The hospital industry is warning that a proposed mandatory model for kidney transplants could introduce “unnecessary disruption and uncertainty to the transplant ecosystem” and ultimately undercut the administration’s goal of greater access.
The Increasing Organ Transplant Access (IOTA) Model, proposed by the Centers for Medicare & Medicaid Services (CMS) in May, is a six-year model tentatively slated to kick off on Jan. 1, 2025.
CMS said its approach incentivizes a streamlined kidney transplant process by measuring participating hospitals by transplant quantity, organ acceptance rates and post-transplant outcomes. The proposed model also includes a health equity performance adjustment and requires hospitals to create health equity plans to identify and address gaps among their patient populations.
Per CMS’ May estimate, 90 of the country’s 257 transplant hospitals would be required to participate in the IOTA Model.
“The organ transplant industry, like every other part of society, is not immune to racial inequities,” Department of Health and Human Services Secretary Xavier Becerra said upon the model’s unveiling. “Black Americans disproportionately struggle with life-threatening kidney disease, yet they receive a smaller percentage of kidney transplants. The Biden administration is taking concrete steps to remove racial bias when calculating wait times and rooting out profiteering and inequity in the transplant process.”
Despite its goals, the administration’s proposal hasn’t landed well with the hospital industry.
In public comments submitted earlier this week, the American Hospital Association wrote that the proposed model “is not fully developed and contains fundamental flaws” that would lead to a “potential negative impact on patient outcomes.”
For starters, the hospital lobby pointed to the proposal’s “untenable” Jan. 1 timeline, which would give entities required to participate “as little as three months’ notice” following publication of the model’s final version. The organization also critiqued the mandatory requirement for participation, which comes at the same time that the government is conducting a major overhaul of the Organ Procurement and Transplantation Network.
“These changes will result in significant workflow, staffing and reporting modifications for stakeholders, including hospitals,” AHA wrote in its comments. “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.”
The composition of the model itself drew concerns as well. Among several other more granular areas of the model’s construction, AHA pointed to its heavy weighting of transplant volume in a hospital’s performance score, writing that without “appropriate risk adjustment” the model could be encouraging hospitals to settle for sub-par organ-recipient matches.
In its own comments submitted this week, America’s Essential Hospitals (AEH) reiterated the call for voluntary participation in the untested IOTA model and noted that “many past [Centers for Medicare and Medicaid Innovation (CMMI)] models have increased costs for providers without resulting in substantial benefits for patients.”
AEH also urged CMS to consider upfront funding for the essential hospitals it represents, which have higher uncompensated care expenses and a greater share of Medicare/Medicaid patients, and to introduce a separate track for safety net care providers “similar to the separate track that CMS recently proposed for the Transforming Episode Accountability Model (TEAM).”
Comments on the proposed model submitted to the agency by groups representing patients, such as the National Patient Advocate Foundation and the Coalition to Transform Advanced Care, generally signaled support for CMS’ rule.
In response to the agency’s specific questions around monitoring outcomes, they encouraged CMS to incorporate two validated patient-reported outcome performance measures (PRO-PM): the 2024 MIPS Measure #495: Ambulatory Palliative Care Patients' Experience of Feeling Heard and Understood and the Ambulatory Palliative Care Patients’ Experience of Receiving Desired Help for Pain.