By Counterforce Health Team in Turalio (pexidartinib) —

Denied for Turalio (pexidartinib) by UnitedHealthcare in Florida? How to Appeal (Templates & Timelines)

Answer Box: Getting Turalio (pexidartinib) Covered by UnitedHealthcare in Florida

UnitedHealthcare requires prior authorization for Turalio (pexidartinib) with strict criteria: confirmed TGCT diagnosis, unresectable disease, and REMS enrollment. If denied, request a peer-to-peer review within 24-72 hours, then file internal appeals within 180 days. Florida offers binding external review through the Department of Financial Services within 4 months of final denial. Start with your denial letter to identify the specific reason code and gather pathology reports, imaging showing unresectability, and REMS documentation.

Table of Contents

  1. Understanding Your Turalio Denial
  2. Coverage Requirements at a Glance
  3. Step-by-Step: Fastest Path to Approval
  4. Peer-to-Peer Review Process
  5. Appeals Playbook for Florida
  6. Medical Necessity Letter Template
  7. Florida External Review Process
  8. Common Denial Reasons & Solutions
  9. Cost Assistance Options
  10. Frequently Asked Questions

Understanding Your Turalio Denial

When UnitedHealthcare denies coverage for Turalio (pexidartinib), the denial letter contains crucial information for your appeal strategy. Look for these key elements:

Reason Codes to Watch For:

  • Medical necessity not established - Most common for TGCT cases
  • Step therapy requirements not met - Surgery not attempted/documented
  • REMS enrollment incomplete - Patient or prescriber not certified
  • Diagnosis not confirmed - Missing pathology or imaging
  • Quantity limits exceeded - Dose exceeds policy parameters
Tip: Save all denial letters, EOBs, and correspondence. Florida's external review process requires complete documentation of your appeal history.

Coverage Requirements at a Glance

Requirement What UnitedHealthcare Needs Where to Find It Timeline
TGCT Diagnosis Pathology report + ICD-10 code Biopsy results, radiology Before PA submission
Unresectable Disease Surgeon's note stating surgery inappropriate Orthopedic oncologist evaluation Required for approval
REMS Enrollment Patient, prescriber, pharmacy certified TURALIO REMS website Must complete before dispensing
Baseline Labs Liver function tests within normal limits Recent lab results Within 30 days of request
Prior Authorization Complete PA form via provider portal UHC Provider Portal Submit before treatment

Sources: UnitedHealthcare Prior Authorization Requirements, TURALIO REMS Program

Step-by-Step: Fastest Path to Approval

1. Gather Essential Documentation

Who: Patient and clinic staff
Timeline: 1-2 days

  • Pathology report confirming TGCT diagnosis
  • MRI showing disease extent and unresectability
  • Surgeon's note explaining why surgery is inappropriate
  • Current liver function tests
  • Insurance card and member ID

2. Complete REMS Enrollment

Who: Prescriber, patient, pharmacy
Timeline: 3-5 business days

3. Submit Prior Authorization

Who: Prescriber or authorized staff
Timeline: Same day via portal

  • Use UnitedHealthcare Provider Portal for fastest processing
  • Include all documentation from step 1
  • Request expedited review if clinically urgent

4. If Denied: Request Peer-to-Peer Review

Who: Prescriber
Timeline: Within 24-72 hours of denial

  • Schedule through provider portal
  • Prepare clinical talking points
  • Have guidelines and imaging readily available

5. File Internal Appeal if P2P Unsuccessful

Who: Prescriber or patient
Timeline: Within 180 days of denial

  • Submit comprehensive medical necessity letter
  • Attach all supporting documentation
  • Request expedited review for urgent cases

Peer-to-Peer Review Process

The peer-to-peer review offers your best chance to overturn a denial quickly. UnitedHealthcare medical directors are often willing to approve cases when presented with clear clinical rationale.

Scheduling Your P2P Call

  1. Request within 24-72 hours of receiving the denial
  2. Use the UnitedHealthcare Provider Portal peer-to-peer scheduling form
  3. Calls typically occur within 3 business days for outpatient cases
  4. Source: UnitedHealthcare Appeals Process

P2P Preparation Checklist

  • Patient summary: Age, TGCT location, symptom severity, functional limitations
  • Imaging results: MRI findings showing diffuse involvement, joint destruction
  • Surgical consultation: Specific reasons surgery is contraindicated or high-risk
  • REMS status: Confirmation of enrollment completion
  • Guidelines: FDA labeling, NCCN when applicable for TGCT management
From our advocates: Many successful appeals involve orthopedic oncologists who clearly explain why surgical resection would cause "severe morbidity or major functional loss" – the exact language from FDA labeling. This clinical specificity often resonates with medical directors during peer-to-peer calls.

Appeals Playbook for Florida

Florida residents have robust appeal rights under state and federal law. Here's your roadmap:

Internal Appeals (Required First Step)

Level 1 Appeal

  • Deadline: 180 days from denial date
  • Decision timeline: 30 days for pre-service, 60 days for post-service
  • How to file: UnitedHealthcare Provider Portal or written submission
  • Expedited option: 72 hours for urgent cases

Level 2 Appeal (if Level 1 denied)

  • Deadline: 60 days from Level 1 denial
  • Decision timeline: 30 days
  • Requirements: Must address Level 1 decision reasons

External Review (After Internal Appeals)

Florida contracts with independent review organizations for binding external reviews.

Eligibility Requirements:

  • Completed UnitedHealthcare internal appeals
  • Denial based on medical necessity or experimental/investigational determination
  • Fully-insured plan (not self-funded ERISA plans)

Timeline and Process:

  • Deadline: 4 months from final internal denial
  • Decision time: 45 days standard, 72 hours expedited
  • Cost: Free to patients
  • How to request: Contact Florida Department of Financial Services at 1-877-MY-FL-CFO
  • Source: Florida External Review Process

Medical Necessity Letter Template

Essential Components for Turalio Appeals

Patient Information Section

  • Member name, DOB, UnitedHealthcare ID
  • Diagnosis: Tenosynovial Giant Cell Tumor (ICD-10: M12.2X)
  • Prescribing physician credentials and specialty

Clinical Justification

Patient presents with symptomatic TGCT of [location] confirmed by [pathology date]. 
Disease is not amenable to improvement with surgery due to [specific surgical risks/contraindications per orthopedic oncologist evaluation dated X].

Prior treatments attempted: [list surgeries, dates, outcomes]
Current functional limitations: [pain scores, range of motion, daily activities affected]

Turalio (pexidartinib) is FDA-approved specifically for symptomatic TGCT not amenable to improvement with surgery causing severe morbidity or functional limitations, which precisely describes this patient's clinical situation.

REMS Compliance Documentation

  • Prescriber REMS certification date
  • Patient enrollment completion
  • Pharmacy REMS verification
  • Baseline liver function tests within normal limits
  • Monitoring plan established

Medical Necessity Conclusion Request approval of Turalio 200mg capsules, 400mg daily (divided doses), dispensed through REMS-certified specialty pharmacy, as the only FDA-approved systemic therapy for this indication.

Florida External Review Process

When UnitedHealthcare's internal appeals fail, Florida's external review provides a final opportunity for coverage approval.

Who Qualifies for External Review

  • Fully-insured UnitedHealthcare plans (not self-funded employer plans)
  • Medical necessity denials for Turalio
  • Completed internal appeals with UnitedHealthcare
  • Within 4 months of final denial letter date

How to Request External Review

  1. Contact Florida DFS: Call 1-877-MY-FL-CFO (1-877-693-5236)
  2. File online complaint: Submit through Florida Department of Financial Services portal
  3. Required documents:
    • All UnitedHealthcare denial letters and appeal decisions
    • Original prior authorization request and clinical documentation
    • Medical necessity letter from treating physician
    • Supporting medical records and imaging

What Happens Next

  • Assignment: Florida DFS assigns case to independent medical reviewer
  • Reviewer qualifications: Must be practicing physician in same or related specialty
  • Decision: Binding on UnitedHealthcare if overturned
  • Timeline: 45 days standard, 72 hours if expedited for urgent cases

Counterforce Health specializes in transforming insurance denials into successful, evidence-backed appeals. Our platform analyzes denial letters, identifies specific coverage criteria, and generates targeted rebuttals that align with each payer's requirements – helping patients, clinicians, and specialty pharmacies navigate complex prior authorization processes more effectively.

Common Denial Reasons & Solutions

Denial Reason Required Documentation Appeal Strategy
"TGCT diagnosis not confirmed" Pathology report with specific TGCT confirmation Include complete pathology report and ICD-10 code M12.2X
"Surgery not attempted" Orthopedic oncologist evaluation Detailed surgical consultation explaining contraindications
"REMS requirements not met" Enrollment confirmations Provide prescriber, patient, and pharmacy REMS certificates
"Not medically necessary" Functional assessments, imaging Document pain scores, range of motion limitations, daily function impact
"Experimental/investigational" FDA approval documentation Cite FDA approval letter and prescribing information

Cost Assistance Options

Even with insurance approval, Turalio's high cost (~$23,850 per month) may require additional support:

Manufacturer Programs

  • Daiichi Sankyo Patient Assistance: Income-based free drug program
  • Commercial insurance copay card: May reduce out-of-pocket costs
  • Contact: Daiichi Sankyo customer service for current programs

Foundation Grants

  • Patient Access Network (PAN) Foundation: Cancer fund assistance
  • HealthWell Foundation: Rare disease coverage
  • National Organization for Rare Disorders (NORD): Patient assistance programs

State Programs

  • Florida Medicaid: May cover for eligible patients
  • 340B pharmacy programs: Reduced-cost dispensing at qualifying hospitals

For comprehensive appeals assistance, Counterforce Health helps transform denials into approvals by creating evidence-based appeals that address each payer's specific coverage criteria and procedural requirements.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Turalio in Florida? Standard PA decisions typically take 15-30 days. Expedited reviews for urgent cases are completed within 72 hours when clinical urgency is documented.

What if Turalio is non-formulary on my UnitedHealthcare plan? Non-formulary drugs can still be covered through medical exception processes. Submit PA with strong medical necessity documentation and request formulary exception.

Can I request an expedited appeal if my condition is worsening? Yes. Document rapid progression, functional decline, or risk of irreversible joint damage. UnitedHealthcare must respond to expedited appeals within 72 hours.

Does step therapy apply if I've failed surgery outside Florida? Prior surgical failures from any location count toward step therapy requirements. Include complete surgical records and outcomes documentation.

What happens if UnitedHealthcare approves Turalio but my pharmacy isn't REMS-certified? The approval is conditional on REMS compliance. Transfer to a REMS-certified specialty pharmacy or have your current pharmacy complete certification.

How do I know if my plan is subject to Florida external review? Fully-insured individual and small group plans qualify. Large employer self-funded plans typically follow federal external review rules instead.

Can my doctor appeal on my behalf? Yes. Providers can file appeals through the UnitedHealthcare Provider Portal. Patient consent may be required for certain communications.

What if I'm hospitalized and need Turalio urgently? Request expedited PA and appeal processes. Hospital case managers can assist with urgent authorization requests and peer-to-peer scheduling.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For additional support with insurance appeals, contact the Florida Department of Financial Services Consumer Helpline at 1-877-MY-FL-CFO.

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