MolDx Local Coverage Determination Statement 2024

The Medicare Administrative Contractors (MACs) have carefully considered all the feedback received from interested parties regarding the MolDx: Molecular Testing for Solid Organ Allograft Rejection proposed local coverage determination (LCD).  In response to public comments and upon further review of the evidence, the MACs are not finalizing the proposed Local Coverage Determination issued on August 10, 2023. Due to the importance of identifying solid organ allograft rejection early and to ensure the public has additional opportunities to comment on the policy, the MACs intend to issue a new LCD in the coming months. When posted, the new proposed LCD will be available for review in the Medicare Coverage Database (MCD) at https://www.cms.gov/medicare-coverage-database/search.aspx

At this time, neither CMS nor the MACs have changed coverage for these blood tests that monitor for organ transplantation rejection when ordered by their physicians in medically appropriate circumstances. Patients with transplanted hearts, lungs, or kidneys who meet Medicare’s existing local coverage criteria can continue to access these blood tests, including under the following circumstances:

• When there are signs or symptoms of rejection;
• After a physician-assessed pretest, including for surveillance testing;
• After an indeterminate biopsy;
• As a replacement for a biopsy when deemed clinically appropriate by the patient’s qualified physician; and
• For evaluation of the adequacy of immunosuppression.

The Medicare coverage database will be fully updated to reflect this decision next week.

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