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

The Requirements Checklist to Get Elevidys (delandistrogene moxeparvovec-rokl) Covered by Aetna (CVS Health) in Ohio

Answer Box: Fast Track to Elevidys Coverage

Who qualifies: Ohio patients with confirmed DMD (excluding exon 8/9 deletions), age 4+, ambulatory status, and anti-AAVrh74 antibody titer <1:400. Fastest approval path: Submit complete prior authorization through CVS Specialty with genetic testing, specialist attestation, and Center of Excellence confirmation. Start today: Call Aetna at 1-855-240-0535 to request the current Elevidys precertification form, then coordinate with your neuromuscular specialist to gather required documentation. Appeals must be filed within 180 days in Ohio if denied.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Essentials
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission: What to Expect
  9. Common Denial Prevention Tips
  10. Appeals Process in Ohio
  11. Printable Checklist

Who Should Use This Checklist

This comprehensive checklist is designed for Ohio families navigating Elevidys coverage through Aetna (CVS Health), along with their healthcare teams. You'll find this most valuable if you're facing:

  • Initial prior authorization submission for Elevidys
  • A recent denial that you want to appeal effectively
  • Preparation for a peer-to-peer review with Aetna's medical director
  • Uncertainty about Ohio-specific appeal rights and timelines

Expected outcome: Following this checklist systematically increases your chances of approval by ensuring all Aetna requirements are met upfront, reducing delays and denials that commonly occur from incomplete submissions.

Member & Plan Basics

Coverage Verification Essentials

Requirement What to Confirm Where to Find It
Active Coverage Member ID, group number, effective dates Aetna member portal
Plan Type Commercial, Medicare Advantage, or Medicaid Insurance card or HR benefits summary
Specialty Pharmacy Benefits CVS Caremark/CVS Specialty in-network Call member services: 1-800-872-3862
Prior Authorization Required Elevidys on 2026 precertification list Aetna precertification lists
Note: Elevidys requires prior authorization across all Aetna plan types. Verify your specific formulary tier and any quantity limits through the member portal.

Clinical Criteria Requirements

Primary Eligibility Standards

Diagnosis Requirements:

  • Confirmed Duchenne muscular dystrophy through genetic testing
  • Critical exclusion: Mutation must NOT involve deletion of exon 8 and/or exon 9
  • ICD-10 code G71.01 (Duchenne or Becker muscular dystrophy)

Patient Characteristics:

  • Age 4 years or older at time of treatment
  • Ambulatory status (able to walk independently)
  • Body weight-appropriate dosing: 1.33 × 10¹⁴ vg/kg for patients <70kg; 9.31 × 10¹⁵ vg (700 mL total) for patients ≥70kg

Laboratory Requirements:

  • Anti-AAVrh74 antibody titer <1:400 (ELISA method)
  • Baseline liver function tests within normal limits
  • Complete blood count and comprehensive metabolic panel

Prescriber Requirements:

  • Prescription from board-certified neurologist or neuromuscular specialist
  • Treatment at FDA-approved Center of Excellence facility
  • Established steroid prophylaxis and hepatic monitoring plan
Tip: The most common denial reason is incomplete genetic testing documentation. Ensure your genetic report explicitly confirms DMD and excludes exon 8/9 deletions.

Coding and Billing Essentials

HCPCS and Billing Information

Code Type Code Description Units
HCPCS J1413 Injection, delandistrogene moxeparvovec-rokl, per therapeutic dose 1 unit = 1 complete treatment
ICD-10 G71.01 Duchenne or Becker muscular dystrophy Primary diagnosis
NDC Patient-specific Weight-based kit (10-70 vials) Varies by patient weight

Key Billing Notes:

  • One-time lifetime treatment only
  • Bill 1 unit of J1413 regardless of number of vials in patient-specific kit
  • No repeat dosing authorized under current FDA labeling
  • Verify exact NDC through Sarepta Therapeutics for weight-based kit

Documentation Packet

Required Clinical Documentation

Genetic Testing Results:

  • Complete DMD gene analysis report with specific mutation details
  • Laboratory confirmation excluding exon 8/9 deletions
  • Report date within past 12 months (verify with Aetna if older)

Specialist Assessment:

  • Neuromuscular specialist evaluation and treatment recommendation
  • Functional assessment documenting ambulatory status
  • Treatment goals and expected outcomes

Laboratory Values:

  • Anti-AAVrh74 antibody titer results (<1:400 required)
  • Baseline liver function tests, CBC, CMP
  • All labs dated within 30 days of submission

Center of Excellence Documentation:

  • Confirmation of treatment at approved COE facility
  • Facility certification for gene therapy administration
  • Infusion and monitoring protocols

Medical Necessity Letter Components

Your specialist's letter should address:

  1. Patient-specific clinical rationale for Elevidys therapy
  2. Prior treatments tried and outcomes (supportive care, steroids)
  3. Current functional status and disease progression
  4. Treatment goals and monitoring plan
  5. References to FDA labeling and clinical trial data
  6. Contraindications assessment and safety considerations

Submission Process

Step-by-Step Submission

Step 1: Obtain Current Forms

  • Call Aetna: 1-855-240-0535 to request latest Elevidys precertification form
  • Verify form version date (forms update regularly)

Step 2: Complete Documentation

  • Gather all required clinical documents listed above
  • Ensure specialist signature and date on all forms
  • Include patient demographics and insurance information

Step 3: Submit Through Preferred Channels

  • Electronic: Availity.com provider portal
  • Alternative: CoverMyMeds platform
  • Fax: 1-877-269-9916 (verify current fax number)

Step 4: Confirmation

  • Obtain confirmation number for electronic submissions
  • Keep fax transmission reports for records
  • Document submission date and method
Important: Submit within 5-7 business days of gathering all documents to prevent any lab results from expiring.

Specialty Pharmacy Routing

CVS Specialty Coordination

Pharmacy Network Requirements:

  • Elevidys available only through limited distribution network
  • CVS Specialty is Aetna's primary specialty pharmacy partner
  • Cannot be dispensed through retail CVS locations

Coordination Steps:

  1. Prescriber Action: Send prescription to CVS Specialty (1-800-237-2767)
  2. Patient Enrollment: CVS Specialty will contact patient for enrollment
  3. Insurance Verification: CVS Specialty coordinates with Aetna benefits
  4. Delivery Coordination: Medication shipped to Center of Excellence facility
  5. Cold Chain Verification: Confirm proper storage and handling protocols

Timeline Expectations:

  • CVS Specialty processing: 2-3 business days after PA approval
  • Delivery to COE facility: Within 48 hours of release
  • Patient notification: 24-48 hours before scheduled infusion

Counterforce Health helps patients and healthcare teams navigate complex specialty pharmacy requirements, turning insurance barriers into successful approvals through evidence-backed appeals and systematic documentation.

After Submission: What to Expect

Timeline and Status Tracking

Milestone Standard Timeline Expedited Timeline How to Check Status
Initial Review 5-10 business days 72 hours Aetna provider portal
Medical Review 15-30 days total 72 hours Call 1-855-240-0535
Final Decision 30-45 days maximum 72 hours Written notification

What to Record:

  • Prior authorization reference number
  • Submission date and method
  • Follow-up call dates and representatives spoken with
  • Any additional information requested
  • Decision date and outcome

Proactive Follow-up Schedule:

  • Day 3: Confirm receipt of submission
  • Day 10: Check initial review status
  • Day 20: Request status update if no decision
  • Day 25: Prepare for potential appeal if denial expected

Common Denial Prevention Tips

Five Critical Pitfalls to Avoid

1. Incomplete Genetic Testing Documentation

  • Problem: Submitting general DMD confirmation without specific mutation analysis
  • Solution: Include complete genetic lab report explicitly excluding exon 8/9 deletions

2. Missing Anti-AAVrh74 Antibody Results

  • Problem: Submitting without required titer testing
  • Solution: Ensure titer <1:400 via ELISA method, dated within 30 days

3. Non-Specialist Prescriber

  • Problem: Prescription from general practitioner or non-neuromuscular specialist
  • Solution: Transfer care to board-certified neurologist or neuromuscular specialist

4. Center of Excellence Issues

  • Problem: Planning treatment at non-approved facility
  • Solution: Verify COE status through Sarepta Therapeutics facility locator

5. Outdated Prior Authorization Forms

  • Problem: Using old form versions that may be rejected automatically
  • Solution: Always request current forms directly from Aetna before submission
From our advocates: "We've seen families wait months for Elevidys approval, only to discover their genetic testing report didn't explicitly exclude the exon 8/9 deletions that disqualify patients. One simple addition to the lab request prevented a six-week delay and potential denial. Always confirm your genetic testing specifically addresses Aetna's exclusion criteria upfront."

Appeals Process in Ohio

Understanding Your Rights

Ohio residents have strong appeal rights under state law, including two levels of internal appeals with Aetna plus external review through independent medical experts.

Internal Appeals Timeline:

  • Level 1: File within 180 days of denial; decision within 30 days (72 hours if expedited)
  • Level 2: File within 60 days of Level 1 denial; decision within 30 days

External Review Process:

  • Eligibility: Available after exhausting internal appeals for medical necessity denials
  • Timeline: Must request within 180 days of final internal denial
  • Process: Submit request to Aetna, who forwards to Independent Review Organization (IRO)
  • Decision: Binding on Aetna; standard review 30 days, expedited 72 hours

How to File Appeals in Ohio

Step 1: Internal Appeal

  • Use denial letter's appeal instructions
  • Submit additional clinical evidence
  • Request peer-to-peer review with Aetna medical director

Step 2: External Review (if needed)

  • Contact Ohio Department of Insurance: 1-800-686-1526
  • Submit External Review Request Form through Aetna
  • Provide additional supporting documentation to IRO

Step 3: State Assistance

  • File complaint with Ohio Department of Insurance if process issues arise
  • Contact UHCAN Ohio (Universal Health Care Action Network) for advocacy support

When patients face complex insurance challenges, Counterforce Health transforms denial letters into targeted, evidence-backed appeals that align with payer-specific requirements and maximize approval chances.

Printable Checklist

Pre-Submission Checklist

Patient Information:

  • Active Aetna coverage verified
  • Member ID and group number confirmed
  • CVS Specialty in-network status verified

Clinical Requirements:

  • DMD genetic testing complete (excluding exon 8/9 deletions)
  • Anti-AAVrh74 antibody titer <1:400 (within 30 days)
  • Baseline labs (LFTs, CBC, CMP) current
  • Patient age 4+ and ambulatory status documented
  • Neuromuscular specialist evaluation complete

Documentation:

  • Current Aetna Elevidys PA form obtained
  • Medical necessity letter from specialist
  • Complete genetic lab report
  • All laboratory results (within 30 days)
  • Center of Excellence facility confirmation

Submission:

  • Preferred submission method identified (Availity/fax)
  • All forms signed and dated
  • Confirmation number obtained
  • Follow-up schedule established

Post-Submission:

  • PA reference number recorded
  • Status check schedule created
  • Appeal timeline noted (180 days in Ohio)
  • CVS Specialty coordination initiated

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance representative for personalized guidance. Appeal rights and timelines may vary based on your specific plan type and Ohio state regulations.

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