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

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

Answer Box: Getting Xenpozyme Covered by Humana in Michigan

Who's eligible: Adults and children with confirmed acid sphingomyelinase deficiency (ASMD/Niemann-Pick types A/B) requiring treatment for non-CNS manifestations. Fastest approval path: Submit prior authorization with genetic testing or enzyme assay showing ASM activity <10% of normal, plus specialist letter documenting liver/lung/spleen involvement and failed supportive care. Start today: Contact your metabolic specialist or geneticist to request a letter of medical necessity and gather baseline organ assessments. Appeals in Michigan have 65 days from denial with external review through DIFS if needed.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Information
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Coordination
  8. After Submission: What to Expect
  9. Common Denial Prevention Tips
  10. Appeals Process in Michigan
  11. Quick Reference Checklist

Who Should Use This Checklist

This guide helps patients and healthcare providers navigate Humana's prior authorization process for Xenpozyme (olipudase alfa-rpcp) in Michigan. You'll need this if:

  • Your doctor has prescribed Xenpozyme for acid sphingomyelinase deficiency
  • Humana is your primary or secondary insurer (Medicare Advantage, commercial, or Medicaid managed care)
  • You're preparing an initial prior authorization request or appealing a denial

Expected outcome: With complete documentation following this checklist, approval rates for properly diagnosed ASMD patients typically exceed 80% on initial submission, according to specialty pharmacy data.

Member & Plan Basics

Verify Active Coverage

Before starting, confirm your Humana coverage is active and includes prescription drug benefits. Check your member ID card for:

  • Plan type (Medicare Advantage, commercial PPO/HMO, Medicaid)
  • Prescription drug coverage indicator
  • Customer service number for benefits verification

Understanding Your Plan Requirements

Xenpozyme requires prior authorization across all Humana plans. Key considerations:

  • Deductible: Medicare Part B drugs like Xenpozyme may be subject to your annual deductible
  • Site of care: Some plans restrict administration to specific infusion centers
  • Specialty pharmacy: Buy-and-bill arrangements may be required depending on your plan
Tip: Call the customer service number on your ID card to verify your specific plan's requirements for specialty infusion medications.

Clinical Criteria Requirements

Primary Indication Requirements

Xenpozyme is FDA-approved for non-central nervous system manifestations of ASMD in adults and pediatric patients. Your documentation must clearly specify treatment targets non-CNS symptoms only.

Required diagnosis confirmation (choose one):

  • Acid sphingomyelinase enzyme activity <10% of normal control sample
  • Documented biallelic disease-causing variants in SMPD1 gene

Baseline Disease Severity Documentation

Prior authorization typically requires evidence of significant organ involvement:

  • Spleen volume: At least 5 times normal for age/gender, OR prior splenectomy
  • Plus one of:
    • Hepatic involvement with documented enlargement
    • Interstitial lung disease (DLCO <70% predicted or imaging evidence)
    • Clinically significant non-transient organ damage

Specialist Requirement

Prescriptions must come from appropriate specialists:

  • Medical geneticist
  • Metabolic disease specialist
  • Hematologist with ASMD experience
  • Pediatric specialist (for patients under 18)

Coding and Billing Information

HCPCS and Billing Codes

  • HCPCS J-code: J0218 (Injection, olipudase alfa-rpcp, 1 mg)
  • Standard dose: 344 billable units (344 mg) every 14 days
  • Administration: Intravenous infusion over several hours with premedication

ICD-10 Diagnosis Codes

Primary diagnosis codes for ASMD:

  • E75.240 - Niemann-Pick disease type A
  • E75.241 - Niemann-Pick disease type B
  • E75.248 - Other sphingolipidosis
  • E75.249 - Sphingolipidosis, unspecified

Medicare Part B vs Part D Coverage

Xenpozyme is covered under Medicare Part B as a physician-administered drug, not Part D. This affects your cost-sharing and appeals process.

Documentation Packet Essentials

Provider Letter of Medical Necessity

Your specialist's letter should include:

Patient identification and diagnosis:

  • Complete ASMD diagnosis with supporting test results
  • ICD-10 codes listed above
  • Disease severity and organ involvement

Treatment rationale:

  • Why Xenpozyme is medically necessary
  • Documentation that supportive care has been insufficient
  • Treatment goals and expected outcomes

Clinical monitoring plan:

  • Baseline assessments completed
  • Follow-up schedule for effectiveness monitoring
  • Safety monitoring protocols

Required Test Results

Submit copies of:

  • Genetic testing results showing SMPD1 variants, OR
  • Enzyme assay showing ASM activity <10% of control
  • Imaging studies documenting organ involvement
  • Pulmonary function tests if lung involvement present
  • Laboratory results showing disease biomarkers

Prior Treatment Documentation

Include records of:

  • Supportive care measures attempted
  • Symptom progression despite current management
  • Any complications from disease progression

Submission Process

Humana Prior Authorization Submission

Online submission: Use Humana's provider portal for fastest processing

Alternative submission methods:

  • Fax: Use the fax number specific to your plan type (verify current number through provider portal)
  • Mail: Submit to address listed on prior authorization form

Required Forms

  • Humana's prior authorization request form (verify current version)
  • Prescriber attestation form
  • Patient consent for treatment

Processing Timeline

  • Standard requests: Decision within 72 hours
  • Expedited requests: Decision within 24 hours (requires urgent medical necessity)
  • Payment decisions: Up to 14 calendar days for coverage determinations

Specialty Pharmacy Coordination

Buy-and-Bill Requirements

For many Humana plans, Xenpozyme must be obtained through buy-and-bill rather than specialty pharmacy. Coordinate with:

  • Your infusion center's pharmacy team
  • Humana's specialty pharmacy network (if applicable)
  • Sanofi's patient support program

Site of Care Considerations

Xenpozyme administration requires:

  • Healthcare provider supervision
  • Premedication protocols
  • Emergency response capabilities
  • Infusion monitoring equipment

Some Humana plans may restrict coverage to specific infusion center networks.

After Submission: What to Expect

Confirmation and Tracking

  • Record your prior authorization reference number
  • Set calendar reminders for follow-up if no response within expected timeframe
  • Monitor your Humana member portal for status updates

Approval Communications

Approvals typically include:

  • Coverage duration (usually 12 months)
  • Quantity limits per administration
  • Required monitoring or follow-up requirements

If Additional Information is Requested

Respond promptly to any requests for:

  • Additional clinical documentation
  • Peer-to-peer review scheduling
  • Clarification of treatment plan

Common Denial Prevention Tips

Five Critical Pitfalls to Avoid

1. CNS treatment requests

  • Problem: Submitting requests that mention CNS or brain involvement
  • Solution: Clearly specify treatment is for non-CNS manifestations only

2. Insufficient diagnostic documentation

  • Problem: Missing enzyme assay results or genetic testing
  • Solution: Include complete test results showing ASM deficiency <10% or SMPD1 variants

3. Non-specialist prescribers

  • Problem: Requests from general practitioners or non-metabolic specialists
  • Solution: Ensure prescription comes from geneticist, metabolic specialist, or appropriate pediatric specialist

4. Missing baseline assessments

  • Problem: No documentation of organ involvement severity
  • Solution: Include imaging, pulmonary function tests, and laboratory evidence of disease impact

5. Incomplete monitoring plan

  • Problem: Vague treatment goals or follow-up schedules
  • Solution: Provide specific monitoring timeline with measurable endpoints

Appeals Process in Michigan

Humana Internal Appeals

If your initial request is denied, you have 65 days from the denial notice to file an appeal.

Medicare Part B appeals timeline:

  • Level 1: Redetermination within 30 days
  • Level 2: Independent review organization within 60 days

Submission methods:

  • Online through your Humana member portal
  • Phone: Customer care number on your ID card
  • Mail/fax: Use Humana's appeal forms

Michigan External Review

If Humana's internal appeal is unsuccessful, Michigan residents can request external review through the Department of Insurance and Financial Services (DIFS).

Key details:

  • Deadline: 127 days from final internal denial
  • Process: Submit online or paper form to DIFS
  • Timeline: Decision within 60 days (72 hours for expedited)
  • Contact: DIFS at 877-999-6442

For urgent situations, request expedited external review with physician letter stating delay would harm patient health.

At Counterforce Health, we help patients and providers navigate complex prior authorization requirements by analyzing denial letters and crafting targeted, evidence-backed appeals. Our platform specializes in turning insurance denials into successful approvals for specialty medications like Xenpozyme.

When to Escalate Further

If external review is unsuccessful, additional options include:

  • Filing complaints with Michigan DIFS
  • Contacting Michigan Attorney General's office
  • Seeking legal counsel for coverage disputes

Quick Reference Checklist

Before You Start:

  • Verify active Humana coverage with prescription benefits
  • Confirm specialist will prescribe (geneticist/metabolic specialist)
  • Gather insurance ID card and member information

Required Clinical Documentation:

  • ASMD diagnosis confirmation (enzyme assay <10% OR SMPD1 genetic testing)
  • Baseline organ assessments (liver, lung, spleen involvement)
  • ICD-10 codes: E75.240, E75.241, E75.248, or E75.249
  • Prior supportive care documentation
  • Specialist letter of medical necessity

Submission Requirements:

  • Complete Humana prior authorization form (current version)
  • HCPCS code J0218 for billing
  • Site of care coordination completed
  • Submit via provider portal or verified fax number

After Submission:

  • Record reference number and submission date
  • Set follow-up reminders (72 hours for standard, 24 hours for expedited)
  • Prepare appeal documents if denial occurs

If Denied:

  • File internal appeal within 65 days
  • Consider Michigan external review through DIFS (127-day deadline)
  • Gather additional clinical evidence if requested
From our advocates: We've seen the strongest approvals when providers submit a comprehensive packet upfront—complete genetic testing, detailed organ involvement documentation, and a clear monitoring plan. Taking time to gather everything before submission often prevents the back-and-forth that delays treatment starts.

Important Note: This guide provides general information about insurance processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance plan directly for coverage determinations.

For additional support with Michigan insurance appeals, contact the Michigan Department of Insurance and Financial Services at 877-999-6442 or visit their external review information page.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies and procedures may change. Always verify current requirements with your insurance plan and consult healthcare professionals for medical decisions.

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