How to Get Fintepla (Fenfluramine) Approved by Humana in Texas: Complete Prior Authorization Guide with Forms and Appeals
Answer Box: Getting Fintepla Covered by Humana in Texas
Fintepla (fenfluramine) requires prior authorization from Humana for Dravet syndrome or Lennox-Gastaut syndrome. The fastest path: (1) Enroll in the FDA REMS program at FinteplaREMS.com, (2) Complete baseline echocardiogram, (3) Submit PA via Humana's provider portal with diagnosis documentation and prior antiseizure medication failures. Standard review takes 7 days; expedited review 72 hours if medically urgent. If denied, you have 65 days to file an internal appeal, followed by Texas external review options.
Table of Contents
- Before You Start: Verify Your Coverage
- What You Need to Gather
- Step-by-Step: Fastest Path to Approval
- Common Denial Reasons & How to Fix Them
- Appeals Process for Humana in Texas
- Costs and Financial Assistance
- Clinician Corner: Medical Necessity Documentation
- FAQ: Common Questions
- When to Escalate in Texas
Before You Start: Verify Your Coverage
First, confirm your Humana plan type and Fintepla's coverage status:
Coverage at a Glance
| Requirement | Details | Where to Find It |
|---|---|---|
| Formulary Status | Tier 4-5, requires PA | Humana Drug List |
| Age Requirement | 2+ years old | FDA labeling |
| Diagnosis Codes | G40.A1 (Dravet), G40.81 (LGS) | ICD-10 documentation |
| REMS Enrollment | Mandatory for all parties | FinteplaREMS.com |
| Step Therapy | ≥2 prior antiseizure medications | Humana PA policy |
| Cardiac Monitoring | Baseline + q6 month echos | FDA REMS requirements |
Note: Humana Medicare Advantage and commercial plans both require PA for Fintepla. Medicaid managed care plans may have separate criteria.
What You Need to Gather
Essential Documentation Checklist:
Medical Records:
- Confirmed diagnosis of Dravet syndrome or Lennox-Gastaut syndrome
- ICD-10 codes: G40.A1 (Dravet) or G40.81 (LGS)
- Neurologist consultation notes
- Current seizure frequency and types
- Patient weight for dosing calculations
Prior Treatment History:
- At least 2 failed antiseizure medications with:
- Medication names and doses
- Duration of trials
- Reasons for discontinuation (ineffective, intolerance, contraindications)
- Documentation of seizure response
REMS Requirements:
- Prescriber REMS certification completion
- Patient enrollment in REMS registry
- Baseline echocardiogram results showing:
- No moderate or greater valve regurgitation
- Pulmonary artery systolic pressure ≤35 mm Hg
Insurance Information:
- Current Humana member ID
- Plan type (Medicare Advantage, commercial, Medicaid)
- Pharmacy benefit details
Step-by-Step: Fastest Path to Approval
1. Complete REMS Enrollment (3-5 days)
- Prescriber: Complete training and knowledge assessment at FinteplaREMS.com
- Patient: Review patient guide and complete enrollment form
- Pharmacy: Verify network specialty pharmacy REMS certification
2. Obtain Baseline Echocardiogram
- Schedule echo before PA submission
- Ensure results document absence of contraindicated cardiac conditions
- Include echo report in PA submission
3. Submit Prior Authorization
- Online: Humana provider portal (fastest)
- Fax: 877-486-2621 (verify current number)
- Phone: 800-555-CLIN (2546), Mon-Fri 8am-8pm local time
4. Include Complete Documentation
- Medical necessity letter from neurologist
- REMS enrollment confirmations
- Echocardiogram results
- Prior medication trial documentation
- Current seizure log or frequency data
5. Request Expedited Review (if applicable)
- Document urgent medical need
- Include prescriber statement about health risks of delay
- Reduces timeline from 7 days to 72 hours
6. Track Your Request
- Save PA reference number
- Monitor via Humana member portal
- Follow up if no response within expected timeframe
7. Coordinate Specialty Pharmacy
- Use Humana-preferred specialty pharmacy (often CenterWell)
- Ensure pharmacy has REMS certification
- Confirm delivery logistics for temperature-sensitive medication
Common Denial Reasons & How to Fix Them
| Denial Reason | Solution | Required Documentation |
|---|---|---|
| Incomplete REMS enrollment | Submit proof of all party enrollment | REMS certificates from FinteplaREMS.com |
| Missing cardiac clearance | Provide baseline echo results | Echocardiogram report with specific measurements |
| Insufficient prior therapy | Document ≥2 failed ASMs with details | Trial dates, doses, outcomes, discontinuation reasons |
| Non-formulary status | Request formulary exception | Medical necessity letter explaining why alternatives inadequate |
| Diagnosis not supported | Provide specialist confirmation | Neurologist notes with ICD-10 codes, EEG results if available |
| Drug-drug interactions | Address safety concerns | Medication reconciliation, monitoring plan |
From Our Advocates: We've seen PA approvals accelerate when families proactively address the most common denial reasons upfront. Including a seizure diary showing current frequency alongside documentation of failed treatments often strengthens the initial submission and reduces back-and-forth requests for additional information.
Appeals Process for Humana in Texas
Level 1: Internal Appeal (Redetermination)
- Deadline: 65 days from denial notice (updated from 60 days effective 1/1/2025)
- Timeline: 7 days standard, 72 hours expedited
- Submit via: Humana member portal or mail/fax using redetermination form
Level 2: Independent Review Entity (IRE)
- Deadline: 60 days from Level 1 denial
- Timeline: 7 days for coverage decisions, 72 hours expedited
- Process: Automatic forwarding by Humana to CMS-contracted reviewer
Texas External Review (for non-Medicare plans)
- Deadline: 4 months from final internal denial
- Timeline: 20 days standard, 5 days urgent
- Process: File with Texas Department of Insurance
- Cost: Paid by insurer if overturned
Appeals Assistance in Texas:
- Texas Department of Insurance: 1-800-252-3439
- Office of Public Insurance Counsel: 1-877-611-6742
- Disability Rights Texas: For specialized advocacy support
Costs and Financial Assistance
Typical Costs:
- Cash price: ~$1,595 per 30mL bottle (varies by dose)
- Humana copay: Depends on tier (4-5) and plan design
- Specialty tier coinsurance: Often 25-40%
Financial Assistance Options:
- UCB Patient Assistance: Contact manufacturer for copay support programs
- Foundation Support: Organizations like Patient Access Network Foundation
- State Programs: Texas may have rare disease assistance (verify current availability)
Tip: Apply for patient assistance programs before filling the prescription. Some programs require prior authorization approval first.
Clinician Corner: Medical Necessity Documentation
Essential Elements for Strong PA Letters:
Clinical Presentation:
- Specific seizure types and frequency
- Functional impact on daily activities
- Developmental considerations
- Quality of life measures
Treatment History:
- Chronological list of prior ASMs
- Specific doses and durations
- Response rates and side effects
- Reasons for discontinuation
Evidence-Based Rationale:
- Reference to FDA labeling for Dravet/LGS
- Clinical trial data supporting efficacy
- Guidelines from epilepsy specialty societies
- Explanation of mechanism of action relevance
Safety Monitoring Plan:
- REMS compliance commitment
- Cardiac monitoring schedule
- Drug interaction screening
- Dosing calculations based on current weight
FAQ: Common Questions
How long does Humana PA take in Texas? Standard review: 7 days. Expedited: 72 hours if medical urgency documented. Timeline starts when complete documentation received.
What if Fintepla is non-formulary on my plan? Request formulary exception with medical necessity documentation. Include prescriber letter explaining why formulary alternatives are inadequate.
Can I request expedited appeal in Texas? Yes, for both internal appeals (72 hours) and Texas external review (5 days for urgent cases). Requires prescriber attestation of health risk.
Does step therapy apply if I failed medications outside Texas? Yes, prior treatment history from any location counts toward step therapy requirements. Ensure documentation includes all relevant details.
What happens if my appeal is denied? Medicare plans: Proceed to Level 2 (IRE) automatically. Commercial plans: Request Texas external review through TDI within 4 months.
How often do I need to renew PA? Typically annually. Include updated seizure logs, continued medical necessity, and ongoing REMS compliance documentation.
When to Escalate in Texas
Contact Texas Department of Insurance if:
- Humana fails to meet appeal deadlines
- External review process is delayed
- You suspect improper denial practices
- Need help understanding your rights
TDI Consumer Help Line: 1-800-252-3439
Online Complaint: TDI Consumer Complaint Portal
Required Information:
- Policy number and member ID
- Timeline of denials and appeals
- All correspondence with Humana
- Medical documentation supporting necessity
At Counterforce Health, we help patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, plan policies, and clinical notes to identify specific denial reasons and draft point-by-point rebuttals aligned with each payer's requirements. For medications like Fintepla, we pull the right evidence—FDA labeling, peer-reviewed studies, and specialty guidelines—while ensuring all procedural requirements are met for both initial submissions and appeals.
Sources & Further Reading
- Humana Prior Authorization Information
- Fintepla REMS Program
- FDA Fintepla Prescribing Information
- Texas Department of Insurance Appeals Guide
- CMS Medicare Part D Appeals Process
- Humana Provider Portal
Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on individual plan terms and medical circumstances. Always consult your healthcare provider about treatment options and work with your insurance plan directly for coverage determinations. Information current as of publication date; verify current requirements with your insurer and state regulators.
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