The Requirements Checklist to Get Elzonris (tagraxofusp-erzs) Covered by Humana in Washington
Answer Box: Getting Elzonris Covered by Humana in Washington
Eligibility: Patients with confirmed CD123-positive BPDCN diagnosis and Humana Medicare Advantage coverage in Washington. Fastest path: Submit prior authorization with pathology report showing CD123 positivity, baseline albumin ≥3.2 g/dL, and detailed CLS monitoring plan. First step today: Contact your hematologist/oncologist to gather diagnostic documentation and initiate the PA request through Humana's provider portal. Standard review takes 14 days; expedited review available within 72 hours for urgent cases.
Table of Contents
- Who Should Use This Checklist
- Member & Plan Basics
- Clinical Criteria Requirements
- Coding & Billing Information
- Documentation Packet Essentials
- Submission Process
- Specialty Pharmacy Requirements
- After Submission: What to Expect
- Common Denial Reasons & Solutions
- Washington State Appeals Process
- Quick Reference Checklist
Who Should Use This Checklist
This guide is designed for Washington residents with Humana Medicare Advantage plans who need coverage for Elzonris (tagraxofusp-erzs) to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN). You'll also find this helpful if you're:
- A patient who received an initial denial and wants to understand the appeal process
- A caregiver helping navigate the prior authorization requirements
- A healthcare provider's office preparing a comprehensive submission
Expected outcome: Following this checklist significantly improves your chances of approval by ensuring all required documentation is complete and properly formatted. In Washington, patients have strong appeal rights through the state's external review process if initial requests are denied.
Member & Plan Basics
Coverage Verification
Before starting the prior authorization process, confirm these basics:
- Active Humana Medicare Advantage coverage (not traditional Medicare with Humana supplement)
- Your member ID and plan effective dates
- Whether you've met any applicable deductible requirements
- Confirmation that your prescribing physician is in-network
Note: Elzonris requires prior authorization for all Humana Medicare Advantage plans as of 2024. The drug is not on standard formulary tiers due to its specialized indication and high cost (~$38,579 per vial).
Plan Type Considerations
Humana Medicare Advantage plans in Washington typically require:
- Prior authorization for specialty oncology medications
- First-dose inpatient administration for high-risk therapies
- Specialty pharmacy distribution for drugs over certain cost thresholds
Clinical Criteria Requirements
Primary Indication
Elzonris is FDA-approved specifically for blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and pediatric patients ≥2 years old. The diagnosis must be confirmed through:
Required pathology documentation:
- Tissue biopsy with immunohistochemistry
- CD123-positive staining (essential for coverage)
- At least 4 of 6 NCCN-recommended BPDCN markers positive
- ICD-10 code: C84.4A (Blastic NK-cell lymphoma, unspecified site)
Safety Prerequisites
Due to the boxed warning for capillary leak syndrome, Humana requires documented evidence of:
- Baseline serum albumin ≥3.2 g/dL
- Adequate cardiac function assessment
- Established monitoring plan for CLS prevention and management
- Prescribing physician must be a hematologist or oncologist
Age and Dosing Requirements
- Patient must be ≥2 years old
- Weight-based dosing documentation required
- Treatment plan specifying cycle duration and monitoring intervals
Coding & Billing Information
Primary Codes
Code Type | Code | Description | Notes |
---|---|---|---|
HCPCS | J9269 | Injection, tagraxofusp-erzs, 10 mcg | Required for billing |
ICD-10 | C84.4A | Blastic NK-cell lymphoma | Primary diagnosis |
CPT | 96413 or 96409 | IV infusion administration | Depends on infusion time |
Revenue | 0636 | Drugs requiring specific identification | For facility billing |
Documentation Requirements
All submissions must include the NDC number and exact vial strength. Verify current NDC with the manufacturer as packaging may change.
Documentation Packet Essentials
Core Medical Documentation
1. Pathology Report (most critical)
- Original biopsy report with CD123 immunostaining results
- Confirmation of BPDCN diagnosis
- Date of diagnosis and staging information
2. Clinical Assessment
- Current laboratory values (albumin, CBC, comprehensive metabolic panel)
- Cardiac function evaluation (ECHO or MUGA scan)
- Performance status assessment
- Weight and BSA calculations for dosing
3. Treatment History
- Previous therapies attempted (if any)
- Reasons for treatment failures or intolerances
- Current medications and potential drug interactions
Letter of Medical Necessity Components
Your physician's letter should address:
- Patient identification and confirmed BPDCN diagnosis
- Clinical rationale for Elzonris specifically
- Safety monitoring plan for capillary leak syndrome
- Expected treatment outcomes and goals
- Alternative treatments considered and why Elzonris is preferred
Clinician Corner: Include specific references to the FDA prescribing information and cite the pivotal clinical trial data supporting efficacy in BPDCN when drafting your medical necessity letter.
Submission Process
Correct Forms and Portals
Primary submission method: Humana Provider Portal
- Use the most current prior authorization form
- Complete all required fields to avoid automatic rejections
- Attach all supporting documentation as PDFs
Alternative submission:
- Fax: 877-486-2621 (formulary exception/PA requests)
- Phone: 800-523-0023 for urgent requests or status inquiries
Required Fields That Commonly Cause Rejections
- Member ID (exactly as appears on insurance card)
- Prescribing physician NPI and contact information
- Specific NDC number and quantity requested
- ICD-10 diagnosis code (C84.4A)
- Site of care specification (inpatient for first cycle)
- Clinical urgency indication if requesting expedited review
Specialty Pharmacy Requirements
Preferred Vendor Network
Humana requires Elzonris to be dispensed through CenterWell Specialty Pharmacy or other approved specialty vendors. The medication cannot be obtained through retail pharmacies due to:
- Complex storage and handling requirements
- Need for patient education and monitoring support
- Cost management protocols
Distribution Process
- Prior authorization approval must be obtained first
- Physician orders Elzonris through CenterWell Specialty
- Patient enrollment in specialty pharmacy services
- Shipment coordination with infusion center
- Delivery confirmation and cold-chain verification
Contact CenterWell Specialty for enrollment and ordering assistance.
After Submission: What to Expect
Timeline Expectations
- Standard review: Decision within 14 days
- Expedited review: Decision within 72 hours (requires clinical urgency documentation)
- Incomplete submissions: May be denied without review; resubmission required
Tracking Your Request
- Record your confirmation number from the portal or fax transmission
- Check status every 3-5 business days through the provider portal
- Document all communications with dates and reference numbers
What to Record
Keep detailed records of:
- Submission date and method
- Confirmation numbers
- Follow-up communications
- Any additional information requests from Humana
- Decision letters and approval/denial reasons
Common Denial Reasons & Solutions
Denial Reason | Solution | Required Documentation |
---|---|---|
Insufficient diagnostic evidence | Resubmit with complete pathology report | CD123+ immunostaining results, BPDCN confirmation |
Missing safety monitoring plan | Provide detailed CLS monitoring protocol | Baseline albumin, cardiac assessment, monitoring schedule |
Site of care not approved | Confirm inpatient facility for first cycle | Hospital credentialing, emergency response capabilities |
Prescriber not qualified | Ensure hematologist/oncologist is prescribing | Board certification, specialty credentials |
Incomplete prior therapy documentation | Document previous treatments and outcomes | Treatment history, failure/intolerance reasons |
Washington State Appeals Process
If your initial request is denied, Washington residents have strong appeal rights:
Internal Appeals (Level 1)
- Timeline: File within 65 days of denial notice
- Method: Written request through Humana member portal or mail
- Expedited option: Available if delay could seriously jeopardize health (72-hour decision)
External Review (Level 2)
After an upheld internal denial, you can request an Independent Review Organization (IRO) review:
- Timeline: Request within 60 days of internal denial
- Process: CMS-appointed independent reviewer evaluates your case
- Cost: Free to the patient
- Decision: Binding on Humana if overturned
State Resources
Washington State Office of the Insurance Commissioner
- SHIBA Program: Free Medicare counseling and appeals assistance
- Phone: 1-800-562-6900
- Website: insurance.wa.gov
From our advocates: "We've seen Washington patients successfully overturn Elzonris denials by working with SHIBA counselors who helped them present comprehensive medical evidence during the external review process. The key was demonstrating that the CD123-positive BPDCN diagnosis met all FDA-approved criteria and that proper safety monitoring was in place."
Quick Reference Checklist
Before You Start:
- Confirm active Humana Medicare Advantage coverage
- Verify prescribing physician is hematologist/oncologist
- Gather complete pathology report with CD123+ results
- Obtain current lab values (albumin ≥3.2 g/dL required)
- Document cardiac function assessment
Submission Checklist:
- Complete current Humana PA form
- Include ICD-10 code C84.4A
- Specify HCPCS code J9269
- Attach pathology report and clinical documentation
- Include detailed CLS monitoring plan
- Submit through provider portal or fax to 877-486-2621
- Record confirmation number and submission date
After Submission:
- Track status every 3-5 business days
- Prepare for potential peer-to-peer review
- If denied, file internal appeal within 65 days
- Consider external review if internal appeal fails
- Contact SHIBA for free assistance with appeals
Getting Elzonris covered by Humana requires careful attention to clinical documentation and safety requirements, but Washington residents have strong appeal rights if initial requests are denied. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and drafting point-by-point rebuttals aligned to each plan's specific requirements.
For complex cases involving rare disease medications like Elzonris, having comprehensive documentation and understanding the appeals process can make the difference between coverage approval and ongoing denials. The combination of Washington's consumer-friendly insurance laws and Humana's relatively low denial rates for properly documented requests creates a favorable environment for patients who need access to this life-saving therapy.
Sources & Further Reading
- Humana Prior Authorization Portal
- Elzonris FDA Prescribing Information
- Washington State Insurance Appeals Guide
- CenterWell Specialty Pharmacy
- Medicare Appeals Process
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 the most current requirements and procedures. Coverage policies may change, and individual circumstances vary.
Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.