Mandatory organ transplant model draws ire from AHA

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The American Hospital Association is saying that the Increasing Organ Transplant Access (IOTA) Model could thwart the Biden administration's goal of expanding access by causing undue disruption and uncertainty into the transplant process.

The Centers for Medicare and Medicaid Services proposed the six-year model in May, with IOTA currently on pace to begin January 1, 2025.

"We are concerned that many of the model design features may in fact exacerbate inequities and negatively impact patients' quality of care," the AHA wrote.

The group said it's especially concerned that the model's heavy focus on transplant volume may incentivize unintended consequences, such as sub-par matches. Because of the potential negative impact on patient outcomes, the AHA urged the Center for Medicare and Medicaid Innovation (CMMI) not to implement IOTA until changes are made.

"As written, it is not fully developed and contains fundamental flaws," the group wrote.

WHAT'S THE IMPACT?

The organ transplant ecosystem is already undergoing significant transformation under the Organ Procurement and Transplantation Network (OPTN) Modernization Initiative and Securing the U.S. Organ Procurement and Transplantation Network Act, the AHA wrote, adding that IOTA would add unnecessary disruption and uncertainty.

Hospitals predicted these changes would result in significant workflow, staffing and reporting modifications for stakeholders, including hospitals.

"Implementing a mandatory organ transplant payment model simultaneously as these transformations would add risk and uncertainty to a complex and critical portion of the care continuum," AHA wrote.

The group added that IOTA's timeline is untenable, saying it would notify participants of their mandatory participation with as little as three months' notice. More time is needed, according to the letter.

The AHA also called mandatory participation "inappropriate." According to the group, the proposed rule would mandate certain hospitals' participation in IOTA. Specifically, it would require participation for certain kidney transplant hospitals with 11 or more kidney transplants in a three-year baseline period – "a threshold that does not come close to ensuring statistical significance and exposes organizations to unwarranted penalties for outlier cases," the organization wrote.

Another criticism is that IOTA heavily emphasizes transplant volume increases. Specifically, 60% of a hospital's performance score would be determined by transplant volume; to receive a maximum score, the hospital would need to increase historical volume by 150% plus a national growth rate.

According to the AHA, by so heavily incentivizing increases in the number of transplants performed, CMMI may also be incentivizing sub-par organ matches. 

"Moreover, we are concerned that the lack of an appropriate risk adjustment incentivizes the selection of healthier patient populations and could exacerbate existing inequities concerning who receives transplants, which impacts underserved and geographically remote transplant facilities," the letter read.

Instead of implementing IOTA, "CMS should evaluate, after implementation of changes under the OPTN modernization initiative, the need for a voluntary payment model," the AHA said.

THE LARGER TREND

Calling the transplant process "complex and fragmented care," HHS said that organ transplantation varies not only by geography, but also by factors such as race, ethnicity, disability status and socioeconomic status.

For example, according to the Scientific Registry of Transplant Recipients Annual Data Report, 32% of wait-listed individuals were Black in 2021, but only 13.5% of recipients of a transplant from a living donor were Black. White individuals made up 35.8% of the wait list and 61.8% of transplant recipients from a living donor.

According to HHS, people with ESRD who receive transplants have better outcomes than people who receive dialysis, but the scarcity of organs, particularly for kidney transplants, leads to increased patient mortality and a significant gap between demand and supply.

Despite this scarcity, about 30% of donor kidneys go unused annually, highlighting gaps in procurement, distribution and utilization.
 

Jeff Lagasse is editor of Healthcare Finance News.
Email: jlagasse@himss.org
Healthcare Finance News is a HIMSS Media publication.