • Include all supporting documentation
  • Request expedited review if urgent

Second level: Available if first appeal denied

  • Automatic or upon request
  • Independent medical review

External Review

Washington's Independent Review Process:

  1. Eligibility: Available after internal appeals exhausted
  2. Timeline: 180 days from final internal denial to request external review
  3. Process: Submit request to Office of the Insurance Commissioner
  4. Review: Independent Review Organization (IRO) makes binding decision
  5. Standard timeline: 30 days for decision
  6. Expedited: 72 hours for urgent cases

Contact Washington OIC:

From our advocates: "We've seen several Washington patients successfully overturn Myozyme denials through external review by providing comprehensive diagnostic documentation and specialist letters emphasizing the life-threatening nature of untreated Pompe disease. The key is addressing every point in the original denial letter with specific clinical evidence."

Quick Reference Checklist

Before You Start

  • Confirm active Cigna coverage with specialty benefits
  • Verify prescriber specialty credentials
  • Gather complete diagnostic documentation
  • Obtain weight/height for dosing calculations

Documentation Packet

  • Completed PA form with all required fields
  • GAA enzyme activity results or genetic testing
  • Medical necessity letter from specialist
  • Insurance card copies (front and back)
  • Clinical notes documenting disease progression

Submission

  • Submit via preferred electronic method (CoverMyMeds)
  • Keep confirmation numbers
  • Set follow-up reminders
  • Prepare for potential peer-to-peer review

If Denied

  • Request detailed denial letter
  • File internal appeal within 180 days
  • Consider external review through Washington OIC
  • Maintain detailed records of all communications

Frequently Asked Questions

Q: How long does Cigna prior authorization take for Myozyme in Washington? A: Standard review is 72 hours to 14 days. Expedited reviews for urgent cases are completed within 24-72 hours.

Q: What if Myozyme is non-formulary on my Cigna plan? A: Request a formulary exception with medical necessity documentation. Non-formulary status doesn't preclude coverage when medically necessary.

Q: Can I request an expedited appeal in Washington? A: Yes, both internal and external appeals can be expedited if your health could be in serious jeopardy without treatment.

Q: Does step therapy apply to Myozyme? A: Cigna doesn't require step therapy for Myozyme, but coverage depends on confirmed Pompe disease diagnosis and specialist prescribing.

Q: What's the success rate for Myozyme appeals? A: While specific statistics aren't published, appeals with complete diagnostic documentation and specialist support have favorable outcomes, especially through Washington's external review process.

Q: Can I use a different specialty pharmacy besides Accredo? A: For Cigna/Express Scripts members, using out-of-network specialty pharmacies may result in denial or reduced reimbursement. Accredo is typically required.

Q: What happens if I miss the appeal deadline? A: Washington allows 180 days for internal appeals and external review requests. Missing deadlines may forfeit appeal rights, so act promptly.

Q: How do I prove medical necessity for infantile-onset Pompe disease? A: Document early symptom onset, cardiac involvement, motor delays, and reference literature showing improved survival with early treatment initiation.

Navigating insurance approvals for rare disease treatments like Myozyme can feel overwhelming, but Counterforce Health specializes in turning denials into approvals by crafting evidence-based appeals that speak directly to payer requirements. Our platform helps clinicians save time while ensuring patients get access to life-saving treatments.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice and should not replace consultation with qualified healthcare providers or insurance professionals. Coverage decisions depend on individual circumstances and plan specifics. Always verify current requirements with Cigna and Washington state regulators, as policies and procedures may change.

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