NEW YORK – Medicare contractor Palmetto GBA has issued a draft local coverage determination for two indications of CareDx's AlloSure, a non-invasive blood test that measures transplant injury via donor-derived cell-free DNA.
Palmetto has proposed to cover AlloSure Kidney to gauge the likelihood of allograft rejection in kidney transplant patients who are clinically suspected to be at risk for rejection. Medicare will cover the test when it is used to help decide whether patients should have a renal biopsy two weeks after receiving a transplant organ.
Palmetto also proposed to cover AlloSure Heart when used alongside CareDx's AlloMap test to asses the risk of organ rejection in heart transplant patients and to determine if they need a heart biopsy 55 days after their transplant. In both indications, AlloSure should be used in conjunction with standard clinical assessments.
Palmetto will accept public comments on the draft LCD from Oct. 7 to Nov. 21.