By Counterforce Health Team in Elaprase (idursulfase) —

The Requirements Checklist to Get Elaprase (idursulfase) Covered by Aetna (CVS Health) in Texas

Quick Answer: Getting Elaprase (idursulfase) Covered by Aetna (CVS Health) in Texas

Who's eligible: Patients with confirmed Hunter syndrome (MPS II) via enzymatic or genetic testing. Fastest path: Complete Aetna's Elaprase precertification form with diagnostic proof and weight-based dosing. First step today: Download the Aetna Elaprase precertification form and gather enzymatic/genetic test results. Texas advantage: Strong external review rights through Texas Department of Insurance if denied—file within 4 months of final denial.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding Requirements
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission
  9. Common Denial Pitfalls
  10. Appeals Process in Texas
  11. Printable Checklist

Who Should Use This Checklist

This guide is for patients, families, and healthcare providers navigating Aetna (CVS Health) prior authorization for Elaprase (idursulfase) in Texas. You'll need this if:

  • Your doctor prescribed Elaprase for Hunter syndrome (MPS II)
  • You have Aetna commercial or Medicare Advantage coverage
  • You received a denial and need to appeal
  • You want to get approval right the first time

Expected outcome: With complete documentation, most approvals come within 30-45 days. Denials often reverse on appeal when proper evidence is submitted.

Member & Plan Basics

Coverage Verification

Before starting, confirm these basics:

Requirement What to Check Where to Find It
Active Coverage Member ID, effective dates Insurance card, Aetna member portal
Plan Type Commercial, Medicare Advantage, Medicaid Benefits summary, HR department
Specialty Benefits Medical vs. pharmacy benefit Call member services: 1-888-632-3862
Deductible Status Amount met, remaining EOB statements, member portal
Note: Elaprase is covered under the medical benefit (not pharmacy) because it requires IV infusion and clinical monitoring.

Prior Authorization Required

Aetna requires precertification for all Elaprase requests. No exceptions. Submit at least 2 weeks before anticipated treatment start to avoid delays.

Clinical Criteria Requirements

Diagnosis Confirmation

Aetna requires definitive proof of Hunter syndrome (MPS II):

Required Evidence (choose one):

  • Enzymatic assay showing iduronate-2-sulfatase deficiency
  • Genetic testing confirming pathogenic IDS gene variant

Additional requirement: At least one other sulfatase enzyme must show normal activity to rule out multiple sulfatase deficiency.

Weight-Based Dosing

FDA-approved dose: 0.5 mg/kg weekly via IV infusion. Aetna will verify your calculation matches this standard.

Example: 21 kg patient = 10.5 mg weekly dose

Step Therapy

Good news: There are no FDA-approved alternatives to Elaprase for MPS II. Step therapy typically doesn't apply, but document any supportive therapies tried (physical therapy, symptom management).

Coding Requirements

Essential Codes

Code Type Code Description Notes
ICD-10 E76.1 Hunter syndrome Primary diagnosis required
HCPCS J1743 Idursulfase, 1 mg Bill per mg administered
NDC 54092-0700-01 6 mg/3 mL vial Include on all claims
CPT 96365, 96366 IV infusion codes Initial hour, additional hours

Billing Units

  • Bill J1743 for exact milligrams administered
  • Use modifier JW if any drug is wasted
  • Don't round to full vials unless contents are used

Documentation Packet

Provider Note Requirements

Your medical record must include:

Clinical History:

  • Confirmed MPS II diagnosis with test dates
  • Current symptoms and organ involvement
  • Previous treatments attempted
  • Response to therapy (for continuation requests)

Treatment Plan:

  • Weight-based dose calculation
  • Infusion schedule and monitoring plan
  • Expected clinical benefits

Medical Necessity Letter Components

Include these elements in your letter:

  1. Patient identification (name, DOB, insurance ID)
  2. Diagnostic confirmation with test results
  3. Clinical rationale for treatment
  4. Dosing justification based on weight
  5. Monitoring plan per FDA requirements
  6. Physician attestation of medical necessity
Tip: Reference FDA labeling and clinical guidelines in your letter. Aetna values evidence-based justification.

Required Attachments

  • Complete enzymatic or genetic test results
  • Recent clinic notes documenting disease status
  • Previous treatment history (if applicable)
  • Infusion monitoring protocol

Submission Process

Step-by-Step Submission

  1. Download the form: Get the Aetna Elaprase precertification form
  2. Complete every section: Missing information causes automatic delays
  3. Submit electronically: Use the Availity provider portal for fastest processing
  4. Alternative submission: Fax using numbers on the form (verify current contact info)
  5. Confirm receipt: Get confirmation number and save it

Common Form Errors

  • Incomplete patient demographics
  • Missing diagnostic test dates
  • Incorrect weight-based dosing calculations
  • Illegible handwriting on faxed forms

Specialty Pharmacy Routing

CVS Specialty Requirements

Once approved, Elaprase must be dispensed through CVS Specialty Pharmacy or another authorized specialty provider.

Infusion Monitoring Plan Required:

  • Emergency equipment must be available
  • Trained healthcare professionals only
  • Start infusion at 8 mL/hr for first 15 minutes
  • Maximum rate: 100 mL/hr
  • Monitor for reactions during and 60+ minutes post-infusion

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform identifies denial reasons and drafts point-by-point rebuttals aligned to each plan's specific requirements, pulling the right citations and weaving them into appeals with required clinical facts.

Transfer Process

  1. Aetna approves prior authorization
  2. Prescription sent to CVS Specialty
  3. Patient enrollment and benefits verification
  4. Drug shipped to infusion site
  5. Infusion scheduled with monitoring protocol

After Submission

Timeline Expectations

  • Standard review: 30-45 days
  • Expedited review: 72 hours (if urgent medical need)
  • Status updates: Check via provider portal or call

What to Track

  • Confirmation number
  • Submission date
  • Expected decision date
  • Case manager contact (if assigned)
From our advocates: "We've seen approvals delayed simply because providers didn't follow up. Set a calendar reminder to check status after two weeks, then weekly until you get a decision. Squeaky wheels get attention."

Common Denial Pitfalls

Denial Reason How to Fix Prevention
Missing diagnostic proof Submit enzymatic/genetic test results Include with initial request
Incomplete dosing justification Recalculate based on current weight Show 0.5 mg/kg calculation
Inadequate monitoring plan Detail infusion protocol and emergency procedures Reference FDA requirements
Non-formulary status Request formulary exception with medical necessity Emphasize no alternatives exist
Experimental/investigational Cite FDA approval and clinical guidelines Include FDA labeling excerpts

Appeals Process in Texas

Internal Appeal (Required First Step)

  • Timeline: File within 180 days of denial
  • Decision: 30 days for pre-service, 60 days for post-service
  • Expedited: 72 hours if urgent
  • How to file: Use Aetna appeals form or written request

External Review (Texas Advantage)

Texas provides strong external review rights through independent review organizations (IROs).

When available: Medical necessity, appropriateness, or experimental/investigational denials

Timeline:

  • File within 4 months of final internal denial
  • Standard review: 20 days
  • Expedited review: 5 days

Cost: Free to patient (insurer pays IRO)

Binding decision: If IRO approves, Aetna must cover

Texas Resources

  • Texas Department of Insurance: 1-800-252-3439
  • Office of Public Insurance Counsel: 1-877-611-6742
  • IRO Information Line: 1-866-554-4926

For complex cases, consider getting help from Counterforce Health, which specializes in turning denials into successful appeals by identifying the specific denial basis and crafting targeted rebuttals with the right evidence.

Printable Checklist

Before You Start

  • Insurance card and member ID
  • Enzymatic or genetic test results
  • Current weight and dose calculation
  • Recent clinic notes
  • Provider contact information

Submission Requirements

  • Complete Aetna Elaprase precertification form
  • Medical necessity letter
  • Diagnostic test results attached
  • Weight-based dosing documented
  • Infusion monitoring plan included
  • All sections legible and complete

After Submission

  • Confirmation number recorded
  • Follow-up calendar reminders set
  • Provider portal access confirmed
  • Appeal forms ready (if needed)

Appeals Ready

  • Denial letter reviewed
  • Additional evidence gathered
  • 180-day deadline noted
  • Texas external review option understood

Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Always consult your healthcare provider about treatment decisions and verify current policy details with your insurer.

Sources & Further Reading

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