By Counterforce Health Team in Vanflyta (quizartinib) —

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

Answer Box: Getting Vanflyta Covered by Humana in Michigan

Vanflyta (quizartinib) requires prior authorization from Humana for FLT3-ITD positive acute myeloid leukemia. Key requirements: FLT3-ITD test results, baseline EKG, and oncologist prescription. First step: Gather FLT3-ITD lab report and submit Humana's prior authorization form through their provider portal. If denied: File internal appeal within 65 days, then Michigan external review through DIFS within 127 days. Expedited appeals available for urgent cases with 72-hour decisions.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Humana plans Humana provider portal Humana PA Search Tool
FLT3-ITD Positive Confirmed by FDA-approved test Lab report from CLIA-certified facility FDA Label Requirements
Baseline EKG QTc monitoring before treatment Cardiology or oncology clinic Black Box Warning
Oncologist Prescription Must be prescribed by hematologist/oncologist Provider credentials verification Humana PA Criteria
REMS Enrollment Both prescriber and pharmacy enrolled REMS program verification Daiichi Sankyo Access Central

ICD-10 Coding and Documentation

Primary Diagnosis Code

The correct ICD-10 code for acute myeloid leukemia is C92.0 (Acute myeloblastic leukemia). Since there's no specific code for FLT3-ITD positive AML, the mutation status must be documented in clinical notes and pathology reports.

Required Documentation

  • FLT3-ITD Test Results: Include the original lab report showing positive FLT3 internal tandem duplication
  • Pathology Report: Confirming AML diagnosis with cytogenetic details
  • Treatment History: Previous therapies tried, failed, or contraindicated (especially midostaurin)
  • Clinical Notes: Documenting medical necessity and treatment plan
Tip: Always attach the actual FLT3-ITD lab report, not just a summary. Humana reviewers need to see the specific test methodology and results.

HCPCS/J-Code and NDC Billing

Medical vs. Pharmacy Benefit

Vanflyta can be billed through different pathways depending on your plan structure:

Medical Benefit (Buy-and-Bill)

  • HCPCS Code: J8999 (oral chemotherapy, not otherwise classified)
  • Used when dispensed in hospital outpatient or infusion settings
  • Requires quantity calculations based on daily dosing

Pharmacy Benefit

  • NDC Billing: Uses FDA-approved National Drug Code
  • Dispensed through specialty pharmacies
  • Subject to quantity limits and days supply restrictions

Billing Units and Calculations

Vanflyta is available in 26.5mg and 53mg tablets. The typical maintenance dose is 26.5mg or 53mg daily, so:

  • 30-day supply = 30 tablets
  • 90-day supply = 90 tablets (if plan allows)

Step-by-Step: Fastest Path to Approval

1. Verify Coverage and Gather Documents

Who: Patient or clinic staff
What: Check Humana formulary status and collect required documents
Timeline: 1-2 business days
Documents needed:

  • Insurance card and policy information
  • FLT3-ITD lab results
  • AML diagnosis confirmation
  • Baseline EKG results
  • Previous treatment history

2. Complete Prior Authorization Form

Who: Prescribing oncologist or authorized staff
What: Submit Humana's prior authorization request
How: Through Humana provider portal or fax
Timeline: Same day submission recommended

3. Include Medical Necessity Letter

Who: Oncologist
What: Detailed clinical rationale supporting Vanflyta use
Key elements: Diagnosis, FLT3-ITD status, treatment phase, monitoring plan

4. Submit Supporting Documentation

Who: Clinic staff
What: Attach all required clinical documents
Include:

  • Complete FLT3-ITD test results
  • Baseline EKG showing QTc ≤450ms
  • Treatment history and prior therapy outcomes
  • REMS program enrollment confirmation

5. Track Decision Timeline

Who: Patient and clinic
What: Monitor for Humana's decision
Standard timeline: 30 days for non-urgent requests
Expedited timeline: 72 hours if urgent criteria met

6. Follow Up if Needed

Who: Clinic staff
What: Contact Humana if decision is delayed
Phone: 800-555-CLIN (2546) for clinical pharmacy review

7. Proceed with Treatment or Appeal

Who: Patient and oncologist
What: Start treatment if approved, or begin appeal process if denied
Next steps: See appeals section below if denial occurs

Medical Necessity Letter Checklist

Your oncologist's letter should include these specific elements:

Patient Information

  • Name, DOB, and Humana member ID
  • Diagnosis: Acute myeloid leukemia (ICD-10: C92.0)
  • FLT3-ITD positive status with test date and methodology

Clinical Rationale

  • Current treatment phase (induction, consolidation, or maintenance)
  • Why Vanflyta is medically necessary for this patient
  • Expected clinical outcomes and treatment goals

Prior Treatments

  • Previous therapies attempted (especially midostaurin)
  • Reasons for discontinuation (failure, intolerance, contraindications)
  • Documentation of treatment responses

Safety Monitoring Plan

  • Baseline EKG results and QTc interval
  • Plan for ongoing cardiac monitoring
  • Electrolyte monitoring schedule
  • REMS program compliance

Supporting Evidence

  • FDA labeling for FLT3-ITD positive AML
  • NCCN guidelines supporting use
  • Relevant clinical studies if applicable

Counterforce Health specializes in helping patients and clinicians create evidence-backed appeals that align with payer requirements. Their platform analyzes denial letters and drafts targeted rebuttals using the right clinical evidence and procedural requirements for each insurance plan.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documents
Missing FLT3-ITD documentation Submit original lab report CLIA-certified FLT3-ITD test results
No baseline EKG Provide cardiac evaluation EKG showing QTc ≤450ms with interpretation
Step therapy not met Document midostaurin trial/failure Treatment records, side effects, contraindications
Use outside FDA indication Clarify treatment phase Medical records showing appropriate use timing
Incomplete medical necessity Enhanced clinical letter Detailed rationale with guidelines support
REMS program not verified Confirm enrollment REMS program documentation for prescriber/pharmacy

Appeals Process in Michigan

Internal Appeal with Humana

Deadline: 65 days from denial notice
How to file: Online through MyHumana, phone, or written request
Required information:

  • Patient name, address, and Medicare number
  • Specific service being appealed
  • Reason for disagreement with denial
  • Supporting medical documentation

Expedited Internal Appeal

  • Available when delay could harm patient health
  • Decision within 72 hours
  • Requires physician statement of urgency

External Review Through Michigan DIFS

If Humana's internal appeal is unsuccessful, Michigan offers external review through the Department of Insurance and Financial Services (DIFS).

Deadline: 127 days after final internal denial
How to file: DIFS External Review Request form online, email, fax, or mail
Decision timeline: 60 days maximum (often faster)
Expedited external review: 72 hours for urgent cases with physician support letter

DIFS Contact Information:

  • Phone: 877-999-6442 (toll-free)
  • Online: Michigan.gov/DIFS
  • Consumer assistance available for appeal questions
Note: External review decisions are binding. If the Independent Review Organization overturns Humana's denial, they must provide coverage.

Costs and Financial Assistance

Vanflyta Pricing

Without insurance, Vanflyta costs approximately $16,100-$17,900 per 28-day supply, depending on dose strength.

Financial Assistance Options

Daiichi Sankyo Patient Support

  • Contact: DSI Access Central at 1-866-4-DSI-NOW
  • Copay assistance programs available
  • Prior authorization support services
  • Appeals assistance during coverage review

Medicare Part D Coverage

  • Most plans place Vanflyta on Tier 5 (specialty tier)
  • Typical copay: 25-33% of drug cost
  • Low Income Subsidy (LIS) may reduce costs significantly

Foundation Grants

  • Leukemia & Lymphoma Society financial assistance
  • Patient Access Network Foundation grants
  • CancerCare financial assistance program

FAQ

How long does Humana prior authorization take for Vanflyta in Michigan? Standard decisions take up to 30 days. Expedited reviews are completed within 72 hours when medical urgency is documented by your oncologist.

What if Vanflyta is not on my Humana formulary? You can request a formulary exception with medical necessity documentation. This process follows the same prior authorization pathway with additional justification for non-formulary coverage.

Can I get an expedited appeal if my treatment is delayed? Yes, both internal and external expedited appeals are available when delays could harm your health. Your oncologist must provide a letter stating the medical urgency.

Does Michigan's step therapy requirement apply if I tried midostaurin in another state? Yes, previous treatments from any location count toward step therapy requirements. Provide complete documentation of prior therapies and outcomes.

What happens if I disagree with Michigan DIFS external review decision? DIFS external review decisions are binding on the insurance company. If approved, Humana must provide coverage. These decisions cannot be further appealed through state processes.

How can I track my Humana appeal status in Michigan? Use MyHumana online portal, call member services, or contact DIFS consumer assistance at 877-999-6442 for external review status updates.

Are there any Michigan-specific programs for cancer drug coverage? Michigan expanded Medicaid (Healthy Michigan Plan) provides coverage for eligible individuals. The state also has prescription assistance programs through the Michigan Department of Health and Human Services.

What if my oncologist is not familiar with Humana's requirements? Counterforce Health provides clinician-friendly templates and evidence-backed appeal strategies. Daiichi Sankyo Access Central also offers prior authorization support at 1-866-4-DSI-NOW.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may change. Always verify current requirements with Humana directly and consult your healthcare team for medical decisions. For personalized assistance with insurance appeals, consider consulting with patient advocacy services or legal professionals specializing in healthcare coverage.

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