Proposed Rule2025-22543
Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model
Primary source
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Published
December 11, 2025
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This proposed rule would update and revise the Increasing Organ Transplant Access (IOTA) Model for Performance Year (PY) 2.
Full Text
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[Federal Register Volume 90, Number 236 (Thursday, December 11, 2025)]
[Proposed Rules]
[Pages 57598-57634]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22543]
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Vol. 90
Thursday,
No. 236
December 11, 2025
Part IV
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 512
Medicare Program; Alternative Payment Model Updates and the Increasing
Organ Transplant Access (IOTA) Model; Proposed Rule
Federal Register / Vol. 90 , No. 236 / Thursday, December 11, 2025 /
Proposed Rules
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 512
[CMS-5544-P]
RIN 0938-AV65
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 would update and revise the Increasing
Organ Transplant Access (IOTA) Model for Performance Year (PY) 2.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by February 9, 2026.
ADDRESSES: In commenting, please refer to file code CMS-5544-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-5544-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-5544-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#397a7474704d4b58574a495558574d795a544a1751514a175e564f"><span class="__cf_email__" data-cfemail="c0838d8d89b4b2a1aeb3b0aca1aeb480a3adb3eea8a8b3eea7afb6">[email protected]</span></a>, for questions related to the Increasing
Organ Transplant Access Model.
Thomas Duvall, (410) 786-8887, for questions related to the
Increasing Organ Transplant Access Model.
Christina McCormick, (410) 786-4012, for questions related to the
Increasing Organ Transplant Access Model.
Lina Gebremariam, (410) 786-8893, for questions related to the
Increasing Organ Transplant Access Model.
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
continues to encourage 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.
Plain Language Summary: In accordance with 5 U.S.C. 553(b)(4), a
plain language summary of this rule may be found at <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
I. Executive Summary and Background
A. Executive Summary
1. Purpose
This proposed rule would make changes to the Increasing Organ
Transplant Access (IOTA) Model for Performance Year (PY) 2, which will
begin on July 1, 2026, and future PYs.
2. Summary of the Major Provisions
The following is a summary of the major provisions in this proposed
rule. A general summary of the changes in this proposed rule is
presented in section II.B of the preamble of this proposed rule.
a. IOTA Participants
In the 2024 Final Rule, CMS finalized that a kidney transplant
hospital is eligible to be selected as an IOTA participant if it meets
both of the following criteria: (1) The kidney transplant hospital
annually performed 11 or more kidney transplants for patients aged 18
years or older, regardless of payer, each of the baseline years; and
(2) the kidney transplant hospital annually performed more than 50
percent of its kidney transplants on patients 18 years of age or older
each of the baseline years. However, per section 1835(d) of the Social
Security Act (the Act) as codified in 42 CFR 411.6, Medicare does not
pay for services furnished by a Federal provider of services or other
Federal agency, nor does Medicare pay for services that are paid for
directly or indirectly by a government entity, with only limited
exceptions. Therefore, we are proposing to modify the eligible kidney
transplant hospital criteria to exclude Department of Veteran's Affairs
(VA) medical facilities and Military medical treatment facilities
(MTFs) from the IOTA Model for PYs 2 through 6, as described in section
II.B.1.b. of this proposed rule.
In the 2024 Final Rule, CMS established a low volume threshold
requiring kidney transplant hospitals to have performed 11 or more
kidney transplants for patients aged 18 years or older annually in each
of the 3 baseline years in order to be eligible for selection into the
IOTA Model, designed to protect beneficiary confidentiality and align
with minimum CMS data display standards while ensuring statistical
significance. However, in response to some IOTA participants expressing
concern about their ability to participate in the model and our
experience in operating the model, we believe it is necessary to
reevaluate the low volume threshold requiring a kidney transplant
hospital to have performed at least 11 kidney transplants annually in
each of the 3 baseline years in order to be eligible for selection into
the IOTA Model. As such, as described in section II.B.1.b. of this
proposed rule, we are proposing to raise the low volume threshold from
a minimum of 11 kidney transplants performed annually during each of
the baseline years to a minimum of 15 kidney transplants performed
annually during each of the baseline years.
b. Performance Assessment
In the 2024 Final Rule, we finalized a policy to assess IOTA
participant performance each PY in the quality domain on post-
transplant outcomes using the composite graft survival rate. While the
model performance period has begun, we indicated that for certain
policies, such as the inclusion of a risk-adjustment methodology when
calculating the composite graft survival rate to account for the
complexities of donors and recipients, and their associated risks, we
would go through rulemaking in the future to promulgate new or updated
policies that would be finalized after the model start date. Therefore,
as described in section II.B.2.b.(2).(a). of this proposed rule, we are
proposing updates to the composite
[[Page 57599]]
graft survival rate metric that would include the following
modifications:
<bullet> Adding a risk-adjustment methodology that includes several
transplant recipient and donor characteristics (for example, transplant
recipient and donor age, diabetes status, sex, kidney function (eGFR/
creatinine).
<bullet> Excluding multi-organ transplants from the composite graft
survival rate exclusion and inclusion criteria, in recognition of their
more complicated results for kidney transplant recipients.
<bullet> Updating the allocation of points awarded for performance
on the composite graft survival rate.
A detailed description of each proposed policy change and the
corresponding scoring criteria can be found in section II.B.2.b. of
this proposed rule.
c. Payment
As finalized in the 2024 Final Rule, each IOTA participant's final
performance score will determine whether: (1) CMS will pay an upside
risk payment to the IOTA participant; (2) the IOTA participant will
fall into a neutral zone where no performance-based incentive payment
will be paid to or owed by the IOTA participant; or (3) the IOTA
participant will owe a downside risk payment to CMS. For a final
performance score greater than 60, CMS will apply the formula for the
upside risk payment, which will be equal to the IOTA participant's
final performance score minus 60, then divided by 40, then multiplied
by $15,000, then multiplied by the number of kidney transplants
furnished by the IOTA participant to attributed patients with Medicare
fee-for-service (FFS) as their primary or secondary payer during the
PY. Final performance scores below 60 in PY 1 and final performance
scores of 40 to 60 (inclusive) in PYs 2 through 6 will fall in the
neutral zone where there will be no payment owed to the IOTA
participant or CMS.
Currently, IOTA Model regulations stipulate that IOTA participants
must remit the downside risk payment to CMS in a single payment at
least 60 days after the date on which the demand letter is issued. As
described in section II.B.3.c.(2). of this proposed rule, CMS is
proposing to modify the policy previously finalized in the 2024 Final
Rule such that IOTA participants must remit the downside risk payment
to CMS in a single payment within 60 days after the date on which the
demand letter is issued. As proposed in section II.B.3.c.(2). of this
proposed rule, if full payment is not received by CMS within 60 days
after demand is made, the remaining amount owed will be considered a
delinquent debt.
Finally, in the 2024 Final Rule, CMS established an Extreme and
Uncontrollable Circumstance (EUC) payment policy recognizing that
events may occur outside the purview and control of the IOTA
participant that may affect their performance in the model. Under the
current provision in the IOTA Model, CMS applies determinations made by
the Quality Payment Program (QPP) with respect to whether an EUC has
occurred, and the areas impacted during the PY. As currently finalized,
in the event of an extreme and uncontrollable circumstance, as
determined by the QPP, CMS may reduce the downside risk payment, if
applicable, prior to recoupment. CMS determines the amount of the
reduction by multiplying the downside risk payment by both the
percentage of total months during the PY affected by the EUC and the
percentage of attributed patients who reside in an area affected by the
EUC. As described in section II.B.3.c.(3). of this proposed rule, CMS
recognizes that QPP policies may not be appropriate for the IOTA Model
due to different payment calculation inputs and program goals. CMS also
acknowledges the limited nature of the current EUC provision to account
for broader impacts that an EUC might have on an IOTA participant's
ability to perform in the model, which only potentially reduces
downside payments without accounting for changes in model inputs or
reporting periods that may affect an IOTA participant's performance
score. Therefore, this proposed rule updates to the EUC provisions that
would provide CMS sole discretionary authority to do the following:
<bullet> Apply flexibilities to IOTA participants located in
emergency areas during emergency periods as defined in section 1135(g)
of the Act with Secretary-issued waivers and in counties, parishes, or
tribal governments designated under major disaster declarations
pursuant to the Stafford Act.
<bullet> Extend payment and reporting accommodations to IOTA
participants impacted by EUC.
<bullet> Adjust the upside risk payment or downside risk payment
amount for the IOTA participant if the IOTA participant is
participating in the IOTA Model when such an emergency period has been
declared.
d. Other Requirements
In the 2024 Final Rule, CMS finalized several other model
requirements for IOTA participants, including transparency
requirements, public reporting requirements, and a health equity plan
requirement which is optional for the IOTA Model performance period. In
the 2024 Final Rule, CMS signaled that there were several policies that
would be updated through future rulemaking. In addition, there were
several policy considerations raised subsequent to the publication of
the 2024 Proposed Rule, including through public comment, which CMS
would like to incorporate into the IOTA Model, but were unable to add
to the 2024 Final Rule. Therefore, this proposed rule proposes updates
to other requirements in the IOTA Model.
a. Transparency
In the 2024 Final Rule CMS finalized that IOTA participants must
publicly post their patient selection waitlist criteria on a website by
the end of PY 1. CMS also stated its intent to use future rulemaking to
determine the cadence of updating this website and patient selection
criteria. As such, this proposed rule proposes updates to this
requirement that includes the following modifications:
<bullet> For all subsequent PYs after PY1, the IOTA participant
must review its publicly posted patient selection waitlist criteria and
ensure that the information on its website is up to date by the end of
each relevant PY.
<bullet> IOTA participants performing living donor transplants must
publicly post their living donor selection criteria for evaluating
potential living donors for kidney transplant waitlist patients by the
end of PY 2. IOTA participants must ensure the accuracy of this
information by the end of each subsequent PY.
Each of the proposed provisions is discussed in detail in section
II.B.4.a.(1). of this proposed rule.
CMS also finalized its intent in the 2024 Final Rule to identify
each IOTA participant for each PY and to post performance across the
achievement domain, efficiency domain, and quality domain for each IOTA
participant on the IOTA Model website annually, as they become
available. As proposed in section II.B.4.a.(2). of this proposed rule,
we are proposing to publish IOTA participant waitlist selection
criteria and the proposed living donor selection criteria, as described
in section II.B.4.a.(1). of this proposed rule, on the IOTA Model
website by the end of the second quarter of each subsequent PY.
As discussed in the 2024 Final Rule, those active on a kidney
transplant waitlist may receive organ offers at any time. However,
there is currently no requirement for providers to discuss organ offers
with their patients. A
[[Page 57600]]
provider may decline an organ offer for any number of reasons; however,
declining without disclosing the rationale with the patient may miss an
important opportunity for shared decision-making. As described in the
2024 Final Rule, CMS proposed monthly transparency requirements for
IOTA participants to inform IOTA waitlist patients who are Medicare
beneficiaries about declined organ offers and the reasons for
declination. However, following feedback from 2024 Proposed Rule public
comments that this policy would impose a significant administrative
burden on IOTA participants, CMS decided not to finalize this
transparency requirement and instead committed to consider
alternatives, such as alternative frequencies for sharing declined
organ offers with Medicare beneficiaries, while remaining invested in
evaluating alternative transparency opportunities for patients on the
waiting list with the transplant community to fulfill this important
need. In this proposed rule, we are proposing an alternative approach
for the model, as described in section II.B.4.a.(3). of this proposed
rule. As proposed in section II.B.4.a.(3). of this proposed rule,
beginning in PY 3, IOTA participants must provide semi-annual (that is,
at least once every 6 months) notifications to ``eligible IOTA waitlist
beneficiaries,'' as defined in section II.B.4.a.(3). of this proposed
rule, detailing the number and reasons for organ declinations made on
their behalf, with eligible IOTA waitlist beneficiaries retaining the
right to opt out of receiving these notifications.
In the 2024 Final Rule, CMS finalized a requirement that IOTA
participants must review organ offer acceptance criteria with their
IOTA waitlist patients who are Medicare beneficiaries at least once
every 6 months that the Medicare beneficiary is on their waitlist. IOTA
participants have since requested that CMS provide clarification on
what acceptance criteria information should be reviewed. Therefore, as
described in section II.B.4.(a).(4). of this proposed rule, we aim to
clarify that review of acceptance criteria pertains to individual
patient transplant organ offer acceptance criteria and not organ offer
filters or kidney transplant hospital level acceptance criteria. For
purposes of the model, we are also proposing to define ``transplant
organ offer acceptance criteria'' as individualized patient acceptance
parameters that kidney waitlist patients, as defined at Sec. 512.402,
may elect regarding the categories of organ offers they are prepared to
accept for transplantation.
Lastly, CMS is proposing the adoption of the following provisions
for IOTA participants to notify its IOTA waitlist patients who are
Medicare beneficiaries when their waitlist status has changed (that is,
from active to inactive) only if it is not redundant with other HHS
guidance: If finalized, the IOTA participant would be required to: (1)
inform IOTA waitlist patients who are Medicare beneficiaries any time
their status on its waitlist is changed that would impact their ability
to receive an organ offer; (2) include the reason, and information
about how IOTA waitlist patients who are Medicare beneficiaries could
become active again; and, (3) notify the dialysis facility (as defined
at 42 CFR 494.10) and managing clinician (as defined at 42 CFR 512.310)
or nephrologist if applicable. IOTA participants would be required to
notify these IOTA waitlist patients who are Medicare beneficiaries of
status changes within 10 days when they become ineligible for organ
offers (if not redundant with existing HHS guidance). This proposed
provision is discussed in detail in section II.B.4.a.(5). of this
proposed rule.
b. Health Equity Plans
In the 2024 Final Rule, CMS finalized that an IOTA participant may
voluntarily submit a health equity plan (HEP) to CMS. CMS finalized
voluntary health equity plan submissions aiming to address reducing
health disparities for attributed patients. However, in an effort to
align with priorities of the Administration and address concerns of
added burdens on IOTA participants in a mandatory model, we decided to
remove the voluntary health equity plan submissions and are proposing
to remove all health equity plan provisions and related definitions
from the IOTA Model as described in section II.B.4.b. of this proposed
rule. This proposed policy change would enable IOTA participants to
focus limited resources on care redesign activities that would improve
their model performance and the quality of care and experience for the
attributed patient. While CMS is not currently proposing a replacement
for these policies, CMS may consider incorporating elements that align
with the current Administration's focus on Making America Healthy Again
(MAHA) in future years through notice and comment rulemaking.
e. Beneficiary Protections
CMS finalized in the 2024 Final Rule that IOTA participants must
provide notice to each attributed patient of its participation in the
IOTA Model. As described in section II.B.5. of this proposed rule, we
are proposing updates to this provision that would include the
following modifications:
<bullet> Limit these notification requirements to Medicare
beneficiaries only.
<bullet> Allow IOTA participants to distribute this notification in
a paper notification at the first in office or outpatient visit, or to
distribute the notification in an electronic format in cases where the
attributed patient has affirmatively opted out of receiving paper
communications.
f. Monitoring
In the 2024 Final Rule, we finalized a comprehensive list of
monitoring activities to ensure compliance and promote the safety of
attributed patients and the integrity of the IOTA Model. However, we
inadvertently omitted monitoring of the review of acceptance criteria
provision as described in Sec. 512.442. Therefore, in this proposed
rule we are proposing to include that CMS may monitor the following
transparency provisions as described in section II.B.6 of this proposed
rule:
<bullet> Informing eligible IOTA waitlist patients who are Medicare
beneficiaries, as defined in section II.B.4.a.(3). of this proposed
rule, of the number of times an organ is declined on the Medicare
beneficiary's behalf in accordance with proposed Sec. 512.442(b);
<bullet> Reviewing selection criteria with IOTA waitlist patients
who are Medicare beneficiaries at least once every 6 months that the
Medicare beneficiary is on their waitlist as specified in Sec.
512.442(c); and
<bullet> Notifying IOTA waitlist patients who are Medicare
beneficiaries when their waitlist status has changed from active to
inactive in accordance with proposed Sec. 512.442(d).
g. Remedial Action and Termination
In the 2024 Final Rule, we finalized a comprehensive list of
reasons for which CMS may immediately or with advance notice terminate
an IOTA participant from the IOTA Model. As mentioned in section
II.B.7. of this proposed rule, we inadvertently omitted the Department
of Health and Human Services (HHS) and the Organ Procurement and
Transplantation Network (OPTN) as sources of vital information
regarding potential events by IOTA participants identified as
presenting a risk to patient safety, public health, and related
concerns that may lead CMS to terminate IOTA participants. Therefore,
in this proposed rule we are proposing to include that CMS may
terminate an IOTA participant from the IOTA Model if HHS or the
[[Page 57601]]
OPTN has determined that an IOTA participant has violated the OPTN's
policies, OPTN's Management and Membership policies, or the HHS's
regulation (42 CFR 121) upon a review conducted pursuant to 42 CFR
121.10, along with minor technical corrections to accommodate this
proposal as described in section II.B.7 of this proposed rule.
h. Request for Information (RFI) on Topics Relevant to IOTA Model
As part of the Medicare Program; Alternative Payment Model Updates
and the Increasing Organ Transplant Access (IOTA) Model Proposed Rule
(2024 Proposed Rule) published in the Federal Register in May 2024 (89
FR 43518), we stated that our goal for the quality domain within the
IOTA Model is to achieve acceptable post-transplant outcomes while
incentivizing increased kidney transplant volume.\1\ We are seeking
public input and comments on a future access to waitlist quality
process measure to be specified, tested, and implemented for future
years of the IOTA Model, titled ``Pre-transplantation Access Process
Measure''.
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\1\ We note that the definition and criteria for ``acceptable''
post-transplant outcomes has not been defined and, as stated in
section II.B.2.b(2) of this proposed rule, we are seeking comment on
how to define an acceptable level (for example, 1 standard deviation
of the national risk-adjusted rate or some other way).
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In the 2024 Final Rule, CMS finalized monitoring allocation out-of-
sequence (AOOS) kidneys as a monitoring activity. In response to the
2024 Proposed Rule, we received numerous comments from the public
worried about the impact of the IOTA Model on further promoting AOOS.
Additionally, on August 30, 2024, HRSA provided a critical comment
letter to the OPTN and OPTN contractor regarding a complaint that they
received, in which HRSA emphasized the OPTN policies requiring each OPO
to maintain a plan for equitable organ allocation among transplant
patients consistent with OPTN obligations. While we did not make any
changes in the 2024 Final Rule based on the comments received, AOOS
remains an issue of concern for CMS and HRSA. As such, in this proposed
rule, we would like to seek public comments on potential policies CMS
could consider to address AOOS as part of the IOTA Model or through
separate regulatory efforts.
3. 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. In section V of this proposed
rule, we set forth a detailed analysis of the impacts that the proposed
changes would have on affected IOTA participants and beneficiaries. We
estimate that as a result of the proposed changes to the IOTA Model,
net Federal savings would increase by $21 million.
B. Model Overview and Background
The Increasing Organ Transplant Access (IOTA) Model is a 6-year
mandatory alternative payment model tested by the CMS Innovation Center
under section 1115A of the Social Security Act (the Act) that began on
July 1, 2025, and will end on June 30, 2031. The model appeared in the
December 4, 2024 Federal Register (89 FR 96280) titled ``Medicare
Program; Alternative Payment Model Updates and the Increasing Organ
Transplant Access (IOTA) Model'' (hereinafter referred to as the 2024
Final Rule), and this proposed rule would update IOTA Model provisions
in response to improvement opportunities that arose during
implementation and to better align the model with new administration
priorities. The IOTA Model is aimed at kidney transplant hospitals with
the goal of increasing the number of kidney transplants, improving
quality, and improving patient experience during the transplant
process.
II. Proposed Changes to the Increasing Organ Transplant Access (IOTA)
Model
A. Background
1. Purpose
The Increasing Organ Transplant Access (IOTA) Model is a 6-year
mandatory alternative payment model tested by the CMS Innovation Center
that began on July 1, 2025, and will end on June 30, 2031. The IOTA
Model is testing whether performance-based incentives paid to or owed
by participating kidney transplant hospitals can increase access to
kidney transplants for kidney transplant waitlist patients, while
preserving or enhancing quality of care and reducing Medicare
expenditures. CMS has selected 103 kidney transplant hospitals to
participate in the IOTA Model and will be measuring and assessing the
participating kidney transplant hospitals' performance during each
performance year (PY) across three performance domains: achievement,
efficiency, and quality.
The IOTA Model was established through notice and comment
rulemaking, finalized in the Medicare Program; Alternative Payment
Model Updates and the Increasing Organ Transplant Access (IOTA) Model
Final Rule (2024 Final Rule), CMS-5535-F, published December 4, 2024.
In the 2024 Final Rule, CMS signaled that there were several policies
that could be addressed through future rulemaking, including: the
addition of a risk-adjustment methodology in the calculation of the
composite graft survival rate, the addition of transplants furnished to
Medicare Advantage beneficiaries to the definition of Medicare kidney
transplants, and the addition of a monthly transparency requirement for
IOTA participants to inform IOTA waitlist patients who are Medicare
beneficiaries about declined organ offers and the reasons for
declination. In addition, there were a number of policy considerations
raised subsequent to the publication of the Medicare Program;
Alternative Payment Model Updates and the Increasing Organ Transplant
Access (IOTA) Model Proposed Rule (2024 Proposed Rule), including
through public comment, which CMS would like to incorporate into the
IOTA Model, but were unable to add to the 2024 Final Rule. Therefore,
this proposed rule proposes updates to the IOTA Model. The policies
delineated in this proposed rule reflect our commitment to ensuring
that the IOTA Model's incentive structure enhances the care delivery
capabilities and efficiency of kidney transplant hospitals selected for
participation, with the goal of improving quality of care while
reducing program spending.
2. Statutory Authority and Background
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
[[Page 57602]]
regarding cooperation in model evaluation; monitoring and compliance;
and beneficiary protections.
Under the authority of section 1115A of the Act, through notice-
and-comment rulemaking, the CMS Innovation Center established the IOTA
Model in the 2024 Final Rule that appeared in December 4, 2024, Federal
Register (89 FR 96280). The intent of the IOTA Model is to reduce
Medicare expenditures and improve performance 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.
Participation in the IOTA Model is mandatory for approximately 50
percent of all eligible kidney transplant hospitals in the United
States, which were selected by a stratified random sampling of donation
service areas (``DSAs''). Mandatory participation in the IOTA Model was
determined to be necessary to minimize the potential for selection bias
and to ensure a representative sample size nationally, thereby
guaranteeing that there would be adequate data to evaluate the model
test. Eligible kidney transplant hospitals included those that: (1)
performed at least 11 kidney transplants for patients 18 years of age
or older annually regardless of payer type during the 3-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. As this is a
mandatory model, the selected kidney transplant hospitals are required
to participate.
CMS measures and assesses IOTA participant performance during each
PY across three performance domains: achievement, efficiency, and
quality. The achievement domain assesses each IOTA participant on the
number of kidney transplants performed during a PY, relative to a
participant-specific transplant target. The efficiency domain assesses
the performance of IOTA participants on the organ offer acceptance rate
ratio relative to national ranking. The quality domain is focused on
improving the quality of care and measures IOTA participants
performance on the composite graft survival rate relative to national
ranking to assess post-transplant outcomes. Each IOTA participant's
performance score across these three domains determines its final
performance score and corresponding amount for the performance-based
incentive payment that CMS will pay to or the payment that will be owed
by the IOTA participant. The upside risk payment will be a lump sum
payment paid by CMS after the end of a PY to an IOTA participant with a
final performance score of 60 or greater. Conversely, beginning PY 2,
the downside risk payment will be a lump sum payment paid to CMS by any
IOTA participant with a final performance score of 40 or lower. There
is no downside risk payment for PY 1 of the IOTA Model.
B. Provisions of the Proposed Regulation
1. IOTA Participants
a. Background
In the 2024 Final Rule (89 FR 96304), we defined ``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 noted that the definition of ``model
participant'' contained in 42 CFR 512.110, would include an IOTA
participant. We also proposed and finalized at Sec. 512.402 the
definition of ``transplant hospital,'' ``kidney transplant hospital,''
and ``kidney transplant.'' We stated that kidney transplant hospitals
are the focus of the IOTA Model because they are the entities that
furnish kidney transplants to ESRD patients on the waiting list and
ultimately decide to accept donor recipients as transplant candidates
(89 FR 96303). 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 organ procurement organizations (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 IOTA Model is
intended to promote improvement activities across selected kidney
transplant hospitals that reduce access barriers, thereby increasing
the number of transplants, quality of care, and cost-effective
treatment. The IOTA Model aims to improve quality of care for ESRD
patients on the waiting list pre-transplant, during transplant, and
during post-transplant care.
b. Mandatory Participation
In the 2024 Final Rule (89 FR 96308), we finalized that
participation in the IOTA Model would be mandatory. We proposed and
finalized that all kidney transplant hospitals that meet the
eligibility requirements at Sec. 512.412(a), and that are selected
through the participation selection process at Sec. 512.412(b) and (c)
would be required to participate in the IOTA Model. Lastly, we also
finalized our provisions for participant eligibility criteria for
kidney transplant hospitals at Sec. 512.412(a) for all eligible kidney
transplant hospitals selected for participation in the model.
As stated in the 2024 Final Rule (89 FR 96308), we proposed kidney
transplant hospital participant eligibility criteria that would
increase the likelihood that: (1) individual kidney transplant
hospitals selected as IOTA participants represent a diverse array of
capabilities across the performance domains; and (2) the results of the
model test would be statistically valid, reliable, and generalizable to
kidney transplant hospitals nationwide should the model test be
successful and considered for expansion under section 1115A(c) of the
Act.
We proposed and finalized our participant eligibility criteria for
kidney transplant hospitals at Sec. 512.412(a) in the 2024 Final Rule
(89 FR 96311). Specifically, that eligible kidney transplant hospitals
are those that: (1) performed 11 or more transplants for patients aged
18 years or older annually, regardless of payer type, each of the
baseline years and (2) furnished more than 50 percent of its kidney
transplants annually to patients over the age of 18 during each of the
baseline years. We also finalized the definition of ``non-pediatric
facility'' and ``baseline years'' at Sec. 512.402.
In the 2024 Final Rule, we finalized at Sec. 512.412(a)(1) a low
volume threshold requiring a kidney transplant hospital to have
performed 11 or more kidney transplants for patients aged 18 years or
older annually in each of the 3 baseline years in order to be eligible
for selection into the IOTA Model.
In our initial proposal in the 2024 Proposed Rule, we stated that
we alternatively considered using a higher threshold, such as 30 adult
kidney transplants or 50 adult kidney transplants during each of the 3
baseline years (89 FR 43541). However, we found that many kidney
transplant hospitals consistently perform between 11 and 50 transplants
per year. We received several comments expressing concern with the
proposed low-volume kidney transplant threshold for IOTA participants.
As described in the 2024 Final Rule at 89 FR 96309, a commenter noted
that there may be some unforeseen or unintended consequences of
advantaging programs classified as ``low volume,'' where the volume is
close to the dividing line, and vice versa. Additional commenters
shared concerns that the low volume threshold of 11 kidney transplants
performed will
[[Page 57603]]
disadvantage kidney transplant hospitals that furnish a smaller number
of kidney transplants, as these transplant programs do not meet the
requirements for Center of Excellence (COE) programs and have limited
contracts with payers, and the low volume threshold does not ensure
statistical significance. Several commenters recommended that CMS
should increase the low volume threshold, setting the number of kidney
transplants at a value such as 25, 50, or 100, to ensure statistical
significance and avoid burden on kidney transplant hospitals that
furnish a smaller number of kidney transplants. Finally, a commenter
suggested CMS should only use the number of Medicare kidney transplants
to determine eligibility, rather than 11 kidney transplants across all
payers. Additionally, as described at 89 FR 96308 a commenter expressed
concerns about the impact of the IOTA Model on small kidney transplant
hospitals if participation was made mandatory. The commenter suggested
that a low volume threshold of 100 kidney transplants, regardless of
payer type, would be more appropriate. This, the commenter believed,
would ensure small kidney transplant hospitals were excluded and
protect access to kidney transplants in less populated areas.
In the 2024 Final Rule, we stated that the low volume threshold was
designed to protect the confidentiality of Medicare and Medicaid
beneficiaries and that this low volume threshold aligns with the
minimum standards for CMS data display, preventing the release of
information that could identify individual beneficiaries while ensuring
statistical significance (89 FR 96309). Additionally, we stated that we
excluded these low-volume kidney transplant hospitals that may lack the
capacity to comply with the model's policies.
Since publication of the 2024 Final Rule, some IOTA participants
close to the current low volume threshold have expressed concern about
their ability to participate in the model and we believe it is
necessary to reevaluate the low volume threshold requiring a kidney
transplant hospital to have performed 11 or more kidney transplants for
patients aged 18 years or older, regardless of payer, annually in each
of the 3 baseline years in order to be eligible for selection into the
IOTA Model. We also received multiple comments from the 2024 Proposed
Rule urging us to increase the low volume threshold. As such, in this
proposed rule, we are proposing at Sec. 512.412(a)(1) to raise this
low volume threshold from a minimum of 11 kidney transplants performed
annually during each of the baseline years to a minimum of 15 kidney
transplants performed annually during each of the baseline years. We
are also proposing this provision in response to our experience in
operating the model. IOTA participants who are above the current
minimum threshold of 11 kidney transplants performed annually, but
below the updated proposed threshold of a minimum of 15 kidney
transplants performed annually are still quite small and have indicated
structural difficulties in achieving the goals of the model and
complying with the requirements of the model. This updated low volume
threshold is designed to balance accommodating the needs of smaller
kidney transplant hospitals to ensure that their transplant programs
can remain viable and continue to serve their communities, while also
trying to ensure a sufficient volume of kidney transplant hospitals to
be able to test the model.
We alternatively considered higher low volume thresholds, such as
20 kidney transplants or 25 kidney transplants performed for patients
aged 18 years or older annually, regardless of payer, during each of
the baseline years, but think that a low volume threshold of 15 kidney
transplants or more performed to patients aged 18 years or older
annually best balances excluding the smallest kidney transplant
hospitals, while still being able to ensure that the model has
sufficient power to be able to test the model. This proposed updated
low volume threshold would only result in the removal of one IOTA
participant as of the model start date, while higher thresholds would
result in additional IOTA participants being removed, which could
diminish the ability to evaluate the model.
We seek comment on our proposal to adjust the low volume threshold
at Sec. 512.412(a)(1) to require that to be eligible for model
participation, a kidney transplant hospital must have performed a
minimum of 15 kidney transplants to patients aged 18 years or older
annually, regardless of payer, each of the baseline years, rather than
a minimum of 11 kidney transplants. We also seek public comment on the
alternatives considered.
Additionally, since publication of the 2024 Final Rule, CMS has
completed IOTA participant selection and notified IOTA participants of
their selection to participate in the IOTA Model. Upon completion of
selecting IOTA participants for inclusion in the model, we realized
that an unintended consequence of the current participant eligibility
criteria at Sec. 512.412(a) is that Department of Veterans Affairs
(VA) medical facilities or military medical hospitals, also known as
military medical treatment facilities (MTFs) could be selected to
participate even though Medicare does not provide reimbursement for VA
medical facilities or MTFs. A total of 103 kidney transplant hospitals
were selected to participate in the model, including four VA medical
facilities and one MTF.
Per 42 CFR 411.6(a), Medicare does not pay for services rendered by
Federal providers of services or other Federal agencies. Additionally,
Medicare does not provide payment for services that receive direct or
indirect funding from a governmental entity (see 42 CFR 411.8). As such
we propose to update the participant eligibility criteria at Sec.
512.412(a). Specifically, we are proposing at Sec. 512.412(a)(3) to
exclude kidney transplant hospitals that are a MTF or VA medical
facility from being eligible to participate in the IOTA Model. We
propose at Sec. 512.402 to define a ``VA medical facility'' as defined
at 38 CFR 17.1505 to mean a VA hospital, a VA community-based
outpatient clinic, or a VA health care center, any of which must have
at least one full-time primary care physician, but not a Vet Center or
Readjustment Counseling Service Center. Additionally, we propose at
Sec. 512.402 to define a ``military medical treatment facility (MTF)''
as it is currently defined at 10 U.S.C. 1073c(j)(3) to mean: (1) any
fixed facility of the Department of Defense that is outside of a
deployed environment and used primarily for health care; and (2) any
other location used for purposes of providing healthcare services as
designated by the Secretary of Defense.
Given that Medicare does not provide coverage for services
furnished by a federal provider, federal agency, or any other
government entity, whether the services are paid for directly or
indirectly by a government source, we believe that VA medical
facilities and MTFs should not be eligible to participate in the IOTA
Model. Additionally, we do not believe that our proposal to exclude
kidney transplant hospitals that are also a VA medical hospital or MTF
from being eligible to participate in the IOTA Model would negatively
affect the remaining IOTA participants or impact the IOTA Model nor
CMS's ability to evaluate the model. Moreover, the model's evaluation
would benefit from an analysis that only focuses on Medicare-
participating kidney transplant hospitals. Since the fundamental
purpose of the IOTA Model is to test interventions specifically within
the Medicare system to improve quality of care and reduce
[[Page 57604]]
Medicare expenditures, including non-Medicare participating facilities
like VA medical facilities and MTFs would introduce confounding
variables that could obscure the model's true effectiveness. VA medical
facilities and MTFs operate under entirely different payment
structures, regulatory frameworks, and patient populations compared to
Medicare-participating hospitals, making direct performance comparisons
inappropriate and potentially misleading.
By excluding these facilities, the model evaluation can focus on a
group of hospitals that all operate under similar Medicare
reimbursement conditions, face comparable regulatory requirements, and
serve similar patient populations, thereby providing more accurate data
on whether the model's performance-based payment incentives actually
drive improvements in transplant outcomes and cost efficiency within
the Medicare system. This approach would also eliminate the analytical
complexity of trying to account for the vastly different operational
contexts between Medicare-participating kidney transplant hospitals and
federal facilities, ultimately yielding more actionable insights for
potential broader implementation of the IOTA Model across the Medicare
program.
We seek comment on our proposal at proposed Sec. 512.412(a)(3) to
exclude kidney transplant hospitals that are a MTF or VA medical
facility as eligible to participate in the model. We also seek comments
on our proposed definitions of MTF and VA medical facility at proposed
Sec. 512.402.
Lastly, to account for our proposed kidney transplant hospital
participant eligibility criteria modifications at proposed Sec.
512.412(a)(1) and (3), we propose updating the language at Sec.
512.412(a). Specifically, we propose replacing ``meets both'' with
``meets all'' to specify that a kidney transplant hospital is eligible
to be selected as an IOTA participant, in accordance with the
methodology described in proposed Sec. 512.412(b)(3), if the kidney
transplant hospital meets all of the eligibility criteria at Sec.
512.412(a).
We seek comment on our proposal at proposed Sec. 512.412(a) to
update existing language to account for our proposals at proposed Sec.
512.412(a)(1) and (3).
2. Performance Assessment
a. Method and Scoring Overview
In the 2024 Final Rule (89 FR 96326), we finalized provisions to
assess IOTA participants in the achievement domain, efficiency domain
and quality domain and performance scoring approach at Sec.
512.422(a). We also finalized at Sec. 512.402 the definition of
``final performance score'' as the aggregate sum of scores earned by
the IOTA participant across all three domains for a designated PY.
b. Quality Domain
(1) Background
In the 2024 Final Rule (89 FR 96358), we finalized at Sec. 512.402
the definition of ``quality domain'' as the performance assessment
category in which CMS assesses the IOTA participant's performance using
a performance measure focused on improving the quality of transplant
care as described in Sec. 512.428. We also finalized general
provisions for the quality domain at Sec. 512.424(a).
We stated at 89 FR 96358, that our goal for the quality domain
within the IOTA Model is to achieve acceptable post-transplant outcomes
while incentivizing increased kidney transplant volume.\2\ We continue
to believe that transplant hospital accountability for patient-
centricity and clinical outcomes continues post-transplantation. While
transplant outcomes have historically received the most attention,
often at the exclusion of other factors, we sought to encourage a
better balance in the system to offer the benefits of transplant to
more patients.
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\2\ We note that the definition and criteria for ``acceptable''
post-transplant outcomes has not been defined and we are seeking
comment on how to define an acceptable level (for example, 1
standard deviation of the national risk-adjusted rate or some other
way), as stated in section II.B.2.b(2) of this proposed rule.
---------------------------------------------------------------------------
(2) Post Transplant Outcomes
In the 2024 Final Rule (89 FR 96361), we finalized at Sec.
512.428(b)(1) a provision to assess IOTA participant performance each
PY on post-transplant outcomes using the composite graft survival rate.
We also proposed and finalized at Sec. 512.402 the definition of
composite graft survival rate (89 FR 96361).
(a) Calculation of Metric
In the 2024 Final Rule (89 FR 96364), we proposed and finalized
provisions for calculating the composite graft survival rate at Sec.
512.428(b)(1).
In our initial proposal in the 2024 Proposed Rule (89 FR 43563), we
stated that we had considered incorporating a risk-adjustment
methodology into our proposed composite graft survival equation, such
as the one used by Scientific Registry of Transplant Recipients (SRTR)
for 1-year post-transplant outcomes conditional on 90-day survival or
constructing our own. We also stated at 89 FR 43563 that we were
interested in comments on whether risk-adjustments were necessary, and
which ones, such as transplant recipient and donor characteristics,
would be significant and clinically appropriate in the context of our
proposed approach. We received over 15 comments expressing concern that
the lack of risk-adjustment in the composite graft survival rate metric
could have adverse consequences and would add additional administrative
burden. As described at 89 FR 96362, many commenters expressed concern
that the unadjusted composite graft survival rate does not account for
the clinical risk factors of the transplant recipient or the donor;
therefore, it may inadvertently lead to disparities in transplant
access by incentivizing IOTA participants to select healthier patients
for transplantation. Several commenters believe that the proposed
measure misaligned with the model's goal of increasing kidney
transplants in a more complex population without risk-adjusting for
allograft and recipient factors. Without proper risk-adjustment, these
commenters suggested the proposed measure could cause IOTA participants
to be more risk averse with the types of organs they accept or
disincentivize IOTA participants from transplanting candidates who have
a higher likelihood of graft failure, such as older candidates or those
with more comorbid conditions. Some commenters suggested specific
transplant recipient and donor characteristics that CMS should risk-
adjust for when calculating the proposed composite graft survival rate.
In the 2024 Final Rule (89 FR 96363), we stated that in light of
commenters suggestions, we considered finalizing a risk-adjustment
methodology that adjusted for donor age, recipient age, and recipient
diabetes. However, we decided to finalize the provisions as proposed as
we did not believe that adjusting for these three variables alone was
appropriate. Organ availability affects kidney transplantation, leading
transplant teams to expand the criteria for accepting organ donors.\3\
In these circumstances, we believe that analysis of the impact of the
donor's characteristics on graft survival becomes mandatory before
incorporating a risk-adjustment methodology. Additionally, given that
the IOTA Model is 6 years,
[[Page 57605]]
and the measure is rolling, meaning that it measures the rolling total
number of functioning grafts relative to the total number of adult
kidney transplants performed for all 6 years, as described in the 2024
Final Rule at 89 FR 96324, we wanted to continue discussions to ensure
that this measure eventually includes a robust and appropriate risk-
adjustment methodology. Furthermore, we continue to believe that the
lack of risk-adjustment for PY 1 would be minimal in terms of impacting
IOTA participants scores and note that IOTA participants do not owe a
downside risk payment in PY 1, as described in Sec. 512.430(b)(3)(i).
We also note that in the 2024 Final Rule at 89 FR 96364, we stated that
while we were finalizing our provision for calculating the composite
graft survival rate as proposed, we would be stratifying the data from
the composite graft survival rate measure to inform a risk-adjustment
methodology for this measure and might consider future notice and
comment rulemaking on this topic.
---------------------------------------------------------------------------
\3\ Olawade, D.B., Marinze, S., Qureshi, N., Weerasinghe, K., &
Teke, J. (2024). Transforming organ donation and transplantation:
Strategies for increasing donor participation and system efficiency.
European Journal of Internal Medicine. <a href="https://doi.org/10.1016/j.ejim.2024.11.010">https://doi.org/10.1016/j.ejim.2024.11.010</a>.
---------------------------------------------------------------------------
Since publication of the 2024 Final Rule, many IOTA participants
have urged CMS to include a risk-adjustment methodology in the
composite graft survival rate calculation. As such, in this proposed
rule, we are proposing at Sec. 512.428(b)(2) to include a risk-
adjustment methodology in the composite graft survival rate
calculation. Specifically, we propose at Sec. 512.428(b)(2)(i)(A) and
(B) that CMS would, in accordance with Sec. 512.428(b)(1) through (3),
risk-adjust the composite graft survival rate to account for multiple
transplant recipient and donor characteristics, that includes at
minimum the following:
<bullet> Transplant recipient characteristics:
++ Age.
++ Sex.
++ Kidney function (eGFR/creatinine).
++ Diabetes status.
++ Hypertension with or without cardiovascular disease.
++ Human leukocyte antigen (HLA) mismatch.
++ Plasma renin activity (PRA) levels.
<bullet> Donor characteristics:
++ Age.
++ Sex.
++ Kidney function (eGFR/creatinine).
++ Diabetes status.
++ Hypertension history with or without cardiovascular disease.
++ Cardiovascular disease.
++ Human leukocyte antigen (HLA) mismatch.
++ Plasma renin activity (PRA) levels.
++ Cause of death.
++ Donation after cardiac death.
We believe that the proposed transplant recipient and donor
characteristics represent well-established, non-modifiable predictors
that significantly influence graft survival independent of care
quality. For example, advanced transplant recipient age increases
mortality and cardiovascular complications, while sex-based differences
in immune response and medication metabolism create distinct risk
profiles requiring fair assessment.\4\ \5\ Diabetes, hypertension, and
cardiovascular disease represent major outcome determinants present at
transplantation that are largely beyond transplant hospitals' short-
term control.\6\ \7\ \8\ Donor age correlates with reduced nephron mass
and shorter graft lifespan, while cause of death and donation type
significantly affect both immediate function and long-term survival,
creating substantial organ quality variation across centers.\9\ Higher
HLA mismatch increases rejection likelihood independent of clinical
management quality, while elevated PRA levels indicate pre-existing
sensitization creating immunological barriers that require intensive
immunosuppression--both characteristics determined by factors largely
beyond a kidney transplant hospital's control.\10\ \11\ Given the
scarcity of donor organs and the IOTA Model's imperative to maximize
transplant opportunities, risk-adjusted allocation strategies support
accepting suboptimal immunological compatibility when clinically
appropriate.\12\
---------------------------------------------------------------------------
\4\ Schwager, Y., Littbarski, S.A., Nolte, A., Kaltenborn, A.,
Emmanouilidis, N., Kleine-D[ouml]pke, D., Klempnauer, J., & Schrem,
H. (2019). Prediction of Three-Year Mortality After Deceased Donor
Kidney Transplantation in Adults with Pre-Transplant Donor and
Recipient Variables. Annals of Transplantation, 24, 273-290. <a href="https://doi.org/10.12659/aot.913217">https://doi.org/10.12659/aot.913217</a>.
\5\ So, S., Au, E.H., Lim, W.H., Lee, V.W., & Wong, G. (2020).
Factors influencing Long-Term patient and allograft outcomes in
elderly kidney transplant recipients. Kidney International Reports,
6(3), 727-736. <a href="https://doi.org/10.1016/j.ekir.2020.11.035">https://doi.org/10.1016/j.ekir.2020.11.035</a>.
\6\ Schwager, Y., Littbarski, S.A., Nolte, A., Kaltenborn, A.,
Emmanouilidis, N., Kleine-D[ouml]pke, D., Klempnauer, J., & Schrem,
H. (2019). Prediction of Three-Year Mortality After Deceased Donor
Kidney Transplantation in Adults with Pre-Transplant Donor and
Recipient Variables. Annals of Transplantation, 24, 273-290. <a href="https://doi.org/10.12659/aot.913217">https://doi.org/10.12659/aot.913217</a>.
\7\ So, S., Au, E.H., Lim, W.H., Lee, V.W., & Wong, G. (2020).
Factors influencing Long-Term patient and allograft outcomes in
elderly kidney transplant recipients. Kidney International Reports,
6(3), 727-736. <a href="https://doi.org/10.1016/j.ekir.2020.11.035">https://doi.org/10.1016/j.ekir.2020.11.035</a>.
\8\ Nishio, A.G., Patel, A., Mehta, S., Yadav, A., Doshi, M.,
Urbanski, M.A., Concepcion, B.P., Singh, N., Sanders, M.L., Basu,
A., Harding, J.L., Rossi, A., Adebiyi, O.O., Samaniego-Picota, M.,
Woodside, K.J., & Parsons, R.F. (2024). Expanding the access to
kidney transplantation: Strategies for kidney transplant programs.
Clinical Transplantation, 38(5). <a href="https://doi.org/10.1111/ctr.15315">https://doi.org/10.1111/ctr.15315</a>.
\9\ Watson, C.J.E., Johnson, R.J., Birch, R., Collett, D., &
Bradley, J.A. (2012). A Simplified Donor Risk Index for Predicting
Outcome After Deceased Donor Kidney Transplantation.
Transplantation, 93(3), 314-318. <a href="https://doi.org/10.1097/tp.0b013e31823f14d4">https://doi.org/10.1097/tp.0b013e31823f14d4</a>.
\10\ Ibid.
\11\ Schwager, Y., Littbarski, S.A., Nolte, A., Kaltenborn, A.,
Emmanouilidis, N., Kleine-D[ouml]pke, D., Klempnauer, J., & Schrem,
H. (2019). Prediction of Three-Year Mortality After Deceased Donor
Kidney Transplantation in Adults with Pre-Transplant Donor and
Recipient Variables. Annals of Transplantation, 24, 273-290. <a href="https://doi.org/10.12659/aot.913217">https://doi.org/10.12659/aot.913217</a>.
\12\ Riley S, Zhang Q, Tse WY, Connor A, Wei Y. Using
information available at the time of donor offer to predict kidney
transplant survival Outcomes: A Systematic Review of Prediction
Models. Transplant International. 2022;35. https://doi:10.3389/
ti.2022.10397.
---------------------------------------------------------------------------
We propose at Sec. 512.428(b)(2)(ii)(A) that CMS would analyze the
transplant recipient and donor characteristics as specified at proposed
Sec. 512.428(b)(2)(i)(A) and (B). We also propose at Sec.
512.428(b)(2)(ii)(B) that CMS would then apply a risk score to each
individual IOTA transplant patient, as defined at Sec. 512.402, based
on the analysis of the transplant recipient and donor characteristics
at proposed Sec. 512.428(b)(2)(ii)(A). Lastly, we propose at Sec.
512.428(b)(2)(ii)(C)(1) and (2) that CMS would use the calculated
composite graft survival rate risk scores identified at proposed Sec.
512.428(b)(2)(ii)(B) to--
<bullet> Normalize the composite graft survival rate outcome to
control for differences in kidney transplant patient risk; and
<bullet> Adjust the composite graft survival rate, based on the
normalized composite graft survival rate outcome.
We believe this systematic approach to risk-adjusting kidney
transplantation ensures standardized care delivery while accommodating
individual kidney transplant patient needs and optimizing long-term
outcomes through evidence-based protocols, and continuous quality
improvement initiatives. Risk-adjustment accounts for factors that are
associated with the outcome, vary across providers, and are unrelated
to quality of care, so that measure scores reflect true differences in
quality of care.\13\ Accounting for case-mix differences is important
because it recognizes that some IOTA participants care for older or
sicker kidney transplant patients who have lower graft survival rates.
Through the proposed
[[Page 57606]]
risk-adjustment modeling, we believe an appropriate outcome rate is set
for IOTA participants who care for kidney transplant patients with
certain risk factors, decreasing the incentive to select younger,
healthier patients for transplantation.
---------------------------------------------------------------------------
\13\ So, S., Au, E.H., Lim, W.H., Lee, V.W., & Wong, G. (2020).
Factors influencing Long-Term patient and allograft outcomes in
elderly kidney transplant recipients. Kidney International Reports,
6(3), 727-736. <a href="https://doi.org/10.1016/j.ekir.2020.11.035">https://doi.org/10.1016/j.ekir.2020.11.035</a>.
---------------------------------------------------------------------------
We seek comments on our proposed composite graft survival rate
risk-adjustment methodology at proposed Sec. 512.428(b)(2). We also
seek comment on what transplant recipient and donor characteristics,
infectious disease status or other medically complex factors,
transplant recipient comorbidity burden, and immunological risk factors
would be significant and clinically appropriate to include in the
proposed risk-adjustment methodology for the composite graft survival
rate metric.
We considered all recommendations made by public commenters in the
2024 Final Rule. For example, a commenter believed that CMS should
risk-adjust for at least a small number of factors that would allow for
a simple model that is understandable by including the biggest drivers
for variation in outcomes and thereby disincentivize the creation of
additional hurdles for more complex transplant recipients (89 FR
96361). The same commenter believed that a risk-adjustment model that
includes age, ESRD vintage, and diabetes mellitus (y/n) would leverage
currently available data and remain easily measurable and understood.
We strongly considered this recommendation and chose to propose a
similar approach with different factors to account for more scenarios
and to reduce the chance of disincentivizing transplantation.
Multiple commenters in the 2024 Final Rule and some IOTA
participants advocated for the adoption of the SRTR risk-adjustment
methodology, which is presently utilized by both the Organ Procurement
and Transplantation Network (OPTN) and CMS in existing programs. The
SRTR risk-adjustment framework incorporates comprehensive adjustments
for both transplant recipient and donor characteristics, undergoes
annual updates to maintain currency, and is subject to validation and
testing protocols. During each transplant program-specific report (PSR)
cycle, the SRTR conducts a comprehensive refit of the graft survival
prediction model, systematically evaluating numerous potential
predictor variables to optimize the model's predictive accuracy and
clinical relevance. The SRTR calculates the kidney donor risk index
(KDRI) in accordance with the methodology established by Rao et al.\14\
As such, we also considered, but did not propose, using SRTR's 1-year
post-transplant outcomes risk-adjustment methodology for adult (18+)
kidney graft survival with deceased and living donors, which includes a
defined list of transplant recipient and donor characteristics included
in the calculation that are updated periodically.\15\ There is
empirical support for sophisticated risk-adjustment methodologies like
SRTR's, while acknowledging the need for ongoing refinement as
unmeasured risk factors are identified and measurement precision
improves.\16\ \17\ However, we believe this would require increased
sophistication and attention from IOTA participants to interpret the
additional information required and also require additional
communications and education resources at transplant hospitals,
potentially at Organ Procurement Organizations (OPO), and national
levels.\18\
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\14\ Rao, P.S., Schaubel, D.E., Guidinger, M.K., Andreoni, K.A.,
Wolfe, R.A., Merion, R.M., Port, F.K., & Sung, R.S. (2009). A
Comprehensive Risk Quantification Score for Deceased Donor Kidneys:
The Kidney Donor Risk Index. Transplantation, 88(2), 231-236.
<a href="https://doi.org/10.1097/TP.0b013e3181ac620b">https://doi.org/10.1097/TP.0b013e3181ac620b</a>.
\15\ Technical methods for the Program-Specific reports. (n.d.-
b). <a href="https://www.srtr.org/about-the-data/technical-methods-for-the-program-specific-reports/">https://www.srtr.org/about-the-data/technical-methods-for-the-program-specific-reports/</a>.
\16\ Axelrod, D.A., Schwantes, I.R., Harris, A.H., Hohmann,
S.F., Snyder, J.J., Balakrishnan, R., Lentine, K.L., Kasiske, B.L.,
& Schnitzler, M.A. (2022). The need for integrated clinical and
administrative data models for risk adjustment in assessment of the
cost transplant care. Clinical Transplantation, 36 (12), e14817.
<a href="https://doi.org/10.1111/ctr.14817">https://doi.org/10.1111/ctr.14817</a>.
\17\ Israni, A.K., Hirose, R., Segev, D.L., Hart, A.,
Schaffhausen, C.R., Axelrod, D.A., Kasiske, B.L., & Snyder, J.J.
(2022). Toward continuous improvement of Scientific Registry of
Transplant Recipients performance reporting: Advances following 2012
consensus conference and future consensus building for 2022
consensus conference. Clinical Transplantation, 36 (8), e14716.
<a href="https://doi.org/10.1111/ctr.14716">https://doi.org/10.1111/ctr.14716</a>.
\18\ Technical methods for the Program-Specific reports. (n.d.-
b). <a href="https://www.srtr.org/about-the-data/technical-methods-for-the-program-specific-reports/">https://www.srtr.org/about-the-data/technical-methods-for-the-program-specific-reports/</a>.
---------------------------------------------------------------------------
Additionally, SRTR implements more frequent model rebuilds in
addition to refitting the models every 6 months. The purpose of
rebuilding each cycle is to ensure that new transplant recipient and
donor characteristics are incorporated into the risk-adjustment
methodology. Therefore, for the purposes of risk-adjusting the
composite graft survival rate, we considered, but did not propose,
using only SRTR's post-transplant outcomes adult kidney model strata
and most recently available set of coefficients. Alternatively, we also
considered but did not propose utilizing a more limited set of
characteristics than those employed by SRTR for simplification
purposes.
A primary criticism of the SRTR risk-adjustment framework concerns
the potential for encouraging risk aversion.\19\ \20\ \21\ \22\ \23\
\24\ Kidney transplant hospitals may prioritize statistical performance
over kidney transplant waitlist patient access to care, potentially
limiting transplant opportunities for kidney transplant waitlist
patients who would benefit despite higher risk profiles.\25\ There have
been persistent questions about ``whether the OPTN data are adequate
for risk-adjustments used in SRTR program-specific reporting.'' \26\
While the current methodology provides adequate risk-adjustment for
available data, the collection of additional risk factors such as local
comorbidity indexes, community risk factors, cardiovascular risk
factors, and anatomical abnormalities or vascular injury in donor
kidneys could further
[[Page 57607]]
enhance the accuracy and fairness of IOTA Model evaluations.\27\ Given
that the objective of the IOTA Model is to increase kidney transplant
volume, we did not propose using SRTR's risk-adjustment methodology or
using only SRTR's post-transplant outcomes adult kidney model strata
and most recently available set of coefficients due to concerns that it
creates stronger incentives for risk aversion compared to alternative
approaches. Additionally, given that the composite graft survival rate
is a rolling measure, we also had operational concerns in the use of
SRTRs risk-adjustment methodology in future PYs.
---------------------------------------------------------------------------
\19\ Schenk, A.D., Logan, A.J., Sneddon, J.M., Faulkner, D.,
Han, J.L., Brock, G.N., & Washburn, W.K. (2022). Textbook Outcome as
a Quality Metric in Living and Deceased Donor Kidney
Transplantation. Journal of the American College of Surgeons,
235(4), 624-642. <a href="https://doi.org/10.1097/xcs.0000000000000301">https://doi.org/10.1097/xcs.0000000000000301</a>.
\20\ Kasiske, B.L., Salkowski, N., Wey, A., Israni, A.K., &
Snyder, J.J. (2018). Scientific Registry of Transplant Recipients
program-specific reports: where we have been and where we are going.
Current Opinion in Organ Transplantation, 24(1), 58-63. <a href="https://doi.org/10.1097/mot.0000000000000597">https://doi.org/10.1097/mot.0000000000000597</a>.
\21\ Jay, C., & Schold, J.D. (2017). Measuring Transplant Center
Performance: the Goals Are Not Controversial but the Methods and
Consequences Can Be. Current Transplantation Reports, 4(1), 52-58.
<a href="https://doi.org/10.1007/s40472-017-0138-9">https://doi.org/10.1007/s40472-017-0138-9</a>.
\22\ Snyder, J.J., Salkowski, N., Wey, A., Israni, A.K., Schold,
J.D., Segev, D.L., & Kasiske, B.L. (2016). Effects of High-Risk
Kidneys on Scientific Registry of Transplant Recipients Program
Quality Reports. American Journal of Transplantation, 16(9), 2646-
2653. <a href="https://doi.org/10.1111/ajt.13783">https://doi.org/10.1111/ajt.13783</a>.
\23\ Bowring, M.G., Massie, A.B., Craig-Schapiro, R., Segev,
D.L., & Nicholas, L.H. (2018). Kidney offer acceptance at programs
undergoing a Systems Improvement Agreement. American Journal of
Transplantation, 18(9), 2182-2188. <a href="https://doi.org/10.1111/ajt.14907">https://doi.org/10.1111/ajt.14907</a>.
\24\ Abecassis, M.M., Burke, R., Klintmalm, G.B., Matas, A.J.,
Merion, R.M., Millman, D., Olthoff, K., & Roberts, J.P. (2009).
American Society of Transplant Surgeons Transplant Center Outcomes
Requirements--A Threat to Innovation. American Journal of
Transplantation, 9(6), 1279-1286. <a href="https://doi.org/10.1111/j.1600-6143.2009.02606.x">https://doi.org/10.1111/j.1600-6143.2009.02606.x</a>.
\25\ Kasiske, B.L., Salkowski, N., Wey, A., Israni, A.K., &
Snyder, J.J. (2018). Scientific Registry of Transplant Recipients
program-specific reports: where we have been and where we are going.
Current Opinion in Organ Transplantation, 24(1), 58-63. <a href="https://doi.org/10.1097/mot.0000000000000597">https://doi.org/10.1097/mot.0000000000000597</a>.
\26\ Schenk, A.D., Logan, A.J., Sneddon, J.M., Faulkner, D.,
Han, J.L., Brock, G.N., & Washburn, W.K. (2022). Textbook Outcome as
a Quality Metric in Living and Deceased Donor Kidney
Transplantation. Journal of the American College of Surgeons,
235(4), 624-642. <a href="https://doi.org/10.1097/xcs.0000000000000301">https://doi.org/10.1097/xcs.0000000000000301</a>.
\27\ Snyder, J.J., Salkowski, N., Wey, A., Israni, A.K., Schold,
J.D., Segev, D.L., & Kasiske, B.L. (2016). Effects of High-Risk
Kidneys on Scientific Registry of Transplant Recipients Program
Quality Reports. American Journal of Transplantation, 16(9), 2646-
2653. <a href="https://doi.org/10.1111/ajt.13783">https://doi.org/10.1111/ajt.13783</a>.
---------------------------------------------------------------------------
We also considered but did not propose a risk-adjustment
methodology that utilizes a Cox regression model,\28\ which accounts
for time-to-event data and can handle censored observations, making it
a strong potential option for risk-adjustment in transplant outcome
studies. In this methodology, censored observations \29\ would include
transplant recipients still alive at the end of the follow-up period,
transplant recipients lost to follow-up before experiencing death or
graft failure, and transplant recipients who withdrew from the study
before the event occurred including two donor and five recipient
variables.\30\ Cox regression models have been cited for strong
performance with extreme categories, discriminative power, and
interpretable results.\31\ \32\ \33\ This methodology also exhibits
several inherent limitations, including restrictive assumptions
concerning proportional hazards and linear effects of variables,
inadequate handling of outliers within continuous variables and
variable interactions, and constraints regarding the limited number of
variables that can be incorporated into the modeling framework.\34\
\35\ While we recognize the importance of incorporating a time-to-event
model in the risk-adjustment methodology to account for the length of
graft survival, we chose not to propose a Cox regression model because
it shows only moderate prediction accuracy overall and needs more
validation.
---------------------------------------------------------------------------
\28\ Cox regression, formally designated as Cox proportional
hazards regression, constitutes a statistical methodology employed
to examine the relationship between the time to event occurrence and
one or more predictor variables. This analytical approach represents
a robust statistical tool for investigating survival data,
particularly when addressing time-to-event outcomes where the event
of interest may encompass mortality, disease onset, or other
clinically relevant occurrences.
\29\ In the context of risk-adjustment, a censored observation
refers to incomplete information about the true timing or occurrence
of an outcome of interest, where only certain boundaries are known
rather than the exact value. This phenomenon is particularly
prevalent in healthcare risk adjustment models when tracking patient
outcomes such as readmissions, complications, or mortality events.
Properly accounting for censored observations through survival
analysis methods is crucial in risk adjustment because ignoring
censoring can lead to biased risk estimates, inaccurate patient
stratification, and flawed predictive models that may unfairly
penalize or reward healthcare providers based on incomplete outcome
data.
\30\ Senanayake, S., Kularatna, S., Healy, H., Graves, N.,
Baboolal, K., Sypek, M.P., & Barnett, A. (2021). Development and
validation of a risk index to predict kidney graft survival: the
kidney transplant risk index. BMC Medical Research Methodology,
21(1). <a href="https://doi.org/10.1186/s12874-021-01319-5">https://doi.org/10.1186/s12874-021-01319-5</a>.
\31\ Ibid.
\32\ Abd ElHafeez, S., D'Arrigo, G., Leonardis, D., Fusaro, M.,
Tripepi, G., & Roumeliotis, S. (2021). Methods to Analyze Time-to-
Event Data: The Cox Regression Analysis. Oxidative Medicine and
Cellular Longevity, 2021(1), 1-6. <a href="https://doi.org/10.1155/2021/1302811">https://doi.org/10.1155/2021/1302811</a>.
\33\ Wey, A., Hart, A., Salkowski, N., Skeans, M., Kasiske,
B.L., Israni, A.K., & Snyder, J.J. (2020). Posttransplant outcome
assessments at listing: Long-term outcomes are more important than
short-term outcomes. American Journal of Transplantation, 20(10),
2813-2821. <a href="https://doi.org/10.1111/ajt.15911">https://doi.org/10.1111/ajt.15911</a>.
\34\ Senanayake, S., Kularatna, S., Healy, H., Graves, N.,
Baboolal, K., Sypek, M.P., & Barnett, A. (2021). Development and
validation of a risk index to predict kidney graft survival: the
kidney transplant risk index. BMC Medical Research Methodology,
21(1). <a href="https://doi.org/10.1186/s12874-021-01319-5">https://doi.org/10.1186/s12874-021-01319-5</a>.
\35\ Scheffner, I., Gietzelt, M., Abeling, T., Marschollek, M.,
& Gwinner, W. (2020). Patient Survival After Kidney Transplantation:
Important Role of Graft-sustaining Factors as Determined by
Predictive Modeling Using Random Survival Forest Analysis.
Transplantation, 104(5), 1095-1107. <a href="https://doi.org/10.1097/tp.0000000000002922">https://doi.org/10.1097/tp.0000000000002922</a>.
---------------------------------------------------------------------------
We considered, but did not propose, a direct standardization risk-
adjustment approach. This method applies standard population risk
profiles \36\ to all IOTA participants. Advantages to this method
include simple interpretation and precedence in Care Compare.\37\
Disadvantages are that it requires large sample sizes and is less
precise for smaller kidney transplant hospitals. We chose not to
propose this method because it could disadvantage smaller IOTA
participants.
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\36\ Standard population risk profiles represent a
methodological framework that establishes a reference population to
enable fair and meaningful comparisons between healthcare centers
when patient populations exhibit different risk characteristics. The
methodology employs all patients from all providers as the reference
population, creating a uniform baseline against which all centers
can be evaluated equitably. The process involves estimating the
relationship between patient characteristics (represented as a
vector of covariates X reflecting potential risk factors) and
clinical outcomes for each healthcare center. This established
relationship is then applied to all patients within the reference
population to calculate expected outcomes as if every patient in the
reference population had received treatment at each specific center
under evaluation. Mathematically, this direct standardization
approach can be expressed as d_c = (1/N) x [Sigma] p5Fc(X_i), where
d_c represents the standardized outcome for center c, N denotes the
total number of patients in the reference population, and p5Fc(X_i)
represents the estimated probability for patient i's characteristics
at center c.
\37\ Schokkaert, E., & Van De Voorde, C. (2008). Direct versus
indirect standardization in risk adjustment. Journal of Health
Economics, 28(2), 361-374. <a href="https://doi.org/10.1016/j.jhealeco.2008.10.012">https://doi.org/10.1016/j.jhealeco.2008.10.012</a>.
---------------------------------------------------------------------------
We considered, but did not propose, an indirect standardization
(observed-to-expected ratios) risk-adjustment approach, which compares
observed outcomes to expected outcomes based on a risk model.
Advantages to this method are that it preserves competitive scoring
while ensuring fairness, works well with small sample sizes, provides
precise estimates, and has precedence with the ESRD Quality Incentive
Program (QIP) Standardized Mortality Ratio (SMR).\38\ \39\ We chose not
to propose this approach because of the complexity of designing a
robust risk model.
---------------------------------------------------------------------------
\38\ Ibid.
\39\ Scheffner, I., Gietzelt, M., Abeling, T., Marschollek, M.,
& Gwinner, W. (2020). Patient Survival After Kidney Transplantation:
Important Role of Graft-sustaining Factors as Determined by
Predictive Modeling Using Random Survival Forest Analysis.
Transplantation, 104(5), 1095-1107. <a href="https://doi.org/10.1097/tp.0000000000002922">https://doi.org/10.1097/tp.0000000000002922</a>.
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We considered, but did not propose, a hierarchical logistic
regression approach with indirect standardization. This approach models
graft survival probability at the individual transplant recipient level
and accounts for kidney transplant hospital-level clustering
effects.\40\ \41\ It produces observed-to-expected ratios for fair
comparison and is compatible with cumulative measure calculation. The
hierarchical logistic regression statistical model structure we
considered using is illustrated in Equation 1:
---------------------------------------------------------------------------
\40\ Hoffman, J.I. (2015). Survival analysis. In Elsevier eBooks
(pp. 621-643). <a href="https://doi.org/10.1016/b978-0-12-802387-7.00035-4">https://doi.org/10.1016/b978-0-12-802387-7.00035-4</a>.
\41\ Hoffman, J.I. (2015a). Logistic regression. In Elsevier
eBooks (pp. 601-611). <a href="https://doi.org/10.1016/b978-0-12-802387-7.00033-0">https://doi.org/10.1016/b978-0-12-802387-7.00033-0</a>.
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Equation 1: Considered Hierarchical Logistic Regression Equation
logit(Pij) = b<INF>0</INF> + b<INF>1</INF>(Age_ij) +
b<INF>2</INF>(Diabetes_ij) + b<INF>3</INF>(DialysisVintage_ij) +
b<INF>4</INF>(KDPI_ij) + b<INF>5</INF>(DCD_ij) + b<INF>6</INF>(PRA_ij)
+ u_j
Where:
Pij = probability of graft survival for kidney transplant patient i
in IOTA participant j
uj ~ N(O,[sigma]u2 represents random IOTA participant--level effects
b<SUP>0</SUP> = intercept
b<SUP>1</SUP>-b<SUP>6</SUP> = fixed effect coefficients for risk
adjustment variables
[[Page 57608]]
This equation risk-adjusts for age, diabetes status, dialysis
vintage, Kidney Donor Profile Index (KDPI), Donation after Cardiac
Death (DCD), which describes donors who are declared dead based on the
cessation of circulatory and respiratory functions, and Panel Reactive
Antibody (PRA). While we acknowledge that this approach demonstrates
substantial technical merit, we believe that the level of complexity
inherent in a hierarchical logistic regression statistical model
structure would introduce operational risks and administrative burden.
Transplant hospital-level variation may not be significant enough to
warrant the added complexity,\42\ as such, we did not believe this was
appropriate to propose for the IOTA Model.
---------------------------------------------------------------------------
\42\ Leyland, A.H., & Groenewegen, P.P. (2020b). Multilevel
Modelling for Public Health and Health Services Research. In
Springer eBooks. Springer Nature. <a href="https://doi.org/10.1007/978-3-030-34801-4">https://doi.org/10.1007/978-3-030-34801-4</a>.
---------------------------------------------------------------------------
We further considered, but did not propose, using machine learning-
based risk-adjustment methodology, which uses ensemble methods (random
forests, gradient boosting) for risk prediction. Machine learning-based
risk-adjustment methodology captures complex interactions and has high
predictive accuracy, but we chose not to propose it due to concerns
that stakeholders may resist the ``black box'' machine learning-based
risk-adjustment methodology and the limited precedence in quality
measurement or at CMS.\43\
---------------------------------------------------------------------------
\43\ Weissman, G.E., & Maddox, K.E.J. (2023). Guiding risk
adjustment models toward machine learning methods. JAMA, 330(9),
807. <a href="https://doi.org/10.1001/jama.2023.12920">https://doi.org/10.1001/jama.2023.12920</a>.
---------------------------------------------------------------------------
We seek comment on the alternatives considered. Although we are not
proposing to include a risk-adjustment methodology that also accounts
for time-to-event data, we seek comment on whether a risk-adjustment
methodology that considers transplant recipient and donor
characteristics in addition to time-to-event data would be appropriate
for calculating the composite graft survival rate in the quality domain
and the best approach to use. We also seek comments on whether the
proposed risk adjustment methodology should also include a time-to-
event model when calculating the composite graft survival rate in the
quality domain.
In the 2024 Final Rule (89 FR 96364), we finalized inclusion and
exclusion criteria for the numerator and denominator when calculating
the composite graft survival rate at Sec. 512.428(b)(1)(iii) and
(iv)(A). Since publication, many IOTA participants have asked CMS to
clarify whether multi-organ transplants are included in both the
numerator and denominator when calculating the composite graft survival
rate. Specifically, questions surrounded the current regulation at
Sec. 512.428(b)(1)(iii)(E), which states that CMS will exclude offers
to multi-organ candidates (except for kidney/pancreas candidates that
are also listed for kidney alone) from the numerator. We clarified that
this exclusion pertains to the offer phase of the transplant process.
The actual transplant outcomes, when including a kidney, remain within
the measurement scope. This interpretation ensures standardized
application of the exclusion criterion while maintaining the measure's
intended focus on kidney transplant outcomes, regardless of concurrent
multi-organ status. We also noted that the denominator calculation, as
finalized in the 2024 Final Rule, does not contain exclusions for
multi-organ transplants, which allows for comprehensive tracking of all
kidney transplant outcomes. Since CMS clarified that multi-organ
transplants are included in the calculation of the composite graft
survival rate, many IOTA participants have urged CMS to exclude them
from the metric due to the additional complexity of multi-organ
transplantation.
In this proposed rule, we are proposing to update the regulation at
Sec. 512.428(b)(1)(iii)(E) to exclude multi-organ transplants (except
for kidney/pancreas transplants) from the numerator. As a result, we
are also proposing to update the provision at Sec.
512.428(b)(1)(iv)(A) to read as follows: When calculating the composite
graft survival rate, CMS only includes single-organ kidney transplants
and kidney/pancreas transplants for transplant recipients who are 18
years of age and older at the time of the kidney transplant or kidney/
pancreas transplant in the number of kidney transplants performed by
the IOTA participant during each PY in the denominator. For purposes of
the model, we propose at Sec. 512.402 to define ``single-organ kidney
transplant'' as a procedure in which a kidney alone is surgically
transplanted from a living or deceased donor. We seek comment on our
proposed definition of single-organ kidney transplant at proposed Sec.
512.402.
We are proposing to exclude multi-organ transplants--procedures in
which a kidney is surgically transplanted from deceased donor to a
transplant recipient along with one or more organs transplanted
simultaneously--except for kidney/pancreas transplants from the
composite graft survival rate metric in recognition of the increased
complexity of clinical outcomes associated with these procedures.\44\
In acknowledgment that multi-organ transplantation represents a
distinct clinical scenario with potentially different risk profiles,
complication rates, and outcomes compared to single-organ kidney
transplantation, we believe it would be methodologically sound to
analyze multi-organ transplant recipients separately from single-organ
kidney transplant and kidney/pancreas transplant recipients. We are
proposing to include kidney/pancreas transplants because, although
these procedures are associated with greater surgical complexity and
higher perioperative risk, clinical evidence demonstrates improved
recipient survival compared with kidney transplantation alone among
patients with Type 1 Diabetes Mellitus.\45\ Kidney/pancreas
transplantation offers a potential cure for both diabetes and kidney
failure in this population.\46\ Additionally, the inclusion of kidney/
pancreas transplants within the composite graft survival rate metric
aligns with established SRTR methodology, which includes kidney/
pancreas transplants while excluding other multi-organ transplant
procedures from their graft survival criteria.\47\ We further note that
that including kidney/pancreas transplants in the composite graft
survival rate metric is consistent with the efficiency domain as
described at Sec. 512.426(b)(1)(iii)(E) where multi-organ kidney
transplant offers (except for kidney/pancreas candidates that are also
listed for kidney alone) are excluded from the organ offer acceptance
rate ratio measure calculation.
---------------------------------------------------------------------------
\44\ Schold, J.D., & Mohan, S. (2021). A deeper dive into the
impact of multiple-organ transplant policy on kidney transplant
candidate prognoses. American Journal of Transplantation, 21(6),
2004-2006. <a href="https://doi.org/10.1111/ajt.16508">https://doi.org/10.1111/ajt.16508</a>.
\45\ Ibid.
\46\ Nagendra, L., Fernandez, C.J., & Pappachan, J.M. (2023).
Simultaneous pancreas-kidney transplantation for end-stage renal
failure in type 1 diabetes mellitus: Current perspectives. World
Journal of Transplantation, 13(5), 208-220. <a href="https://doi.org/10.5500/wjt.v13.i5.208">https://doi.org/10.5500/wjt.v13.i5.208</a>.
\47\ Technical methods for the Program-Specific reports. (n.d.-
b). <a href="https://www.srtr.org/about-the-data/technical-methods-for-the-program-specific-reports/">https://www.srtr.org/about-the-data/technical-methods-for-the-program-specific-reports/</a>.
---------------------------------------------------------------------------
We seek comment on our proposals at proposed Sec. Sec.
512.428(b)(1)(iii)(E) and 512.428(b)(1)(iv)(A) to exclude multi-organ
transplants except for kidney/pancreas transplants from the numerator
and denominator when calculating the composite graft survival rate in
the quality domain.
We considered retaining the inclusion of multi-organ
transplantation in the calculation of the composite graft survival rate
and solely revising the text
[[Page 57609]]
of the regulation for clarification purposes. From 2000 to 2020
deceased donor kidney transplant volume doubled, while multi-organ
transplants involving kidneys increased 6-fold during the same
period.\48\ Including multi-organ transplants in metrics could allow
for more robust monitoring of multi-organ transplant outcomes and
provide a more comprehensive assessment of transplant hospital
capabilities and outcomes across all transplant types, ensuring a fair
comparison of overall program performance.\49\ However, we chose not to
propose including multi-organ transplants because it would require
rigorous analysis considering organ scarcity, dynamic decision-making,
and heterogeneous practice patterns to develop risk-adjustment
methodologies to account for multi-organ transplant allocation
policies.\50\
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\48\ Husain, S. A., Hippen, B., Singh, N., Parsons, R. F.,
Bloom, R. D., Anand, P. M., & Lentine, K. L. (2023). Right-Sizing
multiorgan allocation involving Kidneys. Clinical Journal of the
American Society of Nephrology, 18(11), 1503-1506. <a href="https://doi.org/10.2215/cjn.0000000000000242">https://doi.org/10.2215/cjn.0000000000000242</a>.
\49\ Ibid.
\50\ Schold, J. D., & Mohan, S. (2021). A deeper dive into the
impact of multiple-organ transplant policy on kidney transplant
candidate prognoses. American Journal of Transplantation, 21(6),
2004-2006. <a href="https://doi.org/10.1111/ajt.16508">https://doi.org/10.1111/ajt.16508</a>.
---------------------------------------------------------------------------
We considered excluding all multi-organ transplants, including
kidney/pancreas transplants, from the composite graft survival rate due
to the increased surgical complexity and perioperative
complications.\51\ However, we chose not to proposed excluding all
multi-organ transplants because we believe that the improved clinical
outcomes for kidney/pancreas transplants compared to kidney
transplantation alone for Type 1 Diabetes Mellitus patients outweighed
the added surgical complexity and potential perioperative
complications.\52\ We seek comment on the alternatives considered. We
also seek comment on whether CMS should include multi-organ transplants
in the numerator and denominator and which multi-organ transplants
should CMS include or exclude.
---------------------------------------------------------------------------
\51\ Callaghan, C. J., Ibrahim, M., Counter, C., Casey, J.,
Friend, P. J., Watson, C. J., & Karydis, N. (2021). Outcomes after
simultaneous pancreas-kidney transplantation from donation after
circulatory death donors: A UK registry analysis. American Journal
of Transplantation, 21(11), 3673-3683. <a href="https://doi.org/10.1111/ajt.16604">https://doi.org/10.1111/ajt.16604</a>.
\52\ Ibid.
---------------------------------------------------------------------------
(b) Calculation of Points
In the 2024 Final Rule (89 FR 43518) that established the IOTA
Model, we acknowledged commenter concerns about the proposed points
allocation for the composite graft survival rate, arguing that it
unfairly penalizes transplant hospitals that accept higher-risk
patients and suggesting modifications including lowering the threshold
for maximum points from the 80th to 60th percentile for IOTA
participants (89 FR 96365). In response to comments, we finalized an
alternate scoring methodology, such that IOTA participants would be
awarded points based on the national quintiles, as outlined in Table 1,
such that IOTA participants that perform--
<bullet> At or above the 80th percentile would earn 20 points;
<bullet> In the 60th percentile to below the 80th percentile would
earn 18 points;
<bullet> In the 40th percentile to below the 60th percentile would
earn 16 points;
<bullet> In the 20th to below the 40th percentile would earn 14
points;
<bullet> In the 10th to below the 20th percentile would earn 12
points; and
<bullet> Below the 10th percentile would receive 10 points for the
composite graft survival rate.
[GRAPHIC] [TIFF OMITTED] TP11DE25.011
In addition, we stated that we recognized that for PY 2 and future
PYs there would be more events and a longer time horizon and plan to
implement a more robust methodology that could account for both the
likelihood of graft failure based on the donor and the recipient and
could account for relative benefits of transplantation over remaining
on dialysis (89 FR 96365). We direct readers to the 2024 Final Rule for
a full discussion of this policy, our rationale for this approach, and
alternatives considered (89 FR 96364 through 96366).
Upon further review of our methodology, we are proposing to modify
the composite graft survival rate scoring methodology to allow for a
more even scoring distribution for IOTA participants. Specifically, we
propose in Table 1 to paragraph (d) at Sec. 512.428 that points earned
would be based on the IOTA participants' performance on the composite
graft survival rate relative to national ranking, inclusive of all
eligible kidney transplant hospitals, both those selected and not
selected as IOTA participants, as outlined in Table 2.
We propose that points continue to be awarded based on national
quintiles, as outlined in Table 2. We maintain our belief that
utilizing quintiles aligns with the calculation of the upside and
downside risk payments in relation to the final performance score, as
described in 42 CFR 512.430(b), where average performance yields half
the number of points. The scoring is normalized, meaning an average
performing IOTA participant earns 10 points out of 20, 50 percent of
the total possible points. We recognize that there is an upper limit to
the benefits of quality, and quintiles combine the highest 20 percent
of performers in a point band.
In accordance with Sec. 512.428, we propose the following updates
to the allocation of points for the composite graft survival rate in
Table 1 to paragraph (d) at Sec. 512.428, as illustrated in Table 2:
<bullet> IOTA participants in the 80th percentile and above, 20
points.
<bullet> IOTA participants in the 60th to below the 80th percentile
of performers, 15 points.
<bullet> IOTA participants in the 40th to below the 60th percentile
of performers, 10 points.
[[Page 57610]]
<bullet> IOTA participants in the 20th to below the 40th percentile
of performers, 5 points.
<bullet> IOTA participants who are below the 20th percentile of
performers, 0 points.
[GRAPHIC] [TIFF OMITTED] TP11DE25.012
Utilizing quintiles aligns with the calculation of the upside and
downside risk payments in relation to the final performance score, as
described in 42 CFR 512.430(b), where average performance yields half
the number of points. The scoring is normalized, meaning an average
performing IOTA participant earns 10 points out of 20, 50 percent of
the total possible points. We recognize that there is an upper limit to
the benefits of quality, and quintiles combine the highest 20 percent
of performers in a point band.
Additionally, in the 2024 Final Rule (89 FR 96379), we stated that
we would continue to assess our quality domain methodology and how to
best balance incentives in the efficiency domain and quality domain and
address a new or updated policy pursuant to future notice and comment
rule making. Furthermore, as proposed in section II.B.2.b.(2).(a). of
this proposed rule, we are proposing to incorporate a risk-adjustment
methodology to the calculation of the composite graft survival rate
measure. As such, we believe that the proposed allocation of points, as
illustrated in Table 2, is necessary to account for the proposed
composite graft survival rate risk-adjustment methodology, as described
in section II.B.2.b.(2).(a). of this proposed rule, and best balances
incentives in the quality domain.
We considered applying a two-scoring system in which we would
determine an achievement score and improvement score and award the
point equivalent to the higher value between the two scores; similar to
the organ offer acceptance rate ratio scoring methodology as described
at Sec. 512.426(c). In this considered two-scoring system, the
achievement score would reflect the proposed scoring approach on the
composite graft survival rate, as illustrated in Table 2 of this
section. For improvement scoring on the composite graft survival rate,
we considered the following methodologies:
<bullet> In accordance with the organ offer acceptance rate ratio
improvement scoring methodology at Sec. 512.426(c)(2)(ii).
<bullet> Improvement relative to national ranking from previous PY.
<bullet> Improvement over 2 PYs. In this methodology, improvement
scoring would only be awarded twice (PYs 4 and 6) and would measure
improvement by comparing PYs 1-2 to PYs 3-4 and PYs 3-4 to PYs 5-6.
We considered applying a two-scoring system in which we would
determine an achievement score and improvement score and award the
point equivalent to the higher value between the two scores because we
recognize that if an IOTA participant does not do well one PY on the
composite graft survival rate, as described at Sec. 512.428(b)(1),
that it may be difficult for it to improve during the model performance
period. However, we chose not to propose this methodology (two-scoring
system) because we still had concerns over our ability to measure
improvement year-over-year due to potentially small numbers.
Furthermore, given that we are proposing to incorporate a risk-
adjustment methodology, as proposed in section II.B.2(b)(2)(a) of this
proposed rule, we believe that our proposed scoring approach rewards
both achievement and improvements and is a more rigorous scoring
methodology. Although we are not proposing to include this alternative,
we seek comment on whether a two-scoring system methodology would be
appropriate for the composite graft survival rate and the best approach
for measuring improvement.
We seek comment on our proposed composite graft survival rate
scoring methodology at proposed Table 1 to Paragraph (d) at Sec.
512.428 for purposes of assessing quality domain performance for each
IOTA participant. We also seek comments on alternatives considered.
Additionally, we seek comment on whether there is a scoring methodology
on the composite graft survival rate that recognizes IOTA participants
whose post-transplant outcomes are at an acceptable level and how to
define an acceptable level (for example, 1 standard deviation of the
national risk-adjusted rate or some other way).
3. Payment
a. Background
For the IOTA Model, we proposed and finalized an alternative
payment model (APM) structure that incorporates both upside and
downside risk to existing Medicare fee-for-service (FFS) payments for
kidney transplantations. The IOTA Model will test whether performance-
based payments, including the potential for an upside or downside risk
payment, to IOTA participants increases access to kidney transplants
for attributed patients while preserving or enhancing quality of care
and reducing kidney transplant hospital expenditures.
In the 2024 Final Rule (89 FR 43518), we finalized provisions
regarding downside risk payments and other payments as described in
Sec. 512.430, where, we specified the methodologies for upside risk
payments, neutral zone, and downside risk payments for IOTA
participants. For upside risk payments, if the IOTA participant's final
performance score is 60 points or above, CMS will calculate the IOTA
participant's upside risk payment by subtracting 60 from the IOTA
participant's final performance score, dividing the resulting amount by
40, multiplying the calculated amount by $15,000 and multiplying that
amount by the total number of Medicare kidney transplants performed by
the IOTA participant during the relevant PY. For downside risk
payments, beginning in PY 2, CMS will calculate the downside risk
payment by subtracting the IOTA participant's final performance score
from 40, divide that number by 40, multiplying the resulting amount by
$2,000 and multiplying that amount by the total number of Medicare
kidney transplants performed by the IOTA participant during the
relevant PY.
[[Page 57611]]
b. Alternative Payment Design
In the 2024 Final Rule (89 FR 96383), CMS proposed and finalized
two-sided performance-based payments for ``Medicare kidney
transplants,'' defined at Sec. 512.402 as kidney transplants furnished
to attributed patients whose primary or secondary insurance is Medicare
FFS, as identified in Medicare FFS claims with MS-DRGs 008, 019, 650,
651 and 652.
In our initial proposal in the 2024 Proposed Rule (89 FR 43570), we
stated that we had considered including beneficiaries with Medicare
Advantage (MA) as well in the definition of Medicare kidney
transplants. As stated at 89 FR 96382, we decided to finalize the
policy as proposed as we did not believe that the additional incentive
effects from including MA in the calculation for upside and downside
risk payments were necessary at that point to provide sufficient
incentive to test the model. We noted our plan to further engage with
MA plans to think about the incentives in the IOTA Model and those set
up by MA plans. We also planned to monitor relative enrollment of
beneficiaries who receive kidney transplants in Medicare FFS as opposed
to MA to see if further policy changes would be necessary for future
years of the IOTA Model.
Since publication of the 2024 Final Rule, CMS has continued to
assess its position regarding the potential inclusion of beneficiaries
enrolled in MA within the definition of Medicare kidney transplants for
several key reasons. This ongoing evaluation reflects CMS's commitment
to monitoring changes in MA enrollment trends, analyzing potential
impacts on model incentives and Medicare Trust Fund savings, and
considering the operational and statutory implications of such an
inclusion. CMS is soliciting public comment on this issue more broadly,
on whether to include MA beneficiaries within the IOTA model, as well
as on the specific considerations and requests for input if CMS were to
proceed with such an approach.
We seek comment on whether CMS should include MA transplants in the
calculation for upside risk payments and downside risk payments. We
also seek comment on our consideration to update the definition of
Medicare kidney transplants at Sec. 512.402 to include attributed
patients with MA, to further the incentive effects of the IOTA Model
and in recognition of the growth of MA enrollment relative to Medicare
FFS.
Per the Announcement of Calendar Year (CY) 2026 Medicare Advantage
(MA) Capitation Rates and Part C and Part D Payment Policies, Medicare
FFS enrollment of the total ESRD population enrolled in Medicare is
currently about 45 percent in 2024 and is projected to drop to
approximately 40 percent by 2028. This means that updating the
definition of Medicare kidney transplant would increase the maximum
potential upside risk payments, per the definition in Sec.
512.430(b)(1)(iv), for an IOTA participant given that the number of
Medicare kidney transplants performed would on average also be
increasing. Under this approach, CMS could decrease the maximum upside
risk payment from $15,000 to $10,000 per Medicare kidney transplant.
CMS analyses project that the decreased upside risk payment multiplier
and increased number of kidney transplants that upside and downside
risk payments would apply to under such an approach would approximately
offset each other and approximately have a net zero impact on model
savings from this combination of provisions. CMS could make this change
to balance our goals of creating a strong incentive for IOTA
participants to increase their number of kidney transplants and ensure
savings for the Medicare Trust Fund. We seek comment on our
consideration to decrease the maximum upside risk payment from $15,000
to $10,000 per Medicare kidney transplant should CMS update the
definition of Medicare kidney transplant to include MA beneficiaries.
While there may be benefits to including kidney transplants
furnished to MA beneficiaries in the calculation for the upside risk
payment and downside risk payment, CMS continues to consider potential
concerns or disadvantages. One potential issue is whether the payments
made under such an approach could affect the contracting relationship
between a Medicare Advantage organization (MAO) and the IOTA
participant. We seek feedback from both IOTA participants and from MAOs
about any potential effect that inclusion of beneficiaries with MA in
the definition of Medicare kidney transplants in the IOTA Model could
have on their contracting relationships.
Pursuant to the non-interference clause in section
1854(a)(6)(B)(iii) of the Act, CMS does not interfere in payment
arrangements between MA organizations and their contracted providers.
At the same time, CMS is interested in the potential in achieving
greater alignment between MA and Medicare FFS payment methodologies.
Given the factors described in this section, CMS is soliciting
comments from a broad range of stakeholders and interested parties,
including MA plans, beneficiary advocates, healthcare providers, and
industry experts. We are particularly interested in comments on how MA
could play a role in the IOTA Model. Specifically, we are inviting
public comment on the following:
<bullet> What are any innovative transplant-related strategies
being tested by MAOs?
<bullet> What are the anticipated effects that implementation of
this contemplated policy modification would have on the kidney
transplant strategic initiatives currently under consideration by MAOs?
<bullet> How does the growth of MA compared to Medicare FFS affect
participation and incentives in the IOTA Model?
<bullet> What do MA plans consider as their role in the kidney
transplant process?
<bullet> What performance metrics do MA plans consider when
evaluating kidney transplant hospitals?
<bullet> What performance metrics are the most important for a
kidney transplant hospital?
<bullet> What are kidney transplant hospitals' experiences with
kidney transplant performance metrics from private insurers and MAOs,
outside of their experience with the IOTA Model?
<bullet> How do the IOTA Model performance metrics play a role in
the relationship between an MA plan and a contracted provider?
<bullet> If any, what are potential effects that MA inclusion in
the model could have on a contracting relationship between providers
and MA plans (for example, negotiation of terms)?
<bullet> If any, what are potential unintended consequences of MA
inclusion on utilization management tools employed by MAOs?
<bullet> Would an MA plan consider implementing similar performance
metrics to those included in the IOTA Model?
<bullet> Under what circumstances is it appropriate for CMS to
consider directly incentivizing a behavior change from a provider
contracted in an MA plan?
We extend our sincere appreciation in advance to all commenters, as
their valuable feedback will serve to inform future CMS policy actions
in this domain.
c. Performance-Based Payment Method
(1) Determine Final Performance Score Range Category
In the 2024 Final Rule (89 FR 96384), we finalized using the final
performance scores to determine the upside risk payment, the downside
risk payment, and the neutral zone at Sec. 512.430(a), as illustrated
in Table 3. Additionally, we
[[Page 57612]]
finalized the definitions of downside risk payment, upside risk
payment, and neutral zone at Sec. 512.402.
[GRAPHIC] [TIFF OMITTED] TP11DE25.013
We previously finalized for PYs 2 through 6 that an IOTA
participant would qualify for the neutral zone if their final
performance scores were between 41 and 59 points (inclusive) at Sec.
512.430(b)(2)(ii), as illustrated in Table 3. Since publication some
IOTA participants have expressed confusion about final performance
scores of 40 points and 60 points. In this proposed rule, we are
proposing to update this provision to clarify language about final
performance scores of 40 points and 60 points. Given the final
performances scores described in Table 3, a score of 40 points results
in zero downside risk payments and a score of 60 points results in zero
upside risk payments. As a result, we are proposing to clarify the
language in the rule to address this point and to further clarify the
endpoints where an IOTA participant could receive an upside risk
payment, be in the neutral zone, or receive a downside risk payment.
We propose at Sec. 512.430(b)(1) to clarify that if in PYs 1-6,
the IOTA participant's final performance score is above 60 points, the
IOTA participant qualifies for an upside risk payment. Additionally, we
propose at Sec. 512.430(b)(2)(ii) to clarify that for PYs 2 through 6,
if an IOTA participant's final performance is between 40 to 60 points
(inclusive), the IOTA participant qualifies for the neutral zone.
Finally, we propose at Sec. 512.430(b)(3) to clarify that if an IOTA
participant's final performance score is below 40 points in PYs 1
through 6, the IOTA participant qualifies for a downside risk payment.
We seek comment on our proposals at proposed Sec. 512.430(b)(1),
512.430(b)(2)(ii), and 512.430(b)(3)(i) to clarify the appropriate
final performance score ranges for an IOTA participant to be eligible
to receive an upside risk payment, be in the neutral zone, or receive a
downside risk payment.
(2) Downside Risk Payment
In the 2024 Final Rule (89 FR 96386), we finalized provisions
regarding downside risk payments and other payments as described in
Sec. 512.430. Additionally, we finalized the definition of downside
risk payment and established the methodology for its calculation. Since
publication, we recognized that this section contains a typographical
error that should be corrected regarding the deadline for downside risk
payments and lacks specificity regarding what happens if the IOTA
participant fails to make the downside risk payment for a given PY.
Therefore, we propose to update the provision at Sec.
512.430(d)(6)(ii) to clarify that the IOTA participant must pay the
downside risk payment to CMS in a single payment within 60 days, rather
than at least 60 days, after the date on which the demand letter is
issued. Where the IOTA participant fails to repay CMS in full for all
monies owed, CMS would invoke all legal means to collect the debt,
including referral of the remaining debt to the United States
Department of the Treasury, pursuant to 31 U.S.C. 3711(g).
We seek comment on our proposal at proposed Sec. 512.430(d)(6)(ii)
to clarify that full payment of a downside risk payment must be
received within 60 days after the demand is made and that it will be
considered delinquent debt if not received within that time period.
(3) Extreme and Uncontrollable Circumstances
In the 2024 Final Rule (89 FR 96389), we finalized provisions
regarding a policy related to Extreme and Uncontrollable Circumstances
(EUC) at Sec. 512.436. We finalized that for the IOTA Model, CMS would
apply determinations made under the QPP with respect to whether an
extreme and uncontrollable circumstance has occurred and the affected
area during the PY and that CMS has sole discretion to determine the
period during which an extreme and uncontrollable circumstance occurred
and the percentage of attributed patients residing in affected areas.
If CMS determined then that an EUC occurred, CMS could then reduce the
amount of the IOTA participant's downside risk payment, if applicable,
prior to recoupment and calculate that reduction based on the
percentage of total months during the PY affected by the extreme and
uncontrollable circumstance and the percentage of attributed patients
who reside in an area affected by the extreme and uncontrollable
circumstance.
Since publication of the 2024 Final Rule, CMS has been reviewing
its policy towards EUC events. The current EUC policy for the IOTA
Model reflects the policy used for many accountable care organization
(ACO) type models, including the ACO Realizing Equity, Access, and
Community Health (ACO REACH) and Kidney Care Choices (KCC) Models.
However, CMS recognizes that the policies used for the QPP may not be
appropriate for the IOTA Model, given that the QPP policies may not
account for broader impacts that an EUC might have on an IOTA
participant's ability to perform in the model if allocation systems
were disrupted due to an emergency or if there were disaster conditions
that could disproportionately affect post-transplant outcomes. The
current provision only potentially reduces downside payments and does
not account for any change in the model inputs or reporting period that
may affect an IOTA participant's performance score if their ability to
perform on one of more of the measures were disrupted by an EUC event.
Therefore, we propose to update the provision at Sec.
512.436(a)(1) to state that CMS may, at its sole discretion, apply
flexibilities if the IOTA participant is located in an emergency area
during an emergency period, as those terms are defined in section
1135(g) of the Act, for which the Secretary has issued a waiver under
section 1135 of the Act and if the IOTA participant is located in a
county, parish, or tribal government designated in a major disaster
declaration under the Stafford Act. Additionally, we propose at Sec.
512.436(a)(2) that CMS has the sole discretion to determine the time
period during which payment and reporting
[[Page 57613]]
flexibilities are provided to the IOTA participant. Finally, we propose
at Sec. 512.436(b) that CMS may, at its sole discretion, adjust the
direction and the magnitude of the upside or downside risk payments, if
applicable, prior to recoupment or payment, for the IOTA participant if
the IOTA participant is participating in the IOTA Model when CMS has
declared such an emergency period.
We seek comment on our proposal at proposed Sec. 512.436(a)(1) to
clarify how CMS will determine if an emergency situation occurs for an
IOTA participant beginning in PY 2 of the Model. We also seek comment
about the flexibilities at proposed Sec. 512.436(b) that CMS may
adjust upside or downside payments to respond to a potential emergency
faced by an IOTA participant.
4. Other Requirements
a. Transparency Requirements
(1) Publication of Selection Criteria for Kidney Transplant Evaluations
and Waitlisting
In the 2024 Final Rule (89 FR 96394) that established the IOTA
Model, we finalized that IOTA participants must publicly post their
patient selection waitlist criteria on a website by the end of PY 1 at
Sec. 512.442(a). Additionally, we discussed commenters' suggestions to
provide IOTA participants with flexibility in updating waitlist
selection criteria and balancing accuracy with resource constraints. We
direct readers to the 2024 Final Rule for a full discussion of this
policy, a summary of the comments received, and our responses to those
comments (89 FR 96394 through 96397).
To advance transparency for individuals seeking transplant waitlist
access and to improve patient health literacy regarding transplant
program evaluation processes, we propose to revise Sec. 512.442(a).
Specifically, we are proposing to revise the paragraph heading at Sec.
512.442(a) to remove ``transplant patient'' from Publication of
transplant patient selection criteria and to redesignate the current
requirement from Sec. 512.442(a) to Sec. 512.442(a)(1). For all
subsequent PYs, we propose at Sec. 512.442(a)(2) that the IOTA
participant must review its publicly posted criteria used for
evaluating and selecting patients for addition to its kidney transplant
waitlist and ensure that the information on its website is up to date
by the end of each relevant PY. The proposed modifications aim to
improve patient health and safety while reducing disparities in access
to transplant evaluations and seek to strengthen the transparency
framework within transplant program evaluation processes, thereby
facilitating improved patient understanding and equitable access to
transplant services.
In recognition that transplant hospitals may make changes to its
patient selection criteria for determining a patient's suitability for
placement on a waitlist we believe that this proposed provision would
capture these changes and ensure that the information on its website is
up to date in future PYs. We also believe this policy would address
commenters' suggestions and provide flexibility in updating its
waitlist selection criteria on its website. We seek comment on these
proposals at proposed Sec. 512.442(a)(1) and (2).
We alternatively considered requiring IOTA participants to update
its publicly posted patient selection waitlist criteria to ensure that
this information on its websites remain current within timeframes of 30
days, 60 days, or 90 days following any modification. We acknowledge
that these alternative timeframes would provide more accurate and
timely information while facilitating informed patient decision-making.
However, we are proposing that IOTA participants must review and update
its publicly posted patient selection waitlist criteria by the end of
each relevant PY to align with current and proposed publication
requirements for patient selection criteria, as described in section
II.B.4.a.(1). of this proposed rule, in the IOTA Model. We seek public
comment on the alternatives considered.
If a transplant program performs living donor transplants, the
transplant program's living donor selection criteria must be consistent
with the general principles of medical ethics. The program must use
written donor selection criteria to determine the suitability of
candidates for donation. Transplant programs must also ensure that a
prospective living donor receives a medical and psychosocial
evaluation, document in the living donor's medical records the living
donor's suitability for donation, and document that the living donor
has given informed consent. We recognize that the current regulations
in the IOTA Model do not address publicly posting living donor
selection criteria. As such, for IOTA participants performing living
donor kidney transplants, we propose that those IOTA participants must
publicly post on its website its living donor selection criteria for
evaluating potential living donors for kidney transplant waitlist
patients by the end of PY 2 at Sec. 512.442(a)(3)(i). For all
subsequent PYs, we propose at Sec. 512.442(a)(3)(ii) that the IOTA
participant must review its living donor selection criteria for
evaluating potential living donors for kidney transplant waitlist
patients on its website and ensure that the information publicly posted
on its website is correct by the end of each relevant PY.
We believe requiring IOTA participants that perform living donor
kidney transplants to publicly post on their website its living donor
selection criteria would significantly enhance transparency in the
kidney transplant system by making living donor selection criteria
readily accessible to patients, families, and referring physicians,
allowing them to make more informed decisions about transplant options
and understand the specific requirements each IOTA participant uses to
evaluate potential living donors. Additionally, we believe this
requirement would empower patients by providing them with clear
information about what criteria their kidney transplant hospital uses
to assess living donors, enabling patients, families, and referring
physicians to better prepare potential donors and understand the
evaluation process, which could ultimately lead to more successful
living donor kidney transplant outcomes. We seek comment on these
proposals at proposed Sec. 512.442(a)(3)(i) and (ii). Finally, we
propose finalizing these requirements only if they are not redundant
with other Department of Health and Human Services (HHS) guidance.
We alternatively considered requiring IOTA participants to update
its publicly posted living donor selection criteria to ensure that this
information on its websites remains current within timeframes of 30
days, 60 days, or 90 days following any modification. We recognize that
this alternative would provide more accurate and timely information
while facilitating informed patient decision-making processes. However,
we proposed that IOTA participants must review and update their
publicly posted living donor selection criteria by the end of each
relevant PY to align with current and proposed publication requirements
for patient selection criteria, as described in section II.B.4.a.(1).
of this proposed rule, in the IOTA Model. We seek public comment on the
alternatives considered.
As previously suggested by commenters in the 2024 Final Rule (89 FR
96396), we considered creating a standardized waitlist selection
criteria template for IOTA participants to use that would include
specific details of waitlist selection criteria such as absolute
contraindications, financial and insurance requirements, and
psychosocial factors that impact listing decisions. We also considered
but did
[[Page 57614]]
not propose creating a standardized living donor selection criteria
template for IOTA participants to use that would be relative or
absolute contraindications for donating a kidney. While we are not
proposing to provide standardized waitlist selection criteria or living
donor selection criteria templates that IOTA participants would be
required to use, we are seeking public comment regarding whether the
inclusion of such templates would be preferable and would not impose
additional administrative burden upon IOTA participants. Additionally,
beyond the requirements outlined in 42 CFR 482.90, we seek comment on
what specific requirements or specific detail should be included in
standardized waitlist selection criteria or living donor selection
criteria templates.
(2) Publication of IOTA Participant Selection Criteria
In the Specialty Care Models final rule (85 FR 61114), CMS
established certain general provisions in 42 CFR part 512 subpart A
that apply to all Innovation Center models. One such general provision
pertains to rights in data. Specifically, in the Specialty Care Models
final rule, we stated that to enable CMS to evaluate the Innovation
Center models as required by section 1115A(b)(4) of the Act and to
monitor the Innovation Center models pursuant to Sec. 512.150, in
Sec. 512.140(a) we would use any data obtained in accordance with
Sec. Sec. 512.130 and 512.135 to evaluate and monitor the Innovation
Center models (85 FR 61124). We also stated that, consistent with
section 1115A(b)(4)(B) of the Act, CMS would disseminate quantitative
and qualitative results and successful care management techniques,
including factors associated with performance, to other providers and
suppliers and to the public. We stated that the data to be disseminated
would include, but would not be limited to, patient de-identified
results of patient experience of care and quality of life surveys, as
well as patient de-identified measure results calculated based upon
claims, medical records, and other data sources. We finalized these
policies in 42 CFR 512.140(a).
Consistent with these provisions, in the 2024 Final Rule (89 FR
96403) that established the IOTA Model, we finalized our proposals to
publish results from all PYs of the IOTA Model. Specifically, we stated
that, for each PY, we intend to identify each IOTA participant for the
PY and to post performance across the achievement domain, efficiency
domain, and quality domain for each IOTA participant on the IOTA Model
website annually, as they become available (89 FR 96403). We maintain
our belief that this not only meets CMS requirements but also
demonstrates transparency for the transplant community.
Adding to these provisions, we propose to publish IOTA participant
waitlist selection criteria and the proposed living donor selection
criteria, as described in section II.B.4.a.(1). of this proposed rule,
on the IOTA Model website. Specifically, for each PY, we intend to
publish waitlist selection criteria and the proposed living donor
selection criteria, as described in section II.B.4.a.(1). of this
proposed rule, for each IOTA participant on the IOTA Model website by
the end of the second quarter of each subsequent PY. We propose to
finalize this requirement only if they are not redundant with other HHS
guidance. We believe that the release of this information on the IOTA
Model website would inform the public about IOTA participants'
selection criteria while in the IOTA Model. Furthermore, we believe the
release of this information on the IOTA Model website would address
previous suggestions from commenters to provide this information in a
centralized location (89 FR 96396). Lastly, we note that this would
supplement, not replace, the publication of selection criteria
requirements in the IOTA Model.
We seek comment on our proposal to post this information to the
IOTA Model website, as well as the information we intend to post and
the manner and timing of the posting.
(3) Transparency Into Kidney Transplant Organ Offers
As discussed in the 2024 Final Rule (89 FR 96397), those active on
a kidney transplant waitlist may receive organ offers at any time.
However, there is currently no requirement for providers to discuss
organ offers with their patients. A provider may decline an organ offer
for any number of reasons; \53\ however, declining without disclosing
the rationale to the patient may miss an important opportunity for
shared decision-making.
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\53\ Reasons for declining include concerns about the quality of
the donor organ, such as, donor comorbidity, evidence of disease or
injury, or other clinical factors that could affect long-term graft
survival. Providers may also decline an offer if the organ is not
compatible with the candidate's blood type or antibody profile,
which could increase the risk of rejection. Patient-specific factors
may also play a role, such as the candidate not being medically
stable for surgery at the time of the offer, not meeting weight or
other health requirements, or having unresolved infections or
comorbidities. In some cases, logistical issues like timing,
transport of the organ, or operating room availability may
contribute to a declined offer.
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After 3 years on the waiting list, approximately 27 percent of
kidney transplant waitlist patients receive a deceased donor kidney
transplant (DDKT), while 33 percent remain on the waitlist.\54\
Communication with waitlisted patients is limited, typically focusing
only on discussing eligibility requirements and notifying them when a
transplant program plans to accept an organ offer.<SUP>55 56</SUP>
Furthermore, the National Academy of Sciences, Engineering, and
Medicine (NASEM) released a significant report in 2022 titled
``Realizing the Promise of Equity in the Organ Transplantation
System.'' \57\ The report put forth several key recommendations to
enhance transparency and patient engagement in the organ
transplantation process. Notably, it called for transplant hospitals to
increase transparency with patients regarding declined organ offers,
including providing specific details about the number of declined
offers and the rationale behind these decisions. Secondly, the report
advocated for modifications to the OPTN contract, emphasizing the need
for transplant hospitals to actively involve patients in the decision-
making process when accepting or rejecting organs.
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\54\ Lentine, K.L., Smith, J.M., Miller, J.M., Bradbrook, K.,
Larkin, L., Weiss, S., Handarova, D.K., Temple, K., Israni, A.K., &
Snyder, J.J. (2023). OPTN/SRTR 2021 Annual Data Report: Kidney.
American journal of transplantation: official journal of the
American Society of Transplantation and the American Society of
Transplant Surgeons, 23(2 Suppl 1), S21-S120. <a href="https://doi.org/10.1016/j.ajt.2023.02.004">https://doi.org/10.1016/j.ajt.2023.02.004</a>.
\55\ Bergeron, M. (2020). Transplant Center Criteria and
Inequalities Within Transplant Wait Listing Process [Thesis].
<a href="https://stars.library.ucf.edu/etd2020/175/">https://stars.library.ucf.edu/etd2020/175/</a>.
\56\ Rasheed, H.A., Pensler, M., Diaz, S., Roney, E., Barrett,
M., & Sonnenberg, E.M. (2024). Organ Offer Review Cards: Improving
Transparency on the Kidney Transplant Waitlist. Clinical
Transplantation, 38(7). <a href="https://doi.org/10.1111/ctr.15388">https://doi.org/10.1111/ctr.15388</a>.
\57\ National Academies of Sciences, Engineering, and Medicine.
(2022a). Realizing the Promise of Equity in the Organ
Transplantation System (K.W. Kizer, R.A. English, & M. Hackmann,
Eds.). National Academies Press. <a href="https://doi.org/10.17226/26364">https://doi.org/10.17226/26364</a>.
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We also note the recent release of two studies related to notifying
patients on the waiting list about declined organ offer, since we
issued the 2024 Proposed Rule. One study conducted interviews with
patients and nephrologists about this issue of organ offer
transparency.\58\ This study found that among 755 patient respondents
surveyed, 64 percent expressed a preference to
[[Page 57615]]
receive organ offer reports. Of the total patient respondents, 87
percent indicated that transplant hospitals should be mandated to
inform candidates about the organ offers they receive, while 62 percent
specified that candidates should be notified following each individual
offer. Additionally, 73 percent of nephrologists reported that they
believe patients should be provided with offer information. The second
study, conducted at the University of Michigan in 2022, developed and
evaluated an innovative Organ Offer Review Card (OORC) designed to
enhance transparency in kidney transplant waitlist processes.\59\ In
response to the 2022 NASEM recommendations for increased accountability
in organ offer decisions, researchers created a prototype tool that
summarizes patients' organ offers and reasons for decline over a 6-
month period. This study employed a cross-sectional survey design to
assess patients' perceptions, attitudes, and feedback regarding the
OORC, while also examining perspectives on shared decision-making for
organ offers. The survey found that of 60 randomly selected patients,
43 were reached by phone and 17 (39.5 percent) completed the survey,
almost all of whom believed it was important to be involved in the
decision-making process about organ offers and all of them wanted to
understand why organs were declined on their behalf. The study further
found that a vast majority of patients believe the information enhanced
their understanding of the transplant process and believed that seeing
this information would increase their trust in the transplant hospital.
While these two studies have limited sample size, they represent a
growing interest in how to foster organ offer transparency and patient-
centered care.
---------------------------------------------------------------------------
\58\ Husain, S.A., Rubenstein, J.A., Ramsawak, S., Huml, A.M.,
Yu, M.E., Maclay, L.M., Schold, J.D., & Mohan, S. (2025). Patient
and Provider Attitudes Towards Patient-Facing Kidney Organ Offer
Reporting. Kidney International Reports, 10(4), 1122-1130. <a href="https://doi.org/10.1016/j.ekir.b2025.b01.013">https://doi.org/10.1016/j.ekir.b2025.b01.013</a>.
\59\ Rasheed, H.A., Pensler, M., Diaz, S., Roney, E., Barrett,
M., & Sonnenberg, E.M. (2024). Organ Offer Review Cards: Improving
Transparency on the Kidney Transplant Waitlist. Clinical
Transplantation, 38(7). <a href="https://doi.org/10.1111/ctr.15388">https://doi.org/10.1111/ctr.15388</a>.
---------------------------------------------------------------------------
As described in the 2024 Final Rule (89 FR 96397), we proposed to
add requirements to increase transparency for IOTA waitlist patients
who are Medicare beneficiaries regarding the volume of organ offers
received on their behalf while on the waitlist. Specifically, we
proposed that for each month an organ is offered to an IOTA waitlist
patient who is a Medicare beneficiary, an IOTA participant must inform
the Medicare beneficiary, on a monthly basis, of the number of times an
organ is declined on the Medicare beneficiary's behalf and the
reason(s) for the decline. However, following feedback from public
comments that this policy would impose a significant administrative
burden on IOTA participants, we did not finalize this transparency
requirement to consider alternatives, such as an alternative frequency
of sharing declined organ offers with the Medicare beneficiary. We also
stated that we remain invested in evaluating alternative transparency
opportunities for patients on the waiting list with the transplant
community to fulfill this important need. We direct readers to the 2024
Final Rule for more information on the stakeholder comments regarding
that proposal and our responses to those comments (89 FR 96397 through
96403).
Based on the feedback we received, we are proposing an alternative
approach for the model. Specifically, for PYs 3 through 6 we propose at
Sec. Sec. 512.442(b) and (b)(1) that IOTA participants would be
required to notify eligible IOTA waitlist beneficiaries of the number
of times an organ is declined on the eligible IOTA waitlist
beneficiary's behalf at least once every 6 months that the eligible
IOTA waitlist beneficiary is on the IOTA participant's waitlist. For
purposes of the model, we propose to define ``eligible IOTA waitlist
beneficiaries'' at Sec. 512.402 as IOTA waitlist patients, as defined
at Sec. 512.402, who are Medicare beneficiaries and meet all of the
following criteria:
<bullet> Are active on the IOTA participant's waitlist; and
<bullet> Have accrued a minimum of 3 years of waiting time on the
IOTA participant's waitlist.
We note that our rationale for this proposal is explained further
later in this section. We seek comment on our proposed definition of
eligible IOTA waitlist beneficiaries at proposed Sec. 512.402.
We are proposing that, beginning in PY 3, IOTA participants would
be required to provide notification of declined organ offers for
eligible IOTA waitlist beneficiaries, as defined at proposed Sec.
512.402, who are on their waitlist every 6 months, starting July 1 of
PY 3, subject to the following conditions. IOTA participants would only
have to notify eligible IOTA waitlist beneficiaries with at least 3
years of accrued waiting time. IOTA participants would have to provide
this notification every 6 months after that time period. For example,
if an eligible IOTA waitlist patient has 2 years and 11 months of
accrued waiting time on July 1 of PY 3, the IOTA participant would not
need to provide this notification to that eligible IOTA waitlist
patient because they have not accrued 3 years of waiting time.
Alternatively, if an eligible IOTA waitlist patient has 3 years and 11
months of accrued waiting time on July 1 of PY 3, the IOTA participant
would need to provide this notification to that eligible IOTA waitlist
patient because they have accrued 3 years of waiting time. This
proposed timeframe is designed to balance between the operational
burden for IOTA participants and when eligible IOTA waitlist
beneficiaries could start getting transplantable offers. To respect
beneficiary choice, eligible IOTA waitlist beneficiaries would be able
to opt out of this notification.
For each 6-month period in which an organ offer is received and
declined, we propose at Sec. 512.442(b)(1)(i)(A) through (F) that the
IOTA participant must provide notifications to each eligible IOTA
waitlist beneficiary, as defined at proposed Sec. 512.402, and include
all of the following:
<bullet> How much wait-time the eligible IOTA waitlist beneficiary
is currently listed with and their percent panel-reactive antibody
(PRA) \60\ value.
---------------------------------------------------------------------------
\60\ As defined by the OPTN, the percent PRA value is a measure
of a patient's level of sensitization to HLA antigens. It is the
percentage of cells from a panel of blood donors against which a
potential recipient's serum reacts. The PRA reflects the percentage
of the general population that a potential recipient makes
antibodies (is sensitized) against. For example, a patient with a
PRA of 80 percent will be incompatible with 80 percent of potential
donors. Kidney patients with a high PRA are given priority on the
waiting list. The higher the PRA, the more sensitized a patient is
to the general donor pool, and thus the more difficult it is to find
a suitable donor. A patient may become sensitized as a result of
pregnancy, a blood transfusion, or a previous transplant.
---------------------------------------------------------------------------
<bullet> In each 6-month period, how many match-runs, as defined at
Sec. 512.402, the eligible IOTA waitlist beneficiary came up on and
how many donors they received kidney organ offers from;
<bullet> Unique patient-specific considerations for that eligible
IOTA waitlist beneficiary for which deceased donor kidneys the IOTA
participant would consider for that eligible IOTA waitlist beneficiary.
<bullet> The refusal reason(s) \61\ why offers were declined based
off the OPTN refusal codes in plain language;
---------------------------------------------------------------------------
\61\ Refusal reasons, as defined by the OPTN, are number codes
used on a match run to show the reason an organ was not accepted for
a potential transplant recipient (PTR) receiving the offer.
---------------------------------------------------------------------------
<bullet> Of the deceased donor kidney organ offers declined for
that eligible IOTA waitlist beneficiary how many of those kidneys were
transplanted in another kidney transplant patient, as defined at Sec.
512.402; and
<bullet> Potential avenues to accelerate access to transplant (for
example,
[[Page 57616]]
exploring living donation, being waitlisted at multiple kidney
transplant hospitals, reviewing transplant organ offer acceptance
criteria or ensuring they meet and maintain the patient criteria for
their chosen kidney transplant hospital(s), such as adhering to weight
loss recommendations).
We believe that these proposed requirements would best balance
transparency for the eligible IOTA waitlist beneficiary and ensure the
information is as useful as possible for them. We note that we did not
finalize this provision in the 2024 Final Rule and stated that we were
very interested in transparency, but due to the many concerns that we
received, we recognized that monthly notification to Medicare
beneficiaries regarding volume and reason for organ decline could have
been very burdensome to IOTA participants and their staff in PY 1 since
this was a new initiative and there were not current infrastructure or
database resources to aid in minimizing burden on IOTA participants (89
FR 96397). We believe though that circumstances have changed relative
to when we wrote the 2024 Final Rule for a few reasons:
First, the IOTA Model has already started. The 2024 Final Rule that
established the IOTA Model was finalized in December 2024 and IOTA
participants were notified of their participation status. IOTA
participants have had time to implement their care models.
Additionally, IOTA participants would have plenty of notice of CMS'
intent in this area, with approximately 18 months from the release date
of this proposed rule in Fall 2025 until the start of PY 3 on July 1,
2027, to implement the necessary processes to implement these proposed
notification requirements, if finalized.
Next, we believe that this updated provision that we are proposing
is responsive to many of the administrative burden concerns that were
raised by commenters in response to what we originally proposed in the
2024 Proposed Rule. For example, in this proposed rule we are proposing
that the transparency into kidney transplant organ offers requirement
would only apply for eligible IOTA waitlist beneficiaries, as defined
in section II.B.4.a.(3). of this proposed rule, rather than all IOTA
waitlist patients who are Medicare beneficiaries, and IOTA participants
would only be required to notify eligible IOTA waitlist beneficiaries
every 6 months, rather than monthly.
Additionally, we have been working with the Health Resources and
Services Administration (HRSA) with operational assistance to help to
make sure that this information is easily accessible for IOTA
participants and in a format that could be easily shared with its
eligible IOTA waitlist beneficiaries.
We considered requiring that an IOTA participant begin providing
notification of declined organ offers 3 years from when a beneficiary
started dialysis, but did not propose that as we know some
beneficiaries get onto the waitlist before they start dialysis. We also
considered proposing 1 or 2 years of waitlist time, as well as 4 or 5
years, but decided to propose 3 years as a way to balance when it would
be appropriate for eligible IOTA waitlist beneficiaries to start being
informed of their offers. We seek comment on the alternative
considered.
We considered proposing to require IOTA participants to provide
this notification to eligible IOTA waitlist beneficiaries once they
join the list or with just 1 year or 2 years of waiting list time but
decided to propose 3 years to balance informing these patients with the
workload for IOTA participants. We also considered proposing other
timeframes for potentially notifying eligible IOTA waitlist
beneficiaries about kidney transplant organ offers including monthly,
quarterly, or annually, but proposed every 6 months to align with the
model's review of acceptance criteria requirement at Sec. 512.442(c)
and the proposed change in waitlist status requirement, as described in
section II.B.4.a.(5). of this proposed rule.
Subsequently, we considered a variation of organ offer
notifications, where every 6 months the IOTA participant would be
required to also provide the total number of kidney transplant organ
offers the IOTA participant received and accepted in the relevant 6-
month period in addition to the kidney transplant organ offers for the
individual eligible IOTA waitlist beneficiary. For example, a
notification in January would include the number of received and
accepted kidney transplant offers by the IOTA participant from July 1
to December 31, alongside the number of kidney transplant organ offers
that the individual eligible IOTA waitlist beneficiary received during
that same time frame. We believe that providing total kidneys accepted
by an IOTA participant would help provide a comparison for when
eligible IOTA waitlist beneficiaries receive organ offer notifications
every 6 months. In recognition of the additional reporting complexity
this variation would introduce for IOTA participants, we did not
propose this alternative considered.
We considered limiting this proposed requirement exclusively to
kidney transplant organ offers that were ultimately transplanted;
however, we determined that the requirement to inform eligible IOTA
waitlist beneficiaries of the disposition of each kidney transplant
organ offer would accomplish the same objectives while providing more
comprehensive information to the eligible IOTA waitlist beneficiary. We
also considered not requiring the sharing of offers further up in the
match run, as defined at Sec. 512.402, at spot 100 or higher to align
with the SRTR definition of hard-to-place organ or spot 150, but wanted
to err on the side of providing greater transparency to eligible IOTA
waitlist beneficiaries. We further considered excluding multi-organ
offers from this provision; however, we did not propose such exclusion
because we wanted to ensure that eligible IOTA waitlist beneficiaries
would receive a more complete perspective regarding their care.
We considered requiring other explanations for why each kidney
transplant organ offer was declined, in order to provide additional
specificity where appropriate but decided to propose OPTN refusal codes
in order to provide a standardized approach for IOTA participants using
a format they are already familiar with. We also considered requiring
cumulative information of organ offers declined since the eligible IOTA
waitlist beneficiary was added to the IOTA participant's waitlist but
were unsure if that would provide additional useful information for
these beneficiaries.
Lastly, we considered but did not propose creating a standardized
notification template for IOTA participants to use that would include
the information specified at proposed Sec. 512.442(b)(1)(i)(A) through
(F). We think that requiring IOTA participants to use a CMS-provided
standardized template for these notification requirements could be
beneficial because it would ensure uniform implementation across all
IOTA participants, eliminating variability in how critical patient-
specific information is communicated and significantly reducing the
administrative burden on individual IOTA participants by providing
ready-to-use formats rather than requiring each IOTA participant to
develop custom systems. Additionally, a standardized template would
enhance beneficiary understanding by presenting complex medical
information in a consistent, accessible format across all IOTA
participants, while also facilitating more efficient CMS oversight
[[Page 57617]]
and enabling better aggregation of beneficiary communication data for
program evaluation and quality improvement initiatives. We also
recognize that requiring IOTA participants to use a CMS-provided
notification template presents certain considerations that merit
evaluation. While standardization offers benefits, we recognize that it
may present challenges in addressing diverse patient populations,
varying literacy levels, and unique clinical circumstances that could
benefit from tailored communication approaches. Furthermore, a
standardized notification template may need to be designed with
sufficient flexibility to accommodate the different operational
capabilities, existing communication systems, and established
beneficiary relationships that individual IOTA participants have
developed to avoid potential implementation challenges or reduced
effectiveness in patient communication. While we are not proposing to
provide a standardized notification template that IOTA participants
would be required to use, we are seeking public comment regarding
whether the inclusion of such templates would be preferable and would
not impose additional administrative burden upon IOTA participants.
Additionally, beyond the proposed requirements, we seek comment on what
specific requirements or specific details should be included in or
excluded from such a notification template.
To communicate with the eligible IOTA waitlist beneficiary
effectively, we are proposing at Sec. 512.442(b)(2) that the IOTA
participant must provide this notification via patient visit, email,
electronically, or mail on an individual basis, unless the eligible
IOTA waitlist beneficiary opts out of this notification. We propose at
Sec. 512.442(b)(2)(i) IOTA participants must give eligible IOTA
waitlist beneficiaries the opportunity to opt out of receiving this
notification. We propose at Sec. 512.442(b)(2)(ii) that if an eligible
IOTA waitlist beneficiary opts out of receiving this notification, the
IOTA participant would be required to do the following:
<bullet> Record in the eligible IOTA waitlist beneficiary's medical
record all of the following:
++ The date on which this notification was declined.
++ The method by which this notification was declined.
<bullet> Offer to provide this notification once every 6 months at
which time the eligible IOTA waitlist beneficiary would have the
opportunity to opt out of receiving this notification again.
We note that our rationale for this proposal is explained further
later in the section.
We also propose at Sec. 512.442(b)(3)(i) through (iii) that the
IOTA participant must record in the eligible IOTA waitlist
beneficiary's medical record--
<bullet> That the eligible IOTA waitlist beneficiary received the
notification specified in proposed Sec. 512.442(b)(1);
<bullet> The method by which the notification was delivered; and
<bullet> The date by which the notification was delivered.
Additionally, we are proposing at Sec. 512.442(b)(4) that the
information at proposed Sec. 512.442(b)(1) must be provided with the
eligible IOTA waitlist beneficiary's nephrologist or nephrology
professional, to provide the opportunity for questions and
clarification of information.
We alternatively considered proposing that the IOTA participant
must record in the eligible IOTA waitlist beneficiary's medical
record--
<bullet> That the eligible IOTA waitlist beneficiary was sent the
notification specified in proposed Sec. 512.442(b)(1);
<bullet> The method by which the notification was sent; and
<bullet> The date by which the notification was sent.
In this alternative considered, requiring IOTA participants to
document when a notification was sent rather than when it was delivered
recognizes the practical challenges of verifying receipt while still
ensuring accountability. The IOTA participant would fulfill its
obligation to communicate the required information once a notification
was sent, whether by mail, email, or electronically. However, we chose
not to propose this alternative because we believe recording only when
a notification was sent does not confirm that the information reached
the eligible IOTA waitlist beneficiary. We also believe that requiring
IOTA participants to document delivery of this notification creates a
more accurate medical record, allowing IOTA participants to know with
confidence what information eligible IOTA waitlist beneficiaries have
in hand when engaging in follow-up discussions or counseling.
Furthermore, documenting delivery supports transparency and
accountability by demonstrating that IOTA participants are not only
generating notices, but also ensuring they arrive, reducing the risk
that eligible IOTA waitlist beneficiaries unknowingly miss out on
information necessary for shared decision-making. Ultimately, focusing
on when it was delivered rather than was sent better serves the purpose
of the notification requirement: to keep eligible IOTA waitlist
beneficiaries informed and actively engaged in their path to kidney
transplantation.
We seek comment on our proposals to provide transparency into
kidney transplant organ offers at proposed Sec. 512.442(b). We also
seek comment on the alternatives considered.
(4) Review of Acceptance Criteria
As finalized in the 2024 Final Rule (89 FR 96402), IOTA
participants will be required to review transplant organ offer
acceptance criteria with their IOTA waitlist patients who are Medicare
beneficiaries at least once every 6 months that the Medicare
beneficiary is on their waitlist, unless the Medicare beneficiary opts
out of this review. Under this provision, the IOTA participant must
conduct this review via patient visit, phone, email or mail on an
individual basis, unless the Medicare beneficiary declines this review.
In the 2024 Final Rule, we stated, in response to comments we received,
that we recognized that explaining organ offer filters with waitlisted
patients might not promote the same outcome as reviewing organ offer
acceptance criteria (89 FR 96398). As such, we finalized the
transparency requirements at Sec. 512.442(c) with minor technical
edits. Specifically, we added ``organ offer'' to transplant acceptance
criteria that must be disclosed and removed all references to ``organ
offer filter'' from the provision at Sec. 512.442(c). Additionally, at
Sec. 512.442(c) we replaced ``selection criteria'' to now say
``acceptance criteria''. We stated that these changes were made in
order to clarify the specific provisions regarding the review of
transplant organ offer acceptance criteria.
Since publication of the 2024 Final Rule, IOTA participants have
requested that CMS provide clarification on what acceptance criteria
information should be reviewed. Therefore, in this proposed rule, we
aim to clarify at Sec. 512.442(c) that review of acceptance criteria
pertains to individual patient transplant organ offer acceptance
criteria and not organ offer filters or kidney transplant hospital
level acceptance criteria. For purposes of the model, we propose at
Sec. 512.402 to define ``transplant organ offer acceptance criteria''
as individualized patient acceptance parameters that kidney waitlist
patients, as defined at Sec. 512.402, may elect regarding the
categories of organ offers they are prepared to accept for
transplantation. We seek comment on our proposal at proposed Sec.
512.442(c) to clarify the meaning of transplant organ offer acceptance
criteria. We also seek comment on the proposed definition for
[[Page 57618]]
transplant organ offer acceptance criteria at proposed Sec. 512.402.
As described earlier in this section, in the 2024 Final Rule we
finalized at Sec. 512.442(c)(1) that IOTA participants must conduct
the review of acceptance criteria via patient visit, phone, email or
mail on an individual basis, unless the Medicare beneficiary declines
this review. Additionally, in response to comments we received we
stated at 89 FR 96399 that we would provide further sub-regulatory
guidance on how IOTA waitlist patients who are Medicare beneficiaries
can choose to decline the review of their transplant organ offer
acceptance criteria. Since publication, we provided sub-regulatory
guidance to IOTA participants in the IOTA Model Newsletter on how IOTA
waitlist patients who are Medicare beneficiaries can opt out of this
review. However, upon further review of the sub-regulatory guidance we
provided to IOTA participants, we realized there was a need to clarify
this guidance and account for this requirement when CMS conducts
monitoring activities in the IOTA Model.
As such, we propose at Sec. 512.442(c)(1)(i) that prior to
reviewing transplant organ offer acceptance criteria, as defined at
proposed Sec. 512.402, with IOTA waitlist patients who are Medicare
beneficiaries, IOTA participants must give these beneficiaries an
opportunity to decline this review. We propose at Sec.
512.442(c)(1)(ii) that if the IOTA waitlist patient who is a Medicare
beneficiary declines this review, the IOTA participant must record in
the IOTA waitlist patient who is a Medicare beneficiary's medical
record all of the following:
<bullet> The date on which this review was declined; and
<bullet> The method by which this review was declined.
We also propose that if an IOTA waitlist patient who is a Medicare
beneficiary declines this review, the IOTA participant would then be
required to offer the IOTA waitlist patient who is a Medicare
beneficiary the opportunity to review transplant organ offer acceptance
criteria once every 6 months at which time the IOTA waitlist patient
who is a Medicare beneficiary would have the opportunity to decline
this review again. We seek comment on these proposed requirements at
proposed Sec. 512.442(c)(1)(i) and (ii).
Lastly, to facilitate compliance monitoring, we propose at Sec.
512.442(c)(2)(i) through (iii) that the IOTA participant must record in
the IOTA waitlist patient who is a Medicare beneficiary's medical
record all of the following:
<bullet> The information specified at Sec. 512.442(c) was reviewed
with the IOTA waitlist patient who is a Medicare beneficiary;
<bullet> The date on which this review took place; and
<bullet> The method by which this review was delivered.
We seek comment on these proposed documentation requirements at
proposed Sec. 512.442(c)(2)(i) through (iii).
(5) Change in Waitlist Status
Transplant hospitals are currently required to promptly notify
patients awaiting transplantation of any program-related circumstances
that could affect their ability to receive a transplant (see 42 CFR
482.102(c)). These regulations mandate that transplant hospitals must
inform patients of factors such as the availability of transplant
surgeons and changes in the hospital's operational status. Transplant
hospitals must also notify patients of any modifications to their
Medicare certification status, whether due to voluntary program
inactivation or termination. These notification requirements serve as a
crucial mechanism to ensure transparency and protect patient interests
throughout the transplant waiting period.
Patients on the transplant waiting list are designated as either
``active'' or ``inactive''. Individuals with active status are prepared
and eligible to be matched with available organs, whereas those with
inactive status are not yet ready to, nor can they, receive organ
offers. There are over 90,000 people on the waiting list for a kidney
transplant, but nearly half (49 percent) of these individuals on the
waiting list are listed as ``inactive'' as of 2025, and unable to
receive a kidney transplant.\62\ While awaiting organ transplantation,
kidney transplant waitlist patients' status on the waiting list may
change between active and inactive multiple times before ultimately
receiving a successful transplant. The decision to place a kidney
transplant waitlist patient on inactive status can arise from various
factors, including hospital admission for vascular access issues,
suspected lesions identified during preoperative screening, or poor
compliance with dialysis treatments.<SUP>63</SUP> <SUP>64</SUP>
<SUP>65</SUP> <SUP>66</SUP> <SUP>67</SUP> Any of these concerns may
prompt a temporary inactivation until the problem is resolved, allowing
for the kidney transplant waitlist patient's reactivation. Barriers to
maintaining active status are often multifactorial but frequently
modifiable, encompassing symptoms such as fatigue, depression, stress,
pain, loss of physical function, social isolation, and decreased health
literacy.<SUP>68</SUP> <SUP>69</SUP> Inactive status thus indicates a
kidney transplant waitlist patient's ineligibility to be considered for
organ offers at a given point in time, for many different reasons such
as temporarily too sick, temporarily too well, candidate work-up
incomplete, etc.<SUP>70</SUP> <SUP>71</SUP> <SUP>72</SUP> <SUP>73</SUP>
---------------------------------------------------------------------------
\62\ Hart, A., Smith, J.M., Skeans, M.A., Gustafson, S.K., Wilk,
A.R., Castro, S., Robinson, A., Wainright, J.L., Snyder, J.J.,
Kasiske, B.L., & Israni, A.K. (2019). OPTN/SRTR 2017 Annual Data
Report: Kidney. American Journal of Transplantation, 19, 19-123.
<a href="https://doi.org/10.1111/ajt.15274">https://doi.org/10.1111/ajt.15274</a>; The data was retrieved directly
from the OPTN website (<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>) on April 3, 2025, with the following
filters: Category (Waiting List), Count (Candidates), Organ by
Status.
\63\ Huang, E., Shye, M., Elashoff, D., Mehrnia, A., &
Bunnapradist, S. (2014). Incidence of Conversion to Active Waitlist
Status Among Temporarily Inactive Obese Renal Transplant Candidates.
Transplantation, 98(2), 177-186. <a href="https://doi.org/10.1097/tp.0000000000000037">https://doi.org/10.1097/tp.0000000000000037</a>.
\64\ Hladek, M., Curriero, S., Xue, Q.-L., Crews, D., DeMarco,
M.M., Wilson, D., Brennan, D., & Szanton, S. (2024). CAPABLE
TRANSPLANT: ADAPTATION OF CAPABLE FOR USE WITH OLDER ADULTS WITH
INACTIVE STATUS AWAITING KIDNEY TRANSPLANT. Innovation in Aging,
8(Supplement_1), 181-181. <a href="https://doi.org/10.1093/geroni/igae098.0585">https://doi.org/10.1093/geroni/igae098.0585</a>.
\65\ Shafi, S., Zimmerman, B., & Kalil, R. (2012). Temporary
Inactive Status on Renal Transplant Waiting List: Causes, Risk
Factors, and Outcomes. Transplantation Proceedings, 44(5), 1236-
1240. <a href="https://doi.org/10.1016/j.transproceed.2012.01.126">https://doi.org/10.1016/j.transproceed.2012.01.126</a>.
\66\ Tong, A., Hanson, C.S., Chapman, J.R., Halleck, F., Budde,
K., Josephson, M.A., & Craig, J.C. (2015). ``Suspended in a
paradox''-patient attitudes to wait-listing for kidney
transplantation: systematic review and thematic synthesis of
qualitative studies. Transplant International, 28(7), 771-787.
<a href="https://doi.org/10.1111/tri.12575">https://doi.org/10.1111/tri.12575</a>.
\67\ 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:JASN, 31(12), 2900-2911.
<a href="https://doi.org/10.1681/ASN.2020030335">https://doi.org/10.1681/ASN.2020030335</a>.
\68\ Shafi, S., Zimmerman, B., & Kalil, R. (2012). Temporary
Inactive Status on Renal Transplant Waiting List: Causes, Risk
Factors, and Outcomes. Transplantation Proceedings, 44(5), 1236-
1240. <a href="https://doi.org/10.1016/j.transproceed.2012.01.126">https://doi.org/10.1016/j.transproceed.2012.01.126</a>.
\69\ Hladek, M., Curriero, S., Xue, Q.-L., Crews, D., DeMarco,
M.M., Wilson, D., Brennan, D., & Szanton, S. (2024). CAPABLE
TRANSPLANT: ADAPTATION OF CAPABLE FOR USE WITH OLDER ADULTS WITH
INACTIVE STATUS AWAITING KIDNEY TRANSPLANT. Innovation in Aging,
8(Supplement_1), 181-181. <a href="https://doi.org/10.1093/geroni/igae098.0585">https://doi.org/10.1093/geroni/igae098.0585</a>.
\70\ Norman, S.P., Kommareddi, M., & Luan, F.L. (2013).
Inactivity on the kidney transplant wait-list is associated with
inferior pre- and post-transplant outcomes. Clinical
Transplantation, 27(4), E435-E441. <a href="https://doi.org/10.1111/ctr.12173">https://doi.org/10.1111/ctr.12173</a>.
\71\ Hughes, A., Malhotra, D., Brennan, D., Seldon, L.,
Carberry, H., Morrison, M., & Hladek, M. (2025). Waitlist management
for inactive status kidney transplant patients: a scoping review.
Annals of Medicine & Surgery, 87(4), 2204-2211. <a href="https://doi.org/10.1097/ms9.0000000000003137">https://doi.org/10.1097/ms9.0000000000003137</a>.
\72\ Kataria, A., Gowda, M., Lamphron, B.P., Jalal, K., Venuto,
R.C., & Gundroo, A.A. (2019c). The impact of systematic review of
status 7 patients on the kidney transplant waitlist. BMC Nephrology,
20(1). <a href="https://doi.org/10.1186/s12882-019-1362-6">https://doi.org/10.1186/s12882-019-1362-6</a>.
\73\ OPTN. (2025). Require Patient Notification for Waitlist
Status Changes--OPTN. <a href="http://Hrsa.gov">Hrsa.gov</a>. <a href="https://optn.transplant.hrsa.gov/policies-bylaws/public-comment/require-patient-notification-for-waitlist-status-changes/?j=1275952&sfmc_sub=402742420&l=7077_HTML&u=77544833&mid=100001876&jb=2001">https://optn.transplant.hrsa.gov/policies-bylaws/public-comment/require-patient-notification-for-waitlist-status-changes/?j=1275952&sfmc_sub=402742420&l=7077_HTML&u=77544833&mid=100001876&jb=2001</a>.
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[[Page 57619]]
Numerous research studies have demonstrated that kidney transplant
waitlist patients frequently experience confusion and knowledge
deficits regarding the transplant evaluation and listing
process.<SUP>74</SUP> <SUP>75</SUP> <SUP>76</SUP> <SUP>77</SUP>
<SUP>78</SUP> <SUP>79</SUP> <SUP>80</SUP> <SUP>81</SUP> These knowledge
gaps often contribute to delays in testing and aborted medical
evaluations. Kidney transplant waitlist patients have reported a lack
of clarity about their status in the listing process,
<SUP>82 83 84 85</SUP> a belief that they are already on the waiting
list, <SUP>86</SUP> <SUP>87</SUP> <SUP>88</SUP> unawareness that tests
must be repeated, <SUP>89</SUP> <SUP>90</SUP> and misunderstanding
about being placed on inactive status on the waiting list.
<SUP>91</SUP> <SUP>92</SUP> In addition to difficulties navigating the
healthcare system, these knowledge deficits can lead to negative
perceptions of the transplant process and diminish kidney transplant
waitlist patient motivation to complete the required testing.
Literature also suggests that kidney transplant waitlist patients who
remain in an inactive status for extended periods are less likely to
receive a kidney transplant, which is associated with increased
waitlist mortality.<SUP>93</SUP> <SUP>94</SUP> <SUP>95</SUP>
<SUP>96</SUP> <SUP>97</SUP> <SUP>98</SUP>
---------------------------------------------------------------------------
\74\ Kayler, L.K., Dolph, B., Ranahan, M., Keller, M., Cadzow,
R., & Feeley, T.H. (2021). Kidney Transplant Evaluation and Listing:
Development and Preliminary Evaluation of Multimedia Education for
Patients. Annals of transplantation, 26, e929839. <a href="https://doi.org/10.12659/AOT.929839">https://doi.org/10.12659/AOT.929839</a>.
\75\ Kazley, A.S., Hund, J.J., Simpson, K.N., Chavin, K., &
Baliga, P. (2015). Health literacy and kidney transplant outcomes.
Progress in transplantation (Aliso Viejo, Calif.), 25(1), 85-90.
<a href="https://doi.org/10.7182/pit2015463">https://doi.org/10.7182/pit2015463</a>.
\76\ Browne, T., Amamoo, A., Patzer, R.E., Krisher, J., Well,
H., Gander, J., & Pastan, S.O. (2016). Everybody needs a cheerleader
to get a kidney transplant: a qualitative study of the patient
barriers and facilitators to kidney transplantation in the
Southeastern United States. BMC nephrology, 17(1), 108. <a href="https://doi.org/10.1186/s12882-016-0326-3">https://doi.org/10.1186/s12882-016-0326-3</a>.
\77\ Kazley, A.S., Simpson, K.N., Chavin, K.D., & Baliga, P.
(2012). Barriers facing patients referred for kidney transplant
cause loss to follow-up. Kidney international, 82(9), 1018-1023.
<a href="https://doi.org/10.1038/ki.2012.255">https://doi.org/10.1038/ki.2012.255</a>.
\78\ Patzer, R.E., Perryman, J.P., Pastan, S., Amaral, S.,
Gazmararian, J.A., Klein, M., Kutner, N., & McClellan, W.M. (2012).
Impact of a patient education program on disparities in kidney
transplant evaluation. Clinical journal of the American Society of
Nephrology:CJASN, 7(4), 648-655. <a href="https://doi.org/10.2215/CJN.10071011">https://doi.org/10.2215/CJN.10071011</a>.
\79\ Chisholm-Burns, M.A., Spivey, C.A., & Pickett, L.R. (2018).
Health literacy in solid-organ transplantation: a model to improve
understanding. Patient Preference and Adherence, 12, 2325-2338.
<a href="https://doi.org/10.2147/PPA.S183092">https://doi.org/10.2147/PPA.S183092</a>.
\80\ Park, C., Jones, M.-M., Kaplan, S., Koller, F.L., Wilder,
J.M., Boulware, L.E., & McElroy, L.M. (2022). A scoping review of
inequities in access to organ transplant in the United States.
International Journal for Equity in Health, 21(1). <a href="https://doi.org/10.1186/s12939-021-01616-x">https://doi.org/10.1186/s12939-021-01616-x</a>.
\81\ Khalili, M., Cardinal, H., Ballesteros, F., & Fortin, M.
(2022). Kidney transplant candidates' and recipients' perspectives
on the decision[hyphen]making process to accept or refuse a deceased
donor kidney offer: Trust and graft survival matter. Clinical
Transplantation, 36(5). <a href="https://doi.org/10.1111/ctr.14604">https://doi.org/10.1111/ctr.14604</a>.
\82\ Kazley, A.S., Simpson, K.N., Chavin, K.D., & Baliga, P.
(2012). Barriers facing patients referred for kidney transplant
cause loss to follow-up. Kidney international, 82(9), 1018-1023.
<a href="https://doi.org/10.1038/ki.2012.255">https://doi.org/10.1038/ki.2012.255</a>.
\83\ Kayler, L.K., Dolph, B., Ranahan, M., Keller, M., Cadzow,
R., & Feeley, T.H. (2021). Kidney Transplant Evaluation and Listing:
Development and Preliminary Evaluation of Multimedia Education for
Patients. Annals of transplantation, 26, e929839. <a href="https://doi.org/10.12659/AOT.929839">https://doi.org/10.12659/AOT.929839</a>.
\84\ Khalili, M., Cardinal, H., Ballesteros, F., & Fortin, M.
(2022). Kidney transplant candidates' and recipients' perspectives
on the decision-making process to accept or refuse a deceased donor
kidney offer: Trust and graft survival matter. Clinical
Transplantation, 36(5). <a href="https://doi.org/10.1111/ctr.14604">https://doi.org/10.1111/ctr.14604</a>.
\85\ Bergeron, M. (2020). Transplant Center Criteria and
Inequalities Within Transplant Wait Listing Process [Thesis].
<a href="https://stars.library.ucf.edu/etd2020/175/">https://stars.library.ucf.edu/etd2020/175/</a>.
\86\ Klassen, A.C., Hall, A.G., Saksvig, B., Curbow, B., &
Klassen, D.K. (2002). Relationship between patients' perceptions of
disadvantage and discrimination and listing for kidney
transplantation. American journal of public health, 92(5), 811-817.
<a href="https://doi.org/10.2105/ajph.92.5.811">https://doi.org/10.2105/ajph.92.5.811</a>.
\87\ Gillespie, A., Hammer, H., Lee, J., Nnewihe, C., Gordon,
J., & Silva, P. (2011). Lack of listing status awareness: results of
a single-center survey of hemodialysis patients. American journal of
transplantation:official journal of the American Society of
Transplantation and the American Society of Transplant Surgeons,
11(7), 1522-1526. <a href="https://doi.org/10.1111/j.1600-6143.2011.03524x">https://doi.org/10.1111/j.1600-6143.2011.03524x</a>.
\88\ Bergeron, M. (2020). Transplant Center Criteria and
Inequalities Within Transplant Wait Listing Process [Thesis].
<a href="https://stars.library.ucf.edu/etd2020/175/">https://stars.library.ucf.edu/etd2020/175/</a>.
\89\ Trivedi, P., Rosaasen, N., & Mansell, H. (2016). The
Health-Care Provider's Perspective of Education Before Kidney
Transplantation. Progress in transplantation (Aliso Viejo, Calif.),
26(4), 322-327. <a href="https://doi.org/10.1177/1526924816664081">https://doi.org/10.1177/1526924816664081</a>.
\90\ Bergeron, M. (2020). Transplant Center Criteria and
Inequalities Within Transplant Wait Listing Process [Thesis].
<a href="https://stars.library.ucf.edu/etd2020/175/">https://stars.library.ucf.edu/etd2020/175/</a>.
\91\ Crenesse-Cozien, N., Dolph, B., Said, M., Feeley, T.H., &
Kayler, L.K. (2019). Kidney Transplant Evaluation: Inferences from
Qualitative Interviews with African American Patients and their
Providers. Journal of racial and ethnic health disparities, 6(5),
917-925. <a href="https://doi.org/10.1007/s40615-019-00592-x">https://doi.org/10.1007/s40615-019-00592-x</a>.
\92\ Bergeron, M. (2020). Transplant Center Criteria and
Inequalities Within Transplant Wait Listing Process [Thesis].
<a href="https://stars.library.ucf.edu/etd2020/175/">https://stars.library.ucf.edu/etd2020/175/</a>.
\93\ Hughes, A., Malhotra, D., Brennan, D., Seldon, L.,
Carberry, H., Morrison, M., & Hladek, M. (2025). Waitlist management
for inactive status kidney transplant patients: a scoping review.
Annals of Medicine & Surgery, 87(4), 2204-2211. <a href="https://doi.org/10.1097/ms9.0000000000003137">https://doi.org/10.1097/ms9.0000000000003137</a>.
\94\ 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>.
\95\ Grams, M.E., Massie, A.B., Schold, J.D., Chen, B.P., &
Segev, D.L. (2013). Trends in the Inactive Kidney Transplant
Waitlist and Implications for Candidate Survival. American Journal
of Transplantation, 13(4), 1012-1018. <a href="https://doi.org/10.1111/ajt.12143">https://doi.org/10.1111/ajt.12143</a>.
\96\ Stewart, D., Mupfudze, T., & Klassen, D. (2023b). Does
anybody really know what (the kidney median waiting) time is?
American Journal of Transplantation: Official Journal of the
American Society of Transplantation and the American Society of
Transplant Surgeons, 23(2), 223-231. <a href="https://doi.org/10.1016/j.ajt.2022.12.005">https://doi.org/10.1016/j.ajt.2022.12.005</a>.
\97\ Kulkarni, S., Hall, I., Formica, R., Thiessen, C., Stewart,
D., Gan, G., Greene, E., & Deng, Y. (2017). Transition probabilities
between changing sensitization levels, waitlist activity status and
competing-risk kidney transplant outcomes using multi-state
modeling. PLoS ONE, 12(12), e0190277-e0190277. <a href="https://doi.org/10.1371/journal.pone.0190277">https://doi.org/10.1371/journal.pone.0190277</a>.
\98\ Kataria, A., Gowda, M., Lamphron, B.P., Jalal, K., Venuto,
R.C., & Gundroo, A.A. (2019b). The impact of systematic review of
status 7 patients on the kidney transplant waitlist. BMC Nephrology,
20(1). <a href="https://doi.org/10.1186/s12882-019-1362-6">https://doi.org/10.1186/s12882-019-1362-6</a>.
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Furthermore, while a transplant hospital is required to notify
patients when they are first added to or removed from a waitlist, there
is currently no requirement for transplant hospitals to inform patients
on its waitlist when there is a change in waitlist status (that is,
from active to inactive).<SUP>99</SUP> <SUP>100</SUP> It is important
for transplant candidates to be aware of whether they are active or
inactive on the waiting list and to understand that they are only
eligible to receive an organ for transplant while in an active status.
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\99\ UNOS Transplant Living. (n.d.). The kidney transplant
waitlist. UNOS Transplant Living. Retrieved April 5, 2025, from
<a href="https://transplantliving.org/kidney/the-kidney-transplant-waitlist/">https://transplantliving.org/kidney/the-kidney-transplant-waitlist/</a>.
\100\ While there is currently no requirement for transplant
hospitals to inform patients on its waitlist when there is a change
in waitlist status, we acknowledge that the OPTN has recently
proposed such a policy.
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As such, we are proposing to add new requirements at Sec.
512.442(d) for IOTA participants to notify their IOTA waitlist patients
who are Medicare beneficiaries when their waitlist status has changed.
Specifically, we propose, at Sec. 512.442(d)(1)(i), that IOTA
participants must notify their IOTA waitlist patients who are Medicare
beneficiaries any time their status on its waitlist is changed that
would impact their ability to receive an organ offer (that is, from
active to inactive). We seek comment on our proposal to add a change in
waitlist transparency requirement at proposed Sec. 512.442(d)(1)(i).
We considered but did not propose requiring IOTA participants to
also notify their IOTA waitlist patients who are Medicare beneficiaries
whenever
[[Page 57620]]
their status changes from inactive to active in addition to whenever
their waitlist status changes from active to inactive. We believe this
alternative considered would ensure that IOTA waitlist patients who are
Medicare beneficiaries are immediately informed when they regain
eligibility to receive organ offers, which is critical for their
potential access to life-saving transplantation, while enhancing
beneficiary engagement through transparency about significant changes
in transplant eligibility status and guaranteeing consistent, timely
information across all IOTA participants. However, we recognize that
requiring such notifications could impose significant administrative
burden on IOTA participants, particularly IOTA participants with
limited resources, requiring substantial investments in new systems and
staff time that could divert resources from direct patient care.
Additionally, frequent status change notifications might create patient
anxiety and unrealistic expectations about organ offer immediacy,
potentially overwhelming clinical teams and undermining transparency
goals, while standardized requirements may fail to account for diverse
patient populations with varying literacy levels and communication
needs. While we are not proposing to also require IOTA participants to
notify their IOTA waitlist patients who are Medicare beneficiaries
whenever their status from inactive to active, we are seeking public
comment regarding whether the inclusion of a notification whenever
their waitlist status changes from inactive to active in addition to
whenever their waitlist status changes from active to inactive would be
preferable and would not impose additional administrative burden upon
IOTA participants.
We propose at Sec. 512.442(d)(1)(ii) that IOTA participants must
include all of the following in this notification to IOTA waitlist
patients who are Medicare beneficiaries:
The most recent date the IOTA waitlist patient who is a Medicare
beneficiary became inactive.
<bullet> The reason for the change in waitlist status.
<bullet> That the IOTA waitlist patient who is a Medicare
beneficiary cannot receive organ offers while inactive.
<bullet> Information on how the IOTA waitlist patient who is a
Medicare beneficiary may become active on its waitlist again (for
example, updating personal information, providing new clinical data,
addressing insurance issues or other factors such as medical,
psychosocial, and socioeconomic).
<bullet> How the IOTA waitlist patient who is a Medicare
beneficiary may contact the IOTA participant for more information or
with any questions.
We seek public comment on our proposed change in waitlist status
notification requirements at proposed Sec. 512.442(d)(1)(ii). In
addition, we are also interested in comments on whether the proposed
information to include in the change in waitlist status notification
should include additional information.
We propose at Sec. 512.442(d)(1)(iii) that IOTA participants must
provide this notification to the IOTA waitlist patient who is a
Medicare beneficiary--
<bullet> Electronically or by mail;
<bullet> Within 10 days of the IOTA waitlist patient who is a
Medicare beneficiary's change in waitlist status--consistent with the
patient records requirements at Sec. 482.94(c)(2); and
<bullet> Annually, thereafter, for as long as the Medicare
beneficiary remains inactive (that is; 365 consecutive days).
We considered alternative methodologies for implementing this
provision. For example, we considered delaying the implementation of
this provision until PYs 3 or 4, in conjunction with the proposed
transparency into kidney transplant organ offers requirement to share
information about declined kidney transplant organ offers, as described
in section II.B.4.a(3) of this proposed rule. However, we believe that
this proposed requirement would impose less administrative burden on
IOTA participants than the proposed transparency into kidney transplant
organ offers requirement to share information about declined kidney
transplant organ offers, as described in section II.B.4.a(3) of this
proposed rule, and could be implemented at an earlier stage.
We also considered alternative timelines for continued notification
that an IOTA waitlist patient who is a Medicare beneficiary remains
inactive on an IOTA participants waitlist, such as every 60 days, 90
days, or 180 days, but proposed an annual update based on an attempt to
balance utility to the beneficiary with burden on the IOTA
participants. We further considered alternative timelines not
predicated on consecutive days but instead based on inactive status for
at least 75 percent or 90 percent of days during a specified timeline,
rather than reaching 365 consecutive days. We additionally considered
an alternative timeline structured around the point at which an IOTA
waitlist patient who is a Medicare beneficiary is ultimately discharged
from a hospital. We also considered requiring IOTA participants to
inform IOTA waitlist patients who are Medicare beneficiaries about
internal holds; however, we were uncertain regarding the implementation
methodology for this provision.
We seek public comment on our proposed change in waitlist status
delivery method and timeline requirements at proposed Sec.
512.442(d)(1)(iii)). We also seek comment on the alternatives
considered.
We also propose at Sec. 512.442(d)(2) that the IOTA participant
must record in the IOTA waitlist patient who is a Medicare beneficiary
medical record all of the following:
<bullet> A copy of the notification.
<bullet> The method by which the notification was delivered.
<bullet> The date in which the notification was sent.
Additionally, we propose at Sec. 512.442(d)(3) that for IOTA
waitlist patients who are Medicare beneficiaries and--
<bullet> For ESRD patients, the IOTA participant must also notify
the dialysis facility (as defined at 42 CFR 494.10) and managing
clinician (as defined at 42 CFR 512.310) or nephrologist; or
<bullet> For Non-ESRD patients,\101\ the IOTA participant must also
notify the referring provider or practitioner providing care to the
IOTA waitlist patient who is a Medicare beneficiary.
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\101\ A Non-ESRD patient is someone who has healthy kidneys or
chronic kidney disease (CKD) in a less severe form that does not
constitute irreversible kidney failure. These patients do not
require life-sustaining dialysis treatment or an immediate kidney
transplant, and their condition is managed through other medical
treatments. However, non-ESRD patients may still be eligible to get
wait listed for a preemptive kidney transplant before their kidney
function deteriorates to the point of requiring dialysis.
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This notification timeframe conforms with the current timeframe at
Sec. 482.94, however, we solicit public comment on alternative
timeframes that may be appropriate. We expect that IOTA participants
would be expeditious and deliberate in determining an IOTA waitlist
patient who is a Medicare beneficiary's waitlist status and
communicating that information to them, the OPTN, and others as
appropriate. We propose to finalize these requirements only if they are
not redundant with other HHS guidance.
We seek public comment on these proposed documentation requirements
at proposed Sec. 512.442(d)(2) through (3).
We understand that a kidney transplant waitlist patient's condition
or situation may change over time and warrant kidney transplant
hospitals reassessing the kidney transplant waitlist patient to
determine if their waitlist status should be updated.
[[Page 57621]]
However, we believe kidney transplant waitlist patients should be aware
of these situations and the impact it has on their ability to receive
an offer. Additionally, we also believe that ``internal holds,'' which
are a process used by the kidney transplant hospital to temporarily not
consider offers for a kidney transplant waitlist patient, despite the
kidney transplant waitlist patient being listed as active with the OPTN
are detrimental to the efficiency of the organ allocation system and
could lead to increased organ discards by slowing down the allocation
process. At present, there are no national policies mandating that
kidney transplant waitlist patients be notified when they are
designated as inactive, whether due to patient-specific reasons or
after an extended period of inactivity. We believe that this proposed
requirement would establish consistency across all IOTA participants in
informing IOTA waitlist patients who are Medicare beneficiaries about
their inactive waitlist status and are unable to receive organ offers.
As such, we believe that these IOTA waitlist patients who are Medicare
beneficiaries would gain greater awareness of their listing status and
the necessary steps to become eligible to receive an organ for
transplant.
Furthermore, we believe that the proposals in this section would
improve communication between IOTA participants and their IOTA waitlist
patients who are Medicare beneficiaries regarding their waitlist status
and the implications of being inactive on a waitlist. Although these
proposed requirements could create additional work for transplant
coordinators in particular, we believe that they would promote
effective and safe care for persons with organ failure by increasing
IOTA waitlist patients who are Medicare beneficiaries' awareness of
their inactive waitlist status and provide them with the information
required to be proactive in their reactivation. We note that the intent
of these notifications is to prevent IOTA waitlist patients who are
Medicare beneficiaries from being inactive on a waitlist for
unnecessarily extended period of times.
b. Health Equity Plans
In the 2024 Final Rule (89 FR 96407), in response to comments,\102\
we finalized at Sec. 512.446(a) that an IOTA participant may
voluntarily submit a health equity plan for all performance years (PY 1
through PY 6) and in a form and manner and by the date(s) specified by
CMS. We also finalized that a health equity plan voluntarily submitted
by an IOTA participant must include all elements at Sec. 512.446(a)(1)
through (7). We direct readers to the 2024 Final Rule for a full
discussion of this policy, our rationale for this approach, and
alternatives considered (89 FR 96405 through 96407). Lastly, we
proposed and finalized the definitions for ``Health equity goal'',
``Health equity plan'', ``Health equity plan intervention strategy'',
and ``Health equity plan performance measure'' at Sec. 512.402.
---------------------------------------------------------------------------
\102\ Commenters provided mixed opinions to the proposed health
equity plan provisions, with approximately 70 percent expressing
concern that it would be an unfunded administrative burden and would
have unintended consequences. Approximately 10-15 percent of
commenters expressed clear support and 15-20 percent of commenters
neither clearly supported nor opposed but offered suggestions for
improvement.
---------------------------------------------------------------------------
We continue to maintain that understanding and addressing the
health needs of all IOTA waitlist patients and IOTA transplant patients
remains essential to ensuring their benefit through improved access to
the transplantation ecosystem. However, in consideration of the current
Administration's priorities and concerns regarding the imposition of
additional burden on IOTA participants within a mandatory model, we
propose removing the voluntary health equity plan provisions from the
IOTA Model. We recognize that requesting IOTA participants to submit
health equity plans, even on a voluntary basis, could impose an
additional burden on IOTA participants. As such, we believe removing
the voluntary health equity plan provisions from the IOTA Model would
reduce burden on IOTA participants and constitute a more effective
utilization of IOTA participant resources to focus on increasing access
to kidney transplants, which would enhance their performance within the
model and improve the quality of care.
Therefore, in this proposed rule we are proposing to remove the
health equity plan provisions from Sec. 512.446 (a)(1) through (7).
Though currently there is no replacement for these policies, CMS may
consider adding elements that are consistent with the current
Administration's focus on Making America Healthy Again (MAHA) through
future notice and comment rule making. We believe there is an
opportunity through IOTA Model to drive improvements in overall health
by increasing access to kidney transplants. Lastly, given that we are
proposing to remove all healthy equity provisions at Sec. 512.446, we
propose removing the definitions for health equity goal, health equity
plan, health equity plan intervention strategy, and health equity plan
performance measure at Sec. 512.402. We are proposing to remove all
health equity plan provisions at Sec. 512.446 to reduce burdensome
requirements on IOTA participants to allow IOTA participants to focus
their resources on the core objective of the model, increasing access
to kidney transplants, as well as to comply with Executive Order 14151
Ending Radical and Wasteful Government DEI Programs and Preferencing
(90 FR 8339) \103\ issued January 20, 2025. CMS also wants to reiterate
that allocation and transplantation decisions should be made based on
objective and measurable medical criteria through the framework set up
by the OPTN under 42 CFR 121.8 and should not be made on the basis of
race or other criteria not laid out by the goals described in this
section of the CFR.
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\103\ Ending Radical And Wasteful Government DEI Programs And
Preferencing: <a href="https://www.whitehouse.gov/presidential-actions/2025/01/ending-radical-and-wasteful-government-dei-programs-and-preferencing/">https://www.whitehouse.gov/presidential-actions/2025/01/ending-radical-and-wasteful-government-dei-programs-and-preferencing/</a>.
---------------------------------------------------------------------------
We seek comment on our proposal to remove health equity plans from
the IOTA Model and remove the corresponding regulations at Sec.
512.446. We also seek comment on our proposal at Sec. 512.402 to
remove the definitions of health equity goals, health equity plan
intervention, health equity plan performance measure(s), health equity
project plan, resource gap analysis, target health disparities, and
underserved communities.
5. Beneficiary Protections
a. Background
In the 2024 Final Rule (89 FR 96413), we finalized that IOTA
participants must provide notice to attributed patients that they are
participating in the IOTA Model as described in Sec. 512.450(a)(1).
However, CMS only has the authority to place requirements upon
notifications to Medicare beneficiaries. As such, this notice should
have been limited to Medicare beneficiaries. Therefore, we propose to
update the policy at Sec. 512.450(a)(1) to limit these notification
requirements to Medicare beneficiaries only.
We seek comment on our proposal at proposed Sec. 512.450(a)(1) to
limit the notification requirement to Medicare beneficiaries.
b. Beneficiary Notifications
In the 2024 Final Rule (89 FR 96413), we finalized that in order to
notify attributed patients of their rights and protections, and that
the IOTA participant is participating in the IOTA
[[Page 57622]]
Model, the IOTA participant needed to provide an approved beneficiary
notification template to each attributed patient in a paper format as
described in Sec. 512.450(a)(3)(iii).
Since then, we have received feedback from IOTA participants that
the main form of communication with their patients is through
electronic means, often a patient portal where the patients receive all
communication from the IOTA participant. We propose at Sec.
512.450(a)(3)(iii)(A) and (B) allowing IOTA participants to distribute
the paper copy of this notification to applicable attributed patients
at their first office visit or other outpatient visit with the
attributed patient after the start of the Model or, if the attributed
patient has affirmatively opted out of receiving paper communication
and has chosen to receive communication through electronic methods,
this notification can be distributed through that agreed upon
electronic method.
We seek comment on our proposal at proposed Sec.
512.450(a)(3)(iii)(A) and (B) to allow IOTA participants to distribute
this paper notification at the first in office or outpatient visit, or
to distribute the notification in an electronic format in cases where
the attributed patient has affirmatively opted out of receiving paper
communications.
6. Monitoring
In the 2024 Final Rule (89 FR 96430), we finalized a list of
monitoring activities to ensure compliance and promote the safety of
attributed patients and the integrity of the IOTA Model as described in
Sec. 512.462(b)(2). Monitoring activities include documentation
requests including surveys and questionnaires, audits of claims data,
quality measures, medical records, interviews, site visits, monitoring
attributed patient engagement incentives, monitoring out of sequence
allocation, etc. However, we inadvertently omitted monitoring of the
transparency requirements specified in Sec. 512.442. These include:
<bullet> Publicly posting selection criteria in accordance with
Sec. 512.442(a);
<bullet> Informing eligible IOTA waitlist beneficiaries, as defined
in section II.B.4.a(3) of this proposed rule, of the number of times an
organ is declined on the Medicare beneficiary's behalf in accordance
with proposed Sec. 512.442(b);
<bullet> Reviewing selection criteria with IOTA waitlist patients
who are Medicare beneficiaries at least once every 6 months that the
Medicare beneficiary is on their waitlist as specified in Sec.
512.442(c); and,
<bullet> Notifying IOTA waitlist patients who are Medicare
beneficiaries when their waitlist status has changed from active to
inactive in accordance with proposed Sec. 512.442(d). Therefore, we
propose a
[…truncated; see source link]Indexed from Federal Register on December 11, 2025.
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