By Counterforce Health Team in Vanflyta (quizartinib) —

How to Get Vanflyta (quizartinib) Covered by Humana in Virginia: Complete Coding, Appeals, and Prior Authorization Guide

Answer Box: Getting Vanflyta (quizartinib) Covered by Humana in Virginia

Vanflyta (quizartinib) requires prior authorization on Humana Medicare Advantage plans in Virginia as a non-formulary specialty drug. Your fastest path: Have your oncologist submit PA documentation including FLT3-ITD lab results, baseline EKG, and medical necessity letter via Humana's provider portal. If denied, you can appeal internally (65 days) or file external review with Virginia's Bureau of Insurance (120 days). For cancer treatments, Virginia waives internal appeal exhaustion requirements. Start today: Call Humana member services to confirm your plan's PA requirements and formulary status.

Table of Contents

  1. Coding Basics: Medical vs. Pharmacy Benefit Paths
  2. ICD-10 Mapping for FLT3-ITD Positive AML
  3. Product Coding: HCPCS, J-Codes, and NDC Numbers
  4. Clean Request Anatomy: Prior Authorization Essentials
  5. Frequent Pitfalls and How to Avoid Them
  6. Verification Steps with Humana Resources
  7. Appeals Playbook for Virginia
  8. Quick Audit Checklist

Coding Basics: Medical vs. Pharmacy Benefit Paths

Vanflyta (quizartinib) can be covered under either Medicare Part B (medical benefit) or Part D (pharmacy benefit), depending on how it's administered and your specific Humana plan.

Medical Benefit (Part B) Path

  • When to use: Hospital outpatient or clinic administration
  • Billing code: HCPCS J8999 (oral chemotherapy drug, not otherwise specified) or C9399 (unclassified drugs)
  • Site of service: Clinic, hospital outpatient department
  • Advantages: Often faster approval for oncology drugs, bundled with other treatments

Pharmacy Benefit (Part D) Path

  • When to use: Self-administration at home via specialty pharmacy
  • Billing method: NDC-specific billing through REMS-certified specialty pharmacies
  • Coverage considerations: Subject to formulary placement, step therapy requirements, quantity limits
Note: Vanflyta lacks a permanent HCPCS J-code as of 2025, so temporary codes J8999 or C9399 are used for medical benefit billing.

ICD-10 Mapping for FLT3-ITD Positive AML

Proper ICD-10 coding is essential for Vanflyta coverage. The primary code family is C92 for acute myeloid leukemia.

Required ICD-10 Codes

  • C92.00: Acute myeloblastic leukemia, not having achieved remission
  • C92.01: Acute myeloblastic leukemia, in remission
  • C92.02: Acute myeloblastic leukemia, in relapse

Documentation Requirements

Your medical records must clearly support the selected ICD-10 codes with:

  • FLT3-ITD mutation status: CLIA-certified lab report showing FLT3-ITD positivity
  • Allelic ratio: ITD to wild-type ratio (critical for risk stratification)
  • Clinical context: AML diagnosis with cytogenetic findings
  • Treatment phase: Induction, consolidation, or maintenance phase documentation
Tip: The allelic ratio is crucial—high FLT3-ITD AR (≥0.5) indicates worse prognosis and stronger medical necessity for targeted therapy.

Product Coding: HCPCS, J-Codes, and NDC Numbers

NDC Numbers by Strength

  • 26.5 mg tablets:
    • 14-count: 65597-511-04
    • 28-count: 65597-511-28
  • 17.7 mg tablets:
    • 14-count: 65597-504-04
    • 28-count: 65597-504-28

Billing Units and Dosing

  • Standard dosing: 26.5 mg or 53 mg daily (1 tablet)
  • Billing unit: "EA" (each tablet)
  • 30-day supply: 30 tablets
  • Quantity calculations: Always verify tablet count matches prescribed duration
Coverage Path Billing Code Unit Type Example Quantity
Part B Medical J8999 EA (tablets) 30 EA for 30-day supply
Part D Pharmacy NDC-specific EA (tablets) 30 EA for 30-day supply

Clean Request Anatomy: Prior Authorization Essentials

A successful Vanflyta prior authorization requires specific clinical documentation and proper coding.

Required Documentation Checklist

✓ FLT3-ITD lab results (CLIA-certified with methodology and allelic ratio)
✓ AML diagnosis confirmation (pathology report with ICD-10 codes)
✓ Treatment history (prior therapies tried/failed/contraindicated)
✓ Baseline EKG (QTc ≤450ms within 30 days)
✓ Laboratory values (CBC, comprehensive metabolic panel)
✓ REMS compliance plan (cardiac and electrolyte monitoring schedule)
✓ Medical necessity letter from REMS-certified hematologist/oncologist

Medical Necessity Letter Components

Your oncologist's letter should include:

  1. Patient identification: Name, DOB, Humana member ID
  2. Clinical rationale: FDA approval for FLT3-ITD positive AML
  3. Treatment phase: Specify induction, consolidation, or maintenance
  4. Alternative considerations: Why other FLT3 inhibitors are inappropriate
  5. Safety monitoring plan: EKG and laboratory monitoring schedule
  6. NCCN/guideline support: Reference to evidence-based treatment guidelines

Counterforce Health helps healthcare providers streamline this documentation process by automatically generating evidence-backed appeals that align with payer-specific requirements and clinical guidelines.

Frequent Pitfalls and How to Avoid Them

Common Coding Errors

Wrong NDC selection: Ensure the NDC matches the prescribed strength and package size. Double-check 26.5 mg vs. 17.7 mg formulations.

Missing FLT3-ITD documentation: Humana requires lab confirmation of FLT3-ITD positivity. A general AML diagnosis isn't sufficient.

Incomplete REMS requirements: Vanflyta has mandatory REMS program requirements including prescriber certification and patient monitoring.

Incorrect billing pathway: Verify whether your plan covers Vanflyta under Part B (medical) or Part D (pharmacy) to use the correct billing codes.

Documentation Gaps to Avoid

  • Submitting outdated EKG results (must be within 30 days)
  • Missing allelic ratio in FLT3-ITD lab reports
  • Inadequate prior therapy documentation for step therapy requirements
  • Lack of contraindication explanation for preferred alternatives

Verification Steps with Humana Resources

Before submitting your prior authorization, verify key coverage details:

Step 1: Check Formulary Status

Call Humana member services (number on your insurance card) to confirm:

  • Current formulary tier placement
  • Prior authorization requirements
  • Step therapy protocols
  • Quantity limit restrictions

Step 2: Provider Portal Verification

Healthcare providers should log into Humana's provider portal to:

  • Verify patient eligibility and benefits
  • Check real-time PA status
  • Submit documentation electronically
  • Track approval timelines

Step 3: REMS Pharmacy Network

Confirm your specialty pharmacy is:

  • REMS-certified for Vanflyta dispensing
  • In Humana's preferred network
  • Able to handle prior authorization coordination
Important: Humana is reducing prior authorization requirements by approximately one-third by 2026, but oncology specialty drugs like Vanflyta will continue requiring PA due to their high cost and safety monitoring needs.

Appeals Playbook for Virginia

If Humana denies your Vanflyta prior authorization, Virginia offers robust appeal options with special protections for cancer treatments.

Internal Appeals Timeline

  • Deadline: 65 days from denial notice
  • Standard review: 15 business days for Medicare Advantage decisions
  • Expedited review: 24 hours if health is jeopardized
  • Part D appeals: 7 days standard, 72 hours expedited

Virginia External Review Process

Virginia's Bureau of Insurance provides independent review after internal appeals. Key advantage: For cancer treatments, you don't need to exhaust internal appeals first.

Timeline for External Review:

  • Standard: 45 days from Bureau receipt
  • Expedited: 72 hours if provider certifies serious health jeopardy
  • Filing deadline: 120 days from final internal denial

How to File:

  1. Complete Form 216-A (External Review Request)
  2. Include denial notices and medical records
  3. Submit to Virginia Bureau of Insurance
  4. Request expedited review if urgent
Virginia Advantage: The state's external review process has special provisions for cancer treatment denials, allowing faster access to independent medical review.

For assistance with the appeals process, Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals that align with payer policies and clinical guidelines.

When to Contact Virginia Regulators

If you encounter procedural violations or unfair denials, contact:

  • Virginia Bureau of Insurance: Consumer Services at 1-877-310-6560
  • Managed Care Ombudsman: For HMO and managed care plan issues

Quick Audit Checklist

Before submitting your Vanflyta prior authorization, review this checklist:

Clinical Documentation: □ FLT3-ITD positive lab results with allelic ratio
□ AML diagnosis with appropriate ICD-10 codes
□ Current EKG showing QTc ≤450ms
□ Recent laboratory values (CBC, CMP)
□ Prior therapy documentation

Coding Accuracy: □ Correct NDC for prescribed strength
□ Appropriate billing pathway (Part B vs. Part D)
□ Accurate quantity calculations
□ Proper ICD-10 code selection

REMS Compliance: □ Prescriber REMS certification verified
□ Specialty pharmacy REMS enrollment confirmed
□ Monitoring plan documented

Submission Requirements: □ Medical necessity letter completed
□ All required forms signed
□ Supporting documentation attached
□ Submission method confirmed (portal, fax, mail)

From Our Advocates

"We've seen many Vanflyta approvals succeed when providers include the FLT3-ITD allelic ratio in their initial submission. Payers want to see that specific mutation data upfront, not just a general AML diagnosis. Having the EKG and monitoring plan ready also prevents common delays. This documentation shows medical necessity and safety compliance from day one."

Frequently Asked Questions

How long does Humana prior authorization take for Vanflyta in Virginia?
Standard PA decisions take 15 business days for Medicare Advantage, 7 days for Part D. Expedited reviews are available within 24-72 hours if your doctor certifies urgent medical need.

What if Vanflyta is non-formulary on my Humana plan?
You can request a formulary exception along with your prior authorization. Include documentation showing medical necessity and why formulary alternatives are inappropriate.

Can I get expedited appeals in Virginia?
Yes. Virginia offers expedited external review within 72 hours if your provider certifies that waiting could seriously jeopardize your health.

Does step therapy apply to Vanflyta coverage?
Many Humana plans require trial of preferred FLT3 inhibitors like midostaurin first. Document any contraindications or prior failures with these alternatives.

What copay assistance is available for Vanflyta?
Contact Daiichi Sankyo Access Central at 1-866-374-4669 for manufacturer copay programs and patient assistance options.

How do I verify my specialty pharmacy is REMS-certified?
Check with your pharmacy directly or contact Daiichi Sankyo to confirm REMS program enrollment and Humana network participation.

Cost Considerations

Vanflyta costs approximately $16,100-$17,900 per 28-day supply without insurance coverage. Under Medicare Part D:

  • Deductible phase: Up to $590 (2025 maximum)
  • Initial coverage: 25-33% coinsurance for Tier 5 specialty drugs
  • Catastrophic phase: $0 copay after reaching $2,000 annual out-of-pocket maximum

Financial assistance options:

  • Manufacturer copay cards through Daiichi Sankyo
  • Patient assistance programs for eligible individuals
  • Low-Income Subsidy (LIS) for Medicare beneficiaries
  • Foundation grants for cancer treatment costs

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific insurance plan and medical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For official Virginia insurance appeals information, visit the State Corporation Commission Bureau of Insurance website.

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