By Counterforce Health Team in Naglazyme (galsulfase) —

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

Answer Box: Getting Naglazyme Covered by Humana in Michigan

Naglazyme (galsulfase) requires prior authorization from Humana in Michigan. Submit PA documentation including confirmed MPS VI diagnosis via enzyme assay or genetic testing, baseline functional assessments (6-minute walk test), and clinical necessity letter. If denied, file internal appeal within 65 days, then Michigan DIFS external review within 127 days. First step today: Contact your prescriber to gather enzyme deficiency results and baseline walking capacity data, then submit PA via Humana's provider portal.

Table of Contents

  1. Coverage at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Clinician Corner: Medical Necessity Documentation
  4. Common Denial Reasons & How to Fix Them
  5. Appeals Playbook for Humana in Michigan
  6. Scripts & Templates
  7. Costs & Savings Options
  8. When to Escalate to Michigan DIFS
  9. FAQ

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Humana plans Submit via provider portal or fax Humana PA Lists
Formulary Tier Tier 4 (Specialty) - highest copay Search your specific plan formulary Humana Drug Lists
Diagnosis Code E76.29 (Other mucopolysaccharidosis) ICD-10 coding manual Verify with provider
HCPCS Code J1458 (Galsulfase injection) Medicare fee schedule CMS billing guidelines
Appeals Deadline 65 days from denial notice Humana member materials Humana Appeals
External Review 127 days after final internal denial Michigan DIFS DIFS External Review

Step-by-Step: Fastest Path to Approval

1. Confirm MPS VI Diagnosis (Provider)

Who: Your specialist (geneticist, metabolic physician)
Documents needed: Enzyme assay showing arylsulfatase B deficiency, genetic testing of ARSB gene
Timeline: Results typically available within 2-3 weeks
Source: BioMarin Diagnosis Guide

2. Gather Baseline Functional Data (Provider)

Who: Medical team
Documents needed: 6-minute walk test results, 3-minute stair climb assessment, pulmonary function tests
Timeline: Can be completed in one clinic visit
Source: Clinical assessment protocols for MPS VI

3. Submit Prior Authorization (Provider)

Who: Prescriber or clinic staff
How to submit: Humana provider portal or fax to designated PA line
Expected timeline: 30 days for standard, 72 hours for expedited
Source: Humana PA Process

4. Track PA Status (Patient/Provider)

Who: Either patient or clinic
How: Call Humana customer service with member ID and PA reference number
Timeline: Check after 7-10 business days
Tip: Document all call details and reference numbers

5. If Approved: Coordinate Specialty Pharmacy

Who: Patient with clinic support
Action: Humana will direct to their specialty pharmacy network for Tier 4 drugs
Timeline: 3-5 business days for first shipment coordination

6. If Denied: File Internal Appeal Immediately

Who: Patient or authorized representative
Deadline: Within 65 days of denial notice
How: Submit via Humana appeals portal or mail
Timeline: 30 days for decision

7. If Still Denied: Michigan DIFS External Review

Who: Patient
Deadline: Within 127 days of final internal denial
How: DIFS online form or PDF submission
Timeline: 60 days maximum, often faster

Clinician Corner: Medical Necessity Documentation

Counterforce Health helps clinicians streamline prior authorization appeals by analyzing denial letters and drafting targeted, evidence-backed rebuttals that align with each payer's specific criteria. Learn more at CounterforceHealth.org.

Medical Necessity Letter Checklist

Essential Elements for Naglazyme PA:

  • Confirmed MPS VI diagnosis with enzyme assay results showing arylsulfatase B deficiency
  • Genetic testing confirming biallelic ARSB gene mutations
  • Clinical presentation including corneal clouding, skeletal dysplasia, hepatosplenomegaly
  • Baseline functional assessments: 6-minute walk distance, 3-minute stair climb results
  • Treatment rationale citing FDA labeling for improved walking and stair-climbing capacity
  • Monitoring plan with follow-up functional assessments every 6 months
  • Dosing justification: 1 mg/kg IV weekly with weight-based calculations

Key Clinical References

  • FDA Naglazyme Label: Approved for MPS VI enzyme replacement therapy
  • BioMarin Clinical Data: Demonstrated improvements in walking capacity and endurance
  • MPS Society Guidelines: Standard of care recommendations for enzyme replacement therapy

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
"Diagnosis not confirmed" Submit enzyme assay and genetic testing results Lab reports showing ASB deficiency, ARSB gene analysis
"Not medically necessary" Provide baseline functional data and treatment goals 6MWT results, stair climb assessment, quality of life measures
"Investigational/experimental" Cite FDA approval and clinical evidence FDA label, peer-reviewed studies on efficacy
"Site of care not appropriate" Justify infusion center administration Infusion protocol, safety monitoring requirements
"Quantity limits exceeded" Document weight-based dosing calculation Patient weight, mg/kg dosing rationale

Appeals Playbook for Humana in Michigan

Level 1: Internal Appeal to Humana

  • Deadline: 65 days from denial notice
  • Submit via: Humana appeals portal, fax, or mail to P.O. Box 14165, Lexington, KY 40512-4165
  • Decision timeline: 30 days standard, 72 hours expedited
  • Required: Copy of denial letter, additional clinical evidence, prescriber letter

Level 2: Michigan DIFS External Review

  • Deadline: 127 days from final internal denial
  • Submit via: DIFS online form
  • Decision timeline: 60 days maximum, 72 hours for expedited
  • Cost: Free to patient
  • Required: Final denial letter from Humana, medical records, physician letter supporting urgency (for expedited)

Expedited Appeals

Request expedited review if delay would seriously jeopardize patient's health. Requires physician letter documenting immediate medical need.

Scripts & Templates

Patient Phone Script for Humana

"Hi, I'm calling to check the status of a prior authorization submitted for Naglazyme, member ID [number], submitted on [date]. Can you provide the current status and expected decision date? If there are any missing documents, what specifically do you need?"

Document: Representative name, reference number, next steps

Clinic Staff Peer-to-Peer Request Script

"I'm requesting a peer-to-peer review for a Naglazyme prior authorization, reference [number]. The patient has confirmed MPS VI with documented functional decline. Can we schedule a call with the medical director to discuss the clinical necessity?"

Appeal Letter Template

[Date]

Humana Appeals Department  
P.O. Box 14165  
Lexington, KY 40512-4165

RE: Appeal for [Patient Name], Member ID: [ID Number]  
Claim Reference: [PA Reference Number]  
Drug: Naglazyme (galsulfase)

Dear Medical Review Team,

I am appealing your [denial date] denial of Naglazyme for my patient with confirmed MPS VI (Maroteaux-Lamy syndrome).

**Medical Necessity**: This patient has laboratory-confirmed arylsulfatase B enzyme deficiency and genetic confirmation of MPS VI. Baseline 6-minute walk test shows [distance], indicating functional impairment consistent with progressive MPS VI. Naglazyme is FDA-approved specifically for this indication and represents the standard of care.

**Clinical Evidence**: Enclosed are enzyme assay results, genetic testing, and baseline functional assessments demonstrating medical necessity per FDA labeling.

I request immediate approval based on the enclosed clinical documentation.

Sincerely,  
[Physician Name and Credentials]

Attachments: Denial letter, lab results, clinical notes, functional assessments

Costs & Savings Options

Manufacturer Support

  • BioMarin RareConnections: Patient assistance program for eligible patients
  • Contact: 1-866-906-6100 or visit BioMarin patient support website
  • Services: Prior authorization support, appeals assistance, financial aid screening

Insurance Coverage

  • Humana Tier 4: Specialty tier copay applies (typically highest cost-sharing)
  • Medicare Part D: $2,000 annual out-of-pocket maximum for 2025
  • Coverage gap: May qualify for manufacturer copay assistance programs

When to Escalate to Michigan DIFS

Contact Michigan Department of Insurance and Financial Services if:

  • Humana doesn't respond within required timelines
  • You need help with the external review process
  • You have concerns about improper denial practices

Michigan DIFS Contact: 877-999-6442
External Review Portal: DIFS External Review

From our advocates: "We've seen Michigan DIFS external reviews succeed when families submit comprehensive clinical documentation upfront. Include the enzyme assay, genetic testing, and baseline functional data in your initial external review packet—don't wait for them to request additional information."

FAQ

How long does Humana prior authorization take for Naglazyme in Michigan?
Standard PA decisions take up to 30 days. Expedited requests (when delay risks patient health) are decided within 72 hours.

What if Naglazyme is non-formulary on my Humana plan?
You can request a formulary exception. Humana provides temporary coverage for up to 31 days while reviewing non-formulary requests.

Can I request an expedited appeal in Michigan?
Yes, both Humana internal appeals and Michigan DIFS external reviews offer expedited processes when delay would jeopardize patient health.

Does step therapy apply to Naglazyme?
Typically no, since there are no therapeutic alternatives for MPS VI enzyme replacement therapy.

What happens if Michigan DIFS overturns Humana's denial?
The decision is binding. Humana must provide coverage as directed within 7 days of the DIFS decision.

How do I prove medical necessity for MPS VI?
Submit enzyme assay showing arylsulfatase B deficiency, genetic testing confirming ARSB mutations, and functional assessments like 6-minute walk test results.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance plan directly for guidance specific to your situation.

For personalized help with prior authorizations and appeals, Counterforce Health provides specialized support for patients and clinicians navigating insurance coverage for specialty medications.

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