By Counterforce Health Team in Tracleer (bosentan) —

How to Get Tracleer (bosentan) Covered by Aetna (CVS Health) in Virginia: Complete Prior Authorization and Appeals Guide

Answer Box: Get Tracleer Covered by Aetna (CVS Health) in Virginia

Tracleer (bosentan) requires prior authorization on Aetna (CVS Health) plans and is typically non-formulary in 2025, requiring step therapy with preferred alternatives. To get coverage in Virginia:

  1. Complete REMS enrollment for both patient and prescriber at BosentanREMSProgram.com or call 866-359-2612
  2. Submit prior authorization via Aetna provider portal with step therapy documentation showing preferred ERAs failed or are inappropriate
  3. If denied, appeal through Aetna's internal process (180 days) then Virginia's external review via the State Corporation Commission (120 days)

Standard decisions take 7-14 business days; expedited reviews within 72 hours for urgent cases.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all plans Aetna provider portal Aetna 2024 Precert List
Non-Formulary Status Requires formulary exception Plan drug guide Aetna Drug Guides
Step Therapy Must try preferred ERAs first PA form requirements CVS Caremark Policy
REMS Enrollment Mandatory for all parties BosentanREMSProgram.com FDA REMS Requirements
Monthly Monitoring LFTs and pregnancy tests Provider documentation FDA Label

Step 1: REMS Program Enrollment

Critical first step: CVS Specialty Pharmacy will not dispense Tracleer without confirmed REMS enrollment for both patient and prescriber.

Patient Enrollment Process

  1. Visit BosentanREMSProgram.com or call 866-359-2612
  2. Complete the Patient Authorization Form online or download/print/sign
  3. Alternative submission methods:
    • Fax: 866-279-0669
    • Mail: Janssen CarePath, PO Box 826, South San Francisco, CA 94083
    • Digital: PAHconsent.com

Female Patients Additional Requirements

  • Provide negative pregnancy test documentation
  • Confirm reliable contraception use (two forms required)
  • Agree to monthly pregnancy testing throughout treatment

Prescriber REMS Requirements

Prescribers must complete REMS certification demonstrating:

  • PAH treatment experience
  • Commitment to monthly patient monitoring
  • Documentation of lab results and safety assessments
Tip: Start REMS enrollment immediately when considering Tracleer. The process can take several days and is required before any prescription can be filled.

Step 2: Prior Authorization Process

Required Documentation

Submit the following through Aetna's provider portal (Availity) or fax:

  • Completed Aetna prior authorization form for specialty medications
  • PAH diagnosis documentation with appropriate ICD-10 codes
  • Step therapy documentation showing preferred ERAs (ambrisentan, Opsumit) were tried or are clinically inappropriate
  • REMS enrollment confirmation for both patient and prescriber
  • Monthly monitoring plan for liver function tests and pregnancy testing (if applicable)

Submission Timeline & Process

Type Decision Time How to Submit
Standard 7-14 business days Aetna provider portal or fax
Expedited 72 hours Requires physician certification of urgency

Submission methods:

  • Provider portal: Availity.com (preferred)
  • Fax: Verify current number through provider portal
  • Phone: Provider services line for urgent cases
Note: Many specialty pharmacies like Counterforce Health can help streamline the prior authorization process by ensuring all required documentation is properly formatted and submitted according to Aetna's specific requirements.

Step 3: Appeals Process in Virginia

Internal Appeals (First Level)

Filing deadline: Within 180 days of denial notice

Required documents:

  • Original denial letter
  • Additional clinical documentation
  • Provider appeal letter addressing specific denial reasons
  • Updated lab results or imaging if relevant

Timelines:

  • Standard: 45 business days
  • Expedited: 36-72 hours (requires physician certification that delay jeopardizes health)

Virginia External Review (After Internal Appeal)

If Aetna upholds the denial, Virginia residents can request external review through the Virginia State Corporation Commission (SCC) Bureau of Insurance.

Filing deadline: Within 120 days of final internal denial

How to submit:

  • Email: [email protected]
  • Fax: (804) 371-9915
  • Mail: SCC Bureau of Insurance – External Review, P.O. Box 1157, Richmond, VA 23218

Required forms:

  • Form 216-A (External Review Request)
  • Medical records release form
  • Copy of insurance card
  • Final denial letter from Aetna
  • Supporting medical documentation

Review timelines:

  • Standard: 45 days
  • Expedited: 72 hours (with Form 216-C physician certification)
Virginia Advantage: The SCC's external review process has overturned approximately 50% of denials, and the decision is binding on Aetna. If overturned, coverage must be provided within 1-3 days.

Contact for guidance: SCC Consumer Services at 1-877-310-6560

Common Denial Reasons & Solutions

Denial Reason How to Overturn Documentation Needed
Non-formulary status Request formulary exception Clinical justification for Tracleer over preferred alternatives
Step therapy not completed Document prior failures Specific dates, dosages, and outcomes of ambrisentan or Opsumit trials
REMS non-compliance Complete enrollment REMS confirmation for patient and prescriber
Insufficient monitoring plan Provide detailed protocol Monthly LFT and pregnancy test schedule
"Not medically necessary" Submit comprehensive appeal Peer-reviewed studies, FDA labeling, specialty guidelines

Clinician Corner: Medical Necessity Documentation

Essential Elements for Strong Appeals

Problem statement:

  • WHO Group 1 PAH diagnosis with specific etiology
  • Current functional class and exercise capacity
  • Disease progression despite current therapy

Prior treatment history:

  • Specific ERAs tried (ambrisentan, macitentan)
  • Dosages, duration, and specific reasons for discontinuation
  • Documentation of intolerance or inadequate response

Clinical rationale:

  • FDA-approved indication for PAH
  • Evidence from clinical trials (BREATHE-1, EARLY studies)
  • Specialty society guidelines (AHA/ESC, CHEST)

Monitoring plan:

  • Monthly liver function tests (ALT, AST, bilirubin)
  • Pregnancy testing protocol for female patients
  • Regular functional assessments
From our advocates: We've seen appeals succeed when prescribers include specific functional capacity improvements expected with Tracleer, such as increased 6-minute walk distance or improved WHO functional class. Quantifiable treatment goals strengthen the medical necessity argument significantly.

Cost Support Options

Manufacturer Programs

  • Janssen CarePath: Patient assistance and copay support
  • Phone: 1-877-227-3728
  • Website: JNJWithMe.com

Foundation Support

  • Patient Access Network (PAN) Foundation: Copay assistance for PAH medications
  • Pulmonary Hypertension Association: Patient support and resources

Virginia-Specific Resources

  • Virginia Medicaid: Coverage available for eligible patients
  • Virginia Free Clinic Association: Assistance locating free or reduced-cost care

When navigating complex coverage issues, organizations like Counterforce Health specialize in turning insurance denials into successful appeals by providing evidence-backed documentation that aligns with payer policies and regulatory requirements.

FAQ

How long does Aetna prior authorization take for Tracleer in Virginia? Standard decisions take 7-14 business days. Expedited reviews for urgent cases are completed within 72 hours when physician certification is provided.

What if Tracleer is non-formulary on my Aetna plan? You can request a formulary exception by documenting medical necessity and why preferred alternatives are inappropriate. This requires clinical justification from your prescriber.

Can I request an expedited appeal in Virginia? Yes, both Aetna internal appeals and Virginia external reviews offer expedited timelines (36-72 hours) when a physician certifies that delay would jeopardize your health.

What happens if I don't complete REMS enrollment? CVS Specialty Pharmacy cannot dispense Tracleer without confirmed REMS enrollment for both patient and prescriber. This is a federal requirement that cannot be waived.

Does step therapy apply if I tried other ERAs outside Virginia? Yes, documented trials of preferred ERAs from any location count toward step therapy requirements. Provide complete records including dates, dosages, and outcomes.

How much does Tracleer cost without insurance? Costs vary significantly by pharmacy and location. Contact Janssen CarePath at 1-877-227-3728 for patient assistance options if insurance coverage is denied.

Who can help if Aetna continues to deny coverage? Contact the Virginia SCC Bureau of Insurance at 1-877-310-6560 for external review guidance. The Virginia Poverty Law Center's Health Assistance program also provides consumer advocacy.

What's the success rate for appeals in Virginia? Virginia's external review process overturns approximately 50% of denials. Success rates are higher when appeals include comprehensive clinical documentation and address specific denial reasons.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always verify current information directly with Aetna, your healthcare provider, and Virginia regulatory agencies. For personalized assistance with complex coverage issues, consider consulting with healthcare coverage specialists.

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