Loyola University Chicago School of Law, JD 2021
In December of 2019, two new rules were proposed by the federal government to increase the number of organ transplants in the United States. As of July 2019, 113,000 Americans sat on the national transplant waiting list. The first proposed rule would change the way Organ Procurement Organizations (“OPO”) report data on the number of organs procured. The second proposed rule creates new legislation to assist living donors after their transplant procedures. Both rules were proposed by the Health and Human Services Department (“HHS”) as a follow up to President Trump’s Executive Order on Advancing American Kidney Health.
Organ transplants in the United States
When it comes to organ transplants, the United States falls behind its international counterparts. A study published in JAMA Internal Medicine found that 17% of kidneys donated in the U.S. over a 10-year period were discarded. In France, however, only about 9% of the donated kidneys go unused during the same time period. United States physicians are less likely to implant lower quality kidneys, despite studies showing that the transplant of kidneys with abnormalities result in better outcomes for patients currently undergoing dialysis. In a commentary article attached to the JAMA Internal Medicine article, Dr. Ryoichi Maenosono and Dr. Stefan G. Tullius of Brigham and Women’s Hospital stated that the “superficial five-star ranking approaches” are not necessarily reflective of the best opportunities patients on the waiting list have and should be relying on. A study conducted in 2016 by the National Kidney Foundation, found that 50% of the discarded kidneys could have actually been used for transplants.
OPO data reporting
OPOs are non-profit organizations that have the responsibility to evaluate and procure organs for transplantation. OPOs also identify potential donors, request consent from the families of donors, work with other agencies to identify potential transplant recipients, and ensure that organs are transferred to donor hospitals. There are currently 58 OPOs, all of which are assigned a designated donation service area (“DSA”). The proposed rule is designed to improve organ donation rates by holding OPOs accountable for meeting specific performance standards.
Currently, OPOs are assessed by the Center for Medicare and Medicaid Services (“CMS”). CMS looks at the donation and transplantation rates calculated using data self-reported by the OPOs. Under the proposed rule, CMS would instead use federal death records to calculate the OPO’s donation and transplantation rates. The death records show the entire pool of potential organ donors. OPOs would no longer self-report their data. Under the new rule, OPOs would be required to meet donation and transplantation rates based on the current top 25% of OPOs. In addition, OPOs would be required to become recertified every four years. Under this rule, CMS would also assess the OPO’s performance annually throughout the recertification cycle with the goal of swiftly identifying the OPOs in need of improvement to ensure fewer viable organs are wasted.
Living donor initiatives
The second proposed rule helps decrease the expenses for living donors by funding lost wages as well as child care and elder care costs related to the transplant. It has been found that many potential living donors willing to donate to a friend or family member decide not to donate due to concerns over loss of income during recovery. The proposed rule would work to alleviate some of the stress experienced by living donors.
Another issue that many physicians notice, although unaddressed in either proposed rule, is the cost of anti-rejection medication for donor recipients. After a person receives an organ transplant, the recipient requires and anti-rejection medication to prevent their immune system from attacking and/or rejecting the new organ. Typically, the medication must be taken for the lifetime of the transplanted organ which for some people is the rest of their lives. The problem is that Medicare only pays for the anti-rejection medication for the transplant recipient for three years. After the three year period, if the transplant recipient cannot afford the medication, they stop taking the medication and lose the organ. When the organ is lost, the recipient is forced back onto the waiting list once again.
The two proposed rules are a step in the right direction for the United States to improve its organ transplant process. Despite steps forward, certain issues remain that are not currently being addressed. In the United States, 20 people die each day while waiting on the transplant list and it is time for the U.S. Government to increase its efforts to improve organ transplants.