By Counterforce Health Team in Elaprase (idursulfase) —

The Requirements Checklist to Get Elaprase (Idursulfase) Covered by Blue Cross Blue Shield in Georgia: Forms, Appeals, and Step-by-Step Guide

Answer Box: Getting Elaprase Covered by BCBS in Georgia

Blue Cross Blue Shield of Georgia requires prior authorization for Elaprase (idursulfase) with specific documentation. The fastest path: gather enzymatic/genetic Hunter syndrome confirmation, weight-based dosing calculation, and infusion monitoring plan. Submit via the current PA form from the Georgia Department of Community Health. If denied, you have 60 days to file an external review through the Georgia Department of Insurance. Start today by confirming your coverage status and downloading the latest PA form.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Essentials
  5. Documentation Packet Checklist
  6. Submission Process
  7. Specialty Pharmacy Network
  8. After Submission: What to Expect
  9. Denial Prevention Tips
  10. Appeals Playbook for Georgia
  11. Printable One-Page Checklist
  12. FAQ

Who Should Use This Guide

This checklist is designed for patients with Hunter syndrome (MPS II) and their healthcare teams seeking Elaprase (idursulfase) coverage through Blue Cross Blue Shield in Georgia. You'll need this guide if you're:

  • Starting Elaprase therapy for the first time
  • Transferring from another insurer to BCBS Georgia
  • Facing a denial and need to appeal
  • Preparing for annual reauthorization

Expected outcome: With proper documentation, most medically necessary Elaprase requests are approved. Georgia's external review process provides a strong safety net if initial requests are denied.

Member & Plan Basics

Coverage Verification Steps

Before starting the PA process, confirm:

  1. Active BCBS Georgia coverage - Check your member ID card and verify benefits are current
  2. Plan type - Commercial, Medicaid, or Medicare Advantage plans may have different requirements
  3. Medical benefit coverage - Elaprase is covered under medical benefits (not pharmacy) since it requires IV infusion
  4. Deductible status - Know your annual deductible and out-of-pocket maximum
Tip: Call the member services number on your insurance card to verify Elaprase coverage under your specific plan before beginning the PA process.

Clinical Criteria Requirements

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all BCBS GA plans BCBS GA Provider Portal
Confirmed Diagnosis Enzymatic and/or genetic testing Lab reports, genetic counselor notes
Weight-Based Dosing 0.5 mg/kg IV weekly FDA prescribing information
Infusion Monitoring Safety protocols required Provider treatment plan
Annual Reauth Clinical response assessment Follow-up visit notes

Essential Clinical Documentation

Diagnosis Confirmation Required:

  • Enzymatic assay showing iduronate-2-sulfatase deficiency
  • Genetic testing confirming pathogenic IDS gene mutation
  • Clinical symptoms consistent with Hunter syndrome
  • ICD-10 diagnosis code E76.1

Treatment Justification:

  • No FDA-approved alternatives for Hunter syndrome
  • Weight-based dosing calculation (0.5 mg/kg weekly)
  • Infusion site protocols and emergency response plan
  • Baseline clinical assessments (pulmonary function, mobility, organ size)

Coding and Billing Essentials

Required Codes for Claims

Primary Codes:

  • ICD-10: E76.1 (Mucopolysaccharidosis, type II)
  • HCPCS J-Code: J1743 (Injection, idursulfase, 1 mg per unit)
  • NDC: 54092-0700-01 (6 mg/3 mL vial)
  • CPT Codes: 96365 (initial infusion hour), 96366 (additional hours)

Billing Calculation Example:

  • Patient weight: 25 kg
  • Dose: 25 kg × 0.5 mg/kg = 12.5 mg
  • Bill: 12.5 units of J1743
Note: Use JW modifier to indicate drug wastage if part of a vial is discarded, as required by CMS guidelines.

Documentation Packet Checklist

Medical Necessity Letter Components

Your provider's letter should include:

Patient Information:

  • Full name, date of birth, insurance ID
  • Current weight and dosing calculation
  • Hunter syndrome diagnosis date

Clinical Justification:

  • Enzymatic test results (iduronate-2-sulfatase activity)
  • Genetic testing results (IDS gene mutation)
  • Clinical symptoms and disease progression
  • Previous treatments attempted (if any)
  • Treatment goals and monitoring plan

Supporting Documentation:

  • Lab reports (enzymatic and genetic testing)
  • Baseline assessments (pulmonary function, joint mobility)
  • Infusion center safety protocols
  • Provider specialty credentials

Clinician Corner: Evidence-Based Support

When drafting medical necessity letters, reference these authoritative sources:

  • FDA Prescribing Information: Confirms 0.5 mg/kg weekly dosing for Hunter syndrome
  • Hunter Syndrome Treatment Guidelines: Support enzyme replacement as standard of care
  • Clinical Studies: Document efficacy in reducing GAG storage and improving symptoms

Counterforce Health helps healthcare providers create targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each insurer's specific criteria.

Submission Process

Step-by-Step: Fastest Path to Approval

  1. Download Current Forms (Provider)
  2. Complete Clinical Documentation (Provider)
    • Medical necessity letter with all required elements
    • Attach lab results, genetic testing, clinical notes
    • Include infusion monitoring protocols
  3. Submit PA Request (Provider)
    • Submit via BCBS GA provider portal or designated fax
    • Include all required attachments
    • Keep confirmation number
  4. Verify Receipt (Provider/Patient)
    • Confirm submission within 24-48 hours
    • Note case number for tracking
  5. Monitor Status (Patient)
    • Check status every 3-5 business days
    • Standard review: 15 business days
    • Expedited review: 72 hours (urgent cases)
  6. Receive Decision (Patient)
    • Approval: Coordinate with specialty pharmacy
    • Denial: Begin appeal process immediately
  7. Start Treatment (Patient)
    • Schedule first infusion within authorization timeframe
    • Set up annual reauthorization calendar

Specialty Pharmacy Network

BCBS Georgia works with contracted specialty pharmacies and infusion centers for Elaprase administration. Contact BCBS member services to identify preferred vendors in your area, as this information changes based on contract negotiations.

Key Steps:

  • Verify in-network infusion centers near you
  • Confirm specialty pharmacy benefits
  • Coordinate shipment and administration scheduling
Note: Out-of-network administration may result in higher costs or require additional approvals.

After Submission: What to Expect

Timeline and Follow-Up

Standard Review Process:

  • Initial review: 15 business days
  • Additional information requests: 5-10 business days
  • Final determination: Within 30 days total

What to Record:

  • Submission date and confirmation number
  • All communication with BCBS
  • Additional documentation requests
  • Decision date and reference numbers

Status Checking:

  • Provider portal updates
  • Member services phone line
  • Written correspondence

Denial Prevention Tips

Five Common Pitfalls and Solutions

Common Issue Prevention Strategy
Incomplete diagnostic documentation Include both enzymatic AND genetic testing results
Missing weight calculations Show exact dosing math: weight × 0.5 mg/kg = dose
Outdated PA forms Always download current form from GA Department of Community Health
Insufficient infusion protocols Detail monitoring plans and emergency response procedures
Generic medical necessity letters Customize letters to BCBS-specific criteria and Hunter syndrome guidelines

From Our Advocates

"We've seen the strongest approvals when providers include specific GAG excretion levels and baseline organ measurements alongside the required genetic testing. This objective data helps demonstrate both medical necessity and provides measurable treatment goals for reauthorization reviews."

Appeals Playbook for Georgia

Internal Appeal Process

Level 1: Standard Internal Appeal

  • Deadline: 60 days from denial date
  • Submit: Written request with additional clinical evidence
  • Timeline: 15 business days for standard, 72 hours for expedited

Level 2: External Review (Georgia DOI)

  • Deadline: 60 days from final internal denial
  • Submit: External Review Application to Georgia Department of Insurance
  • Cost: Free to consumer
  • Timeline: 30 business days standard, 72 hours expedited

Required Appeal Documents

  • Original denial letter
  • All clinical documentation
  • Provider letter explaining medical necessity
  • Relevant medical literature supporting treatment
  • Patient impact statement
Important: Georgia law requires insurers to accept external review decisions. This is your strongest appeal option.

Printable One-Page Checklist

Before You Start

  • Verify active BCBS Georgia coverage
  • Confirm Elaprase is covered under medical benefit
  • Download current PA form (August 2025 version)

Clinical Requirements

  • Hunter syndrome diagnosis (ICD-10 E76.1)
  • Enzymatic testing results (iduronate-2-sulfatase deficiency)
  • Genetic testing (pathogenic IDS mutation)
  • Current weight and dosing calculation (0.5 mg/kg weekly)
  • Infusion monitoring protocols

Coding and Billing

  • HCPCS J1743 for billing
  • NDC 54092-0700-01
  • CPT codes 96365/96366 for infusion
  • JW modifier for wastage (if applicable)

Documentation Packet

  • Completed PA form
  • Medical necessity letter
  • Lab reports (enzymatic and genetic)
  • Clinical notes and assessments
  • Infusion safety protocols
  • Provider credentials

Submission

  • Submit via BCBS GA provider portal
  • Keep confirmation number
  • Set follow-up reminders

If Denied

  • File internal appeal within 60 days
  • If unsuccessful, file external review with GA DOI within 60 days
  • Consider Counterforce Health for targeted appeal assistance

FAQ

How long does BCBS Georgia PA take for Elaprase? Standard review is 15 business days. Expedited review (for urgent medical situations) is completed within 72 hours.

What if Elaprase is non-formulary on my plan? File a formulary exception request with medical necessity documentation. Emphasize that no FDA-approved alternatives exist for Hunter syndrome.

Can I request an expedited appeal in Georgia? Yes, if delays pose serious risk to your health. Georgia allows concurrent expedited external review even during internal appeals for urgent cases.

Does step therapy apply to Elaprase? Generally no, since Elaprase is the only FDA-approved enzyme replacement for Hunter syndrome. However, some plans may require documentation of supportive care attempts.

What happens if I move from another state to Georgia? You'll need to restart the PA process with BCBS Georgia, but existing diagnostic documentation can be reused.

How often do I need reauthorization? Typically annually, requiring evidence of clinical benefit such as stabilized organ function, improved mobility, or reduced GAG excretion.

What if my infusion center isn't in-network? Contact BCBS to request a network adequacy exception if no in-network providers are within reasonable distance.

Can Counterforce Health help with my appeal? Yes, Counterforce Health specializes in turning insurance denials into targeted appeals by analyzing your specific denial reasons and crafting evidence-backed responses aligned to BCBS criteria.

This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for the most current requirements. For additional consumer assistance with insurance appeals in Georgia, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298 or visit www.oci.ga.gov.

Sources & Further Reading

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