What would change for Americans awaiting a kidney transplant if transplant programs stood to gain—or lose—significantly more revenue based on much they increased transplant rates, if patients were informed of donor kidneys offered to them and declined on their behalf, or if the federal government graded transplant success over the long term instead of 90-day or 1-year outcomes metrics?
These are a few of the bold questions that the Center for Medicare and Medicaid Innovation (CMMI) aims to ask, test, and answer over the course of a proposed 6-year mandatory payment model for adult kidney transplant programs. CMMI—which over the last decade and under three sequential presidential administrations has increasingly aimed to improve care for people with kidney failure, particularly to incentivize greater access to transplantation—released the Increasing Organ Transplant Access (IOTA) model for public comment in May 2024 (Figure 1). ASN has long advocated for a kidney transplant-focused model at CMMI, and the hallmarks of IOTA reflect many of the key components that ASN has called for in its advocacy efforts (Figure 2).
The Center for Medicare and Medicaid Innovation's ongoing and proposed kidney care models
Citation: Kidney News 16, 9
The Center for Medicare and Medicaid Innovation's IOTA model goals
Citation: Kidney News 16, 9
For example, the model is largely focused on maximizing access to transplantation and ensuring that access is more equitable—ASN's maxim for transplant policy advocacy. As proposed, the model encourages transplant programs to help patients overcome root-cause socioeconomic-related barriers to transplantation and offers greater reimbursement to programs that transplant those with limited financial resources. It also emphasizes transparency for patients—a tenet of ASN advocacy—such as requiring programs to make their waitlist-acceptance criteria public and informing patients on a retrospective basis about kidneys that were declined on their behalf but successfully transplanted into other patients. The latter consideration is a phenomenon that happens more frequently than many realize. According to a previous study, candidates who died while awaiting a transplant received a median of 16 offers that were declined for them but may have ultimately been transplanted into another candidate (1). CMMI also proposed greater focus on long-term graft survival, a long-time ASN recommendation that the society encouraged CMMI to bolster even further, and increasing organ-offer acceptance rates.
Although fully supporting IOTA's aims, the society offered extensive suggestions for strengthening IOTA, with the goals of ensuring kidney transplant programs’ ability to succeed in the model and enabling the model to achieve increased access to transplantation for all patients. Members of the ASN Quality Committee and the ASN Transplant Workgroup participated in an intense multiweek analysis of the proposed IOTA model to inform the society's input to CMMI. Chief among ASN's recommendations were:
Set performance targets at realistically attainable thresholds for IOTA participants. It is well documented that fewer patients receive kidney transplants than needed and that too many viable kidneys go unused, so IOTA's focus on increasing transplant rates is welcome. However, CMMI is well known for establishing “stretch” goals for its model participants. Because ASN's analysis revealed that the transplant growth rates that CMMI proposed were functionally impossible to achieve, the society developed an alternative approach to incentivizing transplant rate growth that strikes a balance between ambitiousness and attainability for kidney transplant programs. ASN also recommended that CMMI set different expectations for growth based on kidney transplant program volume.
Show me the money! Success in IOTA will require greater resources dedicated to kidney transplant programs and meaningful changes in program operation—changes unlikely to be spurred by the modest per-transplant upside ($8000) and downside ($2000) incentives that CMMI proposed. ASN recommended that CMMI increase the scale of the incentives to ensure that the model is sufficiently powered to attract attention and investment in kidney transplant programs, which will be crucial to enable achievement of IOTA's goals. Specifically, ASN recommended a $15,125 upside risk maximum and a $3750 downside risk maximum.
Finalize health-equity boosters. ASN strongly supported CMMI's proposal to encourage greater focus on equity in access to kidney transplantation by applying a 1.2× multiplier that boosts IOTA participants’ performance scores when they successfully transplant patients who are socioeconomically limited. Building on this concept, ASN also recommended that CMMI consider additional performance score multipliers to encourage IOTA participants to make gains on other key goals related to promoting equity and avoiding organ discards:
Apply the same 1.2× multiplier for patients who are socioeconomically limited to long-term outcomes as CMMI proposed applying for those patients’ initial transplant.
Add a multiplier to encourage appropriate use of “hard-to-place” kidneys, which are likely to accrue more cold ischemia time and experience delayed graft function regardless of organ quality.
Add a multiplier to encourage more pre-emptive transplantation, which constitutes fewer than 3% of all transplants despite being optimal from clinical and cost-savings’ perspectives relative to maintenance dialysis.
Increase focus on long-term outcomes. ASN and CMMI share the goals of both increasing access to kidney transplantation and improving long-term outcomes. To balance the appropriate increased emphasis proposed in IOTA on transplanting kidneys or including patients who may not be transplanted under current regulatory dynamics, as well as appropriately encouraging increased emphasis on successful long-term outcomes, ASN recommended that CMMI:
Place greater weight on long-term outcomes (via a composite graft survival-rate metric over 6 years) than originally proposed.
Integrate risk adjustment for at least a few variables.
As noted above, apply the same 1.2× multiplier for patients who are socioeconomically limited to long-term outcomes as CMMI proposed applying for those patients’ initial transplant.
Fund efforts to support patients. CMMI proposed a bevy of innovative waivers allowing IOTA to help more patients receive and keep a kidney transplant healthy in ways that the current rules do not permit, including providing in-home care, cost offsets for immunosuppressive drugs, and transportation. ASN strongly supports these concepts, which could help many patients overcome barriers to transplantation, but urged the Centers for Medicare & Medicaid Services to identify a source of funding to support IOTA participants in conducting these efforts.
Clarify covered costs. ASN asked CMMI to affirm that pretransplant costs incurred by IOTA participants under the model, such as additional resources needed to maintain an active waitlist and providing additional support for patients to complete their evaluation, which are currently covered through the Organ Acquisition Cost Center, would also be covered under the Organ Acquisition Cost Center. This affirmation would clarify that IOTA participants have a pathway to cover many of the additional costs they incur themselves in its efforts to increase equitable access to kidney transplantation and transplant rates.
Check the savings’ math. Despite the promise of IOTA to catalyze major patient-centered changes in kidney transplantation, CMMI estimated a modest additional 2625 transplants over the course of the 6-year model and less than $70 million in total savings. ASN's analysis suggests that the growth in both kidney transplants and savings to the Medicare program could be significantly greater, and the society urged CMMI to revisit the overall savings’ assumptions and calculations for the model.
ASN also supported CMMI's proposal that nephrologists, nephrology practices, and dialysis facilities could elect to participate as formal IOTA “collaborators.” Particularly for nephrologists, nephrology practices, and dialysis facilities participating in ongoing CMMI kidney care models, such as the Comprehensive Kidney Care Contracting pathway in the Kidney Care Choices voluntary model and End-Stage Renal Disease Treatment Choices mandatory model, collaboration with IOTA participants could align favorably to facilitate patient access to kidney transplantation in new ways.
Related, one of the most significant challenges to accomplishing ASN's and CMMI's shared goal of maximizing patient access to kidney transplantation is the shortage of transplant nephrologists and other transplant professionals—a shortage that, ironically, will worsen as the shared goal of increasing transplant rates is attained. In many areas, post-transplant care and the model's success will be dependent on IOTA participants engaging general nephrologists as key IOTA collaborators. ASN offered several recommendations to bolster general nephrology participation in transplant care for CMMI's consideration:
Create, within IOTA, a Monthly Capitated Payment for post-transplant care. With a secure, regular revenue stream for post-transplant care, as there is in dialysis care, community nephrologists may engage more readily in the care of these patients.
Establish a relative value unit adjustment for the care of transplant patients in the model regardless of the nephrologist type (e.g., transplant or general nephrologist).
Increase resources for IOTA participants to support more robust, longer-term post-transplant care coordination with general nephrology partners for patients who are referred back to the transplant center.
CMMI will likely release a final rule regarding IOTA and responding to ASN and other commentators’ input in late fall or early winter. If finalized, the model could take effect as early as January 2025, although ASN and many other commentators recommended a later start date to give IOTA participants and their hospitals and health systems ample time to tee themselves up for success. In the meantime, ASN will continue to advocate across the Department of Health and Human Services and on Capitol Hill in support of increased patient access to transplantation, advances in equity in kidney transplant, and greater transparency for patients across the kidney transplant journey.
Reference
Husain SA et al. Association between declined offers of deceased donor kidney allograft and outcomes in kidney transplant candidates. JAMA Netw Open 2019; 2:e1910312. doi: 10.1001/jamanetworkopen.2019.10312
