By Counterforce Health Team in Tracleer (bosentan) —

How to Get Tracleer (bosentan) Covered by Blue Cross Blue Shield in Pennsylvania: Complete Prior Authorization Guide

Answer Box: Getting Tracleer (bosentan) Covered in Pennsylvania

Blue Cross Blue Shield plans in Pennsylvania require prior authorization for Tracleer (bosentan) with specific REMS program enrollment. The fastest path to approval: 1) Enroll prescriber and patient in the Bosentan REMS Program, 2) Submit PA request with PAH diagnosis confirmation and specialist attestation, 3) Document generic bosentan trial (if applicable). Pennsylvania's external review program offers a 53% overturn rate if initially denied. Start with your prescriber's REMS enrollment today.

Table of Contents

  1. Why Pennsylvania State Rules Matter
  2. Prior Authorization Requirements
  3. REMS Program Enrollment Process
  4. Step Therapy Protections
  5. Appeals Process & Pennsylvania External Review
  6. Practical Scripts & Documentation
  7. Cost Savings Options
  8. When to Escalate
  9. FAQ

Why Pennsylvania State Rules Matter

Pennsylvania's strengthened insurance appeals system gives you significant advantages when fighting for Tracleer coverage. The state launched its Independent External Review Program in January 2024, with 53% of appeals favoring patients in the first year.

Blue Cross Blue Shield operates through multiple independent plans in Pennsylvania—including Independence Blue Cross (southeastern PA), Highmark Blue Shield (western/central PA), and Capital Blue Cross—but all must follow state-mandated appeal timelines and step therapy protections.

Note: Pennsylvania's S.B. 225 step therapy law applies to state-regulated commercial plans. Medicare Part D plans follow federal rules but can use Pennsylvania's external review process.

Prior Authorization Requirements

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Required for all Tracleer prescriptions FEP Blue Policy 540018
REMS Enrollment Mandatory for prescriber, patient, pharmacy BosentanREMSProgram.com
Specialist Prescriber Cardiologist or pulmonologist required FEP Blue Policy
Step Therapy Generic bosentan trial first (brand Tracleer) Plan formularies
Diagnosis PAH (WHO Group I) confirmed Medical records
Age Restriction 18 years or older Policy criteria

Key Criteria for Approval

Pennsylvania Blue Cross Blue Shield plans follow Federal Employee Program (FEP) standards for Tracleer coverage:

  • Confirmed PAH diagnosis (WHO Group I pulmonary arterial hypertension)
  • Specialist prescriber (cardiologist or pulmonologist)
  • REMS program compliance (all parties enrolled)
  • Generic trial (for brand Tracleer, unless contraindicated)
  • Monitoring protocols in place (liver function, pregnancy testing)

REMS Program Enrollment Process

The FDA requires all Tracleer patients, prescribers, and pharmacies to enroll in the Bosentan REMS Program due to serious risks of liver failure and birth defects.

Step-by-Step Enrollment

  1. Prescriber Registration
    • Visit BosentanREMSProgram.com or call 866-359-2612
    • Complete prescriber training on hepatotoxicity and teratogenicity risks
    • Submit Prescriber Enrollment Form
    • Designate staff members if needed
  2. Patient Enrollment
    • Patient completes enrollment at BosentanREMSProgram.com
    • Review and sign patient agreement acknowledging risks
    • Schedule required monitoring appointments
  3. Monitoring Requirements
    • Liver function tests: Monthly for 3 months, then every 3 months
    • Pregnancy testing: Monthly for females of reproductive potential
    • Documentation: Results must be entered in REMS portal before each prescription
Tip: REMS enrollment can take 1-2 business days. Start this process before submitting your PA request to avoid delays.

Step Therapy Protections

Pennsylvania's step therapy law provides four key exceptions when insurers require you to try other medications first:

Medical Exception Criteria

Under Pennsylvania S.B. 225, you can request a step therapy override if:

  • Contraindications exist (including adverse reactions)
  • Expected clinical outcomes of required step therapy are poor
  • Previous failure on the same or similar medication
  • Prior authorization would cause unreasonable delay

Documentation That Helps

When requesting a step therapy exception, include:

  • Previous medication trials and specific reasons for discontinuation
  • Contraindications to formulary alternatives (e.g., drug interactions)
  • Clinical rationale for why Tracleer is medically necessary
  • PAH progression markers or functional class deterioration

Appeals Process & Pennsylvania External Review

Internal Appeals Timeline

Plan Type Standard Review Expedited Review Filing Deadline
Commercial 15 days 24 hours (urgent) 180 days from denial
Medicare Part D 7 days 72 hours 65 days from denial

Pennsylvania External Review

If your internal appeal is denied, Pennsylvania's external review program offers strong patient protections:

Timeline: File within 4 months of Final Adverse Benefit Determination Success Rate: 53% of appeals favor patients Process: Independent medical experts review your case Cost: Free to patients

How to File External Review

  1. Complete your insurer's internal appeal process first
  2. Visit pa.gov/reviewmyclaim or call 1-877-881-6388
  3. Submit denial letter, medical records, and provider support
  4. Standard decision within 7 days; expedited within 72 hours

Practical Scripts & Documentation

Patient Phone Script for Blue Cross Blue Shield

"Hi, I'm calling about prior authorization for Tracleer for pulmonary arterial hypertension. My prescriber and I are enrolled in the REMS program. Can you tell me the specific PA requirements for my plan and provide the submission fax number?"

Key information to request:

  • PA form or portal submission process
  • Required documentation checklist
  • Processing timeline
  • Step therapy requirements for your specific plan

Medical Necessity Letter Checklist

Your prescriber should include:

  • PAH diagnosis with WHO classification and hemodynamics
  • Prior treatments attempted and reasons for discontinuation
  • Clinical rationale for Tracleer specifically
  • Monitoring plan for liver function and pregnancy testing
  • Guideline support from FDA labeling or PAH treatment guidelines
From our advocates: We've seen faster approvals when providers explicitly address step therapy in their initial PA request. For example: "Patient requires brand Tracleer due to documented intolerance to generic bosentan formulation (GI upset leading to non-compliance)." This proactive approach prevents automatic denials.

Cost Savings Options

Manufacturer Support

  • Janssen CarePath: 866-228-3546 for copay assistance and prior authorization support
  • Eligibility: Commercial insurance patients (not Medicare/Medicaid)
  • Benefits: Copay reduction, free drug programs for qualifying patients

State and Foundation Resources

  • Pennsylvania CHIP: Low-cost coverage for children
  • Patient Advocate Foundation: patientadvocate.org for copay relief
  • Pulmonary Hypertension Association: phassociation.org for financial assistance programs

When to Escalate

Contact Pennsylvania regulators if you experience:

  • Missed appeal deadlines by your insurer
  • Denial of expedited review for urgent cases
  • REMS-related access problems

Pennsylvania Insurance Department

FAQ

Q: How long does Blue Cross Blue Shield PA take in Pennsylvania? A: Standard reviews take 2 business days for complete submissions. Expedited reviews (when health is at risk) are decided within 24-72 hours depending on your plan type.

Q: What if Tracleer is non-formulary on my plan? A: Submit a formulary exception request along with your PA. Independence Blue Cross processes these via fax to 1-888-671-5285. Highmark uses their standard PA process.

Q: Can I get coverage if I'm already stable on Tracleer? A: Yes, Pennsylvania's step therapy law includes continuity of care protections. Document your current stability and emphasize that switching could cause clinical deterioration.

Q: Does REMS enrollment guarantee coverage? A: No, but it's required before any coverage consideration. REMS enrollment demonstrates safety protocol compliance, which strengthens your PA request.

Q: What if my prescriber isn't a cardiologist or pulmonologist? A: Most Blue Cross Blue Shield plans require specialist prescribing for Tracleer. Your primary care doctor can refer you, or a specialist can provide collaborative oversight.

Q: How do I prove generic bosentan didn't work? A: Document specific reasons: inadequate response (functional class, 6-minute walk distance), side effects, or adherence issues. Include dates, dosages, and clinical notes.

Counterforce Health helps patients and providers navigate complex prior authorization requirements by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters, identifies specific criteria, and drafts point-by-point rebuttals using the right clinical evidence and payer-specific workflows. Learn more at counterforcehealth.org.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations change frequently. Always verify current requirements with your insurer and consult your healthcare provider for medical decisions. For personalized assistance with prior authorizations and appeals, consider working with advocacy services like Counterforce Health.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.