By Counterforce Health Team in Naglazyme (galsulfase) —

The Requirements Checklist to Get Naglazyme (Galsulfase) Covered by UnitedHealthcare in Florida: Forms, Appeals, and Clinical Criteria

Answer Box: Getting Naglazyme Covered by UnitedHealthcare in Florida

UnitedHealthcare requires prior authorization for Naglazyme (galsulfase) through OptumRx, with no step therapy requirements identified for MPS VI. Submit via UnitedHealthcare Provider Portal with confirmed MPS VI diagnosis (enzyme assay or genetic testing), baseline functional assessments, and medical necessity letter. First step today: Verify your plan type (commercial uses OptumRx) and gather diagnostic confirmation documents. If denied, Florida provides external review through the Department of Financial Services within 4 months of final denial.

Key contacts: OptumRx PA: 1-800-711-4555; Urgent fax: 1-844-403-1027

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria for Coverage
  4. Coding Requirements
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Network
  8. After Submission: What to Expect
  9. Common Denial Reasons & Prevention
  10. Appeals Process in Florida
  11. Patient Assistance Programs
  12. Quick Reference Checklist

Who Should Use This Guide

This checklist is designed for patients with mucopolysaccharidosis type VI (MPS VI) and their healthcare teams seeking UnitedHealthcare coverage for Naglazyme (galsulfase) in Florida. Use this guide if you're facing:

  • Initial prior authorization requests for enzyme replacement therapy
  • Denials citing "not medically necessary" or missing documentation
  • Challenges with specialty pharmacy enrollment
  • Appeals after coverage rejection

Expected outcome: With proper documentation following UnitedHealthcare's enzyme replacement therapy policy, most medically appropriate requests are approved. The key is submitting complete clinical evidence upfront.

Member & Plan Basics

Verify Your Coverage Type

UnitedHealthcare manages Naglazyme differently based on your plan:

Plan Type Pharmacy Benefit Manager Prior Auth Required
Commercial/Employer OptumRx Yes
Medicare Advantage OptumRx (most plans) Yes
Medicaid Varies by state contract Yes

Action step: Check your member ID card or log into myuhc.com to confirm your specific plan type.

Understanding Your Benefits

Naglazyme is typically covered as a specialty tier medication with high cost-sharing. Key benefit details to review:

  • Deductible status: Medical benefit (IV infusion) vs. pharmacy benefit
  • Coinsurance: Often 20-40% for specialty tiers
  • Out-of-pocket maximum: Critical for budgeting high-cost therapies
  • Site of care restrictions: Hospital outpatient vs. infusion center requirements

Clinical Criteria for Coverage

UnitedHealthcare's Medical Therapies for Enzyme Deficiencies policy requires all of the following for initial approval:

1. Confirmed MPS VI Diagnosis

One of these diagnostic methods:

  • Enzyme assay: Deficient N-acetylgalactosamine-4-sulfatase activity in fibroblasts or leukocytes
  • Genetic testing: Pathogenic variants in the ARSB gene

2. Clinical Signs and Symptoms

Documentation must include evidence of:

  • Enlarged liver and spleen (hepatosplenomegaly)
  • Joint limitations or contractures
  • Airway obstruction or pulmonary problems
  • Mobility limitations while still ambulatory

3. FDA-Approved Dosing

  • Standard dose: 1 mg/kg IV infusion once weekly
  • Administration: Hospital or infusion center with monitoring for infusion reactions
  • Premedications: As clinically indicated per FDA labeling

4. Functional Assessment Requirements

For both initial and continuation requests, include:

  • Six-minute walk test (6MWT): Baseline and follow-up distances
  • Pulmonary function tests: FVC, FEV1 values and trends
  • Activities of daily living assessment: Mobility, self-care, school/work participation
  • Joint range of motion documentation: Limitations and progression
From our advocates: We've seen faster approvals when providers include a comprehensive functional assessment table showing baseline measurements and specific treatment goals. This demonstrates the medical team's commitment to monitoring objective outcomes, which aligns with UnitedHealthcare's emphasis on evidence-based care.

Coding Requirements

Primary Diagnosis

  • ICD-10-CM: E76.29 (Other mucopolysaccharidoses)
  • Clinical documentation: Must clearly state "MPS VI (Maroteaux-Lamy syndrome)"

Drug Billing Codes

  • HCPCS: J1458 (Injection, galsulfase, 1 mg)
  • NDC: 68135-0020-01 (5 mg/5 mL vial)
  • Units: Bill J1458 units equal to total mg administered

Administration Codes

  • CPT 96365: IV infusion, initial hour
  • CPT 96366: Each additional hour
  • Document: Exact infusion start/stop times for accurate coding

Documentation Packet

Provider Note Requirements

Your clinical documentation must include:

Diagnosis confirmation:

  • Laboratory results showing enzyme deficiency
  • Genetic test results (if applicable)
  • Clinical history consistent with MPS VI

Treatment rationale:

  • Why Naglazyme is medically necessary
  • Expected functional improvements
  • Consequences of treatment delay

Baseline assessments:

  • Current functional status
  • Objective measurements (6MWT, PFTs)
  • Quality of life impact

Medical Necessity Letter Components

Structure your letter to address UnitedHealthcare's specific criteria:

  1. Patient demographics and plan information
  2. Confirmed MPS VI diagnosis with supporting lab/genetic data
  3. Clinical signs and symptoms per UHC policy
  4. Functional assessment results and treatment goals
  5. FDA-approved dosing plan and administration setting
  6. Expected outcomes and monitoring plan

Required Attachments

  • Most recent clinic notes (within 6 months)
  • Enzyme assay and/or genetic test reports
  • Functional testing results (6MWT, PFTs)
  • Relevant imaging or specialist consultations
  • Any prior denial letters (for appeals)

Submission Process

Step-by-Step Submission

  1. Verify current PA requirements via UnitedHealthcare Provider Portal
  2. Submit prior authorization request:
    • Preferred: UnitedHealthcare Provider Portal or CoverMyMeds integration
    • Alternative: Optum Pro Portal or fax to 1-844-403-1027
  3. For urgent requests: Call 1-800-711-4555 for expedited processing
  4. Track submission: Record confirmation numbers and follow-up dates

Required Fields That Prevent Rejections

Common submission errors include:

  • Missing patient weight for dose calculation
  • Incomplete diagnostic documentation
  • Unclear administration site planning
  • Missing prescriber specialty credentials

Specialty Pharmacy Network

UnitedHealthcare OptumRx preferred specialty pharmacies for Naglazyme include:

  • Accredo Health Group
  • AllianceRx Walgreens Pharmacy
  • Amber Specialty Pharmacy
  • AleraCare
  • FloMed Infusion Services
  • Amerita
  • Orsini Pharmaceutical Services
  • Optum Specialty

Enrollment Process

  1. Upon PA approval: Physician sends prescription to chosen pharmacy
  2. Patient enrollment: Pharmacy contacts patient for benefits verification
  3. Infusion coordination: Pharmacy arranges delivery to infusion site
  4. Administration: IV infusion over several hours with premedications

Contact for pharmacy support: 1-855-427-4682 (24/7)

After Submission: What to Expect

Timeline Expectations

  • Standard PA review: 3-5 business days
  • Expedited review: 24-72 hours (urgent cases)
  • Additional information requests: May extend timeline by 7-10 days

Status Monitoring

  • Check portal daily for updates
  • Document all communication attempts
  • Maintain copies of all submitted materials

Approval Indicators

  • PA number issued
  • Pharmacy notification sent
  • Clear coverage dates and limitations

Common Denial Reasons & Prevention

Denial Reason Prevention Strategy Required Documentation
Lack of confirmed diagnosis Submit complete enzyme assay or genetic testing Lab reports with reference ranges
Missing functional measures Include comprehensive baseline assessments 6MWT, PFTs, ADL evaluations
Unclear medical necessity Provide detailed clinical rationale Specialist letter with treatment goals
Site-of-care issues Confirm infusion center capabilities Administration site verification
Dosing concerns Document weight-based calculations Current weight and dose justification

Five Critical Prevention Tips

  1. Submit complete documentation upfront - Avoid "information pending" delays
  2. Use UnitedHealthcare's exact policy language in your medical necessity letter
  3. Include objective functional measurements - Subjective assessments aren't sufficient
  4. Verify specialty pharmacy network before prescription submission
  5. Document infusion site capabilities for safety monitoring requirements

Appeals Process in Florida

Internal Appeals (UnitedHealthcare)

Timeline: Must file within 180 days of denial for most commercial plans

Submission options:

  • UnitedHealthcare Provider Portal (preferred)
  • Written appeal to address on denial letter
  • Fax to number specified in denial notice

Required elements:

  • Original denial letter
  • Additional clinical documentation
  • Updated medical necessity letter addressing denial reasons
  • Peer-reviewed literature supporting treatment

External Review (Florida Department of Financial Services)

If UnitedHealthcare upholds its denial, Florida residents can request external review:

Timeline: Within 4 months of final internal denial

Process: Contact Florida Department of Financial Services Consumer Services Division

Decision timeline:

  • Standard review: 45 days
  • Expedited review: 72 hours (urgent cases)

Effect: External reviewer's decision is binding on UnitedHealthcare

For assistance with appeals, call the Florida Insurance Consumer Helpline: 1-877-693-5236

Patient Assistance Programs

Manufacturer Support

BioMarin RareConnections provides:

  • Insurance verification and prior authorization support
  • Copay assistance for eligible patients
  • Patient and provider education resources

Contact: Through BioMarin RareConnections program

Additional Resources

  • National Organization for Rare Disorders (NORD): Patient assistance grants
  • HealthWell Foundation: Copay assistance for eligible rare disease patients
  • Patient Advocate Foundation: Insurance navigation and appeals support

Quick Reference Checklist

Before You Start

  • Verify UnitedHealthcare plan type and OptumRx management
  • Gather enzyme assay or genetic test results
  • Complete baseline functional assessments (6MWT, PFTs)
  • Confirm infusion site capabilities and monitoring

Documentation Package

  • Medical necessity letter addressing all UHC criteria
  • Recent clinic notes with MPS VI diagnosis
  • Diagnostic confirmation (enzyme/genetic testing)
  • Functional assessment results
  • Weight-based dose calculation
  • Administration site verification

Submission

  • Submit via UnitedHealthcare Provider Portal
  • Record confirmation number and submission date
  • Set calendar reminders for follow-up
  • Prepare specialty pharmacy transfer upon approval

If Denied

  • Review denial letter for specific reasons
  • Gather additional documentation to address concerns
  • File internal appeal within 180 days
  • Consider external review if internal appeals unsuccessful

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex specialty medications like Naglazyme. Our platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with payer requirements, pulling the right clinical evidence and procedural details to strengthen your case. When facing prior authorization challenges or appeals, having the right documentation strategy can make the difference between approval and prolonged delays.

For the most current forms, policies, and submission requirements, always verify information through official UnitedHealthcare provider resources and your specific plan documents, as policies may change with 30-60 days' notice.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical advice. Coverage decisions depend on individual medical circumstances and specific plan terms. Always consult with your healthcare provider regarding treatment decisions and verify current policy requirements with UnitedHealthcare directly.

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