How to Get Ultomiris (ravulizumab) Covered by Humana in Ohio: Appeals Process and Medical Necessity Requirements
Answer Box: Getting Ultomiris (ravulizumab) Covered by Humana in Ohio
Eligibility: Humana covers Ultomiris with prior authorization for FDA-approved conditions (PNH, aHUS, generalized myasthenia gravis, NMOSD). Fastest approval path: Call Humana Clinical Pharmacy Review at 800-555-CLIN (2546) with complete diagnostic labs, vaccination records, and medical necessity documentation. First step today: Gather your flow cytometry results (PNH), complement genetics (aHUS), or antibody testing (MG/NMOSD), plus meningococcal vaccination records. If denied, you have 65 days to appeal and can request Ohio external review within 180 days of final denial.
Table of Contents
- Policy Overview: How Humana Covers Ultomiris
- Indication Requirements by Condition
- Step Therapy and Medical Exceptions
- Required Diagnostics and Documentation
- Site of Care and Specialty Pharmacy
- Appeals Process in Ohio
- Common Denial Reasons and Solutions
- Cost Assistance Options
- FAQ
Policy Overview: How Humana Covers Ultomiris
Humana requires prior authorization for Ultomiris (ravulizumab) across all plan types—Medicare Advantage, Medicare Part D, and commercial plans. The coverage policy was last updated July 17, 2024, and remains effective through May 21, 2025.
Plan Types and Coverage
- Medicare Advantage: Covered under Part B for infused medications
- Medicare Part D: Covered for self-administered formulations
- Commercial Plans: Varies by employer group; check specific formulary
To initiate prior authorization, providers must contact Humana Clinical Pharmacy Review (HCPR) at 800-555-CLIN (2546) (TTY: 711), available Monday through Friday, 8 a.m. to 6 p.m. Eastern time.
Note: New Humana members benefit from a 90-day grace period where prior authorization isn't required for active treatments that began before enrollment.
Indication Requirements by Condition
Ultomiris is FDA-approved for four conditions, each with specific diagnostic criteria:
Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Required: Flow cytometry showing ≥1% GPI-deficient granulocytes or red blood cells
- Documentation: Complete blood count, LDH levels, evidence of hemolysis
Atypical Hemolytic Uremic Syndrome (aHUS)
- Required: Microangiopathic hemolytic anemia, thrombocytopenia, acute kidney injury
- Must exclude: STEC-HUS (Shiga toxin testing), TTP (ADAMTS13 activity)
- Documentation: Complement genetics testing, C3/C4 levels
Generalized Myasthenia Gravis
- Required: Anti-AChR antibody positive generalized MG
- Documentation: Antibody testing (AChR, MuSK if AChR-negative), MGFA classification
- Clinical evidence: Fatigable weakness, response to cholinesterase inhibitors
Neuromyelitis Optica Spectrum Disorder (NMOSD)
- Required: AQP4-antibody positive NMOSD
- Documentation: AQP4-IgG testing (cell-based assay), MRI findings
- Clinical evidence: Optic neuritis, transverse myelitis, or area postrema syndrome
Step Therapy and Medical Exceptions
Humana implements step therapy requirements for complement inhibitors, particularly for Medicare Advantage plans starting in 2025.
Current Requirements
- Myasthenia gravis: Trial and failure of rituximab (including biosimilars Ruxience or Riabni) required
- PNH/aHUS: May require trial of eculizumab biosimilars (Bkemv, Epysqli) first
- Exception: No step therapy required if patient used complement inhibitor within past 365 days
Medical Exception Pathways
Document any of the following to bypass step therapy:
- Contraindication to preferred agent
- Previous intolerance or failure
- Drug interaction concerns
- Clinical urgency requiring immediate treatment
Clinician Tip: Include specific details about why the preferred agent failed—lack of efficacy, adverse reactions, or contraindications with supporting clinical notes.
Required Diagnostics and Documentation
Essential Laboratory Requirements
| Condition | Primary Test | Supporting Labs | Timing |
|---|---|---|---|
| PNH | Flow cytometry (CD55/CD59) | CBC, LDH, haptoglobin | Within 6 months |
| aHUS | Complement genetics | ADAMTS13, Shiga toxin, C3/C4 | Within 3 months |
| MG | AChR antibodies | MuSK, LRP4 if AChR-negative | Within 12 months |
| NMOSD | AQP4-IgG (cell-based) | MOG-IgG if negative, MRI | Within 6 months |
Mandatory Safety Requirements
- Meningococcal vaccination: Required ≥2 weeks before treatment initiation
- Vaccination documentation: Provide dates and vaccine types (MenACWY, MenB)
- Informed consent: Document discussion of infection risks
Clinical Documentation Checklist
- Diagnosis confirmation with appropriate labs
- ICD-10 codes (D59.5 for PNH, D59.3 for aHUS, G70.00 for MG, G36.0 for NMOSD)
- Previous treatments and outcomes
- Current symptoms and functional impact
- Weight-based dosing calculations
- Vaccination records
- Signed informed consent
Site of Care and Specialty Pharmacy
Humana doesn't specify required sites of care for Ultomiris in public documents, but coverage typically requires:
Approved Administration Sites
- Hospital outpatient departments
- Certified infusion centers
- Specialty clinics with appropriate monitoring capabilities
Pharmacy Network Requirements
- Must use Humana-contracted specialty pharmacy for drug procurement
- Verify in-network status before ordering
- Some plans may require specific specialty pharmacy partners
Important: Always confirm site-of-care requirements with Humana before scheduling infusions, as requirements may vary by specific plan.
Appeals Process in Ohio
If Humana denies your Ultomiris request, Ohio provides multiple appeal levels with specific timelines.
Internal Appeals (Humana)
- Timeline: 65 days from denial notice to file appeal
- Decision timeframe:
- Part C (medical): 30 days pre-service, 60 days post-service
- Part D (prescription): 7 days standard, 72 hours expedited
- How to file: Online portal, phone, or mail
External Review (Ohio)
- Timeline: 180 days from final Humana denial
- Process: File with your health plan, which notifies Ohio Department of Insurance
- Decision: Independent Review Organization (IRO) provides binding decision
- Timeframe: 30 days standard, 72 hours expedited
Ohio Resources
- Ohio Department of Insurance Consumer Services: 1-800-686-1526
- External Review Request Form: Available on ODI website
- UHCAN Ohio: Consumer advocacy for appeal assistance
For self-funded employer plans (ERISA), federal appeal processes apply, but many voluntarily use Ohio's external review system.
Common Denial Reasons and Solutions
| Denial Reason | Solution | Required Documentation |
|---|---|---|
| Insufficient diagnostic evidence | Submit complete lab results | Flow cytometry, antibody tests, complement genetics |
| Missing vaccination records | Provide immunization documentation | Dates and types of meningococcal vaccines |
| Step therapy not completed | Document medical exception | Contraindication or failure details |
| Non-formulary status | Request formulary exception | Medical necessity letter with clinical rationale |
| Quantity/frequency exceeded | Justify dosing requirements | Weight-based calculations, clinical response data |
Medical Necessity Letter Template
Your letter should include:
- Patient presentation: Diagnosis, symptoms, functional impact
- Diagnostic confirmation: Lab results, imaging, clinical findings
- Treatment history: Previous therapies tried and outcomes
- Clinical rationale: Why Ultomiris is medically necessary
- Guideline support: FDA labeling, specialty society recommendations
- Monitoring plan: Safety assessments, efficacy measures
Cost Assistance Options
Manufacturer Support
- Alexion Access Navigator: Patient assistance program
- Eligibility: Income-based financial assistance
- Coverage: May cover copays, deductibles, or full drug cost
Additional Resources
- Patient Access Network Foundation: Rare disease assistance
- HealthWell Foundation: Complement inhibitor fund (when available)
- State pharmaceutical assistance programs: Ohio may offer additional support
Contact the manufacturer's patient support program at the number provided on their official website for current eligibility requirements.
About Counterforce Health: Counterforce Health specializes in turning insurance denials into successful appeals for specialty medications like Ultomiris. Our platform analyzes denial letters and plan policies to create evidence-backed appeals that address specific payer requirements, helping patients access life-saving treatments faster.
FAQ
How long does Humana's prior authorization process take for Ultomiris? Standard decisions take 30 days for Part C coverage and 7 days for Part D. Expedited reviews are available when delays would seriously endanger health, with decisions within 72 hours.
What if Ultomiris isn't on my Humana formulary? Request a formulary exception by submitting medical necessity documentation showing why covered alternatives are inappropriate. Include clinical rationale and supporting guidelines.
Can I get expedited appeal in Ohio if treatment is urgent? Yes, both Humana and Ohio's external review process offer expedited timelines (72 hours) when delays would seriously jeopardize your health. Your doctor must document the urgency.
Do I need to try Soliris first before Ultomiris? This depends on your specific plan and indication. Some plans require step therapy with eculizumab or biosimilars first, but medical exceptions are available for contraindications or previous failures.
What happens if Ohio's external review upholds the denial? The external review decision is binding on Humana, but you retain rights to seek other remedies, including regulatory complaints or legal action if appropriate.
How do I find an in-network infusion site in Ohio? Use Humana's provider directory online or call member services. Verify both the facility and administering physician are in-network before scheduling.
Sources & Further Reading
- Humana Clinical Pharmacy Review Contact
- Humana Drug Coverage Policies
- Ohio Department of Insurance Consumer Services
- Humana Medicare Appeals Process
- FDA Ultomiris Prescribing Information
Disclaimer: This information is for educational purposes only and does not constitute medical advice. Coverage decisions depend on individual circumstances and specific plan details. Always consult with your healthcare provider and insurance plan for personalized guidance. For official Ohio insurance regulations and appeal procedures, contact the Ohio Department of Insurance.
If you're struggling with a Humana denial for Ultomiris, Counterforce Health can help you build a comprehensive appeal that addresses your plan's specific requirements and maximizes your chances of approval.
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