The proposed changes, which would take effect in 2022, could increase organ donation and transplantation from about 36,000 annually to 42,000 by 2024, officials said.
The proposal includes new performance standards for the nation’s 58 organ procurement organizations (OPOs), which collect organs from deceased donors and send them to transplant centers.
“Our proposals, if finalized, would increase the number of organs by completely and totally overhauling the organ procurement system,” said Seema Verma, administrator for the Centers for Medicare and Medicaid Services, which contracts with and funds the organizations.
Dozens of the procurement groups would be out of compliance and face possible closure if the new standards were in place today, officials said. Currently, the groups are allowed to assess themselves and can easily manipulate their organ recovery rates. Under the proposed rule, in contrast, the number of potential donors and transplantable organs would be independently assessed.
Currently, people willing to donate a kidney while still alive are reimbursed for their medical costs. The proposed rule would provide additional federal payments for child care, elder care and other costs, Health and Human Services Secretary Alex Azar said.
“We don’t believe their financial situation should limit their generosity,” he said during a news conference, noting that his father had received a lifesaving kidney transplant.
Joe Grogan, director of the White House’s Domestic Policy Council, said the reimbursements to kidney donors would “particularly benefit” African Americans because they represent about one-third of people on kidney transplant waitlists.
About 37 million people suffer from kidney disease. Medicare spends $114 billion a year on kidney care — about $35 billion of it for the more than 700,000 people whose kidneys have failed and who require dialysis or a transplant to stay alive.
“This is a bold step that will make a big difference in the lives of our patients who are on the waiting list,” said Seth Karp, Vanderbilt University’s transplant chief. “It could eliminate the waiting list for lungs, saving about 400 lives and make a real impact on the list of people dying waiting for organs.”
Kelly Ranum, president of a trade group representing organ procurement organizations, said they welcome the proposed rule and would work with federal regulators as they move to finalize the regulation.
“An independent, verifiable metric for evaluating OPO performance can be an important tool, helping to identify potential opportunities for growth in OPOs’ quest for continual improvement,” Ranum said in a statement from the Association of Organ Procurement Organizations.
The new performance measures will use independent data from the U.S. Centers for Disease Control and Prevention to establish how many eligible donors each OPO could have pursued in their efforts to recover organs each year.
Even CEOs who run the procurement organizations say many OPOs underreport the number to make their overall yield rates look better than they are.
Under the new program, OPOs would also be evaluated annually, instead of every four years. The results would be posted on the CMS website.
“At the end of each recertification cycle, poor-performing OPOs could be decertified, but they’d be replaced by a better performing one,” Verma said.
Verma said she expects much of the growth in available organs will come from OPOs increasing their recovery rates for less-than-perfect organs. In many cases these are from older deceased donors, she said.
A Washington Post analysis last year found that as many as 27,000 people met the criteria in 2016 for organ donation — more than twice the number of actual donors. The vast majority of untapped donors were older than 50.
As part of the proposed new rule, the heath department included two charts that showed which OPOs would fail to pass each of the two proposed performance measures if it were in place today.
Thirty-seven OPOs either did not meet one or both of the measures, including LiveOnNY, which was threatened with closure last year but successfully argued the current metrics used to assess OPOs are flawed.
LiveOnNY officials did not respond to requests for comment.
To come into compliance, some of the OPOs would need to collect a dozen or fewer additional organs each year. However, LiveOnNY and 11 other OPOs would have to recover hundreds more each year.
Greg Segal, co-founder of Organize, which formed in 2013 to fight for changes to the transplant system, said the “OPO industry has been failing across the board for decades, and it’s great to see the government finally step up and take the side of patients. Today’s rule is a big step toward accountability.”
Sen. Todd C. Young (R-Ind.), who introduced legislation this year calling for many of the revisions included in the proposed rule, also lauded the announcement.
The OPOs “have been operating in darkness for too long,” he said in a statement.
Lifes lost, organs wasted