How to Get Naglazyme (Galsulfase) Covered by Humana in California: Complete Prior Authorization and Appeals Guide
Answer Box: Getting Naglazyme (Galsulfase) Covered by Humana in California
Humana requires prior authorization for Naglazyme (galsulfase) for MPS VI. Your fastest path: (1) Submit complete PA with enzyme assay, genetic testing, and baseline functional measures (6-minute walk test, stair climbing capacity), (2) If denied, file internal appeal within 65 days with targeted medical necessity letter, (3) Use California's Independent Medical Review (IMR) if still denied—73% success rate for overturning denials. Start today: Call Humana at the number on your ID card to confirm PA requirements and obtain forms.
Table of Contents
- Understanding Your Coverage
- Prior Authorization Requirements
- Common Denial Reasons & How to Fix Them
- Step-by-Step: Fastest Path to Approval
- Medical Necessity Letter Essentials
- Appeals Process: Humana Internal Review
- California Independent Medical Review (IMR)
- Peer-to-Peer Review Strategy
- Cost-Saving Options
- Frequently Asked Questions
Understanding Your Coverage
Naglazyme (galsulfase) is an enzyme replacement therapy for MPS VI (Maroteaux-Lamy syndrome) that costs approximately $600,000-$1.8 million annually depending on patient weight. Humana covers Naglazyme under both medical and pharmacy benefits, but the pathway differs:
- Medical Benefit (Part C): Hospital or infusion center administration; processed through utilization management
- Pharmacy Benefit (Part D): Specialty pharmacy dispensing; requires Humana Clinical Pharmacy Review (HCPR)
Coverage at a Glance
| Requirement | Details | Where to Find | Source |
|---|---|---|---|
| Prior Authorization | Required for all Humana plans | Humana PA Lists | Humana 2025 PA List |
| Formulary Status | Covered with PA under J1458 | Plan formulary documents | Humana Provider Portal |
| Step Therapy | May apply; alternatives limited | PA determination | Humana Clinical Review |
| Site of Care | Hospital/infusion center preferred | Medical necessity review | UM Guidelines |
| Appeals Deadline | 65 days from denial | Denial notice | Medicare Appeals |
Prior Authorization Requirements
Humana requires comprehensive documentation for Naglazyme approval. Based on their clinical review criteria, you'll need:
Diagnostic Confirmation
- Enzyme assay: ARSB activity <10% of normal in leukocytes or fibroblasts
- Genetic testing: Pathogenic ARSB gene variants from CLIA-certified lab
- Clinical presentation: Documented MPS VI symptoms (skeletal dysplasia, joint contractures, cardiac involvement)
Baseline Functional Measures
- 6-Minute Walk Test: Distance in meters with predicted percentage
- Stair Climbing Test: Steps climbed in 3 minutes or time to climb fixed flight
- Pulmonary Function: FVC and FEV1 percentages
- Cardiac Assessment: Echocardiogram findings
Treatment Plan
- FDA-approved dosing: 1 mg/kg IV weekly
- Site of care justification
- Monitoring protocol including functional reassessments
Common Denial Reasons & How to Fix Them
| Denial Reason | How to Overturn | Required Documentation |
|---|---|---|
| Diagnosis not confirmed | Submit enzyme assay + genetic testing | Mayo Clinic ARSB Test |
| Lack of functional measures | Provide baseline 6MWT, stair climb data | Standardized test results |
| Not medically necessary | Medical necessity letter citing guidelines | FDA Naglazyme Label |
| Site of care issues | Justify infusion center vs. home | Medical records showing infusion reactions |
| Experimental/investigational | Cite FDA approval for MPS VI | Published clinical trials |
Step-by-Step: Fastest Path to Approval
Step 1: Confirm Benefit Type (Day 1)
Who: Patient or clinic staff
Action: Call Humana member services to verify if Naglazyme is covered under medical or pharmacy benefit
Documents: Insurance card, prescription
Timeline: Same day
Source: Humana Member Portal
Step 2: Gather Required Documentation (Days 1-7)
Who: Healthcare team
Action: Collect enzyme assay, genetic testing, baseline functional tests
Documents: Lab reports, clinic notes, test results
Timeline: 1 week
Source: Clinical records
Step 3: Submit Prior Authorization (Day 8)
Who: Prescribing physician
Action: Complete Humana PA form with all supporting documentation
Documents: PA form, medical necessity letter, test results
Timeline: Submit within 24-48 hours of completion
Source: Humana Provider PA Portal
Step 4: Request Expedited Review if Urgent (Day 8)
Who: Physician
Action: Document immediate health threat from delay
Documents: Urgency statement, clinical justification
Timeline: 72 hours for expedited decisions
Source: Medicare expedited review guidelines
Step 5: Track Decision (Days 9-38)
Who: Patient and clinic
Action: Monitor for Humana decision
Timeline: 30 days for medical benefit, 7 days for Part D
Source: Humana Appeals Process
Medical Necessity Letter Essentials
Your specialist should structure the medical necessity letter around these key elements:
Disease Severity Section
"Patient has biochemically and genetically confirmed MPS VI (Maroteaux-Lamy syndrome), a progressive, life-threatening lysosomal storage disorder caused by ARSB deficiency. Without enzyme replacement therapy, patients experience irreversible functional decline, cardiopulmonary complications, and shortened lifespan."
Functional Impairment Documentation
- Baseline 6-minute walk distance with predicted percentage
- Stair climbing capacity (steps per 3 minutes)
- Pulmonary function percentages
- Cardiac findings and sleep study results if applicable
Treatment Rationale
"Naglazyme (galsulfase) is FDA-approved enzyme replacement therapy that has demonstrated improvement in walking capacity and stair-climbing performance in clinical trials. Expert guidelines recommend early initiation to prevent irreversible organ damage."
Monitoring Plan
"Patient will undergo functional reassessment every 6-12 months including 6MWT, pulmonary function testing, and cardiac evaluation to document clinical response and continued medical necessity."
Clinician Corner: Include specific citations from the FDA label and published clinical trials. Reference the 2007 Pediatrics management guidelines for MPS VI, which establish ERT as standard of care for symptomatic patients.
Appeals Process: Humana Internal Review
If your initial PA is denied, you have 65 days from the denial date to file an internal appeal with Humana.
Level 1: Plan Appeal
Timeline: 30 days for medical benefit, 7 days for Part D
How to File: Humana Appeals Forms
Required Documents:
- Original denial notice
- Updated medical necessity letter addressing specific denial reasons
- Additional clinical evidence
- Peer-reviewed literature supporting Naglazyme for MPS VI
Level 2: Independent Review Entity (IRE)
If Humana upholds the denial, your case automatically escalates to Medicare's independent review contractor. The IRE decision is binding on Humana if they overturn the denial.
Timeline: 30 days for standard review
Process: Automatic escalation with instructions provided in Level 1 decision
Source: Medicare Appeals Process
California Independent Medical Review (IMR)
California residents have additional protection through the Department of Managed Health Care's Independent Medical Review process, which has a 73% success rate for overturning denials.
When to Use IMR
- Humana denies Naglazyme as "not medically necessary"
- Plan claims treatment is "experimental/investigational"
- You've completed Humana's internal appeal (or qualify for expedited review)
How to File IMR
- Online submission (recommended): DMHC IMR Portal
- Timeline: Within 6 months of final Humana denial
- Decision: 30 days standard, 3-7 days expedited
- Cost: Free to patients
Required Documentation for IMR
- All Humana denial and appeal letters
- Complete medical records including enzyme assay and genetic testing
- Detailed physician letter explaining medical necessity
- Published literature supporting Naglazyme for MPS VI
- Evidence of functional impairment and expected benefits
Note: If approved, Humana must authorize treatment within 5 business days of the IMR decision.
Counterforce Health specializes in turning insurance denials into successful appeals by creating evidence-backed, targeted rebuttals that align with each payer's specific requirements. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization and appeals processes more effectively.
Peer-to-Peer Review Strategy
Request a peer-to-peer call when Humana's initial review is incomplete or when clinical nuances need clarification.
How to Request
- Call the number on your denial notice
- Ask for "peer-to-peer review with medical director"
- Provide specific times your specialist is available
Preparation Checklist
- Diagnosis confirmation: Have enzyme assay and genetic testing results ready
- Functional data: Current 6MWT distance and stair climbing capacity
- Literature: Key studies showing Naglazyme efficacy in MPS VI
- Patient impact: Specific examples of functional limitations
Key Talking Points
- MPS VI is a progressive, life-threatening condition
- Naglazyme is FDA-approved and standard of care
- Patient meets all diagnostic criteria with objective confirmation
- Functional measures demonstrate significant impairment
- Delay risks irreversible deterioration
Cost-Saving Options
Manufacturer Support
- BioMarin RareConnections: Patient support program
- Copay assistance: May reduce out-of-pocket costs
- Prior authorization support: Dedicated team to help with submissions
Foundation Grants
- National Organization for Rare Disorders (NORD): Financial assistance programs
- Patient Advocate Foundation: Copay relief fund
- HealthWell Foundation: Disease-specific grants
State Programs
- California Children's Services (CCS): Coverage for qualifying conditions
- Medi-Cal: California Medicaid program with expanded eligibility
Frequently Asked Questions
How long does Humana prior authorization take in California? Standard PA decisions: 30 days for medical benefit, 7 days for Part D. Expedited reviews: 72 hours when medical urgency is documented.
What if Naglazyme is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Emphasize that no therapeutic alternatives exist for MPS VI.
Can I request an expedited appeal? Yes, if your physician certifies that waiting for standard review could seriously jeopardize your health. This is common for progressive rare diseases.
Does step therapy apply to Naglazyme? Possibly, but no therapeutic alternatives exist for MPS VI enzyme replacement. Document this in your medical necessity letter.
What happens if I start treatment while appealing? You may be responsible for costs if the appeal fails. Consider manufacturer assistance programs and discuss financial options with your provider.
How do I know if my Humana plan is DMHC-regulated? Most HMO and many PPO plans in California fall under DMHC. Call DMHC Help Center at 888-466-2219 to confirm eligibility for IMR.
Can family members help with appeals? Yes, but you must complete an Appointment of Representative form authorizing them to act on your behalf.
What's the minimum amount needed for federal court appeal? $1,900 for 2025, but most cases resolve at earlier appeal levels or through California's IMR process.
For complex cases involving multiple denials or unique clinical circumstances, Counterforce Health provides specialized support in developing comprehensive appeal strategies tailored to each payer's specific requirements.
Disclaimer: This information is for educational purposes and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific guidance. For additional help with insurance appeals in California, contact the DMHC Help Center at 888-466-2219 or visit healthhelp.ca.gov.
Sources & Further Reading
- Humana Prior Authorization Lists
- Medicare Appeals Process
- DMHC Independent Medical Review
- Humana Provider Portal
- FDA Naglazyme Information
- Mayo Clinic ARSB Testing
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