By Counterforce Health Team in Fintepla (fenfluramine) —

Denied for Fintepla (Fenfluramine) by UnitedHealthcare in Virginia? Complete Appeal Guide with Forms & Timelines

Answer Box: Getting Fintepla Covered by UnitedHealthcare in Virginia

Fintepla (fenfluramine) requires prior authorization from UnitedHealthcare and typically must be filled through OptumRx specialty pharmacy. If denied, you have 180 days to appeal internally, then 120 days for Virginia's external review. First step today: Call the number on your denial letter to request a peer-to-peer review (usually 7-14 days from denial). Document failed trials of at least two antiseizure medications and confirm REMS enrollment with baseline echocardiogram. Virginia's Bureau of Insurance provides free external review using Form 216-A if internal appeals fail.

Table of Contents

  1. Understanding Your Denial
  2. Prior Authorization Requirements
  3. Step-by-Step Appeal Process
  4. Peer-to-Peer Review Strategy
  5. Virginia External Review Process
  6. Medical Necessity Documentation
  7. Appeal Letter Templates
  8. Cost-Saving Options
  9. When to Escalate
  10. Frequently Asked Questions

Understanding Your Denial

UnitedHealthcare denies Fintepla coverage for several common reasons. Your denial letter will specify which applies to your case:

Denial Reason What It Means How to Fix
Missing REMS documentation No proof of echocardiogram monitoring enrollment Submit baseline echo results and REMS enrollment confirmation
Step therapy not met Haven't tried required first-line medications Document trials/failures of at least 2 antiseizure medications
Diagnosis not supported No clear Dravet syndrome or LGS documentation Provide genetic testing (SCN1A) and detailed seizure history
Non-formulary Fintepla not covered on your specific plan Request formulary exception with medical necessity letter
Tip: UnitedHealthcare's denial rate for prior authorizations runs about 9% for Medicare Advantage plans, higher than peer averages. However, well-documented appeals with strong clinical evidence often succeed.

Prior Authorization Requirements

UnitedHealthcare requires prior authorization for Fintepla through their Clinical Pharmacy program, administered via OptumRx. Here's what you need:

Coverage Requirements at a Glance

Requirement Details Documentation Needed
Diagnosis Dravet syndrome or Lennox-Gastaut syndrome ICD-10 codes G40.834/G40.89 (Dravet) or G40.813/G40.814 (LGS)
Prescriber Neurologist or epileptologist (preferred) Provider NPI and specialty designation
Step Therapy Trial/failure of ≥2 antiseizure medications Medication history with dates, doses, outcomes
REMS Enrollment FDA Risk Evaluation and Mitigation Strategy Baseline echocardiogram, ongoing monitoring plan
Pharmacy OptumRx specialty pharmacy (required) Transfer prescription to OptumRx network

Diagnostic Documentation for Dravet Syndrome

For Dravet syndrome approval, your medical records must clearly document:

  • Early seizure onset (2-15 months of age) with prolonged febrile/afebrile seizures
  • Normal early development with later developmental delays
  • SCN1A genetic mutation (present in 80-85% of cases)
  • Worsening with sodium-channel blockers (carbamazepine, lamotrigine, phenytoin)
  • Current seizure frequency and impact on daily functioning

Step-by-Step Appeal Process

Internal Appeals with UnitedHealthcare

Level 1 Appeal (file within 180 days of denial):

  1. Gather documents: denial letter, medical records, prior therapy history
  2. Submit via: UnitedHealthcare provider portal or fax (number in denial letter)
  3. Timeline: 10-15 business days for standard review, 72 hours for urgent
  4. Include: medical necessity letter addressing specific denial reasons

Level 2 Appeal (file within 60 days of Level 1 denial):

  1. Address new issues raised in Level 1 denial
  2. Add supporting evidence: additional studies, specialist consultation
  3. Timeline: 15-20 business days for decision
  4. Outcome: final internal decision before external review rights
Note: UnitedHealthcare accepts electronic submissions through their provider portal, which can speed processing times compared to fax or mail.

Peer-to-Peer Review Strategy

Request a peer-to-peer review immediately after denial—you typically have only 7-14 days. Here's your action plan:

Pre-Call Preparation Checklist

  • Denial letter with reference number
  • Patient's seizure history and current frequency
  • Complete list of failed antiseizure medications
  • Baseline echocardiogram results
  • SCN1A genetic testing report (if available)
  • Current medication regimen and dosing

Phone Script for Peer-to-Peer Request

"I'm calling to request a peer-to-peer review for [patient name], DOB [date], member ID [number]. We received a denial for Fintepla on [date] with reference number [number]. The patient has treatment-resistant Dravet syndrome with documented SCN1A mutation and has failed multiple antiseizure medications. I need to speak with a neurologist or epileptologist about medical necessity. What time slots are available this week?"

During the Peer-to-Peer Call

Lead with impact: "This patient has daily seizures despite trials of [list specific medications]. Fintepla targets serotonin receptors, a different mechanism than failed therapies."

Address safety: "We've completed baseline echocardiogram showing normal cardiac function and enrolled in the REMS program for ongoing monitoring."

Cite evidence: "Current Dravet syndrome guidelines from the Dravet Syndrome Foundation recommend fenfluramine for patients who've failed conventional antiseizure medications."

Virginia External Review Process

If UnitedHealthcare upholds their denial after internal appeals, Virginia law provides external review through the State Corporation Commission's Bureau of Insurance.

Eligibility and Timeline

  • File within: 120 days of final internal denial
  • Standard review: 45 days for decision
  • Expedited review: 72 hours (if delay could jeopardize health)
  • Cost: Free to patients

How to File External Review

  1. Download Form 216-A from the Virginia SCC website
  2. Complete required information:
    • Patient demographics and UnitedHealthcare details
    • Brief summary of denial and clinical need
    • Authorization for medical record release
  3. Submit to: State Corporation Commission, Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218
  4. Contact for help: 1-877-310-6560 or [email protected]
Virginia Advantage: Virginia allows expedited external review for certain medical conditions without exhausting all internal appeals first, recognizing the urgency of some treatments.

Medical Necessity Documentation

Your appeal's success depends on strong clinical documentation. Here's what to include:

Core Elements for Fintepla Medical Necessity

Diagnosis confirmation:

  • Documented Dravet syndrome or LGS with appropriate ICD-10 codes
  • Genetic testing results (SCN1A mutation for Dravet)
  • EEG and MRI findings consistent with syndrome

Treatment history:

  • Chronological list of prior antiseizure medications
  • Specific doses, duration of trials, and reasons for discontinuation
  • Documentation of inadequate seizure control or adverse effects

REMS compliance:

  • Baseline echocardiogram results showing normal cardiac function
  • Plan for ongoing cardiac monitoring every 6 months
  • Prescriber enrollment in Fintepla REMS program

Clinical impact:

  • Current seizure frequency and severity
  • Impact on development, cognition, and quality of life
  • Risk of sudden unexpected death in epilepsy (SUDEP)

Sample Medical Necessity Letter Framework

RE: Medical Necessity Appeal for Fintepla (fenfluramine)
Patient: [Name], DOB: [Date], Member ID: [Number]

CLINICAL SUMMARY:
[Patient name] is a [age]-year-old with treatment-resistant Dravet syndrome 
confirmed by [SCN1A mutation/clinical criteria]. Despite trials of [list 
specific medications with dates and outcomes], seizures remain poorly 
controlled with [current frequency].

PRIOR THERAPY FAILURES:
• Clobazam 20mg daily (6 months): Partial response, discontinued due to sedation
• Valproate 1500mg daily (12 months): No seizure reduction, weight gain
• Topiramate 200mg daily (8 months): Increased seizure frequency

MEDICAL NECESSITY:
Fintepla targets serotonin 5-HT2C receptors, a novel mechanism distinct from 
failed therapies. Clinical trials demonstrate 62.3% reduction in convulsive 
seizures in Dravet syndrome patients. Patient has completed baseline 
echocardiogram showing normal cardiac function and is enrolled in REMS program.

REQUEST:
Approval for Fintepla 2.2mg/mL oral solution per FDA-approved dosing for 
Dravet syndrome, dispensed through OptumRx specialty pharmacy.

Cost-Saving Options

Even with UnitedHealthcare coverage, Fintepla can be expensive. Here are ways to reduce costs:

Manufacturer Support Programs

UCB CarePath (Fintepla manufacturer program):

  • Copay assistance up to $15,000 annually for commercial insurance
  • Patient assistance program for uninsured/underinsured
  • Enrollment: 1-844-827-3728 or UCB-USA.com

Foundation Grants

  • Epilepsy Foundation financial assistance programs
  • Patient Advocate Foundation copay relief
  • Good Days (formerly Chronic Disease Fund) grants

State Resources in Virginia

Virginia's expanded Medicaid program (effective 2019) may provide coverage if you qualify based on income. Contact Virginia Department of Social Services at 1-855-635-4370.

When to Escalate

If appeals fail and external review is denied, you still have options:

File Complaints with Virginia Regulators

State Corporation Commission Bureau of Insurance:

Virginia Attorney General's Office:

  • Healthcare fraud or unfair practices
  • Consumer protection hotline: 1-800-552-9963

Consider consulting an attorney specializing in healthcare law if:

  • UnitedHealthcare violated state or federal coverage requirements
  • External review was improperly denied
  • You suspect discrimination based on disability

Counterforce Health helps patients navigate complex insurance denials by analyzing denial letters, identifying specific appeal strategies, and drafting evidence-backed medical necessity letters. Their platform streamlines the appeal process by matching clinical documentation to payer-specific requirements, increasing approval rates for specialty medications like Fintepla.

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take for Fintepla? A: Standard PA decisions are made within 72 hours to 14 days. Urgent requests (when delay could harm the patient) are processed within 24-72 hours.

Q: Can I fill Fintepla at my local pharmacy? A: No, UnitedHealthcare typically requires Fintepla to be dispensed through OptumRx specialty pharmacy network.

Q: What if I don't have SCN1A genetic testing? A: While SCN1A mutations are found in 80-85% of Dravet syndrome cases, clinical diagnosis based on seizure history and EEG findings may be sufficient. Genetic testing strengthens your case but isn't always required.

Q: Does step therapy apply if I tried medications outside Virginia? A: Yes, your complete medical history counts regardless of where treatment occurred. Document all prior therapies with medical records from previous providers.

Q: Can I request expedited appeal in Virginia? A: Yes, if your doctor certifies that waiting for standard appeal timelines could seriously jeopardize your health. This applies to both UnitedHealthcare internal appeals and Virginia external review.

Q: What happens if UnitedHealthcare changes formularies mid-year? A: Plans must provide 60 days' notice of formulary changes. You may be eligible for exceptions or transition supplies while appealing.

Q: Is there a limit on Virginia external reviews? A: No, you can file external review for each separate denial. However, the same clinical issue cannot be reviewed multiple times without new evidence.

Q: Does Virginia external review cost money? A: No, Virginia provides free external review services to consumers. There are no fees for filing Form 216-A or the review process.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual policy terms and medical circumstances. Consult your healthcare provider about treatment options and contact UnitedHealthcare or Virginia insurance regulators for specific coverage questions.

For personalized help with your Fintepla appeal, visit Counterforce Health to access tools that analyze denial letters and generate targeted appeals based on your specific UnitedHealthcare policy requirements.

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