By Counterforce Health Team in Rezlidhia (olutasidenib) —

The Complete Requirements Checklist to Get Rezlidhia (Olutasidenib) Covered by UnitedHealthcare in Florida

Answer Box: Getting Rezlidhia Covered by UnitedHealthcare in Florida

Fastest path to approval: UnitedHealthcare requires prior authorization for Rezlidhia (olutasidenib) with documented IDH1 mutation testing, relapsed/refractory AML diagnosis, and evidence of failed standard therapies. Submit via the UnitedHealthcare provider portal with complete documentation. If denied, you have 180 days to appeal internally, followed by external review through Florida's independent review process. First step today: Gather your IDH1 mutation test results, complete treatment history, and have your oncologist prepare a medical necessity letter citing NCCN guidelines.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Medical Coding Requirements
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission: What to Expect
  9. Common Pitfalls and How to Avoid Them
  10. Appeals Process for Florida Patients
  11. Printable Quick-Reference Checklist

Who Should Use This Checklist

This comprehensive requirements checklist is designed for adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a confirmed IDH1 mutation and need Rezlidhia (olutasidenib) covered by UnitedHealthcare in Florida. You'll also find this useful if you're a caregiver, oncology nurse, or clinic staff member helping coordinate coverage approval.

Expected outcome: Following this checklist increases your likelihood of first-time approval and helps you avoid the most common reasons for denial. If you do receive a denial, you'll be prepared with the right documentation for a successful appeal.

When to use: Before your oncologist prescribes Rezlidhia, or immediately after receiving a denial letter from UnitedHealthcare.

Member & Plan Basics

Coverage Verification Checklist

Before starting the prior authorization process, confirm these essential details:

  • Active UnitedHealthcare coverage - Check your member ID card and verify benefits are current
  • Plan type identification - Commercial, Medicare Advantage, or Medicaid (requirements may vary slightly)
  • Specialty pharmacy benefit - Confirm your plan covers specialty medications through OptumRx or designated specialty pharmacies
  • Deductible status - Know your annual deductible and current spending toward it
  • Prior authorization requirement confirmed - Rezlidhia requires PA for all UnitedHealthcare plans
Note: UnitedHealthcare's Marketplace (ACA) plans have shown denial rates around 33% for in-network claims, making thorough preparation essential.

Clinical Criteria Requirements

Primary Indication Requirements

UnitedHealthcare will only cover Rezlidhia for its FDA-approved indication:

  • Diagnosis: Relapsed or refractory acute myeloid leukemia (AML) in adults
  • Genetic testing: Confirmed IDH1 mutation detected by FDA-approved test
  • Prescriber: Board-certified hematologist/oncologist
  • Treatment history: Documentation of failed standard AML therapies

Step Therapy Requirements

UnitedHealthcare typically requires patients to try alternative treatments first:

  • First-line requirement: Trial and documented failure or contraindication to ivosidenib (Tibsovo), another IDH1 inhibitor
  • Standard therapy attempts: Evidence of failed or unsuitable conventional AML treatments
  • Medical contraindications: Clear documentation if alternatives cannot be used due to patient-specific factors

Monitoring Plan Requirements

  • Differentiation syndrome monitoring protocol documented
  • Hepatic function monitoring plan in place
  • Regular follow-up schedule established with oncology team

Medical Coding Requirements

Essential Codes for Billing

Code Type Code Description
NDC 71332-005-01 Rezlidhia 150mg capsule, 30-count bottle
HCPCS J3490 or J9999 Miscellaneous drug codes (no permanent J-code assigned)
ICD-10 C92.00 Acute myeloblastic leukemia, not achieved remission
ICD-10 C92.02 Acute myeloblastic leukemia, in relapse

Quantity Limits

  • Standard allowance: Up to 180 capsules per 90 days (verify current limits with UnitedHealthcare)
  • Dosing documentation: 150mg twice daily dosing rationale included

Documentation Packet Essentials

Medical Necessity Letter Components

Your oncologist's letter must include:

  • Patient demographics - Full name, DOB, UnitedHealthcare member ID
  • Complete AML diagnosis - Including date of initial diagnosis, staging, and current disease status
  • IDH1 mutation details - Specific mutation subtype and FDA-approved test used
  • Prior treatment history - Detailed list with dates, outcomes, and reasons for discontinuation
  • Clinical rationale - Why Rezlidhia is medically necessary for this specific patient
  • Guideline references - Citations to NCCN, FDA labeling, or other recognized guidelines
  • Safety monitoring plan - Specific protocols for differentiation syndrome and hepatic monitoring

Required Attachments

  • IDH1 mutation test report - Complete laboratory results with mutation subtype
  • Pathology reports - Confirming AML diagnosis
  • Treatment history documentation - Records of all prior AML therapies and outcomes
  • Recent clinic notes - Supporting current disease status and treatment rationale
  • Bone marrow biopsy results - If recent and relevant to current status

Submission Process

Correct Forms and Portals

  • Submission method: UnitedHealthcare Provider Portal (required for most submissions)
  • Form version: Use current UnitedHealthcare prior authorization form (verify latest version)
  • Electronic submission: As of June 2025, all Florida Medicaid appeals must be submitted electronically

Critical Fields That Cause Rejections

  • Complete member information - Verify all ID numbers and demographics
  • Prescriber NPI - Ensure correct National Provider Identifier
  • Diagnosis codes - Include both primary AML code and any relevant secondary codes
  • Drug-specific information - Exact NDC, dosing, and duration requested
  • Clinical justification - Detailed rationale in designated text fields

Specialty Pharmacy Routing

UnitedHealthcare Preferred Network

  • Verify specialty pharmacy participation - Confirm your chosen pharmacy is in-network
  • OptumRx coordination - Many UnitedHealthcare plans require OptumRx specialty pharmacy
  • Transfer documentation - If switching from another pharmacy, ensure prescription transfer is documented
  • Shipment coordination - Confirm delivery address and timing with pharmacy

Patient Assistance Programs

While waiting for coverage approval, explore:

  • Manufacturer copay assistance - Rigel Pharmaceuticals may offer patient support programs
  • Foundation grants - Organizations like HealthWell Foundation may provide assistance
  • Hospital financial assistance - Many cancer centers offer support programs

After Submission: What to Expect

Timeline and Status Tracking

  • Standard processing: Typically 72 hours for non-urgent requests
  • Expedited processing: 24 hours for urgent medical needs
  • Confirmation number: Record and save for all tracking
  • Status check schedule: Monitor via provider portal every 2-3 business days

What to Record

  • Submission date and time
  • Confirmation/reference numbers
  • Case manager contact information (if assigned)
  • Follow-up dates and outcomes
  • Any requests for additional information

Common Pitfalls and How to Avoid Them

Top 5 Denial Reasons and Solutions

Denial Reason How to Avoid Required Documentation
IDH1 mutation not documented Submit complete FDA-approved test results Full laboratory report with mutation subtype
Step therapy not satisfied Document ivosidenib failure/contraindication Treatment records with dates and outcomes
Non-specialist prescriber Ensure hematology/oncology involvement Board certification documentation
Incomplete medical necessity Include detailed clinical rationale Comprehensive letter citing guidelines
Missing monitoring plan Document safety protocols Written differentiation syndrome plan

Appeals Process for Florida Patients

Internal Appeal Timeline

If your initial request is denied:

  • File within 180 days of denial notice
  • Submit via electronic portal (required in Florida as of 2025)
  • Include additional documentation addressing denial reasons
  • Request expedited review if medically urgent (72-hour decision)

External Review Process

After exhausting internal appeals:

  • Automatic forwarding for Medicare Advantage plans to Independent Review Entity
  • State external review for other plans through Florida Department of Financial Services
  • No cost to patient for external review process
  • Binding decision - Insurer must comply with favorable external review

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed responses. Their platform helps patients and clinicians navigate complex prior authorization requirements and appeals processes for specialty medications like Rezlidhia.

Florida-Specific Resources

  • Florida Department of Financial Services: 1-877-MY-FL-CFO (877-693-5236)
  • Insurance Consumer Helpline: Available for assistance with appeals and external review
  • External review requests: Submit through DFS after internal appeal completion

Printable Quick-Reference Checklist

Before You Start

  • Active UnitedHealthcare coverage verified
  • IDH1 mutation test results in hand
  • Complete prior treatment history documented
  • Hematology/oncology specialist involved

Required Documentation

  • Medical necessity letter from oncologist
  • IDH1 mutation test report (FDA-approved)
  • Complete AML treatment history
  • Differentiation syndrome monitoring plan
  • Current UnitedHealthcare PA form completed

Submission

  • Submit via UnitedHealthcare Provider Portal
  • All required fields completed accurately
  • Confirmation number recorded
  • Follow-up schedule established

If Denied

  • Review denial letter within 24 hours
  • File internal appeal within 180 days
  • Address specific denial reasons
  • Consider expedited review if urgent
  • Prepare for external review if needed

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take for Rezlidhia in Florida? A: Standard processing is typically 72 hours, with expedited review available within 24 hours for urgent medical situations.

Q: What if Rezlidhia is not on my UnitedHealthcare formulary? A: Rezlidhia requires prior authorization on all UnitedHealthcare formularies. Non-formulary status may require additional medical exception documentation.

Q: Can I appeal if I haven't tried ivosidenib first? A: Yes, but you'll need strong clinical documentation explaining why step therapy should be waived, such as contraindications or patient-specific factors.

Q: What counts as an urgent appeal for Rezlidhia? A: Situations where delay could jeopardize health, such as rapidly progressing AML or inability to tolerate current therapy.

Q: Does Florida have any special protections for cancer patients? A: Florida requires coverage of certain clinical trial costs and has limitations on step therapy requirements for prescription medications.

Q: How much does Rezlidhia cost without insurance? A: List price is approximately $32,000 per month, making insurance coverage essential for most patients.

For patients navigating complex insurance requirements, Counterforce Health offers specialized support in converting denials into successful approvals through targeted appeals that align with specific payer policies and clinical evidence requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage requirements can change frequently. Always verify current requirements with UnitedHealthcare and consult with your healthcare provider and insurance representative for the most up-to-date information specific to your situation. For additional assistance with insurance appeals and coverage issues in Florida, contact the Florida Department of Financial Services at 1-877-MY-FL-CFO.

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