By Counterforce Health Team in Defitelio (defibrotide) —

Getting Defitelio (Defibrotide) Covered by Humana in Michigan: PA Requirements, Appeals, and Cost Assistance

Quick Answer: Getting Defitelio Covered by Humana in Michigan

Defitelio (defibrotide) requires prior authorization from Humana in Michigan. The fastest path to approval: Have your prescriber submit clinical documentation proving hepatic veno-occlusive disease (VOD) with organ dysfunction post-stem cell transplant. Submit to CenterWell Specialty Pharmacy with PA request to Humana's provider fax (1-877-486-2621). If denied, you have 65 days to appeal and can request external review through Michigan DIFS within 127 days. Start today: Call your prescriber to begin the PA submission process and register with CenterWell Specialty Pharmacy at 1-800-486-2668.

Table of Contents

  1. Understanding Humana's Coverage Requirements
  2. Step-by-Step: Fastest Path to Approval
  3. Cost-Saving Strategies and Assistance Programs
  4. Common Denial Reasons and How to Fix Them
  5. Appeals Process for Michigan Residents
  6. Specialty Pharmacy Requirements
  7. Clinician Corner: Medical Necessity Documentation
  8. Frequently Asked Questions

Understanding Humana's Coverage Requirements

Defitelio is listed on Humana's 2024 Medicare Advantage Preauthorization List, meaning prior authorization is mandatory before the medication can be dispensed or administered.

Coverage at a Glance

Requirement What It Means Where to Find Details
Prior Authorization Required before treatment Humana PA Lists
Covered Indication VOD with organ dysfunction post-HSCT FDA labeling and Humana medical policy
Specialty Pharmacy Must use CenterWell Specialty Pharmacy Humana Specialty Network
Step Therapy May apply (verify with plan) Plan-specific formulary documents
Quantity Limits Based on FDA labeling Humana pharmacy coverage lookup

What Drives Defitelio's High Cost: As a specialty medication for rare hepatic veno-occlusive disease, Defitelio carries significant costs due to its specialized manufacturing process and limited patient population. Humana manages costs through prior authorization, specialty pharmacy dispensing, and strict medical necessity requirements.

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation (Patient/Family)

  • Insurance card and member ID
  • Complete diagnosis with ICD-10 codes
  • Records of stem cell transplant
  • Documentation of organ dysfunction (renal/pulmonary)
  • Previous treatment attempts and outcomes

2. Prescriber Submits PA Request (Clinic)

  • How: Fax to 1-877-486-2621 or submit via Humana provider portal
  • Timeline: Standard decisions within 30 days; expedited within 72 hours
  • Required: Medical necessity letter with clinical rationale

3. Prescription to Specialty Pharmacy (Clinic)

  • Send to: CenterWell Specialty Pharmacy
  • Contact: 1-877-405-7940 (fax) or e-prescribing
  • Note: Can be done simultaneously with PA request

4. Patient Registration (Patient)

  • Call: CenterWell at 1-800-486-2668
  • Setup: Home delivery, financial assistance screening
  • Timeline: 24-48 hours for new patient setup

5. Monitor PA Decision (Patient/Clinic)

  • Track status: Through Humana provider portal or member services
  • Follow up: If no response within stated timeframes
  • Prepare: For potential appeal if denied

Cost-Saving Strategies and Assistance Programs

Manufacturer Support: JazzCares Program

Jazz Pharmaceuticals offers assistance through JazzCares for eligible patients:

Eligibility Requirements:

  • Valid U.S. prescription for Defitelio
  • Legal U.S. resident (including Puerto Rico, U.S. Virgin Islands)
  • Household income less than 400% of Federal Poverty Level
  • Uninsured or "deemed uninsured" if coverage denied

Application Process:

  1. Download JazzCares enrollment form
  2. Gather income documentation (tax returns, W2s)
  3. Submit via fax (1-855-593-3955) or mail to: JazzCares Program, PO Box 5490, Louisville, KY 40255
  4. Call patient support hotline: 1-833-533-JAZZ (5299)
From Our Advocates: "We've seen patients successfully receive free Defitelio through JazzCares when their insurance initially denied coverage. The key is applying early in the process—don't wait until you've exhausted all insurance appeals. Many families are surprised to learn they qualify based on income, even with insurance coverage."

Humana-Specific Cost Management

CenterWell Specialty Pharmacy Benefits:

  • Financial counseling and assistance program identification
  • Coordination with manufacturer programs
  • Payment plan options for approved medications
  • Clinical support to optimize therapy and reduce waste

Medicare Part D Coverage Considerations:

  • Defitelio may fall under catastrophic coverage after reaching out-of-pocket maximum
  • 2024 Medicare Part D out-of-pocket cap: $3,300 annually
  • Monthly payment plans available through CenterWell

Common Denial Reasons and How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not FDA-approved indication" Provide VOD diagnosis with organ dysfunction Transplant records, lab values, imaging
"Insufficient medical necessity" Submit detailed clinical rationale Prior treatment failures, contraindications
"Step therapy not completed" Document why alternatives inappropriate Allergy history, prior medication trials
"Quantity exceeds limits" Justify dosing based on weight/BSA Patient weight, BSA calculation, dosing rationale
"Site of care restriction" Confirm hospital/specialty clinic setting Facility accreditation, administration plan

Key Documentation for Overturning Denials

Clinical Requirements:

  • Confirmed diagnosis of hepatic VOD/SOS
  • Evidence of renal or pulmonary dysfunction
  • Timeline relationship to stem cell transplant
  • Contraindications to supportive care alternatives

Administrative Requirements:

  • Proper ICD-10 coding for VOD
  • HCPCS/J-codes for billing
  • Site of care verification
  • Prescriber credentials and specialty

Appeals Process for Michigan Residents

Humana Internal Appeals

Timeline: 65 days from denial notice How to Submit:

  • Online: Through Humana member portal
  • Phone: 1-800-281-6918
  • Mail: Address provided in denial letter

Required Documents:

  • Original denial letter
  • New medical information (if available)
  • Prescriber support letter
  • Patient impact statement

Michigan External Review

If Humana's internal appeal is denied, Michigan residents can request external review through the Department of Insurance and Financial Services (DIFS).

Timeline: 127 days from final internal denial How to Submit:

Expedited Review Available:

  • When: Health would be in serious jeopardy by waiting
  • Timeline: 72-hour decision
  • Requirement: Physician letter stating urgency
Tip: Michigan's external review process is binding on insurers. DIFS assigns cases to Independent Review Organizations with relevant medical expertise, giving patients a fair chance at overturning denials.

Specialty Pharmacy Requirements

CenterWell Specialty Pharmacy (Preferred)

Why Required: Humana's specialty network in Michigan is extremely limited, with CenterWell being the primary preferred option for specialty drugs like Defitelio.

Services Provided:

  • Home delivery with temperature-controlled shipping
  • Clinical pharmacist consultation
  • Side effect monitoring and management
  • Adherence support and refill coordination
  • Financial assistance program navigation

Getting Started:

  1. Prescriber: Send prescription via fax (1-877-405-7940) or e-prescribing
  2. Patient: Call 1-800-486-2668 to register
  3. Setup: Complete intake, verify insurance, arrange delivery
  4. Ongoing: Regular check-ins with pharmacy team

Network Alternatives

Limited Options: Very few brick-and-mortar specialty pharmacies in Michigan accept Humana at preferred cost-sharing levels.

Verification Required: Always confirm network status using Humana's pharmacy finder before filling prescriptions elsewhere.

Out-of-Network Consequences: Higher out-of-pocket costs or complete lack of coverage, except in special circumstances outlined in your plan's Evidence of Coverage.

Clinician Corner: Medical Necessity Documentation

Medical Necessity Letter Checklist

Patient Information:

  • Complete diagnosis with ICD-10 codes
  • Stem cell transplant details (date, type, conditioning regimen)
  • Current clinical status and organ dysfunction

Clinical Rationale:

  • Timeline of VOD development post-transplant
  • Severity markers (bilirubin levels, weight gain, ascites)
  • Evidence of renal/pulmonary dysfunction
  • Risk factors and contraindications to alternatives

Treatment Plan:

  • Defitelio dosing rationale (6.25 mg/kg every 6 hours)
  • Duration of therapy (minimum 21 days)
  • Monitoring plan (coagulation studies, clinical response)
  • Site of care requirements (hospital/specialty center)

Supporting Evidence Sources

FDA Labeling: Defitelio prescribing information Clinical Guidelines: EBMT guidelines for VOD diagnosis and treatment Peer-Reviewed Literature: Key studies supporting efficacy in pediatric and adult populations

Note: Humana medical directors are familiar with VOD/SOS criteria. Focus your letter on documenting that the patient meets established diagnostic criteria and has organ dysfunction that warrants treatment.

Frequently Asked Questions

How long does Humana prior authorization take for Defitelio in Michigan? Standard PA decisions are made within 30 days, but urgent requests can be expedited to 72 hours. Submit expedited requests when patient condition is deteriorating.

What if Defitelio is non-formulary on my Humana plan? You can request a formulary exception by submitting medical necessity documentation. The process is similar to PA but focuses on why formulary alternatives are inappropriate.

Can I request an expedited appeal if Humana denies coverage? Yes, if delay would harm the patient's health. Include a physician letter explaining the urgency, and Humana must respond within 72 hours.

Does step therapy apply to Defitelio in Michigan? Step therapy requirements vary by plan. Check your specific formulary or ask your prescriber to verify requirements during PA submission.

What happens if I can't afford Defitelio even with insurance? Apply for the JazzCares patient assistance program, which provides free medication for eligible patients. CenterWell can also help identify additional financial assistance options.

How do I file a complaint if Humana's process seems unfair? Contact Michigan DIFS at 1-877-999-6442 to file a complaint about insurance practices or to get help navigating the appeals process.

Can my doctor request a peer-to-peer review with Humana? Yes, prescribers can request to speak directly with Humana's medical director. This is often helpful for complex cases where written documentation may not fully convey clinical urgency.

What should I do if CenterWell Specialty Pharmacy can't fill my prescription? Contact Humana member services at 1-800-281-6918 to identify alternative network specialty pharmacies or request a network exception.

Getting Additional Support

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. The platform identifies specific denial reasons—whether PA criteria, step therapy, non-formulary status, or medical necessity—and drafts point-by-point responses aligned with each plan's own rules, while pulling the right evidence from FDA labeling, peer-reviewed studies, and specialty guidelines.

When dealing with complex cases like Defitelio coverage, having expert support can make the difference between a successful appeal and ongoing treatment delays. Counterforce Health specializes in the intricate requirements that payers like Humana use for specialty medications, ensuring that appeals meet both clinical and administrative standards.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for the most current coverage requirements and medical guidance. Coverage policies and procedures may change; verify current requirements with your specific plan.

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