By Counterforce Health Team in Oxlumo (lumasiran) —

Get Oxlumo (Lumasiran) Covered by Aetna CVS Health in Florida: Complete Guide with Forms and Appeals

Answer Box: Get Oxlumo Covered by Aetna in Florida

Yes, Aetna CVS Health covers Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1) in Florida with prior authorization. The fastest path to approval requires: (1) confirmed PH1 diagnosis via genetic testing or liver enzyme analysis, (2) prescription from a nephrology or genetics specialist, and (3) completed Aetna Oxlumo precertification form. No step therapy required. Standard approval takes 15 business days; expedited reviews (urgent cases) get decisions within 72 hours. If denied, Florida members have 180 days to appeal internally, then 4 months for external review.

First step today: Contact your nephrologist or request a referral to confirm PH1 diagnosis and initiate the precertification process.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Diagnostic Requirements
  5. Costs and Specialty Pharmacy
  6. Denials and Appeals in Florida
  7. Renewals and Continuing Coverage
  8. Common Questions
  9. When to Escalate

Coverage Basics

Is Oxlumo Covered by Aetna?

Aetna CVS Health covers Oxlumo (lumasiran) as a specialty medication requiring prior authorization for patients with confirmed primary hyperoxaluria type 1 (PH1). The drug is not on standard formulary tiers but is available through Aetna's specialty pharmacy network when medical necessity criteria are met.

Which Aetna Plans Cover Oxlumo?

Coverage applies across Aetna's Florida plans including:

  • Commercial PPO and HMO plans
  • Medicare Advantage plans
  • Medicaid managed care plans (Aetna Better Health Florida)

Note: HMO plans require a specialist referral before submitting prior authorization, while PPO plans allow direct specialist access.

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Confirm PH1 Diagnosis (Patient + Specialist)
  2. Specialist Consultation (Patient)
    • See nephrology or genetics specialist (required for authorization)
    • Gather clinical documentation and treatment history
    • Timeline: 1-2 weeks for appointment
  3. Complete Precertification Form (Specialist's Office)
  4. Submit to Aetna (Specialist's Office)
    • Fax: 888-267-3277
    • Phone: 866-752-7021
    • Online: Aetna provider portal
    • Timeline: Same day submission
  5. Aetna Review (Automated)
    • Standard review: 15 business days
    • Expedited review: 72 hours (if urgent)
    • Acknowledgment within 5 business days
  6. Specialty Pharmacy Setup (If Approved)
    • Coordinate with CVS Specialty Pharmacy
    • Complete enrollment and insurance verification
    • Timeline: 3-5 business days
  7. First Dose Administration (Healthcare Provider)
    • Schedule at approved healthcare facility
    • Timeline: 1-2 weeks after pharmacy coordination
Tip: Request expedited review if your kidney function is declining rapidly or you have active stone formation. Document the urgency in your submission.

Timing and Urgency

Standard Timeline

  • Prior authorization decision: Up to 15 business days from complete submission
  • Acknowledgment: Within 5 business days of receipt

Expedited Review

  • When available: Immediate health risk or rapid kidney function decline
  • Decision timeline: Within 72 hours of request
  • How to request: Note urgency on precertification form and call 866-752-7021

What Counts as Urgent?

According to Aetna's policy:

  • Progressive kidney function decline
  • Recurrent kidney stone formation
  • Severe hyperoxaluria with complications

Diagnostic Requirements

Confirming PH1 Diagnosis

Aetna requires one of the following for coverage approval:

Diagnostic Method What's Required Where to Get It
Genetic Testing Pathogenic or likely pathogenic biallelic AGXT gene mutations Nephrology/genetics specialist order
Liver Enzyme Analysis Absent or significantly reduced alanine:glyoxylate aminotransferase (AGT) activity Specialized metabolic lab

Specialist Requirements

  • Required: Prescription from nephrology or genetics specialist
  • Documentation needed: Clinical notes confirming PH1 diagnosis and treatment rationale
  • Genetic counseling: Recommended for family planning and cascade testing
Note: Some patients may qualify for no-cost genetic testing through Alnylam Act program if eligibility criteria are met.

Costs and Specialty Pharmacy

Formulary Status and Costs

Oxlumo is classified as a specialty tier medication by Aetna, meaning:

  • Coinsurance: Typically 20-40% of drug cost (not flat copay)
  • Annual out-of-pocket maximum: Applies to specialty tier costs
  • Pharmacy: Must use CVS Specialty or approved specialty pharmacy

Cost-Saving Options

  • Manufacturer support: Alnylam Assist program for eligible patients
  • Copay assistance: May be available through patient advocacy foundations
  • Prior authorization: Essential to avoid full retail cost (~$493,000 annually)

Why Specialty Pharmacy?

Oxlumo requires special handling including:

  • Cold storage and shipping
  • Healthcare provider administration
  • Insurance coordination and benefits verification
  • Patient education and support services

Denials and Appeals in Florida

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
No PH1 confirmation Submit genetic test results or liver enzyme analysis AGXT mutation report or AGT enzyme activity
Non-specialist prescriber Transfer prescription to nephrologist/geneticist Specialist consultation notes
Insufficient clinical documentation Provide complete medical history and treatment rationale Chart notes, lab results, imaging
"Not medically necessary" Submit peer-reviewed evidence and FDA labeling Clinical studies, treatment guidelines

Florida Appeal Process

Internal Appeal (First Level)

  • Filing deadline: 180 days from denial letter
  • Decision timeline: 30 days (standard) or 72 hours (expedited)
  • How to file: Follow instructions in denial letter
  • Required: Written request with supporting documentation

External Review (Second Level)

  • Eligibility: After internal appeal denial, if financial responsibility exceeds $500
  • Filing deadline: 4 months after final internal denial
  • Decision timeline: 30 days (standard) or 72 hours (expedited)
  • Process: Independent medical review by board-certified specialist
  • Cost: Free to patient
  • Decision: Binding on Aetna
Florida-Specific: Contact Florida Department of Financial Services at 1-877-693-5236 for assistance with appeals or complaints.

Appeal Scripts

For calling Aetna member services: "I'm calling to appeal the denial of Oxlumo for my primary hyperoxaluria type 1. I have genetic confirmation of PH1 and my nephrologist has documented medical necessity. I'd like to request an expedited internal appeal due to my declining kidney function."

For peer-to-peer review request: "I'm requesting a peer-to-peer review for Oxlumo denial. The patient has genetically confirmed PH1 with progressive nephropathy. Current guidelines support early intervention with lumasiran to prevent irreversible kidney damage."

Renewals and Continuing Coverage

When to Renew

  • Timeline: Before 12-month authorization expires
  • Advance notice: Submit renewal 30-60 days before expiration
  • Automatic reminders: CVS Specialty typically provides renewal alerts

Renewal Requirements

  • Clinical response documentation: Decreased urinary oxalate levels or improved kidney function
  • Continued specialist oversight: Updated consultation notes
  • Adherence confirmation: Proof of consistent dosing per protocol

What Changes May Affect Coverage

  • Plan changes or employer switches
  • Move to different state
  • Medicare eligibility changes
  • Formulary updates (rare for specialty drugs)

Common Questions

How long does Aetna prior authorization take in Florida? Standard decisions take up to 15 business days. Expedited reviews for urgent cases must be decided within 72 hours. Aetna acknowledges receipt within 5 business days.

What if Oxlumo is non-formulary on my plan? Oxlumo requires prior authorization regardless of formulary status. Aetna covers it as a specialty medication when medical necessity criteria are met, even if not listed on standard formularies.

Can I request an expedited appeal if denied? Yes, if waiting for standard appeal timeline could harm your health. Document the urgency (kidney function decline, stone formation) and request expedited review within 72 hours.

Does step therapy apply if I haven't tried other treatments? No. Aetna's policy does not require failure of alternative therapies before approving Oxlumo for confirmed PH1.

What happens if I move from another state to Florida? Your Aetna coverage should continue, but notify them of your address change. Florida's appeal rights and external review process will apply to any future denials.

Can Oxlumo be used with other PH1 treatments? Oxlumo cannot be used concurrently with nedosiran (Rivfloza) per Aetna's coverage policy. Other supportive treatments may be continued as clinically appropriate.

How do I check my prior authorization status? Log into your Aetna member portal online or call member services. Your specialist's office can also check status through the provider portal or by calling 866-752-7021.

What if my genetic test is pending but I need treatment urgently? Request expedited prior authorization with available clinical evidence. Aetna may approve based on strong clinical suspicion while genetic results are pending, especially if kidney function is declining.

When to Escalate

Contact Florida Insurance Regulators

If Aetna doesn't follow proper appeal procedures or timelines:

  • Florida Department of Financial Services
  • Insurance Consumer Helpline: 1-877-693-5236
  • Online complaint: MyFloridaCFO.com

What to Include in Complaints

  • Copy of denial letter and appeal submissions
  • Timeline of communications with Aetna
  • Documentation of missed deadlines or procedural violations
  • Impact on your health from delayed treatment

Additional Support

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters, identifies specific coverage criteria, and drafts point-by-point rebuttals using FDA labeling, peer-reviewed studies, and payer-specific workflows. For complex denials or multiple appeal attempts, professional advocacy can significantly improve approval chances.

Checklist: What to Gather Before You Start

Patient Information:

  • Aetna insurance card and member ID
  • Complete medical history related to kidney stones/PH1
  • List of current medications and prior treatments
  • Family history of kidney disease or hyperoxaluria

Clinical Documentation:

  • Genetic test results (AGXT mutation analysis)
  • Urinary oxalate measurements
  • Kidney function tests (creatinine, eGFR)
  • Imaging studies (kidney ultrasound, CT)
  • Specialist consultation notes

Administrative:

  • Prior authorization forms from previous attempts (if any)
  • Denial letters and explanation of benefits
  • Contact information for current healthcare providers

Sources & Further Reading

This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for specific coverage decisions. Coverage policies may change, and individual circumstances vary. For current forms and procedures, verify directly with Aetna and your healthcare providers.

Need help with a complex denial? Counterforce Health provides specialized support for prescription drug appeals, helping patients and providers navigate insurance requirements with evidence-based strategies tailored to each payer's specific policies.

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