By Counterforce Health Team in Aldurazyme (laronidase) —

How to Get Aldurazyme (Laronidase) Covered by Humana in Florida: Complete PA Guide with Forms and Appeals

Answer Box: Getting Aldurazyme Covered by Humana in Florida

Aldurazyme (laronidase) requires prior authorization from Humana and is covered as a Medicare Part B medical benefit. Your MPS I specialist must submit genetic testing, enzyme assay results, and a detailed treatment plan. Standard approval takes up to 30 days; expedited requests are processed within 72 hours for urgent cases. First step: Contact your prescribing physician to initiate the prior authorization through Humana's provider portal or by faxing to 888-447-3430.

Table of Contents

  1. Coverage at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Required Documentation
  4. Submission Methods and Forms
  5. Common Denial Reasons and Solutions
  6. Appeals Process in Florida
  7. Specialty Pharmacy Setup
  8. Cost Assistance Programs
  9. When to Contact Florida Regulators
  10. Frequently Asked Questions

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all Humana plans Humana PA Lists
Benefit Type Medicare Part B (medical benefit) Humana Provider Portal
Billing Code HCPCS J1931 FDA Prescribing Information
Site of Care Infusion center or hospital outpatient Policy requirement
Specialist Required MPS I specialist evaluation Humana medical policy
Genetic Testing IDUA gene mutations confirmed Clinical requirement
Appeal Deadline 65 days from denial notice Medicare Appeals Process

Step-by-Step: Fastest Path to Approval

1. Verify Your Coverage

Who: You or your clinic
Action: Log into MyHumana or call member services to confirm your plan covers specialty medications under Part B
Timeline: Same day

2. Gather Required Testing

Who: Your MPS I specialist
Action: Order genetic testing (IDUA mutations) and enzyme assay (alpha-L-iduronidase deficiency) if not already completed
Timeline: 1-2 weeks for results

3. Complete Baseline Assessments

Who: Your specialist
Action: Document baseline uGAG levels, functional assessments, and current symptoms
Timeline: 1 clinic visit

4. Submit Prior Authorization

Who: Your physician's office
Action: Submit PA request via Humana Provider Portal or fax to 888-447-3430
Timeline: Same day submission

5. Track Your Request

Who: You or your clinic
Action: Monitor status through provider portal or call 866-461-7273
Timeline: Check after 5 business days

6. Receive Decision

Who: Humana
Action: Standard decisions within 30 days; expedited within 72 hours
Timeline: Up to 30 days

7. Set Up Infusion Services

Who: Your clinic coordinator
Action: Coordinate with approved infusion center once PA is approved
Timeline: 1-2 weeks to schedule

Required Documentation

Your specialist must include these elements in the prior authorization request:

Clinical Documentation Checklist:Confirmed MPS I diagnosis with genetic testing resultsAlpha-L-iduronidase enzyme deficiency documentationBaseline urinary glycosaminoglycan (uGAG) levelsCurrent functional status and symptomsTreatment history and previous therapies triedDetailed infusion monitoring planExpected treatment goals and outcomes

Clinician Corner: Medical Necessity Letter

When writing the medical necessity letter, specialists should address:

  1. Diagnosis confirmation: Include ICD-10 code E76.01 (Hurler's syndrome) or E76.02 (Hurler-Scheie syndrome)
  2. Clinical rationale: Reference FDA prescribing information for approved indications
  3. Treatment plan: Weekly IV infusions with premedication protocol
  4. Monitoring: Regular assessments of respiratory function, hepatosplenomegaly, and mobility
  5. Safety protocols: Infusion reaction management and emergency procedures

Submission Methods and Forms

Primary Submission Routes

Method Contact Information Best For
Provider Portal provider.humana.com Electronic submission with tracking
Fax (Part B) 888-447-3430 Standard PA requests
Phone 866-461-7273 (M-F, 8am-6pm ET) Questions and status updates
Expedited Same numbers, mark "URGENT" Life-threatening situations

Required Forms

  • Standard prior authorization form (available through provider portal)
  • Medical necessity letter from MPS I specialist
  • Supporting clinical documentation
  • Genetic testing results

Common Denial Reasons and Solutions

Denial Reason How to Fix It
Missing genetic confirmation Submit IDUA gene mutation analysis results
Insufficient specialist documentation Provide letter from metabolic specialist or geneticist
Lack of baseline assessments Include uGAG levels and functional evaluations
Incomplete monitoring plan Detail infusion protocols and safety measures
Alternative therapy not tried Document contraindications to HSCT or other treatments
From our advocates: We've seen denials overturned when families work with their specialist to provide comprehensive genetic testing documentation. One family's appeal was successful after their metabolic specialist included detailed enzyme assay results and explained why alternative treatments weren't suitable for their child's specific MPS I subtype.

Appeals Process in Florida

If your initial request is denied, Florida residents have specific appeal rights:

Internal Appeal (First Level)

  • Deadline: 65 days from denial notice
  • Method: Submit written appeal to Humana with additional documentation
  • Timeline: Decision within 30 days for standard appeals, 72 hours for expedited

External Review (Second Level)

State Assistance

Contact the Florida Department of Financial Services Consumer Services division:

  • Phone: 877-693-5236
  • Email: [email protected]
  • Online: File complaints through their consumer portal

Specialty Pharmacy Setup

Once approved, Aldurazyme is typically managed through infusion centers rather than specialty pharmacies, but coordination is still important:

CenterWell Specialty Pharmacy (Humana's Preferred)

Infusion Center Coordination

Your specialist will help coordinate with an approved infusion center that can:

  • Order Aldurazyme directly from the manufacturer
  • Provide appropriate monitoring during infusions
  • Handle insurance billing and prior authorizations
  • Manage any infusion reactions

Cost Assistance Programs

Manufacturer Support

Sanofi/BioMarin offers patient assistance programs. Contact their patient support services for:

  • Copay assistance cards
  • Financial hardship programs
  • Insurance navigation support

Foundation Grants

  • National MPS Society may provide emergency financial assistance
  • Patient Advocate Foundation offers copay relief programs
  • Check eligibility at each organization's website

When to Contact Florida Regulators

Contact the Florida Department of Financial Services if:

  • Humana doesn't respond to appeals within required timeframes
  • You believe the denial violates Florida insurance laws
  • You need help navigating the external review process
  • You suspect bad faith claim handling

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex medications like Aldurazyme. Our platform analyzes denial letters, identifies the specific denial basis, and helps draft point-by-point rebuttals that align with each plan's requirements. For patients facing repeated denials or complex appeal situations, professional advocacy can significantly improve approval rates by ensuring all clinical documentation meets payer-specific criteria.

Frequently Asked Questions

How long does Humana prior authorization take for Aldurazyme in Florida? Standard decisions take up to 30 days from submission. Expedited requests for urgent medical situations are processed within 72 hours.

What if Aldurazyme is not on Humana's formulary? Aldurazyme is covered under Medicare Part B as a medical benefit, not Part D pharmacy benefits, so formulary status doesn't apply. However, prior authorization is still required.

Can I appeal if my child needs to start treatment immediately? Yes, request an expedited appeal by having your physician document the urgent medical need. Expedited appeals must be decided within 72 hours.

What genetic testing is required for approval? Humana typically requires confirmation of IDUA gene mutations and alpha-L-iduronidase enzyme deficiency testing to confirm MPS I diagnosis.

Does step therapy apply to Aldurazyme? Generally no, as there are no equivalent enzyme replacement therapies for MPS I. However, documentation of why HSCT isn't appropriate may be required.

How often do I need to renew authorization? Most plans require annual reauthorization with updated clinical assessments and treatment response documentation.

What if my appeal is denied by Humana? You can request an external review through the Florida Department of Financial Services, which provides independent medical review at no cost to you.

Can I use any infusion center in Florida? You must use a Humana-contracted facility. Your specialist can help identify approved infusion centers in your area.

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions and treatment recommendations.

About Coverage Appeals: Counterforce Health helps patients and clinicians navigate complex insurance approvals by creating targeted appeals that address specific payer requirements and denial reasons.

Sources & Further Reading

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