By Counterforce Health Team in Oxlumo (lumasiran) —

Florida Blue Cross Blue Shield Coverage for Oxlumo (Lumasiran): Complete Prior Authorization and Appeals Guide 2025

Answer Box: Getting Oxlumo Covered by Florida Blue Cross Blue Shield

Florida Blue requires prior authorization for Oxlumo (lumasiran) with strict medical necessity criteria: confirmed PH1 diagnosis via genetic testing, elevated baseline urinary/plasma oxalate levels, specialist prescriber, and pyridoxine trial (unless contraindicated). Fastest path: Have your nephrologist submit PA via Availity.com with genetic test results, oxalate labs, and clinical notes. Start today: Call Florida Blue at 1-877-719-2583 to verify current PA requirements and download forms from their provider portal.

Table of Contents

  1. Florida Blue's Oxlumo Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. Quantity Limits and Dosing Rules
  5. Required Diagnostics and Lab Values
  6. Site of Care and Administration
  7. Evidence to Support Medical Necessity
  8. Fastest Path to Approval: 7 Steps
  9. Appeals Process for Denials
  10. Common Denial Reasons and Solutions
  11. Cost Assistance Programs
  12. FAQ

Florida Blue's Oxlumo Policy Overview

Florida Blue Cross Blue Shield covers Oxlumo (lumasiran) under the medical benefit as a provider-administered specialty drug for primary hyperoxaluria type 1 (PH1). The policy, effective March 13, 2024, applies to all Florida Blue commercial plans and requires prior authorization before administration.

Key Policy Details:

  • HCPCS Code: J0224 (lumasiran, 0.5 mg)
  • Administration: Subcutaneous injection by healthcare provider
  • Policy Number: Medical Coverage Guideline 09-J3000-91
  • Review Timeline: Standard PA decisions within 14 business days
Note: Florida Blue is an independent Blue Cross Blue Shield plan serving Florida, with approximately 36% of the state's insurance market share.

Medical Necessity Requirements

Florida Blue's Medical Coverage Guideline requires all of the following criteria for initial authorization:

Initial Authorization Criteria

Requirement Specific Details Documentation Needed
PH1 Diagnosis Confirmed primary hyperoxaluria type 1 (genetic testing or elevated urinary/plasma oxalate with clinical confirmation) Genetic test results showing AGXT mutations OR specialist confirmation with elevated oxalate levels
No PH2/PH3 Must rule out primary hyperoxaluria types 2 and 3 Genetic panel results or specialist documentation
No Prior Transplant No previous liver transplant Medical records confirmation
Pyridoxine Status Treatment with vitamin B6 unless contraindicated/intolerant OR combined with pyridoxine Prescription records or contraindication documentation
Prior Authorization History Previous approval by Florida Blue or another plan within past 2 years (if applicable) Claims history or prior approval letters

Reauthorization Requirements

For continued coverage, patients must demonstrate:

  • Prior approval within past 2 years with documentation
  • Documented beneficial response (reduction in urine oxalate excretion or plasma oxalate levels)
  • Continued absence of PH2/PH3
  • Submit laboratory evidence showing treatment response

Step Therapy and Exception Pathways

Florida Blue requires evidence of pyridoxine (vitamin B6) trial before approving Oxlumo, unless specific exceptions apply.

Required First-Line Therapy

  • Pyridoxine (Vitamin B6): Standard starting dose 5-10 mg/kg/day
  • Trial Duration: Typically 3-6 months with documented response assessment
  • Response Measurement: Reduction in 24-hour urinary oxalate excretion

Medical Exception Pathways

Pyridoxine can be bypassed if:

  1. Contraindication: Documented allergy or medical contraindication
  2. Intolerance: Adverse effects preventing continued use
  3. Combination Therapy: Oxlumo prescribed alongside continued pyridoxine
Clinician Tip: Document specific reasons for pyridoxine failure or contraindication in your PA request. Include dosage tried, duration, and specific outcomes or adverse effects.

Quantity Limits and Dosing Rules

Oxlumo dosing follows FDA-approved weight-based protocols with specific quantity limits:

Dosing Schedule by Weight

Body Weight Loading Phase (Monthly × 3) Maintenance Phase (Quarterly)
<10 kg 6 mg/kg 3 mg/kg monthly
10-<20 kg 6 mg/kg 6 mg/kg quarterly
≥20 kg 3 mg/kg 3 mg/kg quarterly

Quantity Limits

  • Maximum Units: 756 billable units (HCPCS J0224) monthly during loading phase
  • Vial Size: 94.5 mg/0.5 mL single-dose vials (NDC: 71336-1002-XX)
  • Renewal: Quarterly authorization required for maintenance dosing

Required Diagnostics and Lab Values

Florida Blue requires specific laboratory evidence to establish medical necessity:

Baseline Laboratory Requirements

  • 24-hour Urinary Oxalate: Must exceed age-specific upper limit of normal (ULN)
  • Spot Urinary Oxalate:Creatinine Ratio: Elevated above age-specific normal ranges
  • Plasma Oxalate: If available, levels >ULN support diagnosis
  • Genetic Testing: AGXT gene sequencing confirming PH1 mutations

Documentation Timeline

  • Labs must be recent (typically within 6 months of PA request)
  • Include reference ranges and collecting laboratory information
  • Provide both baseline and follow-up values for reauthorization
Important: The Alnylam Act PH1 program offers free genetic testing for eligible patients through PreventionGenetics.

Site of Care and Administration

Oxlumo is administered subcutaneously by healthcare professionals with no specific site-of-care restrictions from Florida Blue.

Administration Settings

  • Physician Office: Most common setting
  • Outpatient Hospital: Covered under medical benefit
  • Home Healthcare: With qualified nursing services
  • Infusion Centers: Acceptable but not required

Administration Details

  • Injection Sites: Abdomen, thigh, or upper arms (rotate sites)
  • Multiple Injections: Space ≥2 cm apart if multiple doses needed
  • Post-Dialysis: Administer after hemodialysis on dialysis days
  • Storage: Refrigerated until use; allow to reach room temperature before injection

Evidence to Support Medical Necessity

Strong clinical documentation improves approval chances. Include these evidence types:

Clinical Guidelines and Literature

  • FDA Prescribing Information: Official labeling supports PH1 indication
  • Peer-Reviewed Studies: Phase 3 ILLUMINATE-A trial data showing 71% reduction in urinary oxalate
  • Specialist Society Guidelines: International Primary Hyperoxaluria Registry recommendations

Required Clinical Documentation

  1. Diagnosis Confirmation: Genetic testing results or specialist evaluation
  2. Treatment History: Previous therapies tried, dosages, duration, outcomes
  3. Clinical Rationale: Why Oxlumo is medically necessary for this patient
  4. Monitoring Plan: How treatment response will be assessed
  5. Prognosis: Expected outcomes and treatment goals

Fastest Path to Approval: 7 Steps

Step 1: Confirm Diagnosis and Documentation

Who: Nephrologist or PH1 specialist
Action: Ensure genetic confirmation of PH1 and recent oxalate lab values
Timeline: 1-2 weeks for test results if needed

Step 2: Gather Required Documents

Who: Clinical staff
Action: Collect genetic tests, lab reports, prior therapy records, specialist notes
Timeline: 2-3 business days

Step 3: Submit Prior Authorization

Who: Provider or authorized staff
Action: Submit via Availity.com or fax completed forms
Timeline: Same day submission
Forms: Download from Florida Blue provider portal

Step 4: Include Complete Clinical Narrative

Who: Prescribing physician
Action: Write detailed medical necessity letter addressing all criteria
Timeline: 1-2 hours to prepare

Step 5: Follow Up on Submission

Who: Clinical staff
Action: Confirm receipt and track review status
Contact: 1-877-719-2583 or delegate pharmacy benefit manager
Timeline: 14 business days for standard review

Step 6: Respond to Information Requests

Who: Provider
Action: Promptly provide any additional documentation requested
Timeline: Within 24-48 hours to avoid delays

Step 7: Schedule Administration Upon Approval

Who: Clinical coordinator
Action: Order medication and schedule patient for first injection
Timeline: 1-2 weeks from approval to first dose

Appeals Process for Denials

Florida provides robust appeal rights for denied coverage, including external review options.

Internal Appeal Process

Timeline: File within 180 days of denial notice
Review Period: 30 days for prospective services, 60 days for retrospective
Submission: Use Florida Blue member appeal forms or provider portal

External Review Process

If internal appeals fail, Florida offers independent external review:

Eligibility: Denials based on medical judgment or experimental/investigational determinations
Timeline: Request within 4 months of final internal denial
Process: Administered by MAXIMUS Federal Services for HHS
Contact: 1-888-866-6205 or externalappeal.cms.gov
Cost: Free to patients
Decision: Binding on insurer if favorable

Expedited Appeals

For urgent situations where delays could jeopardize health:

  • Standard: 72-hour decision timeline
  • Bypass: Can skip internal appeal if urgent
  • Documentation: Physician certification of urgency required
From Our Advocates: We've seen PH1 cases succeed in external review when providers included detailed documentation of progressive kidney damage and cited FDA approval as evidence of medical necessity. The key is demonstrating that conservative treatments have failed and that delay in starting Oxlumo could lead to irreversible complications.

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
Insufficient PH1 Confirmation Submit genetic testing results AGXT gene sequencing report from CLIA lab
Pyridoxine Not Tried Document trial or contraindication Prescription records, adverse event notes, or medical contraindication letter
Non-Specialist Prescriber Obtain specialist consultation Nephrology, urology, or genetics consultation note
Inadequate Response Documentation Provide comparative lab values Before/after urinary oxalate levels with dates
Missing Clinical Notes Submit comprehensive chart documentation Complete medical records supporting diagnosis and treatment rationale

Cost Assistance Programs

Oxlumo's high cost (approximately $493,000 annually) makes patient assistance crucial:

Manufacturer Support

Alnylam Assist: Comprehensive support program

  • Benefit verification and PA assistance
  • Copay assistance for eligible commercially insured patients
  • Free drug program for uninsured/underinsured patients
  • Contact: Visit alnylamassist.com or call patient services

Foundation Grants

  • Patient Access Network Foundation: Rare disease assistance
  • HealthWell Foundation: Specialty medication copay support
  • Good Days: Chronic disease financial assistance

State Programs

Florida residents may qualify for additional assistance through state pharmaceutical programs for rare diseases.

FAQ

How long does Florida Blue PA take for Oxlumo?
Standard review is 14 business days. Expedited review (for urgent cases) is completed within 72 hours.

What if Oxlumo is non-formulary on my plan?
Submit a formulary exception request with medical necessity documentation. Florida Blue must cover medically necessary treatments even if non-formulary.

Can I request an expedited appeal if denied?
Yes, if delay in treatment could jeopardize your health. Your physician must certify the urgent medical need.

Does step therapy apply if I failed pyridoxine outside Florida?
Yes, document the previous trial with records from your prior physician. Florida Blue will accept out-of-state treatment history.

What happens if my external review is successful?
Florida Blue must cover the treatment as ordered. The external review decision is binding under federal and state law.

Can I get Oxlumo at home?
Yes, with qualified home nursing services. The medication requires healthcare professional administration but doesn't mandate a specific facility.

Sources & Further Reading

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements and turn insurance denials into successful appeals. Our platform analyzes denial letters, identifies the specific basis for coverage rejection, and generates targeted, evidence-backed appeals that align with each payer's own policies. By pulling the right medical literature citations and weaving them together with required clinical facts, we help ensure patients get access to the treatments they need. Visit counterforcehealth.org to learn how our technology can streamline your appeals process.

This guide provides educational information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare provider about treatment decisions and work with your insurance company directly for coverage determinations. For additional help with insurance issues in Florida, contact the Florida Department of Financial Services Consumer Helpline at 1-877-693-5236.

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