By Counterforce Health Team in Tracleer (bosentan) —

How to Get Tracleer (bosentan) Covered by Cigna in Florida: Complete Appeals Guide with Forms and Timelines

Quick Answer: Getting Tracleer (bosentan) Covered by Cigna in Florida

Tracleer requires prior authorization from Cigna and enrollment in the FDA REMS program. Most denials stem from incomplete REMS enrollment, missing liver function monitoring protocols, or inadequate PAH diagnosis documentation. Your fastest path: Have your prescriber submit a complete PA request with right heart catheterization results, REMS certification, and monthly LFT monitoring plan. If denied, file an internal appeal within 180 days, then request external review through Florida's Department of Financial Services within 4 months of final denial.

Start today: Call Cigna at the number on your insurance card to confirm PA requirements and request the current forms.

Table of Contents

  1. Understanding Your Denial Letter
  2. Common Fixable Issues
  3. Coverage Requirements at a Glance
  4. Step-by-Step: Fastest Path to Approval
  5. First-Level Internal Appeal
  6. Peer-to-Peer Review Process
  7. External Review in Florida
  8. Medical Necessity Letter Template
  9. When Appeals Fail: Alternative Options
  10. FAQ

Understanding Your Denial Letter

When Cigna denies Tracleer (bosentan), your denial letter will include specific reason codes. Here are the most common ones and what they mean:

Medical Necessity Denials:

  • "Does not meet clinical criteria" - Usually means PAH diagnosis wasn't confirmed with right heart catheterization
  • "Experimental/investigational" - Often applies to off-label uses outside WHO Group 1 PAH

Administrative Denials:

  • "Prior authorization required" - PA wasn't submitted before dispensing
  • "REMS enrollment incomplete" - Patient or prescriber not enrolled in required safety program
  • "Quantity limit exceeded" - Requesting more than formulary allows

Step Therapy Denials:

  • "Must try formulary alternatives first" - Need to document failed trials of other PAH medications
Tip: Look for the "Important Rights" section in your denial letter—it contains your appeal deadline and instructions specific to your plan.

Common Fixable Issues

Before filing an appeal, check if your denial can be resolved quickly:

Missing REMS Enrollment

Tracleer requires enrollment in the Risk Evaluation and Mitigation Strategy program due to liver toxicity risks. Both prescriber and patient must be certified.

Fix: Visit the Tracleer REMS website (verify with the source linked below) to complete enrollment. Your prescriber needs REMS certification before prescribing.

Incomplete Monitoring Protocols

Cigna requires documentation of monthly liver function test monitoring and, for women of childbearing potential, pregnancy testing.

Fix: Have your prescriber submit a monitoring plan showing scheduled monthly LFTs and appropriate contraception measures.

Wrong Diagnosis Code

PAH coverage requires ICD-10 code I27.0 (Primary pulmonary hypertension) with WHO Group 1 classification.

Fix: Ensure your prescriber uses the correct diagnostic coding and includes right heart catheterization results confirming PAH.

Coverage Requirements at a Glance

Requirement What It Means Where to Find It
Prior Authorization PA required for all indications Cigna Provider Portal
REMS Enrollment FDA-mandated safety program Tracleer REMS Program
Diagnosis Requirement WHO Group 1 PAH confirmed by RHC Cigna Medical Policy (verify with current policy)
Prescriber Requirement Cardiologist or pulmonologist Plan formulary documents
Monitoring Monthly LFTs, pregnancy testing FDA prescribing information
Step Therapy May apply for off-label uses Plan-specific formulary

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis Meets Criteria

Who: Your cardiologist or pulmonologist
What: Document WHO Group 1 PAH with right heart catheterization showing mean PA pressure ≥25 mmHg, PCWP ≤15 mmHg
Timeline: Before PA submission

2. Complete REMS Enrollment

Who: Both prescriber and patient
What: Register at Tracleer REMS website, complete required training
Timeline: 1-2 business days

3. Establish Monitoring Plan

Who: Prescriber
What: Schedule monthly LFTs, pregnancy testing for women of childbearing age
Timeline: Before first prescription

4. Submit Complete PA Request

Who: Prescriber's office
What: PA form with diagnosis, monitoring plan, REMS confirmation
How: Cigna provider portal or fax
Timeline: 72 hours for standard review

5. Follow Up on Decision

Who: Patient or prescriber
What: Call Cigna to confirm receipt and check status
Timeline: 3-5 business days after submission

First-Level Internal Appeal

If your PA is denied, you have 180 days to file an internal appeal with Cigna.

Required Documents:

  • Original denial letter
  • Completed appeal form (verify current form with Cigna)
  • Medical necessity letter from prescriber
  • Supporting clinical documentation
  • Right heart catheterization results
  • Documentation of failed alternative therapies (if applicable)

Submission Options:

  • Online: Cigna member portal
  • Mail: Address on your denial letter
  • Fax: Number provided in denial notification

Timeline: Cigna has 45 days to review standard appeals, 72 hours for expedited appeals.

Note: Request expedited review if delay in treatment could seriously jeopardize your health or ability to regain maximum function.

Peer-to-Peer Review Process

If your initial appeal is denied, your prescriber can request a peer-to-peer review—a phone consultation between your doctor and Cigna's medical director.

How to Schedule:

  1. Call the number on your denial letter
  2. Request peer-to-peer review
  3. Provide your case reference number
  4. Cigna will schedule within 1-2 business days

Preparation Checklist for Your Prescriber:

  • Patient's complete medical history
  • Right heart catheterization results
  • Documentation of functional class and symptoms
  • Evidence of failed alternative therapies
  • Current clinical guidelines supporting Tracleer use
  • Monitoring protocol for liver function

Counterforce Health helps clinicians prepare compelling peer-to-peer presentations by analyzing denial patterns and providing evidence-backed talking points tailored to specific payer requirements. Our platform identifies the most persuasive clinical arguments based on your insurer's own policies and recent approval patterns.

External Review in Florida

If Cigna upholds its denial after internal appeals, you can request an independent external review through Florida's Department of Financial Services.

Eligibility:

  • Completed all internal appeal levels
  • Denial involves medical necessity determination
  • Request submitted within 4 months of final internal denial

How to Request:

Contact: Florida Department of Financial Services
Phone: 1-877-MY-FL-CFO (1-877-693-5236)
Website: MyFloridaCFO.com
Mail: Bureau of Consumer Assistance, Division of Consumer Services, 200 E. Gaines Street, Tallahassee, FL 32399-0322

Required Information:

  • Your insurance information
  • Final denial letter from Cigna
  • All appeal correspondence
  • Medical records supporting necessity
  • Completed external review request form

Timeline: External reviewers have 45 days to make a decision (72 hours for expedited cases). The decision is binding on Cigna.

Medical Necessity Letter Template

Your prescriber should include these key elements in the medical necessity letter:

Patient Information Section:

  • Full name, DOB, member ID
  • Primary diagnosis: Pulmonary arterial hypertension (ICD-10: I27.0)
  • WHO Group 1 classification confirmed by right heart catheterization
  • Current WHO functional class (II, III, or IV)

Clinical Justification:

  • Specific hemodynamic measurements from RHC
  • Current symptoms and functional limitations
  • 6-minute walk distance (if available)
  • Echocardiographic findings

Treatment History:

  • Previous PAH medications tried, with specific names, doses, duration
  • Reasons for discontinuation (ineffective, adverse effects, contraindications)
  • Current medication regimen

Rationale for Tracleer:

  • FDA approval for PAH WHO Group 1, functional class II-IV
  • Clinical trial evidence (BREATHE-1 study)
  • Guideline recommendations from ESC/ERS or AHA/ACC
  • Why formulary alternatives are inappropriate

Safety Monitoring Plan:

  • REMS program enrollment confirmation
  • Monthly LFT monitoring schedule
  • Pregnancy prevention measures (if applicable)
  • Plan for managing potential adverse effects
From our advocates: We've seen success when prescribers emphasize the patient's specific functional limitations and how previous therapies failed to prevent clinical worsening. Quantifiable measures like reduced exercise capacity or increased hospitalizations strengthen the medical necessity argument.

When Appeals Fail: Alternative Options

If your appeals are unsuccessful, consider these options:

Formulary Exception Request

Request coverage of Tracleer as a formulary exception if other ERAs are contraindicated or ineffective.

Alternative ERAs

  • Ambrisentan (Letairis) - may have different coverage criteria
  • Macitentan (Opsumit) - newer ERA with potentially different approval requirements

Patient Assistance Programs

  • Janssen CarePath offers copay assistance and patient support
  • Verify current eligibility requirements and application process

Clinical Trial Participation

Check ClinicalTrials.gov for ongoing PAH studies that might provide access to treatment.

Counterforce Health specializes in turning insurance denials into successful appeals by identifying the specific evidence and documentation that payers require. Our platform analyzes your denial letter, extracts the exact criteria your insurer uses, and helps build targeted appeals that address each denial reason with payer-specific evidence.

FAQ

How long does Cigna prior authorization take for Tracleer in Florida? Standard PA requests are reviewed within 72 hours. Expedited requests (for urgent medical needs) are processed within 24 hours.

What if Tracleer is non-formulary on my Cigna plan? You can request a formulary exception with medical justification from your prescriber. The process is similar to PA but requires additional documentation of why formulary alternatives are inappropriate.

Can I request an expedited appeal if I'm already stable on Tracleer? Yes, if discontinuing treatment would seriously jeopardize your health. Your prescriber must document the medical urgency in the appeal request.

Does step therapy apply if I've tried other PAH medications outside Florida? Yes, documentation of previous therapy failures from any state should satisfy step therapy requirements, provided you have adequate medical records.

What happens if I can't afford the medication while appealing? Contact Janssen CarePath for temporary assistance programs. Some patients may qualify for free medication during the appeal process.

How do I know if my prescriber is REMS-certified? Check the Tracleer REMS website or ask your prescriber's office directly. REMS certification is required before any prescription can be written.

Can I file a complaint with Florida regulators about my denial? Yes, contact the Florida Department of Financial Services Consumer Helpline at 1-877-MY-FL-CFO if you believe Cigna isn't following proper appeal procedures.

What's the success rate for Tracleer appeals in Florida? While specific statistics aren't publicly available, appeals with complete clinical documentation and proper REMS enrollment have higher success rates. External reviews often favor patients when medical necessity is well-documented.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider about your specific medical condition and treatment options. Insurance coverage requirements may vary by plan and change over time. Verify current requirements with your insurer and refer to your plan documents for definitive coverage information.

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