By Counterforce Health Team in Defitelio (defibrotide) —

How to Get Defitelio (Defibrotide) Covered by Aetna CVS Health in Florida: Complete Prior Authorization and Appeals Guide

Quick Start: Getting Defitelio (Defibrotide) Approved by Aetna CVS Health in Florida

Defitelio requires prior authorization from Aetna CVS Health for hepatic veno-occlusive disease (VOD) treatment following hematopoietic stem cell transplant. Your transplant team must document VOD using Baltimore or Cairo criteria plus organ dysfunction. Submit through Aetna's provider portal with complete HSCT records, lab values showing bilirubin ≥2 mg/dL, and evidence of renal/pulmonary dysfunction. If denied, Florida residents have 180 days to appeal internally, followed by binding external review through the Department of Financial Services. Start today: contact your transplant center's financial coordinator to initiate prior authorization.

Table of Contents

  1. Verify Your Aetna Plan and Find Forms
  2. Required Forms and Documentation
  3. Submission Portals and Methods
  4. Specialty Pharmacy Enrollment
  5. Support Lines and Contact Numbers
  6. Florida Appeals and External Review
  7. Common Denial Reasons and Solutions
  8. Costs and Financial Assistance
  9. FAQ

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all Aetna plans Aetna Medical Policy
Formulary Status Non-preferred, requires exception Aetna Formulary
Diagnosis Required VOD/SOS with organ dysfunction post-HSCT Aetna Clinical Criteria
Site of Care Hospital or infusion center only Aetna Policy Guidelines
Age Restrictions None (pediatric and adult approved) FDA Label
Appeals Deadline 180 days for internal appeal Florida DFS

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient/Family)

  • Insurance card with member ID and group number
  • Complete HSCT records from transplant center
  • Recent lab results showing bilirubin ≥2 mg/dL
  • Evidence of organ dysfunction (creatinine, imaging, pulmonary function)

2. Contact Transplant Financial Coordinator (Same Day)

Your transplant center's financial coordinator will initiate the prior authorization through Aetna's provider portal. They need:

  • VOD diagnosis confirmation using Baltimore or Cairo criteria
  • Documentation of concurrent renal or pulmonary dysfunction
  • Medical necessity letter from attending physician

3. Submit Through Provider Portal (Transplant Team)

Required clinical documentation includes:

  • Complete transplant summary with conditioning regimen
  • Laboratory values confirming VOD criteria (bilirubin, hepatomegaly evidence, weight gain >5%)
  • Objective evidence of organ dysfunction
  • Specialist attestation that Defitelio is medically necessary

Timeline: Initial authorization decisions typically within 24-48 hours for urgent cases.

4. Enroll with CVS Specialty Pharmacy (Concurrent)

Complete the CVS Specialty Pharmacy Enrollment Form and submit via:

Processing time: Approximately 2 weeks for enrollment and prior authorization review.

Clinician Corner: Medical Necessity Letter Checklist

For Healthcare Providers: Your medical necessity letter should include:Patient's complete transplant history and conditioning regimenObjective documentation of VOD using Baltimore or Cairo criteriaEvidence of concurrent organ dysfunction with specific lab values/imagingStatement that Defitelio is the only FDA-approved treatment for hepatic VODProposed treatment duration (minimum 21 days, maximum 60 days per course)Monitoring plan during therapy

Key Clinical References:

Submission Methods and Portals

Provider Submissions

  • Primary Method: Aetna provider portal (Availity platform)
  • Appeals Fax: 1-855-633-7673
  • Appeals Phone: 1-866-235-5660

Member Submissions

  • Online: Aetna member website
  • Phone: 1-855-463-0933 (TTY: 711)
  • Mail: Address provided in denial letter

CVS Specialty Pharmacy Enrollment Process

Defitelio is dispensed exclusively through CVS Specialty Pharmacy for Aetna members. The enrollment process requires:

Patient Information: Complete legal name, DOB, address, contact preferences, SSN (last 4 digits)

Clinical Information: Current medications, allergies, height/weight, relevant lab values

Prescriber Information: Full credentials including NPI, DEA, state license number

Submission Requirements: Wet signature required (no stamps accepted)

Contact for Enrollment Questions: 1-800-237-2767

Counterforce Health helps patients and clinicians navigate complex prior authorization requirements by analyzing denial letters and crafting evidence-backed appeals. Their platform streamlines the documentation process and identifies the specific clinical evidence needed to overturn denials.

Key Contact Numbers and Support Lines

Service Phone Number Purpose
Aetna Member Services 1-855-463-0933 General coverage questions
Aetna Appeals 1-866-235-5660 Appeal submissions and status
CVS Specialty Pharmacy 1-800-237-2767 Enrollment and prescription status
Defitelio Patient Support 1-833-533-JAZZ (5299) Manufacturer assistance program
Florida DFS Consumer Help 1-877-MY-FL-CFO Insurance complaints and appeals

Florida Appeals and External Review Process

Internal Appeals

Timeline: 180 days from denial notice to file internal appeal Standard Review: 30 days for future treatments, 60 days for services already rendered Expedited Review: Available for urgent medical situations

External Review Process

If Aetna upholds the denial on internal appeal, Florida residents can request binding external review through the Florida Department of Financial Services.

Key Details:

  • Cost: Free to patients (insurers pay all review costs)
  • Timeline: 4 months after final internal denial to request external review
  • Decision: Binding on insurers if overturned
  • Contact: 1-877-MY-FL-CFO (1-877-693-5236)

Required Documentation for External Review:

  • Copy of insurance denial letter
  • All medical records supporting medical necessity
  • Physician statement explaining why Defitelio is appropriate
  • Evidence that internal appeals were exhausted

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Evidence
"Not medically necessary" Emphasize FDA approval and lack of alternatives FDA label, transplant records, organ dysfunction labs
"Experimental/investigational" Reference FDA approval and Aetna policy FDA approval letter, Aetna policy MP-195
"Non-formulary" Request formulary exception Medical necessity letter, prior authorization approval
"Site of care restriction" Confirm hospital/infusion center administration Facility credentials, administration plan

Financial Assistance and Cost Considerations

Typical Cost-Sharing:

  • Commercial Plans: 20-40% coinsurance after deductible
  • Medicare Advantage: Varies by plan with potential monthly caps
  • High-Deductible Plans: Full cost until deductible met

Assistance Programs:

  • Jazz Pharmaceuticals Patient Support: 1-833-533-JAZZ (5299)
  • Manufacturer copay assistance: Available for eligible commercial patients
  • Foundation grants: Contact National Organization for Rare Disorders (NORD) or similar patient advocacy groups

For patients facing significant out-of-pocket costs, Counterforce Health can help identify additional coverage pathways and assist with appeals that may reduce cost-sharing requirements.

Frequently Asked Questions

How long does Aetna prior authorization take for Defitelio in Florida? Standard authorizations typically take 24-48 hours for urgent cases, up to 15 days for non-urgent requests. Expedited reviews are available for life-threatening situations.

What if Defitelio is denied as "non-formulary"? Request a formulary exception through your physician. Provide medical necessity documentation emphasizing that Defitelio is the only FDA-approved treatment for hepatic VOD.

Can I request an expedited appeal in Florida? Yes, if your health condition could be jeopardized by delays. Expedited appeals typically receive decisions within 72 hours.

Does step therapy apply to Defitelio? Step therapy may apply, but can be overridden when no alternative FDA-approved treatments exist for hepatic VOD. Your physician must document this in the appeal.

What happens if my external review is denied? External review decisions are binding in Florida. If denied, you may need to explore other coverage options or manufacturer assistance programs.

How do I check my appeal status? Contact Aetna Member Services at 1-855-463-0933 with your appeal reference number, or check your online member account.

Can my transplant center help with appeals? Yes, transplant centers typically have financial coordinators experienced with Defitelio authorizations who can assist with documentation and appeals.

Are there any Florida-specific protections for rare disease treatments? Florida law requires coverage of certain clinical trial costs and has limitations on step-therapy requirements. These protections may be relevant for appeals.

From our advocates: We've seen successful appeals when families work closely with their transplant team's financial coordinator from day one. The key is gathering all HSCT records and lab values before submitting the initial authorization. When transplant centers provide comprehensive documentation upfront—including the conditioning regimen, VOD timeline, and objective organ dysfunction evidence—approval rates are significantly higher than when submitting piecemeal documentation.

Important Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions vary by individual plan and medical circumstances. Always consult with your healthcare provider and insurance company for specific guidance about your situation.

Sources and Further Reading

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