On December 17, 2019, CMS and HRSA announced two proposed rules intended to: (1) enforce accountability from Organ Procurement Organizations (OPO) for their performance; and (2) promote more organ donations from living donors. These proposed rules were released in accordance with President Trump’s Executive Order on Advancing American Kidney Health, which directs HHS to improve the organ donation allocation process. The executive order may be found here.

OPOs are non-profit organizations that play a crucial role in ensuring that transplantable human organs are made available to ill patients that are on a waiting list for organ transplant. OPOs are responsible for identifying potential organ donors, procuring as many organs as possible from donors, and ensuring that the organs are properly preserved and transported quickly to a suitable recipient. There are currently 58 OPOs in the United States, which are each assigned to a specific donation service area.

According to CMS, CMS’s proposed rule is intended to improve organ donation rates by holding OPOs accountable in meeting certain performance metrics. Currently, CMS evaluates OPOs based on donation and transplantation rates that are determined using OPOs’ self-reported data. In accordance with CMS’s proposed rule, CMS will use federal death records to determine the size of the pool of potential organ donors when calculating an OPO’s donation and transplantation rates.

CMS’s proposed rule also requires that OPOs meet the donation and transplantation rates of the current, top 25 percent of OPOs. OPOs would have to meet the new donation/transplantation-rate standards at the end of each re-certification cycle. OPOs with rates that are statistically significantly below the top 25% will be required to undergo a quality assurance and performance improvement program, which CMS will assess at least every 12 months. CMS’s proposed rule may be found here.

HRSA’s proposed rule is intended to reduce the financial burden on living organ donors. Current law permits the Secretary of HHS to reimburse for travel and subsistence expenses incurred toward living organ donation. HRSA’s proposed rule would expand the scope of reimbursable expenses to include lost wages, and childcare and eldercare expenses for donors who lack other forms of financial support. HRSA’s proposed rule may be found here.

Comments on CMS’s proposed rule are due 60 days after publication in the Federal Register. At the time of this article’s publication, the proposed rule had not yet been published in the Federal Register. Submissions received should include file code CMS-3380-P.