By Counterforce Health Team in Myozyme (alglucosidase alfa) —

How to Get Myozyme (alglucosidase alfa) Covered by Humana in New Jersey: Coding, Prior Authorization, and Appeals Guide

Answer Box: Getting Myozyme Covered by Humana in New Jersey

Myozyme (alglucosidase alfa) requires prior authorization from Humana Medicare Advantage plans and is covered under Medicare Part B when medically necessary for confirmed Pompe disease. Use ICD-10 code E74.02, HCPCS J0171, and submit PA requests through Humana's provider portal with GAA enzyme assays and genetic testing. If denied, New Jersey's IHCAP external review program provides independent physician review within 45 days. Start today: Verify your Humana plan's formulary status at Humana.com/pharmacy/medicare-drug-list and gather diagnostic documentation.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping for Pompe Disease
  3. Product Coding: HCPCS, J-Codes, and NDC Overview
  4. Clean Request Anatomy
  5. Frequent Pitfalls and Common Mistakes
  6. Verification Steps with Humana Resources
  7. Quick Audit Checklist
  8. Appeals Process in New Jersey
  9. FAQ

Coding Basics: Medical vs. Pharmacy Benefit Paths

Important Update: Myozyme has been discontinued in the United States and replaced by Lumizyme (alglucosidase alfa), though the coding principles remain the same.

Enzyme replacement therapy for Pompe disease typically falls under Medicare Part B (medical benefit) rather than Part D (prescription drug benefit) because it requires intravenous administration in a clinical setting. This distinction is crucial for billing and prior authorization.

Medical Benefit (Part B) Path

  • Coverage: 80% of allowable amount (ASP plus 6%)
  • Patient responsibility: 20% coinsurance
  • Billing entity: Physician or hospital purchases and administers
  • Reimbursement: Based on Average Sales Price plus 6%, updated quarterly

Key Requirements for Coverage

Humana Medicare Advantage plans require prior authorization for alglucosidase alfa, listed on their 2026 Medicare Prior Authorization List. Coverage follows Medicare Part B guidelines when administered incident to physician services.

ICD-10 Mapping for Pompe Disease

The primary diagnosis code for Pompe disease is E74.02 (Pompe disease, glycogen storage disease type 2). This code should appear in the primary diagnosis field on all claims and prior authorization requests.

Documentation Words That Support Coding

Your medical records should include specific terminology that supports the E74.02 diagnosis:

  • "Acid alpha-glucosidase (GAA) deficiency"
  • "Glycogen storage disease type 2"
  • "Confirmed by enzyme assay"
  • "Genetic testing positive for GAA mutations"
  • "Muscle weakness and respiratory involvement"
  • "Hypertrophic cardiomyopathy" (for infantile-onset)
Tip: Include both enzyme activity results (less than 40% of normal) and genetic confirmation when available, as payers often require dual confirmation.

Product Coding: HCPCS, J-Codes, and NDC Overview

Current Billing Codes

  • HCPCS Code: J0171 (for alglucosidase alfa)
  • Historical J-Code: J0221 (10 mg units) - verify current codes with Medicare contractor
  • CPT for Administration: 96365 (IV infusion, initial, up to 1 hour)

Units Calculation

Dosing is typically 20 mg/kg every 2 weeks. For billing purposes:

  • Calculate total mg based on patient weight
  • Convert to billing units per HCPCS descriptor
  • Document weight-based calculation in medical records
Note: Always verify current HCPCS codes with your local Medicare contractor, as codes may have been updated since Myozyme's discontinuation.

Clean Request Anatomy

A complete prior authorization request should include:

Required Clinical Elements

  1. Patient Demographics
    • Full name, DOB, Humana member ID
    • Prescribing physician information
  2. Diagnostic Documentation
    • ICD-10 code E74.02
    • GAA enzyme assay results (<40% of normal)
    • Genetic testing confirmation
    • Clinical severity assessment
  3. Treatment Details
    • HCPCS code J0171
    • Dosing calculation (20 mg/kg q2w)
    • Site of administration
    • Administration plan and monitoring
  4. Medical Necessity Justification
    • Confirmed Pompe disease diagnosis
    • Functional capacity testing (FVC, 6-minute walk test)
    • Evidence of muscle weakness
    • Treatment goals and expected outcomes

Frequent Pitfalls and Common Mistakes

Common Denial Reasons

Based on Humana's Clinical Pharmacy Review standards, these are the most frequent issues:

Denial Reason How to Fix Documentation Needed
Insufficient diagnostic proof Submit complete enzyme and genetic testing GAA assay <40% normal + genetic confirmation
Missing functional assessment Include capacity testing FVC results, 6-minute walk test
Incomplete prior therapy history Document previous treatments Records of failed/contraindicated alternatives
Wrong billing pathway Verify Part B vs Part D coverage Confirm administration setting

Billing Errors to Avoid

  • Missing NDC codes: Include specific NDC with HCPCS codes
  • Incorrect unit conversions: Double-check mg to billing unit calculations
  • Wrong administration codes: Use appropriate CPT codes for infusion
  • Timing errors: Submit PA before service to avoid patient liability

Verification Steps with Humana Resources

Before Submitting

  1. Check formulary status at Humana's drug search tool
  2. Verify PA requirements on the current Prior Authorization List
  3. Confirm submission method: Use provider portal, fax, or phone per Humana guidelines

New Member Grace Period

Humana provides a 90-day grace period for new members continuing existing treatments, but claims may face retrospective review against coverage criteria.

Quick Audit Checklist

Before submitting your prior authorization:

  • ICD-10 code E74.02 included
  • HCPCS code J0171 verified as current
  • GAA enzyme assay results documented (<40% normal)
  • Genetic testing confirmation attached
  • Weight-based dosing calculation shown
  • Administration site and plan specified
  • Functional capacity testing included
  • Prescriber specialty verified (Clinical Geneticist preferred)
  • Prior therapy history documented
  • Medical necessity letter addresses Humana criteria

Appeals Process in New Jersey

If your initial prior authorization is denied, New Jersey offers robust appeal options through the Independent Health Care Appeals Program (IHCAP).

Internal Appeals (First Step)

  • Timeline: Must complete Humana's internal appeal process first
  • Deadline: File within timeframes specified in denial letter
  • Method: Submit through Humana member portal or provider portal

External Review through IHCAP

New Jersey's IHCAP program provides independent physician review for medical necessity denials.

Review Type Timeline When to Use
Standard 45 calendar days Routine denials
Expedited 48 hours Urgent cases where delay would jeopardize health

Filing Requirements

  • Complete internal appeals first (or show plan non-compliance)
  • File within 4 months of final internal denial
  • Submit via IHCAP portal managed by Maximus
  • Include all medical records and denial letters
Note: External appeals are free to patients, and insurers must comply with favorable decisions.

For assistance, contact the NJ Department of Banking and Insurance hotline at 1-800-446-7467 or the IHCAP-specific line at 1-888-393-1062.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for specialty medications like Myozyme. Our platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, pulling the right clinical evidence and operational details that payers expect. For complex prior authorizations and appeals, Counterforce Health helps patients, clinicians, and specialty pharmacies navigate the coverage process more effectively.

FAQ

How long does Humana prior authorization take for Myozyme in New Jersey? Standard PA decisions are typically made within 7-14 days for complete submissions. Expedited reviews for urgent cases can be processed within 72 hours.

What if Myozyme is non-formulary on my Humana plan? You can request a formulary exception through Humana's standard appeal process, providing medical necessity documentation and evidence that preferred alternatives are inappropriate.

Can I request an expedited appeal if treatment is urgent? Yes, both Humana and New Jersey's IHCAP offer expedited reviews when delays would jeopardize patient health. Expedited IHCAP reviews are completed within 48 hours.

Does step therapy apply to Myozyme in New Jersey? Step therapy requirements vary by plan. Check your specific Humana formulary, as some plans may require trial of preferred alternatives before approving Myozyme.

What happens if I start treatment before PA approval? Patients may be responsible for full drug costs if treatment begins without prior authorization. However, retroactive approval may be possible with strong medical necessity documentation.

Who can help me navigate the appeals process in New Jersey? Contact NJ DOBI's Consumer Hotline (1-800-446-7467), the IHCAP line (1-888-393-1062), or consider working with coverage specialists like Counterforce Health for complex cases.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For questions about New Jersey insurance regulations, contact the NJ Department of Banking and Insurance.

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