By Counterforce Health Team in Exondys 51 (eteplirsen) —

Getting Exondys 51 (Eteplirsen) Covered by UnitedHealthcare in Florida: Coding, Appeals, and Success Strategies

Answer Box: Quick Path to Coverage

To get Exondys 51 (eteplirsen) covered by UnitedHealthcare in Florida: Submit prior authorization with genetic testing confirming exon 51-amenable DMD mutation (ICD-10: G71.01), neurologist evaluation, and stable corticosteroid documentation. Use HCPCS J-code J1428 for billing (1 unit = 10mg). If denied, file internal appeal within 180 days, then external review through Florida's independent review program. Start the process 60-90 days before current authorization expires.

First step today: Contact your neurologist to schedule DMD assessment and request genetic test results if not already documented.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Documentation Requirements
  3. HCPCS J-Code and NDC Billing
  4. Clean Prior Authorization Request
  5. Common Coding Pitfalls
  6. UnitedHealthcare Verification Process
  7. Appeals Process in Florida
  8. Pre-Submission Audit Checklist

Coding Basics: Medical vs. Pharmacy Benefit

Exondys 51 (eteplirsen) is covered under UnitedHealthcare's medical benefit, not the pharmacy benefit, because it's administered by healthcare providers through a "buy-and-bill" process. This distinction affects how you code and submit claims.

Key Coverage Requirements:

  • Diagnosis: Duchenne muscular dystrophy with confirmed exon 51-amenable mutation
  • Prior Authorization: Required annually through OptumRx
  • Administration: Weekly IV infusions at approved healthcare facilities
  • Documentation: Genetic testing, neurologist evaluation, and baseline assessments
Note: Unlike traditional pharmacy benefits, medical benefit coverage requires detailed clinical documentation and often involves more complex prior authorization processes.

ICD-10 Documentation Requirements

Primary Diagnosis Code

Use ICD-10 code G71.01 for all Duchenne muscular dystrophy cases, including those with exon 51 mutations. This code covers both Duchenne and Becker muscular dystrophy, so your documentation must clearly specify DMD.

Essential Documentation Elements

Your medical records must include:

Genetic Testing Confirmation:

  • Laboratory report confirming DMD gene mutation
  • Specific notation of exon 51 amenability
  • Date of genetic testing and laboratory name

Clinical Assessment:

  • Neurologist evaluation within 6 months
  • Baseline functional assessments (6-minute walk test, time to rise)
  • Current weight and body surface area
  • Cardiac and renal function tests

Treatment History:

  • Current corticosteroid regimen (stable for 6+ months)
  • Documentation of medical reasons if corticosteroids aren't used
  • Previous DMD treatments and outcomes
Tip: Generic documentation like "muscular dystrophy" without specifying Duchenne and confirming the mutation can trigger automatic denials or audits.

HCPCS J-Code and NDC Billing

Billing Code Structure

HCPCS J-Code: J1428 ("Injection, eteplirsen, 10 mg")

  • 1 billing unit = 10 mg of eteplirsen administered
  • Calculate total units by dividing administered mg by 10

NDC Numbers:

  • 100 mg/2 mL vial: 60923-363-xx
  • 500 mg/10 mL vial: 60923-284-xx

Dosing and Unit Calculations

Patient Weight Typical Dose Billing Units Vials Needed
20 kg 300 mg 30 units 3 x 100mg vials
40 kg 600 mg 60 units 6 x 100mg vials
60 kg 900 mg 90 units 1 x 500mg + 4 x 100mg

Maximum Coverage: Up to 3,500 mg per week (350 billing units), typically allocated as up to 7 vials per 7-day period.

Clean Prior Authorization Request

Required Components

A complete UnitedHealthcare prior authorization for Exondys 51 must include:

Clinical Documentation:

  1. Genetic Report - Confirming exon 51-amenable DMD mutation
  2. Neurologist Evaluation - Within 6 months, documenting continued DMD diagnosis
  3. Functional Assessments - 6MWT results, time to rise (<7 seconds for ambulatory patients)
  4. Weight Documentation - Current weight within 30 days of request
  5. Cardiac/Renal Tests - Annual echocardiogram and serum creatinine

Prescription Information:

  • Prescriber specialty (must be neurologist or neuromuscular specialist)
  • Dosing based on 30 mg/kg weekly
  • Administration site and frequency
  • Treatment duration requested

Insurance Details:

  • Member ID and policy information
  • Previous authorization numbers (for renewals)
  • Pharmacy or infusion center details

Submission Timeline

Start the process 60-90 days before current authorization expires. UnitedHealthcare typically requires 15-30 business days for review, and missing documentation can cause significant delays.

Common Coding Pitfalls

Unit Conversion Errors

Wrong: Billing 1 unit for a 100 mg dose Correct: Billing 10 units for a 100 mg dose (100 mg ÷ 10 = 10 units)

Mismatched Codes

Wrong: Using pharmacy NDC codes for medical benefit claims Correct: Using appropriate NDC for vial strength with J1428 code

Missing Documentation

Common Omissions:

  • Genetic test results not attached to initial request
  • Neurologist evaluation older than 6 months
  • Missing baseline cardiac or renal function tests
  • Incomplete corticosteroid history

Site of Care Issues

Wrong: Requesting coverage for home administration Correct: Specifying approved healthcare facility for IV infusion

UnitedHealthcare Verification Process

Pre-Submission Verification

Before submitting your prior authorization:

  1. Check Formulary Status - Verify Exondys 51 is covered under your specific UnitedHealthcare plan
  2. Confirm Provider Network - Ensure prescribing neurologist is in-network
  3. Validate Infusion Site - Confirm administration facility accepts UnitedHealthcare
  4. Review Policy Updates - Check for recent changes to coverage criteria

Using UnitedHealthcare Resources

Provider Portal: Access current prior authorization forms and status updates OptumRx: Specialty pharmacy coordination and benefit verification Member Services: Coverage verification and appeals assistance

Important: UnitedHealthcare's 2025 policy changes include new restrictions for patients who have previously received gene therapy. Verify current requirements before submitting.

Appeals Process in Florida

Internal Appeal Process

Timeline: File within 180 days of denial Review Period: 15-30 days for standard review, 72 hours for urgent cases Submission Methods:

  • UnitedHealthcare member/provider portal
  • Mail or fax (verify current contact information)
  • Phone follow-up recommended

Required Appeal Documentation

Clinical Evidence:

  • Updated neurologist letter addressing specific denial reasons
  • Additional functional assessments showing continued benefit
  • Peer-reviewed literature supporting medical necessity
  • FDA approval rationale for Exondys 51

Administrative Documents:

  • Original denial letter
  • Complete medical records
  • Insurance policy information
  • Previous authorization history

External Review in Florida

If internal appeals are unsuccessful, Florida residents can request independent external review through the state's contracted review organization.

Eligibility: State-regulated health plans (not self-funded ERISA plans) Timeline: Request within 120 days of final internal denial Cost: Free to patients Success Rate: External reviews overturn 40-60% of specialty drug denials nationally

How to Request:

  1. Contact Florida Department of Financial Services
  2. Submit external review application
  3. Include all appeal documentation
  4. Await independent medical expert decision (typically 45 days, 72 hours for urgent cases)

When Coverage Is Denied

Counterforce Health helps patients navigate complex insurance denials by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals. Their platform identifies specific denial reasons and drafts point-by-point rebuttals aligned with payer requirements, significantly improving approval chances for specialty medications like Exondys 51.

Immediate Steps After Denial:

  1. Request Emergency Supply - Contact OptumRx specialty pharmacy
  2. Contact Manufacturer - Sarepta Therapeutics patient support program
  3. File Appeal Quickly - Don't wait; start internal appeal process immediately
  4. Gather Support - Enlist neurologist and patient advocacy organizations

Pre-Submission Audit Checklist

Clinical Documentation Review

  • Genetic testing confirms exon 51-amenable DMD mutation
  • Neurologist evaluation completed within 6 months
  • ICD-10 code G71.01 properly documented
  • Baseline functional assessments included (6MWT, time to rise)
  • Current weight documented within 30 days
  • Cardiac function assessment (annual echocardiogram)
  • Renal function tests (serum creatinine)
  • Corticosteroid history documented (stable 6+ months or medical contraindication)

Billing Code Verification

  • HCPCS J-code J1428 selected
  • Unit calculation verified (total mg ÷ 10 = billing units)
  • Correct NDC for vial strength
  • Diagnosis code G71.01 matches clinical documentation
  • Administration site specified and approved

Administrative Requirements

  • Prescriber is neurologist or neuromuscular specialist
  • Prior authorization form completely filled out
  • Member ID and policy information accurate
  • Submission timeline allows for processing delays
  • All required attachments included

Florida-Specific Considerations

  • Verify plan type (state-regulated vs. self-funded ERISA)
  • Understand appeal rights under Florida law
  • Have contact information for Florida Department of Financial Services
  • Know external review eligibility and timeline

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take in Florida? Standard review takes 15-30 business days. Urgent cases may be expedited to 72 hours. Start the process 60-90 days before current authorization expires to avoid coverage gaps.

What if Exondys 51 is non-formulary on my plan? Exondys 51 requires prior authorization on most UnitedHealthcare plans but is typically covered for medically necessary cases. Non-formulary status doesn't mean automatic denial—it means additional documentation is required.

Can I request an expedited appeal? Yes, if you can demonstrate urgent medical need. Expedited appeals are typically processed within 72 hours and may be appropriate if treatment delays could cause serious harm.

Does step therapy apply to Exondys 51? UnitedHealthcare doesn't require traditional step therapy, but as of 2025, patients who haven't received gene therapy may need to try it first. Exceptions exist for contraindications or failure.

What happens if my appeal is denied? After exhausting internal appeals, you can request external review through Florida's independent review program. This is free and has a 40-60% success rate for specialty drug denials.

Coverage Success Strategies

Getting Exondys 51 approved requires meticulous documentation and proactive communication with your healthcare team. The key is demonstrating clear medical necessity through genetic confirmation, ongoing clinical benefit, and adherence to UnitedHealthcare's specific criteria.

For optimal results:

  • Work closely with your neurologist to ensure all documentation meets current requirements
  • Start renewal processes early to avoid coverage gaps
  • Keep detailed records of all communications and submissions
  • Don't hesitate to appeal denials with comprehensive clinical evidence

Counterforce Health's platform specializes in turning insurance denials into successful appeals by identifying specific denial reasons and crafting evidence-based responses that align with payer policies. For complex cases like Exondys 51, having expert support can make the difference between approval and denial.

From our advocates: We've seen families successfully overturn initial denials by submitting comprehensive genetic documentation alongside detailed neurologist letters that specifically address each denial criterion. The key is patience and persistence—most approvals come after providing additional clinical evidence rather than accepting the first denial.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions are made by individual payers based on specific policy terms and clinical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. Coverage policies may change, so verify current requirements before submitting requests.

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