By Counterforce Health Team in Elevidys (delandistrogene moxeparvovec-rokl) — 20 Nov 2025

Blue Cross Blue Shield Georgia's Coverage Criteria for Elevidys: What Counts as "Medically Necessary" for DMD Gene Therapy

Answer Box: Getting Elevidys Covered by Blue Cross Blue Shield Georgia

Elevidys requires prior authorization from Blue Cross Blue Shield Georgia with strict medical necessity criteria: confirmed DMD genetic mutation (excluding deletions in exons 8/9), age 4-5 years, ambulatory status, anti-AAVrh74 antibody titer <1:400, and treatment at a manufacturer-approved Qualified Treatment Center. Submit complete documentation including genetic testing, antibody results, and physician medical necessity letter through your provider's BCBS portal. If denied, you have 60 days to request external review through the Georgia Department of Insurance. Start with the prior authorization form from your provider's BCBS portal.

Policy Overview
Indication Requirements
Step Therapy & Exceptions
Quantity & Frequency Limits
Required Diagnostics
Site of Care Requirements
Evidence to Support Medical Necessity
Sample Medical Necessity Narrative
Edge Cases & Special Considerations
Quick Reference Table
Appeals Process in Georgia
FAQ

Policy Overview

Blue Cross Blue Shield of Georgia (operated by Anthem) covers Elevidys (delandistrogene moxeparvovec-rokl) under their specialty pharmacy benefit with mandatory prior authorization for all plan types—HMO, PPO, and individual marketplace plans. The policy aligns with FDA labeling but includes additional utilization management criteria.

Where to Find Official Documentation:

Provider portal: Anthem provider website (prior authorization section)
Member handbook: Available through online member portal
Medical policies: Published on Anthem's clinical guidelines page
Formulary: Updated quarterly, available via provider and member portals

Note: Self-insured employer plans may have different criteria. Verify coverage details directly with the plan administrator.

Indication Requirements

Elevidys coverage is strictly limited to FDA-approved indications for Duchenne muscular dystrophy (DMD). Off-label use is not covered under current policies.

FDA-Approved Indication:

Treatment of pediatric patients with DMD
Age 4-5 years at time of treatment
Confirmed genetic diagnosis of DMD
Specific genetic mutation requirements (see diagnostics section)

Documentation Required:

Copy of FDA prescribing information
Genetic testing report confirming DMD diagnosis
Clinical notes supporting on-label use

Step Therapy & Exceptions

Blue Cross Blue Shield Georgia does not require step therapy for Elevidys, as it's a one-time gene therapy with no therapeutic alternatives. However, patients must demonstrate:

Standard DMD Care History:

Current or prior corticosteroid therapy (prednisolone, deflazacort, or prednisone)
Physical therapy and supportive care documentation
Cardiac and pulmonary monitoring records

Medical Exception Pathways:

Contraindications to corticosteroids must be documented
Alternative DMD therapies (if tried) should be noted with outcomes
Clinical rationale for gene therapy timing

Quantity & Frequency Limits

Elevidys is approved as a single, one-time infusion with the following restrictions:

Coverage Limits:

One lifetime dose per patient
No reauthorization permitted
No retreatment coverage under any circumstances

Dosing Requirements:

Weight-based dosing per FDA label (1.33 × 10^14 vector genomes per kilogram)
Must be administered at approved Qualified Treatment Center
Corticosteroid prophylaxis required (prednisolone 1 mg/kg daily starting 24 hours before infusion, continued for 60 days post-infusion)

Required Diagnostics

Genetic Testing (Mandatory):

Confirmed pathogenic DMD gene mutation
Exclusion: Patients with deletions in exon 8 and/or exon 9 are not eligible
Testing must be performed in CLIA-certified laboratory
Results must be less than 12 months old at time of submission

Anti-AAV Antibody Testing:

Anti-AAVrh74 neutralizing antibody titer must be <1:400
Testing required within 30 days of planned infusion
Retest required if patient received IVIG within 3 months

Baseline Laboratory Requirements:

Complete blood count with platelets
Comprehensive metabolic panel including liver function tests
Troponin-I level
All labs must be within 30 days of treatment

Functional Assessment:

Documentation of ambulatory status (able to walk without assistive devices)
Recent physical therapy evaluation
Pulmonary function tests if clinically indicated

Site of Care Requirements

Elevidys must be administered at manufacturer-approved Qualified Treatment Centers (QTCs) that meet specific criteria:

QTC Requirements:

Sarepta Therapeutics-approved facility
Multidisciplinary team including neuromuscular disease specialist
Experience with gene therapy administration
Intensive care capabilities for monitoring
Protocols for managing infusion reactions

Coverage Restrictions:

No coverage for administration at non-QTC facilities
Out-of-network QTCs may require special authorization
Patient may need to travel to approved center

Tip: Contact Sarepta Therapeutics at 1-888-SAREPTA to locate the nearest QTC in Georgia.

Evidence to Support Medical Necessity

Required Clinical Documentation:

FDA prescribing information for Elevidys
Peer-reviewed studies supporting efficacy (if available)
DMD care guidelines from recognized organizations
Patient-specific clinical rationale

Key Guidelines to Reference:

FDA-approved labeling (primary source)
Duchenne muscular dystrophy care guidelines from neuromuscular societies
Sarepta Therapeutics clinical data and prescribing information

Documentation Tips:

Quote specific sections of FDA label
Include patient's functional status and prognosis
Explain why treatment timing is critical
Address any potential contraindications

Sample Medical Necessity Narrative

"[Patient Name] is a [age]-year-old boy with genetically confirmed Duchenne muscular dystrophy caused by a pathogenic deletion in exons [X-Y] of the DMD gene, confirmed by [laboratory] on [date]. He meets all FDA-approved criteria for Elevidys treatment: age 4-5 years, ambulatory without assistive devices, and anti-AAVrh74 antibody titer of [result] (<1:400).

Current treatment includes corticosteroid therapy with [medication] at [dose], which has been stable for [duration]. Recent functional assessments show [specific findings]. Without gene therapy intervention, [patient] faces progressive muscle weakness and loss of ambulation typically by age 10-12 years.

Elevidys represents the only available gene therapy for DMD and offers the potential to slow disease progression during this critical developmental window. Treatment will occur at [QTC name], an approved Qualified Treatment Center with appropriate monitoring capabilities. All baseline requirements have been met, including normal liver function and appropriate antibody status."

Edge Cases & Special Considerations

Age Considerations:

Patients approaching age 6: Request expedited review
Document urgency of treatment timing
Consider emergency appeal if standard review timeline risks aging out

Comorbidities:

Liver disease: May be contraindication; specialist consultation required
Cardiac involvement: Baseline cardiac assessment needed
Active infections: Must be resolved before treatment

Previous Gene Therapy:

Any prior gene therapy exposure excludes coverage
Document absence of previous investigational treatments
Clinical trial participation history must be disclosed

Escalation Paths:

Peer-to-peer review with medical director
Expedited appeal for urgent cases
External review through Georgia Department of Insurance

Quick Reference Table

Requirement	What It Means	Where to Find It	Common Errors
Prior Authorization	Mandatory approval before treatment	BCBS provider portal	Submitting incomplete documentation
Age 4-5 years	FDA-approved age range	Birth certificate, medical records	Missing age verification
DMD genetic confirmation	Pathogenic mutation (not exons 8/9)	CLIA lab report	Using non-CLIA testing
Anti-AAV antibodies <1:400	No pre-existing immunity	Specialized lab testing	Testing too early/late
QTC administration	Approved treatment center only	Sarepta QTC locator	Scheduling at non-QTC facility
One-time dose	Single lifetime treatment	FDA label	Requesting retreatment
Corticosteroid stable ≥12 weeks	Stable dosing before treatment	Medication history	Recent dose changes

Appeals Process in Georgia

If Blue Cross Blue Shield Georgia denies your Elevidys prior authorization, you have specific appeal rights under Georgia law:

Internal Appeal (First Level):

Deadline: 180 days from denial date for commercial plans
How to file: Through BCBS member portal or written request
Timeline: Decision within 30 days (expedited: 72 hours for urgent cases)
Required documents: Denial letter, additional clinical documentation, physician letter

External Review (Independent Review):

Deadline: 60 days from final internal denial
How to file: Georgia Department of Insurance Consumer Services
Contact: 1-800-656-2298
Timeline: 45 days for standard review, 72 hours for expedited
Cost: Free to consumer

Required Documentation for Appeals:

Original denial letter
Complete medical records
Physician medical necessity letter
Genetic testing results
Anti-AAV antibody test results
Evidence of QTC approval

Important: Georgia's external review decision is binding on the insurer and cannot be overturned except through court proceedings.

Counterforce Health Support

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex therapies like Elevidys. Their platform analyzes denial letters, identifies specific coverage criteria, and drafts point-by-point rebuttals using the right clinical evidence and payer-specific workflows. For families facing Elevidys denials, this targeted approach can significantly improve approval odds by ensuring all medical necessity requirements are properly addressed and documented.

FAQ

Q: How long does BCBS Georgia prior authorization take for Elevidys? A: Standard review is 2-7 business days with complete documentation. Expedited review (for urgent cases) is completed within 72 hours.

Q: What if my child's anti-AAV antibody level is above 1:400? A: Levels ≥1:400 typically result in automatic denial as they may prevent therapy efficacy and increase adverse event risk. Retesting after several months may be considered.

Q: Can I appeal if my child ages out during the review process? A: Yes. Document the timeline urgency and request expedited review. Appeals can cite the delay in coverage determination as grounds for exception.

Q: Does BCBS Georgia cover travel expenses to reach a QTC? A: Standard policies don't cover travel, but some plans offer case management support. Contact member services to inquire about available assistance programs.

Q: What happens if the QTC is out-of-network? A: Request single-case agreement for in-network coverage. Document lack of in-network QTC alternatives in your area.

Q: Are there financial assistance programs for Elevidys? A: Sarepta offers SareptAssist patient support program. Additionally, organizations like Parent Project Muscular Dystrophy provide resources for financial assistance and insurance navigation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies may change, and individual circumstances vary. Always verify current requirements with Blue Cross Blue Shield Georgia and consult with your healthcare provider and insurance representative for personalized guidance. For additional support with insurance appeals and coverage determination, consider consulting with Counterforce Health or other patient advocacy organizations.

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