A pair of proposed rules from the Trump administration that aim to increase oversight of the organ donation process and increase financial assistance for donors are expected to increase the number of organ transplants conducted each year.
The Dec. 17 proposed rule from the Centers for Medicare and Medicaid Services would update evaluation measurements and benchmarks for organ procurement organizations, nonprofit organizations that facilitate the donor process. The update to evaluation metrics is the first time the measures have been significantly changed since 2006, according to the U.S. Department of Health and Human Services, which CMS is a part of.
HHS Secretary Alex Azar said in the Dec. 17 statement that CMS' rule adds needed increased oversight of organ procurement organizations, or OPOs.
"Our broken system of procuring organs and supporting kidney donors' costs thousands of American lives each year," Azar said. "Many organ procurement organizations do wonderful work, but some aren't performing nearly as well as they could. We're going to stop looking the other way while lives are lost and hold OPOs accountable."
A separate proposed rule from the Health Resources and Services Administration would increase the financial assistance for certain living donors by including reimbursement for child and elderly care and for lost pay due to missing work. The proposed rule would increase the number of high-quality organs available and shorten patients' wait times for transplants, according to the agency.
Both rules were directed by a July executive order from President Donald Trump that looked to improve the quality of kidney care and increase the number of organ transplants in the U.S.
There are approximately 113,000 Americans on waitlists for organ transplants, and an average of about 20 people on the waitlist die every day because not enough organs are available for transplant, according to CMS.
OPOs are entities legally allowed to evaluate and procure organs for transplantation, according to CMS. There are 58 OPOs, and each is assigned to what is called a donation service area. CMS reviews organizations every four years depending on whether they meet coverage standards for recertification to participate in Medicare.
Under the proposed rule, OPOs would be analyzed according to new donation and transplantation rate measures and will be reviewed every 12 months, in addition to the four-year review cycle that is already in place, according to the proposed rule.
The agency would redefine what OPOs calculate as a donor to mean someone who donated at least one organ that was transplanted. Currently, OPOs are allowed to count organs that are procured but not transplanted, according to CMS. The donor rate would be defined as the number of donors in a service area as a percentage of overall inpatient deaths among patients 75 years old or younger who were deemed eligible to donate an organ.
CMS looks to change the definition of a transplant to only include organs that are actually transplanted. OPOs are allowed to count organs that are used for research as transplants under the current system, according to CMS. Transplant rate measures would be updated according to the same standards as the donation rate.
OPOs will be required to achieve the same donation and transplant rates that the top 25% of organizations are hitting, according to the proposed rule. The agency would also make these metrics publicly available.
If the organizations meet these benchmarks under the new rate standards, CMS said the number of annual transplants will increase from 32,000 to 37,000 by 2026, with about 15,000 total transplants occurring over this time.
The changes will not take effect until 2022, when the next four-year cycle begins, according to CMS. However, the agency is seeking comments on if the new standards should take effect sooner.