By Counterforce Health Team in Cerezyme (imiglucerase) —

The Complete Requirements Checklist to Get Cerezyme (Imiglucerase) Covered by UnitedHealthcare in Michigan

Answer Box: Getting Cerezyme Covered by UnitedHealthcare in Michigan

Fastest path to approval: Submit prior authorization through OptumRx with confirmed Type 1 Gaucher disease diagnosis (ICD-10: E75.22), evidence of VPRIV failure/intolerance (step therapy requirement), and complete medical necessity documentation. Use HCPCS code J1786 for billing. If denied, Michigan allows 127 days for external review through DIFS. Start today: Contact OptumRx at 800-310-6826 to initiate PA request.

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 Network
  8. After Submission: What to Expect
  9. Denial Prevention Tips
  10. Appeals Process in Michigan
  11. Quick Reference Checklist

Who Should Use This Checklist

This comprehensive guide is designed for Michigan patients with Type 1 Gaucher disease who need Cerezyme (imiglucerase) covered by UnitedHealthcare, as well as their healthcare providers and caregivers. You'll need this checklist if you're facing:

  • Initial prior authorization requests for Cerezyme
  • Denials requiring appeals or peer-to-peer reviews
  • Transitions from other enzyme replacement therapies
  • Reauthorization for continuing therapy

Expected outcome: Following this checklist systematically increases approval likelihood and reduces delays. Counterforce Health has seen that thorough documentation addressing each payer requirement significantly improves first-pass approval rates for complex specialty medications like Cerezyme.

Member & Plan Basics

Verify Active Coverage

Before starting, confirm your UnitedHealthcare plan details:

  • Plan type: Commercial, Medicare Advantage, or Community Plan (Medicaid)
  • Specialty pharmacy benefits: Most UnitedHealthcare plans require specialty medications through their contracted network
  • Prior authorization status: As of October 2024, prior authorization is required for Cerezyme across UnitedHealthcare Community Plan members in Michigan

Key Contact Information

  • OptumRx Prior Authorization: 800-310-6826
  • UnitedHealthcare Community Plan PA Support: 888-397-8129
  • Member Services: Number on your insurance card

Clinical Criteria Requirements

Primary Indication Requirements

UnitedHealthcare requires documented evidence of:

✅ Confirmed Type 1 or Type 3 Gaucher disease diagnosis

  • Enzyme deficiency testing (reduced glucocerebrosidase activity)
  • Genetic testing showing GBA gene mutations (when available)
  • Clinical manifestations (hepatosplenomegaly, cytopenias, bone disease)

Step Therapy Protocol

Critical requirement: UnitedHealthcare mandates trying VPRIV as first-line ERT before approving Cerezyme. You must document:

  • VPRIV failure: Inability to meet clinical goals (persistent anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly)
  • VPRIV intolerance: Documented adverse reactions or contraindications
  • Exemption: Current Cerezyme users within past 365 days may be exempt from step therapy

Dosing Requirements

  • Must align with FDA-approved labeling
  • Typical dosing: 2.5 U/kg three times weekly to 60 U/kg every 2 weeks
  • Individualized based on clinical response and severity

Coding & Billing Essentials

Required Codes

Code Type Code Description Notes
ICD-10 E75.22 Gaucher disease, type 1 Primary diagnosis
HCPCS J1786 Injection, imiglucerase, 10 units 1 billing unit per 10 units
CPT 96365 IV infusion, initial hour For administration
CPT 96366 IV infusion, additional hour If needed

Billing Considerations

  • NDC Code: 58468-4663-1 (verify current packaging)
  • JW Modifier: Required for Medicare when reporting discarded portions
  • Place of Service: Use appropriate 2-digit code for infusion site
  • Units: Calculate total units administered (e.g., 400-unit vial = 40 billing units)

Documentation Packet

Medical Necessity Letter Components

Your provider's letter must include:

Patient Information:

  • Name, DOB, insurance ID
  • Confirmed Gaucher disease diagnosis with ICD-10 code E75.22

Clinical History:

  • Symptom onset and progression
  • Previous treatments and outcomes
  • Current clinical status and functional impact

Treatment Rationale:

  • Why Cerezyme is medically necessary
  • Evidence of VPRIV failure/intolerance (for step therapy exception)
  • Expected clinical benefits and monitoring plan

Supporting Evidence:

  • Laboratory results (CBC, liver function, biomarkers)
  • Imaging studies (organomegaly assessment)
  • Genetic testing results

Required Attachments

  • Complete medical records documenting diagnosis
  • Lab reports and imaging studies
  • Previous treatment history and responses
  • Prescription with detailed dosing instructions
Tip: Sanofi provides a Statement of Medical Necessity template specifically for Cerezyme that addresses UnitedHealthcare's requirements.

Submission Process

Prior Authorization Submission

  1. Access OptumRx portal or call 800-310-6826
  2. Complete PA form with all required clinical information
  3. Attach documentation packet including medical necessity letter
  4. Submit within timeframe (before intended start date)
  5. Obtain confirmation number for tracking

Form Requirements

  • Use current OptumRx prior authorization form
  • Complete all required fields (incomplete submissions cause delays)
  • Include provider NPI and contact information
  • Specify exact dosing regimen and frequency

Processing Timeline

  • Standard review: Up to 72 hours
  • Expedited review: Up to 24 hours (for urgent cases)
  • Additional information requests: May extend timeline

Specialty Pharmacy Network

UnitedHealthcare Requirements

Cerezyme is classified as a specialty medication and must be obtained through UnitedHealthcare's contracted specialty pharmacy network. Key points:

  • Limited to 1-month supply per prescription
  • Not available at retail pharmacies
  • Home delivery or provider office shipment options available

Finding Network Pharmacies

  • Log into myuhc.com/exchange to view options
  • Call Member Services for current preferred vendors
  • Request Provider Vendor Assistance List from UnitedHealthcare

Coordination Steps

  1. Verify pharmacy network status before prescription transfer
  2. Coordinate delivery with infusion site if applicable
  3. Confirm insurance processing before shipment
  4. Track shipment and verify receipt

After Submission: What to Expect

Tracking Your Request

  • Record confirmation number from submission
  • Check status via OptumRx portal or phone
  • Respond promptly to requests for additional information
  • Document all communications with dates and reference numbers

Possible Outcomes

Approval: Proceed with specialty pharmacy coordination Denial: Review reason codes and prepare appeal Pending: Provide requested additional information promptly

Status Check Schedule

  • Day 1-2: Confirm receipt
  • Day 3: Check for additional information requests
  • Day 5-7: Follow up if no determination received

Denial Prevention Tips

Five Common Pitfalls and Solutions

  1. Missing Step Therapy Documentation
    • Problem: No evidence of VPRIV trial/failure
    • Solution: Document specific VPRIV outcomes or contraindications
  2. Incomplete Diagnosis Confirmation
    • Problem: Lacking enzyme testing or genetic confirmation
    • Solution: Include all diagnostic test results supporting Gaucher disease
  3. Dosing Outside FDA Guidelines
    • Problem: Requested dose not aligned with approved labeling
    • Solution: Justify dosing with clinical rationale and literature support
  4. Insufficient Medical Necessity
    • Problem: Generic letter without specific clinical details
    • Solution: Use detailed, patient-specific medical necessity documentation
  5. Wrong Submission Method
    • Problem: Using outdated forms or incorrect portal
    • Solution: Verify current OptumRx requirements and submission process

Appeals Process in Michigan

UnitedHealthcare Internal Appeals

Timeline: 180 days from denial date Levels: Typically 1-2 internal review levels Submission: Via member portal, fax, or mail as specified in denial letter

Michigan External Review

If internal appeals are exhausted, Michigan offers robust external review rights:

Timeline: 127 days from final internal denial to request external review Process: File with Michigan Department of Insurance and Financial Services (DIFS) Decision timeframe: Up to 60 days (often faster) Expedited option: 72 hours for urgent cases with physician attestation

DIFS Contact Information

  • Phone: 877-999-6442 (toll-free)
  • Online: Submit External Review Request form via DIFS website
  • Resources: "How to Appeal a Health Insurance Decision" consumer brochure
Note: Michigan's external review decisions are binding on insurers. The independent medical experts will evaluate whether Cerezyme is medically necessary under your policy terms.

When navigating complex prior authorization requirements, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer-specific requirements, significantly improving approval rates for specialty medications.

Quick Reference Checklist

Before You Start

  • Verify active UnitedHealthcare coverage
  • Confirm Gaucher disease diagnosis documentation
  • Gather VPRIV trial/failure evidence (if applicable)
  • Collect complete medical records and lab results

Clinical Requirements

  • Type 1 Gaucher disease confirmed (ICD-10: E75.22)
  • Step therapy requirement addressed (VPRIV failure/intolerance)
  • FDA-compliant dosing specified
  • Medical necessity clearly documented

Submission Essentials

  • OptumRx prior authorization form completed
  • Medical necessity letter attached
  • All supporting documentation included
  • Confirmation number obtained and recorded

After Submission

  • Status checked within 2-3 days
  • Specialty pharmacy coordination initiated (if approved)
  • Appeal process initiated promptly (if denied)
  • All communications documented with dates/references

FAQ

How long does UnitedHealthcare PA take in Michigan? Standard prior authorization decisions are made within 72 hours. Expedited requests (for urgent medical situations) are processed within 24 hours.

What if Cerezyme is non-formulary on my plan? Even non-formulary medications can be covered with prior authorization and medical necessity documentation. Focus on demonstrating clinical need and step therapy compliance.

Can I request an expedited appeal if denied? Yes, if your health would be in serious jeopardy by waiting. Your physician must provide a letter supporting the urgent need for expedited review.

Does step therapy apply if I've been on Cerezyme outside Michigan? Current users within the past 365 days may be exempt from step therapy requirements. Provide documentation of ongoing therapy.

What happens if my appeal is denied by UnitedHealthcare? You can request external review through Michigan DIFS within 127 days. This independent medical review is binding on the insurer.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and work directly with your insurance plan for coverage determinations. Coverage policies and requirements may change; verify current information with UnitedHealthcare and Michigan regulatory authorities.

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