By Counterforce Health Team in Naglazyme (galsulfase) —

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

Quick Answer: Getting Naglazyme Covered by Humana in Georgia

Humana Medicare Advantage requires prior authorization for Naglazyme (galsulfase) with standard reviews up to 30 days. To get approved: (1) Gather MPS VI diagnosis confirmation (enzyme assay, genetic testing), baseline functional assessments (6-minute walk test, stair climb), and prescriber letter, (2) Submit via Humana Provider Portal or fax 877-486-2621, (3) If denied, appeal within 65 days via resolutions.humana.com or Georgia external review within 60 days through the Georgia Insurance Commissioner.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Verify Your Coverage
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Tracking
  6. Typical Timelines in Georgia
  7. If You Need More Information
  8. If Your Request is Denied
  9. Renewal and Re-Authorization
  10. Quick Reference Checklist

What This Guide Covers

This comprehensive guide helps patients with Mucopolysaccharidosis VI (MPS VI) and their healthcare providers navigate Humana's prior authorization process for Naglazyme (galsulfase) in Georgia. Whether you're dealing with an initial request or appealing a denial, we'll walk you through each step with specific forms, deadlines, and contact information.

Naglazyme is the only FDA-approved enzyme replacement therapy for MPS VI, with an annual cost ranging from $600,000 to $1.8 million depending on patient weight. Given these costs, virtually all insurers—including Humana—require prior authorization to ensure appropriate use.

Before You Start: Verify Your Coverage

Confirm Your Plan Type

Humana Medicare Advantage (Part C): Naglazyme is typically covered under the medical benefit (Part B) as a physician-administered infusion, not under Part D pharmacy benefits. Coverage requires Part B enrollment.

Commercial Humana Plans: Coverage varies by specific plan. Check your Summary of Benefits or call member services at 1-800-457-4708.

Check Formulary Status

Use Humana's Medicare Drug List tool to verify Naglazyme's formulary status. The drug is often non-formulary, requiring a formulary exception along with prior authorization.

Verify Network Status

Ensure your prescribing physician and planned infusion site are in-network. Out-of-network providers may face additional hurdles or denial.

Gather Required Documentation

Core Diagnostic Requirements

Enzyme Assay Results: Arylsulfatase B (ASB) activity <10% of normal in cultured fibroblasts or isolated leukocytes.

Genetic Testing: Pathogenic biallelic mutations in the ARSB gene confirming MPS VI diagnosis.

Urinary GAG Levels: Elevated glycosaminoglycans (dermatan sulfate/chondroitin sulfate) above reference lab upper limit.

ICD-10 Code: E76.29 (Other mucopolysaccharidoses)

Baseline Functional Assessments

Assessment Purpose Requirement
6-minute walk test Exercise tolerance Baseline measurement required
3-minute stair climb test Functional capacity Document current ability
Pulmonary function tests FEV1, FVC measurements Establish respiratory baseline

Clinical Documentation

  • Complete medical history with symptom progression
  • Documentation of clinical features (corneal clouding, skeletal dysplasia, hepatosplenomegaly)
  • Prior treatment attempts and outcomes
  • Contraindications to alternative treatments
  • Treatment goals and expected outcomes

Prescriber Letter of Medical Necessity

Your specialist should include:

  • Clinical rationale for Naglazyme therapy
  • Expected benefits based on baseline assessments
  • Monitoring plan for treatment response
  • References to FDA labeling and clinical guidelines

Submit Your Prior Authorization Request

Preferred Submission Method

Humana Provider Portal: Log in and search "Naglazyme" or use HCPCS code J1458 via the Prior Authorization Search Tool.

Alternative Methods:

  • Fax: 877-486-2621
  • Phone: 866-421-5663 (Mon-Fri 7am-7pm CT)

Required Information

  • Member ID and date of birth
  • Date of service
  • HCPCS code J1458 (bill by patient weight in kg)
  • NDC: 68135-0020-01 (5 mg/5 mL vial)
  • Complete clinical documentation packet
Tip: Request a fax confirmation receipt when submitting by fax, and record the confirmation number for your records.

Follow-Up and Tracking

When to Call

Contact Humana if you haven't received a decision within:

  • Standard review: 30 calendar days for pre-service decisions
  • Part D decisions: 7 calendar days
  • Payment decisions: 60 calendar days

Sample Call Script

"I'm calling to check the status of a prior authorization request for Naglazyme submitted on [date] for member [ID]. The reference number is [if available]. Can you provide the current status and expected decision date?"

Documentation

Keep detailed records of:

  • Submission dates and confirmation numbers
  • Representative names and call reference numbers
  • Any additional information requested
  • Decision dates and outcomes

Typical Timelines in Georgia

Standard Review Process

Initial Decision: Up to 30 days for Medicare Advantage pre-service decisions Expedited Review: 72 hours if physician certifies urgency Part D Appeals: 7 days for redetermination

Georgia-Specific Rights

Georgia residents have additional protections under state insurance law, including the right to external review through the Georgia Department of Insurance if internal appeals fail.

If You Need More Information

Common Requests

Humana may request additional documentation such as:

  • More detailed functional assessments
  • Specialist consultation notes
  • Literature supporting off-label use (if applicable)
  • Clarification of dosing rationale

Response Strategy

Respond promptly to avoid delays. Work with your prescriber to provide comprehensive documentation that addresses each specific question raised.

If Your Request is Denied

Common Denial Reasons and Solutions

Denial Reason Solution
Incomplete diagnostics Submit enzyme assay and genetic testing results
Missing baseline assessments Provide 6-minute walk test and pulmonary function data
Wrong specialist Ensure prescriber is appropriate specialist (geneticist, metabolic specialist)
Site of care issues Clarify infusion center capabilities and billing procedures

Humana Appeals Process

Level 1 (Plan Reconsideration): File within 65 days via resolutions.humana.com, fax 1-877-405-9067, or mail to address on denial notice.

Level 2 (Independent Review Entity): File within 65 days of Humana's decision if Level 1 is denied.

Expedited Appeals: Available if standard review could jeopardize health—common for progressive rare diseases.

Georgia External Review

If Humana's internal appeals fail, Georgia residents can request external review through the Georgia Office of Insurance and Safety Fire Commissioner:

  • Deadline: 60 days from final internal denial
  • Contact: 1-800-656-2298 or online complaint form
  • Cost: Free for consumers
  • Timeline: 30 business days for standard review, 72 hours for urgent cases
From Our Advocates: We've seen cases where initial denials were overturned at the external review level when complete functional assessments and specialist letters clearly demonstrated medical necessity. The key is thorough documentation from the start.

Renewal and Re-Authorization

When to Resubmit

Most Naglazyme authorizations require annual renewal. Calendar your resubmission 60-90 days before expiration to avoid treatment interruption.

Continuation Criteria

Document improvement or stabilization in at least one measure:

  • 6-minute or 12-minute walk test results
  • 3-minute stair climb test
  • Pulmonary function tests
  • Clinical symptoms and quality of life measures

Evidence of Ongoing Benefit

Include comparative data showing treatment response versus baseline, along with specialist assessment of continued medical necessity.

Quick Reference Checklist

Before Starting:

  • Verify Humana plan type and formulary status
  • Confirm provider and infusion site are in-network
  • Gather insurance card and member ID

Required Documentation:

  • MPS VI diagnosis: enzyme assay (<10% normal ASB activity)
  • Genetic testing: ARSB gene mutations
  • Baseline functional tests: 6-minute walk, stair climb, PFTs
  • Prescriber letter of medical necessity
  • ICD-10 code E76.29, HCPCS J1458

Submission:

  • Submit via Humana Provider Portal or fax 877-486-2621
  • Request confirmation receipt
  • Document reference numbers and submission date

Follow-up:

  • Track decision timeline (30 days standard, 7 days Part D)
  • Respond promptly to requests for additional information
  • Prepare appeal documentation if denied

Frequently Asked Questions

How long does Humana prior authorization take for Naglazyme in Georgia? Standard reviews take up to 30 days for Medicare Advantage pre-service decisions. Expedited reviews are completed within 72 hours if your physician certifies urgency.

What if Naglazyme is not on Humana's formulary? Submit a formulary exception request alongside your prior authorization, explaining that Naglazyme is the only FDA-approved treatment for MPS VI with no therapeutic alternatives.

Can I request an expedited appeal in Georgia? Yes, expedited appeals are available if standard review timelines could jeopardize your health. This is common for progressive rare diseases like MPS VI.

What happens if Humana denies my appeal? Georgia residents can request external review through the Georgia Insurance Commissioner within 60 days of the final internal denial. This review is conducted by independent medical experts and is free for consumers.

Does Georgia have special protections for rare disease coverage? While Georgia follows federal guidelines for Medicare plans, state law provides additional external review rights for fully insured plans and consumer assistance through the Department of Insurance.

Counterforce Health helps patients, clinicians, and specialty pharmacies navigate insurance denials by creating targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to identify specific denial reasons, then drafts point-by-point rebuttals aligned with each payer's requirements, pulling the right clinical evidence and procedural details to maximize approval chances.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider about treatment decisions and verify current requirements with Humana directly. For personalized assistance with appeals, consider working with Counterforce Health or other patient advocacy organizations.

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