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

How to Get Elevidys (Delandistrogene Moxeparvovec-rokl) Covered by Cigna in Florida: Appeals, Forms & Timeline Guide

Answer Box: Getting Elevidys Covered by Cigna in Florida

Fastest path to approval: Cigna requires prior authorization for Elevidys (delandistrogene moxeparvovec-rokl) within 72 hours for standard requests, 24 hours for urgent cases. Submit through Express Scripts ExpressPAth portal with complete DMD genetic confirmation, anti-AAV antibody results, and hepatic monitoring plan. If denied, file internal appeal within 180 days—Cigna must decide within 72 hours (24 hours if expedited). External review through Florida DFS available within 120 days of final denial.

First step today: Contact your prescriber to initiate PA submission with all required clinical documentation.

Table of Contents

Why Florida State Rules Matter

Florida's insurance regulations provide critical protections for patients seeking coverage of expensive gene therapies like Elevidys. Unlike federal guidelines alone, Florida law requires Cigna to respond to prior authorization requests within 72 hours for standard cases and 24 hours for urgent situations—much faster than many other states.

Most importantly, Florida restricts step therapy protocols for rare disease treatments. Since July 2022, insurers must provide clear exemption procedures and cannot impose step therapy requirements more stringent than FDA labeling. For Elevidys, which has specific FDA approval for eligible DMD patients, this means Cigna cannot require you to fail other treatments first if you meet the gene therapy's labeled criteria.

Note: These protections apply to fully-insured Cigna plans. Self-funded employer plans may have different rules under federal ERISA law.

Cigna's Prior Authorization Timeline

Cigna manages specialty drugs like Elevidys through Express Scripts and Accredo specialty pharmacy. Here are the key deadlines that apply in Florida:

  • Standard PA review: 72 hours from complete submission
  • Expedited PA review: 24 hours when delay could jeopardize health
  • Internal appeal: 72 hours for standard, 24 hours for expedited
  • Authorization duration: Typically covers the full course of gene therapy

These timelines are calendar days, not business days, and are enforced by Florida insurance regulations.

Step Therapy Override Protections

Florida law provides strong protections against inappropriate step therapy requirements for gene therapies. You can request a medical exception if:

  • The required drug is clinically ineffective or expected to be ineffective
  • The drug is not in your best interest due to adverse effects or interactions
  • You're currently stable on your treatment
  • The required drug hasn't been approved by FDA for your condition
  • Previous failures or contraindications exist

For Elevidys, providers should document that the patient meets FDA-approved criteria and that delays could cause irreversible harm—particularly relevant for progressive DMD.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before dispensing Express Scripts portal Cigna PA Process
Genetic Confirmation DMD mutation documented Clinical notes, genetic testing FDA labeling requirements
Anti-AAV Antibodies Screening required pre-infusion Lab results Sarepta prescribing information
Designated Center Must use approved infusion site Provider network verification Cigna specialty network
Age Requirements Per FDA labeling (verify current) Prescribing information FDA approval details
Hepatic Monitoring Pre/post infusion protocols Treatment protocol documentation Clinical guidelines

Step-by-Step: Fastest Path to Approval

1. Verify Coverage & Network (Patient/Clinic)

  • Confirm Cigna covers Elevidys (check formulary or call member services)
  • Verify infusion center is in-network for gene therapy
  • Timeline: Same day

2. Gather Required Documentation (Clinic)

  • DMD genetic testing results
  • Anti-AAV antibody screening
  • Prior therapy history and outcomes
  • Current functional assessments
  • Timeline: 1-3 days

3. Submit Prior Authorization (Prescriber)

4. Follow Up Within 48 Hours (Clinic)

  • Confirm PA was received and is complete
  • Provide any additional requested information
  • Timeline: 24-72 hours for decision

5. If Approved: Schedule Treatment (Patient/Clinic)

  • Coordinate with specialty pharmacy (Accredo)
  • Schedule pre-infusion assessments
  • Timeline: Per clinical protocol

6. If Denied: File Appeal Immediately (Patient/Prescriber)

  • Request written denial with specific reasons
  • Submit internal appeal with additional evidence
  • Timeline: Must file within 180 days

7. External Review If Needed (Patient)

  • Contact Florida DFS if internal appeals fail
  • Submit within 120 days of final denial
  • Timeline: 45 days for decision (72 hours if urgent)

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Missing genetic confirmation Submit complete DMD genetic testing Genetic lab report with specific mutation
Doesn't meet age criteria Verify current FDA labeling FDA prescribing information, patient age
Elevated anti-AAV antibodies Provide recent screening results Lab results within required timeframe
Not using designated center Transfer to approved facility Network verification, center certification
Inadequate monitoring plan Submit detailed protocol Pre/post-infusion monitoring schedule
"Experimental" determination Cite FDA approval status FDA approval letter, prescribing information

Appeals Playbook for Cigna in Florida

Internal Appeals (First Level)

  • Who can file: Patient, prescriber, or authorized representative
  • Deadline: 180 days from denial notice
  • How to submit: Cigna member portal or written request
  • Timeline: 72 hours for standard, 24 hours for expedited
  • Required documents: Denial letter, medical records, prescriber letter

Internal Appeals (Second Level)

  • Automatic: If first appeal is denied
  • Timeline: Same as first level (72/24 hours)
  • Review: Independent medical professionals
  • Outcome: Final internal decision

Expedited Appeals

  • When available: Delay could seriously jeopardize health or ability to regain maximum function
  • Timeline: 24 hours for decision
  • How to request: Explicitly state "expedited" and provide medical justification

For urgent situations, patients can call Cigna Customer Service at 1-800-882-4462 or the number on their ID card.

When to Escalate: External Review

If Cigna denies your internal appeals, Florida law provides access to independent external review through the Department of Financial Services.

Eligibility: Denials involving medical necessity, appropriateness, or experimental treatment determinations

Timeline:

  • Request within 120 days of final internal denial
  • Standard review: 45 days for decision
  • Expedited review: 72 hours for urgent cases

How to request: Contact Florida DFS Consumer Services at 1-877-MY-FL-CFO (1-877-693-5236)

Required documents:

  • Final denial letter from Cigna
  • Medical necessity letter from prescriber
  • Clinical documentation supporting treatment need
  • Patient's medical history and prior treatments
Important: External review decisions are binding on Cigna. There's no fee for patients, and any filing fees must be refunded if the decision is in your favor.

Continuity of Care Protections

Florida provides specific protections for patients transitioning between health plans, though these have limitations for gene therapy:

Medicaid Managed Care: New plans must honor previously authorized benefits during transitions (effective February 2025)

Commercial Insurance: Pending legislation (Senate Bill 114) would require notice periods and continued coverage when providers go out-of-network

Gene Therapy Considerations: Continuity protections typically apply only to patients in "active treatment"—meaning you must be currently receiving ongoing gene therapy, not just scheduled to begin it.

Actionable steps:

  • Document all prior authorizations before plan changes
  • Request continuity of care immediately upon enrollment in new plan
  • Maintain detailed records of ongoing treatment necessity

Scripts & Templates

Patient Phone Script for Cigna

"Hi, I'm calling about prior authorization for Elevidys gene therapy for my Duchenne muscular dystrophy. My member ID is [number]. My doctor submitted the PA request on [date] through Express Scripts. Can you confirm it was received and tell me the status? If there are any missing documents, I'd like to know what's needed so we can submit them today."

Clinic Staff Peer-to-Peer Request

"I'm requesting a peer-to-peer review for [patient name], member ID [number], regarding the denial for Elevidys gene therapy. The patient has confirmed DMD with [specific mutation], meets all FDA criteria, and has [prior treatment history]. When can Dr. [name] speak with your medical director about this case?"

Medical Necessity Email Template

"Subject: Additional Clinical Information - PA Request for Elevidys

This patient has genetically confirmed Duchenne muscular dystrophy and meets all FDA-approved criteria for Elevidys gene therapy. Clinical justification includes:

  • Genetic testing confirming DMD mutation: [details]
  • Current functional status: [assessment results]
  • Prior treatments and outcomes: [history]
  • Anti-AAV antibody status: [results]
  • Proposed monitoring plan: [protocol]

Please contact me at [number] if additional information is needed."

Frequently Asked Questions

How long does Cigna prior authorization take in Florida? Cigna must respond within 72 hours for standard requests and 24 hours for urgent cases under Florida law. This applies to specialty drugs managed through Express Scripts and Accredo.

What if Elevidys is not on Cigna's formulary? You can request a formulary exception by demonstrating medical necessity. Provide clinical documentation showing why Elevidys is required and no formulary alternatives are appropriate.

Can I request an expedited appeal? Yes, if waiting for the standard appeal timeline could seriously jeopardize your health. Mark your appeal as "expedited" and provide medical justification for the urgency.

Does step therapy apply if I've tried treatments outside Florida? Treatment history from other states should count toward step therapy requirements. Provide complete documentation of prior therapies, outcomes, and reasons for discontinuation.

What happens if my provider goes out of network? Florida law provides some continuity of care protections, but these are limited for new treatments. Contact Cigna immediately to request continuation of care and explore in-network alternatives.

Who pays for external review in Florida? Patients pay no fee for external review. Any filing fees charged must be refunded if the external reviewer overturns Cigna's denial.

Can my doctor submit appeals on my behalf? Yes, prescribers can file appeals as your authorized representative. They should include their medical opinion on why Elevidys is medically necessary for your specific case.

What if I have both Cigna and Medicaid coverage? Coordination of benefits rules apply. Typically, Cigna would be primary and Medicaid secondary, but verify with both plans how gene therapy coverage works with dual coverage.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to draft point-by-point rebuttals that align with each payer's specific requirements. For complex cases like Elevidys gene therapy approvals, Counterforce Health provides the clinical evidence, procedural expertise, and payer-specific workflows needed to navigate Cigna's prior authorization and appeals process successfully.

When facing a gene therapy denial, having the right clinical evidence and procedural knowledge can make the difference between approval and prolonged delays. Counterforce Health's platform pulls the appropriate FDA labeling, peer-reviewed studies, and specialty guidelines while ensuring all required clinical facts and operational details are included in your appeal.

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 circumstances, plan specifics, and clinical factors. Always consult with your healthcare provider and insurance plan for guidance specific to your situation. Coverage policies and procedures may change; verify current requirements with Cigna and Florida insurance regulators.

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