In 2023, there were nearly 4,600 heart transplants in the United States, an all-time high, with 89% occurring in adults. Traditionally, diagnosis of heart transplant rejection has relied on clinical assessment and endomyocardial biopsy (EMB), while biomarkers and imaging techniques are adjunctive tools for identifying graft damage. Organ biopsy is the standard for diagnosing transplant rejection, as it enables direct tissue examination. In the case of heart transplant monitoring, an EMB procedure involves inserting a heart tissue sampling tool through a vein in the neck, advancing it through central veins into the heart, and removing a small amount of tissue from the inner lining of the transplanted heart muscle; this sample is then examined by a pathologist to identify damage or abnormalities.

The average outpatient EMB episode costs nearly $8,000 for a commercially insured heart transplant patient age 15 and older and $15,000 for patients younger than 15. CareDx Inc. commissioned Milliman to perform a claims-based analysis to determine the episode cost of EMBs following heart transplants in the commercially insured population. CareDx provides products and services that support transplant patients, including noninvasive tests to monitor graft function.

Results focus on the following:

• Study demographics by age and gender
• Average outpatient EMB episode costs
• Outpatient EMB episode costs by major service category
• Outpatient EMB episode cost percentiles and distribution

This report was commissioned by CareDx, Inc.