By Counterforce Health Team in Cerezyme (imiglucerase) —

How to Get Cerezyme (Imiglucerase) Covered by Cigna in Florida: Complete Prior Authorization and Appeals Guide

Quick Answer: Do You Qualify for Cerezyme Coverage by Cigna in Florida?

Yes, if you have confirmed Type 1 Gaucher disease with clinical symptoms. Cigna covers Cerezyme (imiglucerase) through Express Scripts/Accredo with prior authorization. Your fastest path: Have your specialist submit a complete PA request via CoverMyMeds with enzyme/genetic test results, clinical documentation, and dosing rationale. Cigna responds within 5 business days. If denied, you have 180 days to appeal, with external review available through Florida's Department of Financial Services within 120 days of final denial.

First step today: Contact your prescribing physician to gather diagnostic test results and initiate the prior authorization process.

Table of Contents

  1. Eligibility Requirements
  2. Prior Authorization Process
  3. Document Checklist
  4. Common Denial Reasons & Solutions
  5. Appeals Process in Florida
  6. Cost Assistance Programs
  7. FAQ
  8. When to Contact Florida Regulators

Eligibility Requirements for Cerezyme Coverage

Primary Requirements

Diagnosis Confirmation Required:

  • Confirmed Type 1 Gaucher disease via β-glucosidase enzyme assay (<15% of normal activity)
  • Genetic testing showing pathogenic GBA1 gene mutations
  • Clinical symptoms including at least one: anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly

Coverage Criteria:

  • Patient age ≥2 years (FDA-approved indication)
  • Prescribing by or consultation with metabolic disease specialist
  • Dosing within FDA label: 2.5 units/kg three times weekly to 60 units/kg once every two weeks
Note: Cigna requires specialty medications like Cerezyme to be dispensed through Accredo specialty pharmacy or approved network providers.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient/Caregiver)

  • Insurance card with Cigna member ID
  • Complete diagnostic test results
  • Previous treatment history records
  • Current lab values and imaging

2. Specialist Initiates PA Request (Physician Office)

  • Submit via CoverMyMeds portal (preferred) or SureScripts EHR integration
  • Alternative: Fax completed Cigna Cerezyme PA form (verify current fax number)
  • Include all required clinical documentation

3. Cigna Review Process

  • Standard timeline: 5 business days from complete submission
  • Expedited review available for urgent cases (call Cigna directly)

4. Authorization Outcome

  • Approval: Prescription can be filled through Accredo
  • Denial: Appeal rights begin (180-day window)

Submission Methods

Method Timeline Best For
CoverMyMeds 1-2 business days processing Most efficient
EHR Integration Same day submission Integrated workflows
Fax 3-5 business days Backup option

Document Checklist

Required Clinical Documentation

Diagnostic Evidence:

  • β-glucosidase enzyme assay results showing deficiency
  • Genetic testing confirming GBA1 pathogenic variants
  • ICD-10 diagnosis code for Type 1 Gaucher disease

Clinical Justification:

  • Documentation of qualifying symptoms (anemia, thrombocytopenia, bone disease, hepato/splenomegaly)
  • Current lab values and clinical assessments
  • Treatment goals and monitoring plan
  • Patient weight for dosing calculations

Provider Information:

  • Prescriber NPI and specialty designation
  • Specialist consultation notes (if applicable)
  • Medical necessity letter addressing FDA-approved indications

Clinician Corner: Medical Necessity Letter Checklist

Your medical necessity letter should address:

  1. Confirmed diagnosis with specific test results and dates
  2. Clinical manifestations requiring treatment per FDA labeling
  3. Dosing rationale within approved range (2.5-60 units/kg)
  4. Treatment goals and expected monitoring parameters
  5. Specialist oversight or consultation documentation

Include citations to FDA prescribing information and relevant clinical guidelines.

Common Denial Reasons & Solutions

Denial Reason How to Overturn
Insufficient diagnostic documentation Submit complete enzyme assay and genetic testing results
Dosing outside guidelines Provide FDA label citation or peer-reviewed evidence for dosing
Lack of specialist involvement Include consultation notes or referral documentation
Missing clinical symptoms Document qualifying manifestations per FDA indications
Incomplete prior authorization form Resubmit with all required fields completed
Tip: Cigna's denial rate for specialty medications is approximately 21% overall, but appeals with complete documentation have higher success rates.

Appeals Process in Florida

Internal Appeal Timeline

First-Level Internal Appeal:

  • Deadline: 180 days from denial notice
  • Review time: 30 days for prior authorization requests
  • Expedited: 72 hours for urgent cases
  • Submit to: Cigna member services (number on insurance card)

Required Appeal Documentation:

  • Original denial letter
  • Additional clinical evidence
  • Updated medical necessity letter
  • Any new supporting studies or guidelines

External Review Process

If internal appeals are unsuccessful, Florida law provides external review rights:

Timeline: Request within 120 days of final internal denial Contact: Florida Department of Financial Services at 1-877-MY-FL-CFO (1-877-693-5236) Review time: 45 days standard, 72 hours expedited Cost: No charge to consumer Decision: Binding on Cigna

Important: The external review decision is final and legally binding on your insurer.

Cost Assistance Programs

Manufacturer Support

  • Sanofi Patient Connection Program: May provide assistance for eligible patients
  • Copay assistance: Available for commercially insured patients (verify current offerings)

Additional Resources

  • State pharmaceutical assistance programs (income-based eligibility)
  • Patient advocacy organizations for Gaucher disease
  • Hospital charity care programs for infusion administration

For comprehensive support navigating insurance coverage and appeals, Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful, evidence-backed appeals by analyzing denial letters and crafting targeted rebuttals aligned with payer policies.

FAQ

How long does Cigna prior authorization take in Florida? Standard review is completed within 5 business days of receiving complete documentation. Expedited reviews for urgent cases are processed within 24 hours.

What if Cerezyme is not on Cigna's formulary? You can request a formulary exception within 72 hours (standard) or 24 hours (expedited). Your physician must document that formulary alternatives are inappropriate or ineffective.

Can I request an expedited appeal? Yes, if delay would seriously jeopardize your health. Mark all requests as "URGENT" and provide clinical justification for expedited review.

Does step therapy apply to Cerezyme? Step therapy requirements vary by plan. If required to try alternative ERTs first, your physician can request an override based on clinical contraindications or prior failures.

What happens if I'm currently taking Cerezyme and coverage is denied? Request expedited review citing continuity of care. Cigna must consider disruption of established therapy in their determination.

Who can help if Cigna continues to deny coverage? Contact Florida's Department of Financial Services Consumer Helpline at 1-877-MY-FL-CFO for assistance with insurance complaints and external review requests.

When to Contact Florida Regulators

Contact the Florida Department of Financial Services if:

  • Cigna fails to respond within required timeframes
  • Appeal rights are not properly communicated
  • You need assistance navigating the external review process
  • Pattern of inappropriate denials for rare disease medications

Florida DFS Consumer Services:

From Our Advocates

We've seen cases where patients initially received denials for Cerezyme due to incomplete diagnostic documentation. When the specialist resubmitted with comprehensive enzyme testing results and detailed clinical notes showing qualifying symptoms, approval was granted within the standard 5-day timeframe. The key is ensuring all FDA-required criteria are clearly documented upfront.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and procedures may change. Always verify current requirements with Cigna directly and consult with your healthcare provider regarding treatment decisions.

Sources & Further Reading

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