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FOR IMMEDIATE RELEASE
November 26, 2024

Contact: CMS Media Relations
(202) 690-6145 | CMS Media Inquiries [ https://www.cms.gov/About-CMS/Public-Affairs/PressContacts/Media-inquiries1.html ]

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*Biden-Harris Administration** Finalizes New Model to Improve Access to Kidney Transplants*

"New Model Aims to Reduce Costs, Streamline Care, and Promote Greater Access and Efficiency "

Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), finalized a rule establishing a new, six-year mandatory model aimed at increasing access to kidney transplants while improving quality of care for people seeking kidney transplants and reducing disparities among individuals undergoing the process to receive a kidney transplant. The Increasing Organ Transplant Access Model’s mandatory participation of transplant hospitals will also help spur innovation nationwide by evenly distributing the model’s effects across the nation while engaging more specialists in value-based care.

“The Biden-Harris Administration is leading an important overhaul of the organ transplantation system,” said CMS Administrator Chiquita Brooks-LaSure. “The Increasing Organ Transplant Access Model will increase the number of kidney transplants that will not only save lives but will enable people to live longer and healthier ones.”

Each year, around 130,000 Americans are diagnosed with chronic kidney disease, which accounts for 24% of annual Medicare spending. Kidney transplantation is widely recognized as the most effective treatment for individuals with chronic kidney disease and end-stage renal disease (ESRD). Patients who receive a kidney transplant often experience significant improvements in their quality of life, as well as a reduction in overall medical costs. Patients often report that transplants free them from the burdens of regular dialysis, allowing them to maintain a more flexible schedule, pursue activities they enjoy, and lead a more fulfilling life.

The Increasing Organ Transplant Access Model aims to improve the effectiveness of the nation's kidney transplant system, which currently is not meeting the needs of many patients. On average, 13 Americans die each day while waiting for a life-saving kidney transplant [ https://www.kidney.org/about/kidney-disease-fact-sheet ]. Despite the significant gap between organ supply and demand, nearly 30% of donor kidneys are discarded each year.[1] [ #_ftn1 ] There are approximately 90,000 people on the kidney transplant waiting list, facing a wait time of three to five years or longer for an offer [ https://www.kidney.org/kidney-topics/kidney-transplant-waitlist ]. However, only 28,000 organs are procured annually [ https://optn.transplant.hrsa.gov/data/view-data-reports/national-data ].

The finalized Increasing Organ Transplant Access Model creates a representative national sample of kidney transplant hospitals. Access to organ transplantation is influenced currently by distance to transplant centers as well as other sociodemographic and economic factors. The finalized Increasing Organ Transplant Access Model aims to tackle long-standing challenges by enhancing the quality of care for patients with ESRD and boosting the number of transplants performed. The model is designed to support greater care coordination, improved patient-centeredness in the process of being waitlisted for and receiving a kidney transplant, and greater access to kidney transplants.

The Increasing Organ Transplant Access Model provides participating transplant hospitals a financial incentive to perform more transplants and a disincentive to perform fewer (i.e., a two-sided risk arrangement). Performance will be measured according to the number of transplants (“achievement”), rates of accepting organs offered (“efficiency”), and post-transplant outcomes (“quality”). Based on its final performance score, a participating transplant hospital will either receive a payment from CMS; fall in a neutral zone in which it neither receives nor owes a payment; or, beginning in performance year two, owe a payment back to CMS. These performance-based payments are in addition to the traditional Medicare fee-for-service payment.

CMS is selecting half of the donation service areas (DSAs) in the country and all eligible kidney transplant hospitals within those DSAs to participate in the model, for a total of 103 kidney transplant hospitals. These hospitals will represent a range of geographic locations and experience with value-based care.

The model will encourage participating transplant hospitals to identify their underserved populations, address gaps in care and social determinants of health (including food insecurity and out-of-pocket prescription drug costs) for donors and transplant recipients, and develop strategies and tools to create a more accessible transplant process. For instance, hospitals may implement programs to educate and support potential living donors from underserved communities or offer transportation assistance to patients on the waitlist.

CMS received 160 comments to its proposed rule, issued on May 17, 2024. In response to this feedback, the agency made significant revisions to the final rule to better support individuals with kidney disease and to reduce burden for participating transplant hospitals. In addition to delaying the model start date to July 1, 2025, to allow participants additional time to prepare, changes include:


* Increasing the maximum amount a transplant hospital may receive from CMS based on its performance score (upside risk payment) from $8,000 to $15,000 per Medicare kidney transplant.
* Removing the requirement for providers to review organ offers declined on behalf of the attributed patient.
* Adjusting the transplant target to reflect the average number of deceased or living donor transplants during the baseline years rather than the highest count.
* Adjusting the quality strategy to allow for additional time for measure identification and stakeholder input, including removing three quality measures from the quality domain.
* Removing the health equity payment adjustment and allowing the health equity plans to be voluntary.

The Increasing Organ Transplant Access Model is an essential part of the HHS Organ Transplant Affinity Group’s strategy, which coordinates a series of initiatives to strengthen the organ transplantation system. Key efforts include:


* Ensuring access to transplants by reducing variability in pre-transplant and referral practices.
* Improving accountability for system performance.
* Increasing the availability and use of donated organs.
* Enhancing education for patients, families, and caregivers.

The final rule also builds on other federal initiatives dating back to 2018, including the Burden Reduction Rule, the updated Organ Procurement Organization Conditions for Coverage, and the Kidney Care Choices and ESRD Treatment Choices models. These efforts all align with the work of the model to align incentives across the transplant process and increase patient access to transplant.

The final rule for the Increasing Organ Transplant Access Model is available in the Federal Register at https://www.federalregister.gov/public-inspection/2024-27841/medicare-program-alternative-payment-model-updates-and-the-increasing-organ-transplant-access-model. It also includes standard provisions applicable to all mandatory CMS Innovation Center models starting on or after January 1, 2025.

A fact sheet on the Increasing Organ Transplant Access Model is available at: https://www.cms.gov/files/document/iota-model-fs.pdf.

More information on the Increasing Organ Transplant Access Model is available on the model webpage [ https://www.cms.gov/priorities/innovation/innovation-models/iota ].

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[1] [ #_ftnref1 ] McKenney, C., Torabi, J., Todd, R., Akhtar, M. Z., Tedla, F. M., Shapiro, R., Florman, S. S., Holzner, M. L., & van Leeuwen, L. L. (2024). Wasted Potential: Decoding the Trifecta of Donor Kidney Shortage, Underutilization, and Rising Discard Rates. "Transplantology", "5"(2), 51-64. https://doi.org/10.3390/transplantology5020006






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