With help from New England Donor Services, Kevin and Michele Decoteau, of Mason, donated their son’s heart to Gary Swain (right) of Marblehead, Massachusetts. They share their story to promote organ donation. (Courtesy)
Dan Decoteau was on life support at Massachusetts General Hospital with a traumatic brain injury, hours from death, when the organ donor team asked his family to make an excruciating decision. Would they donate his organs and tissue to save other lives? Decoteau, 39, of Milford, hadn’t joined the donor registry, so the decision was theirs.
The family talked with each other and the team. They had disparate thoughts about organ donation, his mother, Michele Decoteau, of Mason, said but agreed on this: “(Dan) was a kind, compassionate, selfless person, and we thought he would probably want to save lives.”
They said yes.
Among those lives Decoteau saved was Gary Swain’s, who was in a nearby hospital in desperate need of a heart when Decoteau died on Aug. 6, 2021. Swain underwent transplant surgery the next day, and nine months later, on Mother’s Day, he drove to Nashua to meet Michele Decoteau, pink roses in one hand and a stethoscope in the other so she could hear her son’s heartbeat.
New England Donor Services, which orchestrated that donation and manages donations in most of New England, is at risk of losing its certification under new federal rules that now hold it accountable for ensuring the organs it provides from deceased donors, not living donors, are actually transplanted, a piece of the process it says it can’t control.
It’s not alone.
The Centers for Medicare and Medicaid Services, which oversees “organ procurement organizations,” has said that as of now, only 15 of the country’s 56 organizations would hold onto their certification under the new rules. The threat comes as New England Donor Services and many organizations have seen significant increases in donors over the last 13 years. New England Donor Services has improved donor recruitment by 53 percent since 2020.
In an email, the CMS’s communication office said the new rules are aimed at increasing the number of transplants so fewer people are dying while awaiting an organ. They disputed the argument that donor organizations can’t influence how many organs are transplanted.
And so far, the agency has rejected dire warnings from donor organizations, hospitals, transplant centers, and members of Congress that the new rules will destabilize rather than strengthen the system, potentially leading fewer people to get life-saving transplants. Among New Hampshire’s federal delegation, only Congressman Chris Pappas’ office said he had shared concerns about the new rules.
In a September letter, the heads of the 14 transplant hospitals that work with New England Donor Services, including Dr. Michael Daily at Dartmouth Hitchcock Medical Center in Lebanon, voiced concerns to Secretary Xavier Becerra of the U.S. Department of Health and Human Services.
“We recognize no regulation is ‘perfect,’ and that accountability for (organ procurement organizations) is important to serving the system,” the letter read. “However, this regulatory approach of combining mathematically flawed metrics with draconian consequences for the majority of non-profit organizations in the world’s top performing donation and transplant system seems particularly ill-advised.”
To count organs must be donated and transplanted
While CMS will not determine new certification status for New England Donor Services and the other organizations until 2026, it will base that determination on this year’s organ donation and transplant numbers. The agency has not yet released the 2024 numbers, but last year’s numbers may be an indication of what’s to come.
New England Donor Services’ numbers for 2023 would land it in Tier 2, meaning it would not be automatically recertified but could compete with other donor organizations to hold onto its contract with CMS.
New England Donor Services is risking losing its federal certification even as recruits more organ donors each year. (Screenshot)
In order to move up to Tier 1, where recertification is guaranteed, New England Donor Services would have needed to sign on 46 additional donors in 2023 and report 187 additional organ transplants. They transplanted 1,401 organs that year and recruited 549 donors and expect to hit 662 donors this year. In the Granite State, 55 percent of people with a driver’s license or non-driver ID have opted to add their name to the list at registerme.org.
Instead, despite what President and CEO Alex Glazier described as a record year for donations, New England Donor Services is on track to drop to Tier 3 because of its transplant numbers, she said.
“We’re at 16 percent growth in organ donors this year, which is almost not sustainable … yet we’re not going to even make the median, which doesn’t make any sense,” Glazier said.
In June alone, her organization added six donors from New Hampshire, 27 from Massachusetts, 18 from Connecticut, eight from Maine, and five from Rhode Island. “When you look at a system that is showing that kind of growth, I think what you want to do is make sure that you’re supporting that growth, incentivizing that growth, and assessing it accurately. What you don’t want to do is destabilize it.”
Organs donated and unused
In a 2022 analysis, the Scientific Registry of Transplant Recipients found that nearly 9,345 or 19 percent of organs recovered for transplant nationally went unused that year, a nearly 15 percent increase from the year before. In a study that same year, the National Research Council found that just about every player in the organ donor and transplant system – including donor organizations, transplant centers, and CMS – could do better.
In its email to the Bulletin, the CMS communications department said its new certification metrics are intended to address both findings; by improving the system, more organs will go unused, and more lives would be saved, it said.
“Recent publications have demonstrated the wide variability of organ retrieval by (organizations) that contributes to disparities in the rate of transplants,” the email said. “These studies have found that, if the rates of retrieval among (organizations) were consistently high, many more successful organ transplants would occur throughout the U.S.”
Among the biggest changes is how CMS will evaluate an organ donor organization’s success. Those with the highest donor and transplant numbers will set the standard for everyone; organizations that fall too far below their numbers will risk losing or automatically lose certification, without adjustments for the health of their populations or organ rejections by transplant hospitals.
Dorrie Dils, president of the national Association of Organ Procurement Organizations, said her members share CMS’s goal of saving more lives and do not object to federal regulations and accountability. They don’t believe CMS’s new rules will achieve those goals, however, because they are being measured on aspects of the process they say they cannot control.
“When we have to go back to a donor family, a grieving donor family, and thank them for the gifts that they’ve given and report that sadly, we were unable to use them, that is a tragedy,” Dils said. “It’s also a tragedy for the people who die waiting for an organ transplant in the United States. And somehow we need to create regulations that improve the entire ecosystem, not just one part of it.”
The major issues with the rules
There are four primary complaints about the new rules.
CMS is using data from death certificates to determine the number of potential donors in an organization’s territory. That’s a problem, said Glazier, head of New England Donor Services, because there are inconsistencies among states, from who completes the certificate to what causes are listed.
If a death certificate states someone died in a car accident or of blunt force trauma but does not also note the person had tumors or other malignancies, CMS will count the person as a potential donor even though their organs may not be usable, she said.
“So, the reliability of that data to actually assess the nuance of whether organ donation was an opportunity is really problematic,” Glazier said.
The CMS rules hold all organizations to the same standard but do not factor in their populations’ unique health conditions, socio-economic status, access to health care, or other factors that can determine health outcomes.
“Some areas of the country have very young, healthy populations,” said Dils, whose organization represents all organ donor nonprofits. “Here in the Midwest, that is not true. In the upper Northeast, that is not true. Our populations are older. They’re more likely to have diabetes. They’re more likely to have high blood pressure, strokes, and things that impact their organs. So, for CMS to think that we’re all dealing with the same population is confusing.”
The organizations are recertified every four years, but CMS’s certification decisions will be based on a single year of donor and transplant numbers. That’s unfair, Dils and Glazier said, and contrary to how the federal government measures other health care systems.
‘That would not serve the needs of our rural populations’
The fourth complaint from organizations relates to CMS’s decision to hold it accountable for decisions about organ transplants that are made by hospitals, not them.
That change has created some tension between organ donor organizations and transplant hospitals, namely over how much influence an organization can have over an organ’s chances of being transplanted.
New England Donor Services expects to increase its number of organ transplants again this year. (Screenshot)
In May, for example, New England Donor Services made nearly 24,000 offers to candidates on the 46 livers that were donated that month. Fourteen, or 30 percent, of the livers went unused, even though the organization made nearly 12,720 offers on just those.
Rejections were not unique to livers. Of all 182 hearts, kidneys, lungs, and other organs New England Donor Services offered in May, 87 were not transplanted. Most people on the transplant waiting lists need kidneys, but transplant hospitals rejected 225 kidneys from Glazier’s group in 2023 despite the 1.2 million offers it made to hospitals around the country.
“And we’re held accountable by CMS for the fact that they didn’t get transplanted,” Glazier said.
CMS’s communications office said it is taking other steps to improve hospitals’ transplant rates and offering organizations assistance and training to improve their rates.
Dr. Michael Chobanian, medical director of transplantation surgery at Dartmouth Hitchcock, doesn’t agree with CMS’s new approach to certification and doesn’t want to see New England lose its organization, especially if a large operation like New York’s absorbs it. “The next step would likely be bringing smaller transplant programs under the auspices of the largest programs,” he said. “That would not serve the needs of our rural populations in New Hampshire and Vermont.”
But Chobanian believes organizations have more influence over transplant rates than they suggest.
For example, organs need to be transplanted within hours. Taking too long to obtain information about the donor or testing of organs can render them unusable, he said.
“I believe (organ donor organizations) do need to be more efficient and timely,” Chobanian said in an email. “However, it is not necessarily (an organization’s) fault each and every time an organ is rejected.”
Organs are rejected for many other reasons, including poor quality or indication from a biopsy that a transplant would likely not succeed, Chobanian said. The age and the quality of organs from deceased donors has changed and led to consequences, he said. For example, hospitals are transplanting “marginal” kidneys they wouldn’t have years ago because the wait list for kidneys has grown so long.
“We have been forced to take risks we wouldn’t have had to do before the change,” Chobanian said. “This has forced longer hospital stays, more organs which have not worked as expected … and higher rates of rejection.”
From patient to advocate
Erin Geraghty Contino of Lee got a life-saving heart transplant at 18 months old, a year after being diagnosed with idiopathic dilated cardiomyopathy, a disease that enlarges and weakens the heart. She’d been awaiting a heart transplant at Boston Children’s Hospital for nine days when New England Donor Services, which operated under a different name then, located one.
That was nearly 28 years ago. She’s now an advocate for the organization and worries the new CMS rules will end in decertification.
“I needed that transplant in order to live,” Geraghty Contino said. Without it, she wouldn’t have gone to college, gotten married, or had her son Calvin, now 2.
“New England Donor Services has been amazing and it is just a breath of fresh air to have them on your team,” she said. “They handled it so well that I would be very nervous if (local organ donation) was in someone else’s hands.”