Medicare AdvantagePrior AuthMedium impact
Bosentan Products (Revised)
Humana·Pulmonology, Cardiology, Internal Medicine·Medicare Advantage
Effective date
Jan 1, 2022
We identified it
Jun 25, 2026
Summary
This is a revised Humana Medicare Advantage prior authorization policy for bosentan products (Tracleer) used to treat pulmonary arterial hypertension (PAH). The policy requires prior authorization for all bosentan formulations and mandates that patients have confirmed PAH diagnosis via right heart catheterization. For brand Tracleer and generic bosentan oral suspension, prior treatment, intolerance, or contraindication with generic bosentan tablet must be documented. The policy emphasizes critical safety monitoring including liver function tests, hemoglobin levels, and monthly pregnancy testing due to black box warnings.
Action Required
Immediately: Billing and clinical teams must implement prior authorization requirements for all bosentan product claims (Tracleer tablet, Tracleer tablet for oral suspension, generic bosentan tablet, generic bosentan tablet for oral suspension). For all bosentan requests, verify that members have: (1) confirmed PAH diagnosis documented via right heart catheterization, and (2) for brand Tracleer and generic oral suspension formulations, evidence of prior treatment, intolerance, or contraindication with generic bosentan tablet. Update prior authorization submission templates to capture these criteria. Educate providers on the black box warnings, particularly the requirement for monthly liver function tests (aminotransferase and bilirubin levels), hemoglobin monitoring at 1, 3, and 12 weeks, and monthly pregnancy tests for females of childbearing potential. Ensure claims without prior authorization are flagged for denial per Humana guidelines. Route all bosentan requests through the Bosentan REMS Program verification process before approval. Failure to obtain prior authorization will result in claim denials.