On July 10, 2019, President Trump issued an Executive Order entitled Advancing American Kidney Health. The Executive Order stated that the “state of care for patients with chronic kidney disease and end-stage renal disease (ERSD) is unacceptable” in part because “there are not enough kidneys donated to meet the current demand for transplants.” The Executive Order noted that there were nearly 100,000 Americans on the waiting list to receive a kidney transplant.
In the Executive Order, among other things, President Trump directed the Secretary of Health and Human Services, (a) within 90 days of the Order, to propose a regulation “to enhance the procurement and utilization of organs available through decreased donation by revising Organ Procurement Organization (OPO) rules and evaluation metrics …” and (b) within 180 days of the Order, to “streamline and expedite the process of kidney matching and delivery to reduce the discard rate.”
On December 17, 2019, following on the directives in the Executive Order, the Centers for Medicare and Medicaid Services (CMS), issued a proposed rule to modify the Conditions for Coverage that OPOs must meet to receive Medicare and Medicaid payments. The proposed rule was published in the Federal Register on December 23, 2019. The proposal is not limited to kidney donations.
OPOs in the United States, each of which are and must be a non-profit organization, are responsible for the evaluation and procurement of organs for transplantations. OPOs identify potential organ donors, request consent from families of donors, procure organs and work with other agencies to identify potential transplant recipients and ensure that organs are transferred to hospitals where the organs are to be transplanted. Each OPO is assigned its own donation service area (DSA), of which there are 58 in the United States.
CMS reviews and certifies OPOs every four years according to Conditions for Coverage contained in the regulations. OPOs must correct issues identified in surveys to continue receiving Medicare and Medicaid reimbursement. In an uncommon instance where an OPO is decertified, the DSA is opened up to competition from other OPOs.
The proposed rule would revise the Conditions for Coverage of OPOs with goals of improving the quality of OPO services by increasing organs donated and of holding underperforming OPOs more accountable.
Among the proposed revisions to the Conditions for Coverage are:
CMS also proposes to make publicly available the donation and transplantation rates of OPOs. Further, CMS seeks comments on, among other things, whether OPO outcome measures should include an assessment of organ transplantation rates by type of organ transplanted and whether reviewing performance based on the top 25% donation rates and transplantation rates is appropriate or whether a static level or different criterion would make sense.
Comments on the proposed rule may be submitted up to 5:00 pm Eastern Standard Time on February 21, 2020.