Federal regulators in June took the unusual step of announcing they would shut down a New York-based nonprofit organization responsible for recovering human organs for transplantation. On Friday, regulators reversed that decision even though the organization, LiveOnNY, has received poor performance scores for nearly a decade and its organ recovery rates remain among the lowest in the nation.
LiveOnNY, the second-largest of 58 federally designed organ procurement organizations, confirmed Monday that its contract with the federal government was renewed. The organization declined interview requests and said it would not comment on how it plans to boost organ donation in the New York region.
In a statement, federal regulators said the new agreement with LiveOnNY provides “more frequent oversight” and requires the organ procurement organization, or OPO, to increase its organ recovery rates substantially before the four-year contract expires in 2022.
The Centers for Medicare and Medicaid Services, which is responsible for oversight of the nation’s OPOs, said it decided to keep LiveOnNY open to “lower risk” of disruptions to “patients waiting for organs” while it works with the organization to improve performance.
CMS has been criticized by transplant surgeons, medical researchers, industry officials and some members of Congress for failing to create an oversight system that holds OPOs accountable for their performance in acquiring organs for transplant.
Sen. Todd C. Young (R-Ind.) said Monday the decision by CMS shows weaknesses in the system and that he will ask the agency to explain how LiveOnNY will overhaul itself. “This is yet another example of the need for greater oversight and accountability in our organ donation system,” Young said.
Sander S. Florman, a transplant surgeon and chairman of LiveOnNY’s board of directors, said the organization plans on “being the most effective and productive OPO we can be.”
The decision comes less than two months after The Washington Post published an article about LiveOnNY that showed the organization has been one of the nation’s lowest-performing OPOs for nearly a decade.
LiveOnNY has been short-staffed at critical moments, and interviews and records show that transplant coordinators have shown up late or not at all to speak with grieving families. When they do reach relatives, their approach is sometimes indelicate, causing families to delay signing donation consent forms or to refuse to sign them altogether.
This isn’t the first time LiveOnNY has successfully fought a threatened shutdown. In 2013, CEO Helen Irving wrote to the White House and argued that CMS’s performance measures were flawed and should not be used to decertify them or any other OPO.
Irving pointed out that the data CMS uses to evaluate the organizations is “self-reported” by the OPOs and “unaudited” by CMS or any other outside group.
“Clearly, this type of ‘evidence’ fails to meet any reasonable definition of ‘empirical,’ ” she wrote.
The Association of Organ Procurement Organizations, the industry’s trade group, also took issue with the “self-reported” data, telling White House officials that the “accuracy and consistency of data cannot be assured.”
CMS allowed the organization to submit a performance improvement plan and continue operating.
In June, when CMS threatened decertification again, it took an extra step, sending the OPO a letter saying it “will not renew its agreement with LiveOnNY” when the contract was set to expire Jan. 31. CMS also rejected LiveOnNY’s request for reconsideration in December.
LiveOnNY appealed and entered into settlement negotiations with CMS. Under the new agreement, LiveOnNY agreed that it will not fight decertification in 2022 if it fails to meet the agreed-upon goals.
A longtime Department of Health and Human Services official, who spoke on the condition of anonymity because the person is not authorized to speak to the media, said that a key problem was CMS’s performance measures, which still rely on self-reported data and are not rigorous enough to be used to hold LiveOnNY accountable.
“It’s based on a metric that is not effective,” the official said. “It’s just another indication that they are unclear on what they are doing when it comes to providing oversight to the OPOs and it’s continuing to provide confusion in the field.”
A Post analysis published in December showed the transplant industry could more than double the number of organs available for transplant each year if it expanded efforts to collect and use organs from older and traditionally excluded donors, such as people with hepatitis C.
About 75,000 kidneys, livers, lungs, hearts and other organs could be donated each year, according to a Post analysis of death records — more than double the number transplanted in 2017. That number would essentially wipe out the U.S. waiting list for organs, which contains nearly 115,000 people. Last year, 31,608 organs from deceased donors were transplanted, but each day 33 people die waiting.
The chronic shortage of transplantable organs has spawned lawsuits by lung and liver patients — many who are on waiting lists in New York. One of the patients, 38-year-old Wilnelia Cruz, died last year while waiting for a liver transplant in New York.
In a September interview with The Post from her hospital bed, Cruz said she was told she could get on waiting lists in other states where organs are more plentiful. However, Cruz said she couldn’t afford the travel costs.
“Money should not be a factor for being able to live and see your children grow,” she said.