By Counterforce Health Team in Xenpozyme (olipudase alfa-rpcp) —

The Requirements Checklist to Get Xenpozyme (olipudase alfa-rpcp) Covered by Humana in California

Answer Box: Getting Xenpozyme Covered by Humana in California

Fastest path to approval: Humana requires prior authorization for Xenpozyme (olipudase alfa-rpcp) with strict diagnostic and documentation standards. You'll need confirmed ASMD diagnosis (genetic testing + enzyme deficiency), specialist oversight, and complete medical necessity documentation. Submit via Humana's electronic portal with all required attachments. If denied, California's Independent Medical Review (IMR) process has a 55-69% success rate for overturning medical necessity denials. First step today: Verify your plan's formulary status and gather diagnostic confirmation at Humana's Prior Authorization Search Tool.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Documentation
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission: Tracking Your Request
  9. Common Denial Reasons & How to Avoid Them
  10. Appeals Process in California
  11. Quick Reference Checklist

Who Should Use This Checklist

This guide is designed for patients with acid sphingomyelinase deficiency (ASMD) and their healthcare providers seeking Humana coverage for Xenpozyme (olipudase alfa-rpcp) in California. You should use this checklist if:

  • You have a confirmed ASMD diagnosis (Niemann-Pick disease types A/B)
  • Your doctor has recommended Xenpozyme treatment
  • You're enrolled in a Humana plan (Medicare Advantage, commercial, or Part D)
  • You're facing a prior authorization requirement or denial

Expected outcome: Following this checklist increases your chances of first-time approval and provides a clear roadmap for appeals if needed. California residents have strong appeal rights through the state's Independent Medical Review process, with success rates exceeding 55% for medical necessity denials.

Member & Plan Basics

Coverage Verification Requirements

Requirement What to Check Where to Find It
Active Coverage Verify enrollment status Humana member portal or member ID card
Plan Type Medicare Advantage, Part D, or Commercial Member handbook or benefits summary
Formulary Status Tier placement and restrictions Humana formulary search
Prior Authorization PA requirement confirmation Humana provider portal or pharmacy benefits
Note: Humana designates Xenpozyme as a high-cost specialty medication requiring prior authorization across all plan types. This applies to both Medicare Advantage and commercial plans.

Deductible and Cost-Sharing

  • Medicare Part D plans: Xenpozyme may fall under specialty tier with 25-33% coinsurance
  • Medicare Advantage: Cost-sharing varies by plan; check your Evidence of Coverage
  • Commercial plans: Typically subject to medical benefit deductible and coinsurance

Clinical Criteria Requirements

Humana's clinical criteria for Xenpozyme approval are stringent and based on FDA labeling requirements:

Diagnostic Confirmation Required

Primary requirement: Documented diagnosis of ASMD confirmed by both:

  1. Enzyme deficiency: Absent or deficient acid sphingomyelinase (ASM) enzyme activity (<10% of normal)
  2. Genetic confirmation: Biallelic pathogenic variants in the SMPD1 gene

Disease Classification

  • Approved: ASMD types A/B or B (non-CNS manifestations)
  • Not covered: ASMD type A with predominant CNS involvement
  • ICD-10 code: E75.24 (Acid sphingomyelinase deficiency)

Specialist Oversight Requirement

Prescription must be by or in consultation with a board-certified specialist experienced in ASMD management:

  • Geneticist
  • Hematologist
  • Pulmonologist
  • Metabolic disease specialist

Clinical Manifestations Documentation

Evidence of non-CNS ASMD manifestations must include:

  • Organomegaly (spleen/liver enlargement)
  • Interstitial lung disease or reduced lung function
  • Thrombocytopenia
  • Abnormal liver enzymes
  • Lipid abnormalities

Coding and Documentation

Required Codes

Code Type Code Description
ICD-10 E75.24 Acid sphingomyelinase deficiency
HCPCS J0218 Injection, olipudase alfa-rpcp, 1 mg
NDC Varies by vial size Must match actual product dispensed

Dosing Documentation

Standard dosing protocol:

  • Initial: 0.1 mg/kg IV every 2 weeks (titration phase)
  • Maintenance: 3 mg/kg IV every 2 weeks
  • Document weight-based calculations and titration schedule

Documentation Packet

Medical Necessity Letter Components

Your specialist must provide a comprehensive letter including:

  1. Patient identification and ASMD diagnosis confirmation
  2. Diagnostic test results:
    • ASM enzyme activity levels
    • Genetic testing results (SMPD1 mutations)
    • Biomarker levels (lyso-sphingomyelin)
  3. Clinical manifestations with baseline measurements
  4. Treatment rationale and expected outcomes
  5. Dosing plan with monitoring schedule
  6. Contraindication screening results

Required Attachments

  • Genetic testing report
  • Enzyme activity assay results
  • Specialist consultation notes
  • Baseline imaging (spleen/liver size)
  • Laboratory results (CBC, liver function)
  • Pulmonary function tests (if applicable)
Tip: Use Sanofi's fillable medical necessity form as a template to ensure all required elements are included.

Submission Process

Electronic Submission (Preferred)

  1. Access Humana's provider portal at provider.humana.com
  2. Navigate to prior authorization section
  3. Select Xenpozyme from medication list
  4. Complete all required fields (incomplete submissions cause delays)
  5. Upload all supporting documents in PDF format
  6. Submit and record confirmation number

Processing Timeline

  • Standard requests: 1-3 business days for complete submissions
  • Expedited requests: Within 24-72 hours for urgent cases
  • Incomplete submissions: Additional 3-5 days for document requests
Note: Missing documentation is the leading cause of delays. Ensure all attachments are included before submission.

Specialty Pharmacy Routing

Xenpozyme is only available through limited distribution specialty pharmacies. Humana's preferred network typically includes:

Preferred Specialty Pharmacies

  • CVS Specialty Pharmacy
  • Accredo
  • Orsini Specialty Pharmacy (verify with current Humana contracts)

Transfer Process

  1. Verify pharmacy network status with Humana
  2. Coordinate with prescriber to send prescription to preferred pharmacy
  3. Confirm patient enrollment in pharmacy's patient support program
  4. Schedule delivery and infusion coordination
Important: Using out-of-network specialty pharmacies may result in higher costs or coverage denials.

After Submission: Tracking Your Request

Status Monitoring

  • Check portal daily for status updates
  • Record all reference numbers and correspondence
  • Set calendar reminders for follow-up calls
  • Document all communications with Humana representatives

Expected Communications

Timeline Expected Update Action Required
1-2 days Submission confirmation None
3-5 days Initial review complete Respond to any document requests
5-7 days Final determination If approved, coordinate with specialty pharmacy

Common Denial Reasons & How to Avoid Them

Denial Reason Prevention Strategy Documentation Fix
Incomplete diagnosis Provide both genetic and enzyme testing Submit complete lab reports with reference ranges
Missing specialist oversight Ensure specialist writes prescription Include board certification verification
Inadequate clinical documentation Document all ASMD manifestations Provide baseline measurements and imaging
Incorrect coding Use proper ICD-10 and HCPCS codes Verify codes match FDA indication
Site of care issues Follow Humana's infusion policies Document medical necessity for chosen site

Appeals Process in California

California offers robust appeal rights through multiple pathways:

Internal Appeals (First Step)

  1. File with Humana within 60 days of denial
  2. Include additional clinical evidence not in original submission
  3. Request peer-to-peer review if applicable
  4. Timeline: 30 days for standard appeals, 72 hours for urgent

Independent Medical Review (IMR)

If Humana upholds the denial, California residents can request an Independent Medical Review through the Department of Managed Health Care (DMHC):

  • Success rate: 55-69% of medical necessity denials are overturned
  • Timeline: 30 days for standard, 7 days for urgent cases
  • Cost: Free to patients
  • Contact: DMHC Help Center at 888-466-2219

External Support

California residents can get free assistance from:

  • Health Consumer Alliance
  • Legal aid organizations
  • DMHC consumer advocates

For complex rare disease cases like ASMD, organizations like Counterforce Health specialize in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned with payer policies.

Quick Reference Checklist

Before Submission

  • Confirm active Humana coverage
  • Verify specialty pharmacy network
  • Gather all diagnostic test results
  • Obtain specialist medical necessity letter
  • Complete prior authorization form
  • Collect all required attachments

During Submission

  • Use electronic portal when possible
  • Double-check all required fields
  • Upload clear, legible documents
  • Record confirmation number
  • Set follow-up reminders

After Submission

  • Monitor status daily
  • Respond promptly to requests
  • Coordinate with specialty pharmacy
  • Prepare appeal if denied

If Denied

  • Review denial letter carefully
  • File internal appeal within 60 days
  • Consider peer-to-peer review
  • Prepare for IMR if needed
  • Seek external advocacy support

From our advocates: We've seen ASMD patients succeed with Humana appeals by focusing on the "substrate-shift" risk language in the FDA label. When patients emphasized the medical urgency of enzyme replacement and provided detailed baseline organ measurements, approval rates improved significantly. This composite experience shows the importance of framing Xenpozyme not just as treatment, but as prevention of irreversible organ damage.

Disclaimer: This guide is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. For assistance with appeals or coverage questions, contact the California Department of Managed Health Care at 888-466-2219.

Sources & Further Reading

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