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

How to Get Luxturna (voretigene neparvovec-rzyl) Covered by Humana in Washington: Forms, Appeals, and Resources

Answer Box: Getting Luxturna Covered by Humana in Washington

Luxturna requires prior authorization (PA) from Humana Medicare Advantage plans in 2024-2025. To get approved in Washington: 1) Submit the "Request for Medicare Prescription Drug Coverage Determination" form via CoverMyMeds portal or fax to 877-486-2621, 2) Include confirmed biallelic RPE65 mutation testing and retinal viability documentation, 3) If denied, appeal within 65 days using Humana's internal process, then request external review through CMS's Independent Review Entity (IRE) for Medicare Advantage plans. Start by verifying PA requirements on Humana's provider portal.

Table of Contents

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all Humana Medicare Advantage plans Humana PA List 2024-2025
Indication Biallelic RPE65 mutation-associated retinal dystrophy FDA Label
Age Requirement ≥12 months (not recommended under 12 months) Aetna Policy
Genetic Testing Confirmed biallelic pathogenic/likely pathogenic RPE65 mutations Luxturna HCP Site
Retinal Viability Posterior pole >100 µm on OCT or ≥3-disc areas viable Blue Cross Policy
Appeals Deadline 65 days from denial for Medicare Advantage Medicare Appeals Guide

Step 1: Verify Your Plan and PA Requirements

Before starting the approval process, confirm your specific Humana plan requires prior authorization for Luxturna. Use Humana's PA search tool and search for "Luxturna" or the CPT code C9493.

Key verification steps:

  1. Log into your Humana member portal or have your provider check the formulary
  2. Confirm you have a Medicare Advantage plan (not traditional Medicare Part D)
  3. Review your 2025 plan documents for any specific gene therapy coverage requirements
  4. Check if your plan requires treatment at a specific facility or network
Note: Luxturna appears on Humana's 2025 Medicare PA list, effective through at least December 2024 and continuing into 2025.

Step 2: Complete the Prior Authorization Form

Humana requires the "Request for Medicare Prescription Drug Coverage Determination" form for Luxturna prior authorization. This form is available in both English and Spanish.

Form submission requirements:

  • Download location: Humana PA guidelines page
  • Who can submit: Prescribing physician, patient, or authorized representative
  • Required information: Patient demographics, diagnosis codes (ICD-10), genetic testing results, clinical documentation

Clinical documentation must include:

  1. Confirmed biallelic RPE65 mutation report from CLIA-approved laboratory
  2. Ophthalmologic examination showing retinal viability
  3. Visual field testing (≥30° from fixation, III4e isopter)
  4. OCT showing posterior pole thickness >100 µm or viable retinal areas
  5. Age verification (≥12 months)
  6. Contraindication screening (no active eye infections, previous Luxturna treatment)

Step 3: Submit Through Approved Channels

CoverMyMeds Portal (fastest processing):

  • URL: www.covermymeds.com/epa/humana
  • Processing time: Within 72 hours for complete submissions
  • Account required: Free prescriber registration
  • Support: 1-866-452-5017 (Mon-Fri 8am-11pm EST)

Provider Portal Options:

Fax Submission

Submission Type Fax Number Notes
General Rx PA 877-486-2621 Include NPI, patient demographics
Physician-administered drugs 1-888-790-9999 For office/clinic administration
Gene therapy specialist [email protected] Email option for complex cases

Phone Support

Humana Clinical Pharmacy Review (HCPR):

  • Phone: 866-421-5663
  • Hours: Monday-Friday, 7am-7pm CT
  • Use for: Urgent cases, status inquiries, peer-to-peer reviews

Common Denial Reasons & How to Fix Them

Denial Reason Solution Required Documentation
Missing genetic confirmation Submit CLIA-approved biallelic RPE65 test results ACMG-classified pathogenic/likely pathogenic variants ≤12 months old
Inadequate retinal viability Provide comprehensive ophthalmologic workup OCT, visual fields, fundus photography, retinal specialist assessment
Not at qualified center Confirm treatment at Luxturna-certified facility Center certification documentation
Age requirements not met Document patient age ≥12 months Birth certificate or medical records
Incomplete PA form Resubmit with all required fields Complete form with prescriber signature and date

Appeals Process for Humana in Washington

Internal Appeals (Medicare Advantage)

Level 1: Standard Reconsideration

  • Timeline: 65 days from denial notice
  • Processing: 30 days for pre-service decisions, 60 days for payment
  • How to file: Written request via member portal, mail, or fax
  • Required: Copy of denial letter, additional clinical documentation

Level 2: Expedited Appeal

  • Timeline: 72 hours for urgent cases
  • Criteria: Health could be seriously jeopardized by delay
  • Contact: 1-800-HUMANA (1-800-486-2621)

External Review (Federal Process)

Unlike Washington state insurance appeals, Medicare Advantage external reviews go through CMS's Independent Review Entity (IRE), not the Washington Office of Insurance Commissioner.

CMS IRE Process:

  • Automatic: Cases denied at Level 2 automatically go to IRE
  • Timeline: IRE has 30 days for standard, 72 hours for expedited
  • Cost: No fee for Medicare beneficiaries
  • Decision: Binding on Humana if overturned
Washington State Note: While Washington has an excellent external review process through the Office of Insurance Commissioner (1-800-562-6900), this applies to non-Medicare plans. Medicare Advantage appeals follow federal CMS procedures.

Required Documentation Checklist

Before submitting your PA request, gather:

✓ Insurance Information:

  • Humana member ID card
  • Plan name and effective dates
  • BIN, PCN, and RxGroup numbers

✓ Clinical Documentation:

  • Genetic test report (biallelic RPE65 mutations, CLIA lab, ≤12 months)
  • Ophthalmologic examination notes
  • OCT results showing retinal thickness/viability
  • Visual field testing (III4e isopter, ≥30° from fixation)
  • Prior treatment history and failures
  • Current medications and contraindication screening

✓ Provider Information:

  • Prescribing physician NPI number
  • Retinal specialist credentials
  • Treatment center certification (if applicable)

✓ Administrative:

  • Completed PA form with signatures
  • Prior denial letters (if resubmitting)
  • Authorization for representative (if applicable)

Specialty Pharmacy and Treatment Centers

Humana Specialty Pharmacy (CenterWell)

For Luxturna administration coordination:

  • Website: CenterWell Specialty
  • Process: PA must be approved before specialty pharmacy involvement
  • Services: Coordination with treatment centers, insurance verification

Finding Qualified Treatment Centers

Luxturna can only be administered at Spark Therapeutics-certified treatment centers. While no centers are explicitly listed in Washington state in available sources, patients can:

  1. Use the Luxturna Specialist Locator
  2. Contact Spark Generation Patient Services for center referrals
  3. Consider OHSU Casey Eye Institute in Oregon (near Washington border)

Treatment Requirements:

  • Multidisciplinary team with retinal specialists
  • Genetic counseling services
  • Subretinal injection capabilities
  • Post-treatment monitoring protocols

Support Resources and Contact Information

Humana Member Services

  • Phone: 1-800-HUMANA (1-800-486-2621)
  • Online: Humana member portal
  • TTY: 711
  • Hours: 24/7 for urgent issues

Washington State Resources

  • Office of Insurance Commissioner: 1-800-562-6900
  • Website: insurance.wa.gov
  • Services: Consumer advocacy, complaint filing, appeal guidance
  • Note: For non-Medicare plans only; MA appeals go through federal process

Manufacturer Support

  • Spark Generation Patient Services: mysparkgeneration.com
  • Services: Insurance navigation, financial assistance, treatment coordination
  • Eligibility: All patients considering Luxturna treatment

Third-Party Advocacy

Counterforce Health specializes in turning insurance denials into evidence-backed appeals. Their platform analyzes denial letters and plan policies to create targeted rebuttals that address specific coverage criteria. For complex gene therapy cases like Luxturna, they help gather the right clinical evidence—genetic testing results, FDA labeling citations, and specialty guidelines—while ensuring appeals meet Humana's procedural requirements and deadlines.

FAQ: Luxturna Coverage with Humana

How long does Humana PA take for Luxturna in Washington? Standard prior authorization decisions are made within 72 hours for complete electronic submissions via CoverMyMeds, or up to 30 days for standard mail/fax submissions. Expedited reviews (when health could be jeopardized) are processed within 72 hours.

What if Luxturna is non-formulary on my Humana plan? Luxturna appears on Humana's Medicare PA lists, indicating formulary coverage with prior authorization. If your specific plan excludes it, request a formulary exception with medical necessity documentation.

Can I request an expedited appeal if denied? Yes, if your health could be seriously jeopardized by treatment delay. Contact Humana at 1-800-486-2621 to request expedited reconsideration, which must be processed within 72 hours.

Does step therapy apply to Luxturna? No traditional step therapy applies since Luxturna is the only FDA-approved treatment for biallelic RPE65 mutation-associated retinal dystrophy. However, you must demonstrate confirmed genetic testing and retinal viability.

What happens if the IRE denies my appeal? After IRE denial, you can appeal to an Administrative Law Judge (ALJ) if the amount in controversy is ≥$190 (2025 threshold). File with the Office of Medicare Hearings and Appeals (OMHA) within 60 days.

How much does Luxturna cost without insurance? The list price is approximately $425,000 per eye ($850,000 for bilateral treatment). Spark Therapeutics offers outcomes-based rebate programs, and Counterforce Health can help navigate coverage appeals to avoid these costs.

Do I need to use a specific pharmacy? Luxturna is administered at certified treatment centers, not dispensed through retail pharmacies. CenterWell Specialty coordinates with treatment centers for administration logistics.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions vary by individual plan and circumstances. Always verify current requirements with your insurance plan and healthcare providers. For personalized guidance with complex appeals, consider consulting with specialized advocacy services like Counterforce Health.

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