By Counterforce Health Team in Ultomiris (ravulizumab) —

Requirements Checklist to Get Ultomiris (ravulizumab) Covered by Humana in Pennsylvania: Forms, Appeals, and Approval Timeline

Answer Box: Getting Ultomiris Covered by Humana in Pennsylvania

Who needs this: Pennsylvania patients with PNH, aHUS, generalized myasthenia gravis, or NMOSD whose doctors prescribe Ultomiris (ravulizumab).

Fastest path to approval: 1) Verify active Humana coverage and formulary status, 2) Submit prior authorization with complete clinical documentation including vaccination records and REMS enrollment, 3) Use CenterWell Specialty Pharmacy for streamlined processing.

Start today: Call Humana Customer Care at 1-800-281-6918 to confirm your plan's specific PA requirements and download the current prior authorization form from Humana's provider portal.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Documentation
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Common Denial Prevention Tips
  10. Pennsylvania Appeals Process
  11. Printable Checklist

Who Should Use This Checklist

This guide is designed for Pennsylvania patients and their healthcare providers seeking Humana coverage for Ultomiris (ravulizumab-cwvz), a long-acting complement C5 inhibitor used to treat rare diseases including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD).

Expected outcome: Following this checklist significantly improves your chances of first-try approval. Humana's Medicare Advantage PA denial rate is approximately 3.5%—among the lowest of major insurers—but denials that do occur typically stem from incomplete documentation or missing procedural requirements.

Member & Plan Basics

Coverage Verification Checklist

  • Active Humana coverage confirmed (call 1-800-281-6918 or check member portal)
  • Plan type identified: Medicare Advantage, commercial, or employer-sponsored
  • Deductible status checked: Specialty tier deductible may apply
  • Prior authorization requirement confirmed: Ultomiris requires PA across all Humana plans as of 2024
Note: Ultomiris is typically covered under Medicare Part B (physician-administered) rather than Part D, which affects your cost-sharing and approval process.

Clinical Criteria Requirements

FDA-Approved Indications & Documentation

For PNH (Paroxysmal Nocturnal Hemoglobinuria):

  • Flow cytometry confirmation of PNH clone
  • Elevated LDH levels
  • Transfusion history (if applicable)
  • Evidence of hemolysis or complications

For aHUS (Atypical Hemolytic Uremic Syndrome):

  • Exclusion of STEC-HUS (Shiga toxin-producing E. coli)
  • Evidence of complement-mediated TMA
  • Laboratory markers: elevated LDH, decreased haptoglobin, thrombocytopenia

For Generalized Myasthenia Gravis (gMG):

  • AChR-antibody positive status confirmed
  • MG-ADL score documentation
  • Evidence of inadequate response to conventional therapy

For NMOSD (Neuromyelitis Optica Spectrum Disorder):

  • AQP4-antibody positive confirmation
  • Relapse history documentation
  • MRI findings consistent with NMOSD

Step Therapy & Prior Treatment History

  • Document all prior therapies with dates, dosages, and outcomes
  • Note any failures or intolerances to preferred treatments (may include Soliris)
  • Provide clinical rationale for Ultomiris over alternatives

Coding & Billing Documentation

Required Codes for Claims

Component Code Description Notes
Drug J1303 Ravulizumab-cwvz, 10 mg Bill per 10 mg increments
Administration 96365 IV infusion, initial hour Standard administration code
PNH Diagnosis D59.5 Paroxysmal nocturnal hemoglobinuria Primary diagnosis
aHUS Diagnosis D59.3 Hemolytic-uremic syndrome Primary diagnosis
gMG Diagnosis G70.00/G70.01 Myasthenia gravis Without/with exacerbation
NMOSD Diagnosis G36.0 Neuromyelitis optica Primary diagnosis

NDC and Units

  • Primary NDCs: 25682-0025-01 (300mg) or 25682-0028-01 (1100mg)
  • Calculate total units correctly: Dose in mg ÷ 10 = billable units
  • Include NDC in 11-digit format without dashes

Documentation Packet Essentials

Medical Necessity Letter Components

Your prescriber's letter must include:

  1. Patient identification and diagnosis with ICD-10 code
  2. Clinical justification for Ultomiris over alternatives
  3. Treatment history including failed therapies
  4. Expected outcomes and monitoring plan
  5. Dosing rationale based on patient weight and indication
  6. Vaccination compliance (see REMS requirements below)

REMS Program Requirements

  • Prescriber enrolled in Ultomiris REMS program
  • Patient counseling completed on meningococcal infection risks
  • Patient Safety Card issued and patient instructed to carry at all times
  • Vaccination requirements met:
    • Meningococcal vaccines (ACWY and B) completed ≥2 weeks before treatment
    • OR antibiotic prophylaxis plan documented if urgent treatment needed
Critical: The REMS program is mandatory. Ultomiris cannot be prescribed or dispensed without proper enrollment and documentation.

Supporting Documents Checklist

  • Complete medical records for the past 12 months
  • Laboratory results supporting diagnosis
  • Vaccination records or prophylaxis plan
  • Prior authorization form (current version from Humana)
  • Prescriber attestation letter
  • Insurance card copy

Submission Process

Humana Prior Authorization Submission

Submit via:

  • Provider Portal: Humana Provider Portal (preferred method)
  • Fax: Check current PA form for updated fax number
  • Phone: 1-800-281-6918 for urgent cases

Required Form Fields (Common Rejection Causes)

  • Complete patient demographics including Humana ID
  • Prescriber NPI and DEA numbers
  • Exact drug name and NDC
  • Specific indication (not just "rare disease")
  • Dosing schedule with weight-based calculations
  • Site of care specification
  • All signature fields completed

Specialty Pharmacy Requirements

Preferred Network Pharmacies

CenterWell Specialty Pharmacy (Humana-owned, preferred):

  • Phone: 1-800-486-2668
  • Fax: 1-877-405-7940
  • Services: Home delivery, clinical support, financial assistance coordination

Chartwell Pennsylvania, L.P. (in-network alternative):

  • Phone: 1-800-755-4704
  • Fax: 412-920-2830
  • Services: Direct delivery, 24/7 clinical support

Transfer Process

  1. Obtain PA approval before initiating pharmacy transfer
  2. Coordinate with infusion center for delivery logistics
  3. Verify insurance benefits with specialty pharmacy
  4. Confirm delivery schedule aligns with treatment plan

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform can help identify specific denial reasons and draft point-by-point rebuttals aligned to Humana's policies, potentially saving weeks in the approval process.

After Submission: What to Expect

Timeline Expectations

Step Standard Timeline Expedited Timeline
Initial Review 30 days 72 hours
Additional Info Request 14-day response window 24-hour response
Final Determination Within 60 days total Within 7 days

Status Monitoring

  • Record confirmation number from submission
  • Set calendar reminders for follow-up calls
  • Document all communications with dates and reference numbers
  • Track deadlines for additional information requests

Common Denial Prevention Tips

Five Critical Pitfalls to Avoid

  1. Incomplete vaccination documentation: Always include current meningococcal vaccine records or prophylaxis plan
  2. Missing REMS enrollment proof: Verify prescriber enrollment before submission
  3. Inadequate clinical justification: Don't just state diagnosis—explain why Ultomiris is medically necessary
  4. Wrong site of care designation: Specify infusion center, home health, or physician office
  5. Outdated forms: Always download the most current PA form from Humana's provider portal

Success Strategies

  • Submit complete packages: Incomplete submissions cause automatic delays
  • Use clinical guidelines: Reference FDA labeling and specialty society recommendations
  • Document urgency: For time-sensitive cases, clearly state medical urgency and request expedited review

Pennsylvania Appeals Process

If your initial PA is denied, Pennsylvania offers robust appeal options:

Internal Appeals (Required First Step)

  • Timeline: 65 days from denial notice for Medicare Advantage
  • Method: Submit via Humana member portal or written appeal
  • Required: Copy of denial letter, additional clinical documentation

Pennsylvania External Review

Pennsylvania's new state-run external review program (launched January 2024) has overturned approximately 50% of appealed denials.

Eligibility: Commercial plans (not Medicare Advantage, which uses federal process) Timeline: 45 days for standard review, 72 hours for expedited Cost: Free to consumers Submit: pa.gov/reviewmyclaim or call 1-877-881-6388

From our advocates: We've seen cases where patients received approval on external review after providing additional peer-reviewed studies supporting off-label use. The key was demonstrating medical necessity with current literature and showing why standard alternatives weren't suitable. While outcomes vary, thorough documentation significantly improves success rates.

For Medicare Advantage appeals, use Humana's federal appeal process with similar timelines and documentation requirements.

Printable Checklist

Pre-Submission Checklist

Patient Information:

  • Active Humana coverage verified
  • Member ID and plan details confirmed
  • Deductible and copay information obtained

Clinical Documentation:

  • FDA-approved indication confirmed with supporting labs
  • Prior treatment failures documented
  • Vaccination requirements met or prophylaxis planned
  • REMS enrollment completed

Submission Package:

  • Current PA form completed entirely
  • Medical necessity letter attached
  • Supporting clinical documentation included
  • Specialty pharmacy coordination initiated

Follow-up Plan:

  • Confirmation number recorded
  • Calendar reminders set for status checks
  • Appeal strategy prepared if needed

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters and crafting targeted appeals. Their evidence-based approach can be particularly valuable for high-cost specialty medications like Ultomiris, where documentation requirements are extensive and denial reasons can be highly specific.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions vary by individual circumstances and plan details. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional help with Pennsylvania insurance issues, contact the Pennsylvania Insurance Department's Office of Consumer Services.

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