The nonprofit organization responsible for managing organ donations in Maine and New England is at risk of losing accreditation unless it meets recent federal requirements to increase donation and transplant rates within the next two years. There is a possibility that
The new ranking system is Deployed in 2020 In an effort by the Centers for Medicare and Medicaid Services to reform a system that has faced sharp criticism from the government in recent years. Public health advocates and legislators.
Under the new guidelines, each organization will be classified into one of three tiers based on organ donation and transplantation rates.Those who made it to the top 25th Percentiles are designated as Tier 1 organizations, which are the highest performing organizations. Companies designated as Tier 2 or Tier 3 could face decertification if they do not make improvements by 2026.
New England Donor Services serves Maine and New England. Recent rankings.
Sean Fitzpatrick, chief communications officer for New England Donor Services, said nearly half of the nation’s nonprofit transplant centers, known as organ procurement organizations, face the possibility of deaccreditation or dissolution under the new ranking system. He said that he was on the brink of a crisis.
“If the intent is to close 42% of all OPOs, there is no path forward,” Fitzpatrick said. “That would cause major disruption to the system and put many patients at risk.”
This requirement provides more transparent tracking of the nation’s 56 organ procurement organizations andUnderachievers are responsibleAccording to CMS, which evaluates OPOs.”
Procurement organization staff are responsible for meeting with the families of the deceased and asking them to donate their loved ones’ organs.
They are also responsible for donating organs to transplant hospitals, managing donor clinical requirements, and providing data for entry into national databases important for matching donor organs with people in need of transplants. . Each OPO is the only provider within a different geographic area.
The federal government evaluates OPOs annually on a four-year cycle. Whether an organization faces decertification depends on Determined by performance in 2024.
Under the new rules, Tier 1 organizations (those in the top 25% of all donation and transplant rates) will automatically recertify when their four-year evaluation cycle ends in 2026. Become.
Tier 2 groups must compete with other procurement organizations to maintain certification. Tier 3 organizations (those with donation and transplant rates below the median) may be automatically decertified at the end of the cycle.
New England Donor Services met Tier 1 standards for donations and transplants in 2019, but dropped to Tier 2 in 2020 due to declining transplant rates. In 2021, its transplant and donation rates once again achieved Tier 2 status.
System is at risk
Fitzpatrick and others have questions about the new rules and wonder how they will be enforced.
“We have very real concerns about the CMS metrics. Our biggest concern is that they do not accurately reflect OPO performance,” Fitzpatrick said.
a Multi-state research teams stated in 2020 that the new evaluation method will be “biased in favor of OPOs (large OPOs) with more potential donors and, conversely, in favor of OPOs (small OPOs) with fewer potential donors.” concluded.
That puts organizations like New England Donor Services at a disadvantage when evaluating for recertification, Fitzpatrick said.
Some transplant centers are also raising questions about the new evaluation methods. In a letter to the Department of Health and Human Services last September, leaders from all 14 New England transplant centers, including the chief of nephrology and transplantation at Maine Medical Center, wrote that CMS methods had caused “nearly Half are arbitrarily defined as: It “failed” even though the donation rate increased significantly compared to the previous year. ”
Nationally, OPO performance ratings were downgraded from 2021 to 2023, with the percentage of Tier 1 OPOs dropping from 46 percent to 26 percent and the percentage of Tier 3 OPOs increasing from 26 percent to 42 percent. .
This trend is particularly concerning for New England transplant centers, which said in a 2023 letter to CMS that the organizations at risk of decertification serve more than 80 percent of the U.S. population. He said this could lead to “an unjust and counterproductive disruption of the system.”
Despite the drop in rankings, New England Donor Services increased its organ donation rate by 36 percent from 2020 to 2023, ranking it fourth in the nation in the number of organ donors, according to the rankings. organization.
New rules aim to improve latency and increase portability
Federal regulators say the changes are needed to reform a system that lawmakers, surgeons and activists have long criticized for repeatedly failing to save dying patients.
“For years, OPOs have faced no external incentives to do their jobs. They have evaded public scrutiny, refused to release data showing their successes and failures, and operated behind walls of jargon and obfuscation. ,” said Rep. Raja Krishnamoorthi (Ill.), chairman of the Economic and Consumer Policy Subcommittee. hearing In 2021.
“No matter how bad our performance is, OPO has never lost its accreditation,” Krishnamoorthi continued. “They set disappointingly low expectations for themselves and praise each other for lackluster performance, including high executive pay and invitations to lavish executive socials and mutual events.”
is more than 103,000 people He is on the national organ waiting list. More than 6,000 people die each year I have never had a transplant. At least 450 patients in Maine are waiting for at least one organ. Most people require the kidneys (81%) and liver (15%), with the remainder requiring either the pancreas, heart, or lungs.
In 2023, 46,630 transplants were performed across the United States, including 150 from Maine. The time from being on the list to receiving a kidney in Maine is very long “Some patients live longer, but if the patient does not have a living donor, it usually takes three to five years,” said Caroline Cornish, communications director at Maine Medical Center, the only hospital in the state that performs transplants. Told.
The new code of practice aims to increase the number of organs collected by encouraging OPOs to pursue all potential donors, including the elderly and those who can only donate one organ.
The regulations also aim to increase transplant rates by evaluating groups based on the number of organs transplanted. Under the old standard, organizations were given credit for procuring organs, but were not evaluated on whether the organs were ultimately transplanted.
The government is also starting to calculate outcomes based on death certificate data rather than relying on self-reported data from OPOs, which discourages OPO organizations from actively searching for every available organ. Critics say there is.
The Centers for Medicare and Medicaid has announced that new evaluation methods will 5,600 more organ transplants per year.
Incentive misalignment, waste, and uncertainty
OPOs are encouraged to procure as many eligible organs as possible, but many factors determine whether those organs are transplanted.
These include how much time has passed since the organ was removed from the donor, how properly the organ was handled during birth, and whether changes in the patient’s condition may cause rejection of the organ. , and other factors that the transplant center considers in its decision. Organs are suitable for transplantation.
According to federal data, by 2022, more than 20 percent of donated kidneys will be not ported. Some are lost in transit or delayed for too long to be used. Because kidneys have a longer shelf life than other organs, they are most likely to be sent on commercial flights or transported as cargo, exposing them to the problems associated with flight.
“The biggest volume problem we have in organ transport is transport by commercial aircraft,” PJ Geraghty wrote in a 2023 paper. article Published by United Network for Organ Sharing. Ms. Geraghty serves as vice chair of her OPO Committee for the Organ Procurement and Transplant Network, which unites all professionals involved in organ donation and transplantation in the United States. “It’s mainly a kidney issue and commercial air is completely unreliable.”
Once the organ arrives, the hospital team will determine if it can be transplanted.
“The biggest inefficiency is the mismatch between the number of organs we’re recovering and the willingness of some transplant centers to use those organs,” Fitzpatrick said. . “This is largely a result of misaligned incentives within the system.”
“Transplant centers are evaluated by the federal government and insurance companies on transplant performance. This means that transplants have an incentive to use really good organs and avoid using marginal organs,” he said. added.
In Fitzpatrick’s view, the degree of organ selectivity offered by transplant centers does not best serve waiting patients. “The question is not, ‘Is this a perfect kidney?'” he said. But is this a better kidney transplant than dialysis?” he said.