A Medicare coverage change is putting patient care in jeopardy.
On March 3, 2023, the Medicare Contractor MolDX issued a billing article related to molecular testing for allograft rejection that restricts health care coverage of non-invasive post-transplant diagnostic tests like donor-derived cell free-DNA (dd-cfDNA) and gene expression profiling (GEP), which are routinely used instead of tissue biopsies to monitor a patient’s transplanted organ health and immune status, respectively.
Since the March 2023 billing article was announced, the transplant community has made clear the importance of access to these innovative diagnostics for organ recipients:
The billing article does not pose restrictions or changes to coverage of more invasive, costly biopsies. It went into effect just 30 days after its release and without following appropriate procedures for changing coverage policy, including incorporating patient input and a public comment process—leading to a substantial care gap for patients and disproportionately impacting transplant recipients in under-resourced communities.