By Counterforce Health Team in Tracleer (bosentan) —

How to Get Tracleer (Bosentan) Covered by Humana in North Carolina: Complete Decision Tree and Appeals Guide

Answer Box: Quick Eligibility Check

Most likely to get Tracleer (bosentan) covered by Humana in North Carolina: You have WHO Group 1 pulmonary arterial hypertension confirmed by right heart catheterization (mPAP ≥25 mmHg, PCWP ≤15 mmHg, PVR >3 Wood units), your prescriber is enrolled in the REMS program, and you've completed monthly liver function tests and pregnancy monitoring (if applicable). First step today: Have your prescriber submit prior authorization to Humana with complete diagnostic documentation and REMS enrollment confirmation. If denied: Medicare Advantage members follow federal appeals (not North Carolina Smart NC), while other Humana plans may use Smart NC external review within 120 days.

Table of Contents

How to Use This Decision Tree

This guide helps you determine your likelihood of getting Tracleer (bosentan) covered by Humana and provides specific next steps based on your situation. Tracleer is an endothelin receptor antagonist (ERA) used to treat WHO Group 1 pulmonary arterial hypertension (PAH) and requires enrollment in a Risk Evaluation and Mitigation Strategy (REMS) program due to liver toxicity and birth defect risks.

Start here: Answer the questions in the eligibility triage section below, then follow the pathway that matches your situation.

Eligibility Triage: Do You Qualify?

Question 1: Do you have confirmed WHO Group 1 PAH?

✅ YES if you have:

  • Right heart catheterization showing mPAP ≥25 mmHg, PCWP ≤15 mmHg, and PVR >3 Wood units
  • Documented exclusion of other causes (left heart disease, lung disease, chronic thromboembolic PH)
  • ICD-10 diagnosis code for PAH

❌ NO if:

  • Diagnosis based only on echocardiogram or clinical suspicion
  • You have WHO Groups 2-5 pulmonary hypertension
  • Right heart catheterization pending or incomplete

Question 2: Are REMS requirements met?

✅ YES if:

  • Your prescriber is enrolled in the Tracleer Access Program (T.A.P.)
  • You're enrolled as a patient in the REMS program
  • Monthly liver function tests are current
  • Monthly pregnancy tests completed (if female of childbearing potential)
  • Pharmacy is REMS-certified

❌ NO if:

  • REMS enrollment incomplete for any party
  • Monitoring requirements not established
  • Pregnancy/contraception counseling not documented

Question 3: Have you tried step therapy requirements?

✅ YES if:

  • You've tried and failed (or have contraindications to) Humana's preferred PAH medications
  • Medical necessity for Tracleer specifically is documented
  • Prior therapy failures are well-documented with dates and reasons

❌ NO if:

  • No previous PAH-specific therapy attempted
  • Preferred alternatives not yet tried
  • Documentation of previous therapies is incomplete

If "Likely Eligible": Document Checklist

If you answered YES to all three questions above, you're likely eligible for coverage. Here's what to submit:

Required Documentation

Clinical Records:

  • Right heart catheterization report with specific hemodynamic measurements
  • Complete diagnostic workup excluding other PH causes
  • Current functional class assessment (WHO/NYHA)
  • Baseline and monthly liver function tests
  • Pregnancy test results and contraception documentation (if applicable)

REMS Documentation:

  • Prescriber REMS enrollment confirmation
  • Patient enrollment in Tracleer Access Program
  • Pharmacy REMS certification
  • Completed patient counseling forms

Prior Authorization Submission:

  • Humana PA form completed by prescriber
  • Medical necessity letter citing FDA-approved indication
  • Documentation of step therapy compliance or medical exceptions

Submission Process

  1. Prescriber submits PA via Humana provider portal or fax to 1-877-486-2621
  2. Timeline: Humana has up to 72 hours for standard requests, 24 hours for expedited
  3. Follow up: Track request status through Humana member portal or by calling member services
Tip: Expedited review is available if delay would seriously jeopardize your health. Have your prescriber request this with supporting documentation.

If "Possibly Eligible": Tests to Request

If you're missing key diagnostic elements, work with your healthcare team to complete:

Diagnostic Workup

  • Right heart catheterization (essential for PAH diagnosis and insurance approval)
  • Comprehensive PH evaluation including CT chest, pulmonary function tests, sleep study if indicated
  • Connective tissue disease screening and HIV testing
  • Genetic counseling if familial PAH suspected

REMS Enrollment

  • Prescriber enrollment in Tracleer Access Program at [BosentanREMSProgram.com](verify with the source linked below)
  • Patient enrollment and counseling completion
  • Baseline monitoring establishment (liver function, pregnancy testing)

Timeline to reapply: Allow 4-6 weeks for complete diagnostic workup and REMS enrollment before submitting PA.

If "Not Yet": Alternatives and Exception Requests

If you don't meet standard criteria, consider these options:

Alternative PAH Therapies

  • Other ERAs: Ambrisentan (Letairis), macitentan (Opsumit)
  • PDE5 inhibitors: Sildenafil (Revatio), tadalafil (Adcirca)
  • Prostacyclin pathway: Selexipag (Uptravi), treprostinil (Remodulin)
  • sGC stimulator: Riociguat (Adempas)

Formulary Exception Process

If Tracleer isn't on your Humana formulary, request a formulary exception:

  1. Prescriber contacts Humana to request exception
  2. Medical necessity statement must demonstrate covered alternatives are ineffective or cause adverse effects
  3. Timeline: 72 hours for standard, 24 hours for expedited decisions
  4. Appeal rights: 65 days if initially denied

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with each plan's specific coverage rules.

If Denied: Appeal Path Chooser

Your appeal options depend on your specific Humana plan type:

Medicare Advantage Plans

❌ Smart NC does NOT apply to Medicare Advantage denials.

Appeal Path:

  1. Internal appeal with Humana (required first step)
  2. Independent Review Entity (IRE) - automatic referral after internal denial
  3. Administrative Law Judge hearing if dispute value ≥$180

Timelines:

  • Internal appeal: Follow plan instructions, typically 30 days to file
  • IRE review: 30 days standard, 72 hours expedited
  • Must exhaust internal appeals before IRE review

Commercial/ACA Plans

✅ Smart NC external review available for state-regulated plans.

Appeal Path:

  1. Internal appeals with Humana (two levels typically required)
  2. Smart NC external review within 120 days of final internal denial
  3. Timeline: 45 days standard, 72 hours expedited

To request Smart NC review:

Note: Self-funded employer plans may not be eligible for Smart NC review. Contact your HR department for appeal options.

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed Source
Prior Authorization PA required before coverage Completed PA form, clinical notes [Humana formulary policies](verify with the source linked below)
WHO Group 1 PAH Confirmed diagnosis via RHC Hemodynamic measurements, diagnostic workup FDA labeling requirements
REMS Enrollment All parties enrolled in safety program Enrollment confirmations, monitoring plans [Bosentan REMS Program](verify with the source linked below)
Step Therapy Try preferred drugs first Documentation of failures/contraindications Humana medical policies
Monthly Monitoring LFTs and pregnancy tests Lab results, negative pregnancy tests FDA REMS requirements

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
REMS non-compliance Complete all REMS enrollment steps Enrollment confirmations from all parties
Lack of RHC confirmation Submit hemodynamic measurements Right heart catheterization report
Step therapy not met Document failures of preferred drugs Treatment history with dates and outcomes
Off-label use Request formulary exception Medical necessity letter citing evidence
Quantity limits exceeded Request utilization exception Clinical justification for higher doses

FAQ: Tracleer Coverage in North Carolina

How long does Humana prior authorization take in North Carolina? Standard PA decisions: 72 hours. Expedited requests (when health is at risk): 24 hours. Timeline is the same regardless of your North Carolina location.

What if Tracleer is non-formulary on my Humana plan? Request a formulary exception through your prescriber. Humana must decide within 72 hours (24 hours expedited) and provide coverage at a predetermined cost-sharing level if approved.

Can I request an expedited appeal in North Carolina? Yes, for both Humana internal appeals and (if eligible) Smart NC external review. Your prescriber must document that delay would seriously jeopardize your health or ability to regain function.

Does the North Carolina Smart NC program apply to Medicare Advantage? No. Medicare Advantage appeals follow federal procedures through Independent Review Entities, not Smart NC external review.

What's the difference between Humana Medicare and commercial plan appeals in NC? Medicare Advantage follows federal timelines and uses IREs. Commercial plans may be eligible for Smart NC external review with different timelines and procedures.

How much does Tracleer cost with Humana coverage? Costs vary by plan type and formulary tier. Contact Humana member services for your specific copay or coinsurance. Manufacturer copay assistance may be available for eligible patients.

Resources and Next Steps

If you need additional help navigating Tracleer coverage with Humana in North Carolina, Counterforce Health provides specialized support for patients, clinicians, and specialty pharmacies to get prescription drugs approved by analyzing denial letters and drafting targeted appeals based on each plan's specific coverage criteria.

Key Contacts

  • Humana Member Services: Number on your insurance card
  • Humana Provider Services: 1-877-486-2621 (PA submissions)
  • Smart NC (non-Medicare plans): 855-408-1212
  • Tracleer REMS Program: 866-359-2612

Official Resources

Next Steps Checklist

  • Confirm your specific Humana plan type (Medicare Advantage vs. commercial)
  • Verify Tracleer's formulary status for your plan
  • Ensure REMS enrollment completion for all parties
  • Gather complete diagnostic documentation
  • Submit prior authorization with comprehensive medical necessity letter
  • Track approval status and prepare appeal strategy if needed

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by plan and change over time. Always verify current requirements with Humana and consult your healthcare provider for medical decisions. For official North Carolina insurance help, contact Smart NC at 855-408-1212 or visit the NC Department of Insurance website.

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