By Counterforce Health Team in Gilenya (fingolimod) —

How to Get Gilenya (fingolimod) Covered by UnitedHealthcare in Texas: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Gilenya Covered by UnitedHealthcare in Texas

UnitedHealthcare requires prior authorization for Gilenya (fingolimod) in Texas. Submit through the UnitedHealthcare Provider Portal with complete documentation: baseline EKG, ophthalmology exam, vaccination records, and step therapy documentation. If denied, you have 60 days for internal appeal, then 4 months for external review through Texas Department of Insurance. First step today: Contact your neurologist to schedule required baseline tests and gather prior MS therapy records.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for Multiple Sclerosis
  3. Product Coding: NDC and HCPCS Requirements
  4. Clean Prior Authorization Request
  5. Common Coding Pitfalls
  6. Verification with UnitedHealthcare Resources
  7. Pre-Submission Audit Checklist
  8. Appeals Process in Texas
  9. Cost Assistance Options
  10. FAQ

Coverage at a Glance

Requirement What It Means Where to Find It Timeline
Prior Authorization Required for all plans UnitedHealthcare Provider Portal 7 days for specialty drugs
Baseline EKG Cardiac safety screening Cardiology or primary care Before first dose
Eye Exam Macular edema screening Ophthalmologist Within 30 days of start
Vaccination Records Varicella immunity proof Primary care records Before initiation
Step Therapy Failed first-line MS drugs Neurology records Document 2+ failures

Coding Basics: Medical vs. Pharmacy Benefit

Gilenya (fingolimod) is an oral medication dispensed under the pharmacy benefit, not the medical benefit. This distinction affects how you code and bill for coverage.

Pharmacy Benefit Path:

  • Use NDC codes for billing
  • Prior authorization through OptumRx
  • Dispensed by specialty pharmacies
  • Patient self-administers at home

Medical Benefit (Rare):

  • Only in exceptional circumstances
  • Requires HCPCS J-code J8499 (unclassified oral drug)
  • Typically not applicable for Gilenya
Note: Nearly all UnitedHealthcare plans in Texas cover Gilenya under the pharmacy benefit. Confirm your specific benefit structure by calling the member services number on your insurance card.

ICD-10 Mapping for Multiple Sclerosis

Current ICD-10 Code (through September 2025):

  • G35: Multiple sclerosis (primary code)

New Codes Effective October 1, 2025:

  • G35.A: Relapsing-remitting multiple sclerosis
  • G35.B1: Active primary progressive MS
  • G35.B2: Non-active primary progressive MS
  • G35.C1: Active secondary progressive MS
  • G35.C2: Non-active secondary progressive MS
  • G35.D: Multiple sclerosis, unspecified

Documentation Requirements: Your neurologist must document specific MS phenotype and activity status. Key phrases that support coding include:

  • "Relapsing-remitting course with active lesions"
  • "Secondary progressive with continued relapses"
  • "MRI showing new T2 lesions"
  • "Clinical progression despite treatment"
Tip: Starting October 2025, using the generic G35 code may result in claim delays. Ensure your provider updates to the specific phenotype codes.

Product Coding: NDC and HCPCS Requirements

NDC Codes for Gilenya:

  • 0078-0607-15: 0.5 mg capsules, 30-count
  • 0078-0607-51: 0.5 mg capsules, 30-count
  • 0078-0607-89: 0.25 mg capsules, 30-count
  • 0078-0965-89: 0.5 mg capsules, 7-count starter pack

HCPCS J-Code:

  • No specific J-code (oral medications don't typically have J-codes)
  • If medical benefit billing required: J8499 (unclassified oral drug)

Units and Billing:

  • Standard dosing: One capsule daily
  • 30-day supply = 30 units
  • 90-day supply = 90 units (if plan allows)

Counterforce Health helps patients and providers navigate these coding complexities by automatically generating properly formatted prior authorization requests with the correct NDC codes and clinical documentation.

Clean Prior Authorization Request Anatomy

Essential Components:

  1. Patient Information:
    • Name, DOB, member ID
    • Prescribing physician (must be neurologist)
    • Diagnosis: Multiple sclerosis with specific ICD-10
  2. Clinical Documentation:
    • Baseline EKG results (within 30 days)
    • Ophthalmology exam report
    • Vaccination records (especially varicella)
    • Complete blood count and liver function tests
  3. Prior Therapy Documentation:
    • At least 2 failed or contraindicated first-line therapies
    • Specific reasons for failure (lack of efficacy, intolerance)
    • Trial duration and outcomes
  4. Prescription Details:
    • NDC code: 0078-0607-15 (most common)
    • Strength: 0.5 mg daily
    • Quantity: 30 capsules per 30 days
    • Days supply: 30

Submission Methods:

Common Coding Pitfalls and How to Avoid Them

Pitfall 1: Wrong Benefit Category

  • Error: Billing under medical benefit
  • Fix: Always use pharmacy benefit with NDC codes

Pitfall 2: Missing Baseline Tests

  • Error: Submitting PA without EKG or eye exam
  • Fix: Complete all FDA-required monitoring before submission

Pitfall 3: Generic ICD-10 Code

  • Error: Using G35 after October 2025
  • Fix: Specify MS phenotype with new granular codes

Pitfall 4: Incomplete Step Therapy Documentation

  • Error: Not proving failure of first-line therapies
  • Fix: Document specific trials, durations, and failure reasons

Pitfall 5: Wrong NDC Code

  • Error: Using discontinued or incorrect NDC
  • Fix: Verify current NDC with Novartis or pharmacy

Verification with UnitedHealthcare Resources

Before Submission:

  1. Check Formulary Status:
  2. Review PA Requirements:
    • Download current prior authorization form
    • Check for plan-specific criteria
    • Verify submission deadlines
  3. Contact OptumRx:
    • Call 888-397-8129 for provider support
    • Confirm NDC codes and quantity limits
    • Ask about expedited review criteria

Pre-Submission Audit Checklist

Clinical Documentation ✓

  • Neurologist prescription with clear MS diagnosis
  • Baseline EKG (within 30 days)
  • Comprehensive eye exam report
  • Vaccination records (varicella immunity)
  • Complete blood count and liver function tests

Prior Therapy Documentation ✓

  • At least 2 first-line MS therapy trials documented
  • Specific failure reasons (efficacy, tolerability)
  • Trial durations and discontinuation dates
  • Contraindications to alternatives (if applicable)

Prescription Details ✓

  • Correct NDC code (verify with current packaging)
  • Appropriate quantity (typically 30 capsules/30 days)
  • Prescriber is neurologist or MS specialist
  • Patient age ≥10 years documented

Submission Requirements ✓

  • UnitedHealthcare Provider Portal access confirmed
  • All supporting documents in PDF format
  • Patient consent for information sharing
  • Backup fax number available (1-844-403-1027)

Appeals Process in Texas

Internal Appeal (UnitedHealthcare):

  • Deadline: 60 days from denial letter
  • Timeline: 7 calendar days for specialty drug decisions
  • Expedited: 72 hours for urgent medical situations
  • Submission: UnitedHealthcare member services or provider portal

External Review (Texas IRO):

  • Eligibility: After internal appeal denial (state-regulated plans only)
  • Deadline: 4 months from final internal denial
  • Timeline: 5 calendar days for urgent cases
  • Cost: Free to patient (insurer pays)
  • Contact: Texas Department of Insurance at 866-554-4926

Required Documentation for Appeals:

  • Original denial letter
  • Complete medical records
  • Letter of medical necessity from neurologist
  • Published clinical guidelines supporting Gilenya use
  • Prior therapy failure documentation
Important: ERISA self-funded employer plans follow federal appeals rules, not Texas IRO process. Check with HR to determine your plan type.

Clinician Corner: Medical Necessity Letter

Essential Elements:

  1. Clinical Problem Statement:
    • Specific MS phenotype and current disease activity
    • Functional impairment and quality of life impact
    • Risk of progression without effective treatment
  2. Prior Treatment History:
    • Specific medications tried with dates
    • Reasons for discontinuation (side effects, lack of efficacy)
    • Documentation of adequate trial duration
  3. Clinical Rationale for Gilenya:
    • FDA-approved indication match
    • Expected clinical benefits
    • Monitoring plan for known side effects
  4. Supporting Guidelines:

Cost Assistance Options

Manufacturer Support:

  • Gilenya Go Program: Copay assistance up to $20,000/year
  • Patient assistance program: For uninsured/underinsured patients
  • Contact: 1-800-445-3692 or Novartis patient support

Foundation Programs:

  • National MS Society: Financial assistance programs
  • HealthWell Foundation: Copay assistance for eligible patients
  • Patient Access Network Foundation: MS-specific grants

State Resources:

  • Texas Health and Human Services: Medicaid coverage options
  • ADAP (AIDS Drug Assistance Program): For qualifying conditions

Counterforce Health can help identify all available cost assistance programs and guide you through the application process, ensuring you don't miss any opportunities to reduce your out-of-pocket costs.

From Our Advocates

"We've seen many Texas patients get Gilenya approved on appeal by focusing on the monitoring requirements. One patient's initial denial was overturned within a week when their neurologist resubmitted with a detailed first-dose monitoring plan and cardiac clearance letter. The key was showing UnitedHealthcare that all safety protocols would be followed."

FAQ

Q: How long does UnitedHealthcare prior authorization take in Texas? A: Standard specialty drug PAs are decided within 7 calendar days. Expedited reviews for urgent medical situations are completed within 72 hours.

Q: What if Gilenya is not on my formulary? A: You can request a formulary exception with strong clinical justification. Document why preferred alternatives are inappropriate or have failed.

Q: Can I request an expedited appeal? A: Yes, if delaying treatment would seriously jeopardize your health. Both internal appeals and Texas IRO reviews offer expedited timelines.

Q: Does step therapy apply if I failed MS drugs outside Texas? A: Yes, prior therapy failures from any location count toward step therapy requirements. Ensure your new Texas neurologist has complete records.

Q: What's the difference between OptumRx and UnitedHealthcare? A: OptumRx is UnitedHealthcare's pharmacy benefit manager. Drug PAs go through OptumRx, but appeals may involve both entities.

Q: Can my primary care doctor prescribe Gilenya? A: Most UnitedHealthcare plans require a neurologist or MS specialist to prescribe Gilenya due to monitoring requirements.

Q: What if I'm switching from another MS drug to Gilenya? A: Document the medical reason for switching (inadequate response, side effects). Some plans may require a washout period between medications.

Q: Are generic versions of fingolimod covered differently? A: Generic fingolimod may have different PA requirements and NDC codes. Check your specific plan's formulary for coverage details.

When to Escalate

Contact the Texas Department of Insurance at 1-800-252-3439 if:

  • UnitedHealthcare doesn't respond within required timeframes
  • You need help understanding your appeal rights
  • You suspect improper denial practices

File a complaint online at the TDI website for persistent coverage issues.

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 plan terms and medical circumstances. Always consult with your healthcare provider and insurance company for decisions about your specific situation. Coverage policies and requirements may change; verify current information with official sources.

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