This document addresses laboratory tests for the early detection of rejection following a heart transplant. This includes the Heartsbreath test, which measures the chemical byproducts of allograft rejection, AlloMap^® gene expression testing, AlloSure^® Heart, myTAI_HEART cell-free DNA (cfDNA), MMDx Heart and others.

Even with modern drug therapy, rejection remains a constant hazard, and transplant recipients must be tested repeatedly for signs of renewed rejection. Currently, the gold standard to detect heart transplant rejection is endomyocardial biopsy (EMB). This is typically performed weekly for the first 6 weeks, biweekly until the third month, monthly to 6 months and then every 1 to 3 months, as indicated. The use of EMB is not addressed in this document.

Position Statement

Medically Necessary:

AlloMap molecular expression testing is considered medically necessary as a non-invasive method of determining the risk of rejection in heart transplant recipients between 6 months and 5 years post-transplant.

Investigational and Not Medically Necessary:

Breath testing with the Heartsbreath test is considered investigational and not medically necessary for use as an aid in the diagnosis of heart transplant rejection.

AlloMap molecular expression testing is considered investigational and not medically necessary when the criteria above are not met.

Additional tests for detection of heart transplant rejection are considered investigational and not medically necessary including, but not limited, to AlloSure Heart, AlloSeq cell-free DNA, MMDx Heart and myTAI_Heart.