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

How to Get Luxturna (Voretigene Neparvovec-rzyl) Covered by Aetna CVS Health in Virginia: Complete Guide with Forms and Appeals

Answer Box: Getting Luxturna Covered by Aetna CVS Health in Virginia

Luxturna requires prior authorization from Aetna CVS Health. You'll need confirmed biallelic RPE65 mutations via CLIA-certified genetic testing, proof of retinal viability (OCT showing ≥100 μm thickness), and treatment at an Aetna Institutes® GCIT Network facility. First step: Call Aetna at (866) 752-7021 to initiate precertification. If denied, Virginia allows external review within 120 days through the State Corporation Commission Bureau of Insurance. Standard decisions take 30-45 days; expedited reviews complete within 72 hours for urgent cases.

Table of Contents

Is Luxturna Covered by Aetna CVS Health?

Yes, but with strict requirements. Luxturna (voretigene neparvovec-rzyl) is covered by Aetna CVS Health for patients with biallelic RPE65 mutation–associated retinal dystrophy, but it requires prior authorization and must meet specific clinical criteria outlined in Aetna's Clinical Policy Bulletin 0927.

The gene therapy is not considered experimental by Aetna since FDA approval in 2017. However, coverage is limited to first-time treatment in each eye—repeat dosing in the same eye is deemed investigational.

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Must be approved before treatment Aetna Precert List 2026
Genetic Testing Biallelic RPE65 mutations confirmed CLIA-certified laboratory
Retinal Viability OCT showing ≥100 μm thickness Ophthalmologist assessment
Qualified Center Aetna Institutes® GCIT Network Verify with Aetna
Age Range Typically 3-65 years Plan-specific
Appeals Deadline 180 days internal, 120 days external Virginia law

Prior Authorization Requirements

Aetna requires comprehensive documentation before approving Luxturna. Here's what you need:

Essential Documentation

  • Aetna Luxturna Prior Authorization Form (completed by prescriber)
  • Genetic testing report from CLIA-certified laboratory showing biallelic RPE65 mutations
  • OCT imaging demonstrating retinal thickness ≥100 μm in posterior pole
  • Ophthalmologist consultation note with detailed clinical history
  • Visual field testing results
  • Letter of medical necessity

Genetic Testing Criteria

The genetic testing must confirm biallelic RPE65 mutations, meaning either:

  • Homozygous variants (identical mutations in both copies)
  • Compound heterozygous variants (different mutations on each copy) with segregation analysis proving they're on different chromosomes

Retinal Viability Requirements

Patients must have viable retinal cells demonstrated by at least one of:

  • OCT showing posterior pole retinal thickness ≥100 μm
  • At least 3 disc areas of retina without atrophy or pigmentary degeneration
  • Remaining visual field within 30° of fixation

Step-by-Step: Fastest Path to Approval

1. Verify Network Status

Who: Patient or clinic staff
Action: Call Aetna member services (number on insurance card) to confirm your plan covers Luxturna and identify in-network GCIT facilities
Timeline: Same day

2. Complete Genetic Testing

Who: Prescribing ophthalmologist
Action: Order biallelic RPE65 testing from CLIA-certified lab if not already done
Timeline: 2-4 weeks for results

3. Gather Clinical Documentation

Who: Ophthalmologist and clinic staff
Action: Collect OCT images, visual field tests, clinical photos, and comprehensive eye exam notes
Timeline: 1-2 weeks

4. Submit Prior Authorization

Who: Prescriber or authorized clinic staff
Action: Complete Aetna Luxturna PA form and submit via provider portal, fax (888) 267-3277, or phone (866) 752-7021
Timeline: Same day submission

5. Track Decision

Who: Clinic staff
Action: Monitor Aetna provider portal for determination; standard decisions take 30-45 days
Timeline: 30-45 days (72 hours if expedited)

6. Coordinate with CVS Specialty

Who: Clinic and patient
Action: Once approved, CVS Specialty will contact you to arrange delivery to the treatment center
Timeline: 7-14 days after approval

7. Schedule Treatment

Who: Patient and treatment center
Action: Coordinate surgery dates with qualified retinal specialist at approved facility
Timeline: Based on center availability

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing Prior Auth Submit precertification immediately Complete Aetna Luxturna PA form
Inadequate Genetic Testing Provide CLIA-certified results Biallelic RPE65 report with segregation analysis
Insufficient Retinal Viability Submit detailed ophthalmologic assessment OCT images ≥100 μm, visual fields, clinical photos
Non-Network Facility Switch to GCIT center or request exception Verify network status; document access issues if rural
Age Outside Limits Appeal with medical necessity letter Clinical justification for treatment at patient's age
"Experimental" Designation Cite FDA approval and Aetna policy Reference CPB 0927, FDA approval letter
From Our Advocates: We've seen patients initially denied for "inadequate genetic testing" successfully appeal by ensuring their lab report explicitly states "biallelic RPE65 mutations" and includes segregation analysis for compound heterozygous cases. The specific terminology matters—generic "RPE65 variants" language often triggers denials.

Appeals Process in Virginia

If Aetna denies your Luxturna prior authorization, Virginia offers a robust appeals process through the State Corporation Commission Bureau of Insurance.

Internal Appeal with Aetna

Deadline: 180 days from denial notice
How to File: Aetna member portal, phone, or written appeal
Timeline: 30 days for standard review, 72 hours for expedited

Virginia External Review

Deadline: 120 days from final internal denial
Process: File Form 216-A with Virginia Bureau of Insurance
Timeline: 45 days for standard review, 72 hours for expedited

Virginia External Review Steps:

  1. Submit Request: File Form 216-A within 120 days
  2. Preliminary Review: Aetna has 5 business days to determine eligibility
  3. Assignment: Bureau assigns independent review organization within 1 business day
  4. Review: Independent physicians review all evidence within 45 days
  5. Decision: Binding determination issued; if overturned, Aetna must authorize within 24-72 hours

Contact Virginia Bureau of Insurance:

For complex cases, consider contacting Virginia's Office of the Managed Care Ombudsman at (888) 859-9199 for guidance.

Costs and Patient Assistance Programs

Luxturna's list price is approximately $425,000 per eye ($850,000 for both eyes). However, multiple assistance programs can significantly reduce out-of-pocket costs.

Spark Therapeutics Generation Patient Services

Eligibility: Commercial insurance, confirmed RPE65 diagnosis
Benefit: Potentially reduces copay to $0
Contact: (833) 772-7577

PAN Foundation Inherited Retinal Disease Premium Assistance

Eligibility: Income <500% Federal Poverty Level, US resident
Benefit: Up to $4,800-$9,800 annually for premiums and copays
Contact: (866) 316-7263 or online application

Virginia Medicaid Coverage

Status: Not routinely covered; requires prior authorization exception
Process: Submit medical necessity request through Virginia Department of Medical Assistance Services
Contact: (855) 652-8249

Counterforce Health helps patients navigate these complex coverage requirements by analyzing denial letters and crafting targeted appeals based on each payer's specific criteria and Virginia's regulatory requirements.

When Treatment Gets Transferred to CVS Specialty

Once Aetna approves your prior authorization, Luxturna distribution is handled exclusively through CVS Specialty Pharmacy, which coordinates with Spark Therapeutics-designated treatment centers.

What to Expect:

  • Contact from CVS Specialty: They'll reach out within 7-14 days of approval
  • Center Verification: CVS confirms your treatment center is qualified and ready
  • Delivery Coordination: Patient-specific vials delivered directly to the treatment center
  • Timeline: Typically 7-14 days from approval to center delivery

CVS Specialty Contact: (855) 240-0535

Treatment Center Requirements:

Treatment centers must be designated by Spark Therapeutics and meet specific criteria for gene therapy administration. Use Spark's Specialist Locator to find qualified centers in Virginia.

Troubleshooting Common Issues

Portal Access Problems

If you can't access Aetna's provider or member portal, call member services directly at the number on your insurance card. Have your member ID and the specific issue ready.

Missing Forms or Documents

The most current Aetna Luxturna prior authorization form is available on Aetna's healthcare professional forms page. If links are broken, call (866) 752-7021 for assistance.

Delayed Decisions

If your prior authorization is taking longer than 45 days, you can request expedited review if your physician certifies that delays could jeopardize your health. Submit expedited requests by calling Aetna directly.

Geographic Access Issues

If no qualified treatment centers are within reasonable travel distance, document this in your appeal and request an exception to use the nearest qualified facility, even if out-of-network.

FAQ: Most Common Questions

How long does Aetna prior authorization take for Luxturna in Virginia?
Standard decisions take 30-45 days. Expedited reviews for urgent cases can be completed within 72 hours if your physician certifies medical urgency.

What if Luxturna is non-formulary on my Aetna plan?
Even non-formulary drugs can be covered through medical exception processes. Submit the standard prior authorization with emphasis on medical necessity and lack of alternatives.

Can I request an expedited appeal in Virginia?
Yes. Both Aetna internal appeals and Virginia external reviews offer expedited timelines (72 hours) if your physician certifies that delays could harm your health.

Does step therapy apply to Luxturna?
No. There are no alternative treatments for RPE65-associated retinal dystrophy, so step therapy requirements don't apply.

What happens if I move from Virginia during treatment?
Contact Aetna member services immediately to ensure continued coverage and identify qualified treatment centers in your new location.

Can family members help with my appeal?
Yes, but Aetna requires an authorized representative form. Family members can also contact Virginia's Bureau of Insurance for guidance on your behalf with proper authorization.

How much will I pay out-of-pocket?
This depends on your specific plan's specialty drug tier, deductible, and out-of-pocket maximum. Spark's copay assistance program may reduce costs to $0 for eligible patients with commercial insurance.

What if my genetic testing shows variants of uncertain significance?
Aetna requires confirmed pathogenic or likely pathogenic biallelic RPE65 mutations. Variants of uncertain significance typically don't meet coverage criteria unless additional evidence supports pathogenicity.

This guide is for informational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan details. For personalized assistance with your specific situation, consult with your healthcare provider and insurance plan.

Need help with a complex denial or appeal? Counterforce Health specializes in turning insurance denials into successful appeals by analyzing payer-specific requirements and crafting evidence-backed rebuttals tailored to each plan's criteria.

Sources & Further Reading

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