By Counterforce Health Team in Tracleer (bosentan) —

How to Get Tracleer (Bosentan) Covered by Blue Cross Blue Shield in North Carolina: Complete Prior Authorization Guide

Answer Box: Getting Tracleer (Bosentan) Covered in North Carolina

Tracleer (bosentan) requires prior authorization from Blue Cross Blue Shield of North Carolina (BCBSNC) for WHO Group 1 pulmonary arterial hypertension. Key requirements: REMS program enrollment, specialist prescriber (cardiologist/pulmonologist), baseline liver tests, and trial of generic bosentan first. If denied, North Carolina offers robust external review through Smart NC with ~61% success rates for specialty drugs.

First step today: Confirm your BCBSNC plan type and verify REMS enrollment at bosentanremsprogram.com.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Plan Verification
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Timelines
  6. Common Denial Reasons & Solutions
  7. Appeals Process in North Carolina
  8. Smart NC External Review
  9. Costs and Patient Support
  10. FAQ

What This Guide Covers

This comprehensive guide helps patients with pulmonary arterial hypertension (PAH) and their healthcare teams navigate Blue Cross Blue Shield of North Carolina's prior authorization process for Tracleer (bosentan). Whether you're facing an initial denial or planning your first submission, we'll walk through every step—from REMS enrollment to North Carolina's external review system.

Tracleer is an endothelin receptor antagonist (ERA) used to treat WHO Group 1 PAH, but it requires careful monitoring due to liver toxicity risks and comes with strict FDA requirements. Understanding BCBSNC's specific criteria can mean the difference between approval and denial.

Before You Start: Plan Verification

Confirm Your Plan Type

Not all Blue Cross plans follow the same rules. Here's what you need to verify:

Plan Type Prior Auth Process External Review Options
Commercial/ACA BCBSNC portal/fax Smart NC (North Carolina DOI)
Medicare Advantage Availity.com Federal IRE process
Self-Funded Employer Check with HR Limited appeal rights

Action step: Call BCBSNC member services at 833-540-2106 or check your insurance card for plan details.

Check Formulary Status

Tracleer appears on BCBSNC formularies but requires prior authorization. Generic bosentan is typically preferred, meaning you'll need to try the generic first unless there's a medical exception.

Verify current formulary: Use BCBSNC's prior authorization search tool to confirm Tracleer's status and PA requirements.

Gather Required Documentation

Essential Clinical Information

Your healthcare provider will need to compile:

Diagnosis Requirements:

  • WHO Group 1 PAH confirmed by right heart catheterization
  • Mean pulmonary artery pressure >25 mmHg
  • Pulmonary capillary wedge pressure ≤15 mmHg
  • Pulmonary vascular resistance >3 Wood Units
  • NYHA functional class II-IV

Laboratory and Monitoring:

  • Baseline liver function tests (AST/ALT) within 40 days
  • For women of childbearing potential: negative pregnancy test
  • Complete blood count (hemoglobin baseline)
  • Documentation of monthly monitoring plan

Prior Therapy Documentation:

  • Evidence of generic bosentan trial/failure (unless contraindicated)
  • Records of other PAH therapies tried
  • Contraindications to alternative treatments

REMS Program Enrollment

Critical requirement: Both prescriber and patient must enroll in the Bosentan REMS Program before any prescription can be dispensed.

Prescriber requirements:

  • Complete REMS training modules
  • Order baseline liver function tests
  • Commit to monthly LFT monitoring
  • Document pregnancy prevention plan (if applicable)

Patient requirements:

  • Complete enrollment acknowledging risks
  • Agree to monthly blood tests
  • Use approved pharmacy network
From our advocates: We've seen many initial denials simply because REMS enrollment wasn't completed properly. One patient's approval was delayed three weeks because the prescriber hadn't finished the online training modules, even though all clinical criteria were met. Always verify REMS status before submitting your PA request.

Submit Your Prior Authorization Request

BCBSNC Submission Process

For Commercial Plans:

Required PA Components:

  1. Completed prior authorization form
  2. Medical necessity letter from specialist
  3. REMS enrollment confirmation
  4. Baseline laboratory results
  5. Diagnostic documentation (echo, catheterization)
  6. Prior therapy records

Medical Necessity Letter Checklist

Your prescriber's letter should address:

  • Clinical presentation: PAH symptoms, functional limitations
  • Diagnostic confirmation: Right heart cath results, WHO Group 1 classification
  • Treatment rationale: Why Tracleer is medically necessary
  • Step therapy compliance: Generic bosentan trial or contraindication
  • Monitoring plan: Monthly LFTs, pregnancy tests, hemoglobin checks
  • Alternative considerations: Why other ERAs aren't suitable

Follow-Up and Timelines

Standard Processing Times

BCBSNC Commercial Plans:

  • Standard PA: 15 calendar days
  • Expedited PA: 72 hours (urgent medical need)
  • Appeals: 30 days for standard, 72 hours for expedited

When to Follow Up:

  • Day 10: Check status if no response
  • Day 14: Request expedited review if urgent
  • Day 16+: File appeal if denied without response

Sample Follow-Up Script: "I'm calling about prior authorization request #[reference number] for Tracleer submitted on [date]. Can you provide the current status and expected decision date?"

Common Denial Reasons & Solutions

Denial Reason Solution Documentation Needed
REMS not enrolled Complete enrollment first REMS confirmation email
Generic not tried Submit step therapy exception Medical necessity letter
Missing labs Submit baseline tests LFTs, pregnancy test, CBC
Non-specialist prescriber Transfer to cardiologist/pulmonologist New prescription from specialist
Insufficient diagnosis Provide complete workup Right heart cath, echo results

Step Therapy Exceptions

If generic bosentan isn't appropriate, document:

  • Intolerance: Specific adverse reactions
  • Contraindications: Drug interactions, allergies
  • Inadequate response: Lack of clinical improvement on generic
  • Formulation needs: Specific dosing requirements

Appeals Process in North Carolina

Internal Appeals (First Level)

Timeline: Must file within 180 days of denial Process:

  1. Submit appeal letter addressing denial reasons
  2. Include additional clinical evidence
  3. Request peer-to-peer review if available
  4. BCBSNC has 30 days to respond

Second-Level Internal Appeal

If first appeal is denied:

  • Timeline: 30 days from first denial
  • Enhanced evidence: Specialist consultation, literature review
  • Peer-to-peer: Request physician-to-physician discussion

Appeal Letter Template: "I am formally appealing the denial of prior authorization for Tracleer (bosentan) for [patient name], member ID [number]. The denial was based on [reason], which I respectfully contest for the following clinical reasons..."

Smart NC External Review

When to Use External Review

After exhausting internal appeals, North Carolina residents with state-regulated plans can request external review through Smart NC.

Eligibility Requirements:

  • State-regulated commercial or ACA plan
  • Completed internal appeals process
  • Denial based on medical necessity
  • Request filed within 120 days of final internal denial

Smart NC Process

Timeline:

  • Standard review: 45 days
  • Expedited review: 72 hours (serious health jeopardy)

How to File:

  1. Download external review form from NC Department of Insurance
  2. Gather all denial letters and medical records
  3. Submit via online portal or mail
  4. Call Smart NC helpline: 1-855-408-1212

Success Factors: Based on similar specialty drug cases, external reviews succeed approximately 61% of the time when proper clinical documentation supports medical necessity.

Expedited External Review

For urgent situations where delay could seriously jeopardize health:

  • Criteria: Immediate need for treatment
  • Timeline: 72 hours for decision
  • Process: Can bypass remaining internal appeals

Costs and Patient Support

Manufacturer Support Programs

Janssen CarePath:

Alternative Funding Sources

  • Patient Assistance Programs: Income-based eligibility
  • State Pharmaceutical Assistance: North Carolina programs (verify with state health department)
  • Specialty Pharmacy Support: Many offer financial counseling

Counterforce Health: Streamlining Your Appeal

When facing complex prior authorization denials, Counterforce Health helps patients and providers turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters, identifies specific denial reasons, and creates point-by-point rebuttals aligned with your plan's own policies—pulling the right clinical evidence and procedural requirements to maximize approval chances.

FAQ

How long does BCBSNC prior authorization take for Tracleer? Standard processing is 15 calendar days. Expedited requests (for urgent medical need) receive decisions within 72 hours.

What if Tracleer isn't on my formulary? Submit a formulary exception request with medical necessity documentation. BCBSNC must respond within 72 hours for urgent requests, 24 hours for non-formulary drugs.

Can I appeal if I'm on a self-funded employer plan? Self-funded plans aren't eligible for Smart NC external review. Check with your HR department about internal appeal rights and consider federal options under ERISA.

Does step therapy apply if I've used Tracleer before? Prior successful use of Tracleer may qualify for a step therapy exception. Document previous response and any reasons generic bosentan isn't suitable.

What counts as "urgent" for expedited review? Serious jeopardy to life, health, or ability to regain maximum function. Your prescriber must document why delay would cause harm.

How do I find my plan's specific PA form? Use BCBSNC's provider portal or call provider services at 833-540-2106.

Renewal and Re-authorization

When to Resubmit

Most PA approvals last 12-24 months. Calendar renewal 30 days before expiration to avoid treatment gaps.

Renewal Documentation:

  • Updated clinical assessment
  • Current laboratory results
  • Treatment response documentation
  • Continued medical necessity

Quick Reference Checklist

Before Submitting:

  • Confirm BCBSNC plan type and formulary status
  • Complete REMS enrollment (prescriber and patient)
  • Gather baseline labs (LFTs, pregnancy test, CBC)
  • Document generic bosentan trial or exception
  • Obtain specialist consultation (cardiology/pulmonology)

PA Submission Packet:

  • Completed PA form
  • Medical necessity letter
  • REMS enrollment confirmation
  • Laboratory results
  • Diagnostic studies (echo, catheterization)
  • Prior therapy documentation

If Denied:

  • Review denial reason carefully
  • Submit internal appeal within 180 days
  • Request peer-to-peer review
  • Consider Smart NC external review
  • Contact Counterforce Health for appeal assistance

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Insurance policies vary, and requirements change frequently. Always verify current information with your specific plan and consult healthcare providers for medical decisions. For personalized assistance with appeals and prior authorizations, consider contacting qualified patient advocacy services.

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