By Counterforce Health Team in Vigabatrin (generic; Sabril originator Lundbeck) —

Coding That Helps Get Vigabatrin Approved by UnitedHealthcare in New York: ICD-10, HCPCS, and NDC Guide

Quick Answer: Getting Vigabatrin Coded for UnitedHealthcare Coverage in New York

Vigabatrin requires prior authorization from UnitedHealthcare with strict REMS enrollment and vision testing documentation. Use ICD-10 codes G40.82X for infantile spasms or G40.219 for refractory complex partial seizures. Bill under pharmacy benefit with specific NDC numbers (e.g., 43598-0651-01 for 500mg tablets). All prescribers, patients, and pharmacies must be REMS-certified before dispensing. If denied, New York residents can file external appeals through the Department of Financial Services within 4 months, with expedited 24-hour reviews available for urgent drug denials.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping for Vigabatrin Coverage
  3. Product Coding: HCPCS, J-Codes, and NDC Numbers
  4. Clean Prior Authorization Request Anatomy
  5. Frequent Coding Pitfalls to Avoid
  6. Verification with UnitedHealthcare Resources
  7. Quick Audit Checklist
  8. New York Appeal Options

Coding Basics: Medical vs. Pharmacy Benefit Paths

Vigabatrin coverage through UnitedHealthcare follows pharmacy benefit rules in nearly all cases. Understanding this distinction is crucial for proper coding and billing.

Pharmacy Benefit (Standard Path)

  • Coverage: Oral tablets and solution through specialty pharmacy
  • Billing: Uses NDC numbers and unit-based calculations
  • Authorization: Prior authorization through OptumRx
  • REMS: Mandatory enrollment for prescriber, patient, and pharmacy

Medical Benefit (Rare Cases)

  • Coverage: Only if administered in clinical setting under observation
  • Billing: HCPCS J3490 (unclassified drugs) with NDC notation
  • Authorization: Medical necessity review required
  • Documentation: Site of care justification needed
Note: Over 95% of vigabatrin prescriptions are covered under pharmacy benefits. Medical benefit billing is reserved for exceptional circumstances requiring clinical administration.

ICD-10 Mapping for Vigabatrin Coverage

Accurate ICD-10 coding directly impacts approval success. UnitedHealthcare requires diagnosis codes that match FDA-approved indications for vigabatrin.

Primary Indication Codes

Condition ICD-10 Code Documentation Requirements
Infantile spasms (not intractable) G40.822 EEG showing hypsarrhythmia, age 1 month-2 years
Infantile spasms (intractable) G40.824 Failed ACTH or other first-line therapy
Refractory complex partial seizures G40.219 Failed 2+ antiepileptic drugs, documented seizure frequency

Supporting Documentation Language

When documenting for insurance approval, use specific terminology that supports your ICD-10 selection:

For Infantile Spasms:

  • "Epileptic spasms with hypsarrhythmia on EEG"
  • "West syndrome, refractory to ACTH therapy"
  • "Developmental regression with spasm clusters"

For Refractory Complex Partial Seizures:

  • "Treatment-resistant focal seizures"
  • "Failed adequate trials of levetiracetam and topiramate"
  • "Breakthrough seizures despite therapeutic levels"

Product Coding: HCPCS, J-Codes, and NDC Numbers

NDC Numbers and Billing Units

Vigabatrin requires specific NDC identification for accurate billing:

Common Generic NDCs:

  • 43598-0651-01: Dr. Reddy's 500mg tablets, 30-count bottle
  • 43598-0651-02: Dr. Reddy's 500mg tablets, 100-count bottle

Billing Unit Calculations:

  • Unit = Each tablet (for 500mg strength)
  • 90-day supply example: 1,000mg daily = 2 tablets × 90 days = 180 units
  • Liquid formulation: Bill per mL dispensed

HCPCS J-Code (Medical Benefit Only)

When billing under medical benefit:

  • J3490: Unclassified drugs
  • Required notation: Include full NDC, dose, and route
  • Supporting documentation: Clinical justification for site of care
Tip: Always verify current NDC numbers with your specialty pharmacy, as manufacturers may update packaging or introduce new generic versions.

Clean Prior Authorization Request Anatomy

A complete prior authorization request includes all required elements in the correct format. Here's what UnitedHealthcare expects:

Essential Components Checklist

Patient Information:

  • UnitedHealthcare member ID
  • Date of birth and demographics
  • Primary ICD-10 diagnosis code
  • Prescribing physician NPI and specialty

Clinical Documentation:

  • REMS enrollment confirmation (prescriber, patient, pharmacy)
  • Baseline vision exam results
  • EEG findings (for infantile spasms)
  • Prior medication trials and outcomes
  • Current seizure frequency and severity

Product Details:

  • Specific NDC number
  • Strength and quantity requested
  • Days supply calculation
  • Administration instructions

Sample Request Format

Diagnosis: G40.824 - Epileptic spasms, intractable
Patient: 18-month-old with West syndrome
Prior Therapies: Failed ACTH (4-week trial), developed hypertension
Current Status: 15-20 spasm clusters daily, developmental regression
REMS Status: All parties enrolled (confirmation #XXXX)
Vision Baseline: Normal visual fields (attached report)
Requested: Vigabatrin 500mg tablets, NDC 43598-0651-01
Dosing: 50mg/kg/day divided BID, 90-day supply

Frequent Coding Pitfalls to Avoid

Unit Conversion Errors

  • Wrong: Billing mg instead of tablets
  • Right: 500mg tablet = 1 unit, regardless of prescribed dose

Mismatched Age/Indication Codes

  • Wrong: Using infantile spasm codes for adult patients
  • Right: G40.822-824 only for ages 1 month-2 years

Missing REMS Documentation

  • Wrong: Submitting PA without REMS enrollment proof
  • Right: Include confirmation numbers for all three parties

Incomplete Vision Testing

  • Wrong: "Vision exam scheduled"
  • Right: "Baseline visual fields completed, report attached"

Start Date Confusion

  • Wrong: Backdating to initial consultation
  • Right: Date of first REMS-compliant dispensing

Verification with UnitedHealthcare Resources

Before submitting any prior authorization or claim, verify requirements through official UnitedHealthcare channels:

Provider Portal Verification

  1. Log into UnitedHealthcare Provider Portal
  2. Navigate to "Prior Authorization" section
  3. Search for vigabatrin or Sabril
  4. Download current policy requirements
  5. Verify NDC coverage under patient's specific plan

Phone Verification

  • Provider Services: 1-888-842-4571
  • OptumRx Prior Auth: 1-855-857-6243
  • Ask for: Current PA criteria, REMS requirements, appeal procedures

Cross-Reference Resources

  • Vigabatrin REMS Program: vigabatrinrems.com
  • FDA Orange Book: Verify approved NDC numbers
  • New York DFS: External appeal procedures and forms

Quick Audit Checklist

Use this pre-submission checklist to catch common errors:

Clinical Documentation:

  • ICD-10 code matches patient age and indication
  • Prior therapy failures documented with dates and outcomes
  • EEG results included for infantile spasms
  • Specialist involvement confirmed (pediatric neurology for IS)

REMS Compliance:

  • Prescriber REMS certification current
  • Patient enrolled with confirmation number
  • Specialty pharmacy REMS-certified
  • Baseline vision exam completed and documented

Coding Accuracy:

  • NDC number verified against current packaging
  • Unit calculations match dispensed quantity
  • Days supply aligns with prescribed dosing
  • J-code used only if medical benefit billing

Submission Format:

  • All required fields completed
  • Supporting documents attached
  • Contact information current
  • Urgency level appropriate (standard vs. expedited)

New York Appeal Options

New York residents have robust appeal rights when UnitedHealthcare denies vigabatrin coverage.

Internal Appeals (First Step)

  • Timeline: Must complete before external review
  • Deadline: 180 days from denial notice
  • Process: Submit through UnitedHealthcare provider portal
  • Documentation: Include all missing clinical information

External Appeals Through New York DFS

  • Eligibility: After final internal denial
  • Deadline: 4 months from final adverse determination
  • Fee: $25 (waived for Medicaid or financial hardship)
  • Expedited Review: 24 hours for urgent drug denials

When to Request Expedited Review

Your prescriber can certify urgency if:

  • Waiting 30 days would seriously jeopardize health
  • Patient experiencing uncontrolled seizures
  • Vigabatrin is not on UnitedHealthcare formulary
  • Developmental regression is progressing
From our advocates: In our experience with New York external appeals, cases with complete REMS documentation and clear evidence of prior therapy failures have higher success rates. The key is demonstrating that vigabatrin meets FDA criteria and that alternatives have been appropriately tried or are contraindicated.

Filing Your External Appeal

  1. Complete internal appeals with UnitedHealthcare first
  2. Gather documentation: denial letters, clinical notes, EEG results
  3. File online at New York DFS External Appeals Portal
  4. Pay fee ($25, refunded if successful)
  5. Request expedited review if medically urgent
  6. Await decision (30 days standard, 24-72 hours expedited)

Counterforce Health helps patients and clinicians navigate complex prior authorization and appeal processes by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and creates point-by-point rebuttals aligned with payer policies, incorporating the right clinical evidence and procedural requirements to improve approval rates.

Consumer Assistance Resources

  • Community Health Advocates: 888-614-5400 (free counseling)
  • New York DFS Consumer Assistance: Help with appeal preparation
  • Counterforce Health: counterforcehealth.org for automated appeal generation

FAQ

How long does UnitedHealthcare prior authorization take for vigabatrin in New York? Standard determinations are issued within 72 hours; expedited reviews within 24 hours for urgent cases.

What if vigabatrin is non-formulary on my UnitedHealthcare plan? Non-formulary medications qualify for expedited external appeals in New York, with decisions issued within 24 hours through the DFS process.

Can I request an expedited appeal if my child is having uncontrolled infantile spasms? Yes, uncontrolled seizures qualify for expedited review. Your neurologist must certify that waiting would seriously jeopardize your child's health.

Does step therapy apply to vigabatrin if I've tried other medications outside New York? Prior therapy trials from other states count toward step therapy requirements. Include complete documentation of failed treatments and outcomes.

What happens if my REMS enrollment expires during treatment? Coverage will be suspended until re-enrollment is complete. Maintain current enrollment status for all three parties (prescriber, patient, pharmacy).

How do I find a REMS-certified specialty pharmacy in New York? Use the pharmacy locator at vigabatrinrems.com or contact UnitedHealthcare's specialty pharmacy network.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change frequently. Always verify current requirements with UnitedHealthcare and consult your healthcare provider for medical decisions. For official New York insurance regulations and appeal procedures, visit the New York Department of Financial Services.

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