Cross-posted with permission from Health Affairs Forefront.

On May 8, 2024, the Centers for Medicare and Medicaid Services (CMS) proposed the Increasing Organ Transplant Access (IOTA) model: a six-year mandatory payment model designed to expand equitable access to kidney transplantation—the preferred treatment option for kidney failure (that is, end-stage renal disease [ESRD]) over dialysis given the higher survival rates and quality of life at lower costs. The IOTA model shares key design aspects with other ongoing CMS kidney payment models, such as the ESRD Treatment Choices (ETC) model: a seven-year mandatory payment model designed to increase home dialysis and kidney transplant waitlisting. Unlike other voluntary kidney payment models—such as the Kidney Care Choices (KCC) model and the Comprehensive ESRD Care model—both the ETC and IOTA models randomize participants, which allows CMS to evaluate the causal impact of the models’ incentives on outcomes such as kidney transplantation rates. Together, the ETC and IOTA models offer a unique opportunity to test whether access to kidney transplantation for patients with kidney disease can be improved by comprehensive and complementary policies that attempt to reform care delivery across the kidney care continuum—the ETC model affecting general nephrologists/dialysis organizations and the IOTA model affecting transplant hospitals (that is, transplant centers).

CMS has frequently leveraged kidney payment models to test new policies that were subsequently integrated into non-kidney payment models. For example, the ETC model was the first CMS model to include a health-equity incentive to address health disparities. As such, CMS’s new considerations for health equity within the IOTA model may inform future changes that may occur in other CMS non-kidney payment models. Additionally, as both models have been intentionally designed to improve health equity, the models provide an opportunity to evaluate whether health-equity incentives embedded within payment policy can address health disparities nationally.

In this article, we briefly summarize the proposed IOTA model, describe how CMS’s health-equity strategies have evolved from the ETC model to the IOTA model, and highlight potential challenges and opportunities that may impact inequities in kidney transplantation.

An Overview Of The IOTA—The Increasing Organ Transplant Access Model

As currently proposed, the IOTA model is a mandatory payment model that will adjust payments for kidney transplantation for approximately 90 transplant hospitals within the US—from January 2025 to December 2030—across a random selection of 50 percent of the 56 donation service areas (DSAs), each of which is an administrative area served by a single organ procurement organization. The IOTA model is the first payment model that directly incentivizes transplant centers to 1) increase kidney transplantation rates (from both deceased and living kidney donors); 2) decrease organ discard rates by improving allocation efficiency; 3) improve patient engagement (for example, through shared decision making); 4) improve the quality of pre- and post-transplant care; 5) address disparities in kidney transplantation rates among socioeconomically disadvantaged individuals; and 6) reduce Medicare expenditures.

Within the IOTA model, transplant hospitals randomized to the intervention arm can receive a bonus of up to $8,000 per kidney transplanted to a patient with Medicare fee-for-service (or, after the second year in the model, a penalty of up to $2,000). This amount of $8,000 is estimated to be 33 percent of the average Medicare fee-for-service reimbursement for kidney transplantation based on Medicare severity diagnosis related groups 650-652. These bonuses and penalties are calculated and assigned based on a performance score of up to 100 points across three domains:

1. Achievement (60 points)—primarily determined by how many transplants are performed;
2. Efficiency (20 points)—based on the rate of acceptance of offered organs; and
3. Quality (20 points)—based on composite post-transplant survival that uses a period prevalence measure (that is, not just one-year post-transplant survival, but the proportion of post-transplant patients alive relative to the total number of kidney transplants performed in that period of time) and three additional quality measures centered on shared-decision making, colorectal cancer screening, and a care transition measure.

Transplant hospitals will receive bonuses for scores less than or equal to 60 and penalties for scores greater than or equal to 40. For more details on the model, see CMS’s fact sheet and the full model description.

Overall, the IOTA model represents a model that is cognizant of the socioeconomic disparities in access to transplantation, the rising organ discard rate (that is, an increase in the percentage of potentially transplantable kidneys being discarded, suggesting missed opportunities for patients to receive a transplant), decreasing allocation efficiency (for example, kidneys are declined by more centers for their patients before eventually being accepted), and the wide variation in center behavior (in terms of their threshold or willingness to accept a kidney for transplantation). Despite the limited transplant-specific quality measures endorsed by CMS, the IOTA model creates an increased emphasis on longer-term outcomes using a period prevalence model while emphasizing the role of transplant center behavior on the efficiency of the deceased donor kidney allocation system.

Incorporating Equity Into The IOTA Model: How Has CMS’s Health-Equity Strategy Evolved Since 2020?

Consistent with the extensive literature that has underscored the barriers to transplantation experienced by socioeconomically disadvantaged individuals, the IOTA model intentionally incorporates health equity as a key goal for the model. This upfront and foundational equity goal within the IOTA model represents a notable advancement in CMS’s model design. For context, when CMS revised the ETC model in 2022 based on public feedback to include a health-equity incentive, the ETC model became the first CMS payment model in history to directly provide performance adjustments to address disparities driven by socioeconomic inequities. Since then, CMS has created a health-equity framework to better understand and address disparities in care for Medicare beneficiaries. Subsequently, CMS implemented a requirement for primary care practices in the Accountable Care Organization Realizing Equity, Access, and Community Health (REACH) (ACO REACH) model to design and implement a health-equity plan and has gone on to include payment and benchmark adjustments based on Medicare-Medicaid dual-eligibility status and area deprivation indices in several other models.

To address equity, the IOTA model incorporates features from both the ETC and ACO REACH models. Within the IOTA model, CMS will require transplant hospitals to create a health-equity plan and add a health-equity performance adjustment to payments to incentivize transplant hospitals to improve access to transplantation for socioeconomically disadvantaged individuals belonging to a “low-income population,” specifically: Medicaid beneficiaries, Medicare-Medicaid dually eligible beneficiaries, the uninsured, recipients of the Medicare low-income subsidy, and recipients of reimbursement from the living organ donation reimbursement program administered by the National Living Donor Assistance Center.

When a participating transplant hospital provides a kidney transplant to an IOTA model-defined low-income population, CMS proposes to multiply the score for that transplant by 1.2, hence providing an opportunity for the transplant hospital to achieve an incentive payment on the IOTA model’s performance-based measures. By adding focus on specific populations that are currently less likely to complete the multiple steps to be waitlisted and subsequently receive a transplant, the model is theorized to increase equitable access to organ transplantation by incentivizing health care systems to invest in resources that address the social determinants that can hinder the journey to transplantation (for example, transportation and food insecurity). To complement this approach, CMS requires a health-equity action plan for transplant hospitals to outline their resources and strategies to mitigate disparities that limit access to transplantation.

Challenges And Opportunities That May Affect The IOTA Model

While the IOTA model’s design is strengthened by the fact that it is a randomized trial at a national level, there are nuances to consider that may complicate the evaluation. Most notably, while CMS’s payment models predominantly target Medicare fee-for-service beneficiaries, as of January 2021, Medicare fee-for-service beneficiaries with kidney failure can enroll in Medicare Advantage; as a result, the percentage of patients receiving dialysis who are Medicare fee-for-service beneficiaries fell to 53 percent as of December 2022. This is a particular challenge for CMS payment models because CMS can only directly adjust payments for Medicare fee-for-service beneficiaries—a population that is shrinking as more beneficiaries transition to Medicare Advantage. While there is no mechanism to address the dropout of patients from the ETC model through a switch to Medicare Advantage, CMS is attempting to address this problem within the IOTA model by including all beneficiaries (regardless of payer) into their calculations to determine performance scores for each transplant hospital (while continuing to limit payment adjustments to only Medicare fee-for-service patients). Accordingly, transplant hospitals are incentivized to increase transplant access and quality for all patients, not just Medicare fee-for-service beneficiaries. This consideration of all beneficiaries in the evaluation of transplant center performance is an important means of underscoring the fact that transplantation—especially preemptive transplantation or early transplantation—will likely result in an even greater reduction of Medicare costs in the long term compared to patients continuing on dialysis.

Another methodologic challenge is that the voluntary KCC model continues until December 2026. As the KCC model also incentivizes transplantation, differential participation in the KCC model across the two arms of the IOTA model may be a source of confounding because participants in the KCC model receive a separate bonus for each transplant performed; accounting for these potential differences in the evaluation of the IOTA model will be crucial.

Finally, we note that the ETC and IOTA models will run simultaneously for 2.5 years between January 2025 and June 2027 (see exhibit 1). CMS should consider whether to approach this overlap of the two mandatory kidney payment models as a challenge or an opportunity. On one hand, having two randomized policy trials overlap may make it challenging to fully understand which payment model is influencing kidney transplantation, particularly when factoring the possible differential participation of sites in the voluntary KCC payment model. On the other hand, the randomization that occurs via the IOTA and ETC models will create four arms of regions facing different payment policies (that is, ETC intervention/IOTA control; ETC control/IOTA intervention; ETC intervention/IOTA intervention; and ETC control/IOTA control; see exhibit 1). The regions randomized to the intervention arm of both the ETC and IOTA models will represent a unique landscape where clinicians and health care settings across the full spectrum of kidney transplantation may be fully aligned to improve access to kidney transplantation. We believe that this overlap could represent a unique opportunity to learn from these regions through rigorous mixed-methods studies.

Exhibit 1: Overview of the commonalities and differences between the two mandatory kidney payment models in the United States: the End-Stage Renal Disease Treatment Choices model and the Increasing Organ Transplant Access model

Source: Authors’ creation.

In summary, the IOTA model is a new proposed mandatory randomized kidney payment model from CMS that is focused on kidney transplantation. The IOTA model will directly incentivize transplant hospitals to increase both living and deceased donor kidney transplantation rates, while also focusing on quality of care and addressing social determinants that drive disparities in transplantation. The IOTA model may be a promising opportunity to increase kidney transplantation rates and narrow disparities while also focusing on improving quality of care, living donation, allocation efficiency, and organ use.

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Amol S. Navathe, MD, PhD, Yuvaram Reddy, MBBS, MPH, Sri Lekha Tummalapalli, MD, MBA, Gaurav Jain, MD, Sumit Mohan, MD, MPH, Mallika L. Mendu, MD, MBA, Advancing Equity In Kidney Transplantation Through The Increasing Organ Transplant Access Model, Health Affairs Forefront, August 1, 2024, https://www.healthaffairs.org/content/forefront/advancing-equity-kidney-transplantation-through-increasing-organ-transplant-access: Copyright © [2024] Health Affairs by Project HOPE – The People-to-People Health Foundation, Inc.

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