By Counterforce Health Team in Exondys 51 (eteplirsen) —

How to Get Exondys 51 (Eteplirsen) Covered by Humana in New York: Complete Guide to Prior Authorization, Appeals & Forms

Quick Answer: Getting Exondys 51 Covered by Humana in New York

Eligibility: Patients with Duchenne muscular dystrophy (DMD) and confirmed genetic mutation amenable to exon 51 skipping can get Exondys 51 covered through Humana Medicare Advantage or commercial plans in New York.

Fastest path: Submit prior authorization with complete genetic testing report, baseline cardiac/pulmonary function tests, and specialist prescriber documentation. Use HCPCS code J1428 for billing.

Start today: Contact your neurologist to order genetic testing if not already done, and request they submit PA documentation to Humana's Medication Intake Team at 1-888-447-3430.

If denied, New York residents have strong appeal rights through the state's external review system, with decisions binding on insurers.

Table of Contents

  1. Start Here: Verify Your Plan and Find Forms
  2. Required Forms and Documentation
  3. Submission Portals and Methods
  4. Genetic Testing Requirements
  5. Step-by-Step: Fastest Path to Approval
  6. Common Denial Reasons and Solutions
  7. Appeals Process in New York
  8. Specialty Pharmacy Coordination
  9. Support Contacts and Resources
  10. FAQ: Most Common Questions

Start Here: Verify Your Plan and Find Forms

Before submitting any paperwork, confirm your exact Humana plan type. Exondys 51 coverage varies significantly between Medicare Advantage, commercial, and Medicaid plans.

Plan Verification Steps:

  1. Call the member services number on your Humana ID card
  2. Ask specifically about "prior authorization requirements for HCPCS code J1428 (eteplirsen)"
  3. Request the current prior authorization form for professionally administered drugs
  4. Confirm whether your plan covers Exondys 51 as a medical benefit (Part B) or pharmacy benefit
Note: Exondys 51 is typically covered under medical benefits, not pharmacy benefits, because it's administered by IV infusion in clinical settings.

Coverage at a Glance

Requirement Details Where to Find It
Prior Authorization Required for all Humana plans Humana PA Portal
Genetic Testing DMD mutation amenable to exon 51 skipping CLIA-certified lab report
Prescriber Specialty Neurologist or neuromuscular specialist preferred Provider credentials
Baseline Testing Cardiac/pulmonary function, 6MWT Clinical documentation
Billing Code HCPCS J1428 (eteplirsen, 10mg) Medicare fee schedule
Appeal Deadline 65 days from denial notice Humana appeals page

Required Forms and Documentation

Primary Forms Needed:

  • Humana Prior Authorization Form for professionally administered drugs (verify current version with Humana)
  • Genetic testing report from CLIA-certified laboratory
  • Medical necessity letter from prescribing neurologist
  • Baseline function assessments (cardiac echo, pulmonary function tests, 6-minute walk test)

Essential Documentation Checklist:

  • Complete genetic analysis showing exon 51-amenable DMD mutation
  • ICD-10 diagnosis code G71.01 (Duchenne muscular dystrophy)
  • Prior treatment history with corticosteroids
  • Current ambulatory status documentation
  • Prescriber NPI and specialty credentials
  • Patient weight and dosing calculations (30 mg/kg weekly)
  • Site of care information and administration plan
Tip: Incomplete genetic reports are the #1 cause of initial denials. Ensure your lab report specifically states the mutation is "amenable to exon 51 skipping," not just that DMD is present.

Submission Portals and Methods

Online Submission:

  • Humana Availity Portal: Primary method for providers
  • Member Portal: Limited functionality for members to check status

Fax Submission:

  • Medication Intake Team: 1-888-447-3430
  • General Prior Authorization: 1-877-486-2621
  • Always include a cover sheet with member ID, prescriber NPI, and "URGENT: Exondys 51 PA Request"

Phone Support:

  • Provider Line: 1-800-555-2546
  • Member Services: Number on back of ID card

Required Upload Documents:

  • Complete PA form (PDF)
  • Genetic testing report (PDF)
  • Medical necessity letter (PDF)
  • Baseline function tests (PDF)
  • Treatment history notes (PDF)

Genetic Testing Requirements

Genetic confirmation is absolutely critical for Exondys 51 approval. Approximately 13% of DMD patients have mutations amenable to exon 51 skipping.

What the Lab Report Must Include:

  • Patient identifying information
  • Specific DMD gene deletion or mutation
  • Explicit statement: "This mutation is amenable to exon 51 skipping"
  • Laboratory CLIA certification number
  • Date of testing and reporting physician signature

Acceptable Testing Methods:

  • Multiplex ligation-dependent probe amplification (MLPA)
  • Array comparative genomic hybridization (aCGH)
  • Next-generation sequencing panels

Common Genetic Testing Issues:

  • Reports that only confirm "DMD mutation present" without exon specificity
  • Outdated reports (>2 years old may require confirmation)
  • Non-CLIA certified laboratory results
From our advocates: "We've seen cases where families had genetic testing done years ago, but the report didn't specifically mention exon 51 amenability. Getting a supplemental interpretation from the original lab or a genetics counselor can often resolve this without repeating the entire test."

Step-by-Step: Fastest Path to Approval

1. Genetic Testing Confirmation (Patient/Family)

  • Obtain complete genetic report or request supplemental interpretation
  • Timeline: 1-2 weeks if already tested, 4-6 weeks for new testing

2. Specialist Consultation (Patient)

  • Schedule appointment with neurologist or neuromuscular specialist
  • Bring all previous DMD treatment records
  • Timeline: 2-4 weeks for appointment

3. Baseline Testing (Clinic)

  • Order cardiac echo, pulmonary function tests, 6-minute walk test
  • Document current functional status
  • Timeline: 1-2 weeks

4. Prior Authorization Submission (Prescriber)

  • Complete Humana PA form with all required documentation
  • Submit via Availity portal or fax to 1-888-447-3430
  • Timeline: Same day submission possible

5. PA Review (Humana)

  • Standard review: 30 days maximum
  • Expedited review: 72 hours if urgent medical need documented
  • Timeline: Variable based on submission completeness

6. Approval and Coordination (All parties)

  • Coordinate with CenterWell Specialty Pharmacy for medication delivery
  • Schedule infusion appointments
  • Timeline: 1-2 weeks after approval

7. Treatment Initiation (Clinical team)

  • Begin weekly IV infusions at approved facility
  • Monitor for adverse effects and treatment response
  • Timeline: Ongoing weekly schedule

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Insufficient genetic evidence Submit complete lab report with exon 51 amenability statement Full genetic analysis from CLIA lab
Non-specialist prescriber Transfer care to neurologist or obtain specialist consultation Neurology consultation note
Missing baseline assessments Complete cardiac, pulmonary, and functional testing Echo, PFTs, 6MWT results
Inadequate prior therapy documentation Provide complete treatment history Corticosteroid trial records
Incorrect billing codes Use HCPCS J1428 with proper dosing units Updated PA form with correct coding
Site of care issues Confirm approved infusion facility Facility credentialing documentation

Medical Necessity Letter Essentials:

  • Clear DMD diagnosis with ICD-10 G71.01
  • Genetic confirmation of exon 51-amenable mutation
  • Prior corticosteroid use or documented contraindication
  • Current ambulatory status and functional capacity
  • Treatment goals and monitoring plan
  • Citations to FDA labeling and clinical guidelines

Appeals Process in New York

New York residents have particularly strong appeal rights through the state's external review system.

Internal Appeal with Humana:

  • Deadline: 65 days from denial notice
  • Timeline: 7 days for standard Part D appeals, 30 days for medical benefit appeals
  • Expedited: 72 hours if urgent medical need
  • Forms: Humana Redetermination Form

New York External Appeal:

  • Deadline: 4 months after final internal denial
  • Timeline: 30 days standard, 72 hours expedited (24 hours for urgent drug appeals)
  • Cost: $25 maximum (waived for financial hardship)
  • Contact: New York Department of Financial Services

External Appeal Requirements:

  • Complete NY External Appeal Application
  • Copy of Humana's final denial letter
  • Physician attestation form (if applicable)
  • All supporting medical documentation
Note: New York's external review decisions are binding on insurers. If you win your appeal, Humana must cover the treatment and may refund your appeal filing fee.

Specialty Pharmacy Coordination

Humana partners with CenterWell Specialty Pharmacy for Exondys 51 distribution and support.

Enrollment Process:

  1. Insurance Verification: CenterWell confirms Humana coverage and PA approval
  2. Clinical Assessment: Pharmacist reviews dosing and administration plan
  3. Financial Counseling: Discussion of copays and assistance programs
  4. Delivery Coordination: Medication shipped to infusion facility
  5. Ongoing Support: Clinical monitoring and refill coordination

Provider Coordination:

  • Fax medication orders to CenterWell at 1-877-405-7940
  • Include complete dosing instructions and administration schedule
  • Coordinate delivery timing with infusion appointments

Patient Support Services:

  • SareptAssist case management program
  • Copay assistance enrollment (if eligible)
  • Clinical support and adherence monitoring
  • Insurance navigation assistance

Counterforce Health specializes in helping patients navigate complex prior authorization and appeals processes for specialty medications like Exondys 51. Their platform can help identify specific denial reasons and draft targeted appeals that address Humana's exact coverage criteria.

Support Contacts and Resources

Humana Contacts:

  • Member Services: Number on back of ID card
  • Provider Services: 1-800-555-2546
  • Prior Authorization Support: 1-888-447-3430
  • CenterWell Specialty Pharmacy: 1-877-405-7940

New York State Resources:

  • Department of Financial Services: (800) 400-8882
  • Community Health Advocates: (888) 614-5400 (free insurance counseling)
  • New York State Department of Health: (866) 881-2809

Manufacturer Support:

  • SareptAssist: (888) 737-3782
  • Sarepta Medical Information: (888) 737-3782
  • Patient Assistance Program: Available through SareptAssist

What to Ask When Calling:

  • "What is the current status of my Exondys 51 prior authorization?"
  • "What specific documentation is missing or insufficient?"
  • "Can you provide the medical director's fax for a peer-to-peer review?"
  • "What is the exact coverage determination timeline?"

FAQ: Most Common Questions

How long does Humana prior authorization take for Exondys 51 in New York? Standard review is 30 days maximum for medical benefits, 7 days for Part D. Expedited review (72 hours) is available if urgent medical need is documented by your physician.

What if Exondys 51 is not on Humana's formulary? You can request a formulary exception with medical necessity documentation. This is separate from prior authorization and may require additional appeals steps.

Can I request an expedited appeal in New York? Yes, both Humana internal appeals and New York external appeals offer expedited review if waiting could seriously harm your health. Your physician must complete attestation forms.

Does step therapy apply to Exondys 51? Typically yes - most plans require trial of corticosteroids first. However, documented contraindications or intolerance can override step therapy requirements.

What happens if I lose ambulation during treatment? Humana's policy requires patients to remain ambulatory for coverage continuation. Loss of ambulation may result in treatment discontinuation, though appeals are possible.

How much will Exondys 51 cost with Humana coverage? Costs vary by plan type and coverage tier. Medicare Advantage plans typically have copays of $47-$150 per infusion. Manufacturer copay assistance may be available.

Can I transfer from another insurer's approval? Each insurer requires separate prior authorization. Previous approvals can support your case but don't guarantee automatic approval with Humana.

What if my neurologist won't prescribe Exondys 51? You can seek a second opinion from another neuromuscular specialist. Some physicians are more conservative about prescribing due to limited efficacy data.

For complex cases or repeated denials, Counterforce Health offers specialized support in turning insurance denials into successful appeals by identifying specific policy gaps and crafting evidence-based responses tailored to each payer's requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies change frequently - always verify current requirements with Humana and consult your healthcare team for medical decisions. For personalized assistance with insurance appeals and coverage issues, consider consulting with qualified patient advocates or healthcare attorneys.

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