By Counterforce Health Team in Elevidys (delandistrogene moxeparvovec-rokl) —

How to Get Elevidys Covered by Humana in Illinois: Complete PA Guide and Appeal Forms

Answer Box: Getting Elevidys Covered by Humana in Illinois

Elevidys requires prior authorization from Humana and must be administered at certified centers like Lurie Children's Hospital in Chicago. The fastest path: 1) Confirm DMD genetic testing and anti-AAV antibody levels meet criteria, 2) Submit PA through Humana's provider portal with complete medical necessity documentation, 3) If denied, file internal appeal within 60 days, then Illinois external review within 4 months. Start today: Contact your neuromuscular specialist to verify eligibility and gather required documentation for the PA submission.

Table of Contents

Patient Profile: Who Needs Elevidys

Elevidys (delandistrogene moxeparvovec-rokl) is a one-time gene therapy for Duchenne muscular dystrophy (DMD) that carries a list price of approximately $3.2 million. The therapy is approved for patients aged 4 years and older with confirmed DMD genetic mutations.

Typical candidate profile:

  • Confirmed DMD diagnosis with pathogenic variant in the DMD gene
  • Age 4+ years (both ambulatory and non-ambulatory patients eligible)
  • Anti-AAVrh74 antibody levels below exclusion threshold (typically <1:400)
  • No prior AAV-based gene therapy exposure
  • Access to a certified treatment center

In Illinois, Ann & Robert H. Lurie Children's Hospital of Chicago is currently the only facility certified to administer Elevidys.

Pre-Authorization Preparation

Required Documentation Checklist

Genetic Testing Requirements:

  • DMD gene mutation confirmation by CLIA-certified laboratory
  • Genetic counseling documentation (pre- and post-test)
  • Specialist referral from neurologist or geneticist

Laboratory Studies:

  • Anti-AAVrh74 antibody titer results (must be below threshold)
  • Baseline liver function tests
  • Complete blood count and comprehensive metabolic panel

Clinical Documentation:

  • Comprehensive neuromuscular evaluation
  • Current functional status assessment
  • Prior therapy history (corticosteroids, other DMD treatments)
  • Treatment goals and expected outcomes

Medical Necessity Letter Components

Your clinician's letter should address:

  1. Clinical presentation with ICD-10 codes (G71.0 for DMD)
  2. Genetic confirmation with specific mutation details
  3. Eligibility criteria including antibody levels and age
  4. Treatment rationale based on FDA labeling and clinical evidence
  5. Monitoring plan for safety and efficacy
Tip: Counterforce Health specializes in turning insurance denials into targeted appeals by identifying specific denial reasons and crafting evidence-backed rebuttals aligned to each plan's requirements.

Submission Process

Coverage Under Medicare Part B

Elevidys is covered under Medicare Part B as a medical benefit, not Part D pharmacy coverage. The therapy will be billed using specific J-codes for physician-administered drugs in clinical settings.

Humana Prior Authorization Steps

  1. Verify coverage through Humana's Prior Authorization Search Tool
  2. Submit PA request via Humana provider portal or fax
  3. Include all documentation from the preparation checklist
  4. Request expedited review if clinically urgent (decision within 72 hours)

Standard timeline: Humana typically responds to PA requests within 14 days for standard reviews.

Initial Outcome Scenarios

Common Approval Scenarios

  • Complete documentation with clear eligibility criteria met
  • Certified treatment center identified and available
  • All safety requirements addressed

Common Denial Reasons and Solutions

Denial Reason Solution
Missing genetic confirmation Submit CLIA-certified DMD gene test results
Elevated anti-AAV antibodies Provide updated antibody titer below threshold
Inadequate safety monitoring plan Include detailed hepatic monitoring protocol
Non-certified treatment facility Transfer care to Lurie Children's Hospital
Incomplete prior therapy documentation Submit records of previous DMD treatments

Appeals Process

Humana Internal Appeals

Timeline: Must be filed within 60 days of denial notice Process: Submit through Humana member portal or by mail Decision timeframe: 30 days for standard appeals, 72 hours for expedited

Illinois External Review

If Humana's internal appeal is denied, Illinois residents have strong external review rights:

Key deadlines:

  • 4 months to request external review after final denial
  • 45 days for standard external review decision
  • 72 hours for expedited external review

Required forms:

Contact: Illinois Department of Insurance at 877-527-9431 or idoi.illinois.gov

Note: External review decisions are binding on insurers, with penalties up to $50,000 for non-compliance under 2025 Illinois regulations.

Resolution and Next Steps

Upon Approval

  • Scheduling: Coordinate with Lurie Children's Hospital for treatment
  • Pre-treatment requirements: Complete vaccination schedule and corticosteroid regimen
  • Insurance coordination: Verify coverage details and any patient responsibility

Ongoing Monitoring

  • Regular hepatic function monitoring as required by FDA labeling
  • Long-term follow-up for safety and efficacy outcomes
  • Coordination with DMD care team for comprehensive management

Key Takeaways

What works best:

  • Complete documentation package submitted together
  • Early coordination with certified treatment center
  • Clear medical necessity rationale tied to FDA labeling
  • Prompt response to any requests for additional information

What to avoid:

  • Submitting incomplete genetic testing documentation
  • Missing anti-AAV antibody requirements
  • Delays in appeal filing that could miss deadlines
  • Attempting treatment at non-certified facilities

Forms and Resources

Patient Support Resources

  • Sarepta Therapeutics Patient Support: Financial assistance and care coordination
  • Parent Project Muscular Dystrophy: parentprojectmd.org for DMD advocacy and resources
  • Illinois Attorney General Health Care Helpline: 1-877-305-5145

FAQ

How long does Humana prior authorization take for Elevidys? Standard PA decisions are typically made within 14 days. Expedited reviews for urgent cases are decided within 72 hours.

What if Elevidys is denied due to "experimental" status? Elevidys has FDA approval and should not be denied as experimental. If this occurs, appeal immediately with FDA approval documentation.

Can I get Elevidys at any hospital in Illinois? No. Currently only Lurie Children's Hospital in Chicago is certified to administer Elevidys in Illinois.

What are my appeal rights if Humana denies coverage? You have 60 days for internal appeal, then 4 months for Illinois external review. Both processes have specific forms and requirements.

Does insurance cover the full $3.2 million cost? With proper approval, Medicare Part B through Humana should cover the therapy according to your plan's benefit structure, minus any applicable deductibles or coinsurance.

What documentation is most important for approval? Genetic confirmation of DMD mutation and anti-AAV antibody levels below threshold are the most critical requirements for eligibility.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. The platform analyzes denial letters and plan policies to create targeted, evidence-backed rebuttals that address specific payer requirements. For complex cases like gene therapy approvals, Counterforce Health identifies the exact denial basis and crafts point-by-point responses using the right clinical evidence and procedural requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Insurance policies and state regulations may change; verify current requirements with official sources.

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