CMS New Rules for Organ Donation Won't Fix Transplantation

Pam Harrison

March 30, 2021

The Centers for Medicare & Medicaid Services' (CMS') proposed rule that would make organ procurement organizations (OPOs) solely responsible for improving transplantation performance across the United States will backfire, say experts in the transplantation community, because those rules are not nuanced enough to fix the gaps in a complex, highly coordinated system.

"You can talk about OPOs, you can talk about transplantation centers, and you can talk about [transplantation professional societies] as if they were individual and not interconnected, but the reality is, we are intimately interconnected," Richard Formica, MD, president, the American Society of Transplantation (AST), told Medscape Medical News.

"So if the OPOs either don't do their job or are forced to close or are disrupted in their performance, then I in my role as medical direct of kidney transplantation here at Yale University can't do my job, because my job is to take care of people who have come to me with organ failure and who are dying, and I need organs to try and fix that problem," he emphasized.

The presidents of the three transplantation societies — the United Network for Organ Sharing (UNOS), the American Society of Transplant Surgeons (ASTS), and the AST — sent a letter to the CMS administrator in response to the CMS' proposed conditions for OPO coverage during the public comment phase of the rule, which ends today.

The US government requires a public comment phase with regard to any changes proposed by the CMS before those changes become law.

Quantifiable Measures Are Fundamentally Flawed

The metrics that are being used to assess the performance of OPOs are fundamentally flawed, explained David Mulligan, MD, president, UNOS, and director of the Yale New Haven Transplantation Center, New Haven, Connecticut.

Using the number of organs, or the number of organs per donor, or the number of donors per a given population doesn't take into account how the number of potential donors in any given area of the country can vary, he says.

"In the northeast and on the west coast, the average age of death is higher, people live longer than they do in the southeast and the central US, and in the southeast and the central US, there is a lot more trauma and a lot less gun regulation, so there are a whole number of reasons why we have big differences in the age of death, and age of death certainly impacts the usability of donors," Mulligan told Medscape Medical News.

Mulligan pointed out that people in the southeast and central United States are less trustful of doctors and thus are less likely to have timely control of their blood pressure or blood glucose level.

Thus, they are at higher risk for strokes and heart attacks at earlier ages than people in places such as New York. This helps explain why the metrics for transplantation are better in the southeast and central US than they are in New York.

Moreover, the CMS death database, which currently is being proposed to assess improvements in the OPOs' performance, is 12 to 18 months out of date, "so if you are going to use this database for real-time process improvement, it's delayed," Formica notes.

Insisting that all OPOs perform as well as those in the top quartile of all OPOs in the country ― as the proposed rule stipulates ― is also dipping into the realm of the impossible, he added.

Should OPOs not achieve this lofty level of performance, they would be threatened with decertification, and there has been no thought for a plan to pick up the slack.

"Plan B" Needed for Poorly Performing OPOs

One reason why an OPO might be underperforming relative to other OPOs elsewhere in the country could be that the OPO is in an area where transplant centers do not make use of certain types of organs.

The OPO's administrators would know this, says Formica. Why would the OPO pursue donors if it knows that the organs it recovers are not going to used? And if an OPO does invest energy and resources into pursuing a donor organ that ultimately goes unused, "they do not get reimbursed for that effort," Formica noted, "and they are taken away from pursuing other donors whose organs are more likely to be used."

The solution is to improve organ offer and organ acceptance rates and to bring the transplant centers into alignment with their OPOs to work together to fix the system, say the experts.

"You also can't just shut the donor procurement organizations down — who is going to do the work, and who is going to be able to get them up to speed?" Mulligan asks.

Instead, Mulligan and colleagues have proposed that room be made for "plan B," whereby if an OPO is performing poorly, it can develop an improvement plan and show it is making improvements in a relatively short period.

For those OPOs that are eventually decertified, there should be a transition plan to ensure that organ recovery continues and that the system still moves forward without causing undue patient harm, he stressed.

Instead of using an out-of-date database to measure improvement in an OPO's performance, experts like Formica wonder, "Why not use real-time data from hospital-based electronic medical records, as they do in New England?" This would give OPOs more accurate and more detailed data with which to work.

"If you are going to use a metric and it's a flawed metric to begin with, you are only going to get yourself in trouble," Formica reemphasized.

Time-Crunching Realities and Variations in Biopsy Results

Apart from trying to assess the relative performance of all OPOs across the United States, there are the time-crunching realities for OPOs and transplant centers alike. These realities start with gaining familial consent to use a loved one's organs, to recovering those organs in a superhumanly short period, and to transporting and transplanting the organs into waiting recipients, who themselves have to be prepared to receive their new organ.

One factor in this process involves the distinction between brain death and circulatory death. "Brain death is when a donor has a really severe brain injury and there is no functional brain stem reflex left," Mulligan explained. Circulatory death occurs when a patient is taken off life support. Although such patients still have irreversible brain injuries, they don't meet the criteria for brain death.

In both cases, organ harvesting must occur a timely manner, but cases involving circulatory death are particularly time sensitive.

From the moment life support is removed and the patient expires, the transplant team has less than 30 minutes to recover the lungs or the heart and about the same time to recover the liver. They have between 60 and 90 minutes to recover the kidneys.

"If a patient expires within those times, we can use those organs; otherwise, we can't," Mulligan explained.

"And only 45% of these circulatory death donors progress within those time frames," he added.

There is also the problem of the quality of the recovered organ and whether it is the right organ for an individual patient. Formica and Mulligan agree that this is a thorny issue and one that transplantation experts take exceptionally seriously.

Currently, in about half of donor kidneys, biopsy is performed to determine the organ's quality. From 30% to 50% of kidneys are discarded because of biopsy findings.

"The reason why biopsies are done are for things like prolonged ischemia in the donor," Formica explains. They are performed at least in part because surgeons want some assurance that they are doing the right thing for their patient. The problem is that biopsies are performed in different ways, and, depending on the type of biopsy, different portions of the kidney are sampled. If the biopsy specimen is removed from a more superficial portion of the kidney, it is more prone to sclerosis and potential risk for discard.

In addition, kidneys are usually prepared through use of a frozen section, which distorts the anatomy. This another reason why organs are discarded.

"Biopsies are also read by whoever is on call that night for pathology," Formica observed. If the pathologist happens to specialize in breast pathology, there's no guarantee that his or her interpretation is going to be as accurate as that of a kidney specialist — "so you think you are getting a very concrete piece of information because it's a biopsy, but in reality, the information is very variable, and it does not give you the assurance that you believe it does," he explained.

Frustrating Wait for Ex Vivo Perfusion Devices in the US

There is also the less-discussed issue of accepting an organ that might be considered borderline on the basis of biopsy findings, and the patient subsequently rejects that organ relatively quickly.

"There are transplant centers that don't do any biopsies, they just put every kidney in that has any potential for transplantation, but the problem is, if they put that kidney in and the organ barely works or works only for a few months, then the patient is back on dialysis, and there are a lot of bad things that patients have to go through because of this," Mulligan said.

Some organs do not function immediately after transplantation, which presents another problem, one involving compensation.

In cases involving delayed graft function, patients usually require a prolonged hospital stay, and they may again require dialysis for a period. There is no additional compensation for this, regardless of how long that period is, Formica points out.

One way to extend the time frame during which viable organs can be recovered is through the use of ex vivo perfusion devices, which some countries, such as Canada, have been using.

In the United States, the US Food and Drug Administration has yet to approve such devices — a situation that Mulligan says is "really frustrating," given that in countries where the devices have been used, many more recipients receive healthy donor organs because of their use.

The issue regarding the use of biopsy to assess organ quality will likely remain thorny for some time to come, at least in the United States.

The Critical Issue of Trust at the Heart of All Transplant Transactions

Formica, Mulligan, and colleagues suggest that the CMS consider a more equitable payment model for cases in which organs require additional time and resources to become functional.

Mulligan explained that at one point, in an effort to increase the availability of organs for transplant, donor families were given financial incentives. Tax benefits have also been proposed as a means of incentivizing organ donation.

"These incentives did have some impact, but [the result]…was not as great as we thought it might be, and there was a lot of conflict," he recalled. It seemed that families began to suspect that healthcare providers weren't really trying to save their loved one's life because the providers needed their loved ones' organs. This raised a critical issue regarding trust, which is at the heart of all transplantation transactions, Mulligan notes.

Spain has a program of presumed consent in which every person who is medically eligible is deemed a donor unless a legal document indicates otherwise.

"We all wanted to get on the bandwagon and get behind presumed consent," Mulligan said.

"But what we actually found was, people opted out because they didn't want the medical profession to not try and save their life, so it caused more disincentives than incentives," he added. Formica agrees with these sentiments, adding that organ donation is not a commodity.

"These are human beings who have died. Perhaps they were altruistic in life and they signed up to be an organ donor, or their families were altruistic because they wanted to make other people's lives better," he said.

"So as the rhetoric goes back and forth about this, I don't want people to lose sight of this, because this is very important," Formica stressed.

Could US Perform 10,000 More Transplants per Year?

In an independent white paper recently published by Oliver Wyman Health, researchers projected that deceased donor kidney recovery and transplantation cases could increase from 17,583 in 2020 to 28,310 in 2026 — a 61% increase beyond current transplantation levels.

In their letter to the CMS, the presidents of the three transplant societies endorsed the idea that by working more closely together, 10,000 more transplants per year could be performed than the number predicted on the basis of changes in the CMS rule.

On the other hand, a recent report from the International Registry in Organ Donation and Transplantation shows that the United States has surpassed all other countries in rates of deceased organ donation, pulling ahead of Spain, which previously had held the number one spot but lost it because of the COVID-19 pandemic.

Formica and Mulligan have disclosed no relevant financial relationships.

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