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Rule2024-27841

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

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Published

December 4, 2024

Effective

January 3, 2025

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

This final rule describes a new mandatory alternative payment model, the Increasing Organ Transplant Access Model (IOTA Model), that will test whether performance-based upside risk payments or downside risk 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 final rule also adopts standard provisions that will apply to the Radiation Oncology Model, the End-Stage Renal Disease (ESRD) Treatment Choices Model, and mandatory Innovation Center models, including the IOTA Model, whose first performance period begins on or after January 1, 2025. The finalized 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.

Full Text

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[Federal Register Volume 89, Number 233 (Wednesday, December 4, 2024)]
[Rules and Regulations]
[Pages 96280-96463]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27841]

[[Page 96279]]

Vol. 89

Wednesday,

No. 233

December 4, 2024

Part II

Department of Health and Human Services

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Centers for Medicare & Medicaid Services

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42 CFR Part 512

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

Federal Register / Vol. 89 , No. 233 / Wednesday, December 4, 2024 /
Rules and Regulations

[[Page 96280]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 512

[CMS-5535-F]
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: Final rule.

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SUMMARY: This final rule describes a new mandatory alternative payment
model, the Increasing Organ Transplant Access Model (IOTA Model), that
will test whether performance-based upside risk payments or downside
risk 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 final rule also adopts
standard provisions that will apply to the Radiation Oncology Model,
the End-Stage Renal Disease (ESRD) Treatment Choices Model, and
mandatory Innovation Center models, including the IOTA Model, whose
first performance period begins on or after January 1, 2025. The
finalized 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: These regulations are effective January 3, 2025.

FOR FURTHER INFORMATION CONTACT:
Thomas Duvall (410) 786-8887, for questions related to the
Increasing Organ Transplant Access Model.
Lina Gebremariam, (410) 786-8893, for questions related to the
Increasing Organ Transplant Access Model.
Christina McCormick (410) 786-4012, for questions related to the
Increasing Organ Transplant Access Model.
<a href="/cdn-cgi/l/email-protection#1c5f515155686e7d726f6c707d72685c7f716f3274746f327b736a">[email&#160;protected]</a> for questions related to the Increasing
Organ Transplant Access Model.
<a href="/cdn-cgi/l/email-protection#5f1c121216720c2b3e313b3e2d3b0f2d3029362c3630312c1f3c322c7137372c71383029">[email&#160;protected]</a> for questions related to the
Standard Provisions for Innovation Center Models.

SUPPLEMENTARY INFORMATION:

Current Procedural Terminology (CPT) Copyright Notice

Throughout this final rule, we use CPT[supreg] codes and
descriptions to refer to a variety of services. We note that
CPT[supreg] codes and descriptions are copyright 2020 American Medical
Association (AMA). All Rights Reserved. CPT[supreg] is a registered
trademark of the American Medical Association. 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 the Department 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. Specifically,
section 1115A(b)(2)(a) of the Act states that ``the Secretary shall
select models to be tested from models where the Secretary determines
that there is evidence that the model addresses a defined population
for which there are deficits in care leading to poor clinical outcomes
or potentially avoidable expenditures. The Secretary shall focus on
models expected to reduce program costs under the applicable title
while preserving or enhancing the quality of care received by
individuals receiving benefits under such title.'' \1\ This final 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 will begin on July 1, 2025, and end on June 30,
2031. In this final rule, we address payment policies, participation
requirements, and other provisions to test the IOTA Model. We will test
whether performance-based incentives (including both upside and
downside risk payments) for participating kidney transplant hospitals
can increase the number of functioning 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 greater accountability by participating kidney
transplant hospitals by tying payments to the value of the care
provided. The IOTA Model is also intended to advance health equity by
improving equitable access to the transplantation ecosystem for all
patients, such as rural and underserved populations, through design
features such as voluntary health equity plans to address health
outcome disparities.
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\1\ U.S. Congress. (1940) United States Code: Social Security
Act, 42 U.S.C. 1315a(b)(2)(a).
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This final rule also includes standard provisions that will apply
to the RO Model, the ETC model, and all mandatory Innovation Center
models whose first performance periods begin on or after January 1,
2025. The standard provisions address beneficiary protections;
cooperation in model evaluation and monitoring; audits and record
retention; rights in data and intellectual property; monitoring and
compliance; remedial action; model termination by CMS; limitations on
review; miscellaneous provisions on bankruptcy and other notifications;
and the reconsideration review process.
As we stated in the notice of proposed rulemaking, the IOTA Model
will test ways to reduce Medicare expenditures while preserving or
enhancing the quality of care furnished to beneficiaries. We are
finalizing several, but not all, of the provisions discussed in the
proposed rule, and we intend to address certain other provisions
discussed in the proposed rule in future rulemaking. We also note that
some of the public comments were outside of the scope of the proposed
rule. These out-of-scope public comments are not addressed in this
final rule. We have summarized the public comments that are within the
scope of the proposed rule and have included our responses to those
public comments. However, we note that in this final rule we are not
addressing most comments received with respect to the provisions of the
proposed rule that we are not finalizing at this time. Rather, we will
address them at a later time, in a subsequent rulemaking document, as
appropriate. We are clarifying and emphasizing our intent that if any
provision of this final rule is held to be invalid or unenforceable by
its terms, or as applied to any person or circumstance, or stayed
pending further action, it shall be severable from other parts of this
final rule, and from rules and regulations currently in effect, and not
affect the remainder thereof or the application of the provision to
other persons not similarly situated or to other, dissimilar

[[Page 96281]]

circumstances. Through this rule, we adopt provisions that are intended
to and will operate independently of each other, even if each serves
the same general purpose or policy goal. Where a provision is
necessarily dependent on another, the context generally makes that
clear.

B. Summary of the Provisions

1. Standard Provisions for Innovation Center Models
The standard provisions for Innovation Center models will be
applicable to the RO Model, the ETC Model, and all mandatory Innovation
Center models whose first performance periods begin on or after January
1, 2025.
We are codifying these standard provisions to increase
transparency, efficiency, and clarity in the operation and governance
of mandatory Innovation Center models, and to avoid the need to restate
the provisions in each model's governing documentation. The standard
provisions include terms that have been repeatedly memorialized, with
minimal variation, in existing models' governing documentation. The
standard provisions are not intended to encompass all of the terms and
conditions that will apply to each mandatory Innovation Center model,
as each model includes 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 will continue to be included in each model's governing
documentation. We note that while we are not finalizing our proposal to
apply the standard provisions to voluntary Innovation Center models, we
expect to utilize the provisions in voluntary models and will
incorporate them by reference into the models' governing documentation
as appropriate based on the model's design. Model-specific provisions
applicable to the IOTA Model are described in section III of this final
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.\2\ 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.\3\ 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.4 5 However, despite these
benefits of kidney transplantation, 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.6 7 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).\8\ Consistent with this priority, and
through joint efforts with HHS' Health Resources and Services
Administration (HRSA), the IOTA Model will aim to reduce Medicare
expenditures and improve quality performance and equity in kidney
transplantation by creating performance-based incentive payments for
participating kidney transplant hospitals tied to kidney transplant]
access and quality of care for ESRD patients on the hospitals'
waitlists.
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\2\ End-Stage Renal Disease (ESRD) [verbar] CMS. (n.d.). <a href="https://www.cms.gov/medicare/coordination-benefits-recovery/overview/end-stage-renal-disease-esrd">https://www.cms.gov/medicare/coordination-benefits-recovery/overview/end-stage-renal-disease-esrd</a>.
\3\ 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.
\4\ 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.
<a href="https://doi.org/10.1111/j.1600-6143.2011.03686.x">https://doi.org/10.1111/j.1600-6143.2011.03686.x</a>.
\5\ 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:10.1001/jamanetworkopen.2022.1847.
\6\ 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. <a href="https://doi.org/10.1111/ajt.15368">https://doi.org/10.1111/ajt.15368</a>.
\7\ 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.
\8\ <a href="https://doi.org/10.1016/j.ekir.2023.02.1081">https://doi.org/10.1016/j.ekir.2023.02.1081</a>.
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The IOTA Model will be a mandatory model that will begin on July 1,
2025, and end on June 30, 2031, resulting in a 6-year model performance
period comprised of 6 individual performance years (``PYs''). The IOTA
Model will 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 will
select kidney transplant hospitals to participate in the IOTA Model
through the methodology proposed in section III.C.3.d of this final
rule. As this will be a mandatory model, the selected kidney transplant
hospitals will be required to participate. CMS will measure and assess
the participating kidney transplant hospitals' performance during each
PY across three performance domains: achievement, efficiency, and
quality.
The achievement domain will 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 will assess the kidney organ offer acceptance rate
ratios of each participating kidney transplant hospital relative to a
national ranking or the participating kidney transplant hospital's past
organ offer acceptance rate ratio. The quality domain will assess the
quality of care provided by the participating kidney transplant
hospitals via a composite graft survival ratio. Each participating
kidney transplant hospital's performance score across these three
domains will determine its final performance score and corresponding
amount for the upside risk payment that CMS would pay to the
participating kidney transplant hospital, or the downside risk payment
that would be owed by the participating kidney transplant hospital to
CMS. The upside risk payment will 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
in PY 2, the downside risk payment will be a lump sum payment paid to
CMS by any participating kidney transplant hospital with a final
performance score of 40 or lower. There is no downside risk payment for
PY 1 of the model.

[[Page 96282]]

b. Model Scope
Participation in the IOTA Model will be mandatory for approximately
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.
Additionally, we note that we intend to publicly post information
regarding the selection process and how it resulted in the list of DSAs
and kidney transplant hospitals selected to participate in the model.
As discussed in section III.C.3.b. of this final 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.
Eligible kidney transplant hospitals will 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) are non-
pediatric transplant facilities that furnished more than 50 percent of
the hospital's annual kidney transplants to patients 18 years of age or
older during that same period. CMS will 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
final rule, a DSA has the same meaning given to that term at 42 CFR
486.302.
c. Performance Assessment
CMS will assess each participating kidney transplant hospital's
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 will 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 will 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 will be heavily weighted on the achievement domain to align with
the IOTA Model's goal to increase access to kidney transplants to
improve the quality of care and reduce Medicare expenditures. 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.
CMS will 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), as described in section III.C.5.c of the
final rule. Each IOTA participant's transplant target for a given PY
will 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. Section III.C.5.c. of this
final 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 will 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 due to this calculation
methodology.
The efficiency domain will 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. CMS will assess the kidney organ offer acceptance rate
ratio 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 CMS using whichever
method results in the IOTA participant receiving the most points, with
performance on the efficiency domain being worth up to 20 points.
Finally, the quality domain will assess IOTA participants'
performance on a composite graft survival ratio measuring post-
transplant outcomes--relative to the composite graft survival ratio
across all kidney transplant hospitals, with performance on this domain
being worth up to 20 points.
Each IOTA participant's final performance score will be the sum of
the points earned for each domain: achievement, efficiency, and
quality. The final performance score in a PY will determine whether the
IOTA participant will 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 final rule.
d. Performance-Based Upside Risk Payment and Downside Risk Payment
Formula
Each IOTA participant's final performance score will determine
whether: (1) CMS will pay an upside risk payment to the IOTA
participant; (2) the IOTA participant will fall into a neutral zone
where no performance-based incentive payment will be paid to or owed by
the IOTA participant; or (3) the IOTA participant will owe a downside
risk payment to CMS. For a final performance score of 60 and above, CMS
will apply the formula for the upside risk payment, which will be equal
to the IOTA participant's final performance score minus 60, then
divided by 40, then multiplied by $15,000, then multiplied by the
number of kidney transplants furnished by the IOTA participant to
attributed patients with Medicare Fee-for-Service (FFS) 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 (inclusive)
in PYs 2-6 will fall in the neutral zone where there will be no payment
owed to the IOTA participant or CMS.
We will phase-in the downside risk payment beginning in PY2. We
explain in section III.C.5.b of this final 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 utilizes an upside
risk-only approach for PY 1 as an incentive in each of the three
performance domains. This will give IOTA participants time to consider,
invest in, and implement value-based care and quality improvement
initiatives before downside risk payments begin. Beginning in PY 2, for
a final performance score of 40 and below, CMS will apply the formula
for the downside risk payment, which will be equal to 40 minus the IOTA
participant's final performance score, then divided by 40, then
multiplied by $2,000, then multiplied by the number of kidney
transplants furnished by the IOTA participant to attributed patients
with Medicare FFS as their primary or secondary payer during the PY.
CMS will pay the upside risk payment in a lump sum to the IOTA
participant after the PY. The IOTA participant will pay the downside
risk payment to CMS in a lump sum after the PY.

[[Page 96283]]

e. Data Sharing
CMS will 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 will also share certain
data with IOTA participants upon request as described in section
III.C.3.a. of this final rule and as permitted by the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) Privacy Rule and
other applicable law. We will 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 will be
allowed only to the extent permitted by the HIPAA Privacy Rule and
other applicable law and CMS policies. We will also share certain
aggregate, de-identified data with IOTA participants.
f. Other Requirements
There are several other model requirements for selected transplant
hospitals, including transparency requirements and public reporting
requirements. IOTA participants may also submit a voluntary health
equity plan during the model, as described in section III.C.8. of this
rule.
(1) Transparency Requirements
Patients are often unsure whether they qualify for a kidney
transplant at a given kidney transplant hospital. IOTA participants
will 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.
(2) Health Equity Requirements
An IOTA participant may submit a health equity plan (``HEP'') to
CMS. The submission of HEPs will be voluntary for IOTA participants for
the duration of the model. The HEP will identify health disparities
within the IOTA participant's population of attributed patients and
outline a course of action to address them.
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 will issue these waivers
using our waiver authority under section 1115A(d)(1) of the Act, which
states that the Secretary may waive such requirements of titles XI and
XVIII and of sections 1902(a)(1), 1902(a)(13), 1903(m)(2)(A)(iii), and
1934 (other than subsections (b)(1)(A) and (c)(5) of such section) as
may be necessary solely for purposes of carrying out this section with
respect to testing models described in section 1115A(b) of the Act.
Each of the waivers is discussed in detail in section III.C.11.i. of
this final 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 participates in multiple Innovation Center
models. We believe that the IOTA Model will be compatible with existing
models and programs that provide opportunities to improve care and
reduce spending. The IOTA Model will 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 implements
performance-based payments separate from what participants will be paid
by CMS for furnishing kidney transplants to Medicare beneficiaries.
Additionally, we will 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
are allowing overlaps between the IOTA Model and other Innovation
Center models and CMS programs.
i. Monitoring
We will closely monitor the implementation and outcomes of the IOTA
Model throughout its duration consistent with the monitoring
requirements in the Standard Provisions for Innovation Center models in
section II of this final rule and the requirements in section III.C.13.
of this final rule. The purpose of this monitoring will 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 mentioned in section III.C.10. of this final rule, CMS will not
allow beneficiaries or patients to opt out of attribution to an IOTA
participant; however, the IOTA Model will not restrict a beneficiary's
freedom to choose another kidney transplant hospital or any other
provider or supplier for healthcare services, and IOTA participants
will be subject to the Standard Provisions for Innovation Center Models
outlined in section II of this final rule protecting Medicare
beneficiary freedom of choice and access to medically necessary
services. We also 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.

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. Based on quantitative and
qualitative analyses, there is reasonable evidence that the savings to
Medicare resulting from an incremental growth in transplantation as a
result of the IOTA Model will potentially exceed the payments projected
under the model's 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 to reduce program expenditures
under the applicable titles [Medicare, Medicaid, and CHIP] while
preserving or enhancing the quality of care furnished to individuals
under such titles . . . In selecting such models, the Secretary shall
give preference to models that also improve the coordination, quality,
and efficiency of health care services . . .'' 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

[[Page 96284]]

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.\9\ 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, in the notice of proposed rulemaking, we explained that we now
believe the general provisions should apply to Innovation Center models
more broadly. As we noted, the Innovation Center models share numerous
similar provisions, and we explained that we believed codifying the
general provisions in regulation to expand their applicability across
models, except where otherwise explicitly specified in a model's
governing documentation, would 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.
---------------------------------------------------------------------------

\9\ 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) (<a href="https://aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx">https://aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx</a>), 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
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 Sec. 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 Sec. 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 proposed 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
explained that we believe 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 proposed 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 proposed 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 previously. We
proposed specific revisions that would be necessary to expand the scope
of several of the current general provisions, but otherwise proposed
that the general provisions (which would be referred to as the
``standard provisions for Innovation Center models'') would not change.
In particular, we proposed 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:
Sec. 512.120 Beneficiary protections; Sec. 512.130 Cooperation in
model evaluation and monitoring; Sec. 512.135 Audits and record
retention; Sec. 512.140 Rights in data and intellectual property:
Sec. 512.150 Monitoring and compliance; Sec. 512.160 Remedial action;
Sec. 512.165 Innovation center model termination by CMS; Sec. 512.170
Limitations on review; and Sec. 512.180 Miscellaneous provisions on
bankruptcy and other notifications.

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

We proposed 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

[[Page 96285]]

closely aligns with the other changes we proposed 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 proposed to amend the title of subpart A to read
``Standard Provisions for Innovation Center Models'' to use the term we
proposed to define the provisions codified at 42 CFR part 512 subpart
A.
Additionally, we proposed to amend Sec. 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
proposed 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 noted in the proposed rule that these standard provisions are
necessary for the testing of the IOTA Model. As such, as an alternative
to the previous proposal, we proposed 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.
We specified in the proposed rule that these proposed standard
provisions would not, except as specifically noted in section II of the
proposed rule, affect the applicability of other provisions affecting
providers and suppliers under Medicare fee-for-service (FFS). We
invited public comment on these proposed changes.
Comment: We received a comment that emphasized that the proposed
standard provisions should not affect the applicability of other
provisions affecting providers and suppliers under Medicare fee-for-
service. The commenter believed that standardization of provisions
across models would decrease administrative burden for providers and
simplify understanding of complex models.
Response: We thank the commenter for their comment. We agree. We
are finalizing the proposed regulation text at Sec. 512.100(b)(3) to
provide that, except as specifically noted in subpart A of Part 512,
the standard provisions will not affect the applicability of other
provisions affecting providers and suppliers under Medicare fee-for-
service, including provisions regarding payment, coverage, and program
integrity. We agree with the commenter that the standardization of
provisions across models will decrease administrative burden and
simplify understanding of our Innovation Center models.
After consideration of the public comment we received, we are
finalizing the proposed revisions to the titles for 42 CFR part 512 and
for subpart A as described later in this section. Further, we are
finalizing the proposed revisions to the basis and scope provision at
42 CFR 512.100 with modification to apply the standard provisions to
mandatory Innovation Center models that begin their performance periods
on or after January 1, 2025, rather than to both mandatory and
voluntary Innovation Center models. After further consideration, we do
not believe it is necessary to adopt the standard provisions for
voluntary models because we can include those provisions, or other
provisions, if necessary, in the models' governing documentation. We
also are not including in the final regulation text the reference to
applying the standard provisions ``unless otherwise specified in the
Innovation Center model's governing documentation'' at proposed Sec.
512.100(b)(ii) because we are able to include the standard provisions,
or other provisions as appropriate, in voluntary Innovation Center
model participation agreements. We anticipate utilizing the standard
provisions in most voluntary Innovation Center model participation
agreements and will reference them or incorporate them by reference as
appropriate.
We also are not codifying the proposed regulation text at Sec.
512.100(b)(i), which provided that the standard provisions would apply
to each Innovation Center model that began its first performance period
before January 1, 2025, if incorporated by reference, in whole or in
part, into the Innovation Center model's governing documentation. If we
believe it is appropriate to apply the standard provisions, in whole or
in part, to an Innovation Center model for which the first performance
period began before January 1, 2025, we will amend the model's
governing documentation as appropriate, including through notice and
comment rulemaking if necessary. We are finalizing that the standard
provisions will apply to the RO and ETC Models as well as all other
mandatory Innovation Center models, including the IOTA model.
We are finalizing revised titles for 42 CFR part 512 and subpart A
that refer to ``Standard Provisions for Mandatory Innovation Center
Models.'' We are revising Sec. 512.100(a)--``Basis''--to provide that
the standard provisions apply to ``certain'' Innovation Center models.
At Sec. 512.100(b)--``Scope''--we are adding language to provide that
the standard provisions apply to the RO Model, the ETC Model, and to
Innovation Center Models ``for which participation by Model
participants is mandatory.''

D. Provisions Revising Certain Definitions

We proposed 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 proposed 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 proposed to add a new definition of the term ``governing
documentation'' at Sec. 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 proposed to add a new definition, ``standard provisions for
Innovation Center models,'' at Sec. 512.110 to mean the provisions
codified in 42 CFR part 512 subpart A. We proposed to add a new
definition, ``performance period,'' at Sec. 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 proposed to amend the definitions of ``Innovation
Center model activities,'' ``model beneficiary,'' and ``model
participant'' to pertain to all ``Innovation Center models,'' as we
proposed to define that term, instead of just the models previously
implemented under part 512. As such, we proposed

[[Page 96286]]

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 proposed to define ``model
beneficiary'' to mean ``a beneficiary attributed to a model participant
or otherwise included in an Innovation Center model.'' We proposed to
define ``model participant'' to mean ``an individual or entity that is
identified as a participant in the Innovation Center model.''
We invited 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.''
Comment: We received a comment that was supportive of our proposed
definitions.
Response: We appreciate the commenter's support of our proposed
definitions.
After consideration of the public comment we received, we are
finalizing the proposed revisions to the definitions at Sec. 512.110
without modification.

E. Proposed Reconsideration Review Process

We proposed to add a new Sec. 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 proposed at
Sec. 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 proposed at Sec. 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 proposed 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 proposed at Sec. 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 proposed
at Sec. 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 proposed at Sec. 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 proposed at Sec. 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 Sec. 512.190(b)(2), we proposed that requests that
do not meet the requirements of paragraph (b)(1) would be denied.
We proposed at Sec. 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 proposed to codify at Sec. 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 proposed that the reconsideration review
process would not be available to the model participant with regard to
that model-specific payment.
We proposed to codify standards for reconsideration at Sec.
512.190(c). First, during the course of the reconsideration, we
proposed 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 Sec. 512.190(b)(3).
Finally, we proposed 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 proposed to codify at Sec. 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 Sec. 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 Sec. 512.190(b)(3)(ii) and that meet
the standards of submission under proposed Sec. 512.190(b)(1) as well
as any

[[Page 96287]]

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 proposed at Sec.
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
Sec. 512.190(b)(3)(ii). Under proposed Sec. 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 Sec. Sec. 512.190(e)(1)
and (2).
We proposed to codify at Sec. 512.190(e) a process for the CMS
Administrator to review reconsideration determinations made under Sec.
512.190(d). We proposed 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
Sec. 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 Sec. 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 invited public comment on the proposed reconsideration review
process for Innovation Center models.
We received no comments on this proposal and are finalizing this
provision as proposed with a few technical changes for clarity.

III. Increasing Organ Transplant Access (IOTA) Model

A. Introduction

In this final rule, we finalize the IOTA Model, a new mandatory
Medicare alternative payment model that will be tested under the
authority of the Innovation Center at section 1115A(b) of the Act, that
will begin on July 1, 2025, and end on June 30, 2031. The IOTA Model
will test whether using performance-based incentive payments in the
form of upside risk payments and downside risk payments to and from
transplant hospitals selected to participate in the model 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 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 the medical and non-medical needs
of patients; and increased awareness, education, and support for living
donations. The IOTA Model payment structure will 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
will reduce Medicare expenditures by reducing dialysis expenditures and
avoidable health care service utilization and will improve the quality
of life for patients with ESRD.
As discussed in section III.B of this final 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.\10\ 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 and hold them
financially accountable for not doing so. The IOTA Model's payment
structure includes upside and 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'') that are tied to performance on achievement,
efficiency, and quality domains.
---------------------------------------------------------------------------

\10\ 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. <a href="https://doi.org/10.1016/j.kint.2018.02.016">https://doi.org/10.1016/j.kint.2018.02.016</a>.
---------------------------------------------------------------------------

The achievement domain will 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 will
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, to 20 points. or to the IOTA participant's
own past kidney organ offer acceptance rate ratio, with performance on
this domain being worth up to 20 points. The quality domain will assess
performance based on post-transplant outcomes, with performance on this
domain being worth up to 20 points. The achievement domain will be
weighted more heavily than the other two domains because increasing the
number of transplants is a key goal of the model and will be a primary
factor in determining the amount of the performance-based payment.
The final performance score for each IOTA participant will be the
sum of the points earned across the achievement domain, efficiency
domain, and quality domain. The final performance score will determine
whether an upside risk payment or downside risk payment would be owed
and the amount of such payment. Specifically:

[[Page 96288]]

<bullet> 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.(2)(a) of this final rule (final
performance score minus 60, then divided by 40, then multiplied by
$15,000, then multiplied by the number of kidney transplants furnished
by the IOTA participant to beneficiaries with Medicare FFS as a primary
or secondary payer during the PY).
<bullet> 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.
<bullet> 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.
<bullet> For PY 2 and each subsequent PY, if an IOTA participant
achieves a final performance score of 40 points or below, it would be
subject to the downside risk payment in accordance with the calculation
methodology described in section III.C.6.c.(2)(b) of this final rule
(40 minus final performance score, 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 FFS 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 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 will 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 payment methodology will act in
concert with efforts that are currently under development by HRSA to
increase the numbers of both deceased and living donor organ
transplants.
This 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.\11\
---------------------------------------------------------------------------

\11\ Moody-Williams, J.D., & Nair, S. (2023, September 15).
Organ Transplantation Affinity Group (OTAG): Strengthening
accountability, equity, and performance [verbar] CMS. BLOG. <a href="https://www.cms.gov/blog/organ-transplantation-affinity-group-otag-strengthening-accountability-equity-and-performance">https://www.cms.gov/blog/organ-transplantation-affinity-group-otag-strengthening-accountability-equity-and-performance</a>.
---------------------------------------------------------------------------

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 and is discussed in section III.B.3.d of
this final rule.\12\ 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.\13\ 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.\14\ 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.\15\ The IOTA Model includes 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 proposed the IOTA
Model as a complement to wider efforts aimed at transplant ecosystem
performance and equity improvements as discussed in section III.B of
the proposed rule. Ultimately, we seek a set of interventions that
focus on ESRD patients in need of a kidney transplant. In section III.B
of the proposed rule, we summarized the transplant ecosystem and HHS
oversight within CMS and HRSA related to kidney transplantation,
highlight related initiatives and priorities nationally, and outlined
our rationale for the proposed IOTA Model informed by literature, data,
and studies.
---------------------------------------------------------------------------

\12\ Penn Medicine News. (2020, December 16). Too Many Donor
Kidneys Are Discarded in U.S. Before Transplantation--Penn Medicine.
(2020, December 16). <a href="http://www.pennmedicine.org">www.pennmedicine.org</a>. <a href="https://www.pennmedicine.org/news/news-releases/2020/december/too-many-donor-kidneys-are-discarded-in-us-before-transplantation">https://www.pennmedicine.org/news/news-releases/2020/december/too-many-donor-kidneys-are-discarded-in-us-before-transplantation</a>
<a href="http://www.pennmedicine.org">www.pennmedicine.org</a>.
\13\ Hariharan, S., Israni, A.K., & Danovitch, G. (2021). Long-
Term Survival after Kidney Transplantation. New England Journal of
Medicine, 385(8), 729-743. <a href="https://doi.org/10.1056/nejmra2014530">https://doi.org/10.1056/nejmra2014530</a>.
\14\ 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. <a href="https://doi.org/10.1097/tp.0000000000001539">https://doi.org/10.1097/tp.0000000000001539</a>.
\15\ 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. <a href="https://doi.org/10.1016/j.kint.2018.02.016">https://doi.org/10.1016/j.kint.2018.02.016</a>.
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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.\16\ For kidney transplantation, it also includes ESRD
facilities, commonly known as dialysis facilities.
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\16\ Moody-Williams, J.D., & Nair, S. (2023, September 15).
Organ Transplantation Affinity Group (OTAG): Strengthening
accountability, equity, and performance [verbar] CMS. BLOG. <a href="https://www.cms.gov/blog/organ-transplantation-affinity-group-otag-strengthening-accountability-equity-and-performance">https://www.cms.gov/blog/organ-transplantation-affinity-group-otag-strengthening-accountability-equity-and-performance</a>.
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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 is
a network that coordinates the nation's organ procurement,
distribution, and transplantation systems.
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

[[Page 96289]]

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 for organ acquisition costs to be payable under Title XVIII
and Title XIX. Separately, 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, and donor and beneficiary evaluation. 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(b), 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.\17\ 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.\18\
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\17\ 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.
<a href="https://doi.org/10.1053/j.ajkd.2020.01.001">https://doi.org/10.1053/j.ajkd.2020.01.001</a>.
\18\ 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. <a href="https://doi.org/10.1097/TP.0000000000003136">https://doi.org/10.1097/TP.0000000000003136</a>.
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Once placed on the waitlist, potential recipients must maintain
active status to be eligible to receive a deceased donor
transplant.\19\ 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.' \20\ 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.21 22 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.\23\
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\19\ National kidney Foundation. (2017, February 10). The Kidney
Transplant Waitlist--What You Need to Know. National Kidney
Foundation. <a href="https://www.kidney.org/atoz/content/transplant-waitlist">https://www.kidney.org/atoz/content/transplant-waitlist</a>.
\20\ The kidney transplant waitlist. (n.d.). Transplant Living.
<a href="https://transplantliving.org/kidney/the-kidney-transplant-waitlist/">https://transplantliving.org/kidney/the-kidney-transplant-waitlist/</a>.
\21\ National kidney Foundation. (2019, June 12). Understanding
the transplant waitlist. National Kidney Foundation. <a href="https://www.kidney.org/content/understanding-transplant-waitlist">https://www.kidney.org/content/understanding-transplant-waitlist</a>.
\22\ National kidney Foundation. (2016, August 4). Multiple
Listing for Kidney Transplant. National Kidney Foundation. <a href="https://www.kidney.org/atoz/content/multiple-listing">https://www.kidney.org/atoz/content/multiple-listing</a>.
\23\ Transplant Nephrology Fellowship. (n.d.).
<a href="http://www.hopkinsmedicine.org">www.hopkinsmedicine.org</a>. Retrieved May 30, 2023, from <a href="https://www.hopkinsmedicine.org/nephrology/education/transplant-fellowship">https://www.hopkinsmedicine.org/nephrology/education/transplant-fellowship</a>.
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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.\24\ 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

[[Page 96290]]

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.\25\
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\24\ 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.
\25\ Mission, Vision, and Values. (n.d.). <a href="http://www.srtr.org">www.srtr.org</a>. <a href="https://www.srtr.org/about-srtr/mission-vision-and-values/">https://www.srtr.org/about-srtr/mission-vision-and-values/</a>.
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CMS oversees and evaluates OPO performance. OPOs must meet
performance measures and participate in, and abide by certain rules of,
the OPTN.\26\ 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.
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\26\ U.S. Congress. (1934) United States Code: Social Security
Act, 42 U.S.C. 301-Suppl. 4 1934.
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Additionally, OPTN policies 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).\27\ 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.
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\27\ Bylaws-OPTN. (n.d.). <a href="http://Optn.transplant.hrsa.gov">Optn.transplant.hrsa.gov</a>. Retrieved
September 13, 2024, from <a href="https://optn.transplant.hrsa.gov/media/lgbbmahi/optn_bylaws.pdf">https://optn.transplant.hrsa.gov/media/lgbbmahi/optn_bylaws.pdf</a>.
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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 kidney acquisition costs including
kidney registry fees, surgeons' fees for excising a kidney for
transplant, and laboratory tests associated with the evaluation of a
Medicare transplant candidate. The evaluation or preparation of a
living kidney 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 for a Medicare beneficiary. 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 51732). 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.\28\
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\28\ The Organ Procurement Organizations Annual Public
Aggregated Performance Report for 2023 is available at <a href="https://www.cms.gov/files/document/opo-annual-public-performance-report-2023.pdf">https://www.cms.gov/files/document/opo-annual-public-performance-report-2023.pdf</a>.
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While these regulatory changes 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.29 30 In
particular, we recognize that further action must be taken to address
health disparities and lower rates of transplantation for underserved
populations observed across transplant hospitals.
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\29\ One study--Doby, B. One study--Doby, B. One study--Doby, B.
One study showed that deceased donor organ donation increased during
2019, during the period of public debate about regulating OPO
performance. See 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. <a href="https://doi.org/10.1111/ajt.16527">https://doi.org/10.1111/ajt.16527</a>.
\30\ 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).
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We published a request for information in the Federal Register on

[[Page 96291]]

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:
<bullet> Continue to improve systems of care for all patients in
need of a transplant;
<bullet> Increase the number of organs available for transplant for
all solid organ types;
<bullet> Encourage the use of dialysis in alternate settings or
modalities over in-center hemodialysis where clinically appropriate and
advantageous;
<bullet> Ensure that the CMS and HHS policies appropriately
incentivize the creation and use of future new treatments and
technologies; and
<bullet> 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--
<bullet> Executive Order on Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government (E.O. 13985, 86
FR 7009, January 20, 2021);
<bullet> 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
<bullet> 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.\31\ The CEC Model focused on patients being treated in ESRD
facilities, with no explicit incentives to encourage increases in
kidney transplantation.
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\31\ The results of the CMS-sponsored evaluation of the CEC
Model are available at <a href="https://innovation.cms.gov/innovation-models/comprehensive-esrd-care">https://innovation.cms.gov/innovation-models/comprehensive-esrd-care</a>. 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.
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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

[[Page 96292]]

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). As of the second model evaluation report covering the first two
years of the model, the model has not shown statistically significant
results as home dialysis grew similarly across ETC areas and the
comparison group and no statistically significant differences in
waitlisting and living donor transplant rates. As noted earlier, CMS
will continue to evaluate the effectiveness of the ETC Model.
CMS is also operating the ETC Learning Collaborative, which is
focused on increasing the availability of deceased donor organs for
transplantation.\32\ 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).
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\32\ Centers for Medicare & Medicaid Services. <a href="https://innovation.cms.gov/innovation-models/esrd-treatment-choices-model">https://innovation.cms.gov/innovation-models/esrd-treatment-choices-model</a>.
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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.\33\
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\33\ The evaluation report for the first two years (2021, 2022)
of the ETC Model is available at <a href="https://www.cms.gov/priorities/innovation/innovation-models/esrd-treatment-choices-model">https://www.cms.gov/priorities/innovation/innovation-models/esrd-treatment-choices-model</a> and the
evaluation report for the first year (2022) of the KCC Model is
available at <a href="https://www.cms.gov/priorities/innovation/innovation-models/kidney-care-choices-kcc-model">https://www.cms.gov/priorities/innovation/innovation-models/kidney-care-choices-kcc-model</a>.
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The IOTA Model will complement the ETC and KCC Models and expand
kidney model participation to 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.\34\ 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.\35\ 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.
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\34\ HRSA Announces Organ Procurement and Transplantation
Network Modernization Initiative [verbar] HRSA. (n.d.).
<a href="http://www.hrsa.gov">www.hrsa.gov</a>. Retrieved August 20, 2023, from <a href="https://www.hrsa.gov/optn-modernization/march-2023">https://www.hrsa.gov/optn-modernization/march-2023</a>.
\35\ The White House. (2023, September 22). Bill Signed: H.R.
2544. The White House. <a href="https://www.whitehouse.gov/briefing-room/legislation/2023/09/22/bill-signed-h-r-2544/">https://www.whitehouse.gov/briefing-room/legislation/2023/09/22/bill-signed-h-r-2544/</a>.
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Effective July 14, 2022, revisions to OPTN policies 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: \36\
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\36\ OPTN. (n.d.). Bylaws. Retrieved September 15, 2024 from
<a href="https://optn.transplant.hrsa.gov/media/lgbbmahi/optn_bylaws.pdf">https://optn.transplant.hrsa.gov/media/lgbbmahi/optn_bylaws.pdf</a>.
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<bullet> 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
<bullet> 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--
<bullet> Providing information about the program structure,
procedures, protocols and quality;
<bullet> Review processes;
<bullet> Adopting and implementing a plan for improvement;
<bullet> Participating in an informal discussion with MPSC members;
and
<bullet> 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

[[Page 96293]]

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 OPTN policies, 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 Center of Excellence (COE)
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.\37\
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.'' \38\ Collectively, CMS and
HRSA seek to--
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\37\ Moody-Williams, J.D., & Nair, S. (2023, December 13). Organ
Transplantation Affinity Group (OTAG): Strengthening accountability,
equity, and performance [verbar] CMS. BLOG. <a href="https://www.cms.gov/blog/organ-transplantation-affinity-group-otag-strengthening-accountability-equity-and-performance">https://www.cms.gov/blog/organ-transplantation-affinity-group-otag-strengthening-accountability-equity-and-performance</a>.
\38\ Moody-Williams, J.D., & Nair, S. (2023, December 13). Organ
Transplantation Affinity Group (OTAG): Strengthening accountability,
equity, and performance [verbar] CMS. BLOG. <a href="https://www.cms.gov/blog/organ-transplantation-affinity-group-otag-strengthening-accountability-equity-and-performance">https://www.cms.gov/blog/organ-transplantation-affinity-group-otag-strengthening-accountability-equity-and-performance</a>.
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<bullet> Reduce variation of pre-transplant and referral practices;
\39\
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\39\ 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.
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<bullet> Increase availability and use of donated organs;
<bullet> Increase accountability for organ procurement and
matching;
<bullet> Promote equitable access to transplants; and
<bullet> Empower patients, families, and caregivers to actively
engage in the transplant journey.
As discussed in section III.C. of the proposed rule, we believe the
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 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. The IOTA
Model is targeted to kidney transplant programs, but it will test
specific modifications for Medicare payment and other programmatic
measures that could establish a framework for interventions for
transplantation that could potentially be applied to the other solid
organ types in the future.
In the following sections of this final rule, we review scientific
literature that outlines specific ways to enhance kidney
transplantation. Our analysis is focused on kidney transplantation, but
we also present findings pertaining to the transplantation of other
organs, especially livers. We aim to show how the types of
interventions that we proposed 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 to
the IOTA Model's use of upside risk payments and downside risk payments
as a policy lever to increase the number of kidney transplants and
achieve a fairer distribution. of kidney transplants.
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.\40\ Prevalence of ESRD varied by Health
Service Area (HSA) and ESRD Network.\41\ Stratified by age and race/
ethnicity, ESRD was consistently more prevalent among older people (65
and older) and in Black people.\42\ Diabetes and hypertension are most
often the primary cause of ESRD.\43\ According to the National Kidney
Foundation, these diseases disproportionately affect minority
populations, increasing the risk of kidney disease.\44\ 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.\45\ Studies show that people

[[Page 96294]]

with kidney transplants live longer than those who remain on
dialysis.46 47 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.\48\
In 2021, 72,864 patients with ESRD were on the kidney transplant
waitlist, of which 27,413 were listed during that year.\49\ The IOTA
Model will partially 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.\50\
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\40\ United States Renal Data System. 2023. End Stage Renal
Disease: Chapter 1. Figure 1.5.
\41\ United States Renal Data System. 2023. End Stage Renal
Disease: Chapter 1. Figure 1.7.
\42\ United States Renal Data System. 2023. End Stage Renal
Disease: Chapter 1. Figure 1.8.
\43\ United States Renal Data System. 2023. End Stage Renal
Disease. Chapter 1. Table 1.3.
\44\ National Kidney Foundation. (2016, January 7). Race,
Ethnicity and Kidney Disease. National Kidney Foundation. <a href="https://www.kidney.org/atoz/content/minorities-KD">https://www.kidney.org/atoz/content/minorities-KD</a>.
\45\ United States Renal Data System. 2023. End Stage Renal
Disease. Chapter 1. Figure 1.1.
\46\ Strohmaier, S., Wallisch, C., Kammer, M., Geroldinger, A.,
Heinze, G., Oberbauer, R., & Haller, M.C. (2022). Survival Benefit
of First Single-Organ Deceased Donor Kidney Transplantation Compared
With Long-term Dialysis Across Ages in Transplant-Eligible Patients
With Kidney Failure. JAMA Network Open, 5(10), e2234971. <a href="https://doi.org/10.1001/jamanetworkopen.2022.34971">https://doi.org/10.1001/jamanetworkopen.2022.34971</a>.
\47\ 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.
<a href="https://doi.org/10.1111/j.1600-6143.2011.03686.x">https://doi.org/10.1111/j.1600-6143.2011.03686.x</a>.
\48\ United States Renal Data System. 2023. End Stage Renal
Disease: Chapter 7. Figure 7.16.
\49\ United States Renal Data System. 2023. End Stage Renal
Disease: Chapter 7. Figures 7.1 and 7.2.
\50\ United States Renal Data System. 2022. End Stage Renal
Disease: Chapter 9.
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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 aims 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.\51\ 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.\52\ The
kidney in such a simultaneous transplant may come from a living or
deceased donor, but other organs mostly come from a deceased donor.
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\51\ 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
<a href="https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/">https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/</a>.
\52\ Health Resources and Services Administration. (2020).
Scientific Registry for Transplant Recipients. OPTN/SRTR 2020 Annual
Data Report: Pancreas. <a href="https://srtr.transplant.hrsa.gov/annual_reports/2020/Pancreas.aspx">https://srtr.transplant.hrsa.gov/annual_reports/2020/Pancreas.aspx</a>.
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About three-quarters of kidney transplants in the U.S. are deceased
donor kidney transplants.\53\ 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 number of deceased donor kidney donations has
increased over the past decade, while living donor kidney donation has
remained relatively constant, declining in 2020 with the COVID-19
pandemic.\54\
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\53\ 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.
\54\ 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.
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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.\55\ According to one source, the majority of
deceased donor kidneys are expected to function for about 9 years, with
high quality organs lasting longer.\56\ A systematic review of studies
worldwide finds significantly lower mortality and risk of
cardiovascular events associated with kidney transplantation compared
with dialysis.\57\ Additionally, this review finds that patients who
receive transplants experience a better quality of life than treatment
with dialysis.\58\ 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.\59\ Among transplant
recipients, there are lower rates of hospitalizations, emergency
department visits, and readmissions compared to those still on
dialysis.\60\ 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.61 62
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\55\ Get the Facts on Kidney Transplantation Before You Start
Dialysis--Penn Medicine. (2019, July 24). <a href="http://www.pennmedicine.org">www.pennmedicine.org</a>.
<a href="https://www.pennmedicine.org/updates/blogs/transplant-update/2019/july/kidney-transplant-facts-before-dialysis">https://www.pennmedicine.org/updates/blogs/transplant-update/2019/july/kidney-transplant-facts-before-dialysis</a>.
\56\ Organ Procurement and Transplantation Network. Kidney Donor
Profile Index (KDPI) Guide for Clinicians. <a href="https://optn.transplant.hrsa.gov/professionals/by-topic/guidance/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/</a>#:~:<a href="https://optn.transplant.hrsa.gov/professionals/by-topic/guidance/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/</a>.
\57\ 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.
<a href="https://doi.org/10.1111/j.1600-6143.2011.03686.x">https://doi.org/10.1111/j.1600-6143.2011.03686.x</a>.
\58\ Ibid.
\59\ 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.
\60\ 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.
\61\ 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). <a href="https://doi.org/10.5812/numonthly.12182">https://doi.org/10.5812/numonthly.12182</a>.
\62\ 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.
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A cost advantage also arises with kidney transplantation. Per-
person per-

[[Page 96295]]

year Medicare FFS spending for beneficiaries with ESRD with a
transplant is less than half that for either hemodialysis or peritoneal
dialysis.\63\ 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.\64\ 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.\65\
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\63\ 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.
\64\ 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. <a href="https://doi.org/10.1097/txd.0000000000000974">https://doi.org/10.1097/txd.0000000000000974</a>.
\65\ 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. <a href="https://doi.org/10.1046/j.1523-1755.2003.00102.x">https://doi.org/10.1046/j.1523-1755.2003.00102.x</a>.
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Despite these positive outcomes associated with kidney
transplantation, 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.\66\ In 2016, only 2.8 percent
of incident ESRD patients (patients newly diagnosed with ESRD) received
a preemptive kidney transplant, allowing them to avoid dialysis.\67\
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.\68\ 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.
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\66\ United States Renal Data System. 2022 Annual Data Report.
Volume 2. End Stage Renal Disease Chapter 7 Transplantation Figure
7.16.
\67\ 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 <a href="https://www.niddk.nih.gov/about-niddk/strategic-plans-reports/usrds/prior-data-reports/2018">https://www.niddk.nih.gov/about-niddk/strategic-plans-reports/usrds/prior-data-reports/2018</a>.
\68\ United States Renal Data System. 2022. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 11.17b.
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d. Kidney Transplant Rates and Unmet Needs
Annually, more than one hundred thousand individuals in the U.S.
begin treatment for ESRD.\69\ 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.70 71 72 These
trends have persisted for several decades despite increases in the
number of kidney transplants from deceased donors and living donors.
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\69\ 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.
\70\ Scientific Registry of Transplant Recipients. Program
Specific Reports. <a href="http://www.srtr.org">www.srtr.org</a>. Retrieved June 15, 2023, from
<a href="https://www.srtr.org/reports/program-specific-reports/">https://www.srtr.org/reports/program-specific-reports/</a>.
\71\ Penn Medicine News. (2020, December 16). Too Many Donor
Kidneys Are Discarded in U.S. Before Transplantation--Penn Medicine.
<a href="http://www.pennmedicine.org">www.pennmedicine.org</a>. <a href="https://www.pennmedicine.org/news/news-releases/2020/december/too-many-donor-kidneys-are-discarded-in-us-before-transplantation">https://www.pennmedicine.org/news/news-releases/2020/december/too-many-donor-kidneys-are-discarded-in-us-before-transplantation</a>.
\72\ United States Renal Data System. 2022 Annual Data Report.
Volume 2. End Stage Renal Disease Chapter 7 Transplantation Figure
7.4.
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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.73 74 In 2018 and 2019, the total number of kidney
transplants rose steadily as compared to previous years.\75\ 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.\76\ 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.\77\ 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.\78\
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.\79\ At the end of 2021, 72,864 individuals were on the
waitlist for a kidney transplant.\80\
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\73\ Hariharan, S., Israni, A.K., & Danovitch, G. (2021). Long-
Term Survival after Kidney Transplantation. New England Journal of
Medicine, 385(8), 729-743. <a href="https://doi.org/10.1056/nejmra2014530">https://doi.org/10.1056/nejmra2014530</a>.
\74\ 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. <a href="https://doi.org/10.7326/M17-2451">https://doi.org/10.7326/M17-2451</a>.
\75\ United States Renal Data System. 2021. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.11.
\76\ United States Renal Data System. 2021. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.7.
\77\ United States Renal Data System. 2022. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.10b.
\78\ United States Renal Data System. 2022. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.16.
\79\ United States Renal Data System. 2023. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.1.
\80\ United States Renal Data System. 2023. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.2.
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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 2021.81 82 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.\83\ 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.\84\ A study in 2013 of OPTN data found that the decline in living
donation

[[Page 96296]]

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.\85\
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\81\ United States Renal Data System. 2012. Annual Data Report.
Atlas ESRD. Table 7.1.
\82\ United States Renal Data System. 2023. Annual Data report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.10a.
\83\ United States Renal Data System. 2022. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.10a.
\84\ Charnow, J.A. (2021, June 8). Living Donor Kidney
Transplants Declined in the Last Decade. Renal and Urology News.
<a href="https://www.renalandurologynews.com/news/living-donor-kidney-transplantation-decreased-after-2010-united-states-trends/">https://www.renalandurologynews.com/news/living-donor-kidney-transplantation-decreased-after-2010-united-states-trends/</a>.
\85\ 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. <a href="https://doi.org/10.1097/tp.0b013e318298fa61">https://doi.org/10.1097/tp.0b013e318298fa61</a>.
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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.86 87 88 89 90 A 2020 study
showed substantial disparities in kidney transplant rates among
transplant programs at a national level, as well as both among and
within donation service areas (DSAs).91 92 This 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.\93\ 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.\94\ 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.\95\ 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.\96\ 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.
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\86\ 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. <a href="https://doi.org/10.1681/ASN.2020030335">https://doi.org/10.1681/ASN.2020030335</a>.
\87\ 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).
\88\ United States Renal Data System. 2022. Annual Data Report.
Supplements: COVID-19, Racial and Ethnic Disparities Figures 14.14
and 14.15.
\89\ 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. <a href="https://doi.org/10.2215/cjn.04860420">https://doi.org/10.2215/cjn.04860420</a>.
\90\ 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, 1. <a href="https://doi.org/10.1097/tp.0000000000003002">https://doi.org/10.1097/tp.0000000000003002</a>.
\91\ With the enactment of NOTA, CMS designated 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.
\92\ 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. <a href="https://doi.org/10.1681/ASN.2020030335">https://doi.org/10.1681/ASN.2020030335</a>.
\93\ King et al. 2020. 2900.
\94\ King et al. 2020. 2903.
\95\ King et al., 2020. 2903.
\96\ King et al. 2020. 2903-2904.
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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.\97\ This underscores
the need for initiatives and processes among transplant hospitals to
encourage living donations to reduce geographic disparities.
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\97\ 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).
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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.\98\ 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.\99\
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\98\ United States Renal Data System. 2022. Annual Data Report.
Supplements: COVID-19, Racial and Ethnic Disparities Figures 14.14
and 14.15.
\99\ National Kidney Foundation. (2016, January 7). Race,
Ethnicity, & Kidney Disease. National Kidney Foundation. <a href="https://www.kidney.org/atoz/content/minorities-KD">https://www.kidney.org/atoz/content/minorities-KD</a>.
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The literature over several decades has also addressed the effect
of differences in age, gender, socioeconomic status (SES), and cultural
aspects.\100\ 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.101 102 103 104 This

[[Page 96297]]

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.
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\100\ Patzer, R.E., & Pastan, S.O. (2020). Policies to promote
timely referral for kidney transplantation. Seminars in Dialysis,
33(1), 58-67. <a href="https://doi.org/10.1111/sdi.12860">https://doi.org/10.1111/sdi.12860</a>.
\101\ 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. <a href="https://doi.org/10.1111/j.1600-6143.2011.03927.x">https://doi.org/10.1111/j.1600-6143.2011.03927.x</a>.
\102\ 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. <a href="https://doi.org/10.2215/cjn.04860420">https://doi.org/10.2215/cjn.04860420</a>.
\103\ 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, 1. <a href="https://doi.org/10.1097/tp.0000000000003002">https://doi.org/10.1097/tp.0000000000003002</a>.
\104\ 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. <a href="https://doi.org/10.2215/cjn.08620910">https://doi.org/10.2215/cjn.08620910</a>.
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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.\105\ 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.\106\
As described in recent literature, a person's SDOH may contribute to
inequities in their prospects for waitlist registration and receipt of
transplantation.107 108 109 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.\110\ More specifically,
SDOH include variations in employment, neighborhood factors, education,
social support systems, and healthcare coverage that impact health
outcomes.
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\105\ 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.(7), 1324-
1325.-1325. <a href="https://doi.org/10.1097/TP.0000000000003003">https://doi.org/10.1097/TP.0000000000003003</a>.
\106\ National Academies of Sciences, Engineering, and Medicine.
(2022). Realizing the Promise of Equity in the Organ Transplantation
System (K.W. Kizer, R.A. English, & M. Hackmann, Eds.; pp. 88-93).
National Academies Press. <a href="https://doi.org/10.17226/26364">https://doi.org/10.17226/26364</a>.
\107\ Centers for Disease Control and Prevention. Social
Determinants of Health at CDC. Retrieved June 13, 2023, from <a href="https://www.cdc.gov/about/priorities/social-determinants-of-health-at-cdc.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html">https://www.cdc.gov/about/priorities/social-determinants-of-health-at-cdc.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html</a>.
\108\ Wesselman et al, 2021.
\109\ Ng et al, 2020.
\110\ Centers for Disease Control and Prevention. Social
Determinants of Health at CDC. Retrieved June 13, 2023, from <a href="https://www.cdc.gov/about/priorities/social-determinants-of-health-at-cdc.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html">https://www.cdc.gov/about/priorities/social-determinants-of-health-at-cdc.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html</a>.
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A salient group of recent analyses focused on 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.111 112 One of the studies
reports that racial difference showed a weaker association with the
rate of waitlist registration after the introduction of the KAS.
Another of these studies, focusing on transplant rates as the outcome,
showed that even after accounting for social determinants of health,
Black patients had a lower likelihood of kidney transplant and living-
donor transplant, but not deceased-donor transplant. Black race, older
age, lower income, public insurance, more comorbidities, being
transplanted before changes to the KAS, greater religiosity, less
social support, less transplant knowledge, and fewer learning
activities were each associated with a lower probability of any kidney
transplant.\113\ Similarly, an earlier study of a population at a
single transplant hospital found that income and insurance attenuated
the association between racial difference and placement on the waitlist
for a kidney transplant.\114\ The findings in these studies of the
enduring influence of cultural, socioeconomic and demographic factors
apart from racial difference underscore the need to consider
initiatives and improvement activities aimed at addressing SDOH for
ESRD patients to remove barriers to access to kidney transplantations.
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\111\ Ng Y et al. 2020. 1453.
\112\ Wesselman et al, 2021. 271.
\113\ Wesselman et al. 2021. 262.
\114\ Schold et al, 2021.
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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 with deceased donor
donation.\115\ 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.\116\ 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.117 118
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\115\ Wesselman et al, 2021. 270.
\116\ United States Renal Data System. 2022. Annual Data Report.
End Stage Renal Disease Chapter 7 Transplantation Figure 7.10a.
\117\ 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. <a href="https://doi.org/10.1053/j.ackd.2012.01.008">https://doi.org/10.1053/j.ackd.2012.01.008</a>.
\118\ 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.
<a href="https://doi.org/10.2215/cjn.00700115">https://doi.org/10.2215/cjn.00700115</a>.
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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.119 120 121 122 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).\123\ 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.\124\
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\119\ 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. <a href="https://doi.org/10.1001/jama.2017.19152">https://doi.org/10.1001/jama.2017.19152</a>.
\120\ 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. <a href="https://doi.org/10.1053/j.ajkd.2011.12.021">https://doi.org/10.1053/j.ajkd.2011.12.021</a>.
\121\ 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. <a href="https://doi.org/10.1111/j.1600-6143.2009.02620.x">https://doi.org/10.1111/j.1600-6143.2009.02620.x</a>.
\122\ Rodrigue et al. 2015.
\123\ Purnell et al. 2015. 58.
\124\ Purnell et al. 2015. 59.
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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

[[Page 96298]]

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.\125\ 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.\126\
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\125\ Hall et al. 2012. 855.
\126\ Hall et al. 2012. 855.
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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.\127\ 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.\128\ 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.\129\
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\127\ See, for example, National Council on Disability. (2019).
Organ Transplant Discrimination Against People with Disabilities:
Part of the Bioethics and Disability Series. <a href="https://www.ncd.gov/report/organ-transplant-discrimination-against-people-with-disabilities">https://www.ncd.gov/report/organ-transplant-discrimination-against-people-with-disabilities</a>.
\128\ Id. at 38-40.
\129\ Am. Soc'y of Transplant Surgeons, Statement Concerning
Eligibility for Solid Organ Transplant Candidacy (Feb. 12, 2021),
<a href="https://asts.org/advocacy/position-statements.https://asts.org/advocacy/position-statements">https://asts.org/advocacy/position-statements.https://asts.org/advocacy/position-statements</a>.
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CMS kept these concerns in mind when developing the IOTA Model
proposals. The IOTA Model uses 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 proposed that the IOTA participants would be required to
develop and submit a Health Equity Plan to CMS. This 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.
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.\130\
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.\131\ 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.\132\ 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).\133\
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\130\ United States Renal Data System. 2023. Annual Data Report.
Volume 2. End Stage Renal Disease. Transplantation. Figures 7.19a
and 7.19b.
\131\ United States Renal Data System. 2023. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figures 7.20a and 7.20b.
\132\ United States Renal Data System. 2023. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.21a.
\133\ United States Renal Data System. 2023. Annual Data Report
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.21b.
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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.\134\ 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.\135\
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\134\ Hariharan, S., Israni, A.K., & Danovitch, G. (2021). Long-
Term Survival after Kidney Transplantation. New England Journal of
Medicine, 385(8), 729-743. <a href="https://doi.org/10.1056/nejmra2014530">https://doi.org/10.1056/nejmra2014530</a>.
\135\ Hariharan, S., Israni, A.K., & Danovitch, G. (2021). Long-
Term Survival after Kidney Transplantation. New England Journal of
Medicine, 385(8), 729-743. <a href="https://doi.org/10.1056/nejmra2014530">https://doi.org/10.1056/nejmra2014530</a>.
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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.136 137 138 139 140 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

[[Page 96299]]

in non-utilization.\141\ 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.142 143
According to one analysis, the deceased donor kidney discard rate
peaked at 27 percent during the fourth quarter of 2021.\144\
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\136\ 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. <a href="https://doi.org/10.1016/j.kint.2018.02.016">https://doi.org/10.1016/j.kint.2018.02.016</a>.
\137\ 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. <a href="https://doi.org/10.1001/jamainternmed.2019.2322">https://doi.org/10.1001/jamainternmed.2019.2322</a>.
\138\ 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. <a href="https://doi.org/10.1111/ajt.15719">https://doi.org/10.1111/ajt.15719</a>.
\139\ 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. <a href="https://doi.org/10.1097/tp.0000000000001539">https://doi.org/10.1097/tp.0000000000001539</a>.
\140\ Health Resources and Services Administration. OPTN.
(2017). Two year analysis shows effects of kidney transplantation
system. <a href="http://Optn.transplant.hrsa.gov">Optn.transplant.hrsa.gov</a>. Retrieved May 30, 2023, from
<a href="https://optn.transplant.hrsa.gov/news/two-year-analysis-shows-effects-of-kidney-allocation-system/">https://optn.transplant.hrsa.gov/news/two-year-analysis-shows-effects-of-kidney-allocation-system/</a>.
\141\ Mohan, Chiles et al. (2018).
\142\ 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.
\143\ Following 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 <a href="https://www.pennmedicine.org/news/news-releases/2020/august/penn-researchers-advance-transplantation-hepatitis-c-virus-infected-kidneys-hcv-negative-recipients">https://www.pennmedicine.org/news/news-releases/2020/august/penn-researchers-advance-transplantation-hepatitis-c-virus-infected-kidneys-hcv-negative-recipients</a>.
\144\ 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. <a href="https://doi.org/10.1007/s40472-022-00384-z">https://doi.org/10.1007/s40472-022-00384-z</a>.
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Since the KAS went into effect in 2014, the 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.\145\ The KAS also revised the system that matched waitlisted
individuals with available organs.\146\ 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.\147\ 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.\148\
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\145\ OPTN Kidney Transplantation Committee. (n.d.). The New
Kidney Allocation System (KAS) Frequently Asked Questions. Retrieved
December 6, 2023, from <a href="https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf">https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf</a>. p. 4.
\146\ OPTN. (n.d.) The New Kidney Allocation System (KAS)
Frequently Asked Questions. <a href="https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf">https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf</a>. p. 4.
\147\ OPTN. (n.d.). The New Kidney Allocation System Frequently
Asked Questions. <a href="https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf">https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf</a>. pp. 8-9.
\148\ OPTN. (n.d.). The New Kidney Allocation System Frequently
Asked Questions . <a href="https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf">https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf</a>. p. 4.
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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.\149\
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\149\ OPTN. (n.d.). The New Kidney Allocation System Frequently
Asked Questions. <a href="https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf">https://optn.transplant.hrsa.gov/media/1235/kas_faqs.pdf</a>. p. 4.
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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.\150\ The 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.\151\
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\150\ OPTN. (2017, July 9). Two Year Analysis shows effects of
Kidney Allocation System. Retrieved June 9, 2023, from <a href="https://optn.transplant.hrsa.gov/news/two-year-analysis-shows-effects-of-kidney-allocation-system/">https://optn.transplant.hrsa.gov/news/two-year-analysis-shows-effects-of-kidney-allocation-system/</a>.
\151\ OPTN. (2017, July 9). Two Year Analysis shows effects of
Kidney Allocation System. Retrieved June 9, 2023, from <a href="https://optn.transplant.hrsa.gov/news/two-year-analysis-shows-effects-of-kidney-allocation-system/">https://optn.transplant.hrsa.gov/news/two-year-analysis-shows-effects-of-kidney-allocation-system/</a>.
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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.152 153
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.\154\
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\152\ 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. <a href="https://doi.org/10.1053/j.ajkd.2021.11.005">https://doi.org/10.1053/j.ajkd.2021.11.005</a>.
\153\ Penn Medicine. (2021, November 17). Update: Change in
Organ Allocation Designed to Increase Equity in US Kidney and
Pancreas Transplantation. Penn Medicine Physician Blog. <a href="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">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</a>.
\154\ Potluri, Bloom. (2021). 897-898.
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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.\155\
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.156 157 158 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

[[Page 96300]]

geographic areas.\159\ Another report cited unpublished SRTR data,
saying that preliminary results suggest an increase in the transplant
rate overall, but a trend toward higher donor kidney discard and
increased cold ischemia time.\160\
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\155\ Potluri, Bloom. (2021) 898.
\156\ 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. <a href="https://doi.org/10.1002/lt.23942">https://doi.org/10.1002/lt.23942</a>.
\157\ 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. <a href="https://doi.org/10.1097/tp.0000000000001957">https://doi.org/10.1097/tp.0000000000001957</a>.
\158\ 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. <a href="https://doi.org/10.1111/ajt.16441">https://doi.org/10.1111/ajt.16441</a>.
\159\ Adler et al., 2021. 2012.
\160\ 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. <a href="https://doi.org/10.1007/s40472-022-00384-z">https://doi.org/10.1007/s40472-022-00384-z</a>.
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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
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\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. <a href="https://doi.org/10.1681/asn.v123589">https://doi.org/10.1681/asn.v123589</a>.
\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
Donor Transplantation With High-KDPI Kidneys. American Journal of
Transplantation, 14(10), 2310-2316. <a href="https://doi.org/10.1111/ajt.12830">https://doi.org/10.1111/ajt.12830</a>.
\166\ Cohen, J.B., Eddinger, K.C., Locke, J.E., Forde, K.A.,
Reese, P.P., & Sawinski, D. (2017). Survival Benefit of
Transplantation with a Deceased Diabetic Donor Kidney Compared with
Remaining on the Waitlist. Clinical Journal of the American Society
of Nephrology, 12(6), 974-982. <a href="https://doi.org/10.2215/cjn.10280916">https://doi.org/10.2215/cjn.10280916</a>.
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Research at this time suggests that CMS regulatory requirements and
OPTN policies may have been contributing to transplant hospitals
growing more selective in choosing organs for their waitlisted
patients. A study from 2017 examined OPTN registry data for deceased
donors from 1987 to 2015, showing that changes in the donor pool and
certain clinical practices explained about 80 percent of the increase
in non-utilization of deceased donor kidneys.\167\ However, according
to the study, the remainder of kidney discards, not accounted for by
these factors, suggests that increased risk aversion was leading
transplant hospitals to be more selective about the kidneys they
accept, regardless of the actual risk profile. Furthermore, increasing
reliance on the part of OPTN, CMS, and private insurers on program-
specific reports that assessed the performance of transplant hospitals
on transplant graft and recipient survival rates might have been
contributing to the overall trend of organs going unused.\168\
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\167\ Stewart et al. (2017). 575.
\168\ Stewart et al. (2017). 585.
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The finding of high rates of non-use of organs that could
potentially be transplanted with positive outcomes has led to closer
examination of trends among transplant hospitals in declining the
possible use of organs for specific patients. Information on each organ
that is recovered by an OPO is shared with the OPTN, which runs the
matching system that determines which organ should be offered to which
recipient. If an organ is determined to be a good match for a
particular patient, then the OPTN would offer that organ to the
transplant hospital at which the patient is waitlisted on the patient's
behalf.\169\ A transplant hospital can decline an offer without
informing the candidate of the offer or the reason it was
declined.\170\ A study in 2019 focused on patient outcomes associated
with declines in offers of organs by transplant hospitals. Using OPTN
data, the study identified a cohort of 280,041 adults on the kidney
transplant waitlist (out of 367,405 candidates on the waitlist from
2008 through 2015, the study period) who received one or more offers
for a deceased donor kidney during that period. More than 80 percent of
deceased donor kidneys were declined on behalf of one or more
candidates before being accepted for transplant, and a mean of 10
candidates who previously received an offer died every day during the
study period.\171\ As reported by transplant hospitals, organ or donor
quality concerns accounted for 92.6 percent of all declined offers,
whereas 2.6 percent of offers were refused because of patient-related
factors, and an even smaller number for logistical limitations or other
concerns. While organ or donor quality concerns remained the primary
reason for declined offers across all KDPI ranges, the study observed
marked State-level variability in the interval between first offer and
death or transplant and in the likelihood of dying while having
remained on the wait list after receiving an offer.\172\
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\169\ National kidney Foundation. (2017, February 10). The
Kidney Transplant Waitlist--What You Need to Know. National Kidney
Foundation. <a href="https://www.kidney.org/atoz/content/transplant-waitlist">https://www.kidney.org/atoz/content/transplant-waitlist</a>.
\170\ Husain, S.A., King, K.L., Pastan, S., Patzer, R.E., Cohen,
D.J., Radhakrishnan, J., & Mohan, S. (2019). Association Between
Declined Offers of Deceased Donor Kidney Allograft and Outcomes in
Kidney Transplant Candidates. JAMA Network Open, 2(8), e1910312.
<a href="https://doi.org/10.1001/jamanetworkopen.2019.10312">https://doi.org/10.1001/jamanetworkopen.2019.10312</a>.
\171\ Husain et al. 2019.
\172\ Husain et al. 2019.
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The methodology and findings of this study are notable since they
draw a correlation between the specific patterns among transplant
hospitals of organ non-acceptance and the longevity of patients on the
wait list. The tendency among certain hospitals to choose to not use
kidneys for specific patients is shown apart from the distinct finding
of organs going unused and being discarded. The study shows the
potential for a similar effect on patient survival from organ offer
non-acceptance as for organ non-use. The authors of an earlier study
commented that low acceptance rates of organ offers lead to
inefficiency, longer ischemia time, unequal access to donated kidneys,
and perhaps to higher rates of discarded organs.\173\ The findings in
the

[[Page 96301]]

2019 study of a wide range of organ offer acceptance rates among
transplant hospitals nationwide, as well as of the relation between
organ offer declines and patient deaths, suggest the need for
incentives for transplant hospitals to accept earlier offers for their
patients, which, in turn, could reduce cold ischemia time, and, on the
whole, increase patient survival.
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\173\ Wolfe, R.A., Laporte, F., Rodgers, A.M., Roys, E., Fant,
G., & Leichtman, A.B. (2007). Developing Organ Offer and Acceptance
Measures: When ``Good'' Organs Are Turned Down. American Journal of
Transplantation, 7, 1404-1411. <a href="https://doi.org/10.1111/j.1600-6143.2007.01784.x">https://doi.org/10.1111/j.1600-6143.2007.01784.x</a>.
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h. Non-Acceptance and Discards in Transplantation for Other Solid Organ
Types
SRTR has also tracked the non-use, or discard rate, of other solid
organ types. In 2020, 9.5 percent of livers recovered were not
transplanted, with livers from older donors less likely to be
transplanted.\174\ The discard rate for pancreases was 23.4 percent in
2020; organs from obese donors were highly likely not to be
transplanted.\175\ The discard rate for hearts in 2020 was one percent,
having stayed similar over the previous decade.\176\
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\174\ OPTN/SRTR 2020 Annual Data Report. 2020. Liver. Figures LI
49, 50.
\175\ OPTN/SRTR 2021 Annual Data Report. Pancreas. Figures PA
39, 43.
\176\ OPTN/SRTR 2021 Annual Data Report. Heart. Figure HR 52.
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Liver transplantation shows survival benefits for individuals with
chronic liver disease, but liver transplantation suffers from a severe
shortage of donor organs.177 178 A study from 2012 shows
organ offer non-acceptance patterns on the part of transplant programs
affect mortality for individuals with end-stage liver disease in a
similar manner as for ESRD patients. According to the study, most
candidates for a liver transplant who died or were removed from the
wait list had received at least one organ offer, suggesting that a
substantial portion of waitlist mortality results in part from declined
organ offers.\179\ As the IOTA Model does for kidney transplantation,
understanding and addressing why livers, and possibly other organs, are
not chosen for specific patients also has the potential to lead to
improved outcomes and longer lives.
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\177\ Merion, R.M., Schaubel, D.E., Dykstra, D.M., Freeman,
R.B., Port, F.K., & Wolfe, R.A. (2005). The Survival Benefit of
Liver Transplantation. American Journal of Transplantation, 5(2),
307-313. <a href="https://doi.org/10.1111/j.1600-6143.2004.00703.x">https://doi.org/10.1111/j.1600-6143.2004.00703.x</a>.
\178\ Ross, K., Patzer, R.E., Goldberg, D.S., & Lynch, R.J.
(2017). Sociodemographic Determinants of Waitlist and Posttransplant
Survival Among End-Stage Liver Disease Patients. American Journal of
Transplantation, 17(11), 2879-2889. <a href="https://doi.org/10.1111/ajt.14421">https://doi.org/10.1111/ajt.14421</a>.
\179\ Lai, J.C., Feng, S., & Roberts, J.P. (2012). An
Examination of Liver Offers to Candidates on the Liver Transplant
Wait-List. Gastroenterology, 143(5), 1261-1265. <a href="https://doi.org/10.1053/j.gastro.2012.07.105">https://doi.org/10.1053/j.gastro.2012.07.105</a>.
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i. Organ Transplant Affinity Group
On September 15, 2023, CMS published a blog post titled ``Organ
Transplantation Affinity Group (OTAG): Strengthening accountability,
equity, and performance.'' \180\ This blog discussed the formation of
OTAG, a Federal collaborative with staff from CMS and HRSA working
together to strengthen accountability, equity, and performance to
improve access to organ donation, procurement, and transplantation for
patients, donors, families and caregivers, and providers. The IOTA
Model is a part of this coordinated effort from the OTAG and relies on
input from across CMS and HRSA.
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\180\ Moody-Williams, J., Nair, S. Organ Transplantation
Affinity Group (OTAG): Strengthening accountability, equity, and
performance. CMS Blog, September 15, 2023. <a href="https://www.cms.gov/blog/organ-transplantation-affinity-group-otag-strengthening-accountability-equity-and-performance">https://www.cms.gov/blog/organ-transplantation-affinity-group-otag-strengthening-accountability-equity-and-performance</a>.
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C. Provisions of the Regulation

1. Implementing the IOTA Model
In this section III.C of the final rule, we discuss our policies
for the IOTA Model, including model-specific definitions and the
general framework for implementation of the IOTA Model. The upside risk
payments owed to the IOTA participants and the downside risk payments
owed to CMS are designed to increase access to kidney transplants for
patients with ESRD on the IOTA participant's waitlist. As described in
section I of this final rule, access to kidney transplants varies
widely by region and across transplant hospitals, and disparities by
demographic characteristics are pervasive, raising the need to
strengthen and improve performance by kidney transplant hospitals. We
theorize that the IOTA Model financial incentives will promote
improvement activities across selected transplant hospitals that
address access barriers, including SDOH, thereby increasing the number
of transplants, quality of care, and the provision of cost-effective
treatment. Selected transplant hospitals may be motivated to revisit
processes and policies around deceased and living donor organ
acceptance to identify opportunities for improvement. The IOTA Model
payments incentivize selected transplant hospitals to engage in care
delivery transformation to better coordinate and manage patient care
and needs, invest in infrastructure, improve the patient, family, and
caregiver experience, and engage a care delivery team that is tasked
with holistic patient care.
a. Model Performance Period
In section III.C.1.a of the proposed rule, we proposed a 6-year
``model performance period.'' We proposed to define the model
performance period as the 72-month period from the model start date,
comprised of 6 individual PYs. The IOTA participants' performance would
be measured and assessed during the model performance period for
purposes of determining their performance-based payments. We proposed
to define the ``performance year'' (PY) as a 12-month calendar year
during the model performance period. We proposed to define the start of
the model performance period as the ``model start date,'' and we
proposed a model start date of January 1, 2025, meaning that PY 1 would
be January 1, 2025, to December 31, 2025, and the model performance
period would end on December 31, 2030. We proposed a 6-year model
performance period to allow sufficient time for selected transplant
hospitals to invest in care delivery transformation and realize returns
on investments.
We alternatively considered a 3- or 5-year model performance
period; however, we believe that a 3-year model performance period
would be too short to allow adequate time for selected transplant
hospitals to invest in care delivery transformations. Additionally, our
analyses detailed in section V of this final rule project that
considerable savings to Medicare will be achieved after the fifth PY,
which is another reason why we proposed a 6-year model performance
period. We also considered a 10-year model performance period similar
to some more recent Innovation Center models; however, given that this
is a mandatory model, we felt it was important to limit the duration of
the initial test to a shorter period.
We alternatively considered proposing to begin the IOTA Model on
April 1, 2025, or July 1, 2025, to allow selected transplant hospitals
more time to prepare to implement the model and to better align the
model performance period with that of our data sources, as detailed in
section III.C.5.a of this final rule. However, we proposed a January 1,
2025, start date because we believed that there would be sufficient
time for IOTA participants to prepare for the model. A proposed start
date of January 1, 2025, also aligned with other CMS calendar year
rules. We separately proposed that in the event the model start date is
delayed from the proposed start date, the model performance period for
the entire model would be 6

[[Page 96302]]

PYs, with each PY being a 12-month period that begins on the model
start date. For example, if the IOTA Model were to begin on April 1,
2025, ``performance year'' would be defined as a 12-month period
beginning on the model start date, meaning April 1, 2025, to March 31,
2026. As a result, the model performance period would also shift to
include a 72-month period from the model start date. In this example,
the model performance period would be April 1, 2025, to March 31, 2031.
We sought comment on the proposed model performance period of 6
years and the proposed model start date. We also sought comment on the
alternative model performance periods that we considered of 3, 5, and
10 years. Finally, we sought comment on the alternative start dates of
April 1, 2025, and July 1, 2025, and the subsequent adjustments to the
model performance period if the model start date were to change.
Comment: A few commenters supported the proposed model length of
six years, indicating that is an appropriate length of time to be able
to evaluate a model to determine success.
Response: We thank the commenters for the support and agree a six-
year model test should provide sufficient evidence to determine if the
IOTA Model is achieving its goals of improving quality of care and
reducing Medicare expenditures.
Comment: Several commenters expressed concern around the six-year
model performance period. A few commenters felt that a post-transplant
evaluation time horizon of six-years contradicts the current OPTN
standard of one to three years of post-transplant follow-up. A few
commenters also felt that six-years is too long of a model performance
period as a shorter model performance period may allow for more
immediate assessment and refinement and an adjustment period for
unintended consequences. Finally, a commenter felt that the six-year
model performance period should be suspended in the event that CMS
changes the organ acquisition methodology as initially proposed in the
Fiscal Year 2022 Hospital Inpatient Prospective Payment System notice
of proposed rulemaking in order to first evaluate the unintended
consequences of that proposed change.
Response: We appreciate commenters expressing concern about the
six-year model performance period. We believe a six-year model
performance period is necessary to allow selected kidney transplant
hospitals enough time to invest in care delivery changes necessary for
success under the model. CMS research also shows that savings to the
Medicare trust fund occur after at least five years of a model
performance period. We disagree that a six-year model performance
period contradicts current OPTN metrics given that the main focus of
the model is to increase the number of transplants year over year, and
not to follow post-transplant outcomes after six years. We believe the
composite graft survival ratio discussed in section III.C.5.e(1) of
this final rule does not contradict the OPTN standard of one to three
years of post-transplant follow-up, but rather expands upon existing
metrics. Furthermore, models are constantly evaluated and modified even
during the model performance period through subsequent rulemaking. A
shorter model performance period is not required to make changes
responsive to IOTA participant feedback.
We recognize that there may be other efforts occurring
simultaneously with the implementation of the IOTA Model, such as the
OPTN Modernization efforts and the implementation of the updated OPO
Conditions for Coverage. We believe these efforts are synergistic
rather than antagonistic because they broadly share the aims of
increasing the number of successful transplants and improve quality
outcomes for transplant recipients. Therefore, we do not believe that
we need to make changes to the six-year model performance period.
Comment: Several commenters felt that the proposed January 1, 2025,
model start date did not

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