By Counterforce Health Team in Naglazyme (galsulfase) —

How to Get Naglazyme (Galsulfase) Covered by Blue Cross Blue Shield in Michigan: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Naglazyme Covered by BCBS Michigan

Blue Cross Blue Shield of Michigan requires prior authorization for Naglazyme (galsulfase) with specific MPS VI diagnostic criteria. The fastest approval path: 1) Gather enzyme/genetic testing confirming MPS VI diagnosis, 2) Submit complete PA through BCBS Michigan's provider portal with specialist letter, and 3) Use Walgreens Specialty Pharmacy. If denied, you have 180 days for internal appeals, then 127 days for Michigan DIFS external review. Start today by confirming your formulary tier and gathering diagnostic documentation.

Table of Contents

Why Michigan State Rules Matter

Michigan's insurance landscape is unique—Blue Cross Blue Shield of Michigan covers approximately 67% of commercial plan members, making their policies especially influential. While Michigan lacks comprehensive step therapy reform protections (unlike 35+ other states), patients have strong appeal rights under the Patient's Right to Independent Review Act (PRIRA).

For rare disease treatments like Naglazyme, Michigan provides:

  • 127-day external review window (longer than the federal 120-day standard)
  • 72-hour expedited appeals for urgent cases with physician attestation
  • Binding external review decisions through Michigan Department of Insurance and Financial Services (DIFS)

Understanding these state-specific timelines is crucial since Naglazyme costs roughly $600K-$1.8M annually, making coverage denials financially devastating for families.

BCBS Michigan Coverage Requirements

Coverage Criteria Table

Requirement What It Means Where to Find It Source
Prior Authorization PA required for specialty injectables BCBS Michigan PA Drug List BCBS Michigan
Confirmed MPS VI Diagnosis Enzyme assay or genetic testing Policy 2138471 BCBS Michigan ERT Policy
Specialist Prescription Genetics, metabolic, or rare disease expert Policy requirements BCBS Michigan
Specialty Pharmacy Walgreens Specialty Pharmacy only Network requirements BCBS Michigan
Formulary Tier Specialty (SP) with potential quantity limits Clinical Drug List BCBS Michigan

Medical Necessity Criteria

BCBS Michigan's Enzyme Replacement Therapy for Mucopolysaccharidosis (MPS) policy requires ALL of the following:

  • FDA-approved indication: Treatment of MPS VI (Maroteaux-Lamy syndrome)
  • Confirmed diagnosis: Reduced arylsulfatase B activity in leukocytes/fibroblasts OR biallelic pathogenic ARSB variants
  • Clinical manifestations: Documented skeletal dysplasia, joint contractures, or organ involvement
  • Baseline assessments: 6-minute walk test, pulmonary function, joint mobility measures
  • Proper dosing: 1 mg/kg IV weekly with infusion premedication protocols

Prior Authorization Timeline & Process

Standard Timeline: 15 calendar days for routine PA decisions Urgent Cases: 72 hours with physician attestation of urgency

Required Documentation Checklist

✓ Diagnostic Testing: Enzyme assay results showing reduced arylsulfatase B activity ✓ Genetic Testing: If available, ARSB gene mutation analysis ✓ Clinical Notes: Specialist documentation of MPS VI symptoms ✓ Baseline Assessments: Functional capacity measurements ✓ Insurance Verification: Current BCBS Michigan member ID and plan details ✓ Prescription: From qualified specialist with proper dosing (1 mg/kg weekly)

Tip: Submit through the Availity portal for fastest processing. Incomplete submissions add 7-14 days to the review timeline.

Step-by-Step: Fastest Path to Approval

1. Verify Coverage & Formulary Status

Who: Patient or clinic staff Action: Check BCBS Michigan drug lists for Naglazyme's tier status Timeline: Same day

2. Gather Diagnostic Documentation

Who: Specialist clinic Documents: Enzyme assay, genetic testing, clinical progression notes Timeline: May require 1-2 weeks if tests need ordering

3. Complete Baseline Assessments

Who: Treating specialist Required: 6-minute walk test, pulmonary function tests, joint mobility assessment Timeline: 1-2 clinic visits

4. Submit Prior Authorization

Who: Prescribing physician Method: Availity portal or BCBS Michigan provider portal Include: All documentation plus medical necessity letter Timeline: Same day submission

5. Coordinate Specialty Pharmacy

Who: Clinic or patient Contact: Walgreens Specialty Pharmacy at 1-866-515-1355 Action: Verify network status and setup delivery Timeline: 2-3 business days

6. Follow Up on PA Status

Who: Clinic staff Timeline: Check status after 7 business days if no response Action: Call BCBS Michigan provider line for updates

7. Plan for Infusion Setup

Who: Patient with clinic coordination Requirements: In-network infusion center, premedication protocols Timeline: Schedule once PA approved

Common Denial Reasons & Solutions

Denial Reason How to Overturn Key Documentation
"Diagnosis not confirmed" Submit enzyme assay showing <10% normal activity Lab results with reference ranges
"Not medically necessary" Provide functional decline documentation 6-minute walk test, pulmonary function trends
"Missing baseline measures" Complete and submit required assessments All baseline tests within 6 months
"Non-formulary drug" File formulary exception request Letter explaining why no alternatives exist
"Site of care issues" Verify in-network infusion center Provider network confirmation

Appeals Process in Michigan

Internal Appeals with BCBS Michigan

First-Level Appeal

  • Deadline: 180 days from initial denial
  • Processing Time: 30 days (72 hours if expedited)
  • How to File: Written request with supporting documentation
  • Required: Original denial letter, updated medical records, specialist letter

Second-Level Appeal

  • Deadline: 60 days from first-level denial
  • Processing Time: 30 days standard
  • Additional Requirements: May include peer-to-peer review option
Note: BCBS Michigan must provide appeal forms with denial letters. Request expedited review if treatment delays would harm your health.

Clinician Corner: Medical Necessity Letter Essentials

Your specialist should include these key elements:

Problem Statement

  • Confirmed MPS VI diagnosis with specific enzyme/genetic findings
  • Current clinical manifestations and functional limitations

Prior Treatments

  • Document that no alternative ERTs exist for MPS VI
  • Any supportive therapies tried (physical therapy, surgical interventions)

Clinical Rationale

  • Reference FDA labeling for Naglazyme
  • Cite clinical studies showing functional improvements
  • Explain dosing rationale (1 mg/kg weekly)

Monitoring Plan

  • Regular functional assessments
  • Safety monitoring protocols
  • Treatment goals and success metrics

Michigan DIFS External Review

If BCBS Michigan denies your internal appeals, Michigan's external review process provides an independent, binding decision.

Eligibility & Timeline

Filing Deadline: 127 days after final internal denial Standard Processing: 28-56 days (can extend to 84 days) Expedited Review: 72 hours with physician letter confirming urgency

Required Documents for DIFS

✓ FIS 0018 External Review Form (sections 4-7 if patient ≥18) ✓ All denial letters from BCBS Michigan ✓ Complete medical records supporting the claim ✓ Physician urgency letter (for expedited review only)

How to File

Online: DIFS External Review Portal Phone: 877-999-6442 (Monday-Friday, 8am-5pm) Cost: Free process

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to identify the specific denial basis and draft point-by-point rebuttals. For complex cases like Naglazyme appeals, their platform can help identify the right citations from FDA labeling, peer-reviewed studies, and specialty guidelines while ensuring all procedural requirements are met.

From Our Advocates

"We've seen MPS VI cases succeed in external review when families provide comprehensive functional decline documentation alongside genetic confirmation. One family's appeal was strengthened by including before-and-after videos showing mobility changes, which helped the independent reviewer understand the urgent medical necessity beyond just lab values."

Costs & Financial Assistance

Expected Costs Post-Approval

  • Specialty Tier Coinsurance: Typically 25-50% of drug cost
  • Annual Out-of-Pocket: Varies by plan; may reach annual maximum quickly
  • Infusion Costs: Additional facility and administration fees

Financial Assistance Options

BioMarin Patient Assistance

  • Contact: BioMarin RareConnections® at 1-866-906-6100
  • Eligibility: Based on income and insurance status
  • Coverage: May cover copays, coinsurance, or full drug cost

Foundation Grants

  • National Organization for Rare Disorders (NORD)
  • Patient Access Network Foundation
  • Good Days (formerly Chronic Disease Fund)

State Programs

  • Michigan's Medicaid expansion may provide secondary coverage
  • Contact Michigan Department of Health and Human Services

Scripts & Templates

Patient Phone Script for BCBS Michigan

"Hi, I'm calling about a prior authorization for Naglazyme for MPS VI. My member ID is [ID number]. Can you tell me the current status and what additional documentation might be needed? I'd also like to confirm that Walgreens Specialty Pharmacy is still the required network pharmacy."

Clinic Staff Script for PA Status

"This is [name] from [clinic] calling about a Naglazyme PA for patient [name], member ID [number]. We submitted on [date] through Availity. Can you provide the current status and expected decision timeline? If there are any missing documents, we'd like to submit them today."

FAQ

How long does BCBS Michigan PA take for Naglazyme? Standard decisions within 15 calendar days; urgent cases within 72 hours with physician attestation.

What if Naglazyme is non-formulary on my plan? File a formulary exception request with clinical documentation explaining why no covered alternatives exist for MPS VI.

Can I request an expedited appeal in Michigan? Yes, both BCBS Michigan (72 hours) and DIFS external review (72 hours) offer expedited processes with physician letters confirming urgency.

Does step therapy apply to Naglazyme? Typically no, since no alternative ERTs exist for MPS VI. However, verify your specific plan's requirements.

What happens if DIFS external review is denied? You can seek judicial review in Michigan circuit court within 60 days of the DIFS decision.

Who can file appeals on my behalf? Your physician or authorized representative can file appeals with your written consent under Michigan law.

Are there any Michigan-specific protections for rare diseases? While Michigan lacks comprehensive step therapy reform, PRIRA provides strong external review rights with longer filing deadlines than federal standards.

Sources & Further Reading

For specialized guidance on complex appeals, Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by providing targeted, evidence-backed documentation that meets specific payer requirements.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations may change. Always verify current requirements with your insurer and consult healthcare professionals for medical decisions. For official Michigan insurance assistance, contact DIFS at 877-999-6442.

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