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

Federal RegisterMay 17, 2024

Ask Donna

What actually matters in this document.

Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 512

[CMS-5535-P]

RIN 0938-AU51

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

AGENCY:

Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).

ACTION:

Proposed rule.

SUMMARY:

This proposed rule describes a new mandatory Medicare payment model, the Increasing Organ Transplant Access Model (IOTA Model), that would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals increase access to kidney transplants for patients with end-stage renal disease (ESRD) while preserving or enhancing the quality of care and reducing Medicare expenditures. This proposed rule also includes standard provisions that would apply to Innovation Center models whose first performance period begins on or after January 1, 2025, and also would apply, in whole or part, to any Innovation Center model whose first performance period begins prior to January 1, 2025 should such model's governing documentation incorporate the provisions by reference in whole or in part. The proposed standard provisions relate to beneficiary protections; cooperation in model evaluation and monitoring; audits and records retention; rights in data and intellectual property; monitoring and compliance; remedial action; model termination by CMS; limitations on review; miscellaneous provisions on bankruptcy and other notifications; and the reconsideration review process.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, by July 16, 2024.

ADDRESSES:

In commenting, please refer to file code CMS-5535-P.

Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

Electronically.

You may submit electronic comments on this regulation to

http://www.regulations.gov.

Follow the “Submit a comment” instructions.

By regular mail.

You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-5535-P, P.O. Box 8013, Baltimore, MD 21244-8013.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

By express or overnight mail.

You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services,Department of Health and Human Services, Attention: CMS-5535-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

For information on viewing public comments, see the beginning of the

SUPPLEMENTARY INFORMATION

section.

FOR FURTHER INFORMATION CONTACT:

CMMItransplant@cms.hhs.gov

for questions related to the Increasing Organ Transplant Access Model.

CMMI-StandardProvisions@cms.hhs.gov

for questions related to the Standard Provisions for Innovation Center Models.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments:

All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received:

http://www.regulations.gov.

Follow the search instructions on that website to view public comments. CMS will not post on

Regulations.gov

public comments that make threats to individuals or institutions or suggest that the commenter will take actions to harm an individual. CMS encourages individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.

Current Procedural Terminology (CPT) Copyright Notice

Throughout this proposed rule, we use CPT® codes and descriptions to refer to a variety of services. We note that CPT® codes and descriptions are copyright 2020 American Medical Association. All Rights Reserved. CPT® is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

Section 1115A of the Social Security Act (the Act) gives the Secretary of Health and Human Services the authority to test innovative payment and service delivery models to reduce program expenditures in Medicare, Medicaid, and the Children's Health Insurance Program (CHIP) while preserving or enhancing the quality of care furnished to individuals covered by such programs. This proposed rule describes a new mandatory Medicare payment model to be tested under section 1115A of the Act—the Increasing Organ Transplant Access Model (IOTA Model)—which would begin on January 1, 2025 and end on December 31, 2030. In this proposed rule, we propose payment policies, participation requirements, and other provisions to test the IOTA Model. We propose to test whether performance-based incentives (including both upside and downside risk) for participating kidney transplant hospitals can increase the number of kidney transplants (including both living donor and deceased donor transplants) furnished to End Stage Renal Disease (ESRD) patients, encourage investments in care processes and patterns with respect to patients who need kidney transplants, encourage investments in value-based care and improvement activities, and promote kidney transplant hospital accountability by tying payments to value. The IOTA Model is also intended to advance health equity by improving equitable access to the transplantation ecosystem through design features such as a proposed health equity plan requirement to address health outcome disparities and a health equity performance adjustment.

This proposed rule also includes proposed standard provisions that would apply to Innovation Center models whose first performance periods begin on or after January 1, 2025, unless otherwise specified in a model's governing documentation, as well as to Innovation Center models whose first performance periods begin prior to January 1, 2025, provided the standard provisions are incorporated into such models' governing documentation. The proposed 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; miscellaneous provisions on bankruptcy and other

notifications; and the reconsideration review process.

We seek public comment on these proposals, the alternatives considered, and the request for information (RFI) in section III.D. of this proposed rule.

B. Summary of the Proposed Provisions

1. Standard Provisions for Innovation Center Models

The proposed standard provisions for Innovation Center models would be applicable to all Innovation Center models whose first performance periods begin on or after January 1, 2025, subject to any limitations specified in a model's governing documentation. The proposed standard provisions also would apply to all Innovation Center models whose first performance periods begin prior to January 1, 2025, provided the standard provisions are incorporated into such models' governing documentation.

We are proposing to codify these standard provisions to increase transparency, efficiency, and clarity in the operation and governance of Innovation Center models, and to avoid the need to restate the provisions in each model's governing documentation. The proposed standard provisions include terms that have been repeatedly memorialized, with minimal variation, in existing models' governing documentation. The proposed standard provisions are not intended to encompass all of the terms and conditions that would apply to each Innovation Center model, because each model embodies unique design features and implementation plans that may require additional, more tailored provisions, including with respect to payment methodology, care delivery and quality measurement, that would continue to be included in each model's governing documentation. Model-specific provisions applicable to the IOTA Model proposed herein are described in section III of this proposed rule.

2. Model Overview—Proposed Increasing Organ Transplant Access Model

a. Proposed IOTA Model Overview

End-Stage Renal Disease (ESRD) is a medical condition in which a person's kidneys cease functioning on a permanent basis, leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life.

The best treatment for most patients with kidney failure is kidney transplantation. Nearly 808,000 people in the United States are living with ESRD, with about 69 percent on dialysis and 31 percent with a kidney transplant.

For ESRD patients, regular dialysis sessions or a kidney transplant is required for survival. Relative to dialysis, a kidney transplant can improve survival, reduce avoidable health care utilization and hospital acquired conditions, improve quality of life, and lower Medicare expenditures.

However, despite these benefits, evidence shows low rates of ESRD patients placed on kidney transplant hospitals' waitlists, a decline in living donors over the past 20 years, and underutilization of available donor kidneys, coupled with increasing rates of donor kidney discards, and wide variation in kidney offer acceptance rates and donor kidney discards by region and across kidney transplant hospitals.

Further, there are substantial disparities in both deceased and living donor transplantation rates among structurally disadvantaged populations. Strengthening and improving the performance of the organ transplantation system is a priority for the Department of Health and Human Services (HHS). Consistent with this priority, and through joint efforts with HHS' Health Resources and Services Administration (HRSA), the proposed IOTA Model would aim to reduce Medicare expenditures and improve performance and equity in kidney transplantation by creating performance-based incentive payments for participating kidney transplant hospitals tied to access and quality of care for ESRD patients on the hospitals' waitlists.

End-Stage Renal Disease (ESRD) | CMS. (n.d.).

https://www.cms.gov/medicare/coordination-benefits-recovery/overview/end-stage-renal-disease-esrd.

United States Renal Data System. 2022 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2022.

Tonelli, M., Wiebe, N., Knoll, G., Bello, A., Browne, S., Jadhav, D., Klarenbach, S., & Gill, J. (2011). Systematic review: kidney transplantation compared with dialysis in clinically relevant outcomes.

American Journal of Transplantation: Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 11

(10), 2093-2109.

https://doi.org/10.1111/j.1600-6143.2011.03686.xhttps://doi.org/10.1111/j.1600-6143.2011.03686.

Cheng, X. S., Han, J., Braggs-Gresham, J. L., Held, P. J., Busque, S., Roberts, J. P., Tan, J. C., Scandling, J. D., Chertow, G. M., & Dor, A. (2022). Trends in Cost Attributable to Kidney Transplantation Evaluation and Waitlist Management in the United States, 2012-2017.

JAMA network open, 5

(3), e221847.

https://doi.org/10.1001/jamanetworkopen.2022.184.

Al Ammary, F., Bowring, M. G., Massie, A. B., Yu, S., Waldram, M. M., Garonzik-Wang, J., Thomas, A. G., Holscher, C. M., Qadi, M. A., Henderson, M. L., Wiseman, A. C., Gralla, J., Brennan, D. C., Segev, D. L., & Muzaale, A. D. (2019). The changing landscape of live kidney donation in the United States from 2005 to 2017.

American journal of transplantation: official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 19

(9), 2614-2621.

https://doi.org/10.1111/ajt.15368.

Mohan, S., Yu, M., King, K. L., & Husain, S. A. (2023). Increasing Discards as an Unintended Consequence of Recent Changes in United States Kidney Allocation Policy.

Kidney international reports, 8

(5), 1109-1111.

https://doi.org/10.1016/j.ekir.2023.02.1081.

The proposed IOTA Model would be a mandatory model that would begin on January 1, 2025 and end on December 31, 2030, resulting in a 6-year model performance period (“model performance period”) comprised of 6 individual performance years (each a “performance year” or “PY”). The proposed IOTA Model would test whether performance-based incentives paid to, or owed by, participating kidney transplant hospitals can increase access to kidney transplants for patients with ESRD, while preserving or enhancing quality of care and reducing Medicare expenditures. CMS would select kidney transplant hospitals to participate in the IOTA Model through the methodology proposed in section III.C.3.d of this proposed rule. As this would be a mandatory model, the selected kidney transplant hospitals would be required to participate. CMS would measure and assess the participating kidney transplant hospitals' performance during each PY across three performance domains: achievement, efficiency, and quality.

The achievement domain would assess each participating kidney transplant hospital on the overall number of kidney transplants performed during a PY, relative to a participant-specific target. The efficiency domain would assess the kidney organ offer acceptance rates of each participating kidney transplant hospital relative to the national rate. The quality domain would assess the quality of care provided by the participating kidney transplant hospitals across a set of proposed outcome metrics and quality measures. Each participating kidney transplant hospital's performance score across these three domains would determine its final performance score and corresponding amount for the performance-based incentive payment that CMS would pay to, or the payment that would be owed by, the participating kidney transplant hospital. The proposed upside risk payment would be a lump sum payment paid by CMS after the end of a PY to a participating kidney transplant hospital with a final performance score of 60 or greater. Conversely, beginning after PY 2, the downside risk payment would be a lump sum payment paid to CMS by any participating kidney transplant hospital

with a final performance score of 40 or lower. We are not proposing a downside risk payment for PY 1 of the model.

b. Model Scope

We propose that participation in the IOTA Model would be mandatory for 50 percent of all eligible kidney transplant hospitals in the United States. We anticipate that a total of approximately 90 kidney transplant hospitals will be selected to participate in the IOTA Model. As discussed in section III.C.3.b. of this proposed rule, we believe that mandatory participation is necessary to minimize the potential for selection bias and to ensure a representative sample size nationally, thereby guaranteeing that there will be adequate data to evaluate the model test.

We propose that eligible kidney transplant hospitals would be those that: (1) performed at least eleven kidney transplants for patients 18 years of age or older annually regardless of payer type during the three-year period ending 12 months before the model's start date; and (2) furnished more than 50 percent of the hospital's annual kidney transplants to patients 18 years of age or older during that same period. We propose to select the kidney transplant hospitals that will be required to participate in the IOTA Model from the group of eligible kidney transplant hospitals using a stratified random sampling of donation service areas (“DSAs”) to ensure that there is a fair selection process and representative group of participating kidney transplant hospitals. For the purposes of this proposed rule, a DSA has the same meaning given to that term at 42 CFR 486.302.

c. Performance Assessment

We propose to assess each IOTA participants' performance across three performance domains during each PY of the model, with a maximum possible final performance score of 100 points. The three performance domains would include: (1) an achievement domain worth up to 60 points, (2) an efficiency domain worth up to 20 points, and (3) a quality domain worth up to 20 points.

The achievement domain would assess the number of kidney transplants performed by each IOTA participant for attributed patients, with performance on this domain worth up to 60 points. The final performance score would be heavily weighted on the achievement domain to align with the IOTA Model's goal to increase access to kidney transplants. The IOTA Model theorizes that improvement activities, including those aimed at reducing unnecessary deceased donor discards and increasing living donors, may help increase access to kidney transplants.

We propose that CMS would set a target number of kidney transplants for each IOTA participant for each PY to measure the IOTA participant's performance in the achievement domain (the “transplant target”), as described in section III.C.5.c of this proposed rule. Each IOTA participant's transplant target for a given PY would be based on the IOTA participant's historical volume of deceased and living donor transplants furnished to attributed patients in the relevant baseline years, adjusted by the national trend rate in the number of kidney transplants performed and further adjusted by the proportion of transplants furnished by the IOTA participant to attributed patients who are low income. Section III.C.5.c. of this proposed rule describes the variation in the number of kidney transplants performed across kidney transplant hospitals, which would make it challenging to set transplant targets on a regional or national basis. The IOTA Model would therefore set a transplant target that is specific to each IOTA participant to address this concern, while still accounting for the national trend rate in the number of kidney transplants performed. It is expected that IOTA participants' transplant targets may change from PY to PY because of the way in which the transplant target would be calculated.

The efficiency domain would assess the kidney organ offer acceptance rate ratio for each IOTA participant. The kidney organ offer acceptance rate ratio measures the number of kidneys an IOTA participant accepts for transplant over the expected value, based on variables such as kidney quality. Points for the kidney organ offer acceptance rate ratio would be determined relative to either the kidney organ offer acceptance rate ratio across all kidney transplant hospitals, or the IOTA participant's own past kidney organ offer acceptance rate ratio, with performance on the efficiency domain being worth up to 20 points.

Finally, the quality domain would assess IOTA participants' performance on post-transplant outcomes in addition to three quality measures—the CollaboRATE Shared Decision-Making Score, Colorectal Cancer Screening, and the 3-Item Care Transition Measure, with performance on this domain being worth up to 20 points.

Each IOTA participant's final performance score would be the sum of the points earned for each domain: achievement, efficiency, and quality. The final performance score in a PY would be determinative of whether the IOTA participant would be eligible to receive an upside risk payment from CMS, fall into the neutral zone where no upside or downside risk payment would apply, or owe a downside risk payment to CMS for the PY as described in section III.C.6. of this proposed rule.

d. Performance-Based Incentive Payment Formula

Each IOTA participant's final performance score would determine whether: (1) CMS would pay an upside risk payment to the IOTA participant; (2) the IOTA participant would fall into a neutral zone, in which case no performance-based incentive payment would be paid to or owed by the IOTA participant; or (3) the IOTA participant would owe a downside risk payment to CMS. For a final performance score above 60, CMS would apply the formula for the upside risk payment, which we propose would be equal to the IOTA participant's final performance score minus 60, then divided by 60, then multiplied by $8,000, then multiplied by the number of kidney transplants furnished by the IOTA participant to attributed patients with Medicare as their primary or secondary payer during the PY. Final performance scores below 60 in PY 1 and final performance scores of 41 to 59 in PYs 2-6 would fall in the neutral zone where there would be no payment owed to the IOTA participant or CMS.

We propose to phase-in the downside risk payment beginning in PY2. We explain in section III.C.5.b. of this proposed rule that new entrants to value-based payment models may need a ramp up period before they are able to accept downside risk. Thus, the IOTA Model proposes an upside risk-only approach for PY 1 as an incentive in each of the three performance domains. This would give IOTA participants time to consider, invest in, and implement value-based care and quality improvement initiatives before downside risk payments would begin. Beginning in PY 2, for a final performance score of 40 and below, CMS would apply the formula for the downside risk payment, which would be equal to the IOTA participant's final performance score minus 40, then divided by 40, then multiplied by −$2,000, then multiplied by the number of kidney transplants furnished by the IOTA participant to attributed patients with Medicare as their primary or secondary payer during the PY.

CMS would pay the upside risk payment in lump sum to the IOTA participant after the PY. The IOTA participant would pay the downside

risk payment to CMS in a lump sum after the PY.

e. Data Sharing

We propose to collect certain quality, clinical, and administrative data from IOTA participants for model monitoring and evaluation activities under the authority in 42 CFR 403.1110(b). We would also share certain data with IOTA participants upon request as described in section III.C.3.a. of this proposed rule and as permitted by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule and other applicable law. We propose to offer each IOTA participant the opportunity to request certain beneficiary-identifiable data for their attributed Medicare beneficiaries for treatment, case management, care coordination, quality improvement activities, and population-based activities relating to improving health or reducing health care costs, as permitted by 45 CFR 164.506(c). The data uses and sharing would be allowed only to the extent permitted by the HIPAA Privacy Rule and other applicable law and CMS policies. We also propose to share certain aggregate, de-identified data with IOTA participants.

f. Other Requirements

We propose several other model requirements for selected transplant hospitals, including transparency requirements, public reporting requirements, and a health equity plan requirement which would be optional for PY1 and required for PY 2 through PY 6, as described in section III.C.8. of this proposed rule.

(1) Transparency Requirements

Patients are often unsure whether they qualify for a kidney transplant at a given kidney transplant hospital. We propose that IOTA participants would be required to publish on a public facing website the criteria they use when determining whether or not to add a patient to the kidney transplant waitlist. We also propose to add requirements to facilitate increased transparency for patients regarding the organ offers received on the patient's behalf while the patient is on the waitlist. Specifically, we propose that IOTA participants would be required to inform patients on the waitlist, on a monthly basis, of the number of times an organ was declined on each patient's behalf and the reason(s) why each organ was declined. We believe that notifying patients of the organs declined on their behalf would encourage conversations between patients and their providers regarding a patient's preferences for transplant and facilitate better shared decision-making.

(2) Health Equity Requirements

We propose that during the model's first PY, each IOTA participant would have the option to submit a health equity plan (“HEP”) to CMS. We propose that each IOTA participant would then be required to submit a HEP to CMS for PY 2 and to update its HEP for each subsequent PY. We propose that the IOTA participant's HEP would identify health disparities within the IOTA participant's population of attributed patients and outline a course of action to address them.

We also considered proposing to require IOTA participants to collect and report patient-level health equity data to CMS. Specifically, we considered proposing that IOTA participants would be required to conduct health related social needs screening for at least three core areas—food security, housing, and transportation. We recognize these areas as some of the most common barriers to kidney transplantation and the most pertinent health related social needs for the IOTA patient population.

We have included an RFI in this proposed rule to solicit feedback and comment on such a requirement.

Venkataraman, S., & Kendrick, J. (2020). Barriers to kidney transplantation in ESKD.

Seminars in Dialysis, 33

(6), 523-532.

https://doi.org/10.1111/sdi.12921.

g. Medicare Payment Waivers and Additional Flexibilities

We believe it is necessary to waive certain requirements of title XVIII of the Act solely for purposes of carrying out the testing of the IOTA Model under section 1115A of the Act. We propose to issue these waivers using our waiver authority under section 1115A(d)(1) of the Act. Each of the proposed waivers is discussed in detail in section III.C.10. of this proposed rule.

h. Overlaps With Other Innovation Center Models and CMS Programs

We expect that there could be situations where a Medicare beneficiary attributed to an IOTA participant is also assigned, aligned, or attributed to another Innovation Center model or CMS program. Overlap could also occur among providers and suppliers at the individual or organization level, such as where an IOTA participant or one of their providers would participate in multiple Innovation Center models. We believe that the IOTA Model would be compatible with existing models and programs that provide opportunities to improve care and reduce spending. The IOTA Model would not be replacing any covered services or changing the payments that participating hospitals receive through the inpatient prospective payment system (IPPS) or outpatient prospective payment system (OPPS). Rather, the IOTA Model proposes performance-based payments separate from what participants would be paid by CMS for furnishing kidney transplants to Medicare beneficiaries. Additionally, we would work to resolve any potential overlaps between the IOTA Model and other Innovation Center models or CMS programs that could result in duplicative payments for services, or duplicative counting of savings or other reductions in expenditures. Therefore, we propose to allow overlaps between the IOTA Model and other Innovation Center models and CMS programs.

i. Monitoring

We propose to closely monitor the implementation and outcomes of the IOTA Model throughout its duration consistent with the monitoring requirements proposed in the Standard Provisions for Innovation Center models in section II of this proposed rule and the proposed requirements in section III.C.13. of this proposed rule. The purpose of this monitoring would be to ensure that the IOTA Model is implemented safely and appropriately, that the quality and experience of care for beneficiaries is not harmed, and that adequate patient and program integrity safeguards are in place.

j. Beneficiary Protections

As proposed in section III.C.10. of this proposed rule, CMS would not allow beneficiaries or patients to opt out of attribution to an IOTA participant; however, the IOTA Model would not restrict a beneficiary's freedom to choose another kidney transplant hospital, or any other provider or supplier for healthcare services, and IOTA participants would be subject to the Standard Provisions for Innovation Center Models outlined in section II. of this proposed rule protecting Medicare beneficiary freedom of choice and access to medically necessary services. We also would require that IOTA participants notify Medicare beneficiaries of the IOTA participant's participation in the IOTA Model by, at a minimum, prominently displaying informational materials in offices or facilities where beneficiaries receive care. Additionally, IOTA participants would be subject to the proposed Standard Provisions for Innovation Center Models regarding descriptive model materials and activities in section II. of this proposed rule.

C. Summary of Costs and Benefits

The IOTA Model aims to incentivize transplant hospitals to overcome system-level barriers to kidney transplantation. The chronic shortfall in kidney transplants results in poorer outcomes for patients and increases the burden on Medicare in terms of payments for dialysis and dialysis-based enrollment in the program. There is reasonable evidence that the savings to Medicare resulting from an incremental growth in transplantation would potentially exceed the payments projected under the model's proposed incentive structure.

II. Standard Provisions for Innovation Center Models

A. Introduction

Section 1115A of the Act authorizes the Center for Medicare and Medicaid Innovation (the “Innovation Center”) to test innovative payment and service delivery models expected to reduce Medicare, Medicaid, and CHIP expenditures, while preserving or enhancing the quality of care furnished to such programs' beneficiaries. We have designed and tested both voluntary Innovation Center models—governed by participation agreements, cooperative agreements, and model-specific addenda to existing contracts with CMS—and mandatory Innovation Center models that are governed by regulations. Each voluntary and mandatory model features its own specific payment methodology, quality metrics, and certain other applicable policies, but each model also features numerous provisions of a similar or identical nature, including provisions regarding cooperation in model evaluation; monitoring and compliance; and beneficiary protections.

On September 29, 2020, we published in the

Federal Register

a final rule titled “Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures” (85 FR 61114) (hereinafter the “Specialty Care Models final rule”), in which we adopted General Provisions Related to Innovation Center models at 42 CFR part 512 subpart A that apply to the End-Stage Renal Disease Treatment Choices (ETC) Model and the Radiation Oncology (RO) Model.

The Specialty Care Models final rule codified general provisions regarding 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, and bankruptcy and other notifications. These general provisions were adopted only for the ETC and RO Models (and, in practice, applied only to the ETC Model). However, we now believe the general provisions should apply to Innovation Center models more broadly. As we note, the Innovation Center models share numerous similar provisions, and codifying the general provisions into law to expand their applicability across models, except where otherwise explicitly specified in a model's governing documentation, would, we believe, promote transparency, efficiency, clarity, and ensure consistency across models to the extent appropriate, while avoiding the need to restate the provisions in each model's governing documentation.

In the autumn of 2020, due to the Secretary of Health and Human Services' Determination that a Public Health Emergency Exists for the Coronavirus disease 2019 (COVID-19) (

https://aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx

), CMS revised the RO Model's performance period to begin on July 1, 2021, and to end on December 31, 2025, in the CY 2021 Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems and Quality Reporting Programs final rule with comment period (85 FR 85866). Section 133 of the Consolidated Appropriations Act (CAA), 2021 (Pub. L. 116-260) (hereinafter referred to as “CAA, 2021”), enacted on December 27, 2020, included a provision that prohibited implementation of the RO Model before January 1, 2022. This congressional action superseded the July 1, 2021, start date that we had established in the CY 2021 OPPS/ASC IFC. To align the RO Model regulations with the requirements of the CAA, 2021, we proposed to modify the definition of “model performance period” in 42 CFR part 512.205 to provide for a 5-year model performance period starting on January 1, 2022, unless the RO Model was prohibited by law from starting on January 1, 2022, in which case the model performance period would begin on the earliest date permitted by law that is January 1, April 1, or July 1. We also proposed other modifications both related and unrelated to the timing of the RO Model in the proposed rule that appeared in the August 4, 2021,

Federal Register

titled “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model; Request for Information on Rural Emergency Hospitals” (86 FR 42018). These provisions were finalized in a final rule with comment period titled “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model” that appeared in the November 16, 2021

Federal Register

(86 FR 63458) (hereinafter referred to as the “CY 2022 OPPS/ASC FC”).

On December 10, 2021, the Protecting Medicare and American Farmers from Sequester Cuts Act (Pub. L. 117-71) was enacted, which included a provision that prohibits implementation of the RO Model prior to January 1, 2023. The CY 2022 OPPS/ASC final rule with comment period specified that if the RO Model was prohibited by law from beginning on January 1, 2022, the model performance period would begin on the earliest date permitted by law that is January 1, April 1, or July 1. As a result, under the current definition for model performance period at § 512.205, the RO Model would have started on January 1, 2023, because that date is the earliest date permitted by law. However, given the multiple delays to date, and because both CMS and RO participants must invest operational resources in preparation for implementation of the RO Model, we have considered how best to proceed under these circumstances. In a final rule titled “Radiation Oncology (RO) Model,” which appeared in the

Federal Register

on August 29, 2022 (87 FR 52698), we delayed the start date of the RO Model to a date to be determined through future rulemaking, and modified the definition of the model performance period at § 512.205 to provide that the start and end dates of the model performance period for the RO Model would be established in future rulemaking. We have not undertaken rulemaking to determine the start date for the RO Model and, thus, the model is not active at this time.

We also propose a new provision pertaining to the reconsideration review process that would apply to Innovation Center models that waive the appeals processes provided under section 1869 of the Act.

B. General Provisions Codified in the Code of Federal Regulations That Would Apply to Innovation Center Models

Each Innovation Center model features many unique aspects that must be memorialized in its governing documentation, but each model also includes certain provisions that are common to most or all models. We believe that codifying these common provisions would facilitate their uniform application across models (except where the governing documentation for a particular model dictates otherwise) and promote program efficiency and consistency that would benefit CMS' program administration and model participants.

As such, we propose to expand the applicability of the 42 CFR part 512 subpart A “General Provisions Related to Innovation Center Models” to all Innovation Center models whose first performance periods begin on or after January 1, 2025, unless otherwise specified in the models' governing documentation, and also to any Innovation Center models whose first performance periods begin prior to January 1, 2025 if incorporated by reference into the models' governing documentation. To accomplish this, we propose that the provisions codified at 42 CFR part 512 subpart A for the ETC and RO Models, including those with respect to definitions, beneficiary protections, cooperation in model evaluation and monitoring, audits and record retention, rights in data and intellectual property, monitoring and compliance, remedial action, Innovation Center model termination by CMS, and limitations on review, would be designated as the newly defined “standard provisions for Innovation Center models” and would apply to all Innovation Center models as described

above. We propose specific revisions that would be necessary to expand the scope of several of the current general provisions, but otherwise propose that the general provisions (which would be referred to as the “standard provisions for Innovation Center models”) would not change. In particular, we propose that the substance of the following provisions would not change, except that they would apply to all Innovation Center Models as opposed to just the ETC and RO Models: § 512.120 Beneficiary protections; § 512.130 Cooperation in model evaluation and monitoring; § 512.135 Audits and record retention; § 512.140 Rights in data and intellectual property: § 512.150 Monitoring and compliance; § 512.160 Remedial action; § 512.165 Innovation center model termination by CMS; § 512.170 Limitations on review; and § 512.180 Miscellaneous provisions on bankruptcy and other notifications.

C. Proposed Revisions to the Titles, Basis and Scope Provision, and Effective Date

We propose to amend the title of part 512 to read “Standard Provisions for Innovation Center Models and Specific Provisions for the Radiation Oncology Model and the End Stage Renal Disease Model” so that it more closely aligns with the other changes proposed herein and to ensure that the title indicates that part 512 includes both standard provisions for Innovation Center models and specific provisions for the RO and ETC Models. We also propose to amend the title of subpart A to read “Standard Provisions for Innovation Center Models” to use the term we propose to define the provisions codified at 42 CFR part 512 subpart A.

Additionally, we propose to amend § 512.100(a) and (b) so that the standard provisions would take effect on January 1, 2025, and would apply to each Innovation Center model where that model's first performance period begins on or after January 1, 2025, unless the model's governing documentation indicates otherwise, as well as any Innovation Center model that begins testing its first performance period prior to January 1, 2025, if the model's governing documentation incorporates the provisions by reference in whole or in part. We propose to determine on a case-by-case basis, based on each model's unique features and design, whether the standard provisions would apply to a particular model, or whether we would specify alternate terms in the model's governing documentation.

We believe that these standard provisions are necessary for the testing of the IOTA model, regardless of whether they are finalized as proposed for all Innovation Center models. As such, as an alternative to the previous proposal, we would propose making these standard provisions for Innovation Center models applicable to, and effective for, the IOTA Model beginning on January 1, 2025, absent extending the standard provisions to all Innovation Center models. Under such an alternative, the general provisions in the Specialty Care Models final rule would also still be applicable to the ETC Model and the RO Model.

These proposed standard provisions would not, except as specifically noted in this section II. of this proposed rule, affect the applicability of other provisions affecting providers and suppliers under Medicare fee-for-service (FFS).

We invite public comment on these proposed changes.

D. Provisions Revising Certain Definitions

We propose to amend the definition of “Innovation Center model” at 42 CFR 512.110 by replacing the specific references to the RO and ETC Models with a definition consistent with section 1115A of the Act and intended to encompass all Innovation Center models. We propose to amend the definition for “Innovation Center model” to read as follows: “an innovative payment and service delivery model tested under the authority of section 1115A(b) of the Act, including a model expansion under section 1115A(c) of the Act.”

We propose to add a new definition of the term “governing documentation” at § 512.110 to mean, “the applicable Federal regulations, and the model-specific participation agreement, cooperative agreement, and any addendum to an existing contract with CMS, that collectively specify the terms of the Innovation Center model.” We propose to add a new definition, “standard provisions for Innovation Center models,” at § 512.110 to mean, “the provisions codified in 42 CFR 512 Subpart A.” We propose to add a new definition, “performance period,” at § 512.110 to mean, “the period of time during which an Innovation Center model is tested and model participants are held accountable for cost and quality of care; the performance period for each Innovation Center model is specified in the governing documentation.”

Further, we propose to amend the definitions of “Innovation Center model activities,” “model beneficiary,” and “model participant” to pertain to all “Innovation Center models,” as we propose to define that term, instead of just the models previously implemented under part 512. As such, we propose to define “Innovation Center model activities” to mean “any activities affecting the care of model beneficiaries related to the test of the Innovation Center model.” We propose to define “model beneficiary” to mean “a beneficiary attributed to a model participant or otherwise included in an Innovation Center model.” We propose to define “model participant” to mean “an individual or entity that is identified as a participant in the Innovation Center model.”

We invite public comment on these proposed changes to the definitions of “Innovation Center model,” “Innovation Center model activities,” “model beneficiary,” and “model participant” and the proposed definitions of “governing documentation,” “standard provisions for Innovation Center models,” and “performance period.”

E. Proposed Reconsideration Review Process

We propose to add a new § 512.190 to part 512 subpart A to codify a reconsideration review process, based on processes implemented under current Innovation Center models. The process would enable model participants to contest determinations made by CMS in certain Innovation Center models, where model participants would not otherwise have a means to dispute determinations made by CMS. We propose at § 512.190(a)(1) that such a reconsideration process would apply only to Innovation Center models that waive section 1869 of the Act, which governs determinations and appeals in Medicare, or where section 1869 would not apply because model participants are not Medicare-enrolled. We propose at § 512.190(a)(2) that only model participants may utilize the dispute resolution process, unless the governing documentation for the Innovation Center model states otherwise. Such limitations with respect to such models are, we believe, appropriate, because with respect to such models, model participants do not have another means to dispute determinations made by CMS. We propose to codify a reconsideration review process in regulation in order to have a transparent and consistent method of reconsideration for model participants participating in models that do not utilize the standard reconsideration process outlined in section 1869 of the Act.

This proposed reconsideration review process would be utilized where a model-specific determination has been made and the affected model participant

disagrees with, and wishes to challenge, that determination. Each Innovation Center model features a unique payment and service delivery model, and, as such, requires its own model-specific determination process. Each Innovation Center model's governing documentation details the model-specific determinations made by CMS, which may include, but are not limited to, model-specific payments, beneficiary attribution, and determinations regarding remedial actions. Each Innovation Center model's governing documentation also includes specific details about when a determination is final and may be disputed through the model's reconsideration review processes.

We propose at § 512.190(b) that model participants may request reconsideration of a determination made by CMS in accordance with an Innovation Center model's governing documentation only if such reconsideration is not precluded by section 1115A(d)(2) of the Act, part 512 subpart A, or the model's governing documentation. A model participant may challenge, by requesting review by a CMS reconsideration official, those final determinations made by CMS that are not precluded from administrative or judicial review. We propose at § 512.190(b)(i) that the CMS reconsideration official would be someone who is authorized to receive such requests and was not involved in the initial determination issued by CMS or, if applicable, the timely error notice review process. We propose at § 512.190(b)(ii) that the reconsideration review request would be required to include a copy of CMS's initial determination and contain a detailed written explanation of the basis for the dispute, including supporting documentation. We propose at § 512.190(b)(iii) that the request for reconsideration would have to be made within 30 days of the date of CMS' initial determination for which reconsideration is being requested via email to an address as specified by CMS in the governing documentation. At § 512.190(b)(2), we propose that requests that do not meet the requirements of paragraph (b)(1) would be denied.

We propose at § 512.190(b)(3) that the reconsideration official would send a written acknowledgement to CMS and to the model participant requesting reconsideration within 10 business days of receiving the reconsideration request. The acknowledgement would set forth the review procedures and a schedule that would permit each party an opportunity to submit position papers and documentation in support of its position for consideration by the reconsideration official.

We propose to codify at § 512.190(b)(4) that, to access the reconsideration process for a determination concerning a model-specific payment where the Innovation Center model's governing documentation specifies an initial timely error notice process, the model participant must first satisfy those requirements before submitting a reconsideration request under this process. Should a model participant fail to timely submit an error notice with respect to a particular model-specific payment, we propose that the reconsideration review process would not be available to the model participant with regard to that model-specific payment.

We propose to codify standards for reconsideration at § 512.190(c). First, during the course of the reconsideration, we propose that both CMS and the party requesting the reconsideration must continue to fulfill all responsibilities and obligations under the governing documentation during the course of any dispute arising under the governing documentation. Second, the reconsideration would consist of a review of documentation timely submitted to the reconsideration official and in accordance with the standards specified by the reconsideration official in the acknowledgement at § 512.190(b)(3). Finally, we propose that the model participant would bear the burden of proof to demonstrate with clear and convincing evidence to the reconsideration official that the determination made by CMS was inconsistent with the terms of the governing documentation.

We propose to codify at § 512.190(d) that the reconsideration determination would be an on-the-record review. By this, we mean a review that would be conducted by a CMS reconsideration official who is a designee of CMS who is authorized to receive such requests under proposed § 512.190(b)(1)(i), of the position papers and supporting documentation that are timely submitted and in accordance with the schedule specified under proposed § 512.190(b)(3)(ii) and that meet the standards of submission under proposed § 512.190(b)(1) as well as any documents and data timely submitted to CMS by the model participant in the required format before CMS made the initial determination that is the subject of the reconsideration request. We propose at § 512.190(d)(2) that the reconsideration official would issue to the parties a written reconsideration determination. Absent unusual circumstances, in which the reconsideration official would reserve the right to an extension upon written notice to the model participant, the reconsideration determination would be issued within 60 days of CMS's receipt of the timely filed position papers and supporting documentation in accordance with the schedule specified under proposed § 512.190(b)(3)(ii). Under proposed § 512.190(d)(3), the determination made by the CMS reconsideration official would be final and binding 30 days after its issuance, unless the model participant or CMS were to timely request review of the reconsideration determination by the CMS Administrator in accordance with §§ 512.190(e)(1) and (2).

We propose to codify at § 512.190(e) a process for the CMS Administrator to review reconsideration determinations made under § 512.190(d). We propose that either the model participant or CMS may request that the CMS Administrator review the reconsideration determination. The request to the CMS Administrator would have to be made via email, within 30 days of the reconsideration determination, to an email address specified by CMS. The request would have to include a copy of the reconsideration determination, as well as a detailed written explanation of why the model participant or CMS disagrees with the reconsideration determination. The CMS Administrator would promptly send the parties a written acknowledgement of receipt of the request for review. The CMS Administrator would send the parties notice of whether the request for review was granted or denied. If the request for review is granted, the notice would include the review procedures and a schedule that would permit each party to submit a brief in support of the party's positions for consideration by the CMS Administrator. If the request for review is denied, the reconsideration determination would be final and binding as of the date of denial of the request for review by the CMS Administrator. If the request for review by the CMS Administrator is granted, the record for review would consist solely of timely submitted briefs and evidence contained in the record of the proceedings before the reconsideration official and evidence as set forth in the documents and data described in proposed § 512.190(d)(1)(ii); the CMS Administrator would not consider evidence other than information set forth in the documents and data described in proposed § 512.190(d)(1)(ii). The CMS

Administrator would review the record and issue to the parties a written determination that would be final and binding as of the date the written determination is sent.

We invite public comment on the proposed reconsideration review process for Innovation Center models.

III. Proposed Increasing Organ Transplant Access (IOTA) Model

A. Introduction

In this proposed rule, we are proposing to test the IOTA Model, a new mandatory Medicare alternative payment model under the authority of the Innovation Center, that would begin on January 1, 2025, and end on December 31, 2030. The IOTA Model would test whether using performance-based incentive payments in the form of upside risk payments and downside risk payments to and from select transplant hospitals increases the number of kidney transplants furnished to patients with ESRD, thereby reducing Medicare expenditures while preserving or enhancing quality of care.

The goal of the proposed performance-based payments is: to increase the number of kidney transplants furnished to ESRD patients placed on a kidney transplant hospital's waitlist; encourage investments in value-based care and quality improvement activities, particularly those that promote an equitable kidney transplant process prior to, during, and post transplantation for all patients; encourage better use of the current supply of deceased donor organs and greater provider and community collaborations to address medical and non-medical needs of patients; and increased awareness, education, and support for living donations. The IOTA Model payment structure would also promote IOTA participant accountability by linking performance-based payments to quality. We theorize that increasing the number of kidney transplants furnished to ESRD patients on the participating hospitals' waitlists would reduce Medicare expenditures by reducing dialysis expenditures and avoidable health care service utilization and would improve the quality of life for patients with ESRD.

As discussed in section III.B of this proposed rule, studies show that kidney transplant hospitals are underutilizing donor kidneys and have become more conservative in accepting organs for transplantation, with notable variation by region and across transplant hospitals.

The IOTA Model aims to address these access and equity problems through financial incentives that reward IOTA participants that improve their kidney organ offer acceptance rate ratios over time or hold them financially accountable for not doing so. The IOTA Model's proposed payment structure would include upside or downside performance-based incentive payments (“upside risk payment” or “downside risk payment”) for kidney transplant hospitals selected to participate in the IOTA Model (“IOTA participant”), with these payments being tied to performance on achievement, efficiency, and quality domains.

Mohan, S., Chiles, M.C., Patzer, R.E., Pastan, S.O., Husain, S.A., Carpenter, D.J., Dube, G.K., Crew, R.J., Ratner, L.E., & Cohen, D.J. (2018). Factors leading to the discard of deceased donor kidneys in the United States.

Kidney International, 94

(1), 187-198.

https://doi.org/10.1016/j.kint.2018.02.016.

The achievement domain would assess the number of kidney transplants performed relative to a participant-specific target, with performance on this domain being worth up to 60 points. The efficiency domain would assess kidney organ offer acceptance rate ratios relative to a national rate for all kidney transplant hospitals, including those not selected to participate in the model, with performance on this domain being worth up to 20 points. The quality domain would assess performance based on post-transplant outcomes at one-year after transplant and a proposed set of quality measures, with performance on this domain being worth up to 20 points. The achievement domain would be weighted more heavily than the other two domains because increasing the number of transplants is a key goal of the model and would be a primary factor in determining the amount of the performance-based payment.

The final performance score for each IOTA participant would be the sum of the points earned across the achievement domain, efficiency domain, and quality domain. The final performance score would determine whether an upside risk payment or downward risk payment would be owed and the amount of such payment. Specifically:

• For PY 1, if an IOTA participant has a final performance score between 60 and 100 points, it would qualify for the upside risk payment in accordance with the proposed calculation methodology described in section III.C.6.c(a) of this proposed rule (final performance score minus 60, then divided by 60, then multiplied by $8,000, then multiplied by the number of kidney transplants furnished by the IOTA participant to beneficiaries with Medicare as a primary or secondary payer during the PY).

• For PY 1, if an IOTA participant has a final performance score below 60, it would fall into a neutral zone where no upside risk payment and no downside risk payment would apply.

• For PY 2 and each subsequent PY (PYs 2-6) if an IOTA participant achieves a final performance score of 41 to 59 points, it would fall into a neutral zone where no upside risk payment and no downside risk payment would apply.

• For PY 2 and each subsequent PY, if an IOTA participant achieves a final performance score of 40 points or below, it would qualify for the downside risk payment in accordance with the proposed calculation methodology described in section III.C.6.c.(b). of this proposed rule (final performance score minus 40, then divided by 40, then multiplied by −$2,000, then multiplied by the number of kidney transplants furnished by the IOTA participant to beneficiaries with Medicare as a primary or secondary payer during the PY).

We recognize the complexity of the transplant ecosystem, which requires coordination between transplant hospitals, other health care providers, organ procurement organizations (OPOs), patients, potential donors, and their families. The proposed IOTA Model does not prescribe or require specific processes or policy approaches that each selected IOTA participant must implement for purposes of the model test.

We believe the IOTA Model would complement other efforts in relation to the transplant ecosystem to enhance health and safety outcomes, increase transparency, increase the number of transplants, and reduce disparities. We also believe that the proposed payment methodology would act in concert with measures that are currently under development by HRSA to increase the numbers of both deceased and living donor organ transplants.

This proposed model falls within a larger framework of activities initiated by the Federal Government during the past several years and planned for the upcoming year to enhance the donation, procurement, and transplantation of solid organs. This Federal collaborative, called the Organ Transplantation Affinity Group (OTAG), is a coordinated group working together to strengthen accountability, equity, and performance in organ donation, procurement, and transplantation.

Moody-Williams, J.D., & Nair, S. (2023, September 15). Organ Transplantation Affinity

Group (OTAG): Strengthening accountability, equity, and performance | CMS.

BLOG. https://www.cms.gov/blog/organ-transplantation-affinity-group-otag-strengthening-accountability-equity-and-performance.

B. Background

A review of the literature on kidney transplantation shows that the increasing numbers of kidney transplants is unable to keep pace with the increasing need for organs.

While more people die waiting for a kidney transplant, the short- and long-term outcomes of patients who undergo kidney transplantation have improved, despite both recipients and donors increasing in age and adverse health conditions.

Recent studies show that transplant hospitals have become more conservative in accepting organs for transplantation when offered for specific patients, avoiding the use of less-than-ideal organs on account of perceived risk.

Wide variation among geographic regions and transplant hospitals in rates of kidney transplantation, along with access and equity issues, raises the need to hold kidney transplant hospitals accountable for performance.

The IOTA Model proposes a two-sided performance-based payment structure that rewards IOTA participants for high performance in the achievement, efficiency, and quality domains, and imposes financial accountability on IOTA participants that perform poorly on those domains. We propose the IOTA Model as a complement to wider efforts aimed at transplant ecosystem performance and equity improvements. Ultimately, we seek a set of interventions that focus on ESRD patients in need of a kidney transplant. In this section of the proposed rule, we summarize the transplant ecosystem and HHS oversight within CMS and HRSA related to kidney transplantation, highlight related initiatives and priorities nationally, and outline our rationale for the proposed IOTA Model informed by literature, data, and studies.

Too Many Donor Kidneys Are Discarded in U.S. Before Transplantation—Penn Medicine. (2020, December 16).

www.pennmedicine.org. https://www.pennmedicine.org/news/news-releases/2020/december/too-many-donor-kidneys-are-discarded-in-us-before-transplantation.

Hariharan, S., Israni, A.K., & Danovitch, G. (2021). Long-Term Survival after Kidney Transplantation.

New England Journal of Medicine, 385

(8), 729-743.

https://doi.org/10.1056/nejmra2014530.

Stewart, D.E., Garcia, V.C., Rosendale, J.D., Klassen, D.K., & Carrico, B.J. (2017). Diagnosing the Decades-Long Rise in the Deceased Donor Kidney Discard Rate in the United States.

Transplantation, 101

(3), 575-587.

https://doi.org/10.1097/tp.0000000000001539.

Kidney International, 94

(1), 187-198.

https://doi.org/10.1016/j.kint.2018.02.016.

1. The Transplant Ecosystem

Kidney transplantation occurs within an overall organ donation and transplantation system (also known and referred to as the transplant ecosystem) that comprises a vast network of institutions dedicated to ensuring that patients are evaluated and, if appropriate, placed onto the organ transplant waitlist, and that those on the organ transplant waitlist receive lifesaving organ transplants. Transplantation of livers, hearts, lungs, and other organs is also well established within the U.S. health care system. The transplant ecosystem includes the Organ Procurement and Transplantation Network (OPTN); Organ Procurement Organizations (OPOs); transplant hospitals and providers; histocompatibility laboratories that provide blood, tissue, and antibody testing for the organ matching process; and patients, including ESRD patients in need of a transplant, their families, and caregivers.

For kidney transplantation, it also includes ESRD facilities, commonly known as dialysis facilities.

Moody-Williams, J.D., & Nair, S. (2023, September 15). Organ Transplantation Affinity Group (OTAG): Strengthening accountability, equity, and performance | CMS.

BLOG. https://www.cms.gov/blog/organ-transplantation-affinity-group-otag-strengthening-accountability-equity-and-performance.

The National Organ Transplant Act of 1984, referred to herein as NOTA, established the OPTN, with HHS oversight, to manage and operate the national organ transplantation system (42 U.S.C. 274). The OPTN coordinates the nation's organ procurement, distribution, and transplantation systems. The OPTN is a network of clinical experts, patients, donor families, and community stakeholders who work collectively to develop, implement, and monitor organ allocation policy and performance of the organ transplant ecosystem.

Organ Procurement Organizations (OPOs) are non-profit organizations operating under contract with the Federal Government that are charged, under section 371(b) of the Public Health Service Act (PHS Act, 42 U.S.C. 273(b)) with activities including, but not limited to, identifying potential organ donors, providing for the acquisition and preservation of donated organs, the equitable allocation of donated organs, and the transportation of donated organs to transplant hospitals. Section 371(b) of the Public Health Services Act requires that an OPO must have a defined service area, a concept that is defined at 42 CFR part 486 subpart G as the Donation Service Area (DSA). Section 1138(b) of the Act states that the Secretary may not designate more than one OPO to serve each DSA. There are currently 56 OPOs that serve the United States and Puerto Rico.

Section 1138(b) of the Act lays out the requirements that an OPO must meet to have its costs reimbursed by the Secretary. CMS sets out the components of allowable Medicare organ acquisition costs at 42 CFR 413.402(b). Allowable organ acquisition costs are those costs incurred in the acquisition of organs intended for transplant, and include, but are not limited to: costs associated with special care services, the surgeon's fee for excising the deceased donor organ from the donor patient (limited to $1,250 for kidneys), operating room and other inpatient ancillary services provided to the living or deceased donor, organ preservation and perfusion costs, donor and beneficiary evaluation, and living donor complications. OPOs and transplant hospitals may incur organ acquisition costs and include these and some additional administrative and general costs on the Medicare cost report.

The CMS conditions for coverage for OPOs at 42 CFR 486.322 require an OPO to have written agreements with 95 percent of the Medicare and Medicaid certified hospitals and critical access hospitals in its DSA that have a ventilator and an operating room and have not been granted a waiver to work with another OPO. These hospitals, known as donor hospitals, are required by the CMS conditions of participation for hospitals at 42 CFR 482.45 to have an agreement with an OPO under which the donor hospital must notify the OPO of patients who are expected to die imminently and of patients who have died in the hospital. (Under the hospital conditions of participation, such an agreement is required of all hospitals that participate in Medicare.) Also, under the hospital conditions of participation, donor hospitals are responsible for informing donor patient families of the option to donate organs, tissues, and eyes, or to decline to donate; and to work collaboratively with the OPO to educate hospital staff on donation, improve its identification of potential donors, and work with the OPO to manage the potential donor patient while testing and placement of the potential donor organ occurs.

At 42 CFR 482.70, CMS defines a transplant hospital as “a hospital that furnishes organ transplants and other medical and surgical specialty services

required for the care of transplant patients,” and a transplant program as “an organ-specific transplant program within a transplant hospital,” as so defined. In accordance with 42 CFR 482.98, a transplant program must have a primary transplant surgeon and a transplant physician with the appropriate training and experience to provide transplantation services, who are immediately available to provide transplantation services when an organ is offered for transplantation. The transplant surgeon is responsible for providing surgical services related to transplantation, and the transplant physician is responsible for providing and coordinating transplantation care.

In accordance with CMS' Conditions for Coverage (CfC) for ESRD Facilities at 42 CFR part 494, ESRD facilities are charged with delivering safe and adequate dialysis to ESRD patients, and, among other requirements, informing patients of their treatment modalities, including dialysis and kidney transplantation. The CfCs require ESRD facilities to conduct a patient assessment that includes evaluation of suitability for referral for transplantation, based on criteria developed by the prospective transplantation center and its surgeon(s). General nephrologists refer patients for evaluation for kidney transplants.

Candidates for kidney transplant undergo a rigorous evaluation by a transplant program prior to placement on a waitlist, involving evaluation by a multidisciplinary team for conditions pertaining to the potential success of the transplant, the possibility of recurrence, and surgical issues including frailty, obesity, diabetes and other causes of ESRD, infections, malignancies, cardiac disease, pulmonary disease, peripheral arterial disease, neurologic disease, hematologic conditions, and gastrointestinal and liver disease and an immunological assessment; a psychosocial assessment; assessment of adherence behaviors; and tobacco counseling.

Virmani, S., & Asch, W.S. (2020). The Role of the General Nephrologist in Evaluating Patients for Kidney Transplantation: Core Curriculum 2020.

American Journal of Kidney Diseases, 76,

567-579.

https://doi.org/10.1053/j.ajkd.2020.01.001.

Chadban, S.J., Ahn, C., Axelrod, D.A., Foster, B.J., Kasiske, B.L., Kher, V., Kumar, D., Oberbauer, R., Pascual, J., Pilmore, H.L., Rodrigue, J.R., Segev, D.L., Sheerin, N.S., Tinckam, K.J., Wong, G., & Knoll, G.A. (2020). KDIGO Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation.

Transplantation, 104

(4S1), S11.

https://doi.org/10.1097/TP.0000000000003136.

Once placed on the waitlist, potential recipients must maintain active status to be eligible to receive a deceased donor transplant.

An individual may receive a status of `inactive' if they are missing lab results, contact information, or any of the other requirements that would be necessary for them to receive an organ transplant if offered. An individual may only receive an organ offer if they have a status of `active'.

Each transplant hospital has its own waitlist, and patients can attempt to be placed on multiple waitlists; OPTN maintains a national transplant waiting list that encompasses the waitlists for all kidney transplant hospitals.

20 21

Individuals already on dialysis continue to receive regular dialysis treatments while waiting for an organ to become available. After surgery, a transplant nephrologist manages the possible outcomes of organ rejection and infection, and other medical complications.

National kidney Foundation. (2017, February 10).

The Kidney Transplant Waitlist—What You Need to Know.

National Kidney Foundation.

https://www.kidney.org/atoz/content/transplant-waitlist.

The kidney transplant waitlist.

(n.d.). Transplant Living.

https://transplantliving.org/kidney/the-kidney-transplant-waitlist/.

National kidney Foundation. (2019, June 12).

Understanding the transplant waitlist.

National Kidney Foundation.

https://www.kidney.org/content/understanding-transplant-waitlist.

National kidney Foundation. (2016, August 4).

Multiple Listing for Kidney Transplant.

National Kidney Foundation.

https://www.kidney.org/atoz/content/multiple-listing.

Transplant Nephrology Fellowship.

(n.d.).

Www.hopkinsmedicine.org.

Retrieved May 30, 2023, from

https://www.hopkinsmedicine.org/nephrology/education/transplant_fellowship.html#:~:text=Diagnose%20and%20manage%20acute%20and.

2. HHS Oversight and Priorities

HRSA, which oversees the OPTN, and CMS play a vital role in protecting the health and safety of Americans as they engage with the U.S. health care system.

The OPTN operates a complex network of computerized interactions whereby specific deceased donor organs get matched to individual patients on the national transplant waiting list. The Scientific Registry of Transplant Recipients (SRTR), operated under contract with HRSA, is responsible for providing statistical and analytic support to the OPTN. Section 373 of the PHS Act requires the operation of the SRTR to support ongoing evaluation of the scientific and clinical status of solid organ transplantation.

On March 22, 2023, HRSA announced an initiative that included several actions to strengthen accountability and transparency in the OPTN. These actions include modernization of the OPTN information technology system. HRSA also intends to issue contract solicitations for multiple awards to support the OPTN.

Mission, Vision, and Values.

(n.d.).

Www.srtr.org. https://www.srtr.org/about-srtr/mission-vision-and-values/.

CMS oversees and evaluates OPO performance. OPOs must meet performance measures and participate in, and abide by certain rules of, the OPTN.

The PHS Act requires the Secretary to establish outcome and process performance measures to recertify OPOs (Part H section 371; 42 U.S.C. 273). CMS has promulgated the OPO CfCs at 42 CFR part 486 subpart G.

U.S. Congress. (1934) United States Code: Social Security Act, 42 U.S.C. 301-Suppl. 4 1934.

Additionally, the OPTN Bylaws specify that OPOs whose observed organ yield rates fall below the expected rates by more than a specified threshold would be reviewed by the OPTN Membership Professional Standards Committee (MPSC).

CMS also conducts oversight of transplant programs, located within transplant hospitals, which must abide by both the hospital and the transplant program conditions of participation (CoPs). CMS contracts with quality improvement entities such as the ESRD Networks and Quality Improvement Organizations to provide technical support to providers and patients seeking improvements in the transplant ecosystem.

Bylaws—OPTN. (n.d.). Optn.

transplant.hrsa.gov.

Retrieved May 30, 2023, from

https://optn.transplant.hrsa.gov/policies-bylaws/bylaws/.

Medicare covers certain transplant-related services when provided at a Medicare-approved facility. Medicare Part A covers the costs associated with a Medicare kidney transplant procedure received in a Medicare-certified hospital and any additional inpatient hospital care needed following the procedure, and organ acquisition costs including kidney registry fees and laboratory tests associated with the evaluation of a Medicare transplant candidate. The evaluation or preparation of a living donor, the living donor's donation of the kidney, and postoperative recovery services directly related to the living donor's kidney donation are covered under Medicare. In addition, deductible and coinsurance requirements do not apply to living donors for services furnished to an individual in connection with the donation of a kidney for transplant surgery. Medicare Part B coverage includes the surgeon's fees for performing the kidney transplant procedure and perioperative care. Medicare Part B also covers physician services for the living kidney donor without regard to whether the service would otherwise be covered by

Medicare. Part A and Part B share responsibility for covering blood, including packed red blood cells, blood components and the cost of processing and receiving blood.

Medicare Part B covers immunosuppressive drugs following an organ transplant for which payment is made under Title XVIII. Immunosuppressive drugs following an organ transplant are covered by Part D when an individual did not have Part A at the time of the transplant. Beneficiaries who have Medicare due to ESRD alone lose Medicare coverage 36 months following a successful kidney transplant. Section 402(a) of the Consolidated Appropriations Act (CAA) of 2021 added section 1836(b) of the Act to provide coverage for immunosuppressive drugs beginning January 1, 2023, for eligible individuals whose eligibility for Medicare based on ESRD ends by reason of section 226A(b)(2) of the Act for those three-years post kidney transplant. Under section 1833 of the Act, the amounts paid by Medicare for immunosuppressive drugs are equal to 80 percent of the applicable payment amount; beneficiaries are thus subject to a 20 percent coinsurance for immunosuppressive drugs covered by both Part B and the Medicare Part B Immunosuppressive Drug Benefit (Part B-ID).

3. Federal Government Initiatives To Enhance Organ Transplantation

a. CMS Regulatory Initiatives To Enhance Organ Transplantation

On September 30, 2019, we published the final rule, “Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care” (84 FR 51732). The rulemaking, in part, aimed to address the concern that too many organs are being discarded that could be transplanted successfully, including hearts, lungs, livers, and kidneys. This rule implemented changes to the transplant program regulations, eliminating requirements for re-approval of transplant programs pertaining to data submission, clinical experience, and outcomes. We believed that the removal of these requirements aligned with our goal of increasing access to kidney transplants by increasing the utilization of organs from deceased donors and reducing the organ discard rate (84 FR 51749). We sought improved organ procurement, greater organ utilization, and reduction of burden for transplant hospitals, while still maintaining the importance of safety in the transplant process.

On December 2, 2020, we issued a final rule titled, “Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations” (85 FR 77898), which revised the OPO CfCs by replacing the previous outcome measures with new transparent, reliable, and objective outcome measures. In modifying the metrics used for assessing OPO performance, we sought to promote greater utilization of organs that might not otherwise be recovered or used due to perceived organ quality.

The Organ Procurement Organizations Annual Public Aggregated Performance Report for 2023 is available at

https://www.cms.gov/files/document/opo-annual-public-performance-report-2023.pdf.

While these regulatory changes recently went into effect with the goal of improving the performance of transplant hospitals and OPOs and to promote the procuring of organs and delivering them to prospective transplant recipients, we acknowledged the need for improvements in health, safety, and outcomes across the transplant ecosystem, including in transplant programs, OPOs, and ESRD facilities.

28 29

In particular, we recognize that further action must be taken to address disparities and inequities observed across transplant hospitals.

One study—Doby, B.L., Ross-Driscoll, K., Shuck, M., Wadsworth, M., Durand, C.M., & Lynch, R.J. (2021). Public discourse and policy change: Absence of harm from increased oversight and transparency in OPO Performance.

American Journal of Transplantation, 21

(8), 2646-2652.

https://doi.org/10.1111/ajt.16527

—showed that deceased donor organ donation increased during 2019, that is., during the period of public debate about regulating OPO performance.

In addition, CMS finalized a policy in the final rule for FY 2023 for the Medicare Physician Fee Schedule that Medicare Part A and Part B payment can be made for dental or oral examinations, including necessary treatment, performed as part of a necessary workup prior to organ transplant surgery. In the final rule, CMS describes certain dental services as inextricably linked and integral to the clinical success of organ transplantation. (87 FR 69671-69675).

We published a request for information in the

Federal Register

on December 3, 2021, titled “Request for Information: Health and Safety Requirements for Transplant Programs, Organ Procurement Organizations, and End-Stage Renal Facilities” (86 FR 68594) (hereafter known as the “Transplant Ecosystem RFI”). This RFI solicited public comments on potential changes to the requirements that transplant programs, OPOs, and ESRD facilities must meet to participate in the Medicare and Medicaid programs. Specifically, we solicited public comments on ways to:

• Continue to improve systems of care for all patients in need of a transplant;

• Increase the number of organs available for transplant for all solid organ types;

• Encourage the use of dialysis in alternate settings or modalities over in-center hemodialysis where clinically appropriate and advantageous;

• Ensure that the CMS and HHS policies appropriately incentivize the creation and use of future new treatments and technologies; and

• Harmonize requirements across government agencies to facilitate these objectives and improve quality across the organ donation and transplantation ecosystem.

We also solicited information related to opportunities, inefficiencies, and inequities in the transplant ecosystem and what can be done to ensure all segments of our healthcare systems are invested and accountable in ensuring improvements to organ donation and transplantation rates (86 FR 68596). The Transplant Ecosystem RFI focused on questions in the areas of transplantation, kidney health and ESRD facilities, and OPOs. For transplant programs, specific topics included transplant program CoPs, patient rights, and equity in organ transplantation and organ donation (86 FR 68596). For kidney health and ESRD facilities, topics included maintaining and improving health of patients, ways to identify those at risk of developing chronic kidney disease (CKD), improving detection rates of CKD, and ways to close the CKD detection, education, and care health equity gap (86 FR 68599). Other topics included home dialysis, dialysis in alternative settings such as nursing homes and mobile dialysis, and alternate models of care (86 FR 68600). For OPOs, specific topics included assessment and recertification, organ transport and tracking, the donor referral process, organ recovery centers, organ discards, donation after cardiac death, tissue banks, organs for research, and vascular composite organs. (86 FR 68601 through 68606)

The Transplant Ecosystem RFI followed three executive orders addressing health equity that were issued by President Biden on January 20 and January 21, 2021—

• Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (E.O. 13985, 86 FR 7009, January 20, 2021);

• Executive Order on Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation (E.O. 13988, 86 FR 7023, January 25, 2021); and

• Executive Order on Ensuring an Equitable Pandemic Response and Recovery (E.O. 13995, 86 FR 7193, January 26, 2021).

The RFI was among several issued by CMS in 2021 to request public comment on ways to advance health equity and reduce disparities in our policies and programs.

CMS's regulatory initiatives since 2018 pertaining to organ donation and transplantation have included final rules modifying CoPs and CfCs for transplant programs (84 FR 51732) and OPOs (85 FR 77898), respectively, and our recent RFI on transplant program CoPs, OPO CfCs, and the ESRD facility CfCs (86 FR 68594). These regulations and RFIs have sought to foster greater health and safety for patients, greater transparency for all patients, increases in organ donation and transplantation, and reduced disparities in organ donation and transplantation. Through these regulations, we are working to attain these goals by designing and implementing policies that improve health for all people affected by the transplant ecosystem.

b. CMS Innovation Center Payment Models

The Innovation Center is currently pursuing complementary alternative payment model tests—the ESRD Treatment Choices (ETC) Model and the Kidney Care Choices (KCC) Model—aimed at enhancing kidney transplantation and improving health-related outcomes for patients with late-stage CKD and ESRD, thereby reducing costs to the Medicare program. The impetus for the ETC and KCC Models originated with evaluation findings for the earlier Comprehensive ESRD Care (CEC) Model, which ran from October 2015 through March 2021, that showed large dialysis organizations achieving positive clinical and financial outcomes relating to services to Medicare beneficiaries receiving dialysis, though the CEC Model did not achieve net savings to Medicare.

The CEC Model focused on patients being treated in ESRD facilities, with no explicit incentives to encourage increases in kidney transplantation.

The results of the CMS-sponsored evaluation of the CEC Model are available at

https://innovation.cms.gov/innovation-models/comprehensive-esrd-care.

The 5-year model test reduced Medicare expenses by $217 million, or 1.3 percent relative to the pre-CEC period. These results do not account for shared savings payments to the model participants. There was a 3 percent decrease in the number of hospitalizations and a 0.4 percent increase in the number of outpatient dialysis sessions for Medicare beneficiaries in CEC compared to non-CEC beneficiaries. In addition, the CEC Model improved key quality outcomes.

The ETC and KCC Models have engaged a broader range of health care providers beyond ESRD facilities, including nephrology professionals and transplant providers, and address transplantation. Each model includes direct financial incentives for increasing the number of kidney transplants.

The ETC Model, which began January 1, 2021, and which is scheduled to end on June 30, 2027, is a mandatory model that tests whether greater use of home dialysis and kidney transplantation for Medicare beneficiaries with ESRD reduces Medicare expenditures while preserving or enhancing the quality of care furnished to those beneficiaries. We established requirements for the ETC Model in the Medicare Program; Specialty Care Models to Improve Quality of Care and Reduce Expenditures final rule (85 FR 61114 through 61381). These requirements are codified at 42 CFR subpart C. The ETC Model tests the effects of certain Medicare payment adjustments to participating ESRD facilities and Managing Clinicians (clinicians who manage ESRD beneficiaries and bill the Monthly Capitation Payment (MCP)). The payment adjustments are designed to encourage greater utilization of home dialysis and kidney transplantation, support beneficiary modality choice, reduce Medicare expenditures, and preserve or enhance quality of care. Under the ETC Model, CMS makes upward adjustments to certain payments under the ESRD Prospective Payment System (PPS) to certain dialysis facilities on home dialysis claims, and upward adjustments to the MCP paid to certain Managing Clinicians on home dialysis-related claims (85 FR 61117). In addition, CMS makes upward and downward adjustments to PPS payments to participating ESRD facilities and to the MCP paid to participating Managing Clinicians based on the Participant's home dialysis rate and transplant waitlisting and living donor transplant rate (85 FR 61117). The ETC Model's objectives, as described in the final rule, include supporting paired donations and donor chains, and reducing the likelihood that potentially viable organs are discarded (85 FR 61128). The ETC Model was updated by the final rule dated November 8, 2021, titled “Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model” and the final rule dated November 7, 2022, titled “Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model” (87 FR 67136). We finalized further modifications to the ETC Model related to the availability of administrative review of an ETC Participant's targeted review request in the final rule issued on November 6, 2023, titled “Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model” (88 FR 76345).

CMS is also operating the ETC Learning Collaborative, which is focused on increasing the availability of deceased donor organs for transplantation.

The ETC Learning Collaborative regularly convenes ETC Participants, transplant hospitals, OPOs, and large donor hospitals, with the goal of using learning and quality improvement techniques to systematically spread the best practices of the highest performing organizations. CMS is employing quality improvement approaches to improve performance by collecting and analyzing data to identify the highest performers, and to help others to test, adapt and spread the best practices of these high performers throughout the entire national organ recovery system (85 FR 61346).

Centers for Medicare & Medicaid Services.

https://innovation.cms.gov/innovation-models/esrd-treatment-choices-model.

The KCC Model, which began its performance period on January 1, 2022, and is scheduled to end on December 31, 2026, is a voluntary model that also builds upon the CEC Model structure to encourage health care providers to better manage the care for Medicare beneficiaries with CKD stages 4 and 5 and ESRD, delay the onset of dialysis, and incentivize kidney transplantation. Various entities are participating in the KCC Model, including nephrologists and nephrology practices, dialysis facilities, and other health care providers. The participating entities receive a bonus payment for each aligned beneficiary who receives a

kidney transplant, so long as the transplant remains successful over a certain time period. CMS plans to continue to evaluate the effectiveness of the ETC and KCC Models in achieving clinical goals, improving quality of care, and reducing Medicare costs.

The evaluation report for the first two years (2021, 2022) of the ETC Model is available at

https://www.cms.gov/priorities/innovation/data-reports.

The IOTA Model proposes to complement the ETC and KCC Models and expand kidney model participation to kidney transplant hospitals, which are a key player in the transplant ecosystem, to test whether two-sided risk payments based on performance increase access to kidney transplants for ESRD patients placed on the waitlists of participating transplant hospitals.

c. HRSA Initiatives Involving Kidney Transplants

NOTA established the OPTN almost 40 years ago to coordinate and operate the nation's organ procurement, allocation, and transplantation system. There are about 400 member organizations that comprise the OPTN. Section 372(b)(2)(A) of the PHS Act charges the OPTN with establishing a national list of individuals who need organs and a national computer system to match organs with individuals on the waitlist. HRSA has also undertaken efforts in alignment with CMS efforts and Federal Government initiatives to improve accountability in OPTN functions. On March 22, 2023, HRSA launched the OPTN Modernization Initiative to strengthen accountability, equity, and performance in the organ donation and transplantation system through a focus on five key areas: technology, data transparency, governance, operations, and quality improvement and innovation.

The OPTN Modernization Initiative was further supported by the Securing the U.S. Organ Procurement and Transplantation Network Act (Pub. L. 118-14), which included several key provisions proposed in the President's Fiscal Year 2024 Budget and was signed into law on September 22, 2023.

The new law expressly authorizes HHS to make multiple awards to different entities, which could enable the OPTN to benefit from best-in-class vendors and provide a more efficient system that strengthens oversight and improves patient safety.

HRSA Announces Organ Procurement and Transplantation Network Modernization Initiative | HRSA.

(n.d.).

Www.hrsa.gov.

Retrieved August 20, 2023, from

https://www.hrsa.gov/optn-modernization/march-2023.

The White House. (2023, September 22).

Bill Signed: H.R. 2544.

The White House.

https://www.whitehouse.gov/briefing-room/legislation/2023/09/22/bill-signed-h-r-2544/#:~:text=On%20Friday%2C%20September%2022%2C%202023,Organ%20Procurement%20and%20Transplantation%20Network.

Effective July 14, 2022, revisions to the OPTN Bylaws were made related to the Transplant Program Performance to establish new criteria for identification of transplant programs that enter MPSC performance review based on the following criteria:

OPTN. (n.d.).

Enhance Transplant Program Performance Monitoring System, Phase 1 (July 2022) Sponsoring Committee: Membership and Professional Standards Bylaws Affected.

Retrieved August 20, 2023, from

https://optn.transplant.hrsa.gov/media/hgkksfuu/phase-1_tx-prgm-performance-monitoring_dec-2021.pdf.

• The transplant program's 90-day post-transplant graft survival hazard ratio is greater than 1.75 during the 2.5-year time period; or

• The transplant program's 1-year post-transplant graft survival conditional on 90-day post-transplant graft survival hazard ratio is greater than 1.75 during a 2.5-year period.

Transplant programs that meet either of the criteria, as reported by the SRTR, must participate in the OPTN Membership and Professional Standards Committee (MPSC) performance review, which may require the member to take appropriate actions to determine if the transplant program has demonstrated sustainable improvement, including, but not limited to—

• Providing information about the program structure, procedures, protocols and quality;

• Review processes;

• Adopting and implementing a plan for improvement;

• Participating in an informal discussion with MPSC members; and

• Participating in a peer visit.

The MPSC would continue to review the transplant program under the performance review until the MPSC determines that the transplant program has made sufficient and sustainable improvements to avoid risk to public health or patient safety. If the MPSC's review determines that a risk to patient health or public safety exists, the MPSC may request that a member inactivate or withdraw a designated transplant program, or a specific component of the program, to mitigate the risk. Transplant programs that do not participate in the MPSC performance review process or fail to act to improve their performance are subject to the policies described in Appendix L of the OPTN Bylaws, Reviews and Actions, including the declaration of “Member Not in Good Standing.” While being designated “Member Not in Good Standing” does not necessarily lead to the closure or removal of that program from receiving reimbursement from Federal health insurance programs, the Secretary can, based on a recommendation from the OPTN Board of Directors, revoke OPTN membership, close an OPTN member, or remove the ability of the member to receive Federal funding from Medicare or Medicaid. Additionally, numerous private payers align with the MPSC metrics and SRTR star rating system that evaluate transplant hospitals on post-transplant performance to create their Centers of Excellence programs. Therefore, MPSC reviews and performance on the MPSC monitoring measures are a powerful regulatory incentive for transplant programs.

In the final rule, dated September 22, 2020, titled “Removing Financial Disincentives to Living Organ Donation” (85 FR 59438), HRSA expanded the scope of qualified reimbursable expenses incurred by living donors under the Living Organ Donation Reimbursement Program to include lost wages and dependent care (childcare and elder care) expenses to further the goal of reducing financial barriers to living organ donation. The program previously only allowed for reimbursement of travel, lodging, meals, and incidental expenses. In the final notice, dated September 22, 2020, titled, “Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Program Eligibility Guidelines,” HRSA increased the income eligibility threshold under the Living Organ Donation Reimbursement Program from 300 percent to 350 percent of the Federal Poverty Guidelines (85 FR 59531).

3. Rationale for the Proposed IOTA Model

a. Alignment With Federal Government Initiatives and Priorities

For decades, patients and health care providers have confronted an imbalance in the number of transplant candidates and the supply of acceptable donor organs, including kidneys and other organs. Observed variation in access to organ transplantation by geography, race/ethnicity, disability status, and socioeconomic status, as well as the overall performance of the organ transplantation ecosystem, raised the need to make performance improvements and address disparities.

Strengthening and improving the

performance of the organ transplantation ecosystem is a priority for HHS. To that end, OTAG was established in 2021 by CMS and HRSA and has expanded interagency coordination and collaboration to “drive improvements in donations, clinical outcomes, system improvement, quality measurement, transparency, and regulatory oversight.”

Collectively, CMS and HRSA seek to—

Moody-Williams, J.D., & Nair, S. (2023, December 13). Organ Transplantation Affinity Group (OTAG): Strengthening accountability, equity, and performance | CMS.

BLOG. https://www.cms.gov/blog/organ-transplantation-affinity-group-otag-strengthening-accountability-equity-and-performance.

Moody-Williams, J.D., & Nair, S. (2023, December 13). Organ Transplantation Affinity Group (OTAG): Strengthening accountability, equity, and performance | CMS.

BLOG. https://www.cms.gov/blog/organ-transplantation-affinity-group-otag-strengthening-accountability-equity-and-performance.

• Reduce variation of pre-transplant and referral practices;

Pre-transplant/referral practices are inclusive of the referring physician's assessment criteria, patient education, and feedback to the referring physician from the transplant assessment.

• Increase availability and use of donated organs;

• Increase accountability for organ procurement and matching;

• Promote equitable access to transplants; and

• Empower patients, families, and caregivers to actively engage in the transplant journey.

We believe the proposed IOTA Model has the potential to substantially increase the number of kidney transplants in a way that enhances fairness for all affected individuals, regardless of socioeconomic status or other factors that limit access to care and negatively affect health outcomes, thereby improving quality of care, reducing costs to Medicare, and prolonging lives. The IOTA Model, as proposed, is complementary to the ETC and KCC Models, and to other CMS and HRSA initiatives, with the collective goal of achieving improvements in processes among transplant hospitals that would spur an increase in both deceased donor and living donor kidney transplantation and reduce population health disparities. Furthermore, although we are targeting our proposals to kidney transplant programs, we seek to test specific modifications for Medicare payment and other programmatic measures that would establish a framework for potential future interventions for transplantation relating to the other solid organ types.

In the following sections of this proposed rule, we review scientific literature that outlines specific ways that kidney transplantation can be enhanced. Although not the focus of our analysis, we also present findings pertaining to the transplantation of other organs, especially livers. We aim to show how the types of interventions that we are proposing might also apply for any future efforts to increase transplant numbers for other organ types, and to continue to pursue the goal of greater equity. We also describe recent efforts from CMS and HRSA to enhance organ transplantation that complement our proposals to use payment incentives as a policy lever to increase the number of kidney transplants and achieve a fairer distribution.

b. End Stage Renal Disease Impact

According to the United States Renal Data System (USRDS), in 2021 about 808,536 people in the United States were living with ESRD, almost double the number in 2001.

Prevalence of ESRD varied by Health Service Area (HSA) and ESRD Network.

Stratified by age and race/ethnicity, ESRD was consistently more prevalent among older people (65 and older) and in Black people.

Diabetes and hypertension are most often the primary cause of ESRD.

According to the National Kidney Foundation, these diseases disproportionately affect minority populations, increasing the risk of kidney disease.

Year-over-year, incidence of ESRD continues to increase, as the number of patients newly registered increased from 97,856 in 2001 to 134,837 in 2019 and 135,972 in 2021.

Studies show that people with kidney transplants live longer than those who remain on dialysis.

Despite these positive outcomes, the percentage of prevalent ESRD patients with a functioning kidney transplant remained relatively stable over the past decade, increasing only slightly from 29.7 percent in 2011 to 30.51 percent in 2021.

In 2021, 72,864 patients with ESRD were on the kidney transplant waitlist, of which 27,413 were listed during that year.

The IOTA Model proposes to focus on the ESRD patients who are on the kidney transplant waitlists of the kidney transplant hospitals that would be required to participate in this Model. ESRD patients represent a small portion of the U.S. population, but the disease burden to the patient and to CMS is great in terms of health outcomes, survival, quality of life, and cost. The ESRD population accounted for 6.1% of total Medicare expenditures in 2020.

United States Renal Data System. 2023.End Stage Renal Disease: Chapter 1. Figure 1.5.

United States Renal Data System. 2023. End Stage Renal Disease: Chapter 1. Figure 1.7.

United States Renal Data System. 2023. End Stage Renal Disease: Chapter 1. Figure 1.8.

United States Renal Data System. 2023. End Stage Renal Disease. Chapter 1. Table 1.3.

National Kidney Foundation. (2016, January 7).

Race, Ethnicity and Kidney Disease.

National Kidney Foundation.

https://www.kidney.org/atoz/content/minorities-KD.

United States Renal Data System. 2023. End Stage Renal Disease. Chapter 1. Figure 1.1.

National Kidney Foundation. (2017, February 14).

Kidney Transplant.

National Kidney Foundation.

https://www.kidney.org/atoz/content/kidney-transplant.

United States Renal Data System. 2023. End Stage Renal Disease: Chapter 7. Figure 7.16.

United States Renal Data System. 2023. End Stage Renal Disease: Chapter 7. Figures 7.1 and 7.2.

United States Renal Data System. 2022. End Stage Renal Disease: Chapter 9.

Due to wide variability across eligible kidney transplant hospitals, we are unable to estimate the IOTA Model's attributed patient population until the IOTA participants are randomly selected.

c. Benefits of Kidney Transplantation

ESRD, when a person's kidney function has declined to the point of requiring regular dialysis or a transplant for survival, as the person's kidneys are no longer able to perform life-sustaining functions, is the final stage of CKD. ESRD is a uniquely burdensome condition, with uncertain survival and poor quality of life for patients. The higher mortality and substantially greater expenditures and hospitalization rates for ESRD beneficiaries compared to the overall Medicare population suggest the need to explore policy interventions to enhance patients' survival and life experience, as well as to reduce the impact to Medicare. The IOTA Model proposes to improve patient outcomes by incentivizing increased access to kidney transplantation across IOTA participants. Access to this lifesaving treatment may delay or avert dialysis, reduce costs to the Medicare program and to patients, and enhance survival and quality of life.

A kidney transplant involves surgically transplanting a kidney from a living or deceased donor to a kidney transplant recipient. The replacement organ is known as a graft. Most kidneys are transplanted alone, as kidneys transplanted along with other organs are very rare.

Fewer than 1,000 patients each year receive a simultaneous kidney-pancreas transplant, which is generally conducted for patients who have kidney failure related to type 1 diabetes mellitus.

The kidney in such

a simultaneous transplant may come from a living or deceased donor, but other organs mostly come from a deceased donor.

According to OPTN data, in 2022, there were 389 kidney-heart transplants in the U.S, 789 kidney-liver transplants, 22 kidney-lung transplants, and 3 kidney-intestine transplants. See

https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/.

Health Resources and Services Administration. (2020). Scientific Registry for Transplant Recipients.

OPTN/SRTR 2020 Annual Data Report:

Pancreas. https://srtr.transplant.hrsa.gov/annual_reports/2020/Pancreas.aspx.

About three-quarters of kidney transplants in the U.S. are deceased donor kidney transplants.

For deceased donor transplantation, a patient needs to contact a transplant hospital and arrange for an evaluation to assess the feasibility of surgery. The patient's name would then be added to a list of individuals who can receive organ offers. This is known as the kidney transplant hospital's kidney transplant waitlist. Living donation occurs when a living person donates an organ to a family member, friend, or other individual. People unknown to one another sometimes take part in paired exchanges, which allow the switching of recipients based on blood type and other biological factors. The numbers of deceased donor kidney donation have increased over the past decade, while living donor kidney donation has remained relatively constant, declining in 2020 with the COVID-19 pandemic.

United States Renal Data System. 2022. USRDS Annual Data Report. Volume 2. End-stage Renal Disease (ESRD) in the United States, Chapter 7: Transplantation. Figure 7.10b.

Kidney transplantation is considered the optimal treatment option for most ESRD patients. Although not a cure for kidney disease, a transplant can help a person live longer and improve quality of life. On average, patients experience 14 to 16 years of function from a kidney from a living kidney donor, while few people survive more than a decade on dialysis.

According to one source, the majority of deceased donor kidneys are expected to function for about 9 years, with high quality organs lasting longer.

A systematic review of studies worldwide finds significantly lower mortality and risk of cardiovascular events associated with kidney transplantation compared with dialysis.

Additionally, this review finds that patients who receive transplants experience a better quality of life than treatment with dialysis.

The average dialysis patient is admitted to the hospital nearly twice a year, often as a result of infection, and more than 35 percent of dialysis patients who are discharged are re-hospitalized within 30 days of being discharged.

Among transplant recipients, there are lower rates of hospitalizations, emergency department visits, and readmissions compared to those still on dialysis.

In general, from the standpoint of long-term survival and quality of life, a living donor kidney transplant is considered the best among all kidney transplant options for most people with CKD.

59 60

Get the Facts on Kidney Transplantation Before You Start Dialysis—Penn Medicine.

(2019, July 24).

Www.pennmedicine.org. https://www.pennmedicine.org/updates/blogs/transplant-update/2019/july/kidney-transplant-facts-before-dialysis.

Organ Procurement and Transplantation Network. Kidney Donor Profile Index (KDPI) Guide for Clinicians.

https://optn.transplant.hrsa.gov/professionals/by-topic/guidance/kidney-donor-profile-index-kdpi-guide-for-clinicians/#:~:text=Figure%201%20shows%20that%20a,function%20for%20about%209%20years.

Tonelli, M., Wiebe, N., Knoll, G., Bello, A., Browne, S., Jadhav, D., Klarenbach, S., & Gill, J. (2011). Systematic Review: Kidney Transplantation Compared With Dialysis in Clinically Relevant Outcomes.

American Journal of Transplantation, 11

(10), 2093-2109.

https://doi.org/10.1111/j.1600-6143.2011.03686.x.

Ibid.

United States Renal Data System. 2022. USRDS Annual Data Report. 2022. Volume 2. End-stage Renal Disease (ESRD) in the United States, Chapter 5: Hospitalization. Figures 5.1a, 5.9.

United States Renal Data System. 2021. USRDS Annual Data Report. Volume 2. End-Stage Renal Disease (ESRD) in the United States. Chapter 5: Hospitalization, Figures 5.1a, 5.6a, 5.8.

Nemati, E., Einollahi, B., Lesan Pezeshki, M., Porfarziani, V., & Fattahi, M.R. (2014). Does Kidney Transplantation With Deceased or Living Donor Affect Graft Survival?

Nephro-Urology Monthly, 6

(4).

https://doi.org/10.5812/numonthly.12182.

United States Renal Data System. 2022. USRDS Annual Data Report. Volume 2. End-stage Renal Disease (ESRD) in the United States, Chapter 7: Hospitalization. Figure 7.20.b.

A cost advantage also arises with kidney transplantation. Per person per year Medicare FFS spending for beneficiaries with ESRD with a transplant is less than half that for either hemodialysis or peritoneal dialysis.

While the benefits to patient survival and quality of life from living donor kidney transplantation are more pronounced, a recent literature review shows that deceased donor kidney transplantation generally produced better outcomes at a lower cost compared to dialysis, although old age and a high comorbidity load among kidney transplant patients may mitigate this advantage.

An earlier study, based on a single hospital, showed rates of hospitalization, a substantial factor in health care costs, to be lower among kidney transplant patients than for those on dialysis.

United States Renal Data System. 2022. USRDS Annual Report. Volume 2. End-stage Renal Disease (ESRD) in the United States, Chapter 9: Healthcare Expenditures for Persons with ESRD. Figure 9.11.

Fu, R., Sekercioglu, N., Berta, W., & Coyte, P.C. (2020). Cost-effectiveness of Deceased-donor Renal Transplant Versus Dialysis to Treat End-stage Renal Disease.

Transplantation Direct, 6

(2), e522.

https://doi.org/10.1097/txd.0000000000000974.

Khan, S., Tighiouart, H., Kalra, A., Raman, G., Rohrer, R.J., & Pereira, B.J.G. (2003). Resource utilization among kidney transplant recipients.

Kidney International, 64

(2), 657-664.

https://doi.org/10.1046/j.1523-1755.2003.00102.x.

Despite these outcomes, in 2020, only about 30 percent of prevalent ESRD patients—those with existing ESRD diagnoses—in the U.S. had a functioning kidney transplant, or graft.

In 2016, only 2.8 percent of incident ESRD patients—meaning patients newly diagnosed with ESRD—received a preemptive kidney transplant, allowing them to avoid dialysis.

These rates are substantially below those of other developed nations. The U.S. was ranked 17th out of 42 reporting countries in kidney transplants per 1,000 dialysis patients in 2020, with 42 transplants per 1,000 dialysis patients in 2020.

We seek to test policy approaches aimed at increasing the number of kidney transplants over current levels given these relatively low numbers and the overall benefit to patients from transplantation, as well as the potential savings to Medicare.

United States Renal Data System. 2022 Annual Data Report. Volume 2. End Stage Renal Disease Chapter 7 Transplantation Figure 7.16.

United States Renal Data System.

2018. Annual Data Report. Volume 2. Chapter 1: Incidence, Prevalence, Patient Characteristics, and Treatment Modalities. Figure 1.2.

Retrieved from

https://www.usrds.org/2018/view/v2_01.aspx.

United States Renal Data System. 2022. Annual Data Report. Volume 2. End Stage Renal Disease. Chapter 7. Transplantation. Figure 11.17b.

d. Kidney Transplant Rates and Unmet Needs

Annually, more than one hundred thousand individuals in the U.S. begin treatment for ESRD.

Despite transplantation being widely regarded as the optimal treatment for people with ESRD, as well as being more cost-effective in the long term compared to dialysis, only a minority of people with ESRD (13 percent) are added to the waitlist, and even fewer receive a transplant. To be added to the kidney transplant waitlist, a patient must complete an evaluation at a transplant hospital, and the patient must be found to be a good candidate for a transplant. Nearly 5,000 patients on the national kidney transplant waiting list die each year.

68 69 70

These trends have persisted

for several decades despite increases in the number of kidney transplants from deceased donors and living donors.

United States Renal Data System. 2022. USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD; 2022.Volume 2: End-stage Renal Disease (ESRD) in the United States, Chapter 1: Incidence, Prevalence, Patient Characteristics.

Scientific Registry of Transplant Recipients. Program Specific Reports.

Www.srtr.org.

Retrieved

June 15, 2023, from

https://www.srtr.org/reports/program-specific-reports/.

Too Many Donor Kidneys Are Discarded in U.S. Before Transplantation—Penn Medicine. (2020, December 16).

www.pennmedicine.org. https://www.pennmedicine.org/news/news-releases/2020/december/too-many-donor-kidneys-are-discarded-in-us-before-transplantation.

United States Renal Data System. 2022 Annual Data Report. Volume 2. End Stage Renal Disease Chapter 7 Transplantation Figure 7.4.

From 1996 to 2019, the number of kidneys made available for transplantation from deceased donors grew steadily, in part because of organs that became available as a result of the opioid epidemic.

71 72

In 2018 and 2019, the total number of kidney transplants rose steadily as compared to previous years.

In 2019, almost one third of patients received a transplant within one year of being placed on the waitlist (32.9 percent), and the rate reached 51.8 percent within 5 years of being placed on the waitlist.

The number of kidney transplants increased by 10.2 percent from 2018 to 2019, but fell by 2.7 percent from 2019 to 2020, from 24,511 to 23,853. The reduction was precipitated by a 23.6 percent decline in living donor transplants on account of the COVID-19 pandemic.

The overall number of patients with a functioning graft continued its upward trend, reaching 245,846 in 2020, an increase of 2.7 percent from 2019.

Nonetheless, these gains in kidney transplantation in the U.S. have fallen far short of the prevailing need among individuals with ESRD or facing the prospect of kidney failure. The number of individuals with ESRD added to the waitlist for a kidney transplant reached a high of 28,533 in 2019, but dropped slightly to 25,136 in 2020, while rising to 27,413 in 2021.

At the end of 2021, 72,864 individuals were on the waitlist for a kidney transplant.

Hariharan, S., Israni, A. K., & Danovitch, G. (2021). Long-Term Survival after Kidney Transplantation. New England Journal of Medicine, 385(8), 729-743.

https://doi.org/10.1056/nejmra2014530.

Durand, C.M., Bowring, M.G., Thomas, A.G., Kucirka, L.M., Massie, A.B., Cameron, A., Desai, N.M., Sulkowski, M., & Segev, D.L. (2018). The Drug Overdose Epidemic and Deceased-Donor Transplantation in the United States: A National Registry Study.

Annals of Internal Medicine, 168

(10), 702-711.

https://doi.org/10.7326/M17-2451.

United States Renal Data System. 2021. Annual Data Report. Volume 2. End Stage Renal Disease. Chapter 7. Transplantation. Figure 7.11.

United States Renal Data System. 2021. Annual Data Report. Volume 2. End Stage Renal Disease. Chapter 7. Transplantation. Figure 7.7.

United States Renal Data System. 2022. Annual Data Report. Volume 2. End Stage Renal Disease. Chapter 7. Transplantation. Figure 7.10b.

United States Renal Data System. 2022. Annual Data Report. Volume 2. End Stage Renal Disease. Chapter 7. Transplantation. Figure 7.16.

United States Renal Data System. 2023. Annual Data Report. Volume 2. End Stage Renal Disease. Chapter 7. Transplantation. Figure 7.1.

United States Renal Data System. 2023. Annual Data Report. Volume 2. End Stage Renal Disease. Chapter 7. Transplantation. Figure 7.2.

The increase in deceased donor kidney transplantation was accompanied by a gradual but steady decline in the number of living donor transplants as compared to patients undergoing dialysis. The total number of living donor transplants per year has risen moderately over the past two decades, from 5,048 in 2000 to 5,241 in 2020, and 5,971 in 2021.

79 80

With the overall dialysis population growing, the rate of living donor transplants per 100 patient-years on dialysis declined from 1.4 to 0.8 transplants from 2010 to 2020.

A report states the proportion of patients undergoing living donor kidney donation to have decreased from 37 percent in 2010 to 29 percent in 2019.

A study in 2013 of OPTN data found that the decline in living donation appeared most prominent among men, Black/African Americans, and younger and lower income adults, potentially leading to longer waiting times for transplantation, greater dialysis exposure, higher death rates on the waitlist, lower graft and patient survival for recipients, and higher overall healthcare costs for the care of patients with ESRD.

United States Renal Data System. 2012. Annual Data Report. Atlas ESRD. Table 7.1.

United States Renal Data System. 2023. Annual Data report. Volume 2. End Stage Renal Disease. Chapter 7. Transplantation. Figure 7.10a.

United States Renal Data System. 2022. Annual Data Report. Volume 2. End Stage Renal Disease. Chapter 7. Transplantation. Figure 7.10a.

Charnow, J.A. (2021, June 8).

Living Donor Kidney Transplants Declined in the Last Decade.

Renal and Urology News.

https://www.renalandurologynews.com/home/conference-highlights/american-transplant-congress/living-donor-kidney-transplantation-decreased-after-2010-united-states-trends/.

Rodrigue, J.R., Schold, J.D., & Mandelbrot, D.A. (2013). The Decline in Living Kidney Donation in the United States.

Transplantation Journal, 96

(9), 767-773.

https://doi.org/10.1097/tp.0b013e318298fa61.

e. Disparities

Kidney transplantation research in the U.S. reveals disparities across a number of different axes including geography, race and ethnicity, disability, socioeconomic status, neighborhood factors, and availability of health insurance.

84 85 86 87 88

Studies during the past decade have shown substantial disparities in kidney transplant rates among transplant programs at a national level, as well as both among and within donation service areas (DSAs).

A 2020 study examined data from a registry that included all U.S. adult kidney transplant candidates added to the waitlist in 2011 and 2015, comprising 32,745 and 34,728 individuals, respectively.

Among transplant programs nationwide, in 2015, the study found that the probability of a deceased donor transplant within three years for the average patient to be up to 16 times greater in some transplant hospitals as compared to others.

Substantial differences in probability of deceased donor transplantation were found even within DSAs, where all transplant programs utilize the same OPO and local organ supply. For the 2015 cohort, there was a median 2.3-fold difference between the highest and lowest hospital in each DSA in the 43 of 58 DSAs with more than one transplant hospital. The largest absolute difference in probability of transplant occurred in a DSA with seven transplant programs, with a patient on the waitlist at the transplant program with the highest probability of

transplant being 9.8 times more likely to receive a transplant than a patient at the transplant program with the lowest probability of receiving a transplant.

Factors such as local organ supply, the characteristics of individuals on the waitlist of a given transplant program, the size of the waitlist, and the transplant program's volume of transplants may account for the differences observed nationally across DSAs. However, the variation among transplant programs across DSAs is significantly associated with organ offer acceptance patterns at individual transplant hospitals.

This underscores the need to address geographic disparities and for more transparency on how transplant programs make decisions on organ offers for their waitlist patients.

King, K.L., Husain, S.A., Schold, J.D., Patzer, R.E., Reese, P.P., Jin, Z., Ratner, L.E., Cohen, D.J., Pastan, S.O., & Mohan, S. (2020). Major Variation across Local Transplant Centers in Probability of Kidney Transplant for Wait-Listed Patients. Journal of the

American Society of Nephrology, 31

(12), 2900-2911.

https://doi.org/10.1681/ASN.2020030335.

Melanson T., Basu M., Plantiga L., Pastan S., Mohan S., Patzer R. (2017). Variation in Living Donor Kidney Transplantation among U.S. Transplant Centers.

American Journal of Transplantation, 17

(suppl 3).

United States Renal Data System. 2022. Annual Data Report. Supplements: COVID-19, Racial and Ethnic Disparities Figures 14-4 and 14.15.

Wesselman, H., Ford, C.G., Leyva, Y., Li, X., Chang, C.-C.H., Dew, M.A., Kendall, K., Croswell, E., Pleis, J.R., Ng, Y.H., Unruh, M.L., Shapiro, R., & Myaskovsky, L. (2021). Social Determinants of Health and Race Disparities in Kidney Transplant.

Clinical Journal of the American Society of Nephrology, 16

(2), 262-274.

https://doi.org/10.2215/cjn.04860420.

Ng, Y.-H., Pankratz, V.S., Leyva, Y., Ford, C.G., Pleis, J.R., Kendall, K., Croswell, E., Dew, M.A., Shapiro, R., Switzer, G.E., Unruh, M.L., & Myaskovsky, L. (2019). Does Racial Disparity in Kidney Transplant Wait-listing Persist After Accounting for Social Determinants of Health?

Transplantation,

https://doi.org/10.1097/tp.0000000000003002.

With the enactment of NOTA, CMS designated donation service areas (DSAs); generally, each DSA includes an OPO within its geographic area. Until March 2021, when OPTN implemented the current policy for allocation of deceased donor kidneys, the priority for organs acquired by an OPO was based, among other factors, on an individual's residence within the DSA extending around the OPO.

American Society of Nephrology, 31

(12), 2900-2911.

https://doi.org/10.1681/ASN.2020030335.

King et al. 2020. 2903.

King et al., 2020. 2903.

King et al. 2020. 2903-2904.

Living donor kidney donation also varies widely among transplant hospitals. A 2018 report using OPTN data from 2015 showed that while most transplant hospitals perform few living donor kidney transplants, certain transplant hospitals have substantially higher rates for their waitlist patients than the median rate. Differences among transplant hospitals were correlated with geographic region and the number of deceased donor kidney transplantations performed.

This underscores the need for initiatives and processes among transplant hospitals to encourage living donations to reduce geographic disparities.

Melanson T., Basu M., Plantiga L., Pastan S., Mohan S., Patzer R. (2017). Variation in Living Donor Kidney Transplantation among U.S. Transplant Centers.

American Journal of Transplantation, 17

(suppl 3).

Disparities in kidney transplantation rates for various populations in the U.S. have long been documented. Literature over the past two decades has focused on Non-Hispanic Black patients, who experience lower rates of deceased and living donor kidney transplantation as compared to Non-Hispanic White patients, while being four times more likely to have kidney failure. Black/African Americans and Hispanics/Latinos with kidney failure experience lower rates of kidney transplantation compared with White patients.

Additionally, Black/African Americans and Hispanics/Latinos, along with Asians, American Indian/Alaskan Natives, and other minorities, are at a higher risk of illnesses that may eventually lead to kidney failure, such as diabetes and high blood pressure.

United States Renal Data System. 2022. Annual Data Report. Supplements: COVID-19, Racial and Ethnic Disparities Figures 14-4 and 14.15.

National Kidney Foundation. (2016, January 7). Race, Ethnicity, & Kidney Disease. National Kidney Foundation.

https://www.kidney.org/atoz/content/minorities-KD#:~:text=Black%20or%20African%20Americans%20are.

The literature over several decades has also addressed the effect of differences in age, gender, socioeconomic status (SES), and cultural aspects.

Recent studies have emphasized poverty and income differentials in analyzing the interplay of these and other factors among populations referred for kidney transplantation at several large transplant hospitals.

98 99 100 101

This research extends in time prior to the Kidney Allocation System (KAS) of 2014, which aimed to lessen the impact of racial differences on access to kidney transplantation.

Patzer, R.E., & Pastan, S.O. (2020). Policies to promote timely referral for kidney transplantation.

Seminars in Dialysis, 33

(1), 58-67.

https://doi.org/10.1111/sdi.12860.

Patzer, R. Perryman, J. Schrager, J. Pastan, S. Amaral, S. Gazmararian, J. Klein, M. Kutner, N. McClellan, W. 2012. Patzer, R.E., Perryman, J.P., Schrager, J.D., Pastan, S., Amaral, S., Gazmararian, J.A., Klein, M., Kutner, N., & McClellan, W.M. (2012). The Role of Race and Poverty on Steps to Kidney Transplantation in the Southeastern United States.

American Journal of Transplantation, 12

(2), 358-368.

https://doi.org/10.1111/j.1600-6143.2011.03927.x.

Clinical Journal of the American Society of Nephrology, 16

(2), 262-274.

https://doi.org/10.2215/cjn.04860420.

100

Transplantation,

https://doi.org/10.1097/tp.0000000000003002.

101

Schold, J.D., Gregg, J.A., Harman, J.S., Hall, A.G., Patton, P.R., & Meier-Kriesche, H.-U. (2011). Barriers to Evaluation and Wait Listing for Kidney Transplantation.

Clinical Journal of the American Society of Nephrology, 6

(7), 1760-1767.

https://doi.org/10.2215/cjn.08620910.

Research findings support the proposition that a broad interpretation of social determinants of health (SDOH) may substantially explain racial disparities in both deceased and living donor kidney transplantation.

102

Recently, a comprehensive survey of the literature on disparities in transplantation for kidneys and other organs found that socioeconomic factors may substantially explain disproportionately lower transplant rates and longer wait times.

103

As described in recent literature, a person's SDOH may contribute to inequities in their prospects for waitlist registration and receipt of transplantation.

104 105 106

SDOH is defined more broadly than socioeconomic status, to include those conditions in the places where people live, learn, work, and play that affect a wide range of health and quality of life risks and outcomes.

107

More specifically, SDOH include variations in employment, neighborhood factors, education, social support systems, and healthcare coverage that impact health outcomes.

102

Reed, R.D., & Locke, J.E. (2020). Social Determinants of Health: Going Beyond the Basics to Explore Racial Disparities in Kidney Transplantation. Transplantation, 104, 1324-1325.

https://doi.org/10.1097/tp.0000000000003003.

103

National Academies of Science, Engineering, and Medicine. 2022. “Realizing the Promise of Equity in the Organ Transplantation System. National Academies Press. Washington DC. 88-93.

104

Centers for Disease Control and Prevention.

Social Determinants of Health at CDC.

Retrieved June 13, 2023, from

https://www.cdc.gov/about/sdoh/index.html.

105

Wesselman et al., 2021.

106

Ng et al., 2020.

107

Centers for Disease Control and Prevention.

Salient among recent analyses are those of a cohort of patients initially referred for evaluation for a kidney transplant at a large urban transplant hospital between 2010 and 2012. These studies showed lower waitlist registration and transplant rates for Black/African Americans, regardless of SDOH. However, after the introduction of the KAS in 2014, racial difference showed weaker associations with rates of waitlist registration and receipt of a deceased donor transplant, when controlling for SDOH.

108 109

This finding is consistent with reports showing a decrease nationally in differences in rates of deceased donor kidney transplants among White patients as compared to Black/African American patients and Hispanic/Latino patients on dialysis, following the introduction of the KAS.

110 111

The studies of this patient cohort showed Black/African American race to be associated with a decrease in probability of kidney transplant, while still according influence to clinical, social, demographic and cultural factors. These factors included older age, lower income, public insurance, having more comorbidities, being transplanted pre-KAS, less social support, and less transplant knowledge.

112

Similarly, an earlier study of a population at a single

transplant hospital found that socioeconomic factors attenuated the association between racial difference and placement on the waitlist for a kidney transplant.

113

This underscores the need to consider initiatives and improvement activities aimed at addressing SDOH for ESRD patients to remove barriers to access to kidney transplantations.

108

Ng Y et al. 2020. 8.

109

Wesselman et al., 2021. 271.

110

United States Renal Data System. 2022. Annual Data Report. End Stage Renal Disease Chapter 7 Transplantation. Figures 7.10a, 7.10b.

111

OPTN Two Year Analysis shows effects of Kidney Allocation System https://optn.transplant.hrsa.gov/news/two-year-analysis-shows-effects-of-kidney-allocation-system/.

112

Wesselman et al. 2021. 267.

113

Schold et al., 2021.

Living donor transplantation has demonstrated the enduring influence of racial disparities, but also the importance of SES and neighborhood factors. The cohort of patients identified previously, initially referred for evaluation at a large urban hospital between 2010 and 2012, showed that for living donor transplantation, Black/African American race and lower income held a stronger association with a lower probability of living donor transplant than for deceased donor donation.

114

These results accord with findings nationwide that White patients are more likely to receive a living donor transplant, followed by Asian and Hispanic/Latino patients. Black/African American patients have had lower rates of living donor transplants than other racial or ethnic groups.

115

Explanations for these differences have included disparate rates of diabetes, obesity, and hypertension observed among minority populations that may contraindicate living donation by a relative; cultural differences in willingness to donate or ask for a living donation; concerns about costs among potential donors; and lack of knowledge about living donor transplantation on the part of patients, their families, and health care providers.

116 117

114

Wesselman et al., 2021. 270.

115

United States Renal Data System. 2022. Annual Data Report. End Stage Renal Disease Chapter 7 Transplantation Figure 7.10a.

116

Purnell, T.S., Hall, Y.N., & Boulware, L.E. (2012). Understanding and Overcoming Barriers to Living Kidney Donation Among Racial and Ethnic Minorities in the United States.

Advances in Chronic Kidney Disease, 19

(4), 244-251.

https://doi.org/10.1053/j.ackd.2012.01.008.

117

Rodrigue, J.R., Kazley, A.S., Mandelbrot, D.A., Hays, R., LaPointe Rudow, D., & Baliga, P. (2015). Living Donor Kidney Transplantation: Overcoming Disparities in Live Kidney Donation in the US—Recommendations from a Consensus Conference.

Clinical Journal of the American Society of Nephrology, 10

(9), 1687-1695.

https://doi.org/10.2215/cjn.00700115.

Research over several decades confirms the relation between health care access and SES factors and disparities in living donor kidney transplantation receipt for Black/African American and Hispanic/Latino patients, and, additionally, that these disparities have increased over time.

118 119 120 121

According to one study, between 1995 and 2014, disparities in the receipt of living donor kidney transplantation grew more for Black/African Americans and Hispanics/Latinos: (1) living in poorer (versus wealthier) neighborhoods; (2) without (versus with) a college degree; and (3) with Medicare (versus private insurance).

122

The study suggests that delays in the receipt of kidney care may contribute to reported racial and ethnic differences in the quality and timing of discussions among patients, families, and clinicians about living donor kidney transplantation as a treatment option.

123

118

Purnell, T.S., Luo, X., Cooper, L.A., Massie, A.B., Kucirka, L.M., Henderson, M.L., Gordon, E.J., Crews, D.C., Boulware, L.E., & Segev, D.L. (2018). Association of Race and Ethnicity With Live Donor Kidney Transplantation in the United States From 1995 to 2014.

JAMA, 319

(1), 49.

https://doi.org/10.1001/jama.2017.19152.

119

Hall, E.C., James, N.T., Garonzik Wang, J.M., Berger, J.C., Montgomery, R.A., Dagher, N.N., Desai, N.M., & Segev, D.L. (2012). Center-Level Factors and Racial Disparities in Living Donor Kidney Transplantation.

American Journal of Kidney Diseases, 59

(6), 849-857.

https://doi.org/10.1053/j.ajkd.2011.12.021.

120

Gore, J.L., Danovitch, G.M., Litwin, M.S., Pham, P-T.T., & Singer, J.S. (2009). Disparities in the Utilization of Live Donor Renal Transplantation.

American Journal of Transplantation, 9

(5), 1124-1133.

https://doi.org/10.1111/j.1600-6143.2009.02620.x.

121

Rodrigue et al. 2015.

122

Purnell et al. 2015. 58.

123

Purnell et al. 2015. 59.

One study also established associations between rates of living donor kidney transplantation for Black/African Americans and transplant hospital characteristics. While recognizing the potential effect of clinical factors, the study found that hospitals with high overall rates of living donor kidney transplantation showed significantly decreased racial disparities. The authors suggest that such high rates reveal commitment to living donor kidney transplantation, possibly shown in better education programs, more formalized procedures to reduce failure to complete transplant evaluations, increased use of medically complex and unrelated donors, and more success in reducing financial barriers to living donor kidney donation.

124

The study also notes that hospitals with higher percentages of Black/African American candidates experience greater racial disparities. The authors surmise that such a high percentage might indicate an urban setting exhibiting greater differences in access to health care between Black/African Americans and other populations.

125

124

Hall et al. 2012. 855.

125

Hall et al. 2012. 855.

Studies have also shown discrimination on the basis of disability with regard to organ transplantation, particularly for individuals with intellectual and developmental disabilities, who are often assumed by transplant providers to be unable to manage post-transplantation care requirements.

126

Discrimination occurs even though individuals' disabilities that are not related to the need for an organ transplant generally have little or no impact on the likelihood that the transplant would be successful.

127

The American Society of Transplant Surgeons has recommended that no patient be discriminated against or precluded from transplant listing solely due to the presence of a disability, whether physical or psychological.

128

126

See, for example.,

Nat'l Council on Disability, Organ Transplants Discrimination against People with Disabilities: Part of the Bioethics and Disability Series (2019),

https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf.

127

Id.

at 38-40.

128

Am. Soc'y of Transplant Surgeons,

Statement Concerning Eligibility for Solid Organ Transplant Candidacy

(Feb. 12, 2021),

https://asts.org/advocacy/position-statements.

CMS has kept these concerns in mind when developing the IOTA Model proposals. The IOTA Model proposes performance-based payments that hold transplant hospitals selected as the IOTA participants financially accountable for improvements in access to both deceased and living donor kidney transplantations. To reduce disparities and promote health equity, CMS is proposing that the IOTA participants would be required to develop and submit a Health Equity Plan to CMS in PYs 2 through 6. This proposed model design feature is aimed at encouraging IOTA participants to reassess their processes and policies around living and deceased donor kidneys and promote investments in performance and quality improvement activities that address barriers to care, including SDOH. The sequence of steps that patients need to undertake to gain access to kidney transplantation is complex, and the challenge posed by this process for potential recipients may be compounded by racial, socioeconomic and neighborhood factors. Thus, we believe that a unified framework of interventions to address the distinct social contexts underlying differences among racial groups in deceased donor kidney transplantation and living donor kidney transplantation may result in the desired outcomes of greater overall kidney transplant numbers and equity.

f. Post-Transplant Outcomes

While the need for kidney transplants has grown, the rates of patient and graft survival have increased. Between 2001 and 2020, graft survival rates at 1 and 5 years showed an increasing trend.

129

Patient survival at 1 year increased from 97.5 percent in 2001 to 99.2 percent in 2018, but then declined to 98.9 percent in 2019 and 98.4 percent in 2020; patient survival at 5 years rose from 89.8 percent in 2001 to an all-time high of 93.6 percent in 2013, dropping slightly to 93.2 percent in 2016.

130

For living donor kidney transplants, the rate of graft failure at 3 years decreased from 3.0 per 100 person years in 2010 to 2.1 per 100 person years in 2018. The rate of death at 3 years with a functioning graft also decreased from 1.2 to 1.0 per 100 person-years.

131

For deceased donor kidney transplants, the rate of graft failure at 3 years decreased from 2010 (6.3 per 100 patient years) to 2014 (4.9 per 100 patient years), but increased to 5.3 per 100 patient years in 2018. The same pattern was observed for death with a functioning graft, except that the rate in the 2018 cohort (2.8 per 100 patient years) exceeded that of the 2010 cohort (2.6 per 100 patient years).

132

129

United States Renal Data System. 2023. Annual Data Report. Volume 2. End Stage Renal Disease. Transplantation. Figures 7.19a and 7.19b.

130

United States Renal Data System. 2023. Annual Data Report. Volume 2. End Stage Renal Disease. Chapter 7. Transplantation. Figures 7.20a and 720.b.

131

United States Renal Data System. 2023. Annual Data Report. Volume 2. End Stage Renal Disease. Chapter 7. Transplantation. Figure 7.21a.

132

United States Renal Data System. 2023. Annual Data Report Volume 2. End Stage Renal Disease. Chapter 7. Transplantation. Figure 721.b.

A study published in the New England Journal of Medicine in 2021 shows the advantage of transplantation using deceased donor organs over long-term dialysis, even with an increasing trend of adverse conditions among recipients and donors. Notably, patient survival improved between the 1990s and the period from 2008 to 2011, despite increases in both (a) recipients' age, body-mass index (BMI), frequency of diabetes, and length of time undergoing dialysis, as well as a higher proportion of recipients with a previous kidney transplant; and (b) donors' age and in the percentage of donations after circulatory death.

133

Early referral of patients for transplants, kidney exchange programs, better diagnostic tools to identify early acute rejection, innovative therapies for countering rejection and infection, and optimization of immunosuppressive medications may be opportunities to enhance kidney graft survival.

134

133

Hariharan S, Israni AK, Danovitch G. Long-Term Survival after Kidney Transplantation. N Engl J Med. 2021 Aug 19;385(8):729-743. doi: 10.1056/NEJMra2014530. PMID: 34407344.

134

Hariharan, S., Israni, A. K., & Danovitch, G. (2021). Long-Term Survival after Kidney Transplantation.

New England Journal of Medicine, 385

(8), 729-743.

https://doi.org/10.1056/nejmra2014530

g. Non-Acceptance and Discards in Kidney Transplantation

Studies have documented the substantial extent of deceased donor kidney non-utilization in the U.S. relative to other countries (although methods of defining these rates differ among countries), as well as a steady increase in that trend over the past two decades.

135 136 137 138 139

A study in 2018 described donor-specific factors, such as biopsy findings and donor history, along with an increasing selectivity among transplant hospitals in accepting organs for transplant and inability to locate a recipient as contributing to this increase in non-utilization.

140

Within the context of the COVID-19 pandemic, the non-utilization of deceased donor kidneys in 2020 rose to the highest level up to that time, 21.3 percent, despite the decline in discard of organs from hepatitis C-positive donors.

141 142

An analysis found that the donor kidney discard rate peaked at 27 percent during the fourth quarter of 2021.

143

135

Mohan, S., Chiles, M. C., Patzer, R. E., Pastan, S. O., Husain, S. A., Carpenter, D. J., Dube, G. K., Crew, R. J., Ratner, L. E., & Cohen, D. J. (2018). Factors leading to the discard of deceased donor kidneys in the United States.

Kidney International, 94

(1), 187-198.

https://doi.org/10.1016/j.kint.2018.02.016.

136

Aubert, O. Reese. P. Audry, B. Bouatou, B. Raynaud, M. Viglietti, D. Legendre, C. Glotz, D. Empana, J. Jouben, X. Lefaucheur, C. Jacquelinet, C. Loupy, A. (2019). Disparities in Acceptance of Deceased Donor Kidneys Between the United States and France and Estimated Effects of Increased US Acceptance.

JAMA Internal Medicine, 179

(10), 1365-1374.

https://doi.org/10.1001/jamainternmed.2019.2322.

137

Ibrahim, M., Vece, G., Mehew, J., Johnson, R., Forsythe, J., Klassen, D., Callaghan, C., & Stewart, D. (2019). An international comparison of deceased donor kidney utilization: What can the United States and the United Kingdom learn from each other?

American Journal of Transplantation, 20

(5), 1309-1322.

https://doi.org/10.1111/ajt.15719.

138

Stewart, D. E., Garcia, V. C., Rosendale, J. D., Klassen, D. K., & Carrico, B. J. (2017). Diagnosing the Decades-Long Rise in the Deceased Donor Kidney Discard Rate in the United States.

Transplantation, 101

(3), 575-587.

https://doi.org/10.1097/tp.0000000000001539.

139

Health Resources and Services Administration. OPTN. (2017).

Two year analysis shows effects of kidney transplantation system.

Optn.

transplant.hrsa.gov.

Retrieved May 30, 2023, from

https://optn.transplant.hrsa.gov/news/two-year-analysis-shows-effects-of-kidney-allocation-system/.

140

Mohan, Chiles et al. (2018).

141

Lentine, K. Smith, J. Hart, A. Miller, J. Skeans, M. Larkin, L. Robinson, A. Gauntt, K. Israni, A. Hirose, R. Snyder, J. (2022). OPTN/SRTR 2020 Annual Data Report: Kidney. American Journal of Transplantation 22(Suppl 2) 21-136.

142

Following upon the introduction of certain anti-viral drugs, transplanting kidneys from donors infected with Hepatitis C has shown promising outcomes in recent studies. See Penn Medicine News “Penn Researchers Continue to Advance Transplantation of Hepatitis C Virus-infected kidneys into HCV-Negative Recipients” August 31, 2020

https://www.pennmedicine.org/news/news-releases/2020/august/penn-researchers-advance-transplantation-hepatitis-c-virus-infected-kidneys-hcv-negative-recipients

143

Cron, D. Husain, S. Adler, J. (2022). The new distance-based kidney allocation system: Implications for patients, transplant centers, and Organ Procurement Organizations.

Current Transplantation Reports, 9

(4), 304.

https://doi.org/10.1007/s40472-022-00384-z

Since 2014, when the KAS went into effect, OPTN has aimed to address the high rate of kidneys going unused. The new kidney allocation system was developed in response to higher than necessary discard rates of kidneys, variability in access to transplants for candidates who are harder to match due to biologic reasons, inequities resulting from the way waiting time was calculated, and a matching system that results in unrealized life years and high re-transplant rates.

144

The KAS also revised the system that matched waitlisted individuals with available organs.

145

As part of the KAS, the Kidney Donor Profile Index (KDPI) was implemented to assess the quality of kidneys procured for kidney transplants. The KDPI is based on a preliminary measurement, the Kidney Donor Risk Index (KDRI), which estimates the relative risk of post-transplant kidney graft failure based on scores for the deceased donor on a set of 10 demographic and clinic characteristics, including age, height, weight, ethnicity, history of hypertension, history of diabetes, cause of death, serum creatinine, hepatitis C virus status, and donation after circulatory death status.

146

This relative risk is determined in relation to the overall distribution of a grouping of these scores across the overall deceased donor population for the previous year. The KDPI transforms the KDRI to a zero-to-100 scale. Lower KDPI scores are associated with greater expected post-transplant longevity, while higher KDPI

scores are associated with a worse expected outcome in this regard.

147

144

OPTN Kidney Transplantation Committee. (n.d.).

The New Kidney Allocation System (KAS) Frequently Asked Questions.

Retrieved December 6, 2023, from

https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf.

p. 4.

145

OPTN. (n.d.)

The New Kidney Allocation System (KAS) Frequently Asked Questions. https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf.

p. 4.

146

OPTN. (n.d.).

The New Kidney Allocation System Frequently Asked Questions. https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf.

pp. 8-9.

147

OPTN. (n.d.).

The New Kidney Allocation System Frequently Asked Questions

https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf.

p. 4.

According to these new allocation rules, the KDPI of an available organ was to be assessed, with donor kidneys with low KDPI scores being offered to patients scoring high in terms of expected longevity. New revisions to the KAS also included an individual's time on dialysis prior to waitlisting to assess waiting time used for determining priority for an available organ, and new rules that allowed for greater access for candidates with blood type B to donor kidneys with other blood types.

148

OPTN. (n.d.).

The New Kidney Allocation System Frequently Asked Questions

https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf.

p. 4.

An OPTN data analysis from 2014 to 2016, the first two years after KAS implementation, showed that despite substantial increases in both deceased kidney donor transplants and deceased kidney donation, the kidney discard rate increased to 19.9 percent in 2016.

149

OPTN linked the discard rates to KDPI scores, with fewer than 3 percent of donor kidneys with KDPI between zero and 20 percent discarded, compared with 60 percent of donor kidneys with KDPI between 86 and 100 percent being discarded.

150

149

OPTN. (2017, July 9).

Two Year Analysis shows effects of Kidney Allocation System.

Retrieved June 9, 2023, from

https://optn.transplant.hrsa.gov/news/two-year-analysis-shows-effects-of-kidney-allocation-system/.

150

OPTN. (2017, July 9).

Two Year Analysis shows effects of Kidney Allocation System.

Retrieved June 9, 2023, from

https://optn.transplant.hrsa.gov/news/two-year-analysis-shows-effects-of-kidney-allocation-system/.

In March 2021, OPTN finalized a newer allocation policy, which eliminated the use of DSAs and regions from kidney and pancreas donor distribution. These measures were part of a framework announced in 2019 that also applied to heart, lung, and liver donor distribution, with the goal of reducing the importance of geography in patients' access to organs, and, instead, emphasizing medical urgency.

151 152

The new system instituted a point system with up to 2 points (equal to 2 years on the wait list) for patients listed at transplant hospitals within 250 nautical miles of the donor hospital, and the points decreasing linearly from the donor hospital to the circle perimeter. The more points an individual has, the higher their position on the waitlist and the more likely they are to receive an organ offer. If there is no candidate within the designated radius, the kidney is offered to patients listed at hospitals outside the fixed circle, based on separate proximity points that decrease linearly as the location of a patient approaches 2,500 nautical miles from the donor hospital.

153

151

Potluri, V. S., & Bloom, R. D. (2021). Effect of Policy on Geographic Inequities in Kidney Transplantation.

American Journal of Kidney Diseases, 79

(6), 897-900.

https://doi.org/10.1053/j.ajkd.2021.11.005.

152

Penn Medicine. (2021, November 17). Update: Change in Organ Allocation Designed to Increase Equity in US Kidney and Pancreas Transplantation.

Penn Medicine Physician Blog. https://www.pennmedicine.org/updates/blogs/penn-physician-blog/2021/november/change-in-organ-allocation-designed-to-increase-equity-in-us-kidney-and-pancreas-transplantation.

153

Potluri, Bloom. (2021). 897-898.

Interested parties within the transplant ecosystem commented that the new policy might further contribute to the increasing rate of donor organ non-acceptance. According to one review, sharing kidneys over a broader geographic region means that OPOs would need to work with transplant hospitals with which there was no prior relationship.

154

Concern was also expressed about increased transportation time and procurement costs, risk associated with air transport, and a greater number of interactions between transplant hospitals and OPOs.

155 156 157

One study notes that policymakers would need to assess the extent to which the new kidney allocation policy might affect organ offer acceptance patterns, organ recovery and utilization rates, and wait times both for the transplant hospital and broader geographic areas.

158

Another report cited unpublished SRTR data, saying that preliminary results suggest an increase in transplant rate overall, but a trend toward higher donor kidney discard and increased cold ischemia time.

159

A study at a single transplant hospital showed that the number of organ offers—for livers and kidneys—grew by 140 percent between May 1, 2019, and July 31, 2021, while the number of transplanted organs remained stable, suggesting less efficient allocation of organs after the new change in allocation policy.

160

154

Potluri, Bloom. (2021) 898.

155

Gentry, S.E., Chow, E.K.H., Wickliffe, C.E., Massie, A.B., Leighton, T., & Segev, D.L. (2014). Impact of broader sharing on the transport time for deceased donor livers.

Liver Transplantation, 20

(10), 1237-1243.

https://doi.org/10.1002/lt.23942.

156

Chow, E.M., DiBrito, S.R., Luo, X., Wickliffe, C., Massie, A.B., Locke, J.E., Gentry, S.E., Garonzik-Wang, J., & Segev, D.L. (2018). Long Cold Ischemia Times in Same Hospital Deceased Donor Transplants.

Transplantation, 102

(3), 471-477.

https://doi.org/10.1097/tp.0000000000001957.

157

Adler, J.T., Husain, S.A., King, K.L., & Mohan, S. (2021). Greater complexity and monitoring of the new Kidney Allocation System: Implications and unintended consequences of concentric circle kidney allocation on network complexity.

American Journal of Transplantation, 21

(6), 2007-2013.

https://doi.org/10.1111/ajt.16441.

158

Adler et al., 2021. 2012.

159

Cron, D.C., S. Ali Husain, & Adler, J. T. (2022). The New Distance-Based Kidney Allocation System: Implications for Patients, Transplant Centers, and Organ Procurement Organizations.

Current Transplantation Reports, 9

(4), 302-307.

https://doi.org/10.1007/s40472-022-00384-z.

160

Reddy, V., Briget da Graca, Martinez, E., Ruiz, R., Asrani, S.K., Testa, G., & Wall, A. (2022). Single-center analysis of organ offers and workload for liver and kidney allocation.

American Journal of Transplantation, 22

(11), 2661-2667.

https://doi.org/10.1111/ajt.17144.

A similar study assessing deceased donor kidney discards from 2000 to 2015 found that 17.3 percent of 212,305 procured deceased donor kidneys were discarded, representing a 91.5 percent increase in deceased donor kidney discards during the same time period. The increase in donor kidney discards outpaced the number of organs recovered for transplantation, adversely impacting transplantation rates and waitlist times. Kidneys with higher KDPIs and from donors with more disadvantageous characteristics were more likely to be discarded. The estimated 5-year graft survival for even the lowest quality kidneys substantially exceeds the average 5-year dialysis survival rate, making discard patterns concerning.

161

The study indicates a significant overlap in the quality of discarded and transplanted deceased donor kidneys, and substantial geographical variation in the odds of donor kidney discards, which, as seen previously, would continue to be observed in SRTR data for following years.

162

The study also found patterns that indicate factors beyond organ quality, including biopsy findings, donor history and poor organ function, and inability to locate a kidney donor recipient, may factor into deceased organ acceptance decisions. Other factors may be driving the deceased donor organ discard rates, as the study found that “discarded organs were more likely to come from older, heavier donors who were Black, female, diabetic, hypertensive, with undesirable social behavior and higher terminal creatinine.”

163

This finding accords with observed discard patterns from earlier studies whereby recipients of marginal kidneys, in terms of advanced donor age, hypertension, diabetes, or greater cold ischemia time, showed lower mortality and greater survival benefit for many candidates as

compared to staying on the transplant wait list.

164 165 166

161

Mohan, Chiles et al. 2018. p. 192.

162

Mohan et al. 2018. p. 195.

163

Mohan et al. 2018. 192.

164

Ojo, A.O., Hanson, J.A., Herwig Ulf Meier-Kriesche, Chike Nathan Okechukwu, Wolfe, R.R., Leichtman, A.B., Agodoa, L.Y., Kaplan, B., & Port, F.K. (2001). Survival in Recipients of Marginal Cadaveric Donor Kidneys Compared with Other Recipients and Wait-Listed Transplant Candidates.

Journal of the American Society of Nephrology, 12

(3), 589-597.

https://doi.org/10.1681/asn.v123589.

165

Massie, A.B., Luo, X., Chow, E.K.H., Alejo, J.L., Desai, N.M., & Segev, D.L. (2014). Survival Benefit of Primary Deceased

This text is long and has been trimmed here. Open the source document for the complete record.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.