Every day, an average of twenty people in the United States die due to a shortage of organs available for transplant. To address this problem, the U.S. Department of Health and Human Services (HHS) has issued two proposed rules aimed at increasing the number of organs available for donation. The proposed rules would change the system of donation approval, reduce the waste of usable organs, and provide financial assistance to potential living donors.
The proposed rules come in response to President Donald J. Trump’s executive order from last summer, which aimed to improve kidney care by authorizing additional types of kidney treatments.
The first rule, proposed by the Centers for Medicare and Medicaid Services (CMS) within HHS, would update the Organ Procurement Organization (OPO) conditions for coverage.
OPOs are non-profit organizations that evaluate organs and arrange organ transplants. OPOs obtain organs from deceased donors, ensure that the organs are safe for transplant, and find new donors. Health care providers must meet OPO-set conditions to receive coverage for Medicare and Medicaid payments.
Public health officials claim that OPOs have failed in their duties, since thousands have died waiting for a donor. In response, CMS proposes considerable changes. Indeed, if the changes took effect today, approximately 37 out of the 58 total OPOs would fail to meet the new standards.
CMS’s proposed rule would require all OPOs to match the donation rates of the top 25 percent of OPOs in the United States. The proposed rule would also hold OPOs accountable for their performance rates. Currently, OPOs self-report the data used to calculate donation and transplantation rates. Under the proposal, CMS would use federal death records to calculate donation and transplantation rates of each OPO. Including the entire pool of potential donors—rather than just the self-reported pool—would enable CMS to assess OPO performance rates more accurately.
CMS estimates that its proposed rule would increase the number of annual transplants from 32,000 to 37,000 by 2026.
Public health advocates assert that the proposed changes are long overdue. The current procedure for organ donation requires OPOs to “self-report” and “self-measure their performance.” Self-reporting leads to a lack of oversight and thousands of wasted organs every year, according to public health advocates.
Indeed, studies show that donated kidneys are sometimes thrown away because doctors in the United States are “less inclined to risk using lower-quality kidneys,” even if such kidneys would be better than alternative treatments. In fact, the National Kidney Foundation reported that, in 2016, “as many as 50 percent of discarded kidneys could have been transplanted.” This waste contributes to the shortage of organs available for donation.
The second rule, proposed by HHS’s Health Resources and Services Administration (HRSA), aims to reduce financial barriers for potential living donors.
The loss of money associated with the donation process often deters people from donating their organs. For example, the organ transplant process requires living donors to miss work, which leads to a loss in income during “pre-transplant evaluation, surgery, subsequent recovery time, and follow-up appointments.”
HRSA’s proposed rule would reduce financial barriers by increasing the types of reimbursable expenses for living donors, including lost wages and childcare expenses. This change would make organ donation more affordable and less burdensome for living donors.
Several organ donation organizations have praised these proposed rules. One organization said that these steps will “ultimately save more lives—both through transplantation and the reduction of those who die while waiting for a transplant.” The American Society of Nephrology said that the rules may remove “barriers and hardships for Americans who wish to give the gift of life.”
But some OPO officials suggest that the proposed rules fail to address key issues, such as Medicare reimbursements.
Some organ recipients must take anti-rejection drugs to prevent their immune systems from attacking or rejecting the donor organ. Medicare pays for anti-rejection medications for three years, but afterwards, the organ recipient can no longer be reimbursed. If recipients cannot afford the non-insured price of the medications, they lose the kidney and must rejoin the waiting list to find another kidney, notes an OPO official. Not only must these recipients face the dread of another surgery, but the second organ is perhaps “wasted” on the same patient, rather than a new patient.
Despite leaving some issues unaddressed, the proposed rules mark the first steps toward improving the organ donation crisis in the United States.
The public comment periods for both proposed rules are set to end this week.