By Counterforce Health Team in Naglazyme (galsulfase) —

The Requirements Checklist to Get Naglazyme (galsulfase) Covered by UnitedHealthcare in Michigan

Answer Box: Fast Track to Naglazyme Coverage

Who qualifies: Michigan patients with confirmed MPS VI (Mucopolysaccharidosis VI) needing enzyme replacement therapy. Fastest path: Submit complete prior authorization through UnitedHealthcare provider portal with enzyme assay, genetic testing, specialist letter, and baseline functional measures. Start today: Contact your metabolic specialist to gather diagnostic reports and request a medical necessity letter. Most approvals take 15 business days with complete documentation; expedited review available in 72 hours for urgent cases.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Essentials
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Common Pitfalls to Avoid
  10. Appeals Process in Michigan
  11. Printable Quick Reference

Who Should Use This Checklist

This guide helps Michigan patients, families, and healthcare providers navigate UnitedHealthcare's prior authorization requirements for Naglazyme (galsulfase). You'll need this if you're:

  • Newly diagnosed with MPS VI and starting enzyme replacement therapy
  • Switching to UnitedHealthcare from another insurer
  • Facing a denial or need to renew existing coverage
  • Moving to Michigan with active Naglazyme treatment

Expected outcome: With complete documentation, most initial requests are approved within 15 business days. Incomplete submissions typically face 30-60 day delays or denials.

Member & Plan Basics

Coverage Verification

Before starting, confirm these essential details:

✓ Active UnitedHealthcare coverage - Check your member ID card and verify benefits are current ✓ Plan type identification - Commercial, Medicare Advantage, or Medicaid affects requirements ✓ OptumRx involvement - Most UnitedHealthcare plans use OptumRx for specialty drug management ✓ Deductible status - High-deductible plans may require meeting annual deductible first

Tip: Call the member services number on your insurance card to confirm Naglazyme is covered under your specific plan and whether prior authorization is required.

Coverage at a Glance

Requirement Details Where to Verify
Prior Authorization Required for all plans UHC Provider Portal
Formulary Status Specialty tier, non-preferred Plan's prescription drug list
Step Therapy Generally not applicable (no alternatives) Member benefits summary
Quantity Limits Weight-based dosing (1 mg/kg weekly) UHC medical policy
Site of Care Infusion center or qualified home infusion Network directory

Clinical Criteria Requirements

UnitedHealthcare's enzyme replacement therapy policy requires meeting all these criteria:

Diagnosis Confirmation

✓ Confirmed MPS VI diagnosis via:

  • Enzyme assay showing deficient arylsulfatase B activity, AND/OR
  • Genetic testing confirming pathogenic ARSB mutations
  • ICD-10 code: E76.29 (Other mucopolysaccharidoses)

Prescriber Requirements

✓ Specialist management by:

  • Medical geneticist
  • Metabolic disease specialist
  • Pediatric metabolic specialist
  • Other physician experienced in lysosomal storage disorders

Clinical Documentation

✓ Baseline functional assessment including:

  • 6-minute walk test (if age-appropriate)
  • Stair-climbing capacity
  • Pulmonary function tests
  • Cardiac evaluation (echocardiogram)
  • Joint range of motion assessment

✓ Disease progression evidence such as:

  • Progressive decline in mobility or endurance
  • Worsening cardiac or pulmonary function
  • Increasing pain or joint stiffness
  • Impact on daily activities or quality of life

Coding & Billing Essentials

Required Codes

  • HCPCS J-code: J1458 (Injection, galsulfase, 1 mg)
  • ICD-10 diagnosis: E76.29 (Other mucopolysaccharidoses)
  • Units: Patient weight in kg × 1 mg/kg = total mg per infusion
  • NDC: Verify current NDC with specialty pharmacy

Billing Notes

Naglazyme is typically covered under the medical benefit as a physician-administered drug. Claims should reflect accurate dosing based on current weight and proper place of service codes for the infusion location.

Documentation Packet

Core Requirements Checklist

Medical Records:

  • Specialist consultation note confirming MPS VI diagnosis
  • Enzyme assay results with lab reference ranges
  • Genetic testing report (if available)
  • Baseline functional assessments (walk tests, PFTs, echo)
  • Current weight and calculated dose
  • Previous treatment history and response

Letter of Medical Necessity must include:

  • Patient demographics and UnitedHealthcare member ID
  • Prescriber credentials and specialty
  • Detailed diagnosis with supporting lab values
  • Clinical rationale for Naglazyme therapy
  • Expected treatment goals and monitoring plan
  • Statement that no alternative therapies exist for MPS VI

Supporting Documentation

  • Recent imaging studies (if relevant to MPS VI complications)
  • Cardiology consultation (if cardiac involvement)
  • Pulmonology consultation (if respiratory involvement)
  • Physical therapy evaluations
  • Quality of life assessments
Clinician Corner: The medical necessity letter should explicitly state that Naglazyme is the only FDA-approved enzyme replacement therapy for MPS VI and that supportive care alone is insufficient to prevent disease progression. Include specific functional measures that will be tracked to demonstrate treatment benefit.

Submission Process

Step-by-Step Submission

1. Gather complete documentation (1-2 weeks)

  • Patient/family: Collect insurance information and medical records
  • Timeline: Allow time for specialist appointments and testing

2. Submit prior authorization (Day 0)

  • Provider: Use UHC Provider Portal or CoverMyMeds
  • Include all required attachments in single submission

3. Track submission status (Days 1-15)

  • Provider: Check portal for requests for additional information
  • Patient: Follow up if no response within 10 business days

4. Receive determination (Day 15 or sooner)

  • Approval: Coordinate with specialty pharmacy for drug shipment
  • Denial: Begin internal appeal process immediately

Submission Checklist

  • Complete prior authorization form
  • All required attachments uploaded
  • Correct HCPCS and ICD-10 codes
  • Current patient weight and calculated dose
  • Preferred specialty pharmacy identified
  • Submission confirmation number recorded

Specialty Pharmacy Requirements

UnitedHealthcare typically requires Naglazyme to be dispensed through contracted specialty pharmacies. Common in-network options include:

  • Accredo Specialty Pharmacy
  • CVS Specialty
  • Walgreens Specialty Pharmacy
  • Other UnitedHealthcare-contracted vendors

Coordination Steps

  1. Verify network status - Confirm chosen pharmacy is in-network
  2. Transfer prescription - Prescriber sends to approved specialty pharmacy
  3. Patient enrollment - Complete pharmacy intake process
  4. Infusion coordination - Arrange delivery to infusion site or home
  5. Insurance verification - Pharmacy confirms coverage and copay

Counterforce Health helps patients and providers streamline this coordination by identifying the right specialty pharmacy partners and ensuring all documentation requirements are met before submission.

After Submission: What to Expect

Timeline Expectations

  • Standard review: Up to 15 business days
  • Expedited review: 72 hours (requires physician certification of urgency)
  • Additional information requests: May extend timeline by 5-10 days

Status Monitoring

  • Check UnitedHealthcare provider portal daily
  • Document all communications and reference numbers
  • Maintain contact with specialty pharmacy for coordination

Approval Management

Once approved:

  • Verify approval duration (typically 6-12 months)
  • Schedule first infusion appointment
  • Set calendar reminder for reauthorization (30 days before expiration)
  • Establish baseline monitoring schedule

Common Pitfalls to Avoid

Documentation Errors

❌ Incomplete enzyme testing - Submit full arylsulfatase B assay with reference ranges ✓ Fix: Include both quantitative results and lab interpretation

❌ Missing baseline assessments - UnitedHealthcare requires objective functional measures ✓ Fix: Complete 6-minute walk test, PFTs, and cardiac evaluation before submission

❌ Generic diagnosis coding - Using broad MPS codes instead of specific E76.29 ✓ Fix: Ensure ICD-10 E76.29 is primary diagnosis for all claims

Process Mistakes

❌ Wrong submission pathway - Using pharmacy benefit instead of medical benefit ✓ Fix: Verify benefit design and submit through correct channel

❌ Incomplete prior authorization - Missing required fields or attachments ✓ Fix: Use provided checklist to ensure all elements are included

Appeals Process in Michigan

If UnitedHealthcare denies your Naglazyme request, Michigan law provides strong appeal rights through the Department of Insurance and Financial Services (DIFS).

Internal Appeals (UnitedHealthcare)

  • Timeline: 180 days from denial to file appeal
  • Review period: 30 days for pre-service, 60 days for post-service
  • Expedited: 72 hours when delay could jeopardize health

External Review (Michigan DIFS)

After exhausting UnitedHealthcare's internal appeals:

  • Timeline: 127 days from final denial to request external review
  • Review period: 60 days for standard, 72 hours for expedited
  • Cost: No charge to patient
  • Decision: Binding on UnitedHealthcare

How to File External Review

  1. Complete DIFS External Review Request form online or via paper
  2. Submit within 127 days of final UnitedHealthcare denial
  3. Include all medical records and denial letters
  4. For expedited review, attach physician letter stating delay would harm patient
From our advocates: We've seen successful Michigan external reviews for enzyme replacement therapies when families include a detailed timeline showing disease progression and a clear explanation of why Naglazyme is medically necessary. The key is demonstrating that the denial contradicts established medical evidence for MPS VI treatment.

Michigan DIFS Contact:

When facing persistent coverage challenges, Counterforce Health specializes in turning insurance denials into successful appeals by crafting evidence-backed arguments that align with payer policies and regulatory requirements.

Printable Quick Reference

Pre-Submission Checklist

  • Active UnitedHealthcare coverage verified
  • MPS VI diagnosis confirmed (enzyme + genetic testing)
  • Metabolic specialist identified and engaged
  • Baseline functional assessments completed
  • Current weight documented for dosing
  • In-network specialty pharmacy selected
  • Complete prior authorization packet assembled

Required Documentation

  • Medical necessity letter from specialist
  • Enzyme assay results
  • Genetic testing report (if available)
  • Baseline functional measures
  • Treatment history and prior therapies
  • Current clinical status assessment

After Denial Action Items

  • Review denial letter for specific reasons
  • Gather additional documentation addressing denial reasons
  • File internal appeal within 180 days
  • If denied again, file DIFS external review within 127 days
  • Consider expedited review if delay poses health risk

FAQ

How long does UnitedHealthcare prior authorization take for Naglazyme in Michigan? Standard review takes up to 15 business days. Expedited review is available within 72 hours when a physician certifies that delay could seriously jeopardize the patient's health.

What if Naglazyme is not on my UnitedHealthcare formulary? Naglazyme is typically covered as a specialty medication under the medical benefit rather than the pharmacy formulary. Verify your specific plan's coverage through the member portal or by calling customer service.

Can I request an expedited appeal if UnitedHealthcare denies Naglazyme? Yes, both UnitedHealthcare's internal appeals and Michigan's external review process offer expedited options when delay could harm your health. A physician must provide written certification of medical urgency.

Does step therapy apply to Naglazyme for MPS VI? Generally no, because Naglazyme is the only FDA-approved enzyme replacement therapy for MPS VI. However, some plans may require documentation that supportive therapies alone are insufficient.

What happens if I move to Michigan while already on Naglazyme? Contact UnitedHealthcare immediately to transfer your prior authorization. Michigan's continuation of care laws may require temporary coverage while new authorization is processed.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice or a guarantee of coverage. Always consult with your healthcare provider about treatment decisions and verify current policy requirements with UnitedHealthcare and Michigan DIFS, as policies and procedures may change.

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