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

How to Get Elevidys Gene Therapy Covered by Aetna CVS Health in New York: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Started

To get Elevidys (delandistrogene moxeparvovec-rokl) covered by Aetna CVS Health in New York: Submit prior authorization through the Availity portal with genetic confirmation, ambulatory status documentation, and approved infusion center verification. If denied, file internal appeal within 180 days, then New York external appeal within 4 months through DFS online portal. First step today: Call Aetna member services (number on your ID card) to confirm your plan requires PA and identify network infusion centers with gene therapy capabilities.

Table of Contents

Understanding Your Denial Letter

When Aetna CVS Health denies Elevidys, they'll send an Explanation of Benefits (EOB) or denial letter with specific reason codes. Look for these common patterns:

Medical necessity denials often cite experimental/investigational status or failure to meet FDA criteria. Administrative denials typically involve missing prior authorization, incorrect billing codes (HCPCS J3590), or site-of-care restrictions.

Tip: Save your denial letter immediately—New York's external appeal clock starts ticking from the date of Aetna's final adverse determination.

The denial will include Aetna's internal appeal instructions and deadlines. Don't ignore these even if you plan to escalate to external review—you must exhaust internal appeals first in most cases.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all plans Aetna PA portal 2025 Precert List
Age Eligibility Ambulatory patients ≥4 years FDA label FDA Elevidys page
Genetic Confirmation Confirmed DMD gene mutation Lab report required PA submission form
Infusion Site Network GCIT or specialty center Aetna provider directory Site-of-care policy
Safety Monitoring Baseline liver/cardiac function Clinical documentation FDA prescribing information
Appeals Deadline 4 months for external review NY DFS guidelines External appeal process

Step-by-Step: Fastest Path to Approval

1. Verify Eligibility and Network Status

Who: Patient/family calls Aetna member services
What: Confirm PA requirement, identify network infusion centers
Timeline: Same day
Source: Member ID card phone number

2. Gather Required Documentation

Who: Clinic coordinator
What: Genetic testing, ambulatory assessment, baseline labs (AST/ALT, troponin)
Timeline: 1-2 weeks
Source: FDA prescribing information

3. Submit Prior Authorization

Who: Prescribing physician
What: Complete PA form via Availity portal
Timeline: Submit 2+ weeks before planned infusion
Source: Aetna PA requirements

4. Schedule Peer-to-Peer if Requested

Who: Physician
What: Clinical discussion with Aetna medical director
Timeline: Within 5 business days of request
Source: PA determination letter

5. File Internal Appeal if Denied

Who: Patient or physician
What: Submit appeal with medical necessity letter
Timeline: Within 180 days of denial
Source: Aetna member handbook

6. Request External Review (if needed)

Who: Patient
What: File with NY Department of Financial Services
Timeline: Within 4 months of final internal denial
Source: NY DFS external appeal

7. Follow Up on Approval

Who: Clinic
What: Schedule infusion, confirm benefits verification
Timeline: Coordinate with CVS Specialty
Source: CVS Specialty

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Key Documents
"Experimental/investigational" Cite FDA traditional approval (June 2024) for ambulatory patients FDA approval letter
"Not medically necessary" Document progressive decline despite standard care NSAA scores, 6MWT results, corticosteroid trial records
"Missing genetic confirmation" Submit pathogenic DMD mutation report Genetic lab report with specific mutation
"Non-ambulatory patient" Confirm ambulatory status per November 2025 label restriction Current functional assessment
"Inappropriate site of care" Verify network infusion center with gene therapy capabilities Site attestation letter
"Missing safety labs" Submit baseline liver and cardiac function tests AST/ALT <2x ULN, normal troponin-I

Medical Benefit vs. Pharmacy Benefit

Elevidys falls under medical benefit for infusion administration, while CVS Caremark handles pharmacy coordination. This dual coverage can create confusion during PA submission.

Pharmacy Benefit (CVS Caremark):

  • Drug procurement and enrollment
  • PA submission through CVS portals
  • Benefits verification
  • Contact: CVS Specialty at 1-800-237-2767

Medical Benefit (Aetna):

  • Infusion site approval
  • Administration coverage
  • Medical necessity determination
  • Network provider requirements
Important: Both benefits must align for approval. Ensure your infusion center is contracted with Aetna for gene therapy administration.

Appeals Playbook for New York

Internal Appeals with Aetna

Timeline: 180 days from denial date
Decision: 30 days (standard), 72 hours (expedited)
Submission: Aetna provider portal or member services

Required documents:

  • Original denial letter
  • Medical necessity letter from prescriber
  • Supporting clinical documentation
  • Updated lab results if applicable

New York External Appeals

New York's external appeal process through the Department of Financial Services provides an independent medical review that's binding on Aetna.

Eligibility: Must complete internal appeal first (or receive waiver)
Timeline: File within 4 months of final internal denial
Decision: 30 days (standard), 72 hours (expedited)
Cost: Maximum $25 (waived for Medicaid/financial hardship)

Submission methods:

  • Online: DFS Portal (preferred)
  • Mail: DFS, 99 Washington Avenue, Box 177, Albany, NY 12210
  • Fax: (800) 332-2729
  • Email: [email protected]

For expedited appeals (serious health risk): Include physician attestation and fax immediately, then call 888-990-3991.

Note: New York's external appeal database shows successful overturns for gene therapies when proper medical necessity is documented. Search past decisions at CHA's searchable database.

Getting Help with Appeals

Community Health Advocates provides free assistance to all New Yorkers with insurance appeals:

  • Phone: (888) 614-5400 (Mon-Fri, 9 a.m.–4 p.m.)
  • Email: [email protected]
  • Services: Appeal preparation, form completion, advocacy support

Clinician Corner: Medical Necessity Documentation

Medical Necessity Letter Checklist

Patient presentation:

  • Confirmed DMD with specific genetic mutation
  • Current ambulatory status (NSAA score, 6-minute walk test)
  • Progressive functional decline despite standard care

Prior treatments and outcomes:

  • Corticosteroid therapy (prednisone/deflazacort) with response/tolerance
  • Other DMD therapies tried (eteplirsen, golodirsen if applicable)
  • Documentation of continued progression

Clinical rationale:

  • FDA approval for ambulatory DMD patients ≥4 years
  • One-time gene therapy to address underlying genetic defect
  • No curative alternatives available

Safety considerations:

  • Baseline liver function (AST/ALT <2x upper limit normal)
  • Cardiac assessment (normal troponin-I, echo if indicated)
  • Plan for post-infusion monitoring per FDA label

Guideline citations:

  • FDA prescribing information (November 2025 update)
  • DMD care considerations from neuromuscular societies
  • Aetna's own medical policies when available

Key Talking Points for Peer-to-Peer

"This ambulatory 4+ year-old patient with genetically confirmed DMD meets FDA criteria for Elevidys. Despite corticosteroid therapy, we're seeing progressive functional decline. This one-time gene therapy represents the only disease-modifying treatment available. We've confirmed appropriate infusion site capabilities and safety monitoring protocols."

Costs & Financial Assistance

Elevidys carries a list price of approximately $3.2 million for the one-time dose. Financial assistance options include:

Manufacturer Support:

  • Sarepta patient assistance programs
  • Coverage investigation services
  • Appeals support through medical affairs

Foundation Grants:

  • Patient advocacy organizations
  • Rare disease foundations
  • State pharmaceutical assistance programs

New York State Programs:

  • Medicaid coverage for eligible patients
  • Essential Plan for moderate-income families
  • Child Health Plus

Contact Community Health Advocates at (888) 614-5400 for assistance navigating financial options in New York.

When to Escalate to State Regulators

If Aetna fails to follow proper procedures or deadlines, file a complaint with New York regulators:

New York Department of Financial Services:

  • Website: DFS complaints portal
  • Phone: 1-800-400-8882
  • Issues: Coverage denials, appeal delays, procedural violations

New York Department of Health:

  • For Medicaid managed care issues
  • Coordinate with DFS for dual complaints

Document all communications with Aetna, including dates, representative names, and reference numbers when filing regulatory complaints.

Frequently Asked Questions

How long does Aetna prior authorization take for Elevidys in New York?
Standard PA decisions take 30-45 days. Submit at least 2 weeks before planned infusion. Expedited reviews (72 hours) are available for urgent medical needs.

What if Elevidys is non-formulary on my Aetna plan?
Request a formulary exception with medical necessity documentation. Non-formulary status doesn't prevent coverage if medical necessity is established.

Can I appeal if I was denied outside New York?
Yes, but use your state's external review process. New York external appeals only apply to NY-regulated plans.

Does step therapy apply to Elevidys?
Typically yes—document corticosteroid therapy and any other DMD treatments tried. Contraindications to standard therapies can support step therapy exceptions.

What happens if the external appeal is denied?
New York's external appeals are binding on insurers. If denied, explore alternative coverage options or clinical trials for next-generation therapies.

Can I get help with appeals if I have Medicaid?
Yes, Community Health Advocates provides free assistance. Medicaid enrollees can choose between Fair Hearings or external appeals for coverage disputes.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with payer requirements. For complex gene therapies like Elevidys, we provide the clinical documentation and procedural expertise needed to navigate prior authorization and appeals processes effectively.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan terms and medical circumstances. Consult with your healthcare provider and insurance plan for specific coverage determinations. For personalized appeals assistance in New York, contact Community Health Advocates at (888) 614-5400.

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