By Counterforce Health Team in Oxlumo (lumasiran) —

How to Get Oxlumo (lumasiran) Covered by UnitedHealthcare in New Jersey: Complete Coding, Appeals, and External Review Guide

Answer Box: Getting Oxlumo (lumasiran) Covered by UnitedHealthcare in New Jersey

UnitedHealthcare requires prior authorization for Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1), with coverage based on genetic confirmation, specialist prescribing, and documented oxalate elevation. If denied, you have internal appeals followed by New Jersey's IHCAP external review program. First step today: Have your nephrologist submit a PA request through the UHC Provider Portal with genetic testing results and baseline urinary oxalate levels. Appeals must be filed within 180 days, with external review available within 4 months of final denial.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit
  2. ICD-10 Mapping for Primary Hyperoxaluria
  3. Product Coding: HCPCS, J-Codes, and NDC
  4. Clean Prior Authorization Anatomy
  5. Frequent Coding Pitfalls
  6. Verification with UnitedHealthcare Resources
  7. Appeals Playbook for New Jersey
  8. Quick Audit Checklist

Coding Basics: Medical vs. Pharmacy Benefit

Oxlumo (lumasiran) is typically covered under UnitedHealthcare's medical benefit as a provider-administered injectable. Understanding this distinction is crucial for proper coding and authorization.

Medical Benefit Coverage

  • HCPCS J-code: J0224 (Injection, lumasiran, 0.5 mg)
  • Administration: Subcutaneous injection by healthcare provider
  • Billing: Professional or facility claims using J0224
  • Prior Authorization: Medical drug PA through UHC Provider Portal

UnitedHealthcare's Site of Care policy specifically lists Oxlumo for site-of-care management, confirming medical benefit coverage.

Key Coverage Requirements

Requirement Details Documentation Needed
Diagnosis Primary hyperoxaluria type 1 (PH1) Genetic testing, specialist confirmation
Prescriber Nephrologist or PH1 specialist Provider credentials, consultation notes
Baseline Data Elevated urinary/plasma oxalate Lab reports with dates
No Liver Transplant Confirmed absence Medical history documentation

ICD-10 Mapping for Primary Hyperoxaluria

Proper diagnosis coding is essential for UnitedHealthcare approval. The primary code for PH1 is E74.82 (Hyperoxaluria).

Primary Diagnosis Code

E74.82 - Hyperoxaluria

  • Includes primary hyperoxaluria type 1
  • Requires documentation of genetic/primary etiology
  • Must exclude secondary causes

Supporting Documentation Language

Your medical records should include specific terminology:

  • "Primary hyperoxaluria type 1 due to AGXT mutation"
  • "Bi-allelic pathogenic variants in AGXT gene"
  • "Genetic confirmation of PH1"
  • "Autosomal recessive inheritance pattern"

Additional Codes for Complications

  • N20.0 - Calculus of kidney
  • N18.1-N18.6 - Chronic kidney disease (specify stage)
  • Z94.0 - Kidney transplant status (if applicable)
  • N26.9 - Unspecified contracted kidney
Tip: Document that secondary hyperoxaluria causes (malabsorption, high oxalate intake, inflammatory bowel disease) were evaluated and excluded.

Product Coding: HCPCS, J-Codes, and NDC

HCPCS J-Code Details

J0224 - Injection, lumasiran, 0.5 mg

  • Billing unit: 1 unit = 0.5 mg lumasiran
  • Effective date: July 1, 2021 (replaced temporary codes)
  • Unit calculation: Total mg dose ÷ 0.5 = units to bill

NDC Information

Primary NDC: 71336-1002-01

  • Strength: 94.5 mg/0.5 mL single-dose vial
  • Format: 11-digit NDC required on claims
  • Units: "UN1" for one vial (standard format)

Dosing and Unit Calculations

Oxlumo follows weight-based dosing per FDA labeling:

Loading Phase (first 3 months):

  • <10 kg: 6 mg/kg monthly
  • 10-20 kg: 6 mg/kg monthly
  • ≥20 kg: 3 mg/kg monthly

Maintenance Phase:

  • <10 kg: 3 mg/kg monthly
  • 10-20 kg: 6 mg/kg quarterly
  • ≥20 kg: 3 mg/kg quarterly

Example Calculation: 70 kg adult maintenance dose

  • 70 kg × 3 mg/kg = 210 mg total dose
  • 210 mg ÷ 0.5 mg per unit = 420 units of J0224

Clean Prior Authorization Anatomy

A successful UnitedHealthcare PA request includes these essential elements:

Required Clinical Documentation

  1. Genetic Confirmation
    • AGXT gene testing results
    • Bi-allelic pathogenic variants identified
    • Laboratory report with interpretation
  2. Baseline Disease Markers
    • 24-hour urinary oxalate levels
    • Plasma oxalate (if available)
    • eGFR and kidney function tests
    • Imaging showing nephrocalcinosis/stones
  3. Specialist Assessment
    • Nephrologist or geneticist evaluation
    • Treatment rationale and goals
    • Monitoring plan
  4. Prior Treatment History
    • Conservative measures attempted
    • High fluid intake, citrate therapy
    • Vitamin B6 trial (if applicable)
    • Response or reasons for inadequacy

PA Form Completion

Submit through the UHC Provider Portal using the medical drug PA pathway. Key sections to complete:

  • Diagnosis: E74.82 with PH1 specification
  • Drug Details: Oxlumo (lumasiran), weight-based dosing
  • Clinical Rationale: Medical necessity statement
  • Supporting Documents: Attach all clinical records

Frequent Coding Pitfalls

Unit Conversion Errors

Common Mistake: Billing mg instead of 0.5 mg units Correct Approach: Always divide total mg by 0.5 for J0224 units

Example: 94.5 mg dose = 189 units (not 94.5 units)

Mismatched Diagnosis Codes

Avoid: Generic "kidney stones" (N20.0) without PH1 context Use: E74.82 as primary with supporting stone codes

Missing Start Dates

UnitedHealthcare requires specific treatment start dates for authorization periods. Include:

  • Requested start date
  • Loading phase timeline
  • Maintenance schedule transition

NDC Format Issues

Required: 11-digit NDC format (71336-1002-01) Units: Specify "UN" for unit-based billing Quantity: Match vial count to calculated dose

Verification with UnitedHealthcare Resources

Before submitting your PA, verify requirements using official UHC resources:

Policy Verification

  1. Access Current Policy: Review UnitedHealthcare's Oxlumo Medical Drug Policy
  2. Check Plan-Specific Requirements: Confirm if Exchange, commercial, or community plan policies differ
  3. Formulary Status: Verify tier placement and any step therapy requirements

Coverage Confirmation Steps

Call Member Services: Use the number on the insurance card

  • Ask: "Is Oxlumo (lumasiran) J0224 covered under medical benefit?"
  • Confirm: Prior authorization requirements
  • Verify: Preferred specialty pharmacy or buy-and-bill options

Provider Portal Check:

  • Login to UHC Provider Portal
  • Navigate to Coverage & Benefits
  • Search "Oxlumo lumasiran" under Medical Injectable

Appeals Playbook for New Jersey

If UnitedHealthcare denies your Oxlumo request, New Jersey offers robust appeal rights through internal processes and external review.

Internal Appeals Process

First-Level Appeal (180 days from denial)

  1. Request Denial Details: Obtain written adverse determination with specific criteria not met
  2. Gather Additional Evidence:
    • Enhanced specialist letter addressing denial reasons
    • Updated lab values showing disease progression
    • Peer-reviewed literature supporting medical necessity
  3. Submit Written Appeal: Include point-by-point rebuttal of denial reasons
  4. Request Peer-to-Peer: Ask for medical director consultation

Timeline: 30-60 days for standard review, 72 hours for urgent cases

New Jersey IHCAP External Review

After exhausting internal appeals, New Jersey's Independent Health Care Appeals Program (IHCAP) provides independent medical review.

Eligibility Requirements:

  • Completed UnitedHealthcare internal appeals
  • Fully insured plan subject to NJ law
  • Filed within 4 months of final internal denial

IHCAP Process:

  1. Submit Application: Contact NJ Department of Banking and Insurance at 1-888-393-1062
  2. Independent Review: Board-certified specialists review medical necessity
  3. Binding Decision: If overturned, UnitedHealthcare must provide coverage

Success Factors for IHCAP:

  • Complete medical records with genetic confirmation
  • Specialist letter explaining unique medical necessity
  • Documentation of failed alternatives or contraindications
  • Evidence of disease progression without treatment
Note: IHCAP reviews are free to patients, with insurers bearing all costs.

When to Request Expedited Review

Request urgent review if delay would cause:

  • Rapid kidney function decline
  • Imminent need for dialysis
  • Risk of irreversible organ damage

Documentation Required: Physician attestation of urgent medical need

Quick Audit Checklist

Before submitting your Oxlumo PA or appeal, verify:

Clinical Documentation ✓

  • Genetic testing confirming PH1 (AGXT mutation)
  • Baseline urinary oxalate levels with dates
  • Specialist evaluation by nephrologist/geneticist
  • Documentation of conservative treatment attempts
  • Current kidney function (eGFR)
  • Confirmation of no liver transplant

Coding Accuracy ✓

  • Primary diagnosis: E74.82 (Hyperoxaluria)
  • HCPCS code: J0224 for lumasiran
  • Correct unit calculation (mg ÷ 0.5)
  • Proper NDC format: 71336-1002-01
  • Weight-based dosing per FDA label

Administrative Requirements ✓

  • PA submitted through UHC Provider Portal
  • All supporting documents attached
  • Requested start date specified
  • Loading and maintenance phases outlined
  • Provider NPI and credentials included

Appeal Preparation ✓

  • Denial letter with specific reasons obtained
  • Additional clinical evidence gathered
  • Specialist rebuttal letter prepared
  • Appeal deadline calculated (180 days)
  • IHCAP eligibility confirmed for NJ residents

Manufacturer Support Options

Alnylam Assist offers comprehensive support for Oxlumo access:

  • Benefit Verification: Insurance coverage analysis
  • Prior Authorization Support: Clinical documentation assistance
  • Patient Assistance Program: Free drug for eligible patients
  • Appeal Support: Case management during denial process

Eligibility: Primarily uninsured patients, with some underinsured exceptions based on income and coverage gaps.

FAQ: Common Questions About Oxlumo Coverage in New Jersey

How long does UnitedHealthcare PA take in New Jersey? Standard review: 5-14 business days. Expedited review: 24-72 hours for urgent cases.

What if Oxlumo is non-formulary on my plan? Request formulary exception with medical necessity documentation. Step therapy requirements may apply.

Can I request expedited appeal if denied? Yes, if your physician certifies that delay would seriously jeopardize your health or ability to regain function.

Does step therapy apply if I failed treatments outside New Jersey? Prior treatment history from any state counts. Provide complete documentation of failed alternatives.

What happens if IHCAP overturns UnitedHealthcare's denial? Coverage is mandatory and binding. UnitedHealthcare must provide retroactive coverage for the review period.

How much does external review cost in New Jersey? IHCAP reviews are free to patients. Insurance companies pay all administrative costs.

About Counterforce Health

Counterforce Health transforms insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical evidence to create targeted, evidence-backed responses. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeal processes, turning "no" into "yes" through systematic, data-driven advocacy.

Sources & Further Reading

This guide is for informational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with healthcare providers and insurance representatives for personalized guidance. For additional support with insurance appeals in New Jersey, contact the NJ Department of Banking and Insurance Consumer Hotline at 1-800-446-7467.

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