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

How to Get Xenpozyme (olipudase alfa-rpcp) Covered by Humana in Illinois: Complete Requirements Checklist and Appeals Guide

Answer Box: Getting Xenpozyme Covered by Humana in Illinois

Humana requires prior authorization for Xenpozyme (olipudase alfa-rpcp) across all plan types in Illinois. The fastest path to approval: (1) Confirm ASMD diagnosis with genetic testing and enzyme assay showing <10% acid sphingomyelinase activity, (2) Submit PA request via Humana's provider portal with specialist oversight documentation, and (3) Use HCPCS code J0218 with proper ICD-10 coding. First step today: Verify active coverage and formulary status using Humana's Prior Authorization Search Tool.

Table of Contents

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

Who Should Use This Guide

This comprehensive checklist helps patients with confirmed acid sphingomyelinase deficiency (ASMD/Niemann-Pick disease types A/B) and their healthcare providers navigate Humana's prior authorization process for Xenpozyme in Illinois.

You'll need this guide if:

  • Your doctor has prescribed Xenpozyme for confirmed ASMD
  • You have Humana Medicare Advantage, Part D, or commercial coverage
  • You're facing a prior authorization requirement or denial
  • You need to appeal a coverage decision

Expected outcome: Following this checklist significantly improves approval odds by ensuring complete documentation and proper submission procedures.

Member & Plan Basics

Coverage Verification Steps

1. Confirm Active Enrollment

  • Log into your Humana member portal or call member services
  • Verify coverage is active for the treatment dates
  • Note your member ID and group number

2. Check Plan Type Different Humana plans follow different processes:

  • Medicare Advantage (Part C): Federal appeal timelines apply
  • Medicare Part D: Prescription drug coverage with specialty tiers
  • Commercial plans: May use Illinois state external review process

3. Verify Formulary Status Use Humana's Prior Authorization Search Tool to check:

  • Whether Xenpozyme requires PA (it does for most plans)
  • Formulary tier placement
  • Any quantity limits or site-of-care restrictions
Tip: Screenshot your formulary lookup results with date stamps for your records.

Clinical Criteria Requirements

Diagnosis Confirmation

Required: Confirmed ASMD Diagnosis Humana requires both biochemical and genetic confirmation:

  1. Enzyme Testing: Acid sphingomyelinase activity <10% of normal controls in:
    • Peripheral blood leukocytes (preferred)
    • Cultured skin fibroblasts
    • Dried blood spots
  2. Genetic Testing: Biallelic pathogenic variants in the SMPD1 gene

ICD-10 Diagnostic Codes

Use the appropriate code based on disease type:

  • E75.241: Niemann-Pick disease type B (most common for Xenpozyme)
  • E75.244: Niemann-Pick disease type A/B
  • E75.240: Niemann-Pick disease type A (verify CNS involvement)

Specialist Oversight

Prescription must be from or in consultation with:

  • Board-certified geneticist
  • Hematologist
  • Pulmonologist
  • Hepatologist
  • Pediatric metabolic specialist
  • Physician experienced in ASMD management

Disease Severity Documentation

For patients ≥18 years, document:

  • DLco ≤70% (pulmonary function)
  • Spleen volume ≥6 multiples of normal (MRI measurement)
  • Splenomegaly-related symptom score ≥5

Coding & Billing Requirements

HCPCS Billing Code

Primary Code: J0218 (Injection, olipudase alfa-rpcp, 1 mg)

  • Effective April 1, 2023
  • Bill per mg administered
  • Maximum reimbursement: $385.67 per unit

NDC Information

  • NDC Number: 58468-0050-01
  • Units: Report as "UN1"
  • Available strength: 20 mg single-dose vial

Dosing Requirements

Initial Dosing: 0.1 mg/kg IV every 2 weeks Maintenance Dosing: Up to 3 mg/kg IV every 2 weeks

  • Document weight-based calculations
  • Include dose escalation plan
  • Note infusion monitoring protocols

Documentation Packet

Medical Necessity Letter Components

Your specialist should include:

Patient Information

  • Full name, DOB, member ID
  • Confirmed ASMD diagnosis with test results
  • Disease type (A, B, or A/B)

Clinical Justification

  • Current symptoms and functional limitations
  • Baseline organ involvement (liver, spleen, lungs)
  • Risk of disease progression without treatment

Treatment Plan

  • Weight-based dosing calculations
  • Infusion schedule and monitoring plan
  • Expected clinical outcomes

Supporting Evidence

  • Reference to FDA approval for non-CNS ASMD manifestations
  • Clinical trial data supporting efficacy
  • Specialist society guidelines (if available)

Required Attachments

  • Genetic testing results (SMPD1 variants)
  • Enzyme assay results (<10% activity)
  • Baseline imaging (spleen volume, chest imaging)
  • Pulmonary function tests (if applicable)
  • Laboratory results (lipid profile, blood counts)
  • Specialist consultation notes
Note: Organize documents chronologically with clear labels for faster review.

Submission Process

Electronic Submission (Preferred)

  1. Access Portal: Log into Humana's provider portal
  2. Select Drug: Search for "Xenpozyme" or "olipudase alfa-rpcp"
  3. Complete Forms: Fill all required fields accurately
  4. Upload Documents: Attach all supporting materials as PDFs
  5. Record Confirmation: Save confirmation number and submission date

Decision Timeline

  • Standard Review: 1-7 business days for most requests
  • Expedited Review: 24-72 hours when urgency is documented
  • Auto-escalation: If no decision within 7 days, automatically advances to higher review

Tracking Your Request

Check status daily through the provider portal or by calling Humana's PA department with your confirmation number.

Specialty Pharmacy Network

Humana works with preferred specialty pharmacy partners for Xenpozyme distribution:

Preferred Network Partners

  • CenterWell Specialty Pharmacy (Humana-owned): 1-800-486-2668
  • CVS Specialty Pharmacy
  • Accredo
  • Orsini Specialty Pharmacy
Important: Using out-of-network pharmacies may result in denials or higher costs. Verify network status before prescribing.

Coordination Steps

  1. Enrollment: Patient registers with preferred specialty pharmacy
  2. Prescription Transfer: Coordinate transfer from prescribing provider
  3. Delivery Confirmation: Verify infusion center can receive and store medication
  4. Insurance Verification: Pharmacy confirms coverage before dispensing

After Submission: Tracking Your Request

What to Monitor

  • Confirmation Receipt: Within 24-48 hours
  • Review Status: Check portal daily
  • Decision Notice: 5-7 business days typical

Record Keeping

Document all interactions:

  • Confirmation numbers
  • Representative names and contact information
  • Decision dates and reference numbers
  • Any additional information requests

If Additional Information is Requested

Respond promptly with requested documentation to avoid delays or automatic denials.

Appeals Process in Illinois

Internal Appeals (First Level)

Medicare Plans Timeline:

  • File within: 65 days of denial notice
  • Decision time: 7 calendar days standard, 72 hours expedited
  • Auto-escalation: If no decision in 7 days

Commercial Plans Timeline:

  • File within: Time varies by plan (check your denial letter)
  • Decision time: 15 business days standard, 24 hours expedited

External Review Options

For Medicare Plans:

  • Independent Review Entity (IRE): Federal process through CMS
  • Timeline: 60 days from internal appeal decision
  • Cost: Free to members

For State-Regulated Plans:

  • Illinois External Review: Through Illinois Department of Insurance
  • Timeline: Must request within 30 days of final denial
  • Decision time: 5 business days after IRO receives materials
  • Cost: Free to consumers

Illinois Consumer Assistance

Illinois Department of Insurance Consumer Helpline: 877-527-9431

  • Help with understanding appeal rights
  • Assistance filing external reviews
  • General insurance coverage questions

Common Denial Reasons & How to Avoid Them

Denial Reason Prevention Strategy
Incomplete diagnosis confirmation Submit both genetic testing and enzyme assay results
Non-specialist prescriber Ensure prescription is from qualified specialist or includes consultation documentation
Missing baseline assessments Include spleen imaging, pulmonary function tests, and laboratory results
Inadequate medical necessity Provide detailed symptom documentation and functional impact
Incorrect coding Use proper ICD-10 codes and verify HCPCS J0218 billing

Pro Tips for Approval

  1. Submit complete packages: Incomplete submissions often result in automatic denials
  2. Use proper terminology: Reference "non-CNS manifestations of ASMD" as per FDA indication
  3. Document urgency: For expedited review, clearly state medical urgency
  4. Follow up promptly: Respond to information requests within 24-48 hours
  5. Keep detailed records: Document all communications for potential appeals

Quick Reference Checklist

Before Submission:

  • Verify active Humana coverage
  • Confirm PA requirement via search tool
  • Gather genetic testing results (SMPD1)
  • Obtain enzyme assay results (<10% activity)
  • Document specialist involvement
  • Calculate weight-based dosing
  • Prepare medical necessity letter

Clinical Documentation:

  • ICD-10 code (E75.241, E75.244, or E75.240)
  • HCPCS code J0218
  • NDC 58468-0050-01
  • Baseline organ assessments
  • Treatment monitoring plan

Submission Process:

  • Submit via provider portal
  • Upload all supporting documents
  • Record confirmation number
  • Set up specialty pharmacy coordination
  • Track status daily

If Denied:

  • Review denial reason carefully
  • File appeal within required timeframe
  • Consider expedited appeal if urgent
  • Contact Illinois DOI if needed (877-527-9431)

From our advocates: "We've seen the highest success rates when providers include both the genetic testing results and a detailed letter explaining why Xenpozyme is specifically needed for this patient's non-CNS ASMD manifestations. The key is connecting the diagnosis directly to the FDA-approved indication and documenting baseline organ involvement that justifies treatment urgency."

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals through targeted, evidence-backed strategies. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by analyzing denial letters, plan policies, and clinical notes to create compelling rebuttals aligned with each payer's specific criteria.

When facing a Humana denial for Xenpozyme, Counterforce Health can help identify the exact denial basis—whether it's PA criteria, step therapy, non-formulary status, or "not medically necessary"—and draft point-by-point responses using the right clinical evidence, FDA labeling, and specialty guidelines that payers expect to see.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical advice. Coverage decisions vary by individual circumstances and plan details. Always consult with your healthcare provider about treatment options and contact your insurance company directly for plan-specific information. For personalized assistance with Illinois insurance matters, contact the Illinois Department of Insurance at 877-527-9431.

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