By Counterforce Health Team in Tracleer (bosentan) —

How to Get Tracleer (bosentan) Covered by Cigna in Michigan: Complete Prior Authorization Guide

Answer Box: Getting Tracleer (bosentan) Covered by Cigna in Michigan

Cigna requires prior authorization for Tracleer (bosentan) with specific medical criteria: confirmed WHO Group 1 PAH via right heart catheterization, prescriber specialty (cardiology/pulmonology), REMS program enrollment, and step therapy (generic bosentan first). Your fastest path to approval: 1) Ensure your specialist has complete PAH documentation and monthly LFT/pregnancy test protocols, 2) Complete REMS enrollment at BosentanREMSProgram.com, 3) Submit PA through Accredo specialty pharmacy. If denied, you have 127 days to file an external review with Michigan DIFS.

Table of Contents

  1. Cigna's Coverage Policy for Tracleer (bosentan)
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Process
  4. REMS Program Enrollment
  5. Specialty Pharmacy Requirements
  6. Documentation Checklist
  7. Appeals Process in Michigan
  8. Common Denial Reasons & Solutions
  9. Cost Assistance Options
  10. FAQ

Cigna's Coverage Policy for Tracleer (bosentan)

Cigna classifies Tracleer (bosentan) as a specialty medication requiring prior authorization across all plan types—HMO, PPO, and Medicare Advantage. The drug must be dispensed through Accredo specialty pharmacy to receive coverage benefits.

Plan Coverage Overview:

  • Commercial Plans: Prior authorization required with step therapy
  • Medicare Advantage: Enhanced PA requirements with quantity limits
  • Medicaid Plans: Follow state Medicaid protocols plus Cigna requirements
Note: Coverage policies can vary by specific plan design. Always verify your exact requirements through the myCigna portal or by calling member services.

Medical Necessity Requirements

WHO Group 1 PAH Diagnosis Criteria

Cigna requires documented WHO Group 1 pulmonary arterial hypertension confirmed by right heart catheterization with specific hemodynamic values:

Parameter Required Value
Mean pulmonary arterial pressure (mPAP) >20 mm Hg
Pulmonary arterial wedge pressure (PAWP) ≤15 mm Hg
Pulmonary vascular resistance (PVR) >2 Wood units

Required Documentation:

  • Complete right heart catheterization report with date and hemodynamic measurements
  • Confirmation that diagnosis excludes WHO Groups 2-5 (left heart disease, lung disease, etc.)
  • Clinical notes demonstrating persistent PAH symptoms despite optimal management

Prescriber Requirements

Cigna requires that Tracleer be prescribed by or in consultation with a cardiologist or pulmonologist specializing in pulmonary hypertension.

Step Therapy and Exception Process

Standard Step Therapy Requirements

Before approving brand Tracleer, Cigna typically requires:

  1. Trial of generic bosentan (unless contraindicated)
  2. Documentation of inadequate response, intolerance, or contraindication to generic formulation

Medical Exception Pathways

You can bypass step therapy if your doctor documents:

  • Contraindication to required first-line therapy
  • Previous trial and failure of step therapy medication
  • Drug interactions that make first-line therapy unsafe
  • Allergy or intolerance to required medications

Exception Documentation: Your prescriber must submit clinical notes explaining why step therapy is inappropriate, including specific medical reasons and supporting literature if applicable.

REMS Program Enrollment

Both patient and prescriber must enroll in the Bosentan REMS program due to risks of liver toxicity and birth defects.

Prescriber REMS Requirements

  • Complete REMS certification training
  • Enroll patient in REMS program
  • Order baseline liver function tests (LFTs)
  • For females of childbearing potential: confirm negative pregnancy test
  • Commit to monthly LFT and pregnancy test monitoring

Patient REMS Requirements

  • Enroll online at BosentanREMSProgram.com or via paper form
  • Acknowledge understanding of liver and pregnancy risks
  • Commit to monthly lab monitoring
  • Use effective contraception (females of childbearing potential)
Critical: Pharmacies cannot dispense Tracleer without current REMS enrollment and up-to-date monthly monitoring results.

Specialty Pharmacy Requirements

Accredo Specialty Pharmacy Mandate

Cigna requires Tracleer to be filled through Accredo specialty pharmacy. Filling at retail pharmacies will result in no coverage.

How to Get Started with Accredo:

  1. Have your prescriber send prescription electronically to Accredo
  2. Complete prior authorization paperwork
  3. Provide insurance information and preferred delivery address
  4. Schedule initial consultation with Accredo pharmacist

Accredo Contact: 877-826-7657

Coverage Duration and Renewals

Most Cigna approvals are granted for up to 1 year before reauthorization is required. Renewal requires updated clinical documentation and continued REMS compliance.

Documentation Checklist

Essential Documents for PA Submission

Clinical Documentation:

  • Right heart catheterization report with hemodynamic values
  • Specialist consultation notes (cardiology/pulmonology)
  • Current echocardiogram and other relevant imaging
  • Complete medication history and prior therapy trials
  • Current symptom assessment and functional class

REMS Documentation:

  • REMS enrollment confirmation for prescriber and patient
  • Baseline liver function tests (within 30 days)
  • Negative pregnancy test (females of childbearing potential)
  • Contraception counseling documentation

Administrative Items:

  • Completed prior authorization form
  • Insurance card and member ID
  • Prescriber NPI and contact information

Appeals Process in Michigan

Internal Appeals with Cigna

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

  1. Standard Internal Appeal: Decision within 15-30 days
  2. Expedited Internal Appeal: Decision within 72 hours (urgent cases)

Michigan External Review Process

After exhausting Cigna's internal appeals, you can request an external review through Michigan DIFS:

Timeline: 127 days from final internal denial to file external review request Standard Review: Decision within 60 days Expedited Review: Decision within 72 hours (with physician certification of urgency)

How to File External Review:

  • Submit online form at Michigan.gov/DIFS
  • Call DIFS at 877-999-6442 for assistance
  • Include all denial letters, medical records, and physician statements
From our advocates: We've seen Michigan external reviews succeed when patients include comprehensive clinical documentation showing clear medical necessity and compliance with REMS requirements. The key is demonstrating that Cigna's denial contradicts established medical guidelines for PAH treatment.

Common Denial Reasons & Solutions

Denial Reason Solution
REMS enrollment incomplete Complete patient/prescriber enrollment; submit confirmation
Missing right heart catheterization Provide complete RHC report with hemodynamic values
Non-specialist prescriber Have cardiologist/pulmonologist co-sign or take over prescription
Step therapy not met Document trial/failure of generic bosentan or submit exception request
Incomplete monitoring Submit current LFTs and pregnancy test results

Cost Assistance Options

Manufacturer Support

  • Tracleer Patient Support: Contact 1-866-TRACLEER for copay assistance and patient support services
  • Janssen CarePath: May offer copay cards for eligible commercial insurance patients

Foundation Assistance

  • Patient Access Network (PAN) Foundation: Provides copay assistance for PAH medications
  • HealthWell Foundation: Offers grants for specialty medication costs

Counterforce Health specializes in turning insurance denials into successful appeals through evidence-based advocacy. Our platform analyzes denial letters and creates targeted rebuttals that align with payer policies and clinical guidelines. If you're facing repeated denials for Tracleer or other specialty medications, Counterforce Health can help streamline your appeal process with documentation that meets Cigna's specific requirements.

Frequently Asked Questions

How long does Cigna prior authorization take for Tracleer? Standard PA decisions are typically made within 15 business days. Expedited reviews (for urgent cases) are completed within 72 hours.

What if Tracleer is not on Cigna's formulary? You can request a formulary exception by having your doctor submit clinical justification for why Tracleer is medically necessary compared to formulary alternatives.

Can I get an expedited appeal in Michigan? Yes, if your doctor certifies that delays would seriously jeopardize your health, you can request expedited internal and external reviews with decisions within 72 hours.

Does step therapy apply if I've used Tracleer before? Previous successful treatment with Tracleer may qualify as a medical exception to step therapy requirements, especially if documented by your specialist.

What happens if I miss monthly REMS monitoring? Missing required monthly LFTs or pregnancy tests will result in prescription holds. Contact your prescriber immediately to schedule catch-up testing.

How do I find my specific Cigna formulary? Log into myCigna.com or call the member services number on your insurance card to access your plan's specific formulary and coverage details.

When to Contact Michigan DIFS

Contact Michigan DIFS at 877-999-6442 if:

  • Cigna fails to respond to appeals within required timeframes
  • You need assistance filing an external review
  • You believe Cigna is not following Michigan insurance laws
  • You need help understanding your appeal rights

Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about your specific medical condition and treatment options. Coverage policies can change, and individual circumstances may affect eligibility.

Sources & Further Reading

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