NEW YORK (GenomeWeb) – Medicare contractor Palmetto GBA has issued a draft local coverage determination for Natera's cell-free DNA-based kidney transplantation rejection test, Prospera, the company said today.
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.
The guidance also noted that Prospera could assess kidney transplantation rejection noninvasively with "better performance than current standard of care," and that the agency would continue to monitor the evidence, including results of two post-marketing studies that Natera is conducting.
"I am pleased with the draft coverage decision and look forward to working with Medicare to make this test accessible for those in greatest need," Paul Billings, Natera's chief medical officer, said in a statement.