Facts About Medicare Coverage for Transplant Patient Blood Tests.

Since 2017, Medicare has appropriately covered non-invasive blood tests for transplant patients to detect early signs of rejection without regard to whether an invasive and risky biopsy would have been considered for the patient.

 In 2021, the coverage policy explicitly stated that these blood tests could occur on a routine, “surveillance” basis and were not tied to biopsies (i.e., were not limited to being replacements for biopsies).

On March 2, 2023, without advance notice, a Medicare program called MolDX, administered by a private Medicare Administrative Contractor “MAC”, published Medicare coverage guidance in an “Article,” which tied non-invasive blood tests to biopsies – in direct contradiction to longstanding policy.  There is no legal authority to change coverage policy through an Article.  MolDX is now trying to make these same changes in a pre-baked “Local Coverage Determination” process.  There is no new evidence to restrict coverage of testing long deemed medically necessary.  The body of evidence has only grown.

The immediate result of this Article was a significant loss in access to these critical blood tests due to cancellations, delays, or plain confusion as to whether Medicare coverage would still be provided.

Transplant patient and medical organizations from across the country oppose this March Article on both substantive and procedural grounds.  This includes the American Society for Transplant Surgeons, the American Society of Transplantation, the International Society for Heart and Lung Transplantation, the American Association of Kidney Patients, and the 13-member organizations of the Honor the Gift coalition.

In August a bipartisan letter signed by 14 House Members, led by Reps. Anna Eshoo (D-CA) and Dr. Michael Burgess (R-TX), was sent to CMS expressing concerns about the Article.  In October, Reps. Eshoo and Burgess wrote a follow-up letterpressing for answers. 

Three Wall Street Journal editorials were published on September 10, 22, and 26, calling out this decision and the need for further transparency.