By Counterforce Health Team in Ultomiris (ravulizumab) —

The Requirements Checklist to Get Ultomiris (ravulizumab) Covered by Aetna (CVS Health) in Michigan: Forms, Appeals, and Approval Timeline

Answer Box: Getting Ultomiris (ravulizumab) Covered by Aetna (CVS Health) in Michigan

Aetna requires prior authorization for Ultomiris (ravulizumab) across all FDA-approved indications (PNH, aHUS, anti-AChR+ myasthenia gravis, AQP4+ NMOSD). Your fastest path to approval: 1) Verify active coverage and specialty pharmacy benefits, 2) Complete Aetna's precertification form (GR-69447) with required lab values and vaccination proof, 3) Submit via provider portal or fax to 1-844-268-7263 at least two weeks before treatment. If denied, you have 127 days to file external review with Michigan DIFS. Start with Aetna's precertification requirements.

Table of Contents

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

Who Should Use This Checklist

This guide helps Michigan patients and their healthcare teams navigate Aetna (CVS Health) coverage for Ultomiris (ravulizumab), a complement inhibitor used to treat rare blood disorders and autoimmune conditions. You'll need this if:

  • Your doctor has prescribed Ultomiris for PNH, aHUS, generalized myasthenia gravis, or NMOSD
  • You've received an Aetna denial letter
  • You're switching from eculizumab (Soliris) to Ultomiris
  • Your clinic needs a systematic approach to prior authorization submissions

Expected outcome: Following this checklist typically results in approval within 30-45 days for standard requests, or 72 hours for expedited appeals when medical urgency is documented.

Member & Plan Basics

Verify Active Coverage

Before starting the prior authorization process, confirm:

  • Active Aetna membership with current ID card
  • Specialty pharmacy benefits (most Ultomiris is handled through CVS Specialty)
  • Medical vs. pharmacy benefit coverage (varies by indication and site of care)
  • Deductible status and out-of-pocket maximum
Tip: Call the member services number on your Aetna ID card to verify specialty drug coverage and any applicable deductibles.

Plan Type Requirements

Plan Type Key Considerations Prior Auth Required
Commercial PPO/HMO Standard PA process; 30-45 day decisions Yes, all indications
Medicare Advantage May have additional step therapy requirements Yes, with Medicare timelines
Medicaid (Aetna Better Health) Different PA forms may apply Yes, verify state-specific criteria

Clinical Criteria by Indication

Aetna requires diagnosis-specific medical necessity documentation for each FDA-approved indication:

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Required Documentation:

  • Flow cytometry showing ≥5% PNH clone on ≥2 cell lineages
  • LDH ≥1.5× upper limit of normal
  • Hemoglobin <10 g/dL with clinical symptoms OR transfusion history ≥2 units in 12 months
  • Evidence of clinical hemolysis despite supportive care

Authorization Period: 12 months for established patients demonstrating benefit

Atypical Hemolytic Uremic Syndrome (aHUS)

Required Documentation:

  • Thrombotic microangiopathy excluding STEC-HUS (negative Shiga toxin required)
  • Thrombocytopenia, schistocytes, elevated creatinine
  • ADAMTS13 testing to exclude TTP
  • Elevated LDH levels

Authorization Period: 6 months initial, 12 months for continuation with evidence of benefit

Anti-AChR Antibody-Positive Generalized Myasthenia Gravis

Required Documentation:

  • Positive acetylcholine receptor antibodies
  • MGFA Class II-IV symptoms
  • MG-ADL score ≥5
  • Inadequate response to ≥2 immunosuppressants for ≥12 months
  • Documentation of prior treatment failures or intolerances

AQP4-Antibody Positive Neuromyelitis Optica Spectrum Disorder

Required Documentation:

  • Positive AQP4-IgG antibodies
  • History of ≥1 attack (optic neuritis, myelitis, etc.)
  • MRI findings consistent with NMOSD
  • Relapse history despite prior therapy

Coding & Billing Requirements

HCPCS and Billing Codes

  • Primary HCPCS Code: J1303 (injection, 10 mg per unit)
  • Billing Units: Total mg ÷ 10 (e.g., 3000 mg = 300 units)
  • Administration Code: CPT 96365 (IV infusion, first hour)
  • Modifiers: JZ (zero drug discarded), RE (FDA REMS compliance)

ICD-10 Codes by Indication

Indication Primary ICD-10 Code Additional Codes
PNH D59.5 Document with flow cytometry results
aHUS D59.3, D59.32, D59.39 Exclude STEC-HUS with appropriate testing
Myasthenia Gravis G70.00, G70.01, G70.02 Use specific antibody-positive codes
NMOSD G36.0 (verify current codes) Include relapse/attack documentation

NDC Numbers for Billing

  • 300 mg/3 mL vial: 25682-0025-01
  • 1100 mg/11 mL vial: 25682-0028-01

Documentation Packet Essentials

Letter of Medical Necessity Components

Your prescriber's letter must include:

  1. Patient identification and insurance details
  2. Diagnosis with ICD-10 code and supporting lab values
  3. Clinical rationale for Ultomiris vs. alternatives
  4. Weight-based dosing justification
  5. Prior treatment history and failures/intolerances
  6. Expected outcomes and monitoring plan
  7. REMS compliance attestation
  8. Meningococcal vaccination status
For Clinicians: Alexion provides indication-specific letter templates that can be customized for your patient's specific clinical situation.

Required Laboratory Documentation

All Indications:

  • Complete blood count with differential
  • Comprehensive metabolic panel
  • LDH levels (current and historical)
  • Vaccination records (MenACWY and MenB series)

Indication-Specific Labs:

  • PNH: Flow cytometry for GPI-deficient clones, haptoglobin levels
  • aHUS: ADAMTS13 activity, complement levels, Shiga toxin testing
  • Myasthenia Gravis: AChR antibody titers, MG-ADL scores
  • NMOSD: AQP4-IgG antibodies, MRI reports

REMS Documentation Requirements

Ultomiris has mandatory REMS requirements due to meningococcal infection risk:

  • Prescriber enrollment in Ultomiris REMS program
  • Patient counseling documentation
  • Vaccination proof (completed ≥2 weeks before treatment)
  • Patient safety card acknowledgment

Submission Process

Aetna Precertification Contacts

Submission Timeline

Submit requests at least two weeks in advance of planned treatment start. Standard precertification decisions typically take 30-45 days, though urgent requests may be expedited.

Required Form Fields

The GR-69447 form requires completion of ALL fields including:

  • Patient demographics and insurance information
  • Clinical diagnosis with ICD codes
  • Product information (loading dose, maintenance dose, frequency)
  • Site of care designation
  • Assessment of adverse events and medical stability
  • Prior authorization for concurrent medications

Specialty Pharmacy Routing

CVS Specialty Coordination

Most Aetna plans route Ultomiris through CVS Specialty pharmacy:

  1. Verify specialty pharmacy benefits and preferred vendors
  2. Coordinate with CVS Specialty for shipment and administration scheduling
  3. Confirm site of care requirements (outpatient hospital, physician office, home infusion)
  4. Schedule delivery to align with treatment appointments
Note: Some plans may allow other specialty pharmacies. Verify your specific plan's preferred network before ordering.

After Submission: What to Expect

Decision Timeline

  • Standard requests: 30-45 days maximum
  • Expedited requests: 72 hours for urgent medical situations
  • Confirmation: You'll receive written notification of approval or denial

Status Tracking

  • Reference number: Record your precertification request number
  • Follow-up schedule: Check status weekly if no response within 30 days
  • Contact information: Keep your prescriber's office contact readily available

What to Document

  • Submission date and method
  • Reference/confirmation numbers
  • Contact person at Aetna (if applicable)
  • Any verbal communications or commitments

Denial Prevention Tips

Five Common Pitfalls and How to Avoid Them

  1. Incomplete vaccination documentation
    • Fix: Submit complete MenACWY and MenB vaccination records with dates
  2. Missing REMS enrollment proof
    • Fix: Ensure prescriber completes REMS program enrollment before submission
  3. Inadequate prior therapy documentation
    • Fix: Include detailed records of previous treatments, doses, duration, and reasons for discontinuation
  4. Weight-based dosing errors
    • Fix: Use Aetna's dosing table and clearly document patient weight and corresponding dose
  5. Site of care restrictions
    • Fix: Verify plan's preferred infusion sites and include justification for chosen location

Appeals Process in Michigan

If Aetna denies your Ultomiris request, Michigan law provides strong appeal rights:

Internal Appeals with Aetna

  • Timeline: File within 180 days of denial
  • Standard decision: 30-45 days
  • Expedited appeal: 72 hours for urgent situations requiring physician documentation

External Review through Michigan DIFS

After exhausting Aetna's internal appeals:

  • Timeline: 127 days from final internal denial to file with DIFS
  • Contact: Michigan Department of Insurance and Financial Services at 877-999-6442
  • Forms: Submit online or use form FIS 0018
  • Decision timeline: 60 days maximum (72 hours for expedited)
  • Cost: Free to patients
  • Binding: DIFS decisions are binding on Aetna
Important: For expedited external review, you need a physician letter stating that delay would seriously jeopardize your health.

Required Appeal Documentation

  • All prior denial letters from Aetna
  • Complete medical records supporting medical necessity
  • Physician letters of support
  • Any new clinical evidence or lab results
  • Insurance policy documentation

Quick Reference Checklist

Before You Start:

  • Verify active Aetna coverage and specialty pharmacy benefits
  • Confirm patient weight for dosing calculations
  • Check meningococcal vaccination status

Clinical Documentation:

  • Diagnosis-specific lab values within required ranges
  • Prior treatment history with outcomes documented
  • Letter of medical necessity on prescriber letterhead
  • REMS program enrollment completed

Submission Package:

  • Completed form GR-69447 with all required fields
  • Supporting clinical documentation
  • Laboratory results and imaging (if applicable)
  • Vaccination records
  • Insurance card copy

After Submission:

  • Record confirmation number and submission date
  • Schedule follow-up for status check
  • Coordinate with specialty pharmacy for approved orders
  • Prepare appeal documentation if needed

Getting personalized help: Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed responses. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeals processes for medications like Ultomiris, ensuring that the right clinical evidence and procedural requirements are met for each specific payer and indication.

From Our Advocates: We've seen Michigan patients successfully overturn Aetna denials for Ultomiris by focusing on three key areas: complete REMS documentation, clear evidence of prior treatment failures, and weight-based dosing justification. The most successful appeals include recent lab values showing disease activity and a detailed timeline of previous complement inhibitor therapy. While outcomes vary by individual clinical circumstances, thorough documentation significantly improves approval chances.

Disclaimer

This guide provides general information about insurance coverage processes and should not be considered medical advice. Coverage decisions depend on individual clinical circumstances and specific plan benefits. Always consult with your healthcare provider about treatment options and work directly with your insurance company for coverage determinations. For questions about Michigan's external review process, contact Michigan DIFS at 877-999-6442.

Sources & Further Reading

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.