By Counterforce Health Team in Soliris (eculizumab) —

How to Get Soliris (Eculizumab) Covered by Humana in North Carolina: Complete Prior Authorization Guide with Appeals Process

Answer Box: Getting Soliris Covered by Humana in North Carolina

Humana requires strict prior authorization for Soliris (eculizumab) with specific documentation for FDA-approved conditions. The fastest path: (1) Confirm your diagnosis meets FDA criteria (PNH, aHUS, gMG, or NMOSD) with required labs, (2) Submit complete documentation through CenterWell Specialty Pharmacy including meningococcal vaccination records and REMS enrollment, and (3) If denied, file internal appeal within 65 days, then Smart NC external review within 120 days. Start today by gathering your diagnosis confirmation, vaccination records, and contacting CenterWell at 1-800-486-2668.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Information
  5. Documentation Packet Checklist
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Appeals Process in North Carolina
  10. Common Denial Reasons & How to Fix Them
  11. FAQ

Who Should Use This Guide

This comprehensive guide is designed for patients, caregivers, and healthcare providers navigating Soliris (eculizumab) coverage through Humana in North Carolina. You'll benefit from this resource if you're dealing with:

  • Initial prior authorization requests for Soliris
  • Humana denials that need appealing
  • Questions about North Carolina's external review process
  • Documentation requirements for rare disease treatments

Expected outcome: With proper documentation and following these steps, most medically necessary Soliris requests can be approved, either initially or through the appeals process. North Carolina's Smart NC external review has helped overturn many specialty drug denials when clinical evidence supports medical necessity.

Member & Plan Basics

Coverage Verification

Before starting your prior authorization, confirm these essential details:

  • Active Humana coverage with current member ID
  • Plan type: Medicare Advantage, Medicare Part D, or commercial plan
  • Deductible status: High-cost specialty drugs may apply to medical or pharmacy deductibles
  • Authorization requirements: All Soliris requests require prior authorization regardless of indication
Tip: Call Humana member services at the number on your insurance card to verify your specific plan's specialty drug coverage and deductible information.

Clinical Criteria Requirements

Humana covers Soliris only for FDA-approved indications with strict clinical documentation requirements:

Approved Indications & Required Evidence

Condition ICD-10 Code Required Documentation
Paroxysmal Nocturnal Hemoglobinuria (PNH) D59.5 Flow cytometry confirming PNH clone, elevated LDH, low haptoglobin, elevated indirect bilirubin
Atypical Hemolytic Uremic Syndrome (aHUS) D59.31, D59.39 Hemolytic anemia, thrombocytopenia, acute kidney injury, STEC-HUS ruled out, ADAMTS13 >10%
Generalized Myasthenia Gravis (gMG) G70.00, G70.01 Positive anti-AChR antibody, documented generalized muscle weakness, MG-ADL score
Neuromyelitis Optica Spectrum Disorder (NMOSD) G36.0 Positive anti-AQP4 antibody, relapsing neurological symptoms

Universal Requirements for All Indications

  1. Meningococcal vaccination completed at least 2 weeks before first dose (MenACWY and MenB)
  2. REMS program enrollment for prescriber and patient
  3. Active Humana coverage verification
  4. Medical necessity documentation detailing clinical history and treatment goals

Coding and Billing Information

HCPCS J-Codes

  • J1300: Injection, eculizumab, 10 mg (through March 31, 2025)
  • J1299: Injection, eculizumab, 2 mg (effective April 1, 2025)

Billing Units

  • J1300: 300 mg dose = 30 units
  • J1299: 300 mg dose = 150 units

Required Modifiers

  • RE: Drug furnished in full compliance with REMS (may be required)
  • TB: Acquired with 340B pricing (Medicare only, when applicable)

Documentation Packet Checklist

Core Requirements for All Submissions

Clinical Documentation:

  • Complete medical history supporting FDA-approved diagnosis
  • Laboratory results confirming condition-specific requirements
  • Prior treatment history and outcomes
  • Current medication list and contraindications

Regulatory Requirements:

  • Meningococcal vaccination records (MenACWY and MenB)
  • REMS program enrollment confirmation
  • Signed and dated medical necessity letter from prescriber

Administrative Items:

  • Current insurance card copy
  • Completed Humana prior authorization form
  • Patient demographics and contact information

Medical Necessity Letter Components

Your prescriber's letter should include:

  1. Patient identification and diagnosis with ICD-10 code
  2. Clinical rationale explaining why Soliris is medically necessary
  3. Prior treatments tried and reasons for failure or intolerance
  4. Expected outcomes and monitoring plan
  5. FDA labeling support for the specific indication
  6. Prescriber signature and date

Submission Process

Step-by-Step Submission Guide

Step 1: Obtain Forms Download the current Humana Medicare Prescription Drug Coverage Determination form from Humana's prior authorization page.

Step 2: Complete Documentation Fill out all required fields and gather supporting clinical documentation as outlined in the checklist above.

Step 3: Submit via CenterWell Submit through CenterWell Specialty Pharmacy (preferred) or fax to 877-486-2621 with all supporting documents.

Step 4: Confirmation Obtain confirmation number and expected timeline for decision (typically 15-30 days for standard review).

Note: Incomplete submissions are a leading cause of delays. Double-check that all required fields are completed and all supporting documents are included.

Specialty Pharmacy Requirements

Humana requires Soliris to be dispensed exclusively through CenterWell Specialty Pharmacy. Other specialty pharmacies like Accredo or CVS Specialty are not in-network for Soliris distribution.

CenterWell Contact Information

  • Phone: 1-800-486-2668
  • Services: Prior authorization assistance, REMS enrollment support, home infusion coordination

Distribution Process

  1. Prior authorization approval obtained
  2. Prescription sent to CenterWell
  3. REMS compliance verified
  4. Medication shipped to patient or infusion site
  5. Coordination with healthcare provider for administration

After Submission: What to Expect

Timeline for Decisions

  • Standard review: 15-30 days from complete submission
  • Expedited review: 72 hours (for urgent medical situations)

Status Tracking

  • Use Humana member portal or call member services
  • Record confirmation numbers and reference dates
  • Follow up if no response within expected timeframe

Next Steps Based on Decision

  • Approved: CenterWell will coordinate medication delivery
  • Denied: Review denial reason and prepare appeal within 65 days
  • More information needed: Respond promptly to avoid automatic denial

Appeals Process in North Carolina

If your initial request is denied, North Carolina offers a robust appeals process through multiple levels.

Internal Appeals (Humana)

  • Deadline: 65 days from denial notice
  • Method: Online portal, phone, or written appeal
  • Timeline: Standard appeals decided within 30 days; expedited within 72 hours

Smart NC External Review

North Carolina's external review program provides an independent assessment of denials.

Eligibility Requirements:

  • Completed Humana's internal appeals process
  • Denial based on medical necessity or experimental treatment determination
  • Request filed within 120 days of final internal denial

Timeline:

  • Standard review: 45 days maximum
  • Expedited review: 72 hours for urgent situations

How to File:

From our advocates: "We've seen many Soliris denials overturned through Smart NC's external review process when patients submitted comprehensive clinical documentation and clear evidence of medical necessity. The key is thorough preparation and timely submission of all required materials."

Required Documentation for Appeals

  • Original denial letter from Humana
  • All medical records supporting the diagnosis
  • Physician support letter with clinical rationale
  • Relevant clinical studies or guidelines (when applicable)
  • Evidence of failed alternative treatments

Common Denial Reasons & How to Fix Them

Denial Reason How to Fix
Diagnosis criteria not met Submit complete lab results, flow cytometry, or antibody testing that clearly confirms FDA-approved indication
Missing vaccination records Provide documentation of meningococcal vaccination completed ≥2 weeks before treatment start
REMS enrollment incomplete Confirm prescriber REMS certification and patient enrollment in safety program
Insufficient clinical documentation Submit comprehensive medical history, prior treatment failures, and detailed physician letter
Non-preferred agent Provide clinical rationale for why Soliris is preferred over alternatives like Ultomiris or biosimilars

Counterforce Health: Expert Appeals Support

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, payer policies, and clinical notes to create targeted, evidence-backed rebuttals. Their platform identifies specific denial reasons and drafts point-by-point responses aligned with each plan's requirements, incorporating the right medical evidence and clinical facts that payers expect to see.

For complex cases like Soliris denials, having expert support can make the difference between approval and continued coverage barriers. Counterforce Health helps patients, clinicians, and specialty pharmacies navigate the intricate requirements of prior authorization and appeals processes.

FAQ

How long does Humana prior authorization take for Soliris in North Carolina? Standard review takes 15-30 days from complete submission. Expedited review is available for urgent medical situations and must be decided within 72 hours.

What if Soliris is non-formulary on my Humana plan? You can request a formulary exception with medical necessity documentation. The process follows the same prior authorization requirements with additional justification for why formulary alternatives are inappropriate.

Can I request an expedited appeal in North Carolina? Yes, both Humana internal appeals and Smart NC external review offer expedited processes when delay would seriously jeopardize your health or ability to regain function.

Does step therapy apply if I've tried alternatives outside North Carolina? Yes, documentation of prior treatment failures from any location should be accepted as long as medical records clearly document the trials and outcomes.

What happens if Smart NC external review approves my appeal? The decision is binding on Humana. They must provide coverage within 3 business days of receiving the approval decision.

How much does Soliris cost without insurance? List price can reach $500,000+ annually depending on indication and dosing. Patient assistance programs and foundation grants may be available for eligible patients.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan benefits, clinical circumstances, and payer policies. Always consult with your healthcare provider and insurance plan for specific coverage determinations. For additional help with insurance appeals in North Carolina, contact Smart NC at 1-855-408-1212.

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