By Counterforce Health Team in Aldurazyme (laronidase) —

How to Get Aldurazyme (Laronidase) Covered by Humana in Ohio: Coding, Appeals, and Authorization Guide

Quick Answer: Getting Aldurazyme (Laronidase) Covered by Humana in Ohio

Aldurazyme requires prior authorization from Humana with genetic confirmation of MPS I, baseline assessments, and specialist documentation. Fastest path: Submit complete PA request with ICD-10 code E76.01-E76.03, HCPCS J1931, genetic testing results, and baseline uGAG levels. If denied, you have 65 days to appeal internally, followed by automatic external review. Start today: Contact your MPS specialist to gather genetic testing results and baseline measurements, then submit via Humana's PA portal with complete medical records.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for MPS I
  3. Product Coding: HCPCS, NDC, and Units
  4. Clean Request Anatomy
  5. Frequent Coding Pitfalls
  6. Verification with Humana
  7. Appeals Process in Ohio
  8. Pre-Submission Checklist

Coding Basics: Medical vs. Pharmacy Benefit

Aldurazyme (laronidase) typically falls under the medical benefit for Humana plans since it's administered via IV infusion in clinical settings. This affects both coding and authorization pathways:

Medical Benefit Path:

  • Requires HCPCS J-code billing (J1931)
  • Prior authorization through medical management
  • Claims submitted by infusion centers or hospitals
  • Uses medical deductible and coinsurance

Key Difference: Unlike oral medications processed through pharmacy benefits, Aldurazyme requires medical coding and facility-based administration, making proper HCPCS coding essential for coverage.

ICD-10 Mapping for MPS I

Accurate diagnosis coding is critical for Humana approval. Use these specific ICD-10 codes based on MPS I subtype:

MPS I Subtype ICD-10 Code Documentation Keywords
Hurler syndrome (severe) E76.01 Severe cognitive impairment, early onset, developmental delay
Hurler-Scheie syndrome (intermediate) E76.02 Intermediate severity, variable cognitive involvement
Scheie syndrome (attenuated) E76.03 Mild/attenuated, preserved intelligence, later onset
MPS I unspecified E76.0 Use only if subtype cannot be determined

Documentation Words That Support Coding:

  • "Genetic testing confirms IDUA gene mutations"
  • "Alpha-L-iduronidase enzyme deficiency"
  • "Elevated urinary glycosaminoglycans (uGAG)"
  • "Dysostosis multiplex on imaging"
  • "Progressive multi-organ involvement"
Tip: Always specify the MPS I subtype in clinical documentation. Generic coding (E76.0) may trigger additional review requests from Humana.

Product Coding: HCPCS, NDC, and Units

HCPCS J-Code

J1931: Injection, laronidase, 0.1 mg

  • Each billable unit = 0.1 mg of laronidase
  • Standard dosing: 0.58 mg/kg weekly via IV infusion

NDC Code

58468-0070-01: Aldurazyme 2.9 mg/5 mL single-dose vial

Units Calculation

Formula: Total dose (mg) ÷ 0.1 mg = Billable units

Example: 50 kg patient receiving 0.58 mg/kg

  • Total dose: 50 kg × 0.58 mg/kg = 29 mg
  • Billable units: 29 mg ÷ 0.1 mg = 290 units

Humana Limits:

  • Maximum: 667 billable units every 7 days
  • Maximum: 92 vials every 28 days

Administration Coding

Use these CPT codes for infusion:

  • 96365: IV infusion, first hour
  • 96366: IV infusion, each additional hour

Clean Request Anatomy

A complete Humana PA request for Aldurazyme should include:

Patient Information Section

Patient: [Name, DOB, Humana ID]
Diagnosis: Mucopolysaccharidosis I, Hurler syndrome (E76.01)
Prescriber: [MPS specialist with credentials]

Clinical Documentation

  1. Genetic confirmation: IDUA gene testing results showing biallelic pathogenic mutations
  2. Enzyme testing: Alpha-L-iduronidase deficiency confirmation
  3. Baseline assessments:
    • Urinary glycosaminoglycan (uGAG) levels
    • For patients ≥6 years: FVC, 6-minute walk test, joint ROM
    • For patients 6 months-6 years: cardiac status, growth velocity
  4. Current clinical status: Multi-organ involvement documentation

Product Details

Drug: Aldurazyme (laronidase)
NDC: 58468-0070-01
HCPCS: J1931
Dose: 0.58 mg/kg IV weekly
Units per infusion: [calculated based on weight]
Duration: 12 months

Frequent Coding Pitfalls

Unit Conversion Errors

Wrong: Billing 29 units for a 29 mg dose Right: Billing 290 units (29 mg ÷ 0.1 mg per unit)

Mismatched Diagnosis Codes

Wrong: Using E76.0 (unspecified) when subtype is known Right: Use specific codes E76.01, E76.02, or E76.03

Missing Start Dates

Always include:

  • Treatment start date
  • Authorization period requested (typically 12 months)
  • Next review date

Incomplete Baseline Documentation

Common omissions:

  • uGAG levels not documented
  • Age-appropriate assessments missing
  • Genetic testing results not attached

Verification with Humana

Before submitting your PA request:

  1. Check formulary status: Verify Aldurazyme is on your specific Humana plan's formulary
  2. Confirm PA requirements: Review current Humana prior authorization lists (verify with source linked)
  3. Validate codes: Cross-check HCPCS J1931 is accepted for your plan type
  4. Review limits: Confirm current quantity limits haven't changed

Submission Methods:

  • Humana PA web portal (preferred)
  • Fax submission with tracking
  • Provider portal direct upload

Appeals Process in Ohio

If Humana denies your Aldurazyme request, Ohio residents have structured appeal rights:

Level 1: Internal Appeal (Health Plan Reconsideration)

  • Timeline to file: 65 days from denial notice
  • Humana decision deadline:
    • Pre-service: 30 calendar days
    • Payment: 60 calendar days
    • Part D: 7 calendar days
  • Expedited option: 72 hours if delay could harm health

Level 2: Independent Review (Automatic)

  • Process: Automatically forwarded if Level 1 denied
  • Decision timeline: 30-60 days (standard), 72 hours (expedited)
  • Reviewer: Independent Review Entity (IRE)

Level 3+: Administrative Law Judge

  • Timeline to file: 60 days after Level 2 denial
  • Minimum threshold: $180 (2024)
  • Process: Federal Medicare appeals process
Note: Unlike some states, Ohio Medicare Advantage appeals don't have a 180-day requirement. Standard timelines are much shorter (30-60 days).

Contact Information:

  • Humana Member Services: [Check current number on member ID card]
  • Ohio Department of Insurance: 1-800-686-1526
  • Medicare: 1-800-MEDICARE

Pre-Submission Checklist

Before submitting your Aldurazyme PA to Humana:

Clinical Documentation:

  • Genetic testing confirming IDUA mutations
  • Enzyme assay showing alpha-L-iduronidase deficiency
  • Baseline uGAG levels documented
  • Age-appropriate functional assessments completed
  • MPS specialist evaluation and treatment plan

Coding Verification:

  • Correct ICD-10 code (E76.01, E76.02, or E76.03)
  • HCPCS J1931 units calculated correctly
  • NDC 58468-0070-01 included
  • Administration codes (96365/96366) planned

Administrative:

  • Patient demographics and Humana ID verified
  • Prescriber credentials and NPI included
  • Authorization period specified (typically 12 months)
  • Infusion site and administration plan documented

Safety Requirements:

  • Monitoring plan for infusion reactions
  • Emergency preparedness protocols
  • Baseline cardiac and pulmonary assessments

From Our Advocates

We've seen MPS I families succeed with Humana approvals when they submit complete genetic testing upfront and include detailed baseline measurements. The key is having your specialist document not just the diagnosis, but the specific functional impairments that Aldurazyme can address. This composite guidance reflects patterns we've observed, though individual outcomes vary.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals with evidence-backed strategies. Our platform analyzes denial letters and plan policies to create targeted rebuttals that align with each payer's specific requirements. For complex cases like Aldurazyme approvals, we help identify the exact documentation gaps and craft compelling medical necessity arguments. Learn more about our coverage advocacy services.

FAQ: Aldurazyme Coverage with Humana in Ohio

Q: How long does Humana prior authorization take for Aldurazyme? A: Standard PA decisions take up to 30 days for pre-service requests. Expedited reviews (when health is at risk) must be completed within 72 hours.

Q: What if Aldurazyme isn't on my Humana formulary? A: You can request a formulary exception with medical necessity documentation. Include genetic testing, specialist evaluation, and evidence that no formulary alternatives are appropriate.

Q: Can I get an expedited appeal if Humana denies coverage? A: Yes, if waiting for standard appeal timelines could seriously harm your health. Your doctor must support the expedited request with clinical justification.

Q: Does step therapy apply to Aldurazyme in Ohio? A: Typically no, since Aldurazyme is the only FDA-approved enzyme replacement therapy for MPS I. However, Humana may require documentation that other management approaches were considered.

Q: What baseline tests does Humana require before approving Aldurazyme? A: Required baselines include uGAG levels, age-appropriate functional assessments (FVC, 6-minute walk test for older patients), and comprehensive genetic/enzymatic confirmation of MPS I diagnosis.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice or legal counsel. Coverage policies vary by plan type and may change. Always verify current requirements with Humana directly and consult your healthcare provider for medical decisions. For personalized assistance with Ohio insurance appeals, contact the Ohio Department of Insurance Consumer Services Division at 1-800-686-1526.

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