The Centers for Medicare & Medicaid Services (CMS) and Medicare Administrative Contractors (MACs) are not finalizing the proposed MolDx: Molecular Testing for Solid Organ Allograft Rejection local coverage determination (LCD) that was issued on Aug. 10, 2023, according to an Aug. 16 statement from CMS.

The decision was made in response to public comments and after reviewing additional evidence. The MACs plan to issue a new LCD in the next few months.

There is currently no change in coverage for the blood tests that monitor for organ transplantation rejection. According to CMS, “patients with transplanted hearts, lungs, or kidneys who meet Medicare’s existing local coverage criteria can continue to access these blood tests” when they have signs or symptoms of rejection, after a physician-assessed pretest, after an indeterminate biopsy, as a replacement for biopsy when deemed clinically appropriate, or to evaluate the adequacy of immunosuppression.

When the new LCD is posted, it will be available for review in the Medicare Coverage Database.

 

Sources:

https://www.cms.gov/newsroom/press-releases/moldx-local-coverage-determination-statement

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