By Counterforce Health Team in Ultomiris (ravulizumab) —

How to Get Ultomiris (ravulizumab) Covered by UnitedHealthcare in New Jersey: Coding, Appeals, and Step Therapy Exceptions

Answer Box: Getting Ultomiris Covered by UnitedHealthcare in New Jersey

Ultomiris (ravulizumab) requires prior authorization from UnitedHealthcare in New Jersey, with step therapy typically requiring eculizumab (Soliris) or biosimilars first. To get approval: 1) Submit PA with proper ICD-10 codes (D59.5 for PNH, D59.3 series for aHUS), HCPCS J1303 billing, and meningococcal vaccination proof. 2) If denied, file internal appeal citing step therapy exceptions (contraindication, intolerance, or infusion burden). 3) Use New Jersey's IHCAP external review if internal appeals fail—submit within 4 months to Maximus Federal Services. Success rates for external reviews average 40-50% statewide.

Table of Contents

Coding Basics: Medical vs. Pharmacy Benefit

Ultomiris (ravulizumab) is billed under UnitedHealthcare's medical benefit as an infused specialty biologic, not through retail or mail-order pharmacy. This means providers use HCPCS codes and submit medical claims rather than NCPDP pharmacy claims.

Key billing structure:

  • HCPCS Code: J1303 (Injection, ravulizumab-cwvz, 10 mg)
  • Administration: CPT 96365 for initial IV infusion
  • Benefit: Medical (not pharmacy)
  • Site of Care: Hospital outpatient, infusion center, or clinic

UnitedHealthcare may use "medical pharmacy" or white-bagging programs where specialty pharmacies ship the drug to the infusion site, but billing still occurs under the medical benefit using J1303.

ICD-10 Mapping for Ultomiris Indications

Proper diagnosis coding is critical for UnitedHealthcare prior authorization approval. Use these FDA-approved indication codes:

Indication Primary ICD-10 Code Documentation Requirements
Paroxysmal Nocturnal Hemoglobinuria (PNH) D59.5 - Paroxysmal nocturnal hemoglobinuria Flow cytometry confirming PNH clones; hemolysis markers (LDH >1.5x ULN, low haptoglobin)
Atypical Hemolytic Uremic Syndrome (aHUS) D59.32 - Hereditary hemolytic-uremic syndrome
D59.39 - Other hemolytic-uremic syndrome		 Exclude STEC-HUS; document thrombotic microangiopathy; renal function labs
Generalized Myasthenia Gravis (gMG) G70.00 - Myasthenia gravis without exacerbation AChR-antibody positive; MGFA Class II-IV; inadequate response to standard therapies
Neuromyelitis Optica Spectrum Disorder (NMOSD) G36.0 - Neuromyelitis optica AQP4-IgG positive; relapsing disease; prior therapies documented
Tip: UnitedHealthcare policies often reference "all related diagnoses" but require the primary code to match the FDA-approved indication for that patient's condition.

HCPCS/J-Code and NDC Requirements

HCPCS Unit Calculations

J1303 billing units: 1 unit = 10 mg of ravulizumab

  • 300 mg dose = 30 units
  • 3,000 mg dose = 300 units
  • 3,600 mg dose = 360 units (UnitedHealthcare's maximum per administration)

NDC Information

  • 300 mg/30 mL vial: NDC 25682-0025-01 (convert to 11-digit: 25682002501)
  • 1,100 mg/110 mL vial: NDC 25682-0028-01 (convert to 11-digit: 25682002801)
  • Unit of measure: mL (total volume from all vials used)

Required Modifiers

  • JZ: Zero drug amount discarded (when no wastage occurs)
  • JW: Drug amount discarded (document exact mg wasted)
  • RE: REMS compliance (required for meningococcal vaccination documentation)

Clean Prior Authorization Anatomy

A successful UnitedHealthcare PA request for Ultomiris includes these components:

1. Patient Demographics & Insurance

  • UnitedHealthcare member ID and group number
  • Patient name, DOB, and contact information
  • Prescribing physician NPI and specialty

2. Clinical Documentation

  • Diagnosis: Primary ICD-10 code with supporting lab results
  • Weight: Current weight for dose calculation
  • Prior treatments: Document all previous therapies, dates, outcomes
  • Vaccination status: MenACWY and MenB vaccines with dates and lot numbers

3. Dosing Information

  • Loading dose: Weight-based per FDA label
  • Maintenance dose: Every 8 weeks, weight-tiered
  • HCPCS units: Total mg ÷ 10 for each administration
  • Site of care: Where infusions will be administered

4. Medical Necessity Letter

Include these elements in the prescriber's letter:

  • FDA-approved indication with guideline citations
  • Clinical rationale for Ultomiris vs. alternatives
  • Expected outcomes and monitoring plan
  • Step therapy exception rationale (if applicable)

Step Therapy and Biosimilar Preference

UnitedHealthcare typically requires patients to try eculizumab products before approving Ultomiris:

Preferred First-Line Options

  1. Bkemv (eculizumab-aeeb) - biosimilar, preferred
  2. Epysqli (eculizumab-aagh) - biosimilar, preferred
  3. Soliris (eculizumab) - brand, preferred
  4. Ultomiris (ravulizumab) - non-preferred, requires step therapy

Step Therapy Exceptions

You can bypass eculizumab requirements by documenting:

Medical contraindications:

  • Allergy or serious infusion reaction to eculizumab
  • Clinical instability that would worsen with medication switch

Practical barriers:

  • Inability to attend every-2-week infusions (employment, transportation, geography)
  • Prior documented non-adherence due to infusion frequency
  • Caregiver burden that makes frequent visits unsafe

Clinical rationale:

  • Patient already stable on Ultomiris when switching plans
  • Need for extended dosing interval to improve adherence
  • Documented inadequate response to adequate eculizumab trial
From our advocates: We've seen UnitedHealthcare approve Ultomiris without requiring Soliris trials when patients provide detailed documentation of transportation barriers to frequent infusions, especially in rural areas. The key is quantifying the burden—missed work days, travel distance, and impact on caregivers.

Appeals Playbook for New Jersey

If UnitedHealthcare denies your Ultomiris request, New Jersey offers robust appeal rights:

Internal Appeals (UnitedHealthcare)

Timeline: 180 days from denial date Levels: Up to 2 internal appeal levels How to submit: UnitedHealthcare provider portal or member services Expedited option: Available for urgent medical situations (≤72 hours)

External Review (New Jersey IHCAP)

When to use: After exhausting UnitedHealthcare's internal appeals Timeline: Submit within 4 months (180 days) of final internal denial Process: Submit directly to Maximus Federal Services (contracted by NJ DOBI) Cost: Free to patients; insurers pay all review costs Success rate: Approximately 40-50% of external reviews favor consumers

IHCAP External Review Steps

  1. Complete internal appeals with UnitedHealthcare first
  2. Gather documentation: denial letters, medical records, prescriber notes
  3. Submit IHCAP Form A at nj.gov/dobi/division_insurance/ihcseh
  4. Preliminary review: Maximus confirms eligibility within 5 business days
  5. Medical review: Independent physicians review within 45 days
  6. Binding decision: UnitedHealthcare must comply if overturned

Contact for help: NJ DOBI Consumer Hotline 1-800-446-7467 or IHCAP-specific line 1-888-393-1062

Common Denial Reasons & Fixes

Denial Reason How to Fix Documentation Needed
Step therapy not met Provide exception rationale Prior eculizumab trial/failure OR contraindication letter
Missing vaccination Submit vaccination records MenACWY and MenB dates, lot numbers, provider attestation
Diagnosis not confirmed Strengthen clinical evidence Flow cytometry (PNH), complement studies (aHUS), antibody tests (MG/NMOSD)
Dosing exceeds policy Verify weight-based calculation Current weight, dose calculation worksheet, FDA label reference
Not medically necessary Enhanced medical necessity letter Guideline citations, clinical outcomes data, monitoring plan
Site of care restriction Confirm approved locations UnitedHealthcare provider directory, site credentialing verification

Costs and Patient Support

Manufacturer Support

Alexion Access Navigator provides:

  • Benefits investigation and prior authorization support
  • Appeal letter templates and clinical evidence
  • Patient assistance programs for eligible patients
  • Copay support cards (restrictions may apply)

Contact: alexionaccessnavigator.com or 1-888-765-4747

State and Foundation Resources

  • New Jersey Medicaid: Covers Ultomiris for eligible patients under medical benefit
  • Patient advocacy organizations: Many rare disease foundations offer grant programs
  • 340B programs: Available at qualifying hospitals and clinics

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to draft point-by-point rebuttals with the right clinical evidence and procedural requirements, making the appeals process more efficient for both patients and providers.

FAQ

How long does UnitedHealthcare prior authorization take in New Jersey? Standard PA reviews take 5-14 business days. Expedited reviews for urgent cases are completed within 72 hours. Submit complete documentation to avoid delays.

What if Ultomiris is non-formulary on my UnitedHealthcare plan? Non-formulary drugs can be covered through medical exceptions. Submit enhanced medical necessity documentation and consider Counterforce Health's appeal assistance for complex cases.

Can I request expedited appeal if my condition is worsening? Yes. UnitedHealthcare offers expedited internal appeals for urgent situations. New Jersey's IHCAP also provides expedited external review when delays could cause serious harm.

Does step therapy apply if I was stable on Ultomiris with another insurer? Document your stability and provide clinical rationale for why switching to eculizumab could cause destabilization. This often qualifies as a step therapy exception.

What happens if UnitedHealthcare approves only partial dosing? Appeal the partial approval with weight-based dose calculations and FDA labeling. Include prescriber attestation that the full dose is medically necessary.

How do I find UnitedHealthcare-approved infusion centers in New Jersey? Use the UnitedHealthcare provider directory online or call member services. Confirm the facility is credentialed for specialty infusions and has experience with complement inhibitors.

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 terms and medical circumstances. Always consult with healthcare providers and insurance representatives for case-specific guidance. For additional support with complex appeals, consider professional advocacy services like Counterforce Health.

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