By Counterforce Health Team in Oxlumo (lumasiran) —

How to Get Oxlumo (Lumasiran) Covered by Humana in Georgia: Complete Prior Authorization Guide

Quick Answer: Oxlumo Coverage by Humana in Georgia

You can get Oxlumo (lumasiran) covered by Humana if you have confirmed PH1 with genetic testing, elevated urinary oxalate levels >0.7 mmol/24h, and specialist involvement. The fastest path: Have your nephrologist submit prior authorization with AGXT gene results, two 24-hour urine collections, and medical necessity letter. Standard review takes 30 days; expedited takes 72 hours. If denied, you have 65 days to appeal and can request external review through Georgia's Department of Insurance. First step today: Contact your prescribing physician to ensure specialist consultation and gather required lab documentation.

Table of Contents

How to Use This Guide

This guide walks you through Humana's specific requirements for Oxlumo (lumasiran) coverage in Georgia. Start with the eligibility triage below to determine your approval likelihood, then follow the appropriate pathway. Each section includes specific forms, timelines, and contact information verified from official sources.

Note: This guide applies to Humana Medicare Advantage plans. If you have Humana commercial insurance, some requirements may differ—contact Humana at 1-800-555-2546 to verify your specific plan's criteria.

Eligibility Triage: Do You Qualify?

Likely Eligible ✅

  • Confirmed PH1 diagnosis with AGXT genetic testing results
  • Urinary oxalate >0.7 mmol (64 mg)/24 hours on 2+ separate collections
  • Specialist prescriber (nephrologist, urologist, or geneticist)
  • eGFR ≥30 mL/min/1.73 m² OR plasma oxalate >20 µmol/L if eGFR <30
  • No previous liver transplant for PH1

Possibly Eligible ⚠️

  • Clinical suspicion of PH1 but genetic testing pending
  • Elevated urinary oxalate but <2 documented collections
  • Primary care prescriber willing to obtain specialist consultation
  • Some prior conservative management documented

Not Yet Eligible ❌

  • No genetic confirmation of PH1
  • Normal or borderline urinary oxalate levels
  • Secondary causes of hyperoxaluria not excluded
  • Previous liver transplant for PH1

If You're Likely Eligible: Document Checklist

Required Documentation for Humana Prior Authorization:

□ Genetic Testing Report: AGXT gene mutation confirmation
□ Urinary Oxalate Results: Two 24-hour collections showing >0.7 mmol/24h
□ Specialist Consultation: Nephrologist, urologist, or geneticist involvement
□ Medical Necessity Letter: From prescribing specialist (see template below)
□ Insurance Information: Current Humana member ID and policy details
□ Prior Authorization Form: Humana's standard PA form

Submission Process:

  1. Phone: 1-800-555-2546 (Humana Clinical Pharmacy Review)
  2. Fax: 1-800-310-9071
  3. Online: Humana provider portal (verify current link with your physician)

Timeline: 30 days standard review, 72 hours expedited

If You're Possibly Eligible: Tests to Request

Immediate Next Steps:

  1. Request AGXT Genetic Testing: Available through Alnylam Act PH1 program at no cost
  2. Schedule 24-Hour Urine Collections: Need minimum 2 separate collections showing oxalate, glycolate, citrate, calcium, and creatinine
  3. Obtain Specialist Referral: Contact nephrology or urology for PH1 evaluation
  4. Document Conservative Measures: Record any dietary counseling, increased fluid intake, or citrate therapy attempts

Timeline to Re-apply: Allow 4-6 weeks for genetic testing results, then submit PA immediately upon confirmation.

If You're Not Yet Eligible: Alternatives

While Working Toward Approval:

  • Rivfloza (nedosiran): Alternative siRNA therapy for PH1 with eGFR ≥30
  • Conservative Management: Dietary oxalate restriction, increased fluid intake, citrate supplementation
  • Formulary Exception Request: If Oxlumo is non-formulary on your specific plan

Preparing for Exception Requests: Document why covered alternatives are insufficient—include failed conservative measures, contraindications to alternatives, or disease progression despite standard care.

If Denied: Georgia Appeals Process

Internal Appeal (First Level)

  • Deadline: 65 days from denial notice (extended from 60 days as of 2025)
  • Submit to: Same Humana contact as original PA request
  • Required: Denial letter, additional medical evidence, updated specialist letter

External Review (Georgia Department of Insurance)

  • When: After internal appeal denial or concurrent with expedited internal appeal for urgent cases
  • Deadline: 60 days from final internal denial in Georgia
  • Contact: Georgia DOI Consumer Services at 1-800-656-2298
  • Cost: Free to consumer
  • Timeline: 30 business days standard, 72 hours expedited
  • Binding: Yes—Humana must cover if approved
From our advocates: We've seen Georgians successfully overturn Oxlumo denials by emphasizing disease progression risk in external review. The key was submitting kidney imaging showing nephrocalcinosis progression alongside the original genetic testing—this composite approach helped demonstrate urgent medical necessity to the independent reviewers.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before treatment Humana PA list HCPCS J0224
Genetic Testing AGXT mutation confirmation Alnylam Act program Prevention Genetics
Urinary Oxalate >0.7 mmol/24h on 2+ collections Hospital/clinic lab Humana criteria
Specialist Prescriber Nephrologist preferred Provider directory Humana member portal
Kidney Function eGFR ≥30 or plasma oxalate >20 µmol/L Lab results Standard nephrology panel
Authorization Duration 6 months initial, annual renewal PA approval letter Humana policy

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn
Non-specialist prescriber Obtain nephrologist consultation or transfer prescription
Incomplete genetic confirmation Submit complete AGXT gene testing report
Insufficient urinary oxalate documentation Provide 2+ measurements >0.7 mmol/24h
Missing conservative management Document dietary counseling, fluid recommendations, citrate trials
Inadequate medical necessity Include specialist letter emphasizing disease progression risk

Clinician Corner: Medical Necessity Letter

Essential Elements for Humana Approval:

  1. Patient Demographics: Age, weight, eGFR, PH1 confirmation method
  2. Clinical Presentation: Stone history, nephrocalcinosis, renal function decline
  3. Diagnostic Evidence: AGXT mutation details, urinary oxalate levels with dates
  4. Treatment Rationale: FDA-approved indication, disease progression risk
  5. Monitoring Plan: Quarterly dosing schedule, urinary oxalate tracking, renal function monitoring

Key Guidelines to Reference:

Costs & Patient Assistance

Financial Support Options:

  • Alnylam Assist Program: Copay support and free drug for eligible patients—enrollment information
  • Annual List Price: Approximately $493,000 (varies by weight-based dosing)
  • Humana Coverage: Typically 80% after deductible on Medicare Advantage plans
  • State Programs: Georgia has limited specialty drug assistance; check Georgians for a Healthy Future for current options

Counterforce Health helps patients navigate complex prior authorization requirements by analyzing denial letters and crafting evidence-backed appeals. Their platform specializes in turning insurance denials into targeted rebuttals that align with each payer's specific criteria—particularly valuable for rare disease medications like Oxlumo where documentation requirements are extensive.

FAQ

How long does Humana prior authorization take in Georgia? Standard review takes 30 days; expedited review for urgent cases takes 72 hours. You can request expedited review if treatment delay poses serious health risks.

What if Oxlumo is non-formulary on my plan? Request a formulary exception through the same process, emphasizing that covered alternatives are ineffective or contraindicated for your specific condition.

Can I start treatment while the appeal is pending? Humana provides a one-time 30-day transition supply for continuing therapy while pursuing authorization, effective January 2024.

Does step therapy apply to Oxlumo? Most Humana plans don't require step therapy for rare disease medications, but document any prior conservative management attempts to strengthen your case.

What happens if external review approves coverage? Georgia law requires Humana to accept the Department of Insurance decision and provide coverage—the decision is legally binding.

Who can help me with the appeals process in Georgia? Contact Georgia DOI Consumer Services (1-800-656-2298), Georgians for a Healthy Future, or Georgia Legal Services for assistance with complex cases.

Sources & Further Reading

For complex cases requiring detailed appeal strategy, Counterforce Health provides specialized support in transforming insurance denials into successful approvals through evidence-based advocacy tailored to each payer's specific requirements.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan specifics. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For official appeals assistance in Georgia, contact the Georgia Department of Insurance Consumer Services.

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