By Counterforce Health Team in Soliris (eculizumab) —

Getting Soliris (Eculizumab) Approved by Humana in New York: Complete Coding and Appeal Guide

Quick Answer: Your Path to Approval

Soliris (eculizumab) is covered under Humana Medicare Part B when medically necessary for FDA-approved conditions. Key requirements: proper ICD-10 diagnosis coding, proof of meningococcal vaccination, and specialist documentation. Start today: Have your provider submit a prior authorization using HCPCS code J1299 (2 mg/unit) with complete diagnostic records. Appeals must be filed within 65 days if denied. New York residents have additional external review rights through the Department of Financial Services for non-Medicare plans.

First step: Contact your prescribing physician to initiate the prior authorization process with complete vaccination records and diagnostic confirmation.

Table of Contents

  1. Coverage Overview: Medical vs. Pharmacy Benefit
  2. Essential ICD-10 Codes and Documentation
  3. HCPCS Billing Codes and Unit Calculations
  4. Prior Authorization Requirements
  5. Common Denial Reasons and Solutions
  6. Appeals Process for Humana in New York
  7. Cost Considerations and Financial Assistance
  8. Pre-Submission Checklist

Coverage Overview: Medical vs. Pharmacy Benefit

Soliris (eculizumab) is covered under Humana Medicare Part B as a medical benefit, not Part D pharmacy coverage. This is because it's administered by healthcare professionals via IV infusion and is not self-administered.

Coverage Requirements Table

Requirement Details Source
Prior Authorization Required for all indications Humana Provider Portal
FDA-Approved Uses PNH, aHUS, gMG, NMOSD FDA Label
Vaccination Proof Meningococcal vaccine ≥2 weeks prior FDA Safety Requirements
Specialist Requirement Typically hematologist or neurologist Humana Medical Policy
Site of Care Outpatient infusion center or hospital Part B Guidelines
Note: Humana's Medicare Advantage prior authorization denial rate is approximately 3.5% (2023), among the lowest of major insurers, but denials often stem from incomplete documentation.

Essential ICD-10 Codes and Documentation

Primary ICD-10 Codes for Soliris

Condition ICD-10 Code Documentation Requirements
Paroxysmal Nocturnal Hemoglobinuria D59.5 Flow cytometry confirming PNH clone, clinical symptoms
Atypical Hemolytic Uremic Syndrome D59.3 Microangiopathic hemolytic anemia, thrombocytopenia, AKI
Myasthenia Gravis G70.0 (without exacerbation)
G70.01 (with exacerbation)		 AChR antibody positive, EMG confirmation
Neuromyelitis Optica Spectrum Disorder G36.0 AQP4-IgG positive, clinical/imaging criteria

Documentation Best Practices

Your medical record must include:

  • Confirmed diagnosis using standard nomenclature
  • Objective evidence: lab results, antibody tests, genetic studies
  • Clinical presentation supporting the diagnosis
  • Previous treatment failures or contraindications (if applicable)
  • Specialist evaluation and ongoing monitoring plan
Tip: Ensure diagnostic testing results are dated and include reference ranges. Humana may request additional confirmation if initial documentation is incomplete.

HCPCS Billing Codes and Unit Calculations

Critical Billing Code Change (Effective April 1, 2025)

Code Description Unit Conversion Status
J1299 Injection, eculizumab, 2 mg 1 unit = 2 mg Current (April 2025+)
J1300 Injection, eculizumab, 10 mg 1 unit = 10 mg Discontinued

Dosing Calculation Examples

Patient Dose J1299 Units Calculation
300 mg 150 units 300 ÷ 2 = 150
900 mg 450 units 900 ÷ 2 = 450
1200 mg 600 units 1200 ÷ 2 = 600

Required Modifiers

  • JZ: Zero drug amount discarded
  • RE: REMS compliance (when applicable)
Critical: Unit conversion errors are the leading cause of Soliris billing problems. Always divide total mg by 2 for J1299 units.

Prior Authorization Requirements

Step-by-Step Prior Authorization Process

  1. Provider Initiates Request
    • Submit via Humana provider portal or fax
    • Include complete clinical documentation
    • Timeline: Allow 5-7 business days for processing
  2. Required Documentation
    • Completed prior authorization form
    • Specialist consultation notes
    • Diagnostic test results (antibody studies, flow cytometry)
    • Meningococcal vaccination records (≥2 weeks prior to treatment)
    • Previous treatment history and outcomes
  3. Medical Necessity Letter Components
    • Patient's specific diagnosis and ICD-10 code
    • Clinical presentation and severity
    • Rationale for Soliris vs. alternatives
    • Dosing schedule and monitoring plan
    • Literature supporting off-label use (if applicable)

Vaccination Requirements

Humana requires proof of meningococcal vaccination due to FDA black box warning about increased infection risk. Acceptable vaccines include:

  • Meningococcal conjugate vaccine (MenACWY)
  • Serogroup B meningococcal vaccine (MenB)
  • Must be administered ≥2 weeks before Soliris initiation

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Missing vaccination proof Submit vaccination records CDC vaccination card or provider records
Insufficient diagnostic confirmation Provide additional testing Antibody studies, genetic testing, specialist notes
Non-formulary status Request formulary exception Medical necessity letter, failed alternatives
Site of care restriction Confirm approved facility Infusion center credentialing documents
Quantity limits exceeded Justify dosing Weight-based calculations, specialist rationale

Most Effective Appeal Strategies

When facing a denial, Counterforce Health helps patients and providers turn insurance denials into targeted, evidence-backed appeals by analyzing the specific denial reason and crafting point-by-point rebuttals aligned to the plan's own rules.

Appeals Process for Humana in New York

Internal Appeals Timeline

Appeal Level Who Can File Deadline Decision Time Method
Initial Appeal Member or provider 65 days 30 days (standard)
72 hours (expedited)		 Online portal, mail, phone
Redetermination Member 65 days 30 days Written request required

Required Appeal Documentation

  • Original denial letter
  • Additional clinical evidence
  • Provider letter of support
  • Vaccination records (if applicable)
  • Peer-reviewed literature supporting use

New York-Specific Rights

For non-Medicare Humana plans, New York residents have additional protections:

  • External appeals through NY Department of Financial Services
  • 4-month deadline after final internal denial
  • Independent medical review by external experts
  • Binding decisions on insurers
  • $25 maximum fee (waived for financial hardship)
Important: Medicare Advantage members follow federal appeal rights, not New York state external review processes.

Contact Information

  • Humana Appeals: Submit via member portal or mail to address on denial letter
  • NY DFS External Appeals: NY.gov External Appeals Portal
  • Community Health Advocates: 888-614-5400 (free assistance)

Cost Considerations and Financial Assistance

Medicare Part B Cost-Sharing (2025)

  • Deductible: $257 annually
  • Coinsurance: 20% after deductible
  • Estimated annual cost: $100,000+ (before assistance)

Financial Assistance Programs

  • Alexion Patient Assistance Program: Income-based support
  • Medicare Extra Help: Low-income subsidy program
  • State pharmaceutical assistance: New York EPIC program
  • Foundation grants: Patient advocate organizations

For patients navigating complex coverage decisions, Counterforce Health provides tools to identify the most effective appeal strategies based on your specific plan's requirements and denial patterns.

Pre-Submission Checklist

Before Submitting Your Prior Authorization

✓ Diagnosis confirmed with appropriate ICD-10 code
✓ Vaccination records showing meningococcal vaccine ≥2 weeks prior
✓ Specialist consultation notes supporting medical necessity
✓ Diagnostic test results (antibody studies, flow cytometry)
✓ Previous treatment history documented with outcomes
✓ Correct HCPCS code (J1299 for dates after April 1, 2025)
✓ Unit calculations verified (mg ÷ 2 = billing units)
✓ Provider credentials confirmed for prescribing specialist
✓ Infusion site approved by Humana network
✓ Appeal timeline noted (65 days from any denial)

Final Verification Steps

  1. Cross-check with Humana formulary for current coverage status
  2. Confirm provider network status for prescribing physician
  3. Verify infusion site is in-network and approved
  4. Review medical policy for any recent updates
  5. Document submission date for appeal deadline tracking

From Our Advocates: We've seen cases where patients received approval after initially being denied for "insufficient diagnostic confirmation." The key was working with the specialist to provide additional antibody testing results and a detailed letter explaining why the patient met diagnostic criteria. While every case is different, thorough documentation often makes the difference between approval and denial.

Frequently Asked Questions

How long does Humana prior authorization take for Soliris? Standard decisions are made within 30 days. Expedited reviews (for urgent medical needs) are completed within 24-72 hours.

What if Soliris is non-formulary on my plan? You can request a formulary exception with medical necessity documentation. Provide evidence that formulary alternatives are inappropriate or have failed.

Can I request an expedited appeal in New York? Yes, if a delay could harm your health. Your provider must certify the urgency, and Humana will expedite the review.

Does step therapy apply to Soliris? Some plans may require trying biosimilars (Bkemv, Epysqli) first, unless contraindicated or clinically inappropriate.

What happens if my internal appeal is denied? Medicare Advantage members can request independent review through federal processes. Non-Medicare members can use New York's external appeal system.

Sources & Further Reading

This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always verify current information with Humana and consult your healthcare provider for medical decisions. For assistance with complex coverage appeals, visit Counterforce Health to learn how evidence-backed appeal strategies can improve your chances of approval.

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