By Counterforce Health Team in Aldurazyme (laronidase) —

Getting Aldurazyme (Laronidase) Covered by UnitedHealthcare in New York: Complete Coding and Appeals Guide

Answer Box: Getting Aldurazyme Covered by UnitedHealthcare in New York

Aldurazyme (laronidase) requires prior authorization from UnitedHealthcare for mucopolysaccharidosis I (MPS I) treatment. Three-step fast track: 1) Gather genetic/enzymatic confirmation of MPS I diagnosis with ICD-10 codes E76.01-E76.03, 2) Submit PA using HCPCS J1931 with precise dosing calculations (0.58 mg/kg weekly), and 3) If denied, file internal appeal within 180 days, then external appeal through New York DFS within 4 months. Start today: Contact your specialist to confirm MPS I documentation and initiate the UnitedHealthcare prior authorization process.

Table of Contents

Coding Basics: Medical vs. Pharmacy Benefit

Understanding whether Aldurazyme falls under UnitedHealthcare's medical benefit or pharmacy benefit is crucial for proper coding and approval success.

Medical Benefit (Most Common)

Pharmacy Benefit (OptumRx)

Tip: Verify benefit type before submitting any requests. Contact UnitedHealthcare provider services at the number on the patient's insurance card to confirm coverage pathway.

ICD-10 Mapping for MPS I

Proper diagnosis coding is essential for Aldurazyme approval. Use the most specific ICD-10 code based on clinical phenotype:

MPS I Subtype ICD-10 Code Clinical Features Documentation Requirements
Hurler syndrome (severe) E76.01 Early onset, rapid progression, cognitive involvement Genetic testing, enzyme activity <10%
Hurler-Scheie (intermediate) E76.02 Variable progression, preserved cognition Enzyme activity 10-20% normal
Scheie syndrome (mild) E76.03 Later onset, milder symptoms Enzyme activity >20% normal
Unspecified MPS I E76.0 Use when subtype unclear Confirmed IDUA gene mutation

Required Documentation Words That Support Coding:

  • "Genetically confirmed mucopolysaccharidosis type I"
  • "Deficient alpha-L-iduronidase enzyme activity"
  • "Pathogenic IDUA gene mutations identified"
  • "Multi-system involvement consistent with MPS I"

Reference: WHO ICD-10 Classification for complete coding guidelines.

Product Coding: HCPCS, NDC, and Units

HCPCS Code J1931

  • Description: "Injection, laronidase, 0.1 mg"
  • 1 billable unit = 0.1 mg of laronidase
  • Current NDC: 58468-0070-01 (2.9 mg/5 mL single-dose vial)

Units Calculation Example:

  • Patient weight: 50 kg
  • Dose: 0.58 mg/kg = 29 mg total dose needed
  • Billing units: 29 mg ÷ 0.1 mg per unit = 290 units of J1931

Required Modifiers:

  • JW modifier: Use when drug is discarded (single-use vials)
  • Document exact amount wasted for compliance

Infusion Administration Codes:

  • CPT 96365: Initial hour of infusion
  • CPT 96366: Each additional hour
Note: Always include the NDC 58468-0070-01 on medical claims to avoid processing delays.

Clean Request Anatomy

Here's what a complete prior authorization request should include:

Patient Information Section:

  • Full name, DOB, member ID
  • Primary diagnosis: E76.01 (or appropriate MPS I subtype)
  • Prescribing specialist credentials (geneticist/metabolic specialist preferred)

Clinical Documentation:

  • Genetic test results showing IDUA gene mutations
  • Enzyme activity assay results
  • Baseline assessments: pulmonary function, hepatosplenomegaly, mobility
  • Current symptoms and disease progression

Prescription Details:

  • Drug: Aldurazyme (laronidase) NDC 58468-0070-01
  • Dose: 0.58 mg/kg IV weekly
  • HCPCS: J1931 with calculated units
  • Duration: Ongoing enzyme replacement therapy

Supporting Evidence:

Frequent Coding Pitfalls

Unit Conversion Errors

  • Wrong: Billing 1 unit J1931 for 2.9 mg vial
  • Right: Billing 29 units J1931 for 2.9 mg vial (2.9 ÷ 0.1 = 29)

Missing NDC Code

  • Always include NDC 58468-0070-01 on medical benefit claims
  • Omitting NDC causes automatic denials or payment delays

Incorrect Diagnosis Coding

  • Wrong: Using general metabolic disorder codes
  • Right: Specific MPS I subtype (E76.01, E76.02, or E76.03)

Inadequate Clinical Documentation

  • Missing genetic confirmation
  • No baseline disease severity measurements
  • Incomplete specialist attestation

Verification with UnitedHealthcare

Before Submitting:

  1. Check formulary status: UnitedHealthcare provider portal
  2. Verify PA requirements: Current policy may require specific forms
  3. Confirm benefit type: Medical vs. pharmacy benefit determines coding approach

Cross-Check Resources:

Appeals Playbook for New York

If UnitedHealthcare denies your Aldurazyme request, New York offers robust appeal rights:

Internal Appeals (UnitedHealthcare)

  • Timeline: File within 180 days of denial
  • Process: Submit through UnitedHealthcare member/provider portal
  • Required: Original denial letter, additional clinical evidence, specialist letter
  • Decision: Typically within 30 days (expedited: 72 hours for urgent cases)

External Appeals (New York State)

  • Eligibility: After exhausting internal appeals
  • Timeline: File within 4 months of final internal denial
  • Submit to: NY Department of Financial Services
  • Fee: $25 (waived for financial hardship)
  • Decision: Binding on UnitedHealthcare

Required Documentation for Appeals:

  • All denial letters (initial and final)
  • Complete medical records supporting MPS I diagnosis
  • Physician attestation addressing medical necessity
  • Precedent cases from DFS database for similar rare disease appeals
From our advocates: "We've seen Aldurazyme appeals succeed when families include genetic counselor reports alongside the metabolic specialist's letter. The combination provides comprehensive evidence that reviewers find compelling, especially for rare disease cases where clinical expertise matters most."

Quick Audit Checklist

Before Submission:

  • Correct ICD-10 code (E76.01, E76.02, or E76.03)
  • HCPCS J1931 with accurate unit calculation
  • NDC 58468-0070-01 included on claim
  • Genetic test results attached
  • Enzyme activity assay documented
  • Specialist credentials verified
  • Dosing calculation shows 0.58 mg/kg weekly
  • Prior authorization form complete
  • Patient insurance verification current

Red Flags to Avoid:

  • Generic metabolic disorder diagnosis codes
  • Missing or incorrect NDC
  • Incomplete genetic documentation
  • Wrong unit calculations for J1931

FAQ

How long does UnitedHealthcare prior authorization take for Aldurazyme in New York? Standard PA decisions typically take 5-10 business days. Expedited reviews for urgent medical needs can be completed within 72 hours.

What if Aldurazyme is non-formulary on my UnitedHealthcare plan? Request a formulary exception by demonstrating medical necessity and lack of suitable alternatives. Since Aldurazyme is the only FDA-approved enzyme replacement for MPS I, exceptions are often granted with proper documentation.

Can I request an expedited appeal if my child needs Aldurazyme urgently? Yes. Both UnitedHealthcare internal appeals and New York external appeals offer expedited review for urgent medical situations where delays could jeopardize health.

Does step therapy apply if we've tried other treatments outside New York? Document all prior treatments regardless of location. UnitedHealthcare should accept out-of-state treatment history as evidence for step therapy exceptions.

What's the success rate for Aldurazyme appeals in New York? While specific statistics aren't published, rare disease appeals with strong clinical documentation and genetic confirmation have historically performed well in New York's external review system.

How much does Aldurazyme cost if insurance doesn't cover it? The wholesale acquisition cost is approximately $1,113.38 per 2.9 mg vial as of January 2025. Annual costs can exceed $300,000, making insurance coverage essential.

Can specialty pharmacies help with prior authorization? Yes. Many UnitedHealthcare-approved specialty pharmacies provide PA support services and can coordinate with your healthcare team.

What if my doctor isn't a genetic specialist? While genetic specialists are preferred, any qualified physician can prescribe Aldurazyme. However, having genetic or metabolic specialist involvement strengthens your PA request and appeal chances.

About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Aldurazyme. Our platform analyzes denial letters, identifies specific coverage gaps, and generates evidence-backed appeals tailored to each payer's requirements—helping patients access life-saving treatments faster.

For additional support with UnitedHealthcare denials or appeals in New York, Counterforce Health provides comprehensive assistance with documentation, coding verification, and appeal strategy development specifically designed for rare disease therapies.

Sources & Further Reading

This article is for informational purposes only and does not constitute medical advice. Always consult with qualified healthcare professionals and verify current insurance policies and procedures. Coverage decisions may vary based on individual circumstances and plan details.

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