Companies including iMDx and Natera said the final LCD increases covered surveillance testing for kidney and heart transplants, adds lung coverage, and is expected to take effect on August 30, 2026.
A final MolDx local coverage determination, identified by Natera as LCD L40060 and expected to take effect on August 30, 2026, expands Medicare-backed donor-derived cell-free DNA, or dd-cfDNA, surveillance testing for transplanted organs. iMDx and Natera said the policy raises covered testing frequency for kidney and heart transplant surveillance versus the prior draft, while Natera said it also adds lung surveillance coverage. Under the final policy, kidney surveillance rises to 6 tests in year 1 and 4 per year in years 2-3, heart remains at 12 tests in year 1 and rises to 4 per year in years 2-3, and Natera said lung surveillance is covered at 12 tests in year 1 and 4 per year in years 2-3 for both bilateral and single lung transplantation. iMDx said the final policy also removes the draft’s proposed ceiling of 2 annual tests from year 4 onward when testing has clinical utility, while Natera said for-cause coverage remains unchanged for kidney and heart. Both companies said the final policy is more expansive than the July 2025 draft and supports broader use of their transplant monitoring assays, GraftAssure and Prospera.