The finalized MolDx LCD significantly expands coverage for Natera’s Prospera portfolio. The new version improves transplantation monitoring for many different organ types. Thus, the MolDx LCD improves access to advanced molecular diagnostics.
The company Natera, Inc., which specializes in cell free DNA and precision medicine, brought attention to this change. The policy concerns the use of molecular testing for solid organ allograft rejection under LCD L40060. In addition, the new MolDx LCD enhances testing accessibility in surveillance settings.
The new policy will take effect on August 30, 2026. It outlines expanded testing frequency across kidney, heart, and lung transplants. For kidney patients, coverage includes six tests in the first year. Additionally, it allows four tests annually in years two and three. “For-cause” coverage remains unchanged.
In addition, those who undergo heart transplantation procedures will be tested through twelve tests within the first year, while those to be carried out during subsequent years will include four tests each year. The same applies to patients with lungs transplants, who will benefit from twelve tests in the first year.
Increased Testing Frequency Supports Improved Transplant Monitoring
Previously, the draft for July 2025 included less number of tests. For example, only two tests per year were needed during years two and three, while kidney testing was to be done just four times in the first year. Nevertheless, large medical associations favored more extensive tests. These organizations recommended MolDx.
“The finalized LCD expands access to Prospera across critical post-transplant management settings,” said Matt Mega, senior vice president of market access at Natera. “This new policy provides strong support for molecular testing in surveillance, thereby enabling clinicians to respond to rejection and help prevent irreversible damage to donor organs.”
Importantly, ASTS provided comments on the changes. The AST was also in favor of the revisions. Furthermore, the ISHLT expressed their support for the increased coverage. All of this feedback was critical in forming the final decision. As such, this new revision of the MolDx LCD helps in making more informed decisions as well as early diagnosis, leading to improved patient outcomes. Consequently, Natera is further contributing to precision medicine in transplant medicine.
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News Source: Businesswire.com
