By Counterforce Health Team in Aldurazyme (laronidase) —

Getting Aldurazyme (Laronidase) Covered by Humana in Michigan: Coding Guide for Prior Authorization Success

Answer Box: Getting Started Today

Aldurazyme (laronidase) requires prior authorization from Humana in Michigan. The fastest path to approval: 1) Confirm MPS I diagnosis with genetic testing (ICD-10: E76.01, E76.02, or E76.03), 2) Submit PA request with complete clinical documentation including baseline assessments, and 3) Use correct billing codes (HCPCS J1931, NDC 58468-0070-01). Start today by gathering genetic test results and having your specialist complete the medical necessity letter. If denied, you have 65 days to appeal with expedited review available for urgent cases.

Table of Contents

Coding Basics: Medical vs. Pharmacy Benefit

Aldurazyme (laronidase) falls under Medicare Part B (medical benefit) because it requires intravenous infusion in a clinical setting. This is crucial for Humana Medicare Advantage members in Michigan—the drug won't be covered under Part D (prescription benefit).

Key Coverage Points:

  • Prior authorization required for all Humana plans
  • Specialist prescription mandatory (geneticist, metabolic specialist, or pediatrician experienced with MPS I)
  • Infusion setting: Outpatient hospital, infusion center, or physician office
  • Administration codes needed alongside drug codes for complete billing
Note: Home infusion may be covered under specific circumstances but requires additional documentation and provider arrangements.

ICD-10 Mapping for MPS I

Primary Diagnosis Codes:

  • E76.01: Hurler syndrome (severe form)
  • E76.02: Hurler-Scheie syndrome (intermediate form)
  • E76.03: Scheie syndrome (mild form)

Documentation Requirements for Each Code:

ICD-10 Code Clinical Features to Document Supporting Tests Required
E76.01 Severe developmental delay, coarse facial features, corneal clouding, hepatosplenomegaly Genetic testing showing IDUA gene mutations, enzyme assay confirming α-L-iduronidase deficiency
E76.02 Moderate skeletal abnormalities, cardiac involvement, normal intelligence Same genetic/enzymatic confirmation as E76.01
E76.03 Primarily corneal clouding and joint stiffness, normal intelligence and lifespan Same genetic/enzymatic confirmation as E76.01

Supporting Documentation Words That Strengthen Coding:

  • "Confirmed mucopolysaccharidosis type I"
  • "Elevated urinary glycosaminoglycans"
  • "Dysostosis multiplex on imaging"
  • "α-L-iduronidase enzyme deficiency confirmed"
  • "Pathogenic IDUA gene variants identified"

Product Coding: HCPCS, J-Codes, and NDC

Essential Billing Codes:

  • HCPCS Code: J1931 (injection, laronidase, 0.1 mg)
  • NDC: 58468-0070-01 (2.9 mg/5 mL vial)
  • Administration: CPT 96365 (initial infusion, up to 1 hour) + 96366 (each additional hour)

Dosing and Unit Calculations:

  • Standard dose: 0.58 mg/kg weekly
  • Example: 30 kg patient = 17.4 mg dose = 174 billing units (17.4 mg ÷ 0.1 mg per unit)
  • Vials needed: Round up to whole vials (17.4 mg requires 6 vials = 17.4 mg total)
Tip: Always document the calculation showing patient weight, total dose needed, and vials used to justify billing units.

Modifier Requirements:

  • JW modifier: Required for any discarded drug amount per Medicare billing rules
  • Place of service codes: 11 (office), 22 (outpatient hospital), or 19 (home) as appropriate

Clean Request Anatomy

Complete Prior Authorization Submission Includes:

  1. Patient Demographics
    • Humana member ID and plan details
    • Patient weight (current, within 30 days)
    • Age and date of birth
  2. Diagnosis Documentation
    • ICD-10 code (E76.01, E76.02, or E76.03)
    • Genetic test results showing IDUA mutations
    • Enzyme assay results (if available)
    • Clinical notes describing MPS I symptoms
  3. Prescriber Information
    • Specialist credentials and experience with MPS I
    • Medical necessity letter (see Clinician Corner below)
    • Treatment plan and monitoring schedule
  4. Baseline Assessments
    • Pulmonary function tests
    • Cardiac evaluation (echocardiogram)
    • Growth parameters and development assessment
    • Urinary glycosaminoglycan levels

Clinician Corner: Medical Necessity Letter Checklist

Your medical necessity letter should include:

  • Problem statement: "Patient has confirmed MPS I [specify subtype] requiring enzyme replacement therapy"
  • Diagnostic confirmation: Reference genetic testing and enzyme assay results
  • Clinical rationale: Describe current symptoms and disease progression
  • Treatment goals: Specific outcomes expected (improved pulmonary function, reduced hepatosplenomegaly)
  • Monitoring plan: How you'll assess treatment response
  • Guideline support: Reference FDA prescribing information and expert consensus

Frequent Coding Pitfalls

Common Errors and Solutions:

Pitfall Impact Solution
Wrong ICD-10 subtype Denial for diagnostic mismatch Ensure genetic testing supports specific MPS I subtype
Incorrect unit calculation Claim rejection or audit Double-check: dose (mg) ÷ 0.1 mg = billing units
Missing NDC on claim Payment delay Always include NDC 58468-0070-01
Part D instead of Part B Automatic denial Verify infusion drugs bill to medical benefit
Missing JW modifier Compliance issue Document and bill for any wasted drug

Unit Conversion Double-Check:

  • Patient weight: _____ kg
  • Dose calculation: _____ kg × 0.58 mg/kg = _____ mg total
  • Billing units: _____ mg ÷ 0.1 mg = _____ units for J1931

Verification with Humana Resources

Before Submitting:

  1. Check formulary status: Log into MyHumana or call member services
  2. Verify PA requirements: Access current prior authorization forms through provider portal
  3. Confirm billing codes: Cross-reference J1931 and NDC with Humana's provider manual
  4. Review coverage policies: Search for "enzyme replacement therapy" or "laronidase" policies

Humana Provider Resources:

  • Provider portal: Availity for PA submissions
  • Drug list verification: Humana formulary lookup
  • Coverage policies: Available through provider portal (verify current link)
Note: Humana's coverage policies may vary by plan type (Medicare Advantage vs. commercial). Always verify the specific policy for your patient's plan.

Quick Audit Checklist

Pre-Submission Review:

  • Correct ICD-10 code matches genetic testing results
  • HCPCS J1931 with accurate unit calculation
  • NDC 58468-0070-01 included on all claims
  • Specialist prescriber with relevant credentials
  • Complete baseline assessments attached
  • Medical necessity letter addresses all PA criteria
  • Patient weight documented and current
  • Administration codes (96365/96366) included for infusions
  • JW modifier applied for any drug waste
  • All supporting documents are legible and complete

Appeals Process in Michigan

If your Aldurazyme prior authorization is denied by Humana, you have 65 calendar days to file an appeal.

Humana Internal Appeal:

  • Standard review: 30 days for pre-service decisions
  • Expedited review: 72 hours if delay would jeopardize health
  • How to file: Call member services, submit online, or mail to appeals department

Michigan External Review: If Humana upholds the denial, Michigan residents can request external review through the Department of Insurance and Financial Services (DIFS).

  • Deadline: 127 days from final denial
  • Timeline: 60 days for standard review, 72 hours for expedited
  • Process: Submit External Review Request form to DIFS
  • Contact: 877-999-6442
Tip: For urgent cases, have your prescriber write a letter stating that delay would seriously jeopardize your health to qualify for expedited review.

At Counterforce Health, we help patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements like those for Aldurazyme. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that address payers' specific criteria. By turning insurance denials into successful approvals, we help ensure patients get the treatments they need without unnecessary delays.

FAQ

How long does Humana prior authorization take for Aldurazyme in Michigan? Standard PA decisions are made within 30 days for pre-service requests. Expedited reviews are completed within 72 hours if medical urgency is documented.

What if Aldurazyme isn't on Humana's formulary? Request a formulary exception with medical necessity documentation. Since no FDA-approved alternatives exist for MPS I, exceptions are often approved with proper clinical justification.

Can I get expedited approval if my child needs to start treatment immediately? Yes, if your prescriber documents that delay would seriously jeopardize health. Submit an expedited PA request with supporting clinical documentation.

What happens if I miss the 65-day appeal deadline? Appeals filed after 65 days are typically dismissed unless you can show "good cause" for the delay (hospitalization, family emergency, etc.).

Does step therapy apply to Aldurazyme? Step therapy rarely applies since Aldurazyme is the only FDA-approved treatment for MPS I. However, some plans may require documentation of symptom severity before approval.

How often do I need to renew prior authorization? Most plans require annual reauthorization with updated clinical assessments showing continued medical necessity and treatment benefit.

For complex cases or appeal assistance, Counterforce Health provides specialized support in overturning insurance denials for specialty medications like Aldurazyme.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and may change. Always consult your healthcare provider and insurance plan for the most current requirements. For assistance with appeals or complex coverage issues, consider consulting with a healthcare advocate or legal professional familiar with insurance law.

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