By Counterforce Health Team in Luxturna (voretigene neparvovec-rzyl) —

The Requirements Checklist to Get Luxturna (voretigene neparvovec-rzyl) Covered by Aetna (CVS Health) in Georgia

Answer Box: Getting Luxturna Covered by Aetna in Georgia

Luxturna (voretigene neparvovec-rzyl) requires prior authorization from Aetna with documented biallelic RPE65 mutations, treatment at a designated center, and ophthalmologist involvement. Your fastest path: (1) Confirm genetic testing shows pathogenic variants in both RPE65 copies, (2) Find an Aetna-contracted Luxturna treatment center in Georgia, (3) Have your retinal specialist submit the prior authorization form with all required documentation. If denied, you have 180 days for internal appeal and 60 days for external review through the Georgia Department of Insurance.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Documentation Hygiene
  5. Required Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Coordination
  8. After Submission: What to Expect
  9. Common Pitfalls to Avoid
  10. Appeals Process in Georgia
  11. Printable Checklist

Who Should Use This Checklist

This guide is for Georgia patients with confirmed biallelic RPE65 mutations who need Luxturna gene therapy covered by Aetna (CVS Health), along with their retinal specialists and treatment teams. You'll also find this helpful if you've already been denied and need to appeal.

Expected outcome: With complete documentation following this checklist, most medically appropriate Luxturna requests receive approval. If denied initially, appeals have strong success rates when genetic and clinical evidence clearly demonstrate medical necessity for RPE65-related retinal dystrophy.

Member & Plan Basics

Coverage Verification Steps

Before starting the prior authorization process:

  • Confirm active Aetna coverage through your member portal or by calling the number on your insurance card
  • Verify your plan type (commercial, Medicare Advantage, Medicaid managed care) as submission processes may vary
  • Check deductible status - Luxturna is typically covered under medical benefits, not pharmacy
  • Confirm prior authorization requirement - all Aetna plans require precertification for Luxturna
Note: Luxturna has a list price of approximately $425,000 per eye. Most patients will hit their out-of-pocket maximums, making financial assistance programs crucial.

Clinical Criteria Requirements

FDA-Approved Indication Match

Luxturna is only covered for patients meeting these specific criteria:

Genetic Requirements:

  • Confirmed biallelic RPE65 pathogenic or likely pathogenic variants
  • Either homozygous (same variant in both copies) or compound heterozygous (different variants in each copy)
  • Testing must be performed by a CLIA-certified laboratory

Clinical Requirements:

  • Age ≥12 months (some policies specify ≤65 years)
  • Clinical diagnosis of Leber congenital amaurosis or retinitis pigmentosa due to RPE65 mutations
  • Viable retinal cells demonstrated by one of:
    • OCT showing posterior pole retinal thickness >100 μm
    • ≥3 disc areas of retina without atrophy or pigmentary degeneration
    • Remaining visual field within 30° of fixation

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Use of retinoid compounds (unless discontinued ≥18 months)
  • Recent intraocular surgery (<6 months)
  • Systemic conditions affecting CNS or advanced diabetic retinopathy

Coding & Documentation Hygiene

Required Procedure Codes

Code Type Code Description Notes
HCPCS J3398 Luxturna injection Per eye
CPT 67036 Vitrectomy For administration
CPT 67299 Unlisted posterior segment procedure May be required

Diagnosis Codes (ICD-10)

  • H35.50 - Unspecified hereditary retinal dystrophy
  • H35.51 - Vitreoretinal dystrophy
  • H35.52 - Pigmentary retinal dystrophy
  • H35.53 - Other dystrophies primarily involving the retinal pigment epithelium

Required Documentation Packet

Provider Note Elements

Your retinal specialist's note must include:

  1. Patient demographics and insurance information
  2. Detailed clinical history including symptoms (nyctalopia, visual field loss)
  3. Physical examination findings specific to RPE65-related disease
  4. Genetic testing results with specific variant identification
  5. Retinal viability assessment with imaging results
  6. Treatment rationale explaining why Luxturna is medically necessary

Letter of Medical Necessity Components

The LMN should address:

  • Problem statement: Patient's diagnosis and functional impairment
  • Treatment history: Any supportive care or low-vision interventions tried
  • Clinical rationale: Why Luxturna is the appropriate treatment
  • Prognosis: Expected benefits and timeline
  • Alternative considerations: Why other approaches are inadequate

Required Attachments

  • Genetic testing report showing biallelic RPE65 mutations
  • OCT imaging demonstrating retinal viability
  • Visual field testing results
  • Electroretinogram (ERG) if available
  • Clinical photographs of fundus
  • Previous medical records relevant to retinal dystrophy

Submission Process

Aetna Prior Authorization Requirements

Prescriber Requirements:

Submission Methods:

  • Phone: (866) 752-7021 (Aetna Medical)
  • Fax: (888) 267-3277 (Aetna Medical)
  • Online: Through Aetna provider portal

Form Requirements: Use the official Luxturna Prior Authorization Form with all fields completed.

Timeline Expectations

  • Standard review: 30-45 business days
  • Expedited review: Available for urgent cases (≤72 hours for Medicare)
  • Approval duration: 30 days to complete therapy in both eyes

Specialty Pharmacy Coordination

CVS Caremark Specialty Process

Once Aetna approves your prior authorization:

  1. CVS Caremark Specialty coordinates shipment to your treatment center
  2. Verification required: Treatment center must confirm scheduling and readiness
  3. Patient-specific dosing: Each vial is prepared for individual patient
  4. Delivery timeline: Typically 7-14 days after approval

Contact for specialty pharmacy: 1-855-240-0535 (Commercial plans)

Treatment Center Requirements

Luxturna must be administered at a Spark Therapeutics-designated center. In Georgia, known participating centers include:

  • Emory Eye Center (Atlanta) - verify current network status with Aetna
Tip: Always confirm both Spark designation and Aetna network participation before scheduling.

After Submission: What to Expect

Tracking Your Request

  • Confirmation number: Record this when submitting
  • Status checks: Call Aetna every 7-10 business days for updates
  • Additional information requests: Respond within 10 business days to avoid delays

Documentation to Maintain

Keep copies of:

  • Prior authorization submission with date stamps
  • All correspondence with Aetna
  • Confirmation numbers and reference numbers
  • Contact names and dates of conversations

Common Pitfalls to Avoid

Five Critical Mistakes

  1. Incomplete genetic testing documentation - Ensure the report clearly states "pathogenic" or "likely pathogenic" variants in both RPE65 copies
  2. Missing retinal viability proof - Include OCT measurements or equivalent imaging
  3. Wrong treatment center - Verify both Spark designation and Aetna network status
  4. Inadequate prescriber credentials - Must involve an ophthalmologist per Aetna policy
  5. Missing clinical correlation - Connect genetic findings to patient's specific symptoms and examination

Prevention Strategies

  • Use the official Aetna form rather than generic PA requests
  • Include a cover letter summarizing key approval criteria
  • Attach peer-reviewed literature supporting Luxturna's efficacy
  • Consider requesting a peer-to-peer review if initially denied

Appeals Process in Georgia

Internal Appeals with Aetna

Timeline: 180 days from denial notice to file

Required elements:

  • Member ID and group information
  • Copy of original denial letter
  • Updated clinical documentation
  • Physician statement addressing denial reasons
  • Relevant medical literature

Submission: Online portal, phone, or written appeal

External Review Through Georgia DOI

If Aetna denies your internal appeal:

Timeline: 60 days from final Aetna denial (strictly enforced)

Contact: Georgia Department of Insurance Consumer Services

Decision timeline: 30 business days (72 hours for expedited)

Cost: Free to consumers

Binding: Yes - Aetna must cover if external review approves

From our advocates: We've seen successful Luxturna appeals in Georgia when families included genetic counselor letters explaining the inheritance pattern and retinal specialist attestations about remaining visual function. The key is demonstrating that all clinical criteria are clearly met with objective documentation.

Printable Checklist

Before You Start

  • Active Aetna coverage confirmed
  • Genetic testing shows biallelic RPE65 pathogenic variants
  • Retinal specialist evaluation completed
  • Treatment center identified (Spark-designated + Aetna network)
  • OCT or equivalent imaging shows viable retina

Documentation Packet

  • Completed Aetna Luxturna PA form
  • Genetic testing report (CLIA-certified lab)
  • Retinal specialist consultation note
  • OCT imaging with measurements
  • Visual field testing results
  • Letter of medical necessity
  • Clinical photographs (if available)

Submission

  • All forms signed and dated
  • Submitted via correct method (portal/fax/phone)
  • Confirmation number recorded
  • Follow-up schedule established

If Denied

  • Internal appeal filed within 180 days
  • Additional documentation gathered
  • External review filed within 60 days (if needed)
  • Georgia DOI contact information ready

Getting the coverage you need for Luxturna can feel overwhelming, but you're not alone in this process. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating evidence-backed, targeted rebuttals that address each payer's specific requirements. Their platform analyzes denial letters and plan policies to identify the exact documentation needed for approval.

For additional support with your Luxturna coverage journey, consider reaching out to patient advocacy organizations or working with specialists experienced in rare disease insurance navigation. The key is thorough preparation and persistent follow-through on each step of this checklist.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare providers and insurance representatives for guidance specific to your situation. Coverage policies and procedures may change - verify current requirements with official sources.

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