How to Get Exondys 51 (Eteplirsen) Covered by Aetna CVS Health in Virginia: Complete Coding, Billing, and Appeals Guide
Answer Box: Getting Exondys 51 Covered by Aetna CVS Health in Virginia
Exondys 51 (eteplirsen) requires prior authorization from Aetna CVS Health with specific coding and documentation. Use ICD-10 code G71.01 for Duchenne muscular dystrophy, HCPCS code J1428 for billing (10 mg units), and submit genetic testing confirming exon 51-amenable mutation. Most denials can be appealed through Virginia's external review process within 120 days. Start today: Contact your neurologist to gather genetic test results and baseline function assessments, then submit through Aetna's provider portal with complete clinical documentation.
Table of Contents
- Coding Basics: Medical vs. Pharmacy Benefit
- ICD-10 Mapping for DMD
- HCPCS/J-Code and NDC Overview
- Clean Prior Authorization Request
- Frequent Coding Pitfalls
- Verification with Aetna CVS Health
- Appeals Process in Virginia
- Quick Audit Checklist
Coding Basics: Medical vs. Pharmacy Benefit
Exondys 51 (eteplirsen) is covered under the medical benefit via buy-and-bill, not the pharmacy benefit. This means your healthcare provider purchases the medication and bills Aetna CVS Health directly using medical claim forms (CMS-1500 or UB-04).
Why this matters: Patients often assume specialty drugs go through their prescription coverage, but Exondys 51's weekly IV infusion requires provider administration. According to billing guidance, this routing affects everything from prior authorization forms to copay calculations.
Tip: If Aetna CVS Health directs you to CVS Caremark specialty pharmacy, clarify that Exondys 51 is a provider-administered infusion requiring medical benefit coverage, not specialty pharmacy dispensing.
ICD-10 Mapping for DMD
The primary diagnosis code for Duchenne muscular dystrophy is G71.01 (Duchenne or Becker muscular dystrophy). This billable code became effective October 1, 2018, and applies to all DMD cases, including those with exon 51-amenable mutations.
Documentation Requirements
Your medical records must include:
- Genetic testing results confirming DMD gene deletion/duplication amenable to exon 51 skipping
- Clinical correlation: Progressive proximal muscle weakness, elevated creatine kinase levels
- Family history (if applicable)
- Muscle biopsy results (when performed)
According to the Parent Project Muscular Dystrophy, this specific code improves surveillance and research while supporting access to targeted therapies like Exondys 51.
HCPCS/J-Code and NDC Overview
Primary Billing Codes
| Code | Description | Units | Notes |
|---|---|---|---|
| J1428 | Injection, eteplirsen, 10 mg | 1 unit = 10 mg | Primary drug code; authorization typically required |
| 96413 | IV infusion, first hour | Per infusion | Initial administration |
| 96415 | Each additional hour | Per hour | Add-on code if infusion >1 hour |
Dosing Calculations
Exondys 51 is dosed at 30 mg/kg weekly. For billing purposes:
- Calculate total dose in mg
- Divide by 10 to get J1428 units
- Example: 70 kg patient = 2,100 mg dose = 210 units of J1428
NDC Requirements
The NDC must be configured as 11 digits using "5-4-2" format. Common NDC packages include 100 mg/2 mL vials (50 mg/mL concentration). Always verify current NDCs through CMS databases as they can change.
Special Modifiers
For 340B program participants, include modifier JG or TB on all claims to indicate drugs acquired through 340B pricing.
Clean Prior Authorization Request
Required Clinical Documentation
Genetic Testing Confirmation
- Laboratory report showing DMD mutation amenable to exon 51 skipping
- This is a one-time requirement that doesn't expire
Baseline Assessments
- 6-minute walk test (if ambulatory)
- Cardiac function (echocardiogram or MUGA scan)
- Pulmonary function tests (FVC ≥50% predicted)
- Current weight for dosing calculations
Prescriber Credentials
- Neurologist or neuromuscular specialist
- Experience treating Duchenne muscular dystrophy
Sample Request Structure
Patient: [Name], DOB: [Date], Member ID: [Number]
Diagnosis: G71.01 - Duchenne muscular dystrophy
Requested Drug: Exondys 51 (eteplirsen) - J1428
Dose: 30 mg/kg weekly IV (X units of J1428 per infusion)
Site of Care: Outpatient infusion center
Genetic Testing: [Date] - Exon 51-amenable mutation confirmed
Baseline 6MWT: [Result] meters on [Date]
Prescriber: Dr. [Name], Neurology, [Credentials]
Frequent Coding Pitfalls
Unit Conversion Errors
Problem: Billing incorrect J1428 units Solution: Always divide total mg dose by 10. Double-check math before submission.
Mismatched NDC Quantities
Problem: NDC quantity doesn't match procedure code units Solution: Ensure NDC quantity reflects the strength administered per the J1428 units billed.
Missing Administration Codes
Problem: Billing J1428 without infusion codes Solution: Always include 96413 for the first hour; add 96415 for additional hours.
Wrong Benefit Category
Problem: Submitting to pharmacy benefit instead of medical Solution: Route all Exondys 51 claims through medical benefit buy-and-bill process.
Verification with Aetna CVS Health
Before Submission Checklist
- Confirm formulary status: Check if Exondys 51 requires prior authorization on your specific Aetna plan
- Verify provider network: Ensure your neurologist and infusion site are in-network
- Check quantity limits: Some plans limit monthly units or require specific intervals
- Review step therapy: Confirm if corticosteroids or other treatments are required first
Contact Information
- Provider Services: Use the number on your Aetna provider manual
- Prior Authorization: Submit through Aetna's provider portal (verify current link with your plan)
- Member Services: Number on the back of your insurance card
Note: Aetna CVS Health may route specialty medications through different departments. Always confirm you're speaking with the medical benefit team, not pharmacy benefit.
Appeals Process in Virginia
If Aetna CVS Health denies your Exondys 51 request, Virginia offers robust appeal rights through the State Corporation Commission Bureau of Insurance.
Internal Appeals Timeline
| Step | Timeline | Action Required |
|---|---|---|
| Initial denial | Day 0 | Receive denial notice with appeal rights |
| File internal appeal | Within plan timeframe | Submit additional documentation |
| Internal decision | ~30-45 days | Aetna reviews and issues final determination |
External Review Process
Virginia's external review applies to medical necessity denials after internal appeals are exhausted.
Standard External Review
- File within: 120 days of final internal denial
- Form required: Form 216-A from Virginia SCC
- Decision timeline: Up to 45 days
- Cost: Free to consumers
Expedited External Review
- When to use: Life-threatening situations or serious jeopardy to health
- Timeline: 72 hours for urgent medical necessity cases
- Requirements: Physician certification of urgency
Required Appeal Documentation
- Complete denial notice from Aetna CVS Health
- All medical records supporting medical necessity
- Attending physician recommendation letter
- Genetic testing results
- Baseline function assessments
- Plan documents (if available)
Submit to: Virginia SCC Bureau of Insurance, P.O. Box 1157, Richmond, VA 23218
Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform helps identify denial reasons and drafts point-by-point rebuttals aligned with payer policies, potentially saving weeks in the appeals process.
Quick Audit Checklist
Before Submitting Your Request
Clinical Documentation
- G71.01 diagnosis code properly documented
- Genetic testing confirms exon 51-amenable mutation
- Baseline assessments completed (6MWT, cardiac, pulmonary)
- Current weight documented for dosing
Coding Accuracy
- J1428 units calculated correctly (total mg ÷ 10)
- NDC quantity matches procedure code units
- Administration codes included (96413, 96415 if applicable)
- 340B modifiers added if applicable
Prescriber Requirements
- Neurologist or neuromuscular specialist
- In-network with Aetna CVS Health
- Experience with DMD treatment documented
Submission Details
- Routed to medical benefit (not pharmacy)
- All required forms completed
- Supporting documentation attached
- Member/provider portal submission confirmed
Common Denial Reasons & Fixes
| Denial Reason | Solution | Required Documentation |
|---|---|---|
| No genetic confirmation | Submit genetic testing report | Lab results showing exon 51-amenable mutation |
| Non-specialist prescriber | Transfer care or obtain consultation | Neurologist/neuromuscular specialist prescription |
| Missing baseline assessments | Complete required testing | 6MWT, cardiac function, pulmonary function tests |
| Experimental/investigational | Appeal with FDA approval evidence | FDA label, accelerated approval documentation |
| Step therapy required | Document corticosteroid trial or contraindication | Prior therapy records, intolerance documentation |
FAQ
How long does Aetna CVS Health prior authorization take in Virginia? Standard prior authorizations typically take 30-45 days. Expedited requests for urgent medical situations may be processed within 72 hours.
What if Exondys 51 is non-formulary on my plan? You can request a formulary exception with medical necessity documentation. Include genetic testing, baseline assessments, and specialist recommendation.
Can I request an expedited appeal if denied? Yes, if your physician certifies that waiting could seriously jeopardize your health. Virginia allows expedited external review within 72 hours for urgent cases.
Does step therapy apply if I've tried corticosteroids outside Virginia? Previous treatment records from any state should satisfy step therapy requirements. Ensure documentation is complete and submitted with your request.
What happens if the external review upholds the denial? The decision is binding on both you and Aetna CVS Health. You may still pursue other options like employer appeals (for self-funded plans) or legal consultation.
Costs & Savings Options
Manufacturer Support
- Sarepta Therapeutics offers patient assistance programs
- Check eligibility at the manufacturer's official patient support website
Foundation Grants
- Patient Advocate Foundation
- HealthWell Foundation
- Various DMD-specific organizations
State Programs
- Virginia Medicaid (if eligible)
- Virginia's Children's Specialty Services (for pediatric patients)
When to Escalate
Contact Virginia's State Corporation Commission Bureau of Insurance if:
- Aetna CVS Health doesn't respond within required timeframes
- You believe the denial violates Virginia insurance law
- You need guidance on external review eligibility
Contact: Virginia SCC Bureau of Insurance Consumer Services at 1-877-310-6560
For patients and families navigating complex prior authorization requirements, Counterforce Health provides specialized support in converting insurance denials into successful appeals. Their evidence-backed approach helps ensure that medical necessity letters address specific payer concerns while meeting procedural requirements.
Sources & Further Reading
- Virginia SCC Bureau of Insurance External Review Process
- Exondys 51 Billing Codes and Guidelines
- ICD-10 Code G71.01 for Duchenne Muscular Dystrophy
- Virginia External Review Rights
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on your specific plan terms and clinical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For questions about Virginia insurance regulations, contact the State Corporation Commission Bureau of Insurance.
Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.