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

Myths vs. Facts: Getting Elevidys (Delandistrogene Moxeparvovec-rokl) Covered by Cigna in Virginia – Appeals Guide

Answer Box: Getting Elevidys Covered by Cigna in Virginia

Fastest Path: 1) Confirm your child meets FDA criteria (ambulatory DMD with eligible mutation, anti-AAV antibodies <1:400). 2) Have your neuromuscular specialist submit prior authorization via ExpressPAth with complete genetic testing, functional assessments, and center-of-excellence documentation. 3) If denied, file internal appeal within 180 days using Cigna's member portal. Virginia's external review through the State Corporation Commission provides binding decisions within 45 days after internal appeals are exhausted.

Table of Contents

Why Myths About Gene Therapy Coverage Persist

When your child receives a Duchenne muscular dystrophy diagnosis, the $3.2 million price tag on Elevidys (delandistrogene moxeparvovec-rokl) can feel overwhelming. Well-meaning friends, online forums, and even some healthcare staff perpetuate myths about how insurance coverage actually works for gene therapy.

These misconceptions persist because gene therapy is relatively new, coverage policies change frequently, and each insurer—including Cigna—has specific requirements that differ from traditional medications. In Virginia, where approximately 43% of the commercial market is held by Anthem, Cigna represents a significant portion of families navigating this process.

The stakes are too high for guesswork. Let's separate fact from fiction so you can focus your energy on strategies that actually work.

Myth vs. Fact: What Really Determines Coverage

Myth #1: "If my doctor prescribes Elevidys, Cigna has to cover it."

Fact: Prescriptions don't guarantee coverage. Cigna requires prior authorization for Elevidys with specific clinical criteria including confirmed DMD genetic mutation, ambulatory status, anti-AAVrh74 antibody titers below 1:400, and administration at an approved center of excellence.

Myth #2: "Gene therapy is experimental, so it won't be covered."

Fact: Elevidys received FDA approval in June 2023 and is considered medically necessary when FDA criteria are met. However, as of mid-2025, administration to non-ambulatory patients is suspended due to safety concerns, making ambulatory status a strict requirement.

Myth #3: "If I'm denied once, that's final."

Fact: Virginia law provides multiple appeal levels. After Cigna's internal appeals (which have roughly an 18% overturn rate for PA denials), you can request external review through Virginia's State Corporation Commission within 120 days. The external review decision is binding on Cigna.

Myth #4: "I need to try other treatments first because of step therapy."

Fact: While some states prohibit step therapy for rare disease gene therapies when FDA criteria are met, Virginia doesn't have blanket protections. However, Cigna's policy focuses on meeting FDA labeling criteria rather than requiring specific prior therapies, though documentation of current standard-of-care is typically required.

Myth #5: "My child's age makes them ineligible."

Fact: Cigna's coverage criteria align with FDA labeling, which doesn't specify strict age limits. However, most approvals occur in patients aged 4-5 years who are ambulatory, as this population has the strongest clinical evidence.

Myth #6: "The center where we get care doesn't matter."

Fact: Elevidys must be administered at accredited Duchenne centers of excellence with experience in gene therapy and emergency protocols. Cigna requires documentation of the center's qualifications as part of prior authorization.

From Our Advocates: We've seen families assume their local children's hospital could administer Elevidys, only to discover months later that they needed to establish care at a certified center hours away. Starting this process early—even before genetic confirmation—can save precious time when treatment windows are narrow.

What Actually Influences Cigna's Approval Decision

Understanding Cigna's actual decision-making process helps you prepare stronger submissions. Based on Cigna's coverage policy, approvals depend on:

Clinical Documentation Requirements

  • Genetic confirmation: Documented DMD mutation amenable to micro-dystrophin gene therapy (typically exons 18-58, excluding exons 8-9 deletions)
  • Functional status: Current ambulatory ability with objective measures (6-minute walk test, North Star Ambulatory Assessment)
  • Laboratory values: Anti-AAVrh74 antibody titer <1:400, baseline liver function, troponin-I, platelet count
  • Safety monitoring plan: Pre-treatment steroid protocol and post-infusion hepatic monitoring schedule

Administrative Requirements

  • Provider qualifications: Submission by neuromuscular specialist at accredited center
  • Prior authorization method: Electronic submission via ExpressPAth portal or CoverMyMeds
  • Supporting documentation: Complete medical records, genetic test reports, functional assessments

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters against plan policies and crafting point-by-point rebuttals with the right clinical evidence and procedural requirements.

Avoid These Common Mistakes

These preventable errors can derail even strong cases:

1. Incomplete Genetic Documentation

The mistake: Submitting genetic test results that don't explicitly confirm the specific mutation type or rule out exons 8-9 deletions. The fix: Ensure genetic reports clearly state the mutation is amenable to micro-dystrophin gene therapy per FDA labeling.

2. Missing Anti-AAV Antibody Testing

The mistake: Assuming this specialized test isn't necessary or will be covered automatically. The fix: Coordinate with your center to obtain testing and confirm results are below the 1:400 threshold before prior authorization submission.

3. Generic Medical Necessity Letters

The mistake: Using template letters that don't address Cigna's specific coverage criteria. The fix: Letters must explicitly reference each criterion in Cigna's policy with supporting clinical data.

4. Wrong Submission Method

The mistake: Faxing or calling when electronic submission is required. The fix: Use ExpressPAth or CoverMyMeds unless technical issues prevent electronic submission.

5. Inadequate Center Documentation

The mistake: Failing to document the administering center's accreditation and gene therapy experience. The fix: Include center credentials, safety protocols, and emergency management capabilities in your submission.

Quick Action Plan: Three Steps to Take Today

Step 1: Verify Your Coverage Details

  • Log into your Cigna member portal or call member services
  • Confirm Elevidys is on your formulary (it may require prior authorization even if listed)
  • Ask about your plan's gene therapy benefits and any annual/lifetime maximums

Step 2: Gather Essential Documentation

  • Request complete genetic test results from your child's geneticist
  • Schedule anti-AAV antibody testing if not already completed
  • Obtain recent functional assessments (6-minute walk test, NSAA scores)
  • Collect all DMD-related medical records from the past two years

Step 3: Connect with a Qualified Center

  • Use the Parent Project MD center finder to locate accredited centers in Virginia or nearby states
  • Schedule evaluation appointments (waiting lists can be several months)
  • Ask about their experience with Cigna prior authorizations for Elevidys

Appeals Playbook for Virginia Families

If Cigna denies coverage, Virginia provides structured appeal rights with specific timelines:

Appeal Level Timeline How to File Decision Time Success Rate
Internal (1st) 180 days from denial Cigna member portal 72 hours standard, 24 hours urgent ~18% overturn rate
Internal (2nd) 60 days from 1st denial Same portal or written request 72 hours standard Varies
External Review 120 days from final internal denial Virginia SCC Form 216-A 45 days standard, 72 hours urgent ~30-50% nationally

Internal Appeals Strategy

  1. Address specific denial reasons: Don't resubmit identical documentation
  2. Add new clinical evidence: Recent test results, specialist letters, or guideline citations
  3. Request peer-to-peer review: Have your specialist speak directly with Cigna's medical director

External Review Process

Virginia's State Corporation Commission Bureau of Insurance provides independent review when internal appeals are exhausted. The process:

  1. File within 120 days of Cigna's final denial
  2. Submit Form 216-A with all supporting documentation
  3. Independent review organization assigns board-certified specialists
  4. Decision is binding on Cigna (and you)

For urgent cases where delays could jeopardize health, expedited external review provides decisions within 72 hours.

FAQ: Your Top Questions Answered

Q: How long does Cigna's prior authorization take in Virginia? A: Standard requests receive decisions within 72 hours; urgent requests within 24 hours. Electronic submissions via ExpressPAth typically process faster than fax or phone requests.

Q: What if Elevidys isn't on Cigna's formulary? A: You can request a formulary exception with clinical justification. The process is similar to prior authorization but requires additional documentation of medical necessity and lack of suitable alternatives.

Q: Can I request an expedited appeal if my child's condition is worsening? A: Yes. If your physician certifies that delays could jeopardize your child's health or functional status, both Cigna's internal appeals and Virginia's external review offer expedited timelines.

Q: Does it matter if my employer's plan is self-funded? A: Self-funded plans may have different appeal rights, but many Virginia-based employers opt into the state's external review process. Check your Summary Plan Description or contact HR.

Q: What if we live near the border—can we use centers in other states? A: Yes, but confirm the center accepts Cigna and verify any out-of-network implications. Centers in Washington D.C., Maryland, or North Carolina may be options.

Q: Are there financial assistance programs if Cigna denies coverage? A: Sarepta offers patient assistance programs, and organizations like the MDA provide resources for families navigating coverage challenges.

Resources and Next Steps

Official Resources:

Patient Support:

  • Counterforce Health - Specialized insurance appeals support for complex therapies
  • MDA Resource Center - Financial and care coordination assistance
  • Virginia State Corporation Commission Consumer Services: 1-877-310-6560

Next Steps:

  1. Review your specific Cigna plan documents for gene therapy coverage
  2. Schedule appointments at accredited centers (don't wait for pre-authorization)
  3. Begin gathering required documentation while pursuing approval
  4. Consider consulting with appeal specialists if you receive an initial denial

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific plan terms and clinical circumstances. Always consult with your healthcare providers and review your actual policy documents. For personalized assistance with Virginia insurance appeals, contact the State Corporation Commission Bureau of Insurance.

This guide was last updated in November 2025. Insurance policies and regulations change frequently—verify current requirements with official sources.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.