The Requirements Checklist to Get Fintepla (Fenfluramine) Covered by Humana in New Jersey

Quick Answer: Getting Fintepla Covered by Humana in New Jersey

To get Fintepla (fenfluramine) covered by Humana in New Jersey, you need: (1) Prior authorization with diagnosis documentation for Dravet syndrome or Lennox-Gastaut syndrome, (2) REMS enrollment for both prescriber and patient with baseline echocardiogram, and (3) Step therapy documentation showing failure of at least two preferred anti-seizure medications. Submit through Humana's provider portal or fax to 877-486-2621. If denied, you have 65 days to appeal and can use New Jersey's Independent Health Care Appeals Program (IHCAP) for external review after completing internal appeals.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding Requirements
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission
  9. Common Denial Prevention
  10. Appeals Process in New Jersey
  11. Quick Reference Checklist

Who Should Use This Checklist

This guide is designed for patients with Dravet syndrome or Lennox-Gastaut syndrome who need Fintepla (fenfluramine) covered by their Humana plan in New Jersey. It's also valuable for:

  • Healthcare providers submitting prior authorizations
  • Caregivers navigating the approval process
  • Patients facing initial denials who need to appeal

Expected outcome: With proper documentation and following these steps, most medically appropriate Fintepla requests get approved. Humana has a relatively low denial rate (~3.5% for Medicare Advantage) compared to other major insurers, but thorough preparation is essential.

Member & Plan Basics

Coverage Requirements

  • Active Humana coverage (Medicare Advantage, commercial, or Medicaid)
  • Specialty tier placement (typically Tier 4 with higher copayment)
  • Prior authorization mandatory for all prescriptions and renewals
  • REMS program compliance required by FDA regulation

Plan Type Considerations

Different Humana plans have varying requirements:

  • Medicare Advantage: Follow federal appeal timelines (65 days from denial)
  • Commercial plans: May have different formulary tiers and appeal processes
  • Medicaid: Additional state-specific requirements may apply
Note: Verify your specific plan details by calling the member services number on your insurance card or checking your plan documents.

Clinical Criteria Requirements

FDA-Approved Indications

Fintepla is only covered for:

  • Dravet syndrome in patients ≥2 years old
  • Lennox-Gastaut syndrome in patients ≥2 years old

Step Therapy Requirements

Humana requires documentation of trial and inadequate response or intolerance to at least two preferred anti-seizure medications before approving Fintepla. Common required trials include:

  • Clobazam
  • Cannabidiol (Epidiolex)
  • Valproic acid
  • Levetiracetam
  • Lamotrigine
  • Topiramate
  • Rufinamide

REMS Program Compliance

Both prescriber and patient must be enrolled in the Fintepla REMS program with:

  • Baseline echocardiogram before starting treatment
  • Ongoing echocardiograms every 6 months during treatment
  • Post-treatment echocardiogram 3-6 months after discontinuation

Coding Requirements

ICD-10 Diagnosis Codes

Condition ICD-10 Code Description
Dravet syndrome G40.83 Dravet syndrome
G40.833 Dravet syndrome, intractable, with status epilepticus
G40.834 Dravet syndrome, intractable, without status epilepticus
Lennox-Gastaut syndrome G40.81 Lennox-Gastaut syndrome
G40.814 Lennox-Gastaut syndrome, intractable, without status epilepticus

HCPCS Coding

  • J1417: HCPCS J-code for Fintepla (1 mg fenfluramine) for Medicare Part B billing
  • Use specific NDC numbers for Part D prescription claims

Documentation Packet

Required Clinical Documentation

Medical Necessity Letter must include:

  1. Patient demographics and insurance information
  2. Specific diagnosis with ICD-10 code
  3. Clinical history including seizure frequency and severity
  4. Prior medication trials with dates, doses, duration, and reasons for discontinuation
  5. Current seizure burden and functional impact
  6. Treatment goals and expected outcomes
  7. REMS compliance confirmation

Supporting Documents Checklist

  • REMS enrollment confirmation for prescriber and patient
  • Baseline echocardiogram results (normal findings required)
  • Recent clinic notes documenting diagnosis
  • Seizure logs or EEG results
  • Prior medication history with failure documentation
  • Genetic testing results (if available for Dravet syndrome)
Clinician Corner: Include specific seizure frequency data (seizures per week/month) and functional assessments. Reference FDA labeling and relevant epilepsy guidelines in your medical necessity letter. Cite the American Epilepsy Society's position statements when available.

Submission Process

Humana Prior Authorization Channels

Online Submission:

  • Humana provider portal
  • CoverMyMeds platform

Fax Submission:

  • Fax number: 877-486-2621
  • Include all required documentation in single transmission

Phone Support:

  • Humana Clinical Pharmacy Review: 800-555-CLIN (2546)
  • Hours: Monday–Friday, 8 a.m.–8 p.m. local time

Required Form Fields

Ensure completion of all mandatory fields:

  • Patient demographics and member ID
  • Prescriber NPI and contact information
  • Specific diagnosis with ICD-10 code
  • Requested medication strength and quantity
  • Clinical justification narrative

Specialty Pharmacy Routing

Preferred Network Pharmacy

CenterWell Specialty Pharmacy is Humana's preferred in-network specialty pharmacy for Fintepla:

  • Phone: 1-800-486-2668
  • Hours: Monday to Saturday, Eastern Time
  • Services: Home delivery, clinical support, financial assistance coordination

Prescription Transfer Process

  1. Verify REMS certification of chosen pharmacy
  2. Confirm network status with Humana
  3. Submit prescription with all required documentation
  4. Coordinate shipment to patient's preferred address

After Submission

Timeline Expectations

  • Standard review: Up to 30 days for Medicare Advantage
  • Expedited review: 72 hours when medically urgent
  • Status updates: Available through provider portal or phone

What to Track

  • Confirmation number for submission
  • Date of submission
  • Expected decision date
  • Status check schedule (weekly)
  • Contact information for follow-up

Approval Confirmation

Once approved, verify:

  • Coverage duration and renewal requirements
  • Quantity limits and refill restrictions
  • Ongoing REMS compliance requirements

Common Denial Prevention

Five Common Pitfalls and Solutions

Denial Reason Prevention Strategy
Incomplete REMS documentation Submit REMS enrollment confirmation and current echocardiogram results
Missing step therapy trials Document at least two failed ASM trials with specific reasons for discontinuation
Diagnosis not supported Include genetic testing results for Dravet syndrome when available
Insufficient clinical notes Provide detailed seizure logs and functional impact assessments
Wrong submission channel Use Humana's designated prior authorization portal or fax number

Appeals Process in New Jersey

Internal Appeals with Humana

If your initial request is denied:

Medicare Advantage Members:

  • Timeframe: 65 days from denial notice
  • Standard appeal: 30 days for decision
  • Expedited appeal: 72 hours when urgent

Submission Methods:

  • Online through member portal
  • Mail to address on denial letter
  • Fax to number provided in denial notice

New Jersey External Review (IHCAP)

After completing Humana's internal appeals, New Jersey residents can use the Independent Health Care Appeals Program (IHCAP):

Eligibility:

  • Completed all internal appeals with Humana
  • Coverage denial based on medical necessity
  • New Jersey-regulated insurance plan

Process:

  1. Submit within 180 days of final internal denial
  2. Contact Maximus Federal Services (the state's contracted review organization)
  3. No cost to patient - insurer pays all review fees
  4. Timeline: 5 business days for acceptance, 45 days for decision

Contact Information:

  • IHCAP Hotline: 1-888-393-1062
  • NJ DOBI Consumer Hotline: 1-800-446-7467
Important: Medicare Advantage and self-funded employer plans follow federal appeal rules, not New Jersey's IHCAP process.

From Our Advocates

In our experience helping families navigate specialty medication appeals, the most successful cases include a detailed timeline of seizure frequency before and after each medication trial. One family's appeal was approved after their neurologist included specific data showing a 40% increase in seizure frequency when step therapy medications failed, along with documentation of the child's regression in developmental milestones.

Quick Reference Checklist

Before You Start

  • Confirm active Humana coverage
  • Verify Fintepla is for approved indication (Dravet/LGS)
  • Ensure prescriber is REMS-certified
  • Obtain baseline echocardiogram

Documentation Gathering

  • Medical necessity letter with clinical rationale
  • REMS enrollment confirmations
  • Echocardiogram results (normal findings)
  • Prior medication failure documentation
  • Current seizure logs or EEG results
  • ICD-10 diagnosis codes (G40.83x or G40.81x)

Submission

  • Use correct Humana portal or fax (877-486-2621)
  • Include all required fields and documentation
  • Keep confirmation number and submission date
  • Schedule follow-up for status check

If Denied

  • Review denial reason carefully
  • Gather additional documentation as needed
  • Submit internal appeal within 65 days
  • Consider New Jersey external review if applicable

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Fintepla. Our platform analyzes denial letters and creates targeted, evidence-backed appeals that address specific payer requirements. We help patients, clinicians, and specialty pharmacies navigate prior authorization requirements and appeals processes with higher success rates.

For additional support with your Fintepla appeal or other specialty medication coverage challenges, Counterforce Health provides expert guidance tailored to your specific payer and clinical situation.

Sources & Further Reading


Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance regarding your situation.

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