How to Get Defitelio (Defibrotide) Covered by Humana in Georgia: PA Requirements, Appeals, and Cost Assistance
Answer Box: Getting Defitelio (Defibrotide) Covered by Humana in Georgia
Defitelio (defibrotide) requires prior authorization from Humana for hepatic veno-occlusive disease with organ dysfunction post-stem cell transplant. Your transplant team must submit clinical documentation proving medical necessity. Standard approval takes up to 30 days; expedited review within 72 hours for urgent cases. If denied, you have 65 days to appeal internally, then can request external review through Georgia's Department of Insurance within 60 days.
First step today: Contact your prescriber to initiate prior authorization and register with CenterWell Specialty Pharmacy (1-800-486-2668).
Table of Contents
- Coverage Basics
- Prior Authorization Process
- Timing and Urgency
- Medical Necessity Criteria
- Costs and Financial Support
- Denials and Appeals in Georgia
- Renewal Requirements
- Specialty Pharmacy Requirements
- Troubleshooting Common Issues
- Frequently Asked Questions
Coverage Basics
Is Defitelio (Defibrotide) Covered by Humana?
Humana covers Defitelio for FDA-approved indications when medical necessity criteria are met. Prior authorization is mandatory for all Humana Medicare Advantage and commercial plans.
Coverage Requirements at a Glance:
Requirement | Details | Source |
---|---|---|
Prior Authorization | Required for all plans | Humana PA List |
Specialty Pharmacy | CenterWell required | Provider Resources |
Site of Care | Office/clinic preferred; hospital requires justification | Coverage Policy |
Formulary Status | Medical benefit (not pharmacy) | Medicare Drug Guide |
Appeals Deadline | 65 days from denial | Member Appeals |
Prior Authorization Process
Who Submits the Request?
Your prescribing physician or transplant team must submit the prior authorization request. Patients cannot submit PA requests directly to Humana.
Step-by-Step: Fastest Path to Approval
- Prescriber gathers documentation (diagnosis, prior treatments, clinical notes)
- Submit PA request via Humana provider portal or fax to 877-486-2621
- Include medical necessity letter with specific clinical justification
- Register with CenterWell Specialty Pharmacy at 1-800-486-2668
- Track request status through provider portal or member services
- Follow up within 72 hours if no acknowledgment received
- Prepare appeal materials if initial request is denied
Tip: Submit requests early in the week to avoid processing delays over weekends.
Timing and Urgency
Standard Processing Times
- Standard review: Up to 30 days for coverage determination
- Expedited review: Within 72 hours if patient's health is at serious risk
- Urgent situations: Can request concurrent external review in Georgia
When to Request Expedited Review
Request expedited processing when:
- Patient has active VOD with organ dysfunction
- Delay could worsen clinical outcomes
- Transplant complications are progressing
Expedited reviews require physician attestation of medical urgency.
Medical Necessity Criteria
Clinician Corner: Medical Necessity Documentation
Your prescriber's letter should include:
Required Clinical Elements:
- Diagnosis: Hepatic VOD/SOS with renal or pulmonary dysfunction post-HSCT
- ICD-10 Code: K76.5 (hepatic veno-occlusive disease)
- Prior treatments: Document any supportive care measures attempted
- Clinical rationale: Why Defitelio is medically necessary for this patient
- Dosing plan: Align with FDA-approved dosing (6.25 mg/kg IV q6h)
- Treatment duration: Up to 60 days as clinically indicated
Supporting Documentation:
- Transplant records confirming HSCT
- Laboratory values showing organ dysfunction
- Clinical notes documenting VOD diagnosis
- Any relevant imaging studies
Note: Humana typically does not require step therapy for Defitelio since no FDA-approved alternatives exist for VOD treatment.
Costs and Financial Support
Understanding Your Costs
Defitelio is administered as a hospital-based infusion and typically falls under your medical benefit rather than prescription drug coverage. Cost-sharing depends on your specific Humana plan.
Financial Assistance Options
JazzCares Patient Support Program:
- Free drug program for eligible uninsured patients
- Copay assistance for insured patients
- Insurance navigation and appeals support
- Contact: 1-833-533-JAZZ (5299) or visit JazzCares.com
Additional Resources:
- Hospital financial counselors can help identify assistance programs
- Blood Cancer United provides general cost management guidance at (800) 955-4572
Denials and Appeals in Georgia
Common Denial Reasons and Solutions
Denial Reason | How to Overturn | Required Documentation |
---|---|---|
Not medically necessary | Submit detailed clinical justification | Transplant records, lab values, physician letter |
Off-label use | Clarify FDA-approved indication | FDA label, diagnosis confirmation |
Site of care restriction | Justify hospital administration | Clinical rationale for inpatient setting |
Insufficient documentation | Resubmit with complete records | All missing clinical documents |
Appeals Process in Georgia
Level 1: Internal Appeal
- Deadline: 65 days from denial notice
- How to file: Humana member portal or call member services
- Timeline: Standard 30 days, expedited 72 hours
Level 2: External Review (Georgia)
- Deadline: 60 days from final internal denial
- How to file: Georgia Department of Insurance at 1-800-656-2298
- Cost: Free for consumers
- Timeline: 30 business days (expedited available for urgent cases)
From our advocates: "We've seen Defitelio denials successfully overturned in Georgia when prescribers included comprehensive transplant documentation and emphasized the lack of alternative treatments. The key is demonstrating that VOD with organ dysfunction is life-threatening without immediate intervention."
When to Escalate to Georgia Regulators
Contact the Georgia Office of Commissioner of Insurance if:
- Humana fails to meet processing deadlines
- You need help with the external review process
- You believe your rights under Georgia insurance law have been violated
Renewal Requirements
When to Reauthorize
Humana typically requires reauthorization:
- Every 60 days during active treatment
- When changing dosing or administration schedule
- If treatment is interrupted and restarted
What Changes Require New Authorization
- Dose modifications outside FDA parameters
- Extension beyond 60-day treatment period
- Change in administration site
- New clinical indications
Specialty Pharmacy Requirements
Why CenterWell Specialty Pharmacy?
Humana requires specialty medications like Defitelio to be dispensed through their contracted specialty pharmacy network to ensure:
- Proper handling and storage
- Clinical monitoring and support
- Coordinated care with your medical team
Setting Up Specialty Pharmacy Services
- Register early: Call CenterWell at 1-800-486-2668
- Provide insurance information: Have your Humana member ID ready
- Coordinate delivery: Arrange shipment to infusion site
- Confirm coverage: Verify prior authorization is approved before shipment
Troubleshooting Common Issues
Portal and System Problems
If Humana's provider portal is down:
- Use backup fax submission to 877-486-2621
- Call provider services for status updates
- Document all submission attempts
Missing Forms or Documentation:
- Request forms through member services
- Use CMS standard forms if Humana-specific forms unavailable
- Confirm receipt of all submitted materials
Communication Breakdowns
Between prescriber and Humana:
- Request peer-to-peer review for complex cases
- Ensure all clinical staff understand PA requirements
- Maintain detailed records of all communications
Frequently Asked Questions
How long does Humana prior authorization take for Defitelio in Georgia? Standard review takes up to 30 days; expedited review within 72 hours for urgent medical situations.
What if Defitelio is non-formulary on my Humana plan? Submit a formulary exception request with medical necessity documentation showing why covered alternatives are inappropriate.
Can I request an expedited appeal in Georgia? Yes, both Humana internal appeals and Georgia external reviews offer expedited processing for urgent medical situations.
Does step therapy apply to Defitelio? Typically no, since Defitelio is the only FDA-approved treatment for VOD with organ dysfunction post-HSCT.
What happens if I'm hospitalized out-of-state? Emergency treatment should be covered, but notify Humana within 48 hours and ensure proper authorization for continued care.
How do I check my prior authorization status? Log into your Humana member portal or call the number on your insurance card for real-time status updates.
What if my transplant center isn't in Humana's network? Request a network exception or single-case agreement, especially if it's the only transplant center in your area.
Can I appeal to Georgia even if I have employer insurance? Georgia's external review applies to fully insured plans. Self-funded employer plans may have different appeal processes under federal ERISA law.
About Counterforce Health
Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating targeted, evidence-backed rebuttal letters. Our platform analyzes denial letters and payer policies to draft point-by-point appeals that align with each insurer's specific requirements and cite the right medical evidence.
Sources & Further Reading
- Humana Prior Authorization List 2025
- Georgia Department of Insurance Appeals Process
- Humana Member Appeals and Exceptions
- JazzCares Patient Support Program
- CenterWell Specialty Pharmacy
- Blood Cancer United Drug Information
Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Insurance policies and state regulations may change. For personalized assistance with insurance appeals in Georgia, consider consulting with Counterforce Health or contacting the Georgia Department of Insurance Consumer Services at 1-800-656-2298.
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