By Counterforce Health Team in Exondys 51 (eteplirsen) —

How to Get Exondys 51 (Eteplirsen) Covered by Humana in Georgia: Prior Authorization, Appeals, and Billing Guide

Answer Box: Getting Exondys 51 Covered by Humana in Georgia

Exondys 51 (eteplirsen) requires prior authorization from Humana Medicare Advantage plans in Georgia. The fastest path to approval: 1) Have your neurologist submit genetic testing confirming a DMD mutation amenable to exon 51 skipping, 2) Include baseline cardiac/pulmonary function tests and prior corticosteroid trials, 3) Use HCPCS code J1428 and ICD-10 G71.01. If denied, you have 60 days to appeal internally with Humana, then 60 days for Georgia external review through the state Department of Insurance. Start by gathering your genetic test results and contacting your prescriber today.

Table of Contents

Coverage Requirements Overview

Exondys 51 (eteplirsen) is covered as a Medicare Part B benefit under Humana Medicare Advantage plans, not as a Part D pharmacy benefit. This means it's billed as a provider-administered injection using HCPCS code J1428, typically given weekly via IV infusion in a physician's office or hospital outpatient setting.

Coverage at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all Humana MA plans Complete PA form with clinical records Humana PA List 2024
Genetic Testing DMD mutation amenable to exon 51 skipping Laboratory report with specific mutation Humana Policy Search
Specialist Prescriber Neurologist or neuromuscular specialist Provider credentials and NPI Verify with Humana
Diagnosis Code ICD-10 G71.01 (Duchenne muscular dystrophy) Clinical notes confirming diagnosis ICD-10 Code G71.01
Baseline Testing Cardiac and pulmonary function Echocardiogram, pulmonary function tests Check Humana policy

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Gather Required Documents (Patient/Family)
    • Insurance card and member ID
    • Genetic testing report showing exon 51-amenable mutation
    • Previous treatment records (corticosteroids, physical therapy)
    • Baseline cardiac and pulmonary function tests
  2. Submit Prior Authorization (Prescriber)
    • Use Humana Availity portal or call 800-523-0023
    • Include provider NPI, facility information, and all clinical records
    • Timeline: Submit complete request to avoid delays
  3. Await Decision (7-30 days)
    • Standard review: up to 30 days
    • Expedited review: 72 hours if urgent medical need
    • Humana will contact prescriber if additional information needed

Clinician Corner: Medical Necessity Letter Checklist

Your neurologist's supporting letter should include:

  • Diagnosis confirmation: "Patient has genetically confirmed Duchenne muscular dystrophy (ICD-10 G71.01) with a mutation amenable to exon 51 skipping as documented by [lab name] genetic testing report dated [date]."
  • Prior treatments: Document corticosteroid use, response, and any side effects or contraindications
  • Functional status: Include 6-minute walk test results, timed function tests, or other objective measures
  • Treatment rationale: "Exondys 51 is medically necessary as the only FDA-approved therapy for this patient's specific genetic mutation. No alternative treatments target the underlying genetic defect."
  • Monitoring plan: Outline cardiac, pulmonary, and renal monitoring schedule

Billing and Coding Essentials

Medical vs. Pharmacy Benefit Path

Exondys 51 follows the medical benefit pathway because it requires IV administration by healthcare professionals. This is crucial for billing and coverage:

  • Covered under: Medicare Part B (medical)
  • Not covered under: Medicare Part D (pharmacy)
  • Billing method: Provider buy-and-bill process

Product Coding Breakdown

Code Type Code Description Units
HCPCS J1428 Injection, eteplirsen, 10 mg 1 unit = 10 mg
ICD-10 G71.01 Duchenne muscular dystrophy Primary diagnosis
NDC 100 mg/2 mL or 500 mg/10 mL Single-dose vials Include on claims

Clean Request Anatomy

Example claim line with proper coding:

  • Patient: 15-year-old male, ambulatory DMD
  • Diagnosis: G71.01 (Duchenne muscular dystrophy)
  • Procedure: J1428 x 30 units (300 mg dose based on 30 kg weight)
  • NDC: 500 mg/10 mL vial
  • Place of service: 11 (physician office) or 22 (hospital outpatient)
  • Supporting documentation: Genetic test confirming exon 51 mutation, weight-based dosing calculation

Frequent Pitfalls to Avoid

  • Unit conversion errors: Remember J1428 = 10 mg, not 1 mg
  • Wrong benefit category: Don't submit under Part D pharmacy
  • Missing genetic documentation: Always include lab report, not just summary
  • Incorrect diagnosis code: Use G71.01, not generic muscular dystrophy codes
  • Site of service mismatch: Ensure place of service matches where infusion occurs

Appeals Process in Georgia

If Humana denies your Exondys 51 prior authorization, Georgia residents have specific appeal rights with strict deadlines.

Internal Appeal (First Level)

  • Deadline: 60 days from denial notice
  • Decision timeline: 7 days for Part D drugs, 30 days for medical services
  • How to file: Use Humana member portal or mail/fax per denial letter
  • Required documents: Original denial letter, updated medical records, prescriber statement

Georgia External Review (Second Level)

If the internal appeal fails, Georgia law provides external review through independent medical experts.

  • Deadline: 60 days from final internal denial
  • Cost: Free to consumers
  • Decision timeline: 30 business days (72 hours if expedited)
  • How to file: Contact Georgia Department of Insurance at 1-800-656-2298
  • Binding decision: Humana must comply with external reviewer's decision
From our advocates: We've seen cases where the initial PA denial was overturned after the family provided a more detailed genetic report that clearly specified the exon 51 mutation. The key was working with the neurologist to submit the actual lab results, not just a summary letter. While outcomes vary, thorough documentation often makes the difference.

Common Denial Reasons and Solutions

Denial Reason How to Fix Required Documentation
"Genetic testing insufficient" Submit complete lab report Full genetic analysis showing specific mutation
"Non-specialist prescriber" Transfer care or get consultation Neurologist or neuromuscular specialist referral
"Lack of prior therapies" Document corticosteroid history Treatment records showing steroid use/response
"Age/ambulatory status" Provide current functional assessment Recent 6-minute walk test, timed function tests
"Site of care not covered" Verify approved infusion locations Confirm with Humana which facilities are covered

Cost Support Options

Even with insurance coverage, out-of-pocket costs can be significant. Consider these support programs:

  • Sarepta Therapeutics Patient Services: Manufacturer copay assistance and free drug programs
  • Muscular Dystrophy Association: Financial assistance for treatment-related expenses
  • National Organization for Rare Disorders (NORD): Patient assistance programs for rare disease medications
  • Georgia Medicaid: May provide secondary coverage for eligible patients

Counterforce Health helps patients navigate insurance denials by turning rejection letters into targeted, evidence-backed appeals. Their platform analyzes denial reasons and drafts point-by-point rebuttals using payer-specific policies and clinical evidence.

When to Escalate

Contact these Georgia resources if you need additional help:

  • Georgia Department of Insurance Consumer Services: 1-800-656-2298 for external review requests
  • Georgians for a Healthy Future: Consumer assistance with insurance appeals
  • Georgia Legal Services Program: Legal aid for complex insurance disputes
  • CMS Medicare Ombudsman: For Medicare Advantage plan issues

FAQ

How long does Humana prior authorization take for Exondys 51 in Georgia? Standard review takes up to 30 days, but expedited review is available within 72 hours if there's urgent medical need. Submit complete documentation upfront to avoid delays.

What if Exondys 51 is not on Humana's formulary? You can request a formulary exception with prescriber support showing medical necessity. The process follows the same 60-day appeal timeline if initially denied.

Can I get expedited appeal review in Georgia? Yes, both Humana and Georgia external review offer expedited timelines (72 hours) if delay would jeopardize your health or maximum function.

Does step therapy apply to Exondys 51? Humana may require documentation of corticosteroid use first, as these are standard DMD treatment. Your neurologist should document any prior steroid therapy and response.

What happens if I miss the 60-day appeal deadline? Georgia law is strict about the 60-day deadline for external review. Contact the Georgia Department of Insurance immediately if you're close to the deadline—they may have limited options for late filings.

How much does Exondys 51 cost without insurance? The typical U.S. cash price is approximately $7,822 for a 10 mL vial, but actual costs vary. With proper insurance coverage and manufacturer support, out-of-pocket costs are usually much lower.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations may change. Always verify current requirements with your insurance plan and consult healthcare providers for medical decisions.

Sources & Further Reading

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