By Counterforce Health Team in Ultomiris (ravulizumab) —

How to Get Ultomiris (Ravulizumab) Covered by Humana in New York: Coding, Appeals, and Prior Authorization Guide

Answer Box: Getting Ultomiris Covered by Humana in New York

Ultomiris (ravulizumab) requires prior authorization from Humana Medicare Advantage plans in New York. The fastest path to approval involves proper medical coding (ICD-10: D59.5 for PNH, HCPCS: J1303 for billing), comprehensive clinical documentation, and understanding New York's strong external appeal rights. If denied, you have 65 days for internal appeal and 4 months for external review through New York DFS, which decides within 72 hours for specialty drugs. First step today: Verify your diagnosis code and gather prior treatment records before submitting the PA request through Humana's provider portal.

Table of Contents

  1. Understanding Ultomiris Coverage Basics
  2. ICD-10 Coding for Ultomiris Indications
  3. HCPCS and Billing Code Requirements
  4. Prior Authorization: Building a Clean Request
  5. Common Coding Pitfalls to Avoid
  6. Appeals Process in New York
  7. Pre-Submission Checklist
  8. FAQ: Common Questions

Understanding Ultomiris Coverage Basics

Ultomiris (ravulizumab-cwvz) is a long-acting complement C5 inhibitor engineered from eculizumab, administered as IV infusions every 8 weeks after an initial loading dose. With annual costs often exceeding $470,000, Humana Medicare Advantage plans require prior authorization and subject coverage to utilization management including step therapy and quantity limits.

Coverage Pathways

Medical Benefit (Part B): Ultomiris is covered under Medicare Part B when administered by IV infusion in clinical settings—not Part D. This applies to hospital outpatient departments, physician offices, and infusion centers.

Key Coverage Requirements:

  • Prior authorization approval
  • Appropriate diagnosis with supporting documentation
  • Compliance with REMS (meningococcal vaccination requirements)
  • Proper site of care (facility-administered infusions)

For patients in New York, Counterforce Health's platform can help streamline the prior authorization process by automatically identifying denial patterns and generating evidence-backed appeals tailored to Humana's specific requirements. The system pulls the right clinical citations and formats them according to payer-specific workflows, potentially reducing approval times and minimizing back-and-forth documentation requests.

ICD-10 Coding for Ultomiris Indications

Accurate diagnosis coding is critical for approval. Use these specific ICD-10 codes based on your condition:

Condition ICD-10 Code Documentation Requirements
Paroxysmal Nocturnal Hemoglobinuria (PNH) D59.5 Flow cytometry results, LDH levels, transfusion history, thrombotic events
Atypical Hemolytic Uremic Syndrome (aHUS) D59.3 Complement testing, kidney function, platelet count, exclusion of STEC-HUS
Generalized Myasthenia Gravis G70.0 AChR antibody status, MG-ADL scores, prior immunosuppressive therapy
Neuromyelitis Optica Spectrum Disorder G36.0 AQP4 antibody results, MRI findings, relapse history
Tip: Document any complications or associated conditions with additional codes. For PNH patients with thrombosis, include appropriate I82.x codes to support medical necessity.

HCPCS and Billing Code Requirements

Primary Billing Code

HCPCS J1303: Injection, ravulizumab-cwvz, 10 mg per unit

Critical Unit Calculation

The most common billing error is incorrect unit conversion. Each J1303 unit represents exactly 10 mg of ravulizumab.

Calculation Formula: Total dose administered (mg) ÷ 10 = Units to bill

Examples:

  • 900 mg dose = 90 units
  • 3,000 mg dose = 300 units
  • 3,600 mg dose = 360 units

Required NDC Codes

Include the National Drug Code on claims:

  • 25682-0025-01 (300 mg/30 mL vial)
  • 25682-0028-01 (1100 mg/11 mL vial)

Additional Billing Requirements

  • Administration code: CPT 96365 for IV infusion
  • Modifiers: JZ (zero drug amount discarded), if applicable
  • NDC format: Remove dashes and spaces when entering on claims

Prior Authorization: Building a Clean Request

Medical Necessity Documentation

Essential Elements:

  1. Confirmed diagnosis with laboratory evidence
  2. Prior treatment failures or contraindications to alternatives
  3. Clinical rationale for Ultomiris specifically
  4. Baseline functional status and treatment goals
  5. REMS compliance documentation (vaccination records)

Supporting Documentation Checklist

  • Complete diagnostic workup results
  • Prior therapy history with dates and outcomes
  • Current symptoms and functional impairment
  • Prescriber attestation of medical necessity
  • Meningococcal vaccination records
  • Weight-based dosing calculations
Clinician Corner: When documenting prior failures, be specific about which therapies were tried, duration of treatment, reasons for discontinuation (lack of efficacy vs. intolerance), and clinical markers that demonstrate inadequate response.

Common Coding Pitfalls to Avoid

Unit Conversion Errors

  • Wrong: Entering total milligrams as units (3,000 units for 3,000 mg dose)
  • Right: Dividing by 10 (300 units for 3,000 mg dose)

NDC and Modifier Mistakes

  • Missing or incorrectly formatted NDC numbers
  • Omitting required modifiers like JZ for wastage
  • Using codes from similar drugs (eculizumab) instead of ravulizumab-specific codes

Documentation Mismatches

  • ICD-10 code doesn't match clinical documentation
  • Dose calculations don't align with patient weight/BSA
  • Missing REMS compliance documentation

Appeals Process in New York

If Humana denies your Ultomiris request, New York offers robust appeal rights with specific protections for specialty drugs.

Internal Appeal Timeline

  • Deadline: 65 days from denial notice
  • Submission: Humana provider portal or mail
  • Decision timeframe: 30 days for standard requests

External Review Through New York DFS

New York's external appeal process is particularly strong for specialty drug denials:

Key Advantages:

  • Fast decisions: 72 hours standard, 24 hours for urgent specialty drug needs
  • Low cost: Maximum $25 fee (waived for financial hardship)
  • Binding decisions: Insurers must comply with favorable rulings
  • Expert review: Independent medical professionals evaluate appeals

Filing Requirements:

  • Submit within 4 months of final internal denial
  • Include all denial letters and medical documentation
  • Use New York DFS portal for online submission

Consumer Assistance Resources

Community Health Advocates: Free counseling at 888-614-5400 for New York residents facing insurance denials. They can help prepare documentation and navigate the appeals process.

For complex denials involving multiple clinical factors, Counterforce Health specializes in turning insurance denials into targeted appeals by identifying specific denial reasons and crafting point-by-point rebuttals aligned with each payer's own policies.

Pre-Submission Checklist

Before submitting your Ultomiris prior authorization:

Clinical Documentation:

  • Appropriate ICD-10 code matches diagnosis
  • Laboratory results supporting diagnosis
  • Prior treatment history documented with outcomes
  • Current functional status and symptoms
  • Weight-based dosing rationale

Coding Verification:

  • HCPCS J1303 units calculated correctly (dose ÷ 10)
  • NDC number included and properly formatted
  • Administration codes included (CPT 96365)
  • Required modifiers applied

REMS Compliance:

  • Meningococcal vaccination completed or planned
  • Patient counseling documented
  • Monitoring plan established

Submission Details:

  • Submitted through correct portal/method
  • All required attachments included
  • Contact information current for follow-up

FAQ: Common Questions

How long does Humana prior authorization take for Ultomiris in New York? Standard PA decisions take up to 30 days. For urgent medical needs, request expedited review for decisions within 72 hours.

What if Ultomiris is non-formulary on my Humana plan? File a formulary exception request with medical necessity documentation. New York's external review process can overturn non-formulary denials.

Can I appeal if step therapy requires trying eculizumab first? Yes. Document medical reasons why eculizumab is inappropriate (e.g., dosing frequency concerns, prior intolerance, clinical instability requiring extended dosing intervals).

Does my PNH diagnosis from another state count for New York appeals? Yes, but ensure all diagnostic documentation is complete and transferable. New York external reviewers will evaluate the full clinical picture regardless of where diagnosis was established.

What happens if Humana doesn't respond within required timeframes? Under New York law, failure to respond within mandated timeframes results in automatic approval of the request.

Are there cost assistance programs for Ultomiris? Alexion Access Navigator offers patient support services including financial assistance programs and insurance navigation.

From our advocates: In our experience with complex complement inhibitor appeals, the most successful cases include specific laboratory trending data (like LDH levels for PNH) that demonstrate disease activity and response to treatment. Payers respond well to objective biomarkers rather than subjective symptom descriptions alone. This composite observation reflects patterns we've seen across multiple rare disease appeals, though individual outcomes vary.

When to Escalate

Contact New York Department of Financial Services Consumer Assistance if:

  • Humana fails to meet response deadlines
  • You need help preparing external appeal documentation
  • You believe your rights under New York insurance law have been violated

Sources & Further Reading

Disclaimer: This information is for educational purposes and does not constitute medical advice. Coverage decisions vary by individual circumstances and plan details. Always consult with your healthcare provider and insurance plan for personalized guidance. For official appeals procedures and current forms, refer to your plan documents and New York Department of Financial Services resources.

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