Kidney Transplant Program Drops Patient Notification Rule

In November 2024, the Centers for Medicare & Medicaid Services (CMS) issued its final rule establishing a 6-year mandatory payment program aimed at increasing the volume of kidney transplants, improving the quality of care and reducing disparities among people seeking a life-saving kidney.

Under the Increasing Organ Transplant Access (IOTA) Model, the agency is targeting half of the country’s donation service areas, and all eligible kidney transplant hospitals in those areas will participate, for a total of 103 hospitals. Their performance will be measured based on the number of transplants they perform, their rate of accepting offered organs, and posttransplant outcomes.

Depending on their performance score, each participating hospital will receive a bonus payment of up to $15,000 per case from CMS, fall into a neutral zone with no payment change, or beginning in performance year 2, owe a payment of up to $2000 per case to CMS.

The model will start on July 1, 2025, 6 months later than originally planned. That wasn’t the only change following a months-long public comment period. CMS bumped up the bonus payment maximum from $8000 per case to $15,000 and removed three quality measures.

Disagreement on Patient Notification

In a move that’s caused some controversy, the agency also removed the requirement that transplant centers each month inform Medicare patients on the waiting list of kidney offers declined on their behalf and the reasons why.

Transplant surgeons refuse organs for a variety of reasons. For instance, they may consider an organ likely to fail, to be a poor match for a candidate, or not good enough for someone high on the waiting list who may soon receive a better offer. But patients typically don’t know when such decisions have been made on their behalf.

The goal of the requirement was to encourage shared decision-making, but after reviewing comments, CMS said it recognized that the patient notification requirement “could be very burdensome” to IOTA participants and staff.

“It was the right move on the part of CMS to pause rolling this out, given all the changes happening in the transplant landscape with IOTA and the relatively recent update to allocation,” said Deirdre Sawinski, MD, a transplant nephrologist and associate professor of medicine at Weill Cornell Medical College, New York, and a board member of the American Society of Transplantation. In 2021, the managers of the national transplant system broadened the geographic area used to allocate deceased donor kidneys, which increased the volume of offers each transplant center receives and added complexity to the process, according to research.

But not everyone agrees with the agency’s decision to drop the patient notification requirement.

“We were very disappointed that this was not included in the final rule,” said Jesse Roach, MD, a nephrologist and senior vice president for government relations at the National Kidney Foundation (NKF). “It was one of the strongest and most patient-centric parts of the IOTA Model.”

The NKF has called IOTA a key piece in the larger puzzle of improving the transplant system and saving more lives. Approximately 90,000 people are on the kidney transplant waiting list, and, on average, 13 of them die each day while waiting for an organ. Yet nearly 30% of donor kidneys are discarded annually, according to CMS.

Pros and Cons

Those in favor of patient notification say it’s important for several reasons. One is transparency. “That way a patient can see if they are getting rejected for a lot of organs and can say to their physician, ‘How can I get a kidney faster?’” Roach said.

In addition, patients’ priorities may change the longer they are on dialysis, and they may be more willing to accept a lower-quality kidney, Roach said. Regular patient notification of declined offers would present more opportunities for patients to communicate their wishes to the transplant team, he said.

It would also put pressure on transplant centers to generally accept more kidneys from deceased patients, said Syed Ali Husain, MD, a transplant nephrologist at Columbia University Irving Medical Center, New York.

“If centers knew they would have to inform patients of offers declined on their behalf, they would be more likely to accept offers that reflect some patients’ desire for earlier transplantation with a less-than-ideal organ, thereby leading to fewer declined offers,” Husain said. Most people who die on the waiting list have multiple offers declined on their behalf prior to their death, he said.

But transplant centers and professional transplant societies had several objections to the patient notification requirement.

One is practical, Sawinski said. “If I’m dedicating a staff member to making these phone calls or sending these emails…that is time being diverted away from other activities that patients might find more valuable, like contacting them to make sure their testing is up to date or helping facilitate the appointments they need to get active or stay active on the waiting list,” she said.

“This could also potentially cause some confusion for patients who may not understand all of the intricacies of the transplant offer acceptance process,” Sawinski said.

But there was room for flexibility and compromise on the issue, Roach said. In the original requirement, CMS did not stipulate the method to be used to notify patients, so it could be automated through the patient portal, for instance. Furthermore, the NKF would not have objected if CMS had reduced the notification from every month to every 3 or 4 months or even every 6 months to reduce the burden on transplant centers, Roach said.

To avoid patient confusion, patients could be told at their initial evaluation for the waiting list that they would receive regular notifications about declined offers and be educated about their meaning, Roach said. “There are many things in medicine that are complicated, and it is our jobs as physicians to figure out a way to break it down so that patients can understand,” he said.

It is possible that CMS will adopt a patient notification requirement about declined kidney offers in a year or two. “Transparency is an important principle, and the CMS Innovation Center will continue to work with patient groups and model participants to strike a balance between burden and transparency in the future,” a CMS spokesperson told Medscape Medical News in an email.

Barbara Mantel is an award-winning reporter who writes about public health and health policy.