By Counterforce Health Team in Amondys 45 (casimersen) —

Do You Qualify for Amondys 45 (Casimersen) Coverage by Humana in New Jersey? Complete Decision Tree & Appeals Guide

Answer Box: Quick Qualification Check

Getting Amondys 45 (casimersen) covered by Humana in New Jersey requires three key elements: confirmed DMD with exon 45 mutation (genetic testing), functional walking ability (6-minute walk test ≥300 meters), and specialist neurologist involvement. Humana requires prior authorization for this medication under their 2025 Medicare plans. If denied, you have 65 days to appeal internally, followed by New Jersey's Independent Health Care Appeals Program (IHCAP) through Maximus Federal Services. Start today: Contact your neurologist to order genetic testing and baseline functional assessments, then submit prior authorization through Humana's provider portal.

Table of Contents

  1. How to Use This Decision Tree
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Documentation Checklist
  4. If "Possibly Eligible": Tests to Request
  5. If "Not Yet Eligible": Alternative Options
  6. If Denied: Appeals Path Chooser
  7. New Jersey External Review Process
  8. Common Denial Reasons & Solutions
  9. FAQ: Humana Coverage Questions
  10. Resources & Next Steps

How to Use This Decision Tree

This guide helps you navigate Humana's prior authorization requirements for Amondys 45 (casimersen) in New Jersey. Work through each section in order—the eligibility triage will direct you to the most relevant pathway for your situation.

Note: Amondys 45 requires prior authorization under Humana's 2025 Medicare plans. The medication may be covered under either Part B or Part D depending on administration site and circumstances.

Eligibility Triage: Do You Qualify?

Primary Requirements Checklist

✓ Confirmed DMD Diagnosis

  • Diagnosed by or in consultation with a neurologist specializing in DMD
  • ICD-10 code: G71.01 (Duchenne or Becker muscular dystrophy)

✓ Exon 45 Genetic Mutation

  • Confirmed genetic testing showing dystrophin gene mutation amenable to exon 45 skipping
  • Approximately 9% of DMD patients have mutations treatable with Amondys 45

✓ Functional Walking Ability

  • Six-Minute Walk Test (6MWT) ≥300 meters performed independently, OR
  • North Star Ambulatory Assessment (NSAA) score >17, OR
  • Gower's test (rise time from floor) <7 seconds

✓ Age Requirements

  • Treatment typically initiated before age 14 (verify current Humana criteria)

Coverage Determination: Part B vs Part D

Humana requires information about both the specific use and place of administration to determine whether Amondys 45 falls under Part B or Part D coverage. Contact Humana at the number on your member ID card to clarify coverage pathway for your intended administration site.

If "Likely Eligible": Documentation Checklist

Required Clinical Documentation

Genetic Testing Results

  • Laboratory report confirming exon 45 mutation amenability
  • Include laboratory name, test date, and specific mutation identified

Functional Assessments

  • Recent 6-Minute Walk Test results (within 6 months)
  • Video documentation of independent walking (if available)
  • NSAA or Gower's test results as alternative measures

Specialist Consultation

  • Letter from DMD-specializing neurologist confirming diagnosis
  • Treatment plan including dosing, monitoring schedule, and administration site
  • Documentation of medical necessity addressing Humana's specific criteria

Prior Therapy Documentation

  • Record of current DMD treatments (corticosteroids, other therapies)
  • Documentation that no other exon 45 skipping therapies are available

Submission Process

  1. Gather Documents: Complete checklist above
  2. Submit Prior Authorization: Through Humana provider portal or fax (verify current contact with plan)
  3. Follow Up: Contact Humana within 5-7 business days to confirm receipt
  4. Timeline: Standard determination within 30 days for pre-service requests
Clinician Corner: Medical necessity letters should specifically address Humana's coverage criteria, cite FDA labeling for Amondys 45, and include baseline functional measurements with planned monitoring schedule.

If "Possibly Eligible": Tests to Request

Missing Genetic Testing

  • Request dystrophin gene sequencing and deletion/duplication analysis
  • Ensure testing specifically identifies exon 45 mutation amenability
  • Contact genetic counselor for testing coordination if needed

Missing Functional Assessments

  • Schedule 6-Minute Walk Test with physical therapy or neurology
  • Document current ambulatory status and assistive device use
  • Consider NSAA assessment if 6MWT not feasible

Specialist Consultation Needed

  • Obtain referral to DMD-specializing neurologist
  • Request comprehensive DMD evaluation and treatment planning
  • Ensure specialist is familiar with Amondys 45 coverage requirements

Timeline for Re-Application

  • Allow 2-4 weeks for genetic testing results
  • Schedule functional assessments within 2 weeks of genetic confirmation
  • Submit prior authorization within 30 days of completing documentation

If "Not Yet Eligible": Alternative Options

Current DMD Management

  • Optimize corticosteroid therapy (prednisone, deflazacort)
  • Consider other approved DMD treatments based on mutation type
  • Maintain physical therapy and supportive care

Preparing for Future Eligibility

  • Monitor functional status with regular assessments
  • Track disease progression for potential future qualification
  • Stay current with evolving coverage criteria

Exception Request Pathway

  • Work with neurologist to submit medical necessity exception
  • Document unique clinical circumstances warranting coverage
  • Include literature supporting off-label use if applicable

If Denied: Appeals Path Chooser

Humana Internal Appeals Process

Timeline: You have 65 days from denial to file internal appeal

Standard Appeal

  • Written decision within 30 days (pre-service) or 60 days (post-service)
  • Submit via Humana member portal or mail to Grievance and Appeal Department
  • Include denial letter, additional clinical documentation, and physician letter

Expedited Appeal

  • Request expedited review by calling Humana Enrollee Services at 800-444-9137
  • Required when delay would seriously jeopardize health
  • Faster timeline for specialty drugs when medically urgent

Peer-to-Peer Review

  • Request physician-to-physician discussion during appeal process
  • Allows your neurologist to directly discuss case with Humana medical director
  • Often effective for complex specialty drug cases

Contact Information for Appeals

  • Phone: 800-444-9137 (TTY: 711), Monday–Friday, 7 a.m.–7 p.m. ET
  • Written Confirmation: Received within 5 business days of filing

New Jersey External Review Process

Independent Health Care Appeals Program (IHCAP)

After completing Humana's internal appeals, New Jersey offers external review through the Independent Health Care Appeals Program.

Eligibility Requirements

  • Completed all internal appeal levels with your plan
  • Denial based on medical necessity or similar coverage determination
  • Submit within 4 months (180 days) of final internal denial

Process Overview

  • Submit directly to Maximus Federal Services (contracted review organization)
  • Preliminary review within 5 business days
  • Full physician panel review completed within 45 days
  • No cost to you - insurer pays all review fees

Expedited External Review

  • Available when delay would cause serious harm
  • Much faster timeline (often 1-2 weeks)
  • Request expedited processing when submitting

Binding Decision

  • External review decision is legally binding on insurer
  • If overturned, Humana must provide coverage as determined by review panel

How to File External Review

  1. Contact IHCAP: Call 1-888-393-1062 for forms and guidance
  2. Submit Documentation: Include all denial letters, medical records, and physician statements
  3. Provider Assistance: Your neurologist can file on your behalf with your consent
From our advocates: We've seen external reviews particularly effective for specialty drugs like Amondys 45 when the denial hinges on narrow interpretation of medical necessity. Having your specialist provide detailed literature review alongside functional assessments strengthens the case significantly.

Common Denial Reasons & Solutions

Denial Reason Solution Documentation Needed
Missing genetic testing Submit dystrophin gene analysis Laboratory report confirming exon 45 mutation
Insufficient functional status Provide current assessments 6MWT ≥300m or NSAA >17 or Gower's <7 sec
Non-specialist prescriber Transfer care or consultation Letter from DMD neurologist specialist
Missing prior therapy documentation Document current treatments Complete medication history and responses
Site of care not specified Clarify administration plan Infusion center details and administration schedule
Age restrictions Request exception or appeal Medical necessity for continued treatment

FAQ: Humana Coverage Questions

Q: How long does Humana prior authorization take for Amondys 45? A: Standard pre-service determinations take up to 30 days. Expedited requests are processed faster when medically urgent.

Q: What if Amondys 45 is not on Humana's formulary? A: Request formulary exception with medical necessity documentation. Coverage may still be possible under Part B depending on administration circumstances.

Q: Can I request peer-to-peer review before denial? A: Contact Humana to request physician discussion during initial prior authorization review. This can prevent denials when clinical complexity requires specialist input.

Q: Does step therapy apply to Amondys 45? A: Verify current step therapy requirements with your specific Humana plan. DMD treatments often have unique pathways due to mutation-specific targeting.

Q: What happens if I move from New Jersey during appeals? A: External review rights follow your plan type, not residence. Complete any ongoing New Jersey IHCAP process before plan changes.

Q: Are there copay assistance programs for Amondys 45? A: Contact Sarepta Therapeutics for manufacturer support programs and foundation grant information.

Resources & Next Steps

Essential Contacts

  • Humana Member Services: Number on your member ID card
  • NJ IHCAP Hotline: 1-888-393-1062
  • NJ Department of Banking and Insurance: 1-800-446-7467
  • Sarepta Patient Access: Available through Amondys45.com

Key Documents to Request

  • Current Humana formulary and prior authorization list
  • Your plan's Evidence of Coverage document
  • Humana's specific coverage policy for Amondys 45 (if available)

Professional Support

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with each payer's specific requirements. For complex cases like Amondys 45, where genetic testing, functional assessments, and specialist documentation must align perfectly with coverage criteria, professional appeal assistance can significantly improve approval odds.

The platform pulls appropriate citations from FDA labeling, peer-reviewed studies, and specialty guidelines, weaving them into appeals with required clinical facts and operational details that payers expect for buy-and-bill therapies.

State Resources

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical advice. Coverage criteria and appeal procedures may change. Always verify current requirements directly with Humana and consult with your healthcare provider for medical decisions. For assistance with New Jersey insurance regulations, contact the Department of Banking and Insurance at 1-800-446-7467.

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