The Requirements Checklist to Get Oxlumo (Lumasiran) Covered by Humana in Texas: Complete Prior Authorization Guide
Answer Box: Getting Oxlumo (Lumasiran) Covered by Humana in Texas
Oxlumo requires prior authorization from Humana for all members. The fastest path to approval: (1) Confirm PH1 diagnosis with genetic testing or specialist documentation, (2) Submit PA through Humana provider portal with elevated urinary oxalate labs (>0.7 mmol/24h), and (3) Ensure a specialist (nephrologist, endocrinologist, or geneticist) prescribes or provides consultation. Standard review takes 30 days; expedited review 72 hours for urgent cases. If denied, Texas residents have strong appeal rights including independent external review through the Texas Department of Insurance.
Table of Contents
- Who Should Use This Checklist
- Member & Plan Basics
- Clinical Criteria Requirements
- Coding and Billing Requirements
- Documentation Packet Essentials
- Submission Process
- Specialty Pharmacy Coordination
- After Submission: Tracking and Follow-up
- Common Denial Prevention Tips
- Texas Appeals Process
- Quick Reference Checklist
Who Should Use This Checklist
This checklist is designed for patients with primary hyperoxaluria type 1 (PH1) and their healthcare teams seeking Humana coverage for Oxlumo (lumasiran) in Texas. You'll need this if:
- You've been diagnosed with PH1 and your doctor recommends Oxlumo
- Your initial prior authorization was denied
- You're preparing to switch to Humana and want coverage continuity
- Your current authorization is expiring and needs renewal
Expected outcome: Following this checklist increases your chances of first-time approval and helps you avoid the most common denial reasons that delay treatment access.
Member & Plan Basics
Verify Active Coverage
Before starting the prior authorization process, confirm:
- Your Humana membership is active and current
- You understand your specific plan type (Medicare Advantage, commercial, or Medicaid managed care)
- Your prescription drug benefits are included in your plan
Authorization Requirements
Oxlumo requires prior authorization for all Humana members before treatment initiation. The drug is listed on Humana's Medicare Advantage preauthorization list under code J0224.
Coverage Timeline:
- Initial authorization: 6 months
- Renewal: Annual with response documentation required
Clinical Criteria Requirements
Primary Indication
Oxlumo is FDA-approved for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate in pediatric and adult patients. Your diagnosis must be confirmed through:
Genetic Testing (Gold Standard):
- AGXT gene mutation confirmation with documented variants
- Most common mutations: p.Gly170Arg (28-30% of cases) or c.33dupC
Biochemical Confirmation:
- 24-hour urine collection showing elevated urinary oxalate >0.7 mmol (64 mg)/24 hours on at least 2 assessments
- For patients with eGFR <30 mL/min/1.73 m²: plasma oxalate level >20 µmol/L
Specialist Requirements
Most Humana policies require specialist involvement:
- Nephrologist (preferred for PH1 management)
- Endocrinologist
- Geneticist
- Urologist with rare disease experience
Note: While primary care physicians can technically prescribe Oxlumo, specialist consultation significantly improves approval odds.
Prior Therapy Documentation
Document conservative management attempts and outcomes:
- Dietary oxalate restriction counseling
- Increased fluid intake recommendations
- Citrate therapy trials (if applicable)
- Any previous treatments and reasons for discontinuation
Coding and Billing Requirements
Essential Codes
| Code Type | Code | Description | Source |
|---|---|---|---|
| HCPCS J-code | J0224 | Oxlumo (lumasiran) injection | Humana PA List |
| ICD-10 | E72.530 | Primary hyperoxaluria type 1 | Billing Guide |
Dosing and Administration
- Weight-based subcutaneous dosing
- Loading phase: Monthly × 3 doses
- Maintenance: Quarterly dosing
- Healthcare provider-administered in clinical setting
Required Modifiers
For Medicare claims, include appropriate drug waste modifiers:
- JW modifier: Drug amount discarded/not administered
- JZ modifier: Zero drug amount discarded/not administered
Documentation Packet Essentials
Provider Note Elements
Your specialist's clinical note should include:
Patient History:
- Date of PH1 diagnosis
- Genetic testing results with specific AGXT mutations
- Baseline urinary oxalate levels (mmol/24hr/1.73m²)
- Current kidney function (eGFR)
- Family history of PH1 or kidney stones
Clinical Assessment:
- Current symptoms and disease impact
- Risk of disease progression without treatment
- Previous treatment attempts and outcomes
Treatment Plan:
- Rationale for Oxlumo selection
- Expected treatment goals (target ≥30% reduction in urinary oxalate)
- Monitoring plan for treatment response
Letter of Medical Necessity Components
A comprehensive medical necessity letter should address:
- Patient identification and confirmed PH1 diagnosis
- Clinical rationale citing FDA approval and clinical trial data showing 65-75% urinary oxalate reduction
- Treatment history documenting conservative management attempts
- Monitoring plan with specific biochemical targets
- Urgency factors related to kidney function preservation
Alnylam provides a sample medical necessity letter template that can be customized for individual patients.
Required Attachments
- Complete genetic testing report
- Recent urinary oxalate measurements (baseline and follow-up if available)
- Specialist consultation notes
- Relevant imaging (ultrasound, CT showing nephrocalcinosis if present)
- Insurance card and policy information
Submission Process
Submission Methods
Prior authorization requests can be submitted through multiple channels:
Primary Methods:
- Fax: 502-508-9300
- Phone: 866-421-5663 (Monday-Friday, 7 a.m.-7 p.m. Central time)
- Online: Humana provider portal (verify current link with your provider)
Timeline Expectations
- Standard review: Up to 30 days
- Expedited review: 72 hours for urgent medical situations
Common Rejection Causes
Ensure your submission avoids these frequent issues:
- Incomplete genetic testing documentation
- Missing specialist consultation or prescription
- Inadequate baseline urinary oxalate measurements
- Unclear documentation of conservative management attempts
Specialty Pharmacy Coordination
Humana's Preferred Network
Oxlumo is distributed through CenterWell Specialty Pharmacy, Humana's specialty pharmacy service, with additional distribution partners including:
- PANTHERx Specialty Pharmacy
- Orsini Specialty Pharmacy
- McKesson Specialty Care
Patient Enrollment Process
Once prior authorization is approved:
- Contact CenterWell Specialty Pharmacy: 1-800-486-2668 (TTY: 711)
- Verify prescription transfer from prescribing specialist
- Complete enrollment and delivery preferences
- Coordinate administration at approved healthcare facility
Operating Hours: Monday–Friday 8 a.m. to 11 p.m. and Saturday 8 a.m. to 6:30 p.m. Eastern time
Shipment Verification
- Confirm delivery address and timing
- Verify cold-chain storage requirements are met
- Coordinate with administering healthcare provider for appointment scheduling
After Submission: Tracking and Follow-up
Confirmation and Tracking
- Record your PA reference number immediately after submission
- Save submission confirmation (email or fax confirmation)
- Set calendar reminders for follow-up if no response within expected timeframe
Status Check Schedule
- Day 7: Initial status check if no acknowledgment received
- Day 20: Follow-up call for standard review timeline
- Day 25: Escalation preparation if approaching 30-day deadline
Documentation to Maintain
Keep organized records of:
- All submission confirmations
- Phone call logs with reference numbers
- Any additional documentation requests
- Correspondence with specialty pharmacy
Common Denial Prevention Tips
Five Critical Pitfalls and Solutions
- Non-specialist prescriber
- Fix: Obtain specialist consultation or transfer prescription to nephrologist/endocrinologist
- Incomplete genetic confirmation
- Fix: Submit complete AGXT testing report or arrange testing through Alnylam Act PH1 program
- Insufficient urinary oxalate documentation
- Fix: Provide at least 2 measurements showing levels >0.7 mmol/24h
- Missing conservative management documentation
- Fix: Document dietary counseling attempts and any citrate therapy trials
- Inadequate medical necessity justification
- Fix: Include specialist letter emphasizing disease progression risk and FDA-approved indication
From our advocates: We've seen cases where initial denials were overturned simply by adding a single page documenting the patient's trial of dietary oxalate restriction. Don't assume your doctor's notes are sufficient—be specific about what conservative measures were attempted and why they weren't adequate.
Texas Appeals Process
If your initial prior authorization is denied, Texas provides strong patient appeal rights:
Internal Appeal (First Level)
- Deadline: 65 days from denial notice
- Submission: Written appeal via Humana member portal or mail
- Timeline: 30 days standard, 72 hours expedited
- Required: Original PA request, denial letter, additional supporting evidence
Peer-to-Peer Review
- Often available during internal appeal process
- Involves direct discussion between prescribing specialist and Humana medical director
- Request through provider relations or medical management department
External Independent Review
If internal appeal is denied, Texas law provides access to independent external review:
- Deadline: 4 months from final internal denial
- Process: Texas Department of Insurance coordinates Independent Review Organization (IRO)
- Timeline: 20 days for standard review, 5 days for urgent cases
- Cost: Paid by Humana, not the patient
- Decision: Binding on Humana if overturned
Texas-Specific Resources
- Texas Department of Insurance: 1-800-252-3439
- Office of Public Insurance Counsel (OPIC): 1-877-611-6742
- IRO Information Line: 1-866-554-4926
Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform ingests denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each plan's specific requirements, pulling the right citations for medications and weaving them into appeals with required clinical facts.
Quick Reference Checklist
Before You Start
- Active Humana membership confirmed
- PH1 diagnosis with genetic testing or specialist documentation
- Urinary oxalate measurements >0.7 mmol/24h (at least 2 assessments)
- Specialist consultation or prescription
- Conservative management documentation
Required Documents
- Completed prior authorization form
- Medical necessity letter from specialist
- Genetic testing report (AGXT mutations)
- Urinary oxalate lab results
- Specialist consultation notes
- Insurance card copy
Submission Details
- Correct codes: J0224 (HCPCS), E72.530 (ICD-10)
- Submitted via Humana provider portal, fax (502-508-9300), or phone (866-421-5663)
- Confirmation number recorded
- Follow-up calendar reminders set
After Approval
- CenterWell Specialty Pharmacy contacted (1-800-486-2668)
- Prescription transfer verified
- Administration site and timing coordinated
- Renewal timeline noted (annual)
Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical or legal advice. Coverage policies vary by plan and individual circumstances. Always consult with your healthcare provider about treatment decisions and verify current coverage details with Humana directly.
For additional assistance with Texas insurance appeals, contact the Texas Department of Insurance at 1-800-252-3439 or the Office of Public Insurance Counsel at 1-877-611-6742.
Counterforce Health's platform specializes in turning insurance denials into successful appeals by identifying denial basis and drafting evidence-backed rebuttals aligned to each payer's specific policies. Learn more at counterforcehealth.org.
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