Answer Box: Getting Luxturna Covered in California

Blue Shield of California requires prior authorization for Luxturna (voretigene neparvovec-rzyl) with specific criteria: confirmed biallelic RPE65 mutation via genetic testing, documented viable retinal cells, and no prior gene therapy. Submit clinical documentation via fax for review. If denied, file an internal appeal within 180 days, then escalate to California's Independent Medical Review (IMR) through the Department of Managed Health Care. IMR decisions are binding and have a ~55% overturn rate for medical necessity denials. First step: Contact your retinal specialist to confirm genetic testing and gather clinical documentation before submitting the prior authorization request.

Table of Contents

1. Coverage Requirements at a Glance
2. Step-by-Step: Fastest Path to Approval
3. Common Denial Reasons & How to Fix Them
4. Appeals Process for Blue Shield California
5. Cost Assistance and Financial Support
6. When to Escalate to State Regulators
7. Frequently Asked Questions

Coverage Requirements at a Glance

Requirement	What It Means	Where to Find It	Source
Prior Authorization	Required for all Luxturna requests	Blue Shield provider portal	BSC Policy PDF
Biallelic RPE65 Mutation	Both gene copies must have pathogenic variants	Genetic testing report	BSC Policy
Viable Retinal Cells	Documented sufficient posterior pole retina	OCT imaging, visual field testing	BSC Policy
No Prior Gene Therapy	Cannot have received previous vision gene therapy	Medical records	BSC Policy
Age Requirement	Typically 12+ months (verify current criteria)	Provider documentation	FDA Label
ICD-10 Codes	H35.50, H35.52, H35.54	Diagnosis documentation	BSC Policy
Administration Site	Hospital or qualified outpatient facility	Provider credentials	BSC Policy

Step-by-Step: Fastest Path to Approval

1. Confirm Genetic Testing (Patient + Clinician)

Timeline: 2-4 weeks

• Obtain genetic testing confirming biallelic RPE65 mutations
• Blue Shield covers RPE65 testing (CPT 81406) when medically necessary for Luxturna evaluation
• Document: Pathogenic/likely pathogenic variants in both RPE65 gene copies

2. Gather Clinical Documentation (Clinician)

Timeline: 1-2 weeks

• OCT imaging showing viable retinal tissue
• Visual field testing demonstrating functional vision
• Medical history confirming no prior gene therapy
• Submit via: Blue Shield provider portal or fax (confirm current number)

3. Submit Prior Authorization (Clinician)

Timeline: 5-10 business days for decision

• Include all required clinical documentation
• Reference Blue Shield policy criteria
• Expected response: Approval, denial, or request for additional information

4. If Denied: File Internal Appeal (Patient or Clinician)

Timeline: Must file within 180 days

• Submit appeal with additional clinical evidence
• Include peer-reviewed literature supporting medical necessity
• Decision timeline: 30 days (expedited: 3 days for urgent cases)

5. If Still Denied: Request Independent Medical Review (Patient)

Timeline: File within 6 months of final denial

• Contact DMHC Help Center: (888) 466-2219
• Submit IMR application online at healthhelp.ca.gov
• Decision timeline: 45 days (expedited: 7 days or less)

Common Denial Reasons & How to Fix Them

Denial Reason	How to Overturn	Required Documentation
"Genetic testing insufficient"	Provide comprehensive RPE65 sequencing results	Biallelic mutation confirmation with variant classification
"Experimental/investigational"	Reference FDA approval and Blue Shield policy	FDA label, BSC policy MP document
"Insufficient retinal viability"	Submit detailed imaging and functional testing	OCT scans, visual field testing, ERG if available
"Not medically necessary"	Demonstrate progressive vision loss and treatment goals	Serial vision testing, quality of life impacts
"Provider not qualified"	Confirm administration at approved center	Center credentials, surgeon qualifications

Tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific criteria.

Appeals Process for Blue Shield California

Internal Appeal (First Level)

Who can file: Patient, authorized representative, or provider Deadline: 180 days from denial notice How to file: Written request to Blue Shield member services Timeline: 30 days for standard review, 3 days for expedited

Independent Medical Review (Second Level)

California's IMR process is overseen by the Department of Managed Health Care and has shown favorable outcomes for specialty drug appeals.

Key Statistics:

• Medical necessity denials: ~55% overturn rate for Anthem/Blue Shield plans
• Prescription drugs represent 30-33% of all IMR cases
• No cost to patients for IMR filing

How to file:

1. Call DMHC Help Center: (888) 466-2219
2. Submit application online: healthhelp.ca.gov
3. Provide all medical records and denial correspondence
4. Independent physicians review the case

Required documents:

• Complete medical records
• Genetic testing results
• Provider letter of medical necessity
• Blue Shield denial letter(s)
• Any additional clinical evidence

Clinician Corner: Medical Necessity Letter Checklist

When writing a medical necessity letter for Luxturna, include:

✓ Patient diagnosis: Confirmed biallelic RPE65 mutation-associated retinal dystrophy ✓ Progressive vision loss: Document baseline and current visual function ✓ Failed alternatives: Note that no other FDA-approved treatments exist for RPE65 deficiency ✓ Clinical rationale: Explain why Luxturna is appropriate for this patient ✓ Guideline support: Reference AAO guidelines and FDA labeling ✓ Administration plan: Confirm qualified center and surgical approach ✓ Monitoring plan: Describe follow-up care and outcome measures

Cost Assistance and Financial Support

Spark Therapeutics Patient Support

Program: Generation Patient Services Contact: 1-833-SPARK-PS (1-833-772-7577) Website: mysparkgeneration.com

Services include:

• Insurance navigation and prior authorization support
• Copay assistance for commercial insurance (government insurance excluded)
• Connection to independent foundations for additional support
• Case-by-case eligibility determination

Note: Spark does not publish specific income limits for their patient assistance program. Eligibility is determined individually based on insurance type and financial need.

Additional Resources

• California pharmaceutical assistance: Contact Medi-Cal for state supplemental programs
• Hospital charity care: Many qualified treatment centers offer financial assistance programs
• Independent foundations: Spark can provide referrals to relevant nonprofits

When to Escalate to State Regulators

Department of Managed Health Care (DMHC)

Contact: (888) 466-2219 Website: healthhelp.ca.gov When to contact:

• Blue Shield doesn't respond to appeals within required timelines
• Procedural violations in the review process
• Need assistance filing an IMR

California Department of Insurance (CDI)

Contact: (800) 927-4357 For: PPO or indemnity plans not regulated by DMHC

The Counterforce Health platform can help identify which regulator oversees your specific Blue Shield plan and assist with proper escalation procedures.

Frequently Asked Questions

Q: How long does Blue Shield prior authorization take for Luxturna? A: Standard review is 5-10 business days. Expedited review (for urgent cases) is typically 72 hours.

Q: What if Luxturna is not on Blue Shield's formulary? A: Luxturna is covered under the medical benefit, not pharmacy benefit, so formulary status doesn't apply. Coverage is based on medical necessity criteria.

Q: Can I request an expedited appeal if my vision is rapidly declining? A: Yes. Blue Shield offers expedited appeals for urgent medical situations. Provide documentation of rapid progression and medical urgency.

Q: Does step therapy apply to Luxturna in California? A: No. There are no FDA-approved alternatives for biallelic RPE65 mutation-associated retinal dystrophy, so step therapy doesn't apply.

Q: What happens if my IMR is approved but Blue Shield still denies coverage? A: IMR decisions are binding. Blue Shield must authorize and pay for the treatment if the IMR overturns the denial.

Q: Can I appeal if my genetic testing shows variants of uncertain significance? A: Additional testing may be needed to clarify variant pathogenicity. Work with a genetic counselor to determine if supplemental testing could establish clinical significance.

Q: How do I find a qualified treatment center in California? A: Contact Spark Therapeutics at 1-833-SPARK-PS for a list of certified centers. Not all ophthalmology practices can administer Luxturna.

Q: What if I have both Blue Shield and Medicare? A: Coordination of benefits rules apply. The primary insurer reviews first, then the secondary. Medicare may cover Luxturna under Part B as a physician-administered drug.

What to Gather Before You Start

For Patients:

• Insurance card and policy information
• Complete medical records from your retinal specialist
• Genetic testing results confirming RPE65 mutations
• Documentation of vision loss progression
• Any previous denial letters from Blue Shield

For Clinicians:

• Patient's complete ophthalmologic history
• Genetic testing reports with variant classification
• OCT imaging and visual field testing results
• Documentation of no prior gene therapy
• Confirmation of qualified administration site

Sources & Further Reading

• Blue Shield of California Luxturna Policy
• California DMHC Help Center
• Blue Shield of California Genetic Testing Policy
• Spark Therapeutics Patient Support
• FDA Luxturna Prescribing Information

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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 clinical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For assistance with insurance appeals and coverage issues, contact the California Department of Managed Health Care at (888) 466-2219 or visit healthhelp.ca.gov.

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