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

How to Get Elevidys (delandistrogene moxeparvovec-rokl) Covered by Aetna CVS Health in Georgia: Complete Prior Authorization and Appeals Guide

Quick Answer: Getting Elevidys Approved by Aetna CVS Health in Georgia

To get Elevidys (delandistrogene moxeparvovec-rokl) covered by Aetna CVS Health in Georgia, you need: 1) Confirmed DMD diagnosis with genetic testing (ICD-10 code G71.01), 2) Anti-AAVrh74 antibody titers <1:400, 3) Treatment at an Aetna GCIT-designated center, and 4) Prior authorization through CVS Caremark. If denied, Georgia law gives you 60 days to file an external review with the state Department of Insurance. Start by verifying your plan covers specialty gene therapies and contacting Aetna at 1-855-240-0535 for PA requirements.

Table of Contents

What This Guide Covers

This guide helps patients with Duchenne muscular dystrophy (DMD) and their families navigate Aetna CVS Health's prior authorization process for Elevidys gene therapy in Georgia. Elevidys is a one-time, $3.2 million gene therapy that requires strict eligibility criteria and must be administered at specialized centers.

You'll learn exactly what documents to gather, how to submit requests through the right channels, and what to do if you face a denial. We've also included Georgia-specific appeal rights and timelines that many families don't know about.

Note: This guide applies to Aetna commercial plans in Georgia. If you have Medicaid or Medicare, different processes may apply.

Before You Start: Plan Verification

Check Your Coverage Type

Call the member services number on your Aetna insurance card to verify:

  • Plan type: Commercial, Medicare Advantage, or Medicaid managed care
  • Specialty pharmacy benefit: Confirm Elevidys is covered under medical benefit (not pharmacy benefit)
  • Network status: Verify your DMD specialist is in-network
  • GCIT designation: Ask which Georgia centers are approved for Elevidys administration

Understand Aetna's Gene Therapy Requirements

Aetna requires Elevidys to be administered only at Aetna Institutes GCIT-designated centers that meet their quality and expertise standards. In Georgia, you'll need to confirm which facilities have this designation, as it's separate from general DMD care certification.

Gather Required Documentation

Essential Medical Records

Genetic Testing Results

  • Confirmed DMD gene mutation documentation
  • Critical: Mutation must NOT be a deletion in exon 8 and/or exon 9
  • Use ICD-10 code G71.01 (Duchenne or Becker muscular dystrophy) on all forms

Laboratory Results

  • Anti-AAVrh74 total binding antibody titers (must be <1:400)
  • Baseline liver function tests (normal required)
  • Platelet count (normal required)
  • Troponin levels (normal required)

Clinical Documentation

  • Current functional status (ambulatory vs. non-ambulatory)
  • Patient age verification (must be 4 years or older)
  • Weight for dosing calculations
  • Systemic corticosteroid treatment plan (required before and 60+ days after infusion)

Prior Authorization Forms

Contact Aetna at 1-855-240-0535 to request the current Elevidys prior authorization form, or submit through:

Submit Your Prior Authorization Request

Step-by-Step Submission Process

1. Prepare Complete Documentation Package

  • PA form with all required fields completed
  • Genetic test results with specific mutation details
  • Anti-AAV antibody titer results
  • All baseline laboratory values
  • Corticosteroid treatment protocol
  • Letter of medical necessity from DMD specialist

2. Submit Through Correct Channel Due to Aetna's specialty drug policy changes, Elevidys likely requires routing through CVS specialty pharmacy. Contact 1-800-237-2767 to confirm the current submission process.

3. Include GCIT Center Confirmation Verify your chosen administration site appears on Aetna's GCIT provider list before submitting.

Medical Necessity Letter Checklist

Your DMD specialist should include:

  • Confirmed DMD diagnosis with genetic specifics
  • Patient's current functional status and prognosis
  • Why Elevidys is appropriate for this patient's mutation type
  • Corticosteroid management plan
  • Monitoring protocol for potential side effects
  • References to FDA labeling and current DMD treatment guidelines

Follow-Up and Timeline Management

Expected Timelines

  • Standard review: 30-45 days from complete submission
  • Expedited review: ≤72 hours for urgent medical situations
  • Medicare plans: ≤72 hours for standard coverage decisions

When to Follow Up

Call Aetna every 7-10 business days using this script:

"I'm calling to check the status of prior authorization request [reference number] for Elevidys gene therapy. Can you confirm you have all required documentation and provide an expected decision date?"

Document each call with the representative's name, date, and any new information provided.

If You Need More Information

Aetna may request additional documentation during review. Common requests include:

Clinical Clarification

  • More detailed functional assessments
  • Additional genetic counseling notes
  • Updated laboratory values if baseline tests are older than 30 days

Administrative Requirements

  • GCIT center confirmation letter
  • Updated insurance eligibility verification
  • Revised corticosteroid protocol details

Respond to these requests within 5 business days to avoid processing delays.

When Your Request Gets Denied

Common Denial Codes and Meanings

Denial Reason What It Means How to Address
"Not medically necessary" Clinical criteria not met Submit additional evidence, request peer-to-peer review
"Experimental/Investigational" Not FDA-approved for this use Provide FDA approval documentation, current labeling
"Non-formulary" Not on preferred drug list File formulary exception with medical necessity documentation
"Facility not approved" Wrong administration site Transfer to GCIT-designated center

First-Level Internal Appeal

You have 180 days from the denial date to file an internal appeal with Aetna. Submit:

  • Written appeal letter explaining why coverage should be approved
  • Additional clinical documentation
  • Peer-reviewed literature supporting Elevidys use
  • Request for peer-to-peer review between your doctor and Aetna's medical director

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform can help identify the specific denial basis and draft point-by-point rebuttals aligned to Aetna's own coverage policies, potentially saving weeks in the appeal process.

Georgia External Review Process

If Aetna denies your internal appeal, Georgia law provides a powerful second chance through external review.

Key Requirements and Timeline

  • Deadline: 60 days from Aetna's final denial letter
  • Cost: Up to $25 filing fee (refunded if you win; waived for financial hardship)
  • Decision time: 30 business days for standard review, 72 hours for expedited
  • Outcome: Legally binding on Aetna

How to File

  1. Download the external review application from the Georgia Department of Insurance website
  2. Include all denial correspondence from Aetna
  3. Attach medical records supporting medical necessity
  4. Submit to Georgia Department of Insurance within 60 days

For assistance, call Georgia DOI Consumer Services at 1-800-656-2298.

Expedited External Review

If delaying treatment poses serious health risks, you can request expedited review even while your internal appeal is pending. Clearly mark your application "EXPEDITED REVIEW REQUESTED" and explain the medical urgency.

Renewal and Re-Authorization

Elevidys is a one-time gene therapy, so renewal isn't typically required. However, you may need re-authorization if:

  • Initial approval expires before treatment is administered
  • Treatment is delayed due to medical reasons (infection, elevated liver enzymes)
  • Patient moves to a different GCIT-designated center

Submit renewal requests 30 days before your current authorization expires.

Common Denial Reasons & Solutions

Issue Solution Timeline
Missing genetic confirmation Submit complete DMD gene analysis report 5-7 business days
High anti-AAV antibodies (≥1:400) Retest antibody levels; consider waiting period 2-4 weeks
Non-GCIT facility Transfer care to approved center 2-6 weeks
Incomplete corticosteroid plan Provide detailed steroid protocol 3-5 business days
Age outside criteria Verify patient meets minimum age requirement 1-2 business days

FAQ

How long does Aetna CVS Health prior authorization take in Georgia? Standard reviews take 30-45 days from complete submission. Expedited reviews for urgent situations are completed within 72 hours.

What if Elevidys is non-formulary on my plan? File a formulary exception request with medical necessity documentation. Include FDA approval information and evidence that no formulary alternatives are appropriate for DMD.

Can I request an expedited appeal in Georgia? Yes. If treatment delays pose serious health risks, you can request expedited internal appeals (72 hours) and expedited external review through the Georgia Department of Insurance.

Does step therapy apply to Elevidys? Gene therapy typically doesn't require step therapy, but document any prior DMD treatments (corticosteroids, other therapies) that have been tried.

What happens if my GCIT center isn't in Georgia? Out-of-state GCIT centers may be covered, but verify network status and obtain prior authorization for out-of-network benefits if needed.

How much will I pay out-of-pocket? Costs depend on your specific plan's coinsurance and out-of-pocket maximums. Contact Sarepta's patient support program for potential financial assistance.

Printable Checklist

Before Submitting:

  • Confirmed DMD genetic testing (not exon 8/9 deletion)
  • Anti-AAV antibody titers <1:400
  • Normal liver function, platelets, troponin
  • GCIT-designated center identified
  • Corticosteroid protocol prepared
  • ICD-10 code G71.01 on all forms

Submission Package:

  • Complete PA form
  • Medical necessity letter from DMD specialist
  • All laboratory results
  • Genetic testing report
  • Insurance card copy
  • Prior therapy documentation

After Submission:

  • Reference number documented
  • Follow-up calls scheduled every 7-10 days
  • Appeal deadline noted (180 days from denial)
  • Georgia external review deadline noted (60 days from final denial)

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform ingests denial letters and plan policies to draft point-by-point rebuttals aligned to each payer's specific requirements, potentially reducing the time and complexity of the appeals process.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For official Georgia insurance regulations and appeal procedures, contact the Georgia Department of Insurance at 1-800-656-2298 or visit oci.georgia.gov.

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