By Counterforce Health Team in Uplizna (inebilizumab) —

How to Get Uplizna (Inebilizumab) Covered by Cigna in New York: Complete Appeals Guide

Answer Box: Your Path to Uplizna Coverage

Eligibility: Cigna covers Uplizna (inebilizumab) for AQP4-positive NMOSD and IgG4-related disease with prior authorization. Fastest path: Neurologist submits PA with AQP4-positive labs, HBV screening (negative), and relapse history via Cigna provider portal. Start today: Gather your AQP4 antibody results and HBV test; if denied, New York's external review through the Department of Financial Services often overturns rare disease denials within 30 days.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Cigna plans Provider portal or CoverMyMeds Cigna Policy
Specialist Prescriber Neurologist (NMOSD) or rheumatologist (IgG4-RD) Medical license verification Cigna Requirements
AQP4-Positive Status Lab confirmation required Serology report FDA Label
HBV Screening Must be negative before treatment Blood test results FDA Safety Requirements
Age Limit 18 years or older Birth certificate/ID Cigna Coverage Criteria
Medical Benefit Billed as J1823, not pharmacy Provider administration HCPCS Guidelines

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis

Who: You and your neurologist
Document needed: AQP4 antibody test showing positive result
Timeline: Same day if already tested
Action: If not tested, request AQP4-IgG serology immediately

2. Complete HBV Screening

Who: Your doctor orders, lab processes
Document needed: Hepatitis B surface antigen, core antibody, surface antibody
Timeline: 1-3 days for results
Action: Must show no active infection before Uplizna can start

3. Gather Treatment History

Who: You and care team
Documents needed: Records of prior NMOSD treatments, responses, side effects
Timeline: 1-2 days to compile
Action: Include immunosuppressants, steroids, other biologics tried

4. Submit Prior Authorization

Who: Neurologist's office
Method: Cigna provider portal or CoverMyMeds
Timeline: Decision within 72 hours (24 hours if expedited)
Include: All documentation above plus ICD-10 G36.0

5. If Approved, Schedule Infusion

Who: Infusion center
Billing: J1823 (300 units for 300mg dose)
Timeline: Coordinate with specialty pharmacy
Next: Second dose in 2 weeks, then every 6 months

6. If Denied, File Internal Appeal

Who: You or your doctor
Deadline: 180 days from denial
Method: Written appeal with additional evidence
Timeline: 30 days for standard, 72 hours for expedited

7. External Review (If Still Denied)

Who: You file with New York DFS
Deadline: 4 months after final internal denial
Cost: $25 maximum (waived for financial hardship)
Timeline: 30 days for decision

Coding That Gets Claims Paid

Medical vs. Pharmacy Benefit

Uplizna is administered intravenously in a clinical setting, making it a medical benefit drug. This means it's billed through your medical insurance, not your prescription drug plan.

Essential Codes for Uplizna

HCPCS Code: J1823 (injection, inebilizumab-cdon, 1 mg)
Billing conversion: 1 mg = 1 billing unit
Standard dose: 300 mg = 300 billing units
NDC: 75987-0150-03 (100 mg/10 mL vials)

ICD-10 Code: G36.0 (Neuromyelitis optica)
Administration: CPT 96365 (IV infusion, initial, up to 1 hour)

Units and Billing Math

  • Each 300 mg dose requires 3 vials (100 mg each)
  • Bill as 300 units of J1823
  • Year 1: 3 doses (900 total units)
  • Subsequent years: 2 doses (600 total units)
Tip: Always verify NDC numbers match your vials exactly. Mismatched NDCs are a common cause of claim delays.

Required Modifiers

JZ Modifier: Use when no drug is discarded (Medicare requirement)
UD Modifier: Required for 340B-acquired drugs
59 Modifier: For split billing across multiple claims

Common Denial Reasons & Solutions

Denial Reason How to Fix Required Documents
"Not AQP4-positive" Submit lab report clearly showing positive AQP4-IgG Serology results with reference ranges
"No specialist involvement" Neurologist must be prescriber or consultant Medical license, consultation notes
"Missing HBV screening" Provide complete hepatitis B panel HBsAg, anti-HBc, anti-HBs results
"Insufficient relapse history" Document NMOSD attacks, treatments tried Medical records, MRI reports, treatment logs
"Site of care issues" Confirm infusion center credentials Facility accreditation, billing setup
"Experimental/investigational" Cite FDA approval for your indication FDA approval letter

New York Appeals Process

New York offers robust patient protections for insurance denials, especially valuable for rare disease treatments like Uplizna.

Internal Appeals with Cigna

First Level: Submit written appeal within 180 days
Review time: 30 days (72 hours if expedited)
Success rate: Higher when complete clinical documentation provided

Second Level: If first appeal denied
Timeline: Additional 30 days
Peer review: Often includes specialist consultation

External Review Through New York DFS

New York's external review system is particularly strong for rare diseases. Independent medical experts review your case using current medical literature.

When to use: After exhausting Cigna's internal appeals
Filing deadline: 4 months from final internal denial
Cost: Maximum $25 (waived for Medicaid or financial hardship)
Decision timeline: 30 days standard, 72 hours expedited

Key advantage: External reviewers often overturn denials for FDA-approved rare disease treatments when medical necessity is documented.

Note: New York allows expedited external appeals if delays could seriously jeopardize your health—crucial for NMOSD patients at risk of relapses.

How to File External Review

  1. Complete DFS external appeal form
  2. Include all medical records and denial letters
  3. Submit within 4 months of final Cigna denial
  4. Pay $25 fee (or request waiver)

Contact: New York Department of Financial Services
Phone: 1-800-400-8882
Online: DFS Portal

Costs & Patient Support

Uplizna Pricing Reality

  • List price: ~$140,000 per 300 mg dose
  • Year 1 cost: ~$420,000 (3 doses)
  • Ongoing: ~$280,000 annually (2 doses)

Patient Assistance Programs

Amgen By Your Side: Copay assistance and free drug programs
Eligibility: Income and insurance requirements apply
Contact: 1-833-264-4362
Website: amgenbyyourside.com

Good Days: Grants for copays and insurance premiums
Chronic Disease Fund: Additional financial assistance
Patient Access Network: Copay support for rare diseases

New York State Resources

Medicaid: Covers Uplizna with prior authorization
Essential Plan: Low-cost coverage for moderate incomes
Community Health Advocates: Free insurance counseling at 888-614-5400

When to Escalate

Contact New York regulators if Cigna:

  • Misses appeal deadlines
  • Requests inappropriate documentation
  • Denies FDA-approved indications without medical justification

New York Department of Financial Services
Consumer Hotline: 1-800-342-3736
Online complaint: DFS website

For Medicaid: New York State Department of Health
Fair hearing requests: 1-800-342-3334

Clinician Corner: Medical Necessity Letter

Your neurologist's letter should include:

Clinical presentation: NMOSD diagnosis with AQP4-positive status
Prior treatments: Immunosuppressants tried, outcomes, intolerances
Medical necessity: Why Uplizna is uniquely appropriate
Safety monitoring: HBV screening completed, ongoing monitoring plan
Treatment goals: Relapse prevention, disability limitation
Guidelines support: Reference to FDA labeling and NMOSD treatment guidelines

FAQ

How long does Cigna prior authorization take in New York?
Standard review: 72 hours. Expedited (for urgent cases): 24 hours. Missing documentation can delay decisions.

What if Uplizna isn't on Cigna's formulary?
Request a formulary exception. Your doctor certifies that covered alternatives are medically inappropriate. Decision within 72 hours.

Can I get expedited appeal in New York?
Yes, if delays could seriously harm your health. Both Cigna and New York DFS offer expedited reviews (72 hours or less).

Does step therapy apply to Uplizna?
Often yes. Document prior trials of immunosuppressants, steroids, or other NMOSD treatments to satisfy step requirements.

What if I'm denied after external review?
External review decisions are binding on insurers in New York. If overturned in your favor, Cigna must cover treatment and refund appeal fees.

How do I prove medical necessity for NMOSD?
AQP4-positive lab results, documented relapses, MRI evidence of CNS lesions, and failure/intolerance of standard treatments.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Uplizna. Our platform analyzes denial letters, identifies the specific basis for denial, and generates evidence-backed appeals tailored to each payer's requirements. For rare diseases like NMOSD, we help clinicians navigate prior authorization requirements and compile the clinical documentation that payers expect to see.

When facing a Cigna denial for Uplizna, having the right clinical evidence and appeals strategy can make the difference between coverage and continued denials. Counterforce Health helps patients and providers build stronger cases by identifying exactly what documentation is missing and crafting targeted responses that address payer-specific coverage criteria.

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice. Consult your healthcare provider for medical decisions and verify current insurance policies directly with Cigna and New York regulators.

Sources & Further Reading

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