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Proposed Rule2024-09989

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

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Published

May 17, 2024

Issuing agencies

Health and Human Services DepartmentCenters for Medicare & Medicaid Services

Abstract

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

Full Text

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[Federal Register Volume 89, Number 97 (Friday, May 17, 2024)]
[Proposed Rules]
[Pages 43518-43634]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-09989]

[[Page 43517]]

Vol. 89

Friday,

No. 97

May 17, 2024

Part II

Department of Homeland Security

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Cybersecurity and Infrastructure Security Agency

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42 CFR Part 512

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

Federal Register / Vol. 89 , No. 97 / Friday, May 17, 2024 / Proposed
Rules

[[Page 43518]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 512

[CMS-5535-P]
RIN 0938-AU51

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

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

ACTION: Proposed rule.

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

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

ADDRESSES: In commenting, please refer to file code CMS-5535-P.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-5535-P, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid
Services,Department of Health and Human Services, Attention: CMS-5535-
P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-
1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: <a href="/cdn-cgi/l/email-protection#b3f0fefefac7c1d2ddc0c3dfd2ddc7f3d0dec09ddbdbc09dd4dcc5">[email&#160;protected]</a> for
questions related to the Increasing Organ Transplant Access Model.
<a href="/cdn-cgi/l/email-protection#6c2f212125413f180d02080d1e083c1e031a051f0503021f2c0f011f4204041f420b031a">[email&#160;protected]</a> for questions related to the
Standard Provisions for Innovation Center Models.

SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments. CMS will not post on <a href="http://Regulations.gov">Regulations.gov</a> public
comments that make threats to individuals or institutions or suggest
that the commenter will take actions to harm an individual. CMS
encourages individuals not to submit duplicative comments. We will post
acceptable comments from multiple unique commenters even if the content
is identical or nearly identical to other comments.

Current Procedural Terminology (CPT) Copyright Notice

Throughout this proposed rule, we use CPT[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. All Rights Reserved. CPT[supreg] is a registered trademark
of the American Medical Association (AMA). Applicable Federal
Acquisition Regulations (FAR) and Defense Federal Acquisition
Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

Section 1115A of the Social Security Act (the Act) gives the
Secretary of Health and Human Services the authority to test innovative
payment and service delivery models to reduce program expenditures in
Medicare, Medicaid, and the Children's Health Insurance Program (CHIP)
while preserving or enhancing the quality of care furnished to
individuals covered by such programs. This proposed rule describes a
new mandatory Medicare payment model to be tested under section 1115A
of the Act--the Increasing Organ Transplant Access Model (IOTA Model)--
which would begin on January 1, 2025 and end on December 31, 2030. In
this proposed rule, we propose payment policies, participation
requirements, and other provisions to test the IOTA Model. We propose
to test whether performance-based incentives (including both upside and
downside risk) for participating kidney transplant hospitals can
increase the number of kidney transplants (including both living donor
and deceased donor transplants) furnished to End Stage Renal Disease
(ESRD) patients, encourage investments in care processes and patterns
with respect to patients who need kidney transplants, encourage
investments in value-based care and improvement activities, and promote
kidney transplant hospital accountability by tying payments to value.
The IOTA Model is also intended to advance health equity by improving
equitable access to the transplantation ecosystem through design
features such as a proposed health equity plan requirement to address
health outcome disparities and a health equity performance adjustment.
This proposed rule also includes proposed standard provisions that
would apply to Innovation Center models whose first performance periods
begin on or after January 1, 2025, unless otherwise specified in a
model's governing documentation, as well as to Innovation Center models
whose first performance periods begin prior to January 1, 2025,
provided the standard provisions are incorporated into such models'
governing documentation. The proposed standard provisions address
beneficiary protections; cooperation in model evaluation and
monitoring; audits and record retention; rights in data and
intellectual property; monitoring and compliance; remedial action;
model termination by CMS; limitations on review; miscellaneous
provisions on bankruptcy and other

[[Page 43519]]

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

B. Summary of the Proposed Provisions

1. Standard Provisions for Innovation Center Models
The proposed standard provisions for Innovation Center models would
be applicable to all Innovation Center models whose first performance
periods begin on or after January 1, 2025, subject to any limitations
specified in a model's governing documentation. The proposed standard
provisions also would apply to all Innovation Center models whose first
performance periods begin prior to January 1, 2025, provided the
standard provisions are incorporated into such models' governing
documentation.
We are proposing to codify these standard provisions to increase
transparency, efficiency, and clarity in the operation and governance
of Innovation Center models, and to avoid the need to restate the
provisions in each model's governing documentation. The proposed
standard provisions include terms that have been repeatedly
memorialized, with minimal variation, in existing models' governing
documentation. The proposed standard provisions are not intended to
encompass all of the terms and conditions that would apply to each
Innovation Center model, because each model embodies unique design
features and implementation plans that may require additional, more
tailored provisions, including with respect to payment methodology,
care delivery and quality measurement, that would continue to be
included in each model's governing documentation. Model-specific
provisions applicable to the IOTA Model proposed herein are described
in section III of this proposed rule.
2. Model Overview--Proposed Increasing Organ Transplant Access Model
a. Proposed IOTA Model Overview
End-Stage Renal Disease (ESRD) is a medical condition in which a
person's kidneys cease functioning on a permanent basis, leading to the
need for a regular course of long-term dialysis or a kidney transplant
to maintain life.\1\ 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.\2\ For ESRD patients, regular
dialysis sessions or a kidney transplant is required for survival.
Relative to dialysis, a kidney transplant can improve survival, reduce
avoidable health care utilization and hospital acquired conditions,
improve quality of life, and lower Medicare expenditures.\3\ \4\
However, despite these benefits, evidence shows low rates of ESRD
patients placed on kidney transplant hospitals' waitlists, a decline in
living donors over the past 20 years, and underutilization of available
donor kidneys, coupled with increasing rates of donor kidney discards,
and wide variation in kidney offer acceptance rates and donor kidney
discards by region and across kidney transplant hospitals.\5\ \6\
Further, there are substantial disparities in both deceased and living
donor transplantation rates among structurally disadvantaged
populations. Strengthening and improving the performance of the organ
transplantation system is a priority for the Department of Health and
Human Services (HHS). Consistent with this priority, and through joint
efforts with HHS' Health Resources and Services Administration (HRSA),
the proposed IOTA Model would aim to reduce Medicare expenditures and
improve performance and equity in kidney transplantation by creating
performance-based incentive payments for participating kidney
transplant hospitals tied to access and quality of care for ESRD
patients on the hospitals' waitlists.
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\1\ 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>.
\2\ 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.
\3\ Tonelli, M., Wiebe, N., Knoll, G., Bello, A., Browne, S.,
Jadhav, D., Klarenbach, S., & Gill, J. (2011). Systematic review:
kidney transplantation compared with dialysis in clinically relevant
outcomes. American Journal of Transplantation: Official Journal of
the American Society of Transplantation and the American Society of
Transplant Surgeons, 11(10), 2093-2109. <a href="https://doi.org/10.1111/j.1600-6143.2011.03686.xhttps://doi.org/10.1111/j.1600-6143.2011.03686">https://doi.org/10.1111/j.1600-6143.2011.03686.xhttps://doi.org/10.1111/j.1600-6143.2011.03686</a>.
\4\ 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. <a href="https://doi.org/10.1001/jamanetworkopen.2022.184">https://doi.org/10.1001/jamanetworkopen.2022.184</a>.
\5\ 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>.
\6\ 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. <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 proposed IOTA Model would be a mandatory model that would begin
on January 1, 2025 and end on December 31, 2030, resulting in a 6-year
model performance period (``model performance period'') comprised of 6
individual performance years (each a ``performance year'' or ``PY'').
The proposed IOTA Model would test whether performance-based incentives
paid to, or owed by, participating kidney transplant hospitals can
increase access to kidney transplants for patients with ESRD, while
preserving or enhancing quality of care and reducing Medicare
expenditures. CMS would select kidney transplant hospitals to
participate in the IOTA Model through the methodology proposed in
section III.C.3.d of this proposed rule. As this would be a mandatory
model, the selected kidney transplant hospitals would be required to
participate. CMS would measure and assess the participating kidney
transplant hospitals' performance during each PY across three
performance domains: achievement, efficiency, and quality.
The achievement domain would assess each participating kidney
transplant hospital on the overall number of kidney transplants
performed during a PY, relative to a participant-specific target. The
efficiency domain would assess the kidney organ offer acceptance rates
of each participating kidney transplant hospital relative to the
national rate. The quality domain would assess the quality of care
provided by the participating kidney transplant hospitals across a set
of proposed outcome metrics and quality measures. Each participating
kidney transplant hospital's performance score across these three
domains would determine its final performance score and corresponding
amount for the performance-based incentive payment that CMS would pay
to, or the payment that would be owed by, the participating kidney
transplant hospital. The proposed upside risk payment would be a lump
sum payment paid by CMS after the end of a PY to a participating kidney
transplant hospital with a final performance score of 60 or greater.
Conversely, beginning after PY 2, the downside risk payment would be a
lump sum payment paid to CMS by any participating kidney transplant
hospital

[[Page 43520]]

with a final performance score of 40 or lower. We are not proposing a
downside risk payment for PY 1 of the model.
b. Model Scope
We propose that participation in the IOTA Model would be mandatory
for 50 percent of all eligible kidney transplant hospitals in the
United States. We anticipate that a total of approximately 90 kidney
transplant hospitals will be selected to participate in the IOTA Model.
As discussed in section III.C.3.b. of this proposed rule, we believe
that mandatory participation is necessary to minimize the potential for
selection bias and to ensure a representative sample size nationally,
thereby guaranteeing that there will be adequate data to evaluate the
model test.
We propose that eligible kidney transplant hospitals would be those
that: (1) performed at least eleven kidney transplants for patients 18
years of age or older annually regardless of payer type during the
three-year period ending 12 months before the model's start date; and
(2) furnished more than 50 percent of the hospital's annual kidney
transplants to patients 18 years of age or older during that same
period. We propose to select the kidney transplant hospitals that will
be required to participate in the IOTA Model from the group of eligible
kidney transplant hospitals using a stratified random sampling of
donation service areas (``DSAs'') to ensure that there is a fair
selection process and representative group of participating kidney
transplant hospitals. For the purposes of this proposed rule, a DSA has
the same meaning given to that term at 42 CFR 486.302.
c. Performance Assessment
We propose to assess each IOTA participants' performance across
three performance domains during each PY of the model, with a maximum
possible final performance score of 100 points. The three performance
domains would include: (1) an achievement domain worth up to 60 points,
(2) an efficiency domain worth up to 20 points, and (3) a quality
domain worth up to 20 points.
The achievement domain would assess the number of kidney
transplants performed by each IOTA participant for attributed patients,
with performance on this domain worth up to 60 points. The final
performance score would be heavily weighted on the achievement domain
to align with the IOTA Model's goal to increase access to kidney
transplants. The IOTA Model theorizes that improvement activities,
including those aimed at reducing unnecessary deceased donor discards
and increasing living donors, may help increase access to kidney
transplants.
We propose that CMS would set a target number of kidney transplants
for each IOTA participant for each PY to measure the IOTA participant's
performance in the achievement domain (the ``transplant target''), as
described in section III.C.5.c of this proposed rule. Each IOTA
participant's transplant target for a given PY would be based on the
IOTA participant's historical volume of deceased and living donor
transplants furnished to attributed patients in the relevant baseline
years, adjusted by the national trend rate in the number of kidney
transplants performed and further adjusted by the proportion of
transplants furnished by the IOTA participant to attributed patients
who are low income. Section III.C.5.c. of this proposed rule describes
the variation in the number of kidney transplants performed across
kidney transplant hospitals, which would make it challenging to set
transplant targets on a regional or national basis. The IOTA Model
would therefore set a transplant target that is specific to each IOTA
participant to address this concern, while still accounting for the
national trend rate in the number of kidney transplants performed. It
is expected that IOTA participants' transplant targets may change from
PY to PY because of the way in which the transplant target would be
calculated.
The efficiency domain would assess the kidney organ offer
acceptance rate ratio for each IOTA participant. The kidney organ offer
acceptance rate ratio measures the number of kidneys an IOTA
participant accepts for transplant over the expected value, based on
variables such as kidney quality. Points for the kidney organ offer
acceptance rate ratio would be determined relative to either the kidney
organ offer acceptance rate ratio across all kidney transplant
hospitals, or the IOTA participant's own past kidney organ offer
acceptance rate ratio, with performance on the efficiency domain being
worth up to 20 points.
Finally, the quality domain would assess IOTA participants'
performance on post-transplant outcomes in addition to three quality
measures--the CollaboRATE Shared Decision-Making Score, Colorectal
Cancer Screening, and the 3-Item Care Transition Measure, with
performance on this domain being worth up to 20 points.
Each IOTA participant's final performance score would be the sum of
the points earned for each domain: achievement, efficiency, and
quality. The final performance score in a PY would be determinative of
whether the IOTA participant would be eligible to receive an upside
risk payment from CMS, fall into the neutral zone where no upside or
downside risk payment would apply, or owe a downside risk payment to
CMS for the PY as described in section III.C.6. of this proposed rule.
d. Performance-Based Incentive Payment Formula
Each IOTA participant's final performance score would determine
whether: (1) CMS would pay an upside risk payment to the IOTA
participant; (2) the IOTA participant would fall into a neutral zone,
in which case no performance-based incentive payment would be paid to
or owed by the IOTA participant; or (3) the IOTA participant would owe
a downside risk payment to CMS. For a final performance score above 60,
CMS would apply the formula for the upside risk payment, which we
propose would be equal to the IOTA participant's final performance
score minus 60, then divided by 60, then multiplied by $8,000, then
multiplied by the number of kidney transplants furnished by the IOTA
participant to attributed patients with Medicare as their primary or
secondary payer during the PY. Final performance scores below 60 in PY
1 and final performance scores of 41 to 59 in PYs 2-6 would fall in the
neutral zone where there would be no payment owed to the IOTA
participant or CMS.
We propose to phase-in the downside risk payment beginning in PY2.
We explain in section III.C.5.b. of this proposed rule that new
entrants to value-based payment models may need a ramp up period before
they are able to accept downside risk. Thus, the IOTA Model proposes an
upside risk-only approach for PY 1 as an incentive in each of the three
performance domains. This would give IOTA participants time to
consider, invest in, and implement value-based care and quality
improvement initiatives before downside risk payments would begin.
Beginning in PY 2, for a final performance score of 40 and below, CMS
would apply the formula for the downside risk payment, which would be
equal to the IOTA participant's final performance score minus 40, then
divided by 40, then multiplied by -$2,000, then multiplied by the
number of kidney transplants furnished by the IOTA participant to
attributed patients with Medicare as their primary or secondary payer
during the PY.
CMS would pay the upside risk payment in lump sum to the IOTA
participant after the PY. The IOTA participant would pay the downside

[[Page 43521]]

risk payment to CMS in a lump sum after the PY.
e. Data Sharing
We propose to collect certain quality, clinical, and administrative
data from IOTA participants for model monitoring and evaluation
activities under the authority in 42 CFR 403.1110(b). We would also
share certain data with IOTA participants upon request as described in
section III.C.3.a. of this proposed rule and as permitted by the Health
Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy
Rule and other applicable law. We propose to offer each IOTA
participant the opportunity to request certain beneficiary-identifiable
data for their attributed Medicare beneficiaries for treatment, case
management, care coordination, quality improvement activities, and
population-based activities relating to improving health or reducing
health care costs, as permitted by 45 CFR 164.506(c). The data uses and
sharing would be allowed only to the extent permitted by the HIPAA
Privacy Rule and other applicable law and CMS policies. We also propose
to share certain aggregate, de-identified data with IOTA participants.
f. Other Requirements
We propose several other model requirements for selected transplant
hospitals, including transparency requirements, public reporting
requirements, and a health equity plan requirement which would be
optional for PY1 and required for PY 2 through PY 6, as described in
section III.C.8. of this proposed rule.
(1) Transparency Requirements
Patients are often unsure whether they qualify for a kidney
transplant at a given kidney transplant hospital. We propose that IOTA
participants would be required to publish on a public facing website
the criteria they use when determining whether or not to add a patient
to the kidney transplant waitlist. We also propose to add requirements
to facilitate increased transparency for patients regarding the organ
offers received on the patient's behalf while the patient is on the
waitlist. Specifically, we propose that IOTA participants would be
required to inform patients on the waitlist, on a monthly basis, of the
number of times an organ was declined on each patient's behalf and the
reason(s) why each organ was declined. We believe that notifying
patients of the organs declined on their behalf would encourage
conversations between patients and their providers regarding a
patient's preferences for transplant and facilitate better shared
decision-making.
(2) Health Equity Requirements
We propose that during the model's first PY, each IOTA participant
would have the option to submit a health equity plan (``HEP'') to CMS.
We propose that each IOTA participant would then be required to submit
a HEP to CMS for PY 2 and to update its HEP for each subsequent PY. We
propose that the IOTA participant's HEP would identify health
disparities within the IOTA participant's population of attributed
patients and outline a course of action to address them.
We also considered proposing to require IOTA participants to
collect and report patient-level health equity data to CMS.
Specifically, we considered proposing that IOTA participants would be
required to conduct health related social needs screening for at least
three core areas--food security, housing, and transportation. We
recognize these areas as some of the most common barriers to kidney
transplantation and the most pertinent health related social needs for
the IOTA patient population.\7\ We have included an RFI in this
proposed rule to solicit feedback and comment on such a requirement.
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\7\ Venkataraman, S., & Kendrick, J. (2020). Barriers to kidney
transplantation in ESKD. Seminars in Dialysis, 33(6), 523-532.
<a href="https://doi.org/10.1111/sdi.12921">https://doi.org/10.1111/sdi.12921</a>.
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g. Medicare Payment Waivers and Additional Flexibilities
We believe it is necessary to waive certain requirements of title
XVIII of the Act solely for purposes of carrying out the testing of the
IOTA Model under section 1115A of the Act. We propose to issue these
waivers using our waiver authority under section 1115A(d)(1) of the
Act. Each of the proposed waivers is discussed in detail in section
III.C.10. of this proposed rule.
h. Overlaps With Other Innovation Center Models and CMS Programs
We expect that there could be situations where a Medicare
beneficiary attributed to an IOTA participant is also assigned,
aligned, or attributed to another Innovation Center model or CMS
program. Overlap could also occur among providers and suppliers at the
individual or organization level, such as where an IOTA participant or
one of their providers would participate in multiple Innovation Center
models. We believe that the IOTA Model would be compatible with
existing models and programs that provide opportunities to improve care
and reduce spending. The IOTA Model would not be replacing any covered
services or changing the payments that participating hospitals receive
through the inpatient prospective payment system (IPPS) or outpatient
prospective payment system (OPPS). Rather, the IOTA Model proposes
performance-based payments separate from what participants would be
paid by CMS for furnishing kidney transplants to Medicare
beneficiaries. Additionally, we would work to resolve any potential
overlaps between the IOTA Model and other Innovation Center models or
CMS programs that could result in duplicative payments for services, or
duplicative counting of savings or other reductions in expenditures.
Therefore, we propose to allow overlaps between the IOTA Model and
other Innovation Center models and CMS programs.
i. Monitoring
We propose to closely monitor the implementation and outcomes of
the IOTA Model throughout its duration consistent with the monitoring
requirements proposed in the Standard Provisions for Innovation Center
models in section II of this proposed rule and the proposed
requirements in section III.C.13. of this proposed rule. The purpose of
this monitoring would be to ensure that the IOTA Model is implemented
safely and appropriately, that the quality and experience of care for
beneficiaries is not harmed, and that adequate patient and program
integrity safeguards are in place.
j. Beneficiary Protections
As proposed in section III.C.10. of this proposed rule, CMS would
not allow beneficiaries or patients to opt out of attribution to an
IOTA participant; however, the IOTA Model would not restrict a
beneficiary's freedom to choose another kidney transplant hospital, or
any other provider or supplier for healthcare services, and IOTA
participants would be subject to the Standard Provisions for Innovation
Center Models outlined in section II. of this proposed rule protecting
Medicare beneficiary freedom of choice and access to medically
necessary services. We also would require that IOTA participants notify
Medicare beneficiaries of the IOTA participant's participation in the
IOTA Model by, at a minimum, prominently displaying informational
materials in offices or facilities where beneficiaries receive care.
Additionally, IOTA participants would be subject to the proposed
Standard Provisions for Innovation Center Models regarding descriptive
model materials and activities in section II. of this proposed rule.

[[Page 43522]]

C. Summary of Costs and Benefits

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

II. Standard Provisions for Innovation Center Models

A. Introduction

Section 1115A of the Act authorizes the Center for Medicare and
Medicaid Innovation (the ``Innovation Center'') to test innovative
payment and service delivery models expected to reduce Medicare,
Medicaid, and CHIP expenditures, while preserving or enhancing the
quality of care furnished to such programs' beneficiaries. We have
designed and tested both voluntary Innovation Center models--governed
by participation agreements, cooperative agreements, and model-specific
addenda to existing contracts with CMS--and mandatory Innovation Center
models that are governed by regulations. Each voluntary and mandatory
model features its own specific payment methodology, quality metrics,
and certain other applicable policies, but each model also features
numerous provisions of a similar or identical nature, including
provisions regarding cooperation in model evaluation; monitoring and
compliance; and beneficiary protections.
On September 29, 2020, we published in the Federal Register a final
rule titled ``Medicare Program; Specialty Care Models To Improve
Quality of Care and Reduce Expenditures'' (85 FR 61114) (hereinafter
the ``Specialty Care Models final rule''), in which we adopted General
Provisions Related to Innovation Center models at 42 CFR part 512
subpart A that apply to the End-Stage Renal Disease Treatment Choices
(ETC) Model and the Radiation Oncology (RO) Model.\8\ The Specialty
Care Models final rule codified general provisions regarding
beneficiary protections, cooperation in model evaluation and
monitoring, audits and record retention, rights in data and
intellectual property, monitoring and compliance, remedial action,
model termination by CMS, limitations on review, and bankruptcy and
other notifications. These general provisions were adopted only for the
ETC and RO Models (and, in practice, applied only to the ETC Model).
However, we now believe the general provisions should apply to
Innovation Center models more broadly. As we note, the Innovation
Center models share numerous similar provisions, and codifying the
general provisions into law to expand their applicability across
models, except where otherwise explicitly specified in a model's
governing documentation, would, we believe, promote transparency,
efficiency, clarity, and ensure consistency across models to the extent
appropriate, while avoiding the need to restate the provisions in each
model's governing documentation.
---------------------------------------------------------------------------

\8\ 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 part
512.205 to provide for a 5-year model performance period starting on
January 1, 2022, unless the RO Model was prohibited by law from
starting on January 1, 2022, in which case the model performance
period would begin on the earliest date permitted by law that is
January 1, April 1, or July 1. We also proposed other modifications
both related and unrelated to the timing of the RO Model in the
proposed rule that appeared in the August 4, 2021, Federal Register
titled ``Medicare Program: Hospital Outpatient Prospective Payment
and Ambulatory Surgical Center Payment Systems and Quality Reporting
Programs; Price Transparency of Hospital Standard Charges; Radiation
Oncology Model; Request for Information on Rural Emergency
Hospitals'' (86 FR 42018). These provisions were finalized in a
final rule with comment period titled ``Medicare Program: Hospital
Outpatient Prospective Payment and Ambulatory Surgical Center
Payment Systems and Quality Reporting Programs; Price Transparency
of Hospital Standard Charges; Radiation Oncology Model'' that
appeared in the November 16, 2021 Federal Register (86 FR 63458)
(hereinafter referred to as the ``CY 2022 OPPS/ASC FC'').
On December 10, 2021, the Protecting Medicare and American
Farmers from Sequester Cuts Act (Pub. L. 117-71) was enacted, which
included a provision that prohibits implementation of the RO Model
prior to January 1, 2023. The CY 2022 OPPS/ASC final rule with
comment period specified that if the RO Model was prohibited by law
from beginning on January 1, 2022, the model performance period
would begin on the earliest date permitted by law that is January 1,
April 1, or July 1. As a result, under the current definition for
model performance period at 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 propose a new provision pertaining to the reconsideration
review process that would apply to Innovation Center models that waive
the appeals processes provided under section 1869 of the Act.

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

Each Innovation Center model features many unique aspects that must
be memorialized in its governing documentation, but each model also
includes certain provisions that are common to most or all models. We
believe that codifying these common provisions would facilitate their
uniform application across models (except where the governing
documentation for a particular model dictates otherwise) and promote
program efficiency and consistency that would benefit CMS' program
administration and model participants.
As such, we propose to expand the applicability of the 42 CFR part
512 subpart A ``General Provisions Related to Innovation Center
Models'' to all Innovation Center models whose first performance
periods begin on or after January 1, 2025, unless otherwise specified
in the models' governing documentation, and also to any Innovation
Center models whose first performance periods begin prior to January 1,
2025 if incorporated by reference into the models' governing
documentation. To accomplish this, we propose that the provisions
codified at 42 CFR part 512 subpart A for the ETC and RO Models,
including those with respect to definitions, beneficiary protections,
cooperation in model evaluation and monitoring, audits and record
retention, rights in data and intellectual property, monitoring and
compliance, remedial action, Innovation Center model termination by
CMS, and limitations on review, would be designated as the newly
defined ``standard provisions for Innovation Center models'' and would
apply to all Innovation Center models as described

[[Page 43523]]

above. We propose specific revisions that would be necessary to expand
the scope of several of the current general provisions, but otherwise
propose that the general provisions (which would be referred to as the
``standard provisions for Innovation Center models'') would not change.
In particular, we propose that the substance of the following
provisions would not change, except that they would apply to all
Innovation Center Models as opposed to just the ETC and RO Models:
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. Proposed Revisions to the Titles, Basis and Scope Provision, and
Effective Date

We propose to amend the title of part 512 to read ``Standard
Provisions for Innovation Center Models and Specific Provisions for the
Radiation Oncology Model and the End Stage Renal Disease Model'' so
that it more closely aligns with the other changes proposed herein and
to ensure that the title indicates that part 512 includes both standard
provisions for Innovation Center models and specific provisions for the
RO and ETC Models. We also propose to amend the title of subpart A to
read ``Standard Provisions for Innovation Center Models'' to use the
term we propose to define the provisions codified at 42 CFR part 512
subpart A.
Additionally, we propose to amend 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
propose to determine on a case-by-case basis, based on each model's
unique features and design, whether the standard provisions would apply
to a particular model, or whether we would specify alternate terms in
the model's governing documentation.
We believe that these standard provisions are necessary for the
testing of the IOTA model, regardless of whether they are finalized as
proposed for all Innovation Center models. As such, as an alternative
to the previous proposal, we would propose making these standard
provisions for Innovation Center models applicable to, and effective
for, the IOTA Model beginning on January 1, 2025, absent extending the
standard provisions to all Innovation Center models. Under such an
alternative, the general provisions in the Specialty Care Models final
rule would also still be applicable to the ETC Model and the RO Model.
These proposed standard provisions would not, except as
specifically noted in this section II. of this proposed rule, affect
the applicability of other provisions affecting providers and suppliers
under Medicare fee-for-service (FFS).
We invite public comment on these proposed changes.

D. Provisions Revising Certain Definitions

We propose to amend the definition of ``Innovation Center model''
at 42 CFR 512.110 by replacing the specific references to the RO and
ETC Models with a definition consistent with section 1115A of the Act
and intended to encompass all Innovation Center models. We propose to
amend the definition for ``Innovation Center model'' to read as
follows: ``an innovative payment and service delivery model tested
under the authority of section 1115A(b) of the Act, including a model
expansion under section 1115A(c) of the Act.''
We propose to add a new definition of the term ``governing
documentation'' at 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 propose to add a new definition, ``standard provisions for
Innovation Center models,'' at Sec. 512.110 to mean, ``the provisions
codified in 42 CFR 512 Subpart A.'' We propose 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 propose to amend the definitions of ``Innovation Center
model activities,'' ``model beneficiary,'' and ``model participant'' to
pertain to all ``Innovation Center models,'' as we propose to define
that term, instead of just the models previously implemented under part
512. As such, we propose to define ``Innovation Center model
activities'' to mean ``any activities affecting the care of model
beneficiaries related to the test of the Innovation Center model.'' We
propose to define ``model beneficiary'' to mean ``a beneficiary
attributed to a model participant or otherwise included in an
Innovation Center model.'' We propose to define ``model participant''
to mean ``an individual or entity that is identified as a participant
in the Innovation Center model.''
We invite public comment on these proposed changes to the
definitions of ``Innovation Center model,'' ``Innovation Center model
activities,'' ``model beneficiary,'' and ``model participant'' and the
proposed definitions of ``governing documentation,'' ``standard
provisions for Innovation Center models,'' and ``performance period.''

E. Proposed Reconsideration Review Process

We propose to add a new 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 propose 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 propose 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 propose to
codify a reconsideration review process in regulation in order to have
a transparent and consistent method of reconsideration for model
participants participating in models that do not utilize the standard
reconsideration process outlined in section 1869 of the Act.
This proposed reconsideration review process would be utilized
where a model-specific determination has been made and the affected
model participant

[[Page 43524]]

disagrees with, and wishes to challenge, that determination. Each
Innovation Center model features a unique payment and service delivery
model, and, as such, requires its own model-specific determination
process. Each Innovation Center model's governing documentation details
the model-specific determinations made by CMS, which may include, but
are not limited to, model-specific payments, beneficiary attribution,
and determinations regarding remedial actions. Each Innovation Center
model's governing documentation also includes specific details about
when a determination is final and may be disputed through the model's
reconsideration review processes.
We propose at 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 propose 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 propose 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 propose 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 propose that requests that do
not meet the requirements of paragraph (b)(1) would be denied.
We propose 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 propose 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 propose that the reconsideration review
process would not be available to the model participant with regard to
that model-specific payment.
We propose to codify standards for reconsideration at Sec.
512.190(c). First, during the course of the reconsideration, we propose
that both CMS and the party requesting the reconsideration must
continue to fulfill all responsibilities and obligations under the
governing documentation during the course of any dispute arising under
the governing documentation. Second, the reconsideration would consist
of a review of documentation timely submitted to the reconsideration
official and in accordance with the standards specified by the
reconsideration official in the acknowledgement at Sec. 512.190(b)(3).
Finally, we propose that the model participant would bear the burden of
proof to demonstrate with clear and convincing evidence to the
reconsideration official that the determination made by CMS was
inconsistent with the terms of the governing documentation.
We propose to codify at 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 documents and data timely submitted to CMS by the model
participant in the required format before CMS made the initial
determination that is the subject of the reconsideration request. We
propose at 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 propose to codify at Sec. 512.190(e) a process for the CMS
Administrator to review reconsideration determinations made under Sec.
512.190(d). We propose that either the model participant or CMS may
request that the CMS Administrator review the reconsideration
determination. The request to the CMS Administrator would have to be
made via email, within 30 days of the reconsideration determination, to
an email address specified by CMS. The request would have to include a
copy of the reconsideration determination, as well as a detailed
written explanation of why the model participant or CMS disagrees with
the reconsideration determination. The CMS Administrator would promptly
send the parties a written acknowledgement of receipt of the request
for review. The CMS Administrator would send the parties notice of
whether the request for review was granted or denied. If the request
for review is granted, the notice would include the review procedures
and a schedule that would permit each party to submit a brief in
support of the party's positions for consideration by the CMS
Administrator. If the request for review is denied, the reconsideration
determination would be final and binding as of the date of denial of
the request for review by the CMS Administrator. If the request for
review by the CMS Administrator is granted, the record for review would
consist solely of timely submitted briefs and evidence contained in the
record of the proceedings before the reconsideration official and
evidence as set forth in the documents and data described in proposed
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

[[Page 43525]]

Administrator would review the record and issue to the parties a
written determination that would be final and binding as of the date
the written determination is sent.
We invite public comment on the proposed reconsideration review
process for Innovation Center models.

III. Proposed Increasing Organ Transplant Access (IOTA) Model

A. Introduction

In this proposed rule, we are proposing to test the IOTA Model, a
new mandatory Medicare alternative payment model under the authority of
the Innovation Center, that would begin on January 1, 2025, and end on
December 31, 2030. The IOTA Model would test whether using performance-
based incentive payments in the form of upside risk payments and
downside risk payments to and from select transplant hospitals
increases the number of kidney transplants furnished to patients with
ESRD, thereby reducing Medicare expenditures while preserving or
enhancing quality of care.
The goal of the proposed performance-based payments is: to increase
the number of kidney transplants furnished to ESRD patients placed on a
kidney transplant hospital's waitlist; encourage investments in value-
based care and quality improvement activities, particularly those that
promote an equitable kidney transplant process prior to, during, and
post transplantation for all patients; encourage better use of the
current supply of deceased donor organs and greater provider and
community collaborations to address medical and non-medical needs of
patients; and increased awareness, education, and support for living
donations. The IOTA Model payment structure would also promote IOTA
participant accountability by linking performance-based payments to
quality. We theorize that increasing the number of kidney transplants
furnished to ESRD patients on the participating hospitals' waitlists
would reduce Medicare expenditures by reducing dialysis expenditures
and avoidable health care service utilization and would improve the
quality of life for patients with ESRD.
As discussed in section III.B of this proposed rule, studies show
that kidney transplant hospitals are underutilizing donor kidneys and
have become more conservative in accepting organs for transplantation,
with notable variation by region and across transplant hospitals.\9\
The IOTA Model aims to address these access and equity problems through
financial incentives that reward IOTA participants that improve their
kidney organ offer acceptance rate ratios over time or hold them
financially accountable for not doing so. The IOTA Model's proposed
payment structure would include upside or downside performance-based
incentive payments (``upside risk payment'' or ``downside risk
payment'') for kidney transplant hospitals selected to participate in
the IOTA Model (``IOTA participant''), with these payments being tied
to performance on achievement, efficiency, and quality domains.
---------------------------------------------------------------------------

\9\ 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 would assess the number of kidney
transplants performed relative to a participant-specific target, with
performance on this domain being worth up to 60 points. The efficiency
domain would assess kidney organ offer acceptance rate ratios relative
to a national rate for all kidney transplant hospitals, including those
not selected to participate in the model, with performance on this
domain being worth up to 20 points. The quality domain would assess
performance based on post-transplant outcomes at one-year after
transplant and a proposed set of quality measures, with performance on
this domain being worth up to 20 points. The achievement domain would
be weighted more heavily than the other two domains because increasing
the number of transplants is a key goal of the model and would be a
primary factor in determining the amount of the performance-based
payment.
The final performance score for each IOTA participant would be the
sum of the points earned across the achievement domain, efficiency
domain, and quality domain. The final performance score would determine
whether an upside risk payment or downward risk payment would be owed
and the amount of such payment. Specifically:
<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(a) of this proposed rule (final
performance score minus 60, then divided by 60, then multiplied by
$8,000, then multiplied by the number of kidney transplants furnished
by the IOTA participant to beneficiaries with Medicare as a primary or
secondary payer during the PY).
<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
qualify for the downside risk payment in accordance with the proposed
calculation methodology described in section III.C.6.c.(b). of this
proposed rule (final performance score minus 40, then divided by 40,
then multiplied by -$2,000, then multiplied by the number of kidney
transplants furnished by the IOTA participant to beneficiaries with
Medicare as a primary or secondary payer during the PY).
We recognize the complexity of the transplant ecosystem, which
requires coordination between transplant hospitals, other health care
providers, organ procurement organizations (OPOs), patients, potential
donors, and their families. The proposed IOTA Model does not prescribe
or require specific processes or policy approaches that each selected
IOTA participant must implement for purposes of the model test.
We believe the IOTA Model would complement other efforts in
relation to the transplant ecosystem to enhance health and safety
outcomes, increase transparency, increase the number of transplants,
and reduce disparities. We also believe that the proposed payment
methodology would act in concert with measures that are currently under
development by HRSA to increase the numbers of both deceased and living
donor organ transplants.
This proposed model falls within a larger framework of activities
initiated by the Federal Government during the past several years and
planned for the upcoming year to enhance the donation, procurement, and
transplantation of solid organs. This Federal collaborative, called the
Organ Transplantation Affinity Group (OTAG), is a coordinated group
working together to strengthen accountability, equity, and performance
in organ donation, procurement, and transplantation.\10\
---------------------------------------------------------------------------

\10\ Moody-Williams, J.D., & Nair, S. (2023, September 15).
Organ Transplantation Affinity Group (OTAG): Strengthening
accountability, equity, and performance <radical> 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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[[Page 43526]]

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.\11\ 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.\12\ 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.\13\ 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.\14\ The IOTA Model proposes a
two-sided performance-based payment structure that rewards IOTA
participants for high performance in the achievement, efficiency, and
quality domains, and imposes financial accountability on IOTA
participants that perform poorly on those domains. We propose the IOTA
Model as a complement to wider efforts aimed at transplant ecosystem
performance and equity improvements. Ultimately, we seek a set of
interventions that focus on ESRD patients in need of a kidney
transplant. In this section of the proposed rule, we summarize the
transplant ecosystem and HHS oversight within CMS and HRSA related to
kidney transplantation, highlight related initiatives and priorities
nationally, and outline our rationale for the proposed IOTA Model
informed by literature, data, and studies.
---------------------------------------------------------------------------

\11\ 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>.
\12\ 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>.
\13\ 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>.
\14\ 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>.
---------------------------------------------------------------------------

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.\15\ For kidney transplantation, it also includes ESRD
facilities, commonly known as dialysis facilities.
---------------------------------------------------------------------------

\15\ 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
coordinates the nation's organ procurement, distribution, and
transplantation systems. The OPTN is a network of clinical experts,
patients, donor families, and community stakeholders who work
collectively to develop, implement, and monitor organ allocation policy
and performance of the organ transplant ecosystem.
Organ Procurement Organizations (OPOs) are non-profit organizations
operating under contract with the Federal Government that are charged,
under section 371(b) of the Public Health Service Act (PHS Act, 42
U.S.C. 273(b)) with activities including, but not limited to,
identifying potential organ donors, providing for the acquisition and
preservation of donated organs, the equitable allocation of donated
organs, and the transportation of donated organs to transplant
hospitals. Section 371(b) of the Public Health Services Act requires
that an OPO must have a defined service area, a concept that is defined
at 42 CFR part 486 subpart G as the Donation Service Area (DSA).
Section 1138(b) of the Act states that the Secretary may not designate
more than one OPO to serve each DSA. There are currently 56 OPOs that
serve the United States and Puerto Rico.
Section 1138(b) of the Act lays out the requirements that an OPO
must meet to have its costs reimbursed by the Secretary. CMS sets out
the components of allowable Medicare organ acquisition costs at 42 CFR
413.402(b). Allowable organ acquisition costs are those costs incurred
in the acquisition of organs intended for transplant, and include, but
are not limited to: costs associated with special care services, the
surgeon's fee for excising the deceased donor organ from the donor
patient (limited to $1,250 for kidneys), operating room and other
inpatient ancillary services provided to the living or deceased donor,
organ preservation and perfusion costs, donor and beneficiary
evaluation, and living donor complications. OPOs and transplant
hospitals may incur organ acquisition costs and include these and some
additional administrative and general costs on the Medicare cost
report.
The CMS conditions for coverage for OPOs at 42 CFR 486.322 require
an OPO to have written agreements with 95 percent of the Medicare and
Medicaid certified hospitals and critical access hospitals in its DSA
that have a ventilator and an operating room and have not been granted
a waiver to work with another OPO. These hospitals, known as donor
hospitals, are required by the CMS conditions of participation for
hospitals at 42 CFR 482.45 to have an agreement with an OPO under which
the donor hospital must notify the OPO of patients who are expected to
die imminently and of patients who have died in the hospital. (Under
the hospital conditions of participation, such an agreement is required
of all hospitals that participate in Medicare.) Also, under the
hospital conditions of participation, donor hospitals are responsible
for informing donor patient families of the option to donate organs,
tissues, and eyes, or to decline to donate; and to work collaboratively
with the OPO to educate hospital staff on donation, improve its
identification of potential donors, and work with the OPO to manage the
potential donor patient while testing and placement of the potential
donor organ occurs.
At 42 CFR 482.70, CMS defines a transplant hospital as ``a hospital
that furnishes organ transplants and other medical and surgical
specialty services

[[Page 43527]]

required for the care of transplant patients,'' and a transplant
program as ``an organ-specific transplant program within a transplant
hospital,'' as so defined. In accordance with 42 CFR 482.98, a
transplant program must have a primary transplant surgeon and a
transplant physician with the appropriate training and experience to
provide transplantation services, who are immediately available to
provide transplantation services when an organ is offered for
transplantation. The transplant surgeon is responsible for providing
surgical services related to transplantation, and the transplant
physician is responsible for providing and coordinating transplantation
care.
In accordance with CMS' Conditions for Coverage (CfC) for ESRD
Facilities at 42 CFR part 494, ESRD facilities are charged with
delivering safe and adequate dialysis to ESRD patients, and, among
other requirements, informing patients of their treatment modalities,
including dialysis and kidney transplantation. The CfCs require ESRD
facilities to conduct a patient assessment that includes evaluation of
suitability for referral for transplantation, based on criteria
developed by the prospective transplantation center and its surgeon(s).
General nephrologists refer patients for evaluation for kidney
transplants.\16\ 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.\17\
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\16\ 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>.
\17\ 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.\18\ 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'.\19\ Each transplant hospital has its
own waitlist, and patients can attempt to be placed on multiple
waitlists; OPTN maintains a national transplant waiting list that
encompasses the waitlists for all kidney transplant
hospitals.20 21 Individuals already on dialysis continue to
receive regular dialysis treatments while waiting for an organ to
become available. After surgery, a transplant nephrologist manages the
possible outcomes of organ rejection and infection, and other medical
complications.\22\
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\18\ 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>.
\19\ 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>.
\20\ 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>.
\21\ 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>.
\22\ Transplant Nephrology Fellowship. (n.d.).
<a href="http://Www.hopkinsmedicine.org">Www.hopkinsmedicine.org</a>. Retrieved May 30, 2023, from https://
www.hopkinsmedicine.org/nephrology/education/
transplant_fellowship.html#:~:text=Diagnose%20and%20manage%20acute%20
and.
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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.\23\ The OPTN operates a complex network of
computerized interactions whereby specific deceased donor organs get
matched to individual patients on the national transplant waiting list.
The Scientific Registry of Transplant Recipients (SRTR), operated under
contract with HRSA, is responsible for providing statistical and
analytic support to the OPTN. Section 373 of the PHS Act requires the
operation of the SRTR to support ongoing evaluation of the scientific
and clinical status of solid organ transplantation.\24\
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\23\ On March 22, 2023, HRSA announced an initiative that
included several actions to strengthen accountability and
transparency in the OPTN. These actions include modernization of the
OPTN information technology system. HRSA also intends to issue
contract solicitations for multiple awards to support the OPTN.
\24\ 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.\25\ 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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\25\ U.S. Congress. (1934) United States Code: Social Security
Act, 42 U.S.C. 301-Suppl. 4 1934.
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Additionally, the OPTN Bylaws specify that OPOs whose observed
organ yield rates fall below the expected rates by more than a
specified threshold would be reviewed by the OPTN Membership
Professional Standards Committee (MPSC).\26\ 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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\26\ Bylaws--OPTN. (n.d.). <a href="http://Optn.transplant.hrsa.gov">Optn.transplant.hrsa.gov</a>. Retrieved
May 30, 2023, from <a href="https://optn.transplant.hrsa.gov/policies-bylaws/bylaws/">https://optn.transplant.hrsa.gov/policies-bylaws/bylaws/</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 organ acquisition costs including
kidney registry fees and laboratory tests associated with the
evaluation of a Medicare transplant candidate. The evaluation or
preparation of a living donor, the living donor's donation of the
kidney, and postoperative recovery services directly related to the
living donor's kidney donation are covered under Medicare. In addition,
deductible and coinsurance requirements do not apply to living donors
for services furnished to an individual in connection with the donation
of a kidney for transplant surgery. Medicare Part B coverage includes
the surgeon's fees for performing the kidney transplant procedure and
perioperative care. Medicare Part B also covers physician services for
the living kidney donor without regard to whether the service would
otherwise be covered by

[[Page 43528]]

Medicare. Part A and Part B share responsibility for covering blood,
including packed red blood cells, blood components and the cost of
processing and receiving blood.
Medicare Part B covers immunosuppressive drugs following an organ
transplant for which payment is made under Title XVIII.
Immunosuppressive drugs following an organ transplant are covered by
Part D when an individual did not have Part A at the time of the
transplant. Beneficiaries who have Medicare due to ESRD alone lose
Medicare coverage 36 months following a successful kidney transplant.
Section 402(a) of the Consolidated Appropriations Act (CAA) of 2021
added section 1836(b) of the Act to provide coverage for
immunosuppressive drugs beginning January 1, 2023, for eligible
individuals whose eligibility for Medicare based on ESRD ends by reason
of section 226A(b)(2) of the Act for those three-years post kidney
transplant. Under section 1833 of the Act, the amounts paid by Medicare
for immunosuppressive drugs are equal to 80 percent of the applicable
payment amount; beneficiaries are thus subject to a 20 percent
coinsurance for immunosuppressive drugs covered by both Part B and the
Medicare Part B Immunosuppressive Drug Benefit (Part B-ID).
3. Federal Government Initiatives To Enhance Organ Transplantation
a. CMS Regulatory Initiatives To Enhance Organ Transplantation
On September 30, 2019, we published the final rule, ``Medicare and
Medicaid Programs; Regulatory Provisions To Promote Program Efficiency,
Transparency, and Burden Reduction; Fire Safety Requirements for
Certain Dialysis Facilities; Hospital and Critical Access Hospital
(CAH) Changes To Promote Innovation, Flexibility, and Improvement in
Patient Care'' (84 FR 51732). The rulemaking, in part, aimed to address
the concern that too many organs are being discarded that could be
transplanted successfully, including hearts, lungs, livers, and
kidneys. This rule implemented changes to the transplant program
regulations, eliminating requirements for re-approval of transplant
programs pertaining to data submission, clinical experience, and
outcomes. We believed that the removal of these requirements aligned
with our goal of increasing access to kidney transplants by increasing
the utilization of organs from deceased donors and reducing the organ
discard rate (84 FR 51749). We sought improved organ procurement,
greater organ utilization, and reduction of burden for transplant
hospitals, while still maintaining the importance of safety in the
transplant process.
On December 2, 2020, we issued a final rule titled, ``Medicare and
Medicaid Programs; Organ Procurement Organizations Conditions for
Coverage: Revisions to the Outcome Measure Requirements for Organ
Procurement Organizations'' (85 FR 77898), which revised the OPO CfCs
by replacing the previous outcome measures with new transparent,
reliable, and objective outcome measures. In modifying the metrics used
for assessing OPO performance, we sought to promote greater utilization
of organs that might not otherwise be recovered or used due to
perceived organ quality.\27\
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\27\ 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 recently went into effect with the
goal of improving the performance of transplant hospitals and OPOs and
to promote the procuring of organs and delivering them to prospective
transplant recipients, we acknowledged the need for improvements in
health, safety, and outcomes across the transplant ecosystem, including
in transplant programs, OPOs, and ESRD facilities.28 29 In
particular, we recognize that further action must be taken to address
disparities and inequities observed across transplant hospitals.
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\28\ One study--Doby, B.L., Ross-Driscoll, K., Shuck, M.,
Wadsworth, M., Durand, C.M., & Lynch, R.J. (2021). Public discourse
and policy change: Absence of harm from increased oversight and
transparency in OPO Performance. American Journal of
Transplantation, 21(8), 2646-2652. <a href="https://doi.org/10.1111/ajt.16527">https://doi.org/10.1111/ajt.16527</a>--showed that deceased donor organ donation increased
during 2019, that is., during the period of public debate about
regulating OPO performance.
\29\ 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
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);

[[Page 43529]]

<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.\30\ 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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\30\ 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 donor transplant rate (85 FR 61117).
The ETC Model's objectives, as described in the final rule, include
supporting paired donations and donor chains, and reducing the
likelihood that potentially viable organs are discarded (85 FR 61128).
The ETC Model was updated by the final rule dated November 8, 2021,
titled ``Medicare Program; End-Stage Renal Disease Prospective Payment
System, Payment for Renal Dialysis Services Furnished to Individuals
With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive
Program, and End-Stage Renal Disease Treatment Choices Model'' and the
final rule dated November 7, 2022, titled ``Medicare Program; End-Stage
Renal Disease Prospective Payment System, Payment for Renal Dialysis
Services Furnished to Individuals With Acute Kidney Injury, End-Stage
Renal Disease Quality Incentive Program, and End-Stage Renal Disease
Treatment Choices Model'' (87 FR 67136). We finalized further
modifications to the ETC Model related to the availability of
administrative review of an ETC Participant's targeted review request
in the final rule issued on November 6, 2023, titled ``Medicare
Program; End-Stage Renal Disease Prospective Payment System, Payment
for Renal Dialysis Services Furnished to Individuals With Acute Kidney
Injury, End-Stage Renal Disease Quality Incentive Program, and End-
Stage Renal Disease Treatment Choices Model'' (88 FR 76345).
CMS is also operating the ETC Learning Collaborative, which is
focused on increasing the availability of deceased donor organs for
transplantation.\31\ 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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\31\ 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

[[Page 43530]]

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.\32\
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\32\ 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/data-reports">https://www.cms.gov/priorities/innovation/data-reports</a>.
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The IOTA Model proposes to complement the ETC and KCC Models and
expand kidney model participation to kidney transplant hospitals, which
are a key player in the transplant ecosystem, to test whether two-sided
risk payments based on performance increase access to kidney
transplants for ESRD patients placed on the waitlists of participating
transplant hospitals.
c. HRSA Initiatives Involving Kidney Transplants
NOTA established the OPTN almost 40 years ago to coordinate and
operate the nation's organ procurement, allocation, and transplantation
system. There are about 400 member organizations that comprise the
OPTN. Section 372(b)(2)(A) of the PHS Act charges the OPTN with
establishing a national list of individuals who need organs and a
national computer system to match organs with individuals on the
waitlist. HRSA has also undertaken efforts in alignment with CMS
efforts and Federal Government initiatives to improve accountability in
OPTN functions. On March 22, 2023, HRSA launched the OPTN Modernization
Initiative to strengthen accountability, equity, and performance in the
organ donation and transplantation system through a focus on five key
areas: technology, data transparency, governance, operations, and
quality improvement and innovation.\33\ 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.\34\ 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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\33\ 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>.
\34\ The White House. (2023, September 22). Bill Signed: H.R.
2544. The White House. https://www.whitehouse.gov/briefing-room/
legislation/2023/09/22/bill-signed-h-r-2544/
#:~:text=On%20Friday%2C%20September%2022%2C%202023,Organ%20Procuremen
t%20and%20Transplantation%20Network.
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Effective July 14, 2022, revisions to the OPTN Bylaws were made
related to the Transplant Program Performance to establish new criteria
for identification of transplant programs that enter MPSC performance
review based on the following criteria: \35\
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\35\ OPTN. (n.d.). Enhance Transplant Program Performance
Monitoring System, Phase 1 (July 2022) Sponsoring Committee:
Membership and Professional Standards Bylaws Affected. Retrieved
August 20, 2023, from <a href="https://optn.transplant.hrsa.gov/media/hgkksfuu/phase-1_tx-prgm-performance-monitoring_dec-2021.pdf">https://optn.transplant.hrsa.gov/media/hgkksfuu/phase-1_tx-prgm-performance-monitoring_dec-2021.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 health or patient safety. If the MPSC's review determines
that a risk to patient health or public safety exists, the MPSC may
request that a member inactivate or withdraw a designated transplant
program, or a specific component of the program, to mitigate the risk.
Transplant programs that do not participate in the MPSC performance
review process or fail to act to improve their performance are subject
to the policies described in Appendix L of the OPTN Bylaws, Reviews and
Actions, including the declaration of ``Member Not in Good Standing.''
While being designated ``Member Not in Good Standing'' does not
necessarily lead to the closure or removal of that program from
receiving reimbursement from Federal health insurance programs, the
Secretary can, based on a recommendation from the OPTN Board of
Directors, revoke OPTN membership, close an OPTN member, or remove the
ability of the member to receive Federal funding from Medicare or
Medicaid. Additionally, numerous private payers align with the MPSC
metrics and SRTR star rating system that evaluate transplant hospitals
on post-transplant performance to create their Centers of Excellence
programs. Therefore, MPSC reviews and performance on the MPSC
monitoring measures are a powerful regulatory incentive for transplant
programs.
In the final rule, dated September 22, 2020, titled ``Removing
Financial Disincentives to Living Organ Donation'' (85 FR 59438), HRSA
expanded the scope of qualified reimbursable expenses incurred by
living donors under the Living Organ Donation Reimbursement Program to
include lost wages and dependent care (childcare and elder care)
expenses to further the goal of reducing financial barriers to living
organ donation. The program previously only allowed for reimbursement
of travel, lodging, meals, and incidental expenses. In the final
notice, dated September 22, 2020, titled, ``Reimbursement of Travel and
Subsistence Expenses Toward Living Organ Donation Program Eligibility
Guidelines,'' HRSA increased the income eligibility threshold under the
Living Organ Donation Reimbursement Program from 300 percent to 350
percent of the Federal Poverty Guidelines (85 FR 59531).
3. Rationale for the Proposed IOTA Model
a. Alignment With Federal Government Initiatives and Priorities
For decades, patients and health care providers have confronted an
imbalance in the number of transplant candidates and the supply of
acceptable donor organs, including kidneys and other organs. Observed
variation in access to organ transplantation by geography, race/
ethnicity, disability status, and socioeconomic status, as well as the
overall performance of the organ transplantation ecosystem, raised the
need to make performance improvements and address disparities.\36\
Strengthening and improving the

[[Page 43531]]

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.'' \37\
Collectively, CMS and HRSA seek to--
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\36\ 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>.
\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>.
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<bullet> Reduce variation of pre-transplant and referral practices;
\38\
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\38\ 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.
We believe the proposed IOTA Model has the potential to
substantially increase the number of kidney transplants in a way that
enhances fairness for all affected individuals, regardless of
socioeconomic status or other factors that limit access to care and
negatively affect health outcomes, thereby improving quality of care,
reducing costs to Medicare, and prolonging lives. The IOTA Model, as
proposed, is complementary to the ETC and KCC Models, and to other CMS
and HRSA initiatives, with the collective goal of achieving
improvements in processes among transplant hospitals that would spur an
increase in both deceased donor and living donor kidney transplantation
and reduce population health disparities. Furthermore, although we are
targeting our proposals to kidney transplant programs, we seek to test
specific modifications for Medicare payment and other programmatic
measures that would establish a framework for potential future
interventions for transplantation relating to the other solid organ
types.
In the following sections of this proposed rule, we review
scientific literature that outlines specific ways that kidney
transplantation can be enhanced. Although not the focus of our
analysis, we also present findings pertaining to the transplantation of
other organs, especially livers. We aim to show how the types of
interventions that we are proposing might also apply for any future
efforts to increase transplant numbers for other organ types, and to
continue to pursue the goal of greater equity. We also describe recent
efforts from CMS and HRSA to enhance organ transplantation that
complement our proposals to use payment incentives as a policy lever to
increase the number of kidney transplants and achieve a fairer
distribution.
b. End Stage Renal Disease Impact
According to the United States Renal Data System (USRDS), in 2021
about 808,536 people in the United States were living with ESRD, almost
double the number in 2001.\39\ Prevalence of ESRD varied by Health
Service Area (HSA) and ESRD Network.\40\ Stratified by age and race/
ethnicity, ESRD was consistently more prevalent among older people (65
and older) and in Black people.\41\ Diabetes and hypertension are most
often the primary cause of ESRD.\42\ According to the National Kidney
Foundation, these diseases disproportionately affect minority
populations, increasing the risk of kidney disease.\43\ 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.\44\ Studies show that people with kidney transplants
live longer than those who remain on dialysis.\45\ 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.\46\ In 2021, 72,864 patients with ESRD were on the
kidney transplant waitlist, of which 27,413 were listed during that
year.\47\ The IOTA Model proposes to focus on the ESRD patients who are
on the kidney transplant waitlists of the kidney transplant hospitals
that would be required to participate in this Model. ESRD patients
represent a small portion of the U.S. population, but the disease
burden to the patient and to CMS is great in terms of health outcomes,
survival, quality of life, and cost. The ESRD population accounted for
6.1% of total Medicare expenditures in 2020.\48\
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\39\ United States Renal Data System. 2023.End Stage Renal
Disease: Chapter 1. Figure 1.5.
\40\ United States Renal Data System. 2023. End Stage Renal
Disease: Chapter 1. Figure 1.7.
\41\ United States Renal Data System. 2023. End Stage Renal
Disease: Chapter 1. Figure 1.8.
\42\ United States Renal Data System. 2023. End Stage Renal
Disease. Chapter 1. Table 1.3.
\43\ 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>.
\44\ United States Renal Data System. 2023. End Stage Renal
Disease. Chapter 1. Figure 1.1.
\45\ National Kidney Foundation. (2017, February 14). Kidney
Transplant. National Kidney Foundation. <a href="https://www.kidney.org/atoz/content/kidney-transplant">https://www.kidney.org/atoz/content/kidney-transplant</a>.
\46\ United States Renal Data System. 2023. End Stage Renal
Disease: Chapter 7. Figure 7.16.
\47\ United States Renal Data System. 2023. End Stage Renal
Disease: Chapter 7. Figures 7.1 and 7.2.
\48\ 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 proposes to
improve patient outcomes by incentivizing increased access to kidney
transplantation across IOTA participants. Access to this lifesaving
treatment may delay or avert dialysis, reduce costs to the Medicare
program and to patients, and enhance survival and quality of life.
A kidney transplant involves surgically transplanting a kidney from
a living or deceased donor to a kidney transplant recipient. The
replacement organ is known as a graft. Most kidneys are transplanted
alone, as kidneys transplanted along with other organs are very
rare.\49\ 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.\50\ The
kidney in such

[[Page 43532]]

a simultaneous transplant may come from a living or deceased donor, but
other organs mostly come from a deceased donor.
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\49\ 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>.
\50\ 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.\51\ For deceased donor transplantation, a
patient needs to contact a transplant hospital and arrange for an
evaluation to assess the feasibility of surgery. The patient's name
would then be added to a list of individuals who can receive organ
offers. This is known as the kidney transplant hospital's kidney
transplant waitlist. Living donation occurs when a living person
donates an organ to a family member, friend, or other individual.
People unknown to one another sometimes take part in paired exchanges,
which allow the switching of recipients based on blood type and other
biological factors. The numbers of deceased donor kidney donation have
increased over the past decade, while living donor kidney donation has
remained relatively constant, declining in 2020 with the COVID-19
pandemic.\52\
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\51\ 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.
\52\ 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.\53\ According to one source, the majority of
deceased donor kidneys are expected to function for about 9 years, with
high quality organs lasting longer.\54\ A systematic review of studies
worldwide finds significantly lower mortality and risk of
cardiovascular events associated with kidney transplantation compared
with dialysis.\55\ Additionally, this review finds that patients who
receive transplants experience a better quality of life than treatment
with dialysis.\56\ 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.\57\ Among transplant
recipients, there are lower rates of hospitalizations, emergency
department visits, and readmissions compared to those still on
dialysis.\58\ In general, from the standpoint of long-term survival and
quality of life, a living donor kidney transplant is considered the
best among all kidney transplant options for most people with
CKD.59 60
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\53\ Get the Facts on Kidney Transplantation Before You Start
Dialysis--Penn Medicine. (2019, July 24). Www.pennmedicine.org.
<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>.
\54\ Organ Procurement and Transplantation Network. Kidney Donor
Profile Index (KDPI) Guide for Clinicians. https://
optn.transplant.hrsa.gov/professionals/by-topic/guidance/kidney-
donor-profile-index-kdpi-guide-for-clinicians/
#:~:text=Figure%201%20shows%20that%20a,function%20for%20about%209%20y
ears.
\55\ 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>.
\56\ Ibid.
\57\ 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.
\58\ 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.
\59\ 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>.
\60\ 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 year Medicare FFS spending for beneficiaries with ESRD with
a transplant is less than half that for either hemodialysis or
peritoneal dialysis.\61\ 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.\62\ 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.\63\
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\61\ 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.
\62\ 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>.
\63\ 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 outcomes, in 2020, only about 30 percent of prevalent
ESRD patients--those with existing ESRD diagnoses--in the U.S. had a
functioning kidney transplant, or graft.\64\ In 2016, only 2.8 percent
of incident ESRD patients--meaning patients newly diagnosed with ESRD--
received a preemptive kidney transplant, allowing them to avoid
dialysis.\65\ 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.\66\ 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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\64\ United States Renal Data System. 2022 Annual Data Report.
Volume 2. End Stage Renal Disease Chapter 7 Transplantation Figure
7.16.
\65\ 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.usrds.org/2018/view/v2_01.aspx">https://www.usrds.org/2018/view/v2_01.aspx</a>.
\66\ 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.\67\ Despite transplantation being widely
regarded as the optimal treatment for people with ESRD, as well as
being more cost-effective in the long term compared to dialysis, only a
minority of people with ESRD (13 percent) are added to the waitlist,
and even fewer receive a transplant. To be added to the kidney
transplant waitlist, a patient must complete an evaluation at a
transplant hospital, and the patient must be found to be a good
candidate for a transplant. Nearly 5,000 patients on the national
kidney transplant waiting list die each year.68 69 70 These
trends have persisted

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for several decades despite increases in the number of kidney
transplants from deceased donors and living donors.
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\67\ 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.
\68\ 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>.
\69\ 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>.
\70\ 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.71 72 In 2018 and 2019, the total number of kidney
transplants rose steadily as compared to previous years.\73\ 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.\74\ 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.\75\ 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.\76\
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.\77\ At the end of 2021, 72,864 individuals were on the
waitlist for a kidney transplant.\78\
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\71\ 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>.
\72\ 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>.
\73\ United States Renal Data System. 2021. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.11.
\74\ United States Renal Data System. 2021. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.7.
\75\ United States Renal Data System. 2022. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.10b.
\76\ United States Renal Data System. 2022. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.16.
\77\ United States Renal Data System. 2023. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.1.
\78\ 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 2021.79 80 With the overall dialysis population
growing, the rate of living donor transplants per 100 patient-years on
dialysis declined from 1.4 to 0.8 transplants from 2010 to 2020.\81\ 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.\82\ A study in 2013 of OPTN data found that the decline in living
donation appeared most prominent among men, Black/African Americans,
and younger and lower income adults, potentially leading to longer
waiting times for transplantation, greater dialysis exposure, higher
death rates on the waitlist, lower graft and patient survival for
recipients, and higher overall healthcare costs for the care of
patients with ESRD.\83\
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\79\ United States Renal Data System. 2012. Annual Data Report.
Atlas ESRD. Table 7.1.
\80\ United States Renal Data System. 2023. Annual Data report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.10a.
\81\ United States Renal Data System. 2022. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.10a.
\82\ 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/home/conference-highlights/american-transplant-congress/living-donor-kidney-transplantation-decreased-after-2010-united-states-trends/">https://www.renalandurologynews.com/home/conference-highlights/american-transplant-congress/living-donor-kidney-transplantation-decreased-after-2010-united-states-trends/</a>.
\83\ 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.84 85 86 87 88 Studies
during the past decade have shown substantial disparities in kidney
transplant rates among transplant programs at a national level, as well
as both among and within donation service areas (DSAs).\89\ A 2020
study examined data from a registry that included all U.S. adult kidney
transplant candidates added to the waitlist in 2011 and 2015,
comprising 32,745 and 34,728 individuals, respectively.\90\ 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.\91\ 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

[[Page 43534]]

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.\92\ 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.\93\ 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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\84\ 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>.
\85\ 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).
\86\ United States Renal Data System. 2022. Annual Data Report.
Supplements: COVID-19, Racial and Ethnic Disparities Figures 14-4
and 14.15.
\87\ 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>.
\88\ 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>.
\89\ With the enactment of NOTA, CMS designated donation service
areas (DSAs); generally, each DSA includes an OPO within its
geographic area. Until March 2021, when OPTN implemented the current
policy for allocation of deceased donor kidneys, the priority for
organs acquired by an OPO was based, among other factors, on an
individual's residence within the DSA extending around the OPO.
\90\ 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>.
\91\ King et al. 2020. 2903.
\92\ King et al., 2020. 2903.
\93\ 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.\94\ This underscores
the need for initiatives and processes among transplant hospitals to
encourage living donations to reduce geographic disparities.
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\94\ 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.\95\ 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.\96\
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\95\ United States Renal Data System. 2022. Annual Data Report.
Supplements: COVID-19, Racial and Ethnic Disparities Figures 14-4
and 14.15.
\96\ National Kidney Foundation. (2016, January 7). Race,
Ethnicity, & Kidney Disease. National Kidney Foundation. https://
www.kidney.org/atoz/content/minorities-
KD#:~:text=Black%20or%20African%20Americans%20are.
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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.\97\ Recent studies have emphasized poverty and income
differentials in analyzing the interplay of these and other factors
among populations referred for kidney transplantation at several large
transplant hospitals.98 99 100 101 This research extends in
time prior to the Kidney Allocation System (KAS) of 2014, which aimed
to lessen the impact of racial differences on access to kidney
transplantation.
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\97\ 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>.
\98\ 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>.
\99\ 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>.
\100\ 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>.
\101\ Schold, J.D., Gregg, J.A., Harman, J.S., Hall, A.G.,
Patton, P.R., & Meier-Kriesche, H.-U. (2011). Barriers to Evaluation
and Wait Listing for Kidney Transplantation. Clinical Journal of the
American Society of Nephrology, 6(7), 1760-1767. <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.\102\ Recently, a comprehensive survey of
the literature on disparities in transplantation for kidneys and other
organs found that socioeconomic factors may substantially explain
disproportionately lower transplant rates and longer wait times.\103\
As described in recent literature, a person's SDOH may contribute to
inequities in their prospects for waitlist registration and receipt of
transplantation.104 105 106 SDOH is defined more broadly
than socioeconomic status, to include those conditions in the places
where people live, learn, work, and play that affect a wide range of
health and quality of life risks and outcomes.\107\ More specifically,
SDOH include variations in employment, neighborhood factors, education,
social support systems, and healthcare coverage that impact health
outcomes.
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\102\ Reed, R.D., & Locke, J.E. (2020). Social Determinants of
Health: Going Beyond the Basics to Explore Racial Disparities in
Kidney Transplantation. Transplantation, 104, 1324-1325. <a href="https://doi.org/10.1097/tp.0000000000003003">https://doi.org/10.1097/tp.0000000000003003</a>.
\103\ National Academies of Science, Engineering, and Medicine.
2022. ``Realizing the Promise of Equity in the Organ Transplantation
System. National Academies Press. Washington DC. 88-93.
\104\ Centers for Disease Control and Prevention. Social
Determinants of Health at CDC. Retrieved June 13, 2023, from <a href="https://www.cdc.gov/about/sdoh/index.html">https://www.cdc.gov/about/sdoh/index.html</a>.
\105\ Wesselman et al., 2021.
\106\ Ng et al., 2020.
\107\ Centers for Disease Control and Prevention.
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Salient among recent analyses are those of a cohort of patients
initially referred for evaluation for a kidney transplant at a large
urban transplant hospital between 2010 and 2012. These studies showed
lower waitlist registration and transplant rates for Black/African
Americans, regardless of SDOH. However, after the introduction of the
KAS in 2014, racial difference showed weaker associations with rates of
waitlist registration and receipt of a deceased donor transplant, when
controlling for SDOH.108 109 This finding is consistent with
reports showing a decrease nationally in differences in rates of
deceased donor kidney transplants among White patients as compared to
Black/African American patients and Hispanic/Latino patients on
dialysis, following the introduction of the KAS.110 111 The
studies of this patient cohort showed Black/African American race to be
associated with a decrease in probability of kidney transplant, while
still according influence to clinical, social, demographic and cultural
factors. These factors included older age, lower income, public
insurance, having more comorbidities, being transplanted pre-KAS, less
social support, and less transplant knowledge.\112\ Similarly, an
earlier study of a population at a single

[[Page 43535]]

transplant hospital found that socioeconomic factors attenuated the
association between racial difference and placement on the waitlist for
a kidney transplant.\113\ This underscores the need to consider
initiatives and improvement activities aimed at addressing SDOH for
ESRD patients to remove barriers to access to kidney transplantations.
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\108\ Ng Y et al. 2020. 8.
\109\ Wesselman et al., 2021. 271.
\110\ United States Renal Data System. 2022. Annual Data Report.
End Stage Renal Disease Chapter 7 Transplantation. Figures 7.10a,
7.10b.
\111\ OPTN Two Year Analysis shows effects of Kidney Allocation
System <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>.
\112\ Wesselman et al. 2021. 267.
\113\ 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 for deceased donor
donation.\114\ These results accord with findings nationwide that White
patients are more likely to receive a living donor transplant, followed
by Asian and Hispanic/Latino patients. Black/African American patients
have had lower rates of living donor transplants than other racial or
ethnic groups.\115\ Explanations for these differences have included
disparate rates of diabetes, obesity, and hypertension observed among
minority populations that may contraindicate living donation by a
relative; cultural differences in willingness to donate or ask for a
living donation; concerns about costs among potential donors; and lack
of knowledge about living donor transplantation on the part of
patients, their families, and health care providers.116 117
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\114\ Wesselman et al., 2021. 270.
\115\ United States Renal Data System. 2022. Annual Data Report.
End Stage Renal Disease Chapter 7 Transplantation Figure 7.10a.
\116\ Purnell, T.S., Hall, Y.N., & Boulware, L.E. (2012).
Understanding and Overcoming Barriers to Living Kidney Donation
Among Racial and Ethnic Minorities in the United States. Advances in
Chronic Kidney Disease, 19(4), 244-251. <a href="https://doi.org/10.1053/j.ackd.2012.01.008">https://doi.org/10.1053/j.ackd.2012.01.008</a>.
\117\ Rodrigue, J.R., Kazley, A.S., Mandelbrot, D.A., Hays, R.,
LaPointe Rudow, D., & Baliga, P. (2015). Living Donor Kidney
Transplantation: Overcoming Disparities in Live Kidney Donation in
the US--Recommendations from a Consensus Conference. Clinical
Journal of the American Society of Nephrology, 10(9), 1687-1695.
<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.118 119 120 121 According to one study, between 1995
and 2014, disparities in the receipt of living donor kidney
transplantation grew more for Black/African Americans and Hispanics/
Latinos: (1) living in poorer (versus wealthier) neighborhoods; (2)
without (versus with) a college degree; and (3) with Medicare (versus
private insurance).\122\ The study suggests that delays in the receipt
of kidney care may contribute to reported racial and ethnic differences
in the quality and timing of discussions among patients, families, and
clinicians about living donor kidney transplantation as a treatment
option.\123\
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\118\ Purnell, T.S., Luo, X., Cooper, L.A., Massie, A.B.,
Kucirka, L.M., Henderson, M.L., Gordon, E.J., Crews, D.C., Boulware,
L.E., & Segev, D.L. (2018). Association of Race and Ethnicity With
Live Donor Kidney Transplantation in the United States From 1995 to
2014. JAMA, 319(1), 49. <a href="https://doi.org/10.1001/jama.2017.19152">https://doi.org/10.1001/jama.2017.19152</a>.
\119\ Hall, E.C., James, N.T., Garonzik Wang, J.M., Berger,
J.C., Montgomery, R.A., Dagher, N.N., Desai, N.M., & Segev, D.L.
(2012). Center-Level Factors and Racial Disparities in Living Donor
Kidney Transplantation. American Journal of Kidney Diseases, 59(6),
849-857. <a href="https://doi.org/10.1053/j.ajkd.2011.12.021">https://doi.org/10.1053/j.ajkd.2011.12.021</a>.
\120\ Gore, J.L., Danovitch, G.M., Litwin, M.S., Pham, P-T.T., &
Singer, J.S. (2009). Disparities in the Utilization of Live Donor
Renal Transplantation. American Journal of Transplantation, 9(5),
1124-1133. <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>.
\121\ Rodrigue et al. 2015.
\122\ Purnell et al. 2015. 58.
\123\ 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 showed significantly
decreased racial disparities. The authors suggest that such high rates
reveal commitment to living donor kidney transplantation, possibly
shown in better education programs, more formalized procedures to
reduce failure to complete transplant evaluations, increased use of
medically complex and unrelated donors, and more success in reducing
financial barriers to living donor kidney donation.\124\ The study also
notes that hospitals with higher percentages of Black/African American
candidates experience greater racial disparities. The authors surmise
that such a high percentage might indicate an urban setting exhibiting
greater differences in access to health care between Black/African
Americans and other populations.\125\
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\124\ Hall et al. 2012. 855.
\125\ 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.\126\ Discrimination occurs even though individuals'
disabilities that are not related to the need for an organ transplant
generally have little or no impact on the likelihood that the
transplant would be successful.\127\ The American Society of Transplant
Surgeons has recommended that no patient be discriminated against or
precluded from transplant listing solely due to the presence of a
disability, whether physical or psychological.\128\
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\126\ See, for example., Nat'l Council on Disability, Organ
Transplants Discrimination against People with Disabilities: Part of
the Bioethics and Disability Series (2019), <a href="https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf">https://ncd.gov/sites/default/files/NCD_Organ_Transplant_508.pdf</a>.
\127\ Id. at 38-40.
\128\ 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</a>.
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CMS has kept these concerns in mind when developing the IOTA Model
proposals. The IOTA Model proposes performance-based payments that hold
transplant hospitals selected as the IOTA participants financially
accountable for improvements in access to both deceased and living
donor kidney transplantations. To reduce disparities and promote health
equity, CMS is proposing that the IOTA participants would be required
to develop and submit a Health Equity Plan to CMS in PYs 2 through 6.
This proposed model design feature is aimed at encouraging IOTA
participants to reassess their processes and policies around living and
deceased donor kidneys and promote investments in performance and
quality improvement activities that address barriers to care, including
SDOH. The sequence of steps that patients need to undertake to gain
access to kidney transplantation is complex, and the challenge posed by
this process for potential recipients may be compounded by racial,
socioeconomic and neighborhood factors. Thus, we believe that a unified
framework of interventions to address the distinct social contexts
underlying differences among racial groups in deceased donor kidney
transplantation and living donor kidney transplantation may result in
the desired outcomes of greater overall kidney transplant numbers and
equity.

[[Page 43536]]

f. Post-Transplant Outcomes
While the need for kidney transplants has grown, the rates of
patient and graft survival have increased. Between 2001 and 2020, graft
survival rates at 1 and 5 years showed an increasing trend.\129\
Patient survival at 1 year increased from 97.5 percent in 2001 to 99.2
percent in 2018, but then declined to 98.9 percent in 2019 and 98.4
percent in 2020; patient survival at 5 years rose from 89.8 percent in
2001 to an all-time high of 93.6 percent in 2013, dropping slightly to
93.2 percent in 2016.\130\ For living donor kidney transplants, the
rate of graft failure at 3 years decreased from 3.0 per 100 person
years in 2010 to 2.1 per 100 person years in 2018. The rate of death at
3 years with a functioning graft also decreased from 1.2 to 1.0 per 100
person-years.\131\ For deceased donor kidney transplants, the rate of
graft failure at 3 years decreased from 2010 (6.3 per 100 patient
years) to 2014 (4.9 per 100 patient years), but increased to 5.3 per
100 patient years in 2018. The same pattern was observed for death with
a functioning graft, except that the rate in the 2018 cohort (2.8 per
100 patient years) exceeded that of the 2010 cohort (2.6 per 100
patient years).\132\
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\129\ United States Renal Data System. 2023. Annual Data Report.
Volume 2. End Stage Renal Disease. Transplantation. Figures 7.19a
and 7.19b.
\130\ United States Renal Data System. 2023. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figures 7.20a and 720.b.
\131\ United States Renal Data System. 2023. Annual Data Report.
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 7.21a.
\132\ United States Renal Data System. 2023. Annual Data Report
Volume 2. End Stage Renal Disease. Chapter 7. Transplantation.
Figure 721.b.
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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.\133\ Early
referral of patients for transplants, kidney exchange programs, better
diagnostic tools to identify early acute rejection, innovative
therapies for countering rejection and infection, and optimization of
immunosuppressive medications may be opportunities to enhance kidney
graft survival.\134\
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\133\ Hariharan S, Israni AK, Danovitch G. Long-Term Survival
after Kidney Transplantation. N Engl J Med. 2021 Aug 19;385(8):729-
743. doi: 10.1056/NEJMra2014530. PMID: 34407344.
\134\ Hariharan, S., Israni, A. K., & Danovitch, G. (2021).
Long-Term Survival after Kidney Transplantation. New England Journal
of Medicine, 385(8), 729-743. <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.135 136 137 138 139 A study in 2018 described donor-
specific factors, such as biopsy findings and donor history, along with
an increasing selectivity among transplant hospitals in accepting
organs for transplant and inability to locate a recipient as
contributing to this increase in non-utilization.\140\ Within the
context of the COVID-19 pandemic, the non-utilization of deceased donor
kidneys in 2020 rose to the highest level up to that time, 21.3
percent, despite the decline in discard of organs from hepatitis C-
positive donors.141 142 An analysis found that the donor
kidney discard rate peaked at 27 percent during the fourth quarter of
2021.\143\
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\135\ Mohan, S., Chiles, M. C., Patzer, R. E., Pastan, S. O.,
Husain, S. A., Carpenter, D. J., Dube, G. K., Crew, R. J., Ratner,
L. E., & Cohen, D. J. (2018). Factors leading to the discard of
deceased donor kidneys in the United States. Kidney International,
94(1), 187-198. <a href="https://doi.org/10.1016/j.kint.2018.02.016">https://doi.org/10.1016/j.kint.2018.02.016</a>.
\136\ Aubert, O. Reese. P. Audry, B. Bouatou, B. Raynaud, M.
Viglietti, D. Legendre, C. Glotz, D. Empana, J. Jouben, X.
Lefaucheur, C. Jacquelinet, C. Loupy, A. (2019). Disparities in
Acceptance of Deceased Donor Kidneys Between the United States and
France and Estimated Effects of Increased US Acceptance. JAMA
Internal Medicine, 179(10), 1365-1374. <a href="https://doi.org/10.1001/jamainternmed.2019.2322">https://doi.org/10.1001/jamainternmed.2019.2322</a>.
\137\ Ibrahim, M., Vece, G., Mehew, J., Johnson, R., Forsythe,
J., Klassen, D., Callaghan, C., & Stewart, D. (2019). An
international comparison of deceased donor kidney utilization: What
can the United States and the United Kingdom learn from each other?
American Journal of Transplantation, 20(5), 1309-1322. <a href="https://doi.org/10.1111/ajt.15719">https://doi.org/10.1111/ajt.15719</a>.
\138\ Stewart, D. E., Garcia, V. C., Rosendale, J. D., Klassen,
D. K., & Carrico, B. J. (2017). Diagnosing the Decades-Long Rise in
the Deceased Donor Kidney Discard Rate in the United States.
Transplantation, 101(3), 575-587. <a href="https://doi.org/10.1097/tp.0000000000001539">https://doi.org/10.1097/tp.0000000000001539</a>.
\139\ 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>.
\140\ Mohan, Chiles et al. (2018).
\141\ Lentine, K. Smith, J. Hart, A. Miller, J. Skeans, M.
Larkin, L. Robinson, A. Gauntt, K. Israni, A. Hirose, R. Snyder, J.
(2022). OPTN/SRTR 2020 Annual Data Report: Kidney. American Journal
of Transplantation 22(Suppl 2) 21-136.
\142\ Following upon the introduction of certain anti-viral
drugs, transplanting kidneys from donors infected with Hepatitis C
has shown promising outcomes in recent studies. See Penn Medicine
News ``Penn Researchers Continue to Advance Transplantation of
Hepatitis C Virus-infected kidneys into HCV-Negative Recipients''
August 31, 2020 <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>.
\143\ Cron, D. Husain, S. Adler, J. (2022). The new distance-
based kidney allocation system: Implications for patients,
transplant centers, and Organ Procurement Organizations. Current
Transplantation Reports, 9(4), 304. <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 2014, when the KAS went into effect, OPTN has aimed to
address the high rate of kidneys going unused. The new kidney
allocation system was developed in response to higher than necessary
discard rates of kidneys, variability in access to transplants for
candidates who are harder to match due to biologic reasons, inequities
resulting from the way waiting time was calculated, and a matching
system that results in unrealized life years and high re-transplant
rates.\144\ The KAS also revised the system that matched waitlisted
individuals with available organs.\145\ As part of the KAS, the Kidney
Donor Profile Index (KDPI) was implemented to assess the quality of
kidneys procured for kidney transplants. The KDPI is based on a
preliminary measurement, the Kidney Donor Risk Index (KDRI), which
estimates the relative risk of post-transplant kidney graft failure
based on scores for the deceased donor on a set of 10 demographic and
clinic characteristics, including age, height, weight, ethnicity,
history of hypertension, history of diabetes, cause of death, serum
creatinine, hepatitis C virus status, and donation after circulatory
death status.\146\ This relative risk is determined in relation to the
overall distribution of a grouping of these scores across the overall
deceased donor population for the previous year. The KDPI transforms
the KDRI to a zero-to-100 scale. Lower KDPI scores are associated with
greater expected post-transplant longevity, while higher KDPI

[[Page 43537]]

scores are associated with a worse expected outcome in this
regard.\147\
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\144\ 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.
\145\ 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.
\146\ 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.
\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>. 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.\148\
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\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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An OPTN data analysis from 2014 to 2016, the first two years after
KAS implementation, showed that despite substantial increases in both
deceased kidney donor transplants and deceased kidney donation, the
kidney discard rate increased to 19.9 percent in 2016.\149\ OPTN linked
the discard rates to KDPI scores, with fewer than 3 percent of donor
kidneys with KDPI between zero and 20 percent discarded, compared with
60 percent of donor kidneys with KDPI between 86 and 100 percent being
discarded.\150\
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\149\ 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>.
\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>.
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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.151 152
The new system instituted a point system with up to 2 points (equal to
2 years on the wait list) for patients listed at transplant hospitals
within 250 nautical miles of the donor hospital, and the points
decreasing linearly from the donor hospital to the circle perimeter.
The more points an individual has, the higher their position on the
waitlist and the more likely they are to receive an organ offer. If
there is no candidate within the designated radius, the kidney is
offered to patients listed at hospitals outside the fixed circle, based
on separate proximity points that decrease linearly as the location of
a patient approaches 2,500 nautical miles from the donor hospital.\153\
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\151\ Potluri, V. S., & Bloom, R. D. (2021). Effect of Policy on
Geographic Inequities in Kidney Transplantation. American Journal of
Kidney Diseases, 79(6), 897-900. <a href="https://doi.org/10.1053/j.ajkd.2021.11.005">https://doi.org/10.1053/j.ajkd.2021.11.005</a>.
\152\ Penn Medicine. (2021, November 17). Update: Change in
Organ Allocation Designed to Increase Equity in US Kidney and
Pancreas Transplantation. Penn Medicine Physician Blog. <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>.
\153\ 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.\154\
Concern was also expressed about increased transportation time and
procurement costs, risk associated with air transport, and a greater
number of interactions between transplant hospitals and
OPOs.155 156 157 One study notes that policymakers would
need to assess the extent to which the new kidney allocation policy
might affect organ offer acceptance patterns, organ recovery and
utilization rates, and wait times both for the transplant hospital and
broader geographic areas.\158\ Another report cited unpublished SRTR
data, saying that preliminary results suggest an increase in transplant
rate overall, but a trend toward higher donor kidney discard and
increased cold ischemia time.\159\ A study at a single transplant
hospital showed that the number of organ offers--for livers and
kidneys--grew by 140 percent between May 1, 2019, and July 31, 2021,
while the number of transplanted organs remained stable, suggesting
less efficient allocation of organs after the new change in allocation
policy.\160\
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\154\ Potluri, Bloom. (2021) 898.
\155\ Gentry, S.E., Chow, E.K.H., Wickliffe, C.E., Massie, A.B.,
Leighton, T., & Segev, D.L. (2014). Impact of broader sharing on the
transport time for deceased donor livers. Liver Transplantation,
20(10), 1237-1243. <a href="https://doi.org/10.1002/lt.23942">https://doi.org/10.1002/lt.23942</a>.
\156\ Chow, E.M., DiBrito, S.R., Luo, X., Wickliffe, C., Massie,
A.B., Locke, J.E., Gentry, S.E., Garonzik-Wang, J., & Segev, D.L.
(2018). Long Cold Ischemia Times in Same Hospital Deceased Donor
Transplants. Transplantation, 102(3), 471-477. <a href="https://doi.org/10.1097/tp.0000000000001957">https://doi.org/10.1097/tp.0000000000001957</a>.
\157\ Adler, J.T., Husain, S.A., King, K.L., & Mohan, S. (2021).
Greater complexity and monitoring of the new Kidney Allocation
System: Implications and unintended consequences of concentric
circle kidney allocation on network complexity. American Journal of
Transplantation, 21(6), 2007-2013. <a href="https://doi.org/10.1111/ajt.16441">https://doi.org/10.1111/ajt.16441</a>.
\158\ Adler et al., 2021. 2012.
\159\ Cron, D.C., S. Ali Husain, & Adler, J. T. (2022). The New
Distance-Based Kidney Allocation System: Implications for Patients,
Transplant Centers, and Organ Procurement Organizations. Current
Transplantation Reports, 9(4), 302-307. <a href="https://doi.org/10.1007/s40472-022-00384-z">https://doi.org/10.1007/s40472-022-00384-z</a>.
\160\ Reddy, V., Briget da Graca, Martinez, E., Ruiz, R.,
Asrani, S.K., Testa, G., & Wall, A. (2022). Single-center analysis
of organ offers and workload for liver and kidney allocation.
American Journal of Transplantation, 22(11), 2661-2667. <a href="https://doi.org/10.1111/ajt.17144">https://doi.org/10.1111/ajt.17144</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

[[Page 43538]]

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 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 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 on the part of transplant programs to 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 we propose for kidney transplantation, understanding
and addressing why livers, and possibly other organs, are not chosen
for specific patients also has the

[[Page 43539]]

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 entitled ``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 proposed
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 Proposed Regulation

1. Proposal To Implement the IOTA Model
In this section of the proposed rule, we propose our policies for
the IOTA Model, including model-specific definitions and the general
framework for implementation of the IOTA Model. The proposed upside
risk payment to the IOTA participants and the proposed downside risk
payment from IOTA participants 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 proposed rule, access to
kidney transplants widely varies by region and across transplant
hospitals and disparities by demographic characteristics are pervasive,
raising the need to strengthen and improve performance. We theorize
that the IOTA Model financial structure would promote improvement
activities across selected transplant hospitals that address access
barriers, including SDOH, thereby increasing the number of transplants,
quality of care, and 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 may also require 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. Proposal for Model Performance Period
We are proposing a 6-year ``model performance period.'' We are
proposing to define the model performance period as the 72-month period
from the model start date, comprised of 6 individual PYs. During the
model performance period, the IOTA participants' performance would be
measured and assessed for purposes of determining their performance-
based payments, as proposed in this rule. We propose to define the
``performance year'' (PY) as a 12-month calendar year during the model
performance period. We are proposing to define the start of the model
performance period as the ``model start date,'' and we propose 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 are proposing 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 III.D. of this proposed rule project that
considerable savings to Medicare would be achieved after the fifth PY,
which is another reason why we are proposing 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
would be a mandatory model, we believe it 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 periods with that of our data sources, as detailed in
section III.C. of this proposed rule. However, we are proposing a
January 1, 2025 start date because we believe that there will be
sufficient time for IOTA participants to prepare for the model. A
proposed start date of January 1st also aligns with other CMS calendar
year rules. We propose 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 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 April 1, 2025, ``performance year'' would still 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 end date would also shift to include a 72-month period from the
model start date In the previous example, the model performance period
would be April 1, 2025, to March 31, 2031.
We seek comment on the proposed model performance period of 6 years
and the proposed model start date. We also seek comment on the
alternative model performance periods that we considered of 3, 5, and
10 years. We also seek comment on the alternative start dates (April 1,
2025, and July 1, 2025), and the subsequent adjustments to the model
performance period if the model start date were to change.
b. Other Proposals
We are also proposing additional policies for the IOTA Model,
including the following: (1) the method for selecting transplant
hospitals for participation; (2) the schedule and methodologies for the
performance-based payments, and waivers of certain Medicare payment
requirements solely as necessary to test these payment methodologies
under the model; (3) the performance assessment methodology for
selected transplant hospitals, including the proposed methodologies for
patient attribution, target setting and scoring, and calculation of
performance across the achievement domain, efficiency domain, and
quality domain; (4) monitoring and evaluation; and (5) overlap with
other Innovation Center models and CMS programs.
We propose that IOTA participants would be subject to the general
provisions for Innovation Center models specified in 42 CFR part 512
subpart A and in 42 CFR part 403 subpart K, effective January 1, 2025.
The general provisions at subpart A of part 512 are also the subject of
proposed revisions in this proposed rule. As described in section II.B.
of this proposed rule, we are proposing to expand the applicability of
the general provisions for Innovation Center models to provide a set of
standard provisions for Innovation Center models that are applicable
more broadly across Innovation Center models. We believe that this
approach would promote transparency, efficiency, and clarity in
Innovation Center models and avoid the need to restate the provisions
in each

[[Page 43540]]

model's governing documentation. We believe that applying these
provisions to the IOTA Model would promote these purposes.
We seek comment on our proposal to apply the general provisions for
Innovation Center models, or the proposed standard provisions for
Innovation Center models, to the IOTA Model.
2. Definitions
We propose at Sec. 512.402 to define certain terms for the IOTA
Model. We describe these proposed definitions in context throughout
section III. of this proposed rule. We propose to codify the
definitions and policies of the IOTA Model at 42 CFR part 512 subpart D
(proposed Sec. Sec. 512.400 through 512.460). In addition, we propose
that the definitions contained in the general provision related to
Innovation Center models at subpart A of part 512, and the revisions to
those provisions proposed in this notice of proposed rulemaking, would
also apply to the IOTA Model. We seek comment on these proposed
definitions for the IOTA Model.
3. IOTA Participants
a. Proposed Participants
We propose to define ``IOTA participant'' as a kidney transplant
hospital, as defined at Sec. 512.402, that is required to participate
in the IOTA Model pursuant to Sec. 512.412. In addition, we note that
the definition of ``model participant'' contained in 42 CFR part
512.110, as well as the proposed revisions to that definition, would
include an IOTA participant.
We propose to define ``transplant hospital'' as a hospital that
furnishes organ transplants as defined in 42 CFR 121.2. We propose this
definition to align with the definition used by Medicare. We propose to
define ``kidney transplant hospital'' as a transplant hospital with a
Medicare approved kidney transplant program. Under Sec. 482.70, a
transplant program is ``an organ-specific transplant program within a
transplant hospital (as defined in this section).'' Kidney transplants
are the most common form of transplants, but not all transplant
hospitals have a kidney transplant program. As the focus of the IOTA
Model is kidney transplants, we propose this definition of kidney
transplant hospital to refer specifically to transplant hospitals that
perform kidney transplants. We propose to define ``kidney transplant''
as the procedure in which a kidney is surgically transplanted from a
living or deceased donor to a transplant recipient, either alone or in
conjunction with any other organ(s). As described in section III.B.4.b.
of this proposed rule, the vast majority of kidney transplants are
performed alone. However, we believe that it is necessary to include in
the definition of kidney transplant those kidney transplants that occur
in conjunction with other organ transplants to avoid creating a
disincentive for multi-organ transplants within the IOTA Model.
Kidney transplant hospitals are the focus of the proposed IOTA
Model because they are the entities that furnish kidney transplants to
ESRD patients on the waitlist and ultimately decide to accept donor
recipients as transplant candidates. Kidney transplant hospitals play a
key role in managing transplant waitlists and patient, family, and
caregiver readiness. They are also responsible for the coordination and
planning of kidney transplantation with the OPO and donor facilities,
staffing and preparation for kidney transplantation, and oversight of
post-transplant patient care, and they are largely responsible for
managing the living donation process. The proposed model is intended to
promote improvement activities across selected transplant hospitals
that reduce access barriers, including SDOH, thereby increasing the
number of transplants, quality of care, and cost-effective treatment.
The IOTA Model would also aim to improve quality of care for ESRD
patients on the waitlist pre-transplant, during transplant, and during
post-transplant care. As described in section III.B.4.e. of this
proposed rule, kidney transplant access and acceptance rates vary
nationally across kidney transplant hospitals by geography and other
demographic and socioeconomic factors. The Innovation Center has
implemented models targeting dialysis facilities and nephrology
providers, including in the CEC, ETC, and KCC Models. CMS has also
implemented changes to the OPO CfCs to strengthen performance
accountability for OPOs. However, kidney transplant hospitals have not
been the principal focus of any Innovation Center models to date.
Expanding accountability to kidney transplant hospitals, key players in
the transplantation ecosystem for ESRD patients, aligns with the larger
efforts across CMS and HRSA to improve performance and address
disparities in kidney transplantation.
We alternatively considered having the IOTA participants be
accountable care organizations (ACOs), such as a kidney transplant
ACOs, instead of individual kidney transplant hospitals. In this
alternative conception, a kidney transplant ACO would form as a
separate legal entity, potentially including kidney transplant
hospitals, OPOs, transplant surgeons, and other provider types. The
kidney transplant ACO would assume accountability for the number of
kidney transplants, equity in the distribution of transplants, and the
quality of transplant services from the point of a patient being
waitlisted to after a transplant recipient's condition stabilizes
following transplantation. This alternative would potentially carry
some advantages in the potential for improved coordination among
individual providers and suppliers in the kidney transplant

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