By Counterforce Health Team in Tracleer (bosentan) —

Tracleer (Bosentan) Approval with UnitedHealthcare in Florida: Answers to the Most Common Questions

Answer Box: Quick Path to Tracleer Coverage

Tracleer (bosentan) requires prior authorization from UnitedHealthcare in Florida, with strict REMS program compliance. Your prescriber must be a specialist (cardiologist, pulmonologist, or rheumatologist), enroll both you and themselves in the Bosentan REMS program, and submit comprehensive PAH documentation. First step today: Confirm your specialist is REMS-enrolled and ask them to initiate the PA through the UnitedHealthcare provider portal. Standard approval takes 72 hours; expedited reviews complete within 24 hours for urgent cases.

Table of Contents

Coverage Basics

Is Tracleer Covered by UnitedHealthcare?

Yes, Tracleer (bosentan) is covered by UnitedHealthcare plans in Florida, but it's classified as a Tier 5 specialty medication requiring prior authorization. Coverage applies to both Medicare Advantage and commercial plans, though specific requirements may vary by plan type.

Which UnitedHealthcare Plans Cover Tracleer?

  • Medicare Advantage: Covered with 31% coinsurance after meeting the $175 specialty drug deductible
  • Commercial plans: Coverage varies by employer plan design, typically 20-30% coinsurance
  • Medicaid managed care: May have additional state-specific requirements
Note: All UnitedHealthcare plans require specialty pharmacy dispensing through OptumRx or designated network pharmacies.

Prior Authorization Process

Who Submits the Prior Authorization?

Your prescriber (must be a cardiologist, pulmonologist, or rheumatologist) submits the PA request through the UnitedHealthcare provider portal or OptumRx system. Patients cannot submit PAs directly but can track status through the member portal.

Required Documentation Checklist

Clinical Requirements:

  • Right heart catheterization results confirming PAH diagnosis
  • WHO Group 1 classification
  • NYHA/WHO Functional Class II, III, or IV documentation
  • Prior therapy failures or contraindications (if step therapy applies)

REMS Program Compliance:

  • Provider and patient enrollment in Bosentan REMS program
  • Baseline liver function tests (ALT, AST)
  • Monthly pregnancy test results (females of childbearing potential)
  • Monitoring plan documentation

How to Check PA Status

  1. Provider portal: Real-time status updates and decision notifications
  2. Member services: Call the number on your insurance card
  3. OptumRx: 1-800-711-4555 for specialty drug inquiries

Timing and Urgency

Standard Processing Times

  • Standard PA: 72 hours from complete submission
  • Expedited/urgent: 24 hours with clinical urgency documentation
  • Peer-to-peer review: Scheduled within 1 business day of denial

When to Request Expedited Review

Request expedited processing if:

  • Delay would jeopardize your health or ability to regain function
  • You're experiencing rapid PAH progression
  • Current therapy has failed and immediate alternative is needed
Tip: Include physician attestation of urgency with specific clinical details for fastest processing.

Clinical Criteria and Requirements

Medical Necessity Criteria

Requirement Details Documentation Needed
Diagnosis WHO Group 1 PAH confirmed by right heart catheterization Hemodynamic data: mPAP ≥25 mmHg, PCWP ≤15 mmHg, PVR >3 Wood units
Prescriber Specialist with PAH experience Cardiologist, pulmonologist, or rheumatologist
Dosing Maximum 125 mg twice daily Prescription within FDA-approved dosing
REMS Compliance Both provider and patient enrolled Enrollment confirmation and monitoring plan

Step Therapy Requirements

Some UnitedHealthcare plans require trying preferred alternatives first:

  • Other endothelin receptor antagonists (ambrisentan, macitentan)
  • PDE5 inhibitors (sildenafil, tadalafil)
  • Documentation of failure, intolerance, or contraindication required for exceptions

REMS Program Requirements

Critical for approval: Both you and your prescriber must enroll in the Bosentan REMS program before treatment begins.

Monthly monitoring includes:

  • Liver function tests (ALT, AST)
  • Pregnancy tests for females of childbearing potential
  • Documentation in REMS portal before each refill

Costs and Copays

Medicare Advantage Costs (2025)

Coverage Phase Your Cost Notes
Deductible Phase Full cost until $175 met Applies to Tier 3-5 drugs
Coverage Phase 31% coinsurance per fill Specialty pharmacy required
Catastrophic Phase $0 After $2,000 annual out-of-pocket

Commercial Plan Costs

Costs vary by employer plan but typically range from 20-30% coinsurance. Check your Summary of Benefits for exact amounts.

Cost-Saving Options

  • Janssen CarePath: Patient assistance programs (verify eligibility at J&J WithMe)
  • Medicare Extra Help: Low-income subsidy program
  • State pharmaceutical assistance programs: Contact Florida Department of Health

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Fix
REMS non-compliance Complete provider and patient enrollment; submit documentation
Missing specialist involvement Transfer care to cardiologist, pulmonologist, or rheumatologist
Inadequate medical necessity Submit comprehensive PAH diagnosis with hemodynamic data
Step therapy not met Document prior therapy failures or contraindications

Florida Appeals Process

Internal Appeals (Required First Step):

  • Timeline to file: 180 days from denial notice
  • Decision deadline: 30 days for pre-service, 60 days for post-service
  • Peer-to-peer option: Request within 1 business day of denial

External Review (After Internal Appeal):

  • Timeline to file: 4 months from final internal denial
  • Decision deadline: 45 days standard, 72 hours expedited
  • Administrator: MAXIMUS Federal Services (contracted by Florida)
  • Cost: Free to patients

Appeals Submission Methods

  1. Online: UnitedHealthcare member portal
  2. Mail: Address provided in denial letter
  3. Fax: Number specified in denial notice
  4. Phone: Member services for assistance
Important: Keep copies of all correspondence and track deadlines carefully.

Reauthorization and Renewals

When to Reauthorize

Most Tracleer authorizations require renewal every 12 months. Your prescriber will receive notification 30-60 days before expiration.

Renewal Documentation

  • Ongoing clinical benefit demonstration
  • Continued REMS compliance
  • Updated liver function and pregnancy tests
  • Treatment response documentation

What Changes Trigger New PA

  • Dose increases beyond approved amount
  • Change in diagnosis or indication
  • Prescriber changes (new provider must be REMS-enrolled)

Specialty Pharmacy Requirements

Why Specialty Pharmacy is Required

Tracleer requires special handling due to:

  • REMS program coordination
  • Monthly monitoring requirements
  • Temperature-controlled shipping
  • Patient education and support services

OptumRx Specialty Services

As UnitedHealthcare's preferred specialty pharmacy, OptumRx provides:

  • REMS program coordination
  • Automatic refill reminders aligned with lab schedules
  • Clinical support and medication counseling
  • Insurance benefit coordination

Alternative Specialty Pharmacies

If OptumRx isn't available, other in-network specialty pharmacies may be approved. Confirm network status before transferring prescriptions.

Troubleshooting Common Issues

Provider Portal Problems

Issue: Portal shows "pending" status beyond normal timeframes Solution: Call OptumRx Prior Authorization team at 1-800-711-4555

Issue: Missing REMS documentation error Solution: Verify enrollment status at BosentanREMSProgram.com and resubmit confirmation

Pharmacy Transfer Issues

Issue: Prescription rejected at pharmacy Solution: Confirm specialty pharmacy requirement and transfer to OptumRx or approved network pharmacy

Issue: Insurance shows "not covered" Solution: Verify PA approval status and ensure pharmacy is billing correct insurance information

When to Contact Member Services

  • PA status unclear after 5 business days
  • Denial letter missing or unclear
  • Pharmacy unable to fill approved prescription
  • Questions about appeal deadlines or process

Contact: Number on your insurance card or 1-866-414-1959 for general inquiries

Key Terms Glossary

Prior Authorization (PA): Insurance approval required before coverage begins

REMS: Risk Evaluation and Mitigation Strategy - FDA-required safety program

Step Therapy (ST): Requirement to try preferred medications first

Peer-to-Peer (P2P): Direct discussion between prescribing doctor and insurance medical director

Medical Necessity: Clinical evidence that treatment is appropriate and required

Quantity Limit (QL): Maximum amount covered per time period

Formulary: Insurance company's list of covered medications by tier

EOB: Explanation of Benefits - document showing what insurance paid/denied

External Review: Independent review by state-contracted organization

Specialty Tier: Highest formulary tier for complex, high-cost medications

Counterforce Health specializes in turning insurance denials into successful appeals through evidence-based advocacy. Our platform helps patients and clinicians navigate complex prior authorization requirements like those for Tracleer, identifying denial reasons and drafting targeted rebuttals aligned with payer policies. By combining clinical expertise with payer-specific workflows, we help ensure patients get access to the medications they need. Learn more at www.counterforcehealth.org.

When dealing with specialty medications like Tracleer, having expert support can make the difference between approval and denial. Counterforce Health provides the clinical documentation and appeals expertise needed to navigate UnitedHealthcare's complex requirements successfully.

From Our Advocates

"We've seen Tracleer denials overturned most successfully when providers submit comprehensive hemodynamic data alongside clear documentation of REMS compliance. The key is demonstrating that all regulatory and clinical requirements are met upfront, rather than addressing deficiencies after denial. This composite guidance reflects patterns we've observed across multiple successful appeals."

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage and requirements can change. Always verify current requirements with UnitedHealthcare and consult your healthcare provider for medical decisions. For assistance with Florida insurance issues, contact the Florida Department of Financial Services at 1-877-693-5236.

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