By Counterforce Health Team in Naglazyme (galsulfase) —

The Requirements Checklist to Get Naglazyme (galsulfase) Covered by Humana in Virginia

Answer Box: Getting Naglazyme (galsulfase) Covered by Humana in Virginia

Naglazyme (galsulfase) requires prior authorization from Humana with standard reviews taking up to 30 days and expedited reviews within 72 hours if physician-certified as urgent. Virginia patients have strong appeal rights through the State Corporation Commission's external review process if denied.

Fastest path to approval:

  1. Confirm MPS VI diagnosis with enzyme assay (arylsulfatase B deficiency) and genetic testing
  2. Submit PA via Humana's provider portal or fax to 877-486-2621
  3. Include baseline functional assessments (6-minute walk test, stair climbing capacity)

First step today: Gather insurance card, MPS VI diagnostic results, and contact your prescriber to initiate the PA process.

Table of Contents

Who Should Use This Guide

This comprehensive checklist is designed for Virginia patients with MPS VI (Maroteaux-Lamy syndrome) and their healthcare teams seeking Humana coverage for Naglazyme (galsulfase) enzyme replacement therapy. You'll also find this useful if you've received a denial and need to understand the appeal process.

Expected outcome: Following this guide systematically increases your chances of initial approval and provides a clear roadmap for appeals if needed. Virginia's external review process has helped many patients overturn wrongful denials for specialty medications.

Member & Plan Basics

Coverage Verification

Before starting the PA process, confirm these essential details:

  • Active Humana coverage with current member ID
  • Plan type: Most commonly Medicare Advantage/Part D in Virginia
  • Formulary status: Naglazyme may be non-formulary, requiring exception requests
  • Deductible status: High-cost specialty drugs may apply to deductible
Tip: Call Humana member services at 1-800-457-4708 to verify your specific plan's coverage details and PA requirements.

Authorization Requirements

Humana requires prior authorization for high-cost enzyme replacement therapies like Naglazyme to confirm medical necessity. Filling without approval risks full patient cost responsibility, which can exceed $100,000 annually.

Clinical Criteria Requirements

Primary Indication

ICD-10 Code E76.29 (Other mucopolysaccharidoses) must be supported by:

Diagnostic Requirement Documentation Needed Source
Enzyme Assay Arylsulfatase B activity <10% normal in leukocytes/fibroblasts Naglazyme diagnostic criteria
Genetic Testing Pathogenic ARSB gene mutations (biallelic) MPS VI genetic testing
Clinical Features Corneal clouding, skeletal dysplasia, hepatosplenomegaly FDA label requirements

Baseline Functional Assessments

Required before treatment initiation:

  • 6-minute walk test (6MWT): Measures endurance capacity
  • 3-minute stair climb test: Counts stairs ascended
  • Pulmonary function tests: FEV1, FVC measurements
  • Urinary GAG levels: Elevated dermatan sulfate and chondroitin sulfate
Note: These baseline measurements are critical for demonstrating treatment response during renewal reviews.

Dosing Requirements

  • Standard dose: 1 mg/kg IV weekly
  • Administration: Hospital or infusion center setting
  • HCPCS code: J1458 (1 unit = 1 mg)

Coding & Billing Information

Essential Codes

Code Type Code Description
ICD-10 E76.29 Other mucopolysaccharidoses (MPS VI)
HCPCS J1458 Injection, galsulfase, 1 mg
NDC 68135-0020-01 Naglazyme 5 mg/5 mL vial

Billing Units

Calculate units based on patient weight: 30 kg patient = 30 units of J1458 per weekly infusion.

Documentation Packet Essentials

Provider Letter of Medical Necessity

Your prescriber's letter should include:

Clinical History:

  • MPS VI diagnosis confirmation with enzyme/genetic results
  • Symptom progression and functional limitations
  • Prior treatments attempted (if applicable)

Treatment Rationale:

  • Why Naglazyme is medically necessary
  • Expected clinical benefits
  • Monitoring plan with objective measures

Supporting Evidence:

  • FDA labeling for MPS VI indication
  • Baseline functional test results
  • Treatment goals and success metrics

Required Attachments

  • Insurance card and member ID
  • Complete diagnostic workup results
  • Baseline 6MWT and stair climb results
  • Pulmonary function tests
  • Recent clinical notes from genetics/metabolic specialist

Submission Process

Submission Methods

  1. Online: Humana Provider Portal (preferred)
  2. Fax: 877-486-2621
  3. Phone: 866-421-5663 (Mon-Fri, 7am-7pm CT)

Form Requirements

Use Humana's Medicare PA forms available through the Prior Authorization Search Tool. Search "Naglazyme" or "J1458" for drug-specific requirements.

Common Rejection Causes

  • Incomplete diagnostic documentation
  • Missing baseline functional assessments
  • Incorrect ICD-10 coding
  • Prescriber not recognized as appropriate specialist

Specialty Pharmacy Coordination

Many Humana plans require specialty pharmacy dispensing for Naglazyme. Your prescriber will need to:

  1. Select preferred vendor from Humana's network
  2. Complete transfer paperwork with patient demographics and insurance information
  3. Coordinate delivery to infusion site
  4. Verify receipt and proper storage before administration
Tip: Establish this coordination early in the PA process to avoid delays once approval is received.

After Submission: Tracking Your Request

Timeline Expectations

  • Standard review: Up to 30 days
  • Expedited review: 72 hours (requires physician certification of urgency)
  • Status checks: Call 866-421-5663 with PA reference number

Documentation to Record

  • PA submission date and confirmation number
  • Representative names and call reference numbers
  • Any additional information requests
  • Decision date and approval/denial details

Common Denial Prevention Tips

Five Critical Pitfalls to Avoid

  1. Insufficient diagnostic proof: Ensure both enzyme assay AND genetic testing results are included
  2. Missing baseline assessments: 6MWT and stair climb tests are typically required
  3. Inappropriate prescriber: Must be genetics, endocrinology, or metabolic specialist
  4. Incomplete dosing justification: Include patient weight and mg/kg calculation
  5. Poor clinical narrative: Letter must clearly link MPS VI symptoms to treatment need

Appeals Process in Virginia

If your initial PA is denied, Virginia provides robust appeal rights through the State Corporation Commission Bureau of Insurance.

Internal Appeals (Humana)

  • Deadline: 65 days from denial notice
  • Timeline: 30 days for standard review, 72 hours for expedited
  • Submission: Same portal/fax as initial PA

External Review (Virginia SCC)

After exhausting Humana's internal appeals:

Contact for guidance: Virginia SCC Consumer Services at 1-877-310-6560

From our advocates: We've seen patients succeed in Virginia's external review process when they include comprehensive functional testing results and specialist letters clearly documenting disease progression. The independent medical reviewers appreciate objective data showing how Naglazyme addresses specific MPS VI manifestations.

Printable Checklist

Before Submitting PA:

  • Confirm active Humana coverage and member ID
  • Obtain MPS VI diagnosis with enzyme assay results
  • Complete genetic testing for ARSB mutations
  • Perform baseline 6-minute walk test
  • Complete 3-minute stair climb assessment
  • Obtain pulmonary function tests
  • Gather urinary GAG level results
  • Ensure prescriber is appropriate specialist
  • Calculate correct dosing (1 mg/kg weekly)
  • Prepare comprehensive letter of medical necessity

During Submission:

  • Use correct ICD-10 (E76.29) and HCPCS (J1458) codes
  • Submit via Humana provider portal or fax to 877-486-2621
  • Record confirmation number and submission date
  • Coordinate with specialty pharmacy if required

After Submission:

  • Track status regularly via phone or portal
  • Respond promptly to any information requests
  • If denied, initiate appeal within 65 days
  • Consider Virginia external review if internal appeals fail

FAQ

How long does Humana PA take for Naglazyme in Virginia? Standard reviews take up to 30 days. Expedited reviews (requiring physician certification of urgency) are completed within 72 hours.

What if Naglazyme is non-formulary on my plan? Request a formulary exception with your PA submission. Include prescriber documentation explaining why formulary alternatives are inappropriate for MPS VI.

Can I request an expedited appeal in Virginia? Yes, if your physician certifies that waiting for standard review could seriously jeopardize your health. Virginia's external review process also offers 72-hour expedited decisions.

Does step therapy apply to Naglazyme? Generally no, as Naglazyme is the only FDA-approved treatment specifically for MPS VI. However, some plans may require documentation of supportive care attempts.

What happens if I move from Virginia to another state? Your Humana coverage continues, but state-specific external review rights may change. Contact your new state's insurance department for local appeal processes.

How much does Naglazyme cost without insurance? Annual costs typically range from $600,000 to $1.8 million based on patient weight, making insurance coverage essential for access.

Counterforce Health helps patients navigate complex prior authorization processes by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to identify specific coverage criteria, then drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements. For more information about getting prescription drugs approved, visit CounterforceHealth.org.

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 with your insurance plan directly for coverage determinations. For assistance with Virginia insurance disputes, contact the State Corporation Commission Bureau of Insurance at 1-877-310-6560.

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