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

The Requirements Checklist to Get Luxturna (voretigene neparvovec-rzyl) Covered by Cigna in Michigan

Quick Answer: To get Luxturna covered by Cigna in Michigan, you need genetic testing confirming biallelic RPE65 mutations, retinal viability proof via OCT, and treatment at University of Michigan Kellogg Eye Center. Submit Cigna's Luxturna CCRD Prior Authorization Form to fax 833-910-1625 with all supporting docs. If denied, use Michigan's 127-day external review window through DIFS. First step: confirm your genetic testing results and schedule evaluation at Kellogg Eye Center in Ann Arbor.

Table of Contents

Who Should Use This Checklist

This guide is for Michigan patients with inherited retinal dystrophy due to RPE65 mutations who need Luxturna (voretigene neparvovec-rzyl) gene therapy covered by Cigna. It's also helpful for:

  • Retinal specialists preparing prior authorization requests
  • Patient advocates navigating insurance barriers
  • Families facing initial coverage denials

Expected outcome: Following this checklist improves your chances of first-time approval and provides a clear appeals pathway if needed. Luxturna costs approximately $850,000 for both eyes, making proper documentation critical.

Member & Plan Basics

Verify Active Coverage

  • Confirm current Cigna member ID and plan type (commercial, Medicare Advantage)
  • Check if your plan uses Express Scripts/Accredo for specialty drugs
  • Verify deductible status and any prior authorization requirements

Plan-Specific Requirements

Cigna requires prior authorization for all FDA-approved gene therapies, including Luxturna. The drug is covered under medical benefits (not pharmacy) with specific criteria that must be met before approval.

Clinical Criteria

All patients must meet these medical necessity requirements:

Requirement Specific Criteria Documentation Needed
Genetic Diagnosis Biallelic RPE65 mutation-associated retinal dystrophy Lab report from accredited genetic testing facility
Age ≥12 months and <65 years Birth certificate or medical record confirmation
Retinal Viability Sufficient viable retinal cells per specialist OCT showing >100 μm thickness in posterior pole
Provider Administered by retinal specialist Treatment at qualified gene therapy center
Prior Treatment No previous Luxturna in requested eye(s) Medical history documentation

Michigan Treatment Center

University of Michigan Kellogg Eye Center in Ann Arbor is Michigan's qualified Luxturna treatment center. Contact their Retinal Dystrophy Clinic at 734-936-4000 for evaluation.

Coding Requirements

Primary Codes

  • HCPCS: J3590 (unclassified biologics)
  • ICD-10: H35.50 (unspecified hereditary retinal dystrophy) or more specific codes
  • CPT: 67028 (intravitreal injection) with -RT/-LT modifiers for each eye

Additional Billing Codes

For surgical administration, include:

  • 65778 (placement of amniotic membrane)
  • 11981/11982 (insertion procedures)

Documentation Packet

Core Documents Required

  1. Genetic Testing Report
    • Must confirm biallelic RPE65 mutations
    • Include lab name, methodology, and interpretation
    • Ensure report is from CLIA-certified laboratory
  2. Retinal Viability Assessment
    • OCT report showing retinal thickness >100 μm in posterior pole
    • Fundus photography documenting viable retinal areas
    • Specialist letter confirming "sufficient viable retinal cells"
  3. Clinical History
    • Complete ophthalmologic examination
    • Visual field testing (Goldmann perimetry preferred)
    • Full-field stimulus testing (FST) if available
    • Documentation of no prior intraocular surgery in past 6 months

Medical Necessity Letter Components

Your retinal specialist should include:

  • Patient demographics and diagnosis
  • Prior treatments attempted and outcomes
  • Clinical rationale for Luxturna therapy
  • Treatment goals and expected outcomes
  • Facility certification for gene therapy administration
Clinician Corner: Include specific visual function measurements like baseline visual acuity, visual field extent (degrees), and FST thresholds. Reference FDA labeling and American Academy of Ophthalmology guidelines for inherited retinal dystrophies in your medical necessity letter.

Submission Process

Step-by-Step Submission

  1. Download Form: Get Cigna's Luxturna CCRD Prior Authorization Form
  2. Complete All Fields: Pay special attention to asterisked (*) required fields
  3. Attach Documentation: Include genetic testing, OCT reports, and specialist letter
  4. Fax Submission: Send to 833-910-1625 (secure fax required)
  5. Confirm Receipt: Follow up within 2-3 business days

Required Form Sections

  • Physician Information: Name, specialty, NPI/DEA/TIN, office details
  • Patient Details: Cigna ID, DOB, address, phone
  • Medical Necessity: Check all applicable criteria boxes
  • Administration Site: Specify outpatient hospital, clinic, or other location
  • Urgency Level: Standard or urgent (with clinical justification)

Electronic Alternative

Use ExpressPAth (Express Scripts portal) for faster processing if your facility is registered. This can reduce approval time from days to hours.

Specialty Pharmacy Routing

Preferred Pharmacy

Accredo Specialty Pharmacy is Cigna's nationally preferred vendor for Luxturna. They handle:

  • Prior authorization coordination
  • Insurance verification
  • Direct shipment to treatment center
  • Patient support services

Coordination Steps

  1. Provide Accredo with PA approval number
  2. Confirm shipping address (treatment center)
  3. Schedule delivery coordination with surgical team
  4. Verify cold-chain handling requirements

After Submission

Tracking Your Request

  • Confirmation Number: Record PA request number from Cigna
  • Status Checks: Call 800-753-2851 or use online portal
  • Timeline: Standard review typically takes 5-15 business days
  • Documentation: Keep copies of all submitted materials

What to Record

  • Submission date and confirmation number
  • Primary contact at Cigna for your case
  • Any additional information requests
  • Approval or denial date and details

Common Denial Prevention

Five Most Common Pitfalls

Denial Reason Prevention Strategy
Missing Genetic Testing Submit complete lab report with biallelic RPE65 confirmation
Inadequate Viability Proof Include OCT with specific thickness measurements >100 μm
Age Outside Range Verify patient is 12 months to <65 years with documentation
Non-Qualified Center Ensure treatment at University of Michigan Kellogg Eye Center
Incomplete Form Double-check all asterisked fields and required signatures

Quality Assurance Tips

  • Use only the current version of Cigna's form
  • Include ICD-10 codes that match clinical documentation
  • Ensure prescriber signature and date on all pages
  • Attach supporting documents in order listed on form

At Counterforce Health, we've seen that thorough documentation and proper form completion significantly improve approval rates for high-cost gene therapies like Luxturna. Taking time to gather complete genetic testing results and retinal viability assessments upfront prevents most denials.

Appeals Playbook for Michigan

Internal Appeals Process

If Cigna denies your initial request:

First-Level Internal Appeal

  • Timeline: Submit within 180 days of denial
  • Method: Written appeal via Cigna member portal or mail
  • Decision: Typically within 30 days (15 days for expedited)

Second-Level Internal Appeal

  • Timeline: Submit within 60 days of first-level denial
  • Review: Independent medical reviewers
  • Decision: Final internal determination within 30 days

Michigan External Review

After exhausting internal appeals, Michigan residents have strong external review rights:

Standard External Review

  • Timeline: 127 days from final internal denial to file with DIFS
  • Process: Submit External Review Request form online or by mail
  • Decision: Within 60 days by Independent Review Organization (IRO)
  • Cost: No fee to patient

Expedited External Review

  • When: Doctor certifies delay would jeopardize health
  • Timeline: Decision within 72 hours
  • Requirements: Physician letter stating medical urgency

Michigan DIFS Contact Information

  • Phone: 877-999-6442 (toll-free consumer hotline)
  • Website: michigan.gov/difs
  • Address: Michigan Department of Insurance and Financial Services, Consumer Protection Division, P.O. Box 30220, Lansing, MI 48909
From our advocates: One family in Michigan successfully overturned a Luxturna denial by submitting additional OCT imaging that clearly showed viable retinal tissue. The key was working with their Kellogg Eye Center specialist to provide more detailed measurements and a comprehensive letter explaining why the patient met viability criteria. This demonstrates how thorough documentation can make the difference in complex genetic therapy cases.

Printable Checklist

Before You Start

  • Confirm active Cigna coverage and member ID
  • Verify genetic testing confirms biallelic RPE65 mutations
  • Schedule evaluation at UM Kellogg Eye Center
  • Gather all medical records and prior treatment history

Documentation Gathering

  • Genetic testing report from CLIA-certified lab
  • OCT report showing retinal thickness >100 μm
  • Visual field testing results
  • Specialist letter confirming retinal viability
  • Complete medical history and exam notes

Form Completion

  • Download current Cigna Luxturna CCRD PA form
  • Complete all asterisked (*) required fields
  • Include correct ICD-10 and HCPCS codes
  • Obtain prescriber signature and date
  • Attach all supporting documentation

Submission

  • Fax complete packet to 833-910-1625
  • Confirm secure fax transmission
  • Record confirmation number and submission date
  • Follow up within 2-3 business days

After Submission

  • Track status via Cigna portal or phone
  • Coordinate with Accredo if approved
  • Prepare appeal documents if denied
  • Contact Michigan DIFS if needed for external review

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions are made by individual plans based on specific policy terms and medical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation.

Sources & Further Reading

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