By Counterforce Health Team in Oxlumo (lumasiran) —

How to Get Oxlumo (Lumasiran) Covered by Cigna in Florida: Complete Forms, Appeals & Timeline Guide

Answer Box: To get Oxlumo (lumasiran) covered by Cigna in Florida, you need: (1) confirmed PH1 diagnosis with genetic testing showing biallelic AGXT variants, (2) elevated urinary oxalate levels, and (3) prescription from a nephrologist or urologist. Start by downloading Cigna's Oxlumo Prior Authorization Form and faxing completed documentation to (855) 840-1678. If denied, you have 180 days to appeal internally, then can request external review through Florida's Department of Financial Services.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Diagnosis Confirmed PH1 with biallelic AGXT gene variants or liver biopsy Genetic test report or specialist notes Cigna Policy
Lab Values Urinary oxalate ≥0.5 mmol/24h/1.73 m² or elevated spot ratio Recent lab results Cigna Policy
Prescriber Nephrologist or urologist Provider credentials Cigna Policy
Prior Therapy Pyridoxine trial or contraindication documented Medical records Cigna Policy
Exclusions No liver transplant, no concurrent nedosiran use Provider attestation Cigna Policy

Step-by-Step: Fastest Path to Approval

  1. Verify Insurance Coverage (Patient)
    • Call the number on your Cigna ID card to confirm specialty drug benefits
    • Ask about your plan's formulary tier for Oxlumo and any quantity limits
    • Timeline: 15 minutes
  2. Gather Required Documentation (Clinic)
    • Genetic testing results showing biallelic AGXT mutations
    • Recent urinary oxalate levels (24-hour collection or spot ratio)
    • Documentation of pyridoxine trial or contraindication
    • Complete medical records from specialist
    • Timeline: 1-2 days
  3. Complete Prior Authorization Form (Provider)
    • Download Cigna's Oxlumo PA form
    • Fill all asterisked fields completely
    • Include weight-based dosing calculations
    • Timeline: 30 minutes
  4. Submit Documentation (Provider)
    • Fax completed form and supporting docs to (855) 840-1678
    • For urgent cases, call (800) 882-4462
    • Keep confirmation receipt
    • Timeline: Same day
  5. Follow Up (Patient/Provider)
    • Cigna has 30 days for standard review, 72 hours for expedited
    • Call member services if no response within timeframe
    • Timeline: 3-30 days

Required Forms and Documentation

Primary Authorization Form

The Cigna Oxlumo Prior Authorization Form requires:

  • Patient demographics and insurance information
  • Prescriber details and specialty certification
  • Diagnosis code E72.53 (Primary hyperoxaluria)
  • Weight-based dosing regimen
  • Planned specialty pharmacy (e.g., Accredo, Orsini)

Supporting Documentation Checklist

  • Genetic testing report with biallelic AGXT variants
  • Recent urinary oxalate levels (within 6 months)
  • Specialist consultation notes
  • Documentation of pyridoxine trial or contraindication
  • Current weight and body surface area calculations
  • Complete medical history and prior treatments
Tip: Incomplete forms are the #1 reason for delays. Cigna cannot respond to incomplete submissions due to privacy regulations.

Submission Methods and Contact Information

  • Prior Authorization Fax: (855) 840-1678
  • Appeals Fax: (866) 873-8279
  • Include cover sheet with patient name, DOB, and member ID

Phone Contacts

  • Prior Authorization Line: (800) 882-4462
  • Member Services: Number on back of Cigna ID card
  • Urgent/Expedited Requests: (800) 882-4462 (specify urgency)

Specialty Pharmacy Coordination

Cigna partners with Accredo for Oxlumo fulfillment. Once approved:

  • Accredo will contact patient directly
  • Coordinate delivery and injection training
  • Provide ongoing case management support

Clinician Corner: Medical Necessity Letters

Essential Elements for Approval

When writing medical necessity documentation, include:

  1. Clinical History
    • Age at symptom onset
    • Presenting symptoms (kidney stones, nephrocalcinosis)
    • Family history of hyperoxaluria
  2. Diagnostic Confirmation
    • Genetic testing results with specific AGXT variants
    • Urinary oxalate levels with reference ranges
    • Imaging findings (nephrocalcinosis, stones)
  3. Treatment Rationale
    • Why Oxlumo is medically necessary
    • Expected clinical outcomes (urinary oxalate reduction)
    • Long-term kidney preservation goals
  4. Guideline Support
    • Reference FDA labeling for approved indication
    • Cite relevant nephrology society recommendations
    • Include peer-reviewed literature if applicable
Note: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing payer policies and crafting point-by-point rebuttals with the right clinical evidence and citations.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"No confirmed PH1 diagnosis" Submit genetic testing results Biallelic AGXT variants report
"Insufficient urinary oxalate levels" Provide recent 24-hour collection Lab results ≥0.5 mmol/24h/1.73 m²
"Non-specialist prescriber" Get nephrologist/urologist consultation Specialist evaluation and prescription
"No pyridoxine trial documented" Show prior therapy or contraindication Medical records or allergy documentation
"Experimental/investigational" Cite FDA approval and guidelines FDA label, policy coverage criteria

Appeals Process in Florida

Internal Appeals (Required First Step)

  • Timeline: Must file within 180 days of denial
  • Process: Submit written appeal with supporting evidence
  • Decision: 30 days standard, 72 hours expedited
  • Forms: Use Cigna appeal request form

External Review (After Internal Denial)

From our advocates: We've seen Cigna approvals increase significantly when genetic testing results clearly show biallelic AGXT variants and urinary oxalate levels are well-documented. One common issue is incomplete pyridoxine documentation—make sure to include specific dosing tried and duration, or clear contraindication notes.

When to Escalate to State Regulators

If your appeal is denied or delayed beyond required timeframes, contact:

Florida Department of Financial Services

  • Online: Submit complaint
  • Phone: 1-877-MY-FL-CFO (1-877-693-5236)
  • Services: Mediation, regulatory review, consumer assistance

The state can initiate mediation between you and Cigna, often resolving disputes without formal legal action.

Frequently Asked Questions

How long does Cigna prior authorization take for Oxlumo in Florida? Standard review takes up to 30 days. Expedited review (for urgent medical needs) takes 72 hours. Mark requests as urgent if delay would jeopardize health.

What if Oxlumo is not on Cigna's formulary? File a formulary exception request using Cigna's pharmacy exception form. Include medical necessity documentation and specialist support.

Can I request an expedited appeal in Florida? Yes, if delay would seriously jeopardize your health. Mark all correspondence as "EXPEDITED" and include physician statement supporting urgency.

Does step therapy apply to Oxlumo? Cigna requires documentation of pyridoxine trial or contraindication, but no other step therapy for confirmed PH1 diagnosis.

What happens if my appeal is denied? You can request external review through Florida DFS within 4 months. The external reviewer's decision is binding on Cigna.

How much does Oxlumo cost without insurance? List price is approximately $493,000 annually. Alnylam offers patient assistance programs for eligible patients.

About Coverage Appeals Support

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and payer policies, then drafts point-by-point rebuttals with the right clinical evidence, FDA citations, and procedural requirements for each payer's specific workflow.

Sources & Further Reading

This article is for informational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for personalized guidance. Coverage policies may vary by plan and change over time.

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