AHA Letter to CMS on The Increasing Organ Transplant Access (IOTA) Model

July 16, 2024

The Honorable Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
Hubert H. Humphrey Building
200 Independence Avenue, S.W., Room 445-G
Washington, DC 20201

Submitted Electronically

RE: Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model

Dear Administrator Brooks-LaSure,

On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners - including more than 270,000 affiliated physicians, 2 million nurses and other caregivers - and the 43,000 health care leaders who belong to our professional membership groups, the American Hospital Association (AHA) appreciates the opportunity to provide feedback on the proposed Increasing Organ Transplant Access (IOTA) Model.

Our members have long supported the Center for Medicare and Medicaid Innovation (CMMI) in testing innovative payment models to improve health care quality and reduce costs. However, to accomplish these objectives, models must be carefully designed to ensure that they align with intended goals, are feasible to implement and do not have unintended negative consequences. In fact, we have recommended that CMMI consider common principles in developing such models to make participation more attractive for potential participants. We are concerned that the IOTA model would not meaningfully advance the move to value.

IOTA's goal of increasing access to kidney transplants is one that the AHA shares. However, we are concerned that many of the model design features may in fact exacerbate inequities and negatively impact patients' quality of care. We are particularly concerned that the model's heavy focus on transplant volume may incentivize unintended consequences, such as sub-par matches. Given the potential negative impact on patient outcomes, we urge CMMI to not implement the IOTA model at this time. As written, it is not fully developed and contains fundamental flaws.

The proposed rule's most problematic design elements are delineated below and explained more thoroughly in the attached.

• IOTA would add unnecessary disruption and uncertainty to the transplant ecosystem, which is already undergoing significant transformation. The organ transplant ecosystem is undergoing massive transformation under the Organ Procurement and Transplantation Network (OPTN) Modernization Initiative and Securing the U.S. Organ Procurement and Transplantation Network Act. These changes will 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.
• IOTA's timeline is untenable. Complex (not to mention successful) payment model implementation requires significant time, resources and staffing by hospital participants. But, CMMI has proposed an IOTA start date of Jan. 1, 2025 - less than six months from now and an even briefer time from when the rule will be in its final form. It would notify participants of their mandatory participation with as little as three months' notice. Given the organ transplant system's transformation already occurring as mentioned above, this aggressive timeline is untenable.

• IOTA's mandatory participation is inappropriate. Hospitals must be able to assess whether CMMI models are appropriate for their patients' and communities' needs. Yet, 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.

IOTA's emphasis on volume could incentivize sub-par matches and exacerbate inequities. As proposed, 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. By so heavily incentivizing increases in the number of transplants performed, we are concerned that CMMI is also 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.

• IOTA's other proposed measures run counter to CMS' goal of broadening access to transplants and are discordant with other regulatory requirements. IOTA has built-in conflicting metrics by including measures such as offer-acceptance ratios and graft survival rates. On the one hand, the model would heavily incentivize volume increases, but on the other, offer-acceptance ratios would incentivize more conservative selection of organs for transplants. The methodology for these other measures also differs from the standards and reporting requirements established by OPTN.

Our members are committed to improving access and reducing disparities in kidney transplants. However, the proposed IOTA model not only would fail to help achieve these goals but also may result in reduced quality and exacerbated care inequities. As such we recommend that CMMI not implement this model at this time.Instead, CMS should evaluate, after implementation of changes under the OPTN modernization initiative, the need for a voluntary payment model. That way, CMS would understand areas where further reform may be needed and could effectively test the model without confounding variables.

Our detailed comments are attached. Please contact me if you have questions or feel free to have a member of your team contact Jennifer Holloman, AHA's senior associate director of policy, at [email protected].

Sincerely,

/s/

Ashley Thompson
Senior Vice President
Public Policy Analysis and Development

Cc: Elizabeth Fowler
Director, CMMI

AHA Letter to CMS on The Increasing Organ Transplant Access (IOTA) Model