By Counterforce Health Team in Defitelio (defibrotide) —

Getting Defitelio (Defibrotide) Covered by Blue Cross Blue Shield in New York: PA Requirements, Appeals, and Cost Assistance

Answer Box: Getting Defitelio Covered by Blue Cross Blue Shield in New York

Defitelio (defibrotide) requires prior authorization from Blue Cross Blue Shield plans in New York for hepatic veno-occlusive disease (VOD) with organ dysfunction post-HSCT. Your fastest path: (1) Have your transplant team submit PA with VOD diagnosis documentation and organ dysfunction evidence, (2) If denied, file internal appeal within plan deadlines, then (3) Request external review through New York State Department of Financial Services within 4 months. Apply to JazzCares patient assistance early if coverage is denied.

Table of Contents

  1. Coverage Requirements at a Glance
  2. Step-by-Step: Fastest Path to Approval
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Process for New York
  5. Cost Assistance and Financial Support
  6. Clinician Corner: Medical Necessity Documentation
  7. When to Escalate to State Regulators
  8. Frequently Asked Questions

Coverage Requirements at a Glance

Requirement Details Where to Find Source
Prior Authorization Required for all requests Provider portal or fax submission Blue Shield CA Policy
Indication Hepatic VOD/SOS with renal or pulmonary dysfunction post-HSCT FDA label, clinical documentation FDA Approval
Formulary Tier Likely Tier 3 (non-preferred brand) Member portal or call pharmacy services NYC Empire BCBS Plan
ICD-10 Code K76.5 (Hepatic veno-occlusive disease) Clinical documentation Blue Shield CA Policy
Coverage Period Up to 60 days post-HSCT Policy documents Blue Shield CA Policy
Appeals Deadline 4 months for external review New York State law NY DFS External Appeals

Step-by-Step: Fastest Path to Approval

1. Verify Your Blue Cross Blue Shield Plan Details

Who does it: Patient or family
What you need: Insurance card, member ID
How: Log into your plan's member portal or call the pharmacy services number on your card
Timeline: Same day
Find: Check if you have Empire BlueCross BlueShield, Excellus, or another New York Blue plan, and confirm your specific formulary (Essential, Select, or Exclusive Network).

2. Gather Required Clinical Documentation

Who does it: Transplant team/physician
What you need: HSCT records, VOD diagnosis criteria, organ dysfunction evidence
Documents include:

  • Confirmation of hematopoietic stem cell transplantation
  • VOD/SOS diagnosis using Baltimore, Seattle, or EBMT criteria
  • Evidence of renal dysfunction (creatinine doubling) or pulmonary dysfunction (oxygen requirement)
  • Total bilirubin ≥2 mg/dL plus supporting symptoms

3. Submit Prior Authorization Request

Who does it: Prescribing physician or staff
How: Provider portal, fax, or phone
Include: Clinical documentation, ICD-10 code K76.5, dosing plan (up to 25 mg/kg/day divided every 6 hours)
Timeline: 30 days for standard review, 72 hours for expedited

4. Apply for Patient Assistance Early

Who does it: Patient with physician support
What: JazzCares enrollment form
When: Immediately after PA submission or denial
Contact: 1-833-533-JAZZ (5299)
Eligibility: Uninsured or "deemed uninsured" (coverage denied), income <400% Federal Poverty Level

5. If Denied: File Internal Appeal

Who does it: Patient or authorized representative
Timeline: Follow your plan's internal appeal deadlines (typically 60-180 days)
Include: Original PA documentation plus additional supporting evidence

6. Request External Review (If Internal Appeal Fails)

Who does it: Patient or provider
When: Within 4 months of final adverse determination
How: NY DFS online portal
Forms needed: Comprehensive Physician Attestation, Experimental/Investigational form if applicable

7. Expedite if Urgent

When: Patient hospitalized or health at serious risk
Timeline: 72-hour decision for external review, 24 hours for urgent drug denials
Required: Physician attestation that delay endangers life or health

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Key Documentation
"Not medically necessary" Submit VOD diagnosis criteria evidence EBMT/Baltimore/Seattle criteria, organ dysfunction labs
"Experimental/investigational" Cite FDA approval for VOD with organ dysfunction FDA label, peer-reviewed studies
"No HSCT documented" Provide transplant records and timeline HSCT procedure notes, conditioning regimen details
"Insufficient organ dysfunction" Submit current labs and clinical assessments Creatinine levels, oxygen requirements, pulmonary function
"Off-label use" Clarify FDA-approved indication FDA labeling for VOD with renal/pulmonary dysfunction

Appeals Process for New York

New York offers one of the strongest external appeal systems in the country. Here's how to use it:

Internal Appeal (Required First Step)

  • Timeline: Varies by plan (check your Evidence of Coverage)
  • How to file: Contact member services number on your insurance card
  • Documents: Original PA request plus additional supporting evidence
  • Decision time: 30 days standard, 72 hours expedited

External Review Through NY DFS

  • Eligibility: Denial for "not medically necessary," "experimental/investigational," or out-of-network
  • Timeline: Within 4 months of final internal denial
  • Cost: Up to $25 (waived for financial hardship or Medicaid)
  • Decision authority: Independent medical experts assigned by DFS
  • Binding: Insurer must comply with favorable decisions
Tip: Search the NY DFS External Appeals Database for prior Defitelio or VOD cases to strengthen your appeal with precedent decisions.

Expedited External Review

Available when physician attests that standard timeframe would:

  • Seriously jeopardize life or health
  • Jeopardize ability to regain maximum function
  • Subject patient to severe pain

Decision timeline: 72 hours (24 hours for urgent drug denials)

Cost Assistance and Financial Support

JazzCares Patient Assistance Program

Eligibility:

  • Valid U.S. prescription for Defitelio
  • Legal U.S. resident
  • Uninsured or "deemed uninsured" (insurance denies coverage)
  • Household income <400% Federal Poverty Level

Application process:

  1. Physician completes JazzCares enrollment form
  2. Submit income documentation and insurance card
  3. Fax to 1-855-593-3955 or mail to JazzCares Program, PO Box 5490, Louisville, KY 40255

Services provided:

  • Free medication for eligible patients
  • Benefit investigation and PA support
  • Appeals assistance
  • Billing and coding guidance

Additional Financial Resources

  • Commercial copay assistance: Available through JazzCares referrals
  • Medicare Part D: 2024 out-of-pocket cap of $3,300 may apply
  • Community Health Advocates: Free insurance counseling at 888-614-5400

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical documentation to craft evidence-backed rebuttals. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and appeals processes for specialty medications like Defitelio.

Clinician Corner: Medical Necessity Documentation

Essential Elements for PA Requests

Patient Information:

  • Confirmed HSCT recipient with conditioning regimen details
  • VOD/SOS diagnosis using established criteria (Baltimore, modified Seattle, or 2023 EBMT)
  • Timeline: VOD onset typically ≤21 days post-HSCT (classical) or >21 days (late-onset)

Clinical Evidence Required:

  • Laboratory values: Total bilirubin ≥2 mg/dL, elevated transaminases
  • Physical findings: Hepatomegaly (painful), ascites, weight gain >5%
  • Organ dysfunction:
    • Renal: Creatinine doubling or >1.5x baseline
    • Pulmonary: Oxygen requirement, pulmonary edema

Dosing and Monitoring Plan:

  • Standard dose: 6.25 mg/kg IV every 6 hours (25 mg/kg/day)
  • Duration: Minimum 21 days, up to 60 days post-HSCT
  • Monitoring: Weekly imaging, coagulation studies, bleeding assessment

Key Citations for Appeals

  • FDA approval for VOD with renal or pulmonary dysfunction
  • 2023 EBMT diagnostic criteria for SOS/VOD
  • Mortality data: >80% with multi-organ dysfunction if untreated

When to Escalate to State Regulators

Contact the New York State Department of Financial Services if:

  • Your insurer fails to respond to appeals within required timeframes
  • You're denied access to external review despite meeting eligibility criteria
  • The insurer doesn't comply with a favorable external review decision

Contact Information:

For additional support, Community Health Advocates provides free counseling on insurance denials and appeals at 888-614-5400.

Frequently Asked Questions

Q: How long does Blue Cross Blue Shield PA take in New York?
A: Standard review takes up to 30 days. Expedited review (when physician attests urgency) takes 72 hours. Submit requests early in the treatment planning process.

Q: What if Defitelio is non-formulary on my plan?
A: Request a formulary exception with medical necessity documentation. Emphasize FDA approval and lack of therapeutic alternatives for VOD with organ dysfunction.

Q: Can I request an expedited appeal?
A: Yes, if your physician attests that standard timeframes would jeopardize your health. External expedited appeals through NY DFS are decided within 72 hours.

Q: Does step therapy apply to Defitelio?
A: Step therapy typically doesn't apply since Defitelio is the only FDA-approved treatment for VOD with organ dysfunction. If required, document lack of effective alternatives.

Q: What happens if I move between New York Blue Cross plans?
A: Each Blue Cross affiliate may have different policies. Verify PA requirements and resubmit documentation if changing from Empire BCBS to Excellus, for example.

Q: Can family members help with appeals?
A: Yes, with proper authorization. Complete your plan's authorized representative form to allow family members to communicate with the insurer on your behalf.

Q: How do I find precedent external appeal decisions?
A: Search the NY DFS External Appeals Database by treatment name, diagnosis, or keywords like "experimental" or "medical necessity."

Platforms like Counterforce Health can help streamline this process by analyzing your specific denial letter and plan policy to create targeted appeals that address the exact reasons for denial while incorporating the strongest available evidence for Defitelio coverage.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and coverage criteria may vary. Always consult with your healthcare provider and insurance company for the most current information specific to your situation. For personalized help with insurance appeals and coverage issues, contact Community Health Advocates at 888-614-5400 or the New York State Department of Financial Services at 1-800-400-8882.

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