Insights

CMS Finalizes The Increasing Organ Transplant Acc

CMS Finalizes The Increasing Organ Transplant Access Model

In Short

The Situation: The Increasing Organ Transplant Access Model ("IOTA Model") introduces mandatory financial incentives and penalties for selected kidney transplant hospitals.

The Result: Starting in July, 103 kidney transplant hospitals will be evaluated for their performance across three domains, based on the volume of kidney transplants, matching efficiency, and post-transplant outcomes.

Looking Ahead: In this pre-launch phase, participating hospitals should take steps to evaluate the potential impact of the value-based payments and sharing arrangement structures and be ready to adapt to any new developments under the Trump administration, as necessary.

On November 26, 2024, the Centers for Medicare & Medicaid Services ("CMS") released a final rule setting forth a new alternative payment model, the IOTA Model, which introduces mandatory financial incentives and penalties for certain kidney transplant hospitals ("participants"). CMS has stated that the IOTA Model will evaluate whether performance-based payments can "increase access to kidney transplants while preserving or enhancing the quality of care and reducing Medicare expenditures." We observe that the IOTA Model follows in the footsteps of many CMS initiatives promoting the use of value- and performance-based care for Medicare program beneficiaries, including the MSSP Pathways to Success ACO model, the ACO REACH model, earlier ACO models, as well as models focused on specific specialties. Barring any efforts by the Trump administration to alter the final rule, the IOTA Model will run from July 1, 2025, through June 30, 2031.

Transplant Hospital Participants

CMS selected 103 kidney transplant hospital participants from a defined group of eligible kidney transplant hospitals using a stratified random sampling of donation service areas and has published the list of participants on its website. For the purpose of evaluating the program, non-participating hospitals will serve as the comparison group.  

Performance Assessment 

Financial incentives will include upside and downside performance-based payments, which are based on a participant's performance across three domains: achievement, efficiency, and quality. Each IOTA participant will receive a final performance score, which corresponds to the sum of the points earned in each domain. 

  1. The achievement domain, worth up to 60 points, assesses each participant on the overall number of kidney transplants performed during the performance year. CMS will set a target number of kidney transplants for each participant based on the participant's historical volume of deceased and living donor transplants, adjusted by the national trend rate.
  2. The efficiency domain, worth up to 20 points, assesses the kidney offer acceptance rate ratios of each participant relative to a national ranking or the participant's past organ offer acceptance rate ratio; CMS will apply whichever method results in the most points for the participant.
  3. The quality domain, worth up to 20 points, assesses the quality of care provided by the participant via a composite graft survival ratio. This metric evaluates the participant's post-transplant outcomes relative to all kidney transplant hospitals.

Table displaying kidney transplant performance metrics, including achievement, efficiency, and quality, with corresponding points and evaluation criteria.


Incentive Payments

Based on its performance, a participant will receive a payment from CMS (an "upside risk payment"), owe a payment back to CMS (a "downside risk payment"), or neither receive nor owe a payment. Lump-sum payments will be made to the participants, in addition to the Medicare fee-for-service payments, following the close of each performance year.

  • For the entirety of the program, CMS will apply the formula for the upside risk payment to a final performance score of 60 or greater. The upside risk payment will be equal to the participant's performance score minus 60, then divided by 40, then multiplied by $15,000, then multiplied by the number of kidney transplants furnished by the participant Medicare beneficiaries (primary and secondary payer).
  • Beginning in performance year 2, CMS will apply the formula for the downside risk payment to a final performance score of 40 or lower. The downside risk payment will be equal to 40 minus the IOTA participant's final performance score, then divided by 40, then multiplied by $2,000, then multiplied by the number of kidney transplants furnished by the participant Medicare beneficiaries (primary and secondary payer).
  • In rulemaking, CMS indicated that participants scoring below 60 in performance year 1 or scoring between 41-59 beginning year 2 fall in the neutral zone where no performance-based incentive payment is paid to or owed by CMS. Under the formulas, however, scores of 60 or 40 would nullify any incentive or penalty payment and would seem to place participants in the neutral zone. After reaching out to CMS for clarification, the agency confirmed that a "score of exactly 60 points would yield an upside risk payment of $0 per Medicare kidney transplant and a score of exactly 40 points would yield a downside risk payment of $0 per Medicare kidney transplant." After this initial response, we sought further clarification on whether the neutral zone is therefore inclusive of performance scores of 40 and 60, but did not receive a response. On January 21, 2025, the acting secretary of the Department of Health and Human Services, Dr. Dorothy Fink, sent a memo to the heads of the agency's Operating and Staff Divisions ordering an "Immediate Pause on Issuing Documents and Publication Communications" through February 1, 2025. With the Trump administration's pause on external communications now in effect through the end of the month, minimal additional guidance will be received, at least immediately.

Additional Requirements and Initiatives

The final rule introduces several other requirements and initiatives for participants, including:

  • Data sharing. CMS will collect, and enable participants to request, certain quality, clinical, and administrative data to monitor the IOTA Model and evaluate their performance.
  • Transparency. Participants must publicly post on a website the criteria used to determine whether patients will be placed on their kidney transplant waitlists. CMS intends to further develop on these requirements in future rulemaking.
  • Health equity. Participants may also submit a voluntary health equity plan to identify and address health disparities. Time will tell if the new administration will continue to focus on health equity, which has been a hallmark of the Biden administration.

Sharing Arrangements

CMS has authorized participants to enter into financial arrangements with Medicare providers and suppliers ("collaborators") to share upside and downside risk payments and align performance with the goals of the IOTA Model. More specifically, CMS has authorized gainsharing payments (payments from participants to collaborators), alignment payments (payments from collaborators to participants), and distribution payments (payments from certain collaborators receiving gainsharing payments to "IOTA collaboration agents," meaning an individual or entity that: (i) is an owner or employee of a physician group practice, non-physician provider group practice, or therapy group practice that serves as an IOTA collaborator; and (ii) has entered into a distribution arrangement with that same physician group practice, non-physician provider group practice, or therapy group practice).

In addition, participants may offer patient engagement incentives to help IOTA waitlist and transplant patients ("attributed patients") remain active on the kidney transplant waitlist and adhere to post-transplant care. Attributed patient incentives may include communication devices, transportation to and from a participating hospital, mental health services, and in-home care during the post-transplant period. Participants may also subsidize, in whole or in part, the cost sharing associated with immunosuppressive drugs covered by Medicare Part B, the Part B-ID benefit, and Part D.

To improve the integration and coordination of care, CMS has further determined that the federal Anti-Kickback Statute safe harbor for CMS-sponsored model arrangements and CMS-sponsored model patient incentives (42 CFR §§ 1001.952(ii)(1) and (2)) may protect remuneration exchanged pursuant to the sharing arrangements and attributed patient engagement incentives, so long as the arrangements comply with the requirements set forth in the IOTA rule. Although not expressly discussed in final rulemaking, any arrangement involving physician referrals for designated health services must also meet an exception under the Stark Law.

Standard Provisions for Innovation Center Models

The final rule adopts standard provisions applicable to the Radiation Oncology Model, the End-Stage Renal Disease (ESRD) Treatment Choices Model, and extends their application to all mandatory Innovation Center models, including the IOTA Model. The standard provisions address beneficiary protections, cooperation in model evaluation and monitoring, audits and record retention, rights in data and intellectual property, monitoring and compliance, remedial action, model termination by CMS, limitations on review, provisions on bankruptcy and other notifications, and the reconsideration review process. 

Three Key Takeaways

  1. The IOTA Model is a six-year mandatory model, scheduled to start on July 1, 2025. 
  2. Through the use of incentive and penalty payments, the IOTA Model aims to increase the number of kidney transplants and the quality of pre- and post-transplant care and encourage investments in value-based care.
  3. In the pre-launch phase, transplant hospitals should take note of the IOTA Model's requirements and fine-tune their kidney transplant programs while leaving room for potential adjustments as the Trump administration's agenda unfolds. 
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