HHS on Tuesday announced the release of two proposed rules intended to hold underperforming organ procurement organizations (OPOs) accountable for their performance and promote more organ donations from living donors.
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According to HHS, CMS and the Health Resources and Services Administration (HRSA) released the proposed rules under an executive order President Trump issued in July that directs HHS to overhaul the organ donation allocation process.
Details on the proposed rules
HHS said the proposed rules seek to increase the availability of donated organs for the 113,000 U.S. residents on waiting lists for organ transplants. According to HHS, 20 people on the list die each day.
The proposed rule issued by CMS is designed to improve organ-donation rates by holding OPOs accountable for meeting specific performance metrics. CMS currently assesses OPOs based on donation and transplantation rates that are calculated using data that OPOs self-report. However, under the proposed rule, CMS would use federal death records, which show the entire pool of potential organ donors, to calculate an OPO's donation and transplantation rates. According to the Associated Press, an OPO's potential donor pool is supposed to include anyone age 75 or younger who dies in a hospital from a condition that would not automatically disqualify them from donation.
In addition, the proposed rule would require all OPOs to meet the donation and transplantation rates of the current top 25% of OPOs. Under the proposed rule, OPOs would have to meet the new donation- and transplantation-rate standards every four years, at the end of each re-certification cycle. CMS for the first time would be able to rank the OPOs based on their performance and make that data public.
Further, CMS under the proposed rule would assess OPOs' performance annually throughout the re-certification cycle to more quickly identify which OPOs are in need of improvement and to ensure fewer viable organs are wasted. CMS currently assesses OPS' performance every four years, at the end of the re-certification cycle.
The proposed rule issued by HRSA seeks to reduce financial burdens on living donors. Currently, a transplant recipient's insurer pays for a donor's medical expenses, but a donor's lost wages and other expenses incurred as a result of the donation process often are not covered. The proposed rule would allow insurers to reimburse living donors for lost wages, as well as any child care or elder care expenses they incurred during their hospitalizations for or recoveries from the donation.
Trump administration officials said they hope the proposed rules will increase the number of annual transplants from 32,000 to 37,000 by 2026.
The rules will be open for public comments for 60 days after they are published in the Federal Register.
Several transplant advocates applauded the proposed rules.
Kelly Ranum, CEO of Louisiana's OPO and president of an association that represents OPOs, said the proposed rules provide "an opportunity to drive meaningful changes that will increase the availability of organs for transplant and save more lives."
Greg Segal of the advocacy group Organize, whose father had to wait five years for a heart transplant, said, "This is a great first step. Now the government needs to implement the [proposed rules] as strongly and quickly as possible."
Organize estimated that 37 of the 58 OPOs in the United States would be out of compliance with the proposed regulations if they were in place today (Neergaard, AP/Washington Post, 12/17; AP/Modern Healthcare, 12/17 Sullivan, The Hill, 12/17; Owens, "Vitals," Axios, 12/18; HHS release, 12/17).