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:

• Modification to the outcome measures by which CMS reviews OPOs by modifying the OPO donation rate measure. Currently, OPOs self-report donor potential in their DSA and the proposed rule calls for a more objective and transparent standard. Under the proposed rule, CMS would define donors as those who donated at least one organ that was transplanted. The donation rate measures the percentage of possible deceased donors who become actual donors. Under the proposed rule, the donation rates will be determined by assessing the number of organ donors in an OPO’s DSA as a percentage of all inpatient deaths of patients 75 years or younger from any cause of death that would not prevent donation. These changes are designed to encourage OPOs to seek out all donors, including those only able to donate one organ.
   
• Revisions to the transplantation rate measure to no longer count organs procured for research. The transplantation rate measures the percentage of organs transplanted after procurement. Currently, OPOs are given performance credit for organs procured for research or for other non-transplant reasons. The proposed revision would have the effect of only giving OPOs credit for a procured organ if it is transplanted, thus incentivizing all viable organs to be transplanted and not discarded or used for other purposes. OPOs have asserted that the organ transplant rate depends on the transplant hospital’s acceptance practices for organs and that OPOs should not be held responsible for the transplant hospital’s decisions. The proposed rule reflects CMS’ view that OPOs have influence on the transplant hospital’ practices through their advisory boards.
   
• Institution of more frequent reviews of OPO performance. Under the proposed rule, CMS would review OPO performance every twelve months to provide more frequent feedback and will use the most recent twelve months’ of data in the review. Currently reviews are every four years. If an OPO’s performance on donation rate and transplantation rate falls below the top 25% of OPOs, CMS would require that the OPO revise its quality assurance and improvement program to improve its performance.

• Revisions to the criteria an OPO must meet when competing for an open DSA, with an implicit suggestion that there may be more openings in the future. Currently, OPOs must meet several criteria in order to compete for a DSA when one becomes open. Under the proposed rule, CMS would no longer require OPOs to meet the following two criteria in order to compete for a DSA: 1) OPO’s performance on outcome measures be at or above 100% of the national mean; and 2) OPO’s donation rate be at least 15% higher than the rate of the OPO last designated for the DSA. This proposal is made in an attempt to make consistent all methods of OPO performance assessment.  

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.