Medicare contractor Palmetto GBA has issued a draft local coverage determination for Natera's cell-free DNA-based kidney transplantation rejection test, Prospera.
According to the draft LCD, Palmetto will provide "limited coverage" for Prospera. The assay is intended to "supplement the evaluation and management of kidney injury and active rejection in patients who have undergone renal transplantation." The test can be used along with standard assessments to inform decision-making, helping to rule-in or rule-out rejection when "assessing the need for or results of a diagnostic biopsy." The assay will be covered only for first-time kidney transplant recipients and when a physician has determined that there is a need for further evaluation of the patient for active rejection. The test cannot replace biopsies, the draft LCD noted but could be used in cases when the physician believes that a patient needs to be tested for rejection and the risk/benefit profile of the test is superior to that of a biopsy.