total number of Program-eligible beneficiaries 
assigned to or who elect an ESRD Fee-For- 
Service Integrated Care Model offered by the 
Organization opt out of the Program. 
‘‘(B) OPPORTUNITY FOR CORRECTIVE AC-
TION PLAN AND APPEAL.— 
‘‘(i) IN
GENERAL.—Prior to sus-
pending assignment to or an election of an 
ESRD Fee-For-Service Integrated Care 
Model offered by an Organization or termi-
nating an agreement under this section, 
the Secretary shall afford an Organization 
sufficient opportunity to remedy any defi-
ciencies in complying with any Program re-
quirements under this section by imple-
menting a corrective action plan. Any cor-
rective action plan implemented under this 
subparagraph shall specify a date by which 
the Organization shall resolve such defi-
ciencies and shall remain in effect until 
such time that the Secretary confirms that 
the Organization has achieved compliance. 
‘‘(ii) IMPOSITION OF AGREEMENT SUS-
PENSION OR TERMINATION.—In the case 
of an Organization that fails to achieve 
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compliance by the date specified in correc-
tive action plan, subject to clause (iii) and 
depending on the severity of a compliance 
deficiency, the Secretary in a manner con-
sistent with processes established under 
part C of this title may— 
‘‘(I) 
suspend 
Program-eligible 
beneficiaries’ assignments to or an 
election of an ESRD Fee-For-Service 
Integrated Care Model offered by an 
Organization; or 
‘‘(II) terminate an agreement 
with an Organization under this sec-
tion. 
‘‘(iii) IMMEDIATE AGREEMENT TERMI-
NATION FOR VIOLATING THE PROHIBITION 
ON
DISCRIMINATION.—Notwithstanding 
the corrective action plan process estab-
lished under clause (i), the Secretary may, 
in addition to the circumstances under 
which a contract under part C may be im-
mediately terminated, immediately termi-
nate an agreement under this section with 
an Organization if the Secretary— 
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‘‘(I) notifies the Organization of 
the intent to investigate allegations of 
systematic activities with the intent of 
violating the prohibition on discrimi-
nation established under subsection 
(b)(3)(B)(ii); 
‘‘(II) 
determines, 
after 
con-
ducting a rigorous analysis of all 
available data based on a sufficient 
sample size, that the Organization en-
gaged in systematic activities with the 
intent of violating the prohibition on 
discrimination established in sub-
section (b)(3)(B)(ii); and 
‘‘(III) discloses credible evidence 
to the Organization regarding a deter-
mination made under subclause (II). 
‘‘(iv) RECOVERY
OF
MONTHLY
PRO-
SPECTIVE PAYMENTS.—The Secretary may 
recover the prorated share of any monthly 
prospective payments described in sub-
section (e) covering the period of the 
month following an agreement termination 
if such agreement termination is effective 
in the middle of a calendar month. 
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‘‘(v) NOTIFICATION OF PROGRAM-ELI-
GIBLE
BENEFICIARY
UPON
AGREEMENT 
TERMINATION.—Each 
agreement 
under 
this section between the Secretary and an 
Organization shall require the Organiza-
tion to provide and pay for written notice 
in advance of an agreement’s termination, 
as well as a description of alternatives for 
obtaining benefits under this title, in a 
manner consistent with beneficiary notifi-
cation requirements in the event of a con-
tract termination under part C. 
‘‘(6) PROGRAM
EVALUATION.—The Secretary 
shall conduct an evaluation of the Program under 
this section to inform a determination regarding a 
Program expansion under paragraph (7). Such eval-
uation shall include an analysis of— 
‘‘(A) the quality of care furnished under 
the Program, including the measurement of pa-
tient-level outcomes and patient experience and 
patient-reported outcome measures determined 
appropriate by the Secretary; and 
‘‘(B) the changes in spending under parts 
A and B by reason of the Program. 
‘‘(7) PROGRAM EXPANSION.— 
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‘‘(A) IN
GENERAL.—The Secretary may, 
through rulemaking, expand the duration and 
scope of the Program under this section, to the 
extent determined appropriate by the Secretary, 
if— 
‘‘(i) the Secretary determines that 
such expansion is expected to— 
‘‘(I) reduce spending under this 
title without reducing the quality of 
patient care; or 
‘‘(II) improve the quality of pa-
tient care without increasing spending 
under this title; 
‘‘(ii) the Chief Actuary of the Centers 
for Medicare & Medicaid Services certifies 
that such expansion would reduce (or 
would not result in any increase in) net 
program spending under this title; and 
‘‘(iii) the Secretary determines that 
such expansion would not deny or limit the 
coverage or provision of benefits under this 
title for applicable individuals. 
‘‘(B) ENSURING PROGRAM CONTINUITY.— 
The Secretary shall implement any Program ex-
pansion made in accordance with this para-
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graph in a manner that ensures that Program- 
eligible beneficiaries and Organizations with an 
agreement under this section do not experience 
any disruptions in the Program. 
‘‘(8) PART D DATA SHARING ARRANGEMENT.— 
The Secretary on a monthly basis shall, in accord-
ance with the regulations promulgated under section 
264(c) of the Health Insurance Portability and Ac-
countability Act of 1996, provide access to Organiza-
tions to part D data claims that include part D data 
on Program-eligible beneficiaries assigned to or an 
election of an ESRD Fee-For-Service Integrated 
Care Model offered by an Organization unless a Pro-
gram-eligible beneficiary opts out of such data shar-
ing. 
‘‘(9) FUNDING.—The Secretary shall allocate 
funds made available under section 1115A(f)(1) to 
implement and evaluate the demonstration program 
established under this section. 
‘‘(d) IDENTIFICATION
AND ASSIGNMENT
OF PRO-
GRAM-ELIGIBLE BENEFICIARIES.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish a process for the initial and ongoing identifica-
tion of Program-eligible beneficiaries. 
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‘‘(2) 
ASSIGNMENT
OF
PROGRAM-ELIGIBLE 
BENEFICIARIES TO AN ORGANIZATION’S ESRD FEE- 
FOR-SERVICE INTEGRATED CARE MODEL.— 
‘‘(A) IN GENERAL.—Under the Program, 
the Secretary shall assign all Program-eligible 
beneficiaries to an ESRD Fee-For-Service Inte-
grated Care Model offered by an Organization 
that includes the dialysis facility at which the 
Program-eligible beneficiary primarily receives 
renal dialysis services. 
‘‘(B) OPT-OUT
PERIOD
AND
CHANGES 
UPON
INITIAL
ASSIGNMENT
OR
ELECTION.— 
The Secretary shall provide for a 90-day period 
beginning on the date on which the assignment 
of or election made by a Program-eligible bene-
ficiary into an ESRD Fee-For-Service Inte-
grated Care Model offered by an Organization 
becomes effective during which a Program-eligi-
ble beneficiary may— 
‘‘(i) opt out of the Program; or 
‘‘(ii) make a one-time change of as-
signment or election into an ESRD Fee- 
For-Service Integrated Care Model offered 
by a different Organization. 
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‘‘(C) DEEMED
RE-ASSIGNMENT
AND
RE- 
ELECTION.—The Secretary shall establish a 
process through which a Program-eligible bene-
ficiary assigned to or who elects an ESRD Fee- 
For-Service Integrated Care Model offered by 
an Organization with respect to a year is 
deemed, unless the Program-eligible beneficiary 
otherwise changes such assignment or election 
under this paragraph, to have elected to con-
tinue such assignment or election with respect 
to the subsequent year. 
‘‘(D) ANNUAL OPPORTUNITY TO OPT OUT 
OR
ELECT
AN
ESRD
FEE-FOR-SERVICE
INTE-
GRATED
CARE
MODEL
OFFERED
BY
A
DIF-
FERENT ORGANIZATION.— 
‘‘(i) IN GENERAL.—Annually, a Pro-
gram-eligible beneficiary shall be given a 
90-day period to— 
‘‘(I) opt out of the Program; or 
‘‘(II) make a one-time change of 
assignment or election into an ESRD 
Fee-For-Service 
Integrated 
Care 
Model offered by a different Organiza-
tion. 
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‘‘(ii) ALIGNMENT WITH MEDICARE AD-
VANTAGE
OPEN
ENROLLMENT
PERIOD.— 
To the extent practicable, the Secretary 
shall align the annual 90-day period de-
scribed in clause (i) with the Medicare Ad-
vantage open enrollment period. 
‘‘(E) OPT OUT FOR CHANGE IN PRINCIPAL 
DIAGNOSIS
OR
ENTERING
HOME
DIALYSIS 
TREATMENT.—In addition to any other period 
during which a Program-eligible beneficiary 
may, pursuant to this paragraph, opt out of the 
Program, in the case of a Program-eligible ben-
eficiary who, after assignment under this para-
graph, is diagnosed with a principal diagnosis 
(as defined by the Secretary) other than end- 
stage renal disease or enters into home dialysis 
treatment, such individual shall be given the op-
portunity to opt out of the Program during 
such period as specified by the Secretary. 
‘‘(3) PROGRAM-ELIGIBLE BENEFICIARY NOTIFI-
CATION.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
ensure that an Organization notifies Program- 
eligible beneficiaries about the Program under 
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this section and provides them with materials 
explaining the Program, including— 
‘‘(i) information about receiving bene-
fits under this title through such Organiza-
tion; and 
‘‘(ii) an explanation that they retain 
the right to receive care from any Medicare 
provider. 
‘‘(B) TIMING OF NOTIFICATION.—Upon as-
signment to or election of an ESRD Fee-For- 
Service Integrated Care Model offered by an 
Organization, the Secretary shall provide the 
Organization written notification confirming the 
beneficiary’s assignment or election and not 
later than 15 business days after the date of re-
ceipt of such notification, the Organization shall 
provide written notice to the Program-eligible 
beneficiary of such assignment or election. 
‘‘(C) CONTENT
OF
WRITTEN
NOTICE.— 
Subject to subparagraph (D), such notification 
shall— 
‘‘(i) inform Program-eligible bene-
ficiaries about the Program using an infor-
mation guide developed by the Organiza-
tion and approved by the Secretary; 
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‘‘(ii) include the distribution of other 
Program materials developed by the Orga-
nization and approved by the Secretary; 
‘‘(iii) inform Program-eligible bene-
ficiaries about the importance of transplan-
tation as the best outcome, as well as min-
imum requirements for transplant eligi-
bility before and during dialysis treatment; 
and 
‘‘(iv) provide contact information for 
representatives of the Organization to re-
spond to Program-eligible beneficiaries’ 
questions. 
‘‘(D) LIMITATION ON UNSOLICITED NOTI-
FICATION.— 
‘‘(i) IN
GENERAL.—Under the Pro-
gram, no person or entity (other than the 
Secretary, an employee of the Secretary, or 
an employee or volunteer of a federally au-
thorized State Health Insurance Assistance 
Program (SHIP)), subject to clause (ii), 
may provide any information about the 
Program, including information, materials, 
and assistance described in subparagraph 
(B), to a Program-eligible beneficiary un-
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less such Program-eligible beneficiary re-
quests such information, materials, or as-
sistance. 
‘‘(ii) EXCEPTION
FOR
PROVIDERS 
TREATING
BENEFICIARIES.—An 
eligible 
participating provider that is part of an 
Organization may provide information, ma-
terials, and assistance described in sub-
paragraph (B) to a Program-eligible bene-
ficiary, without prior request of such bene-
ficiary, if such beneficiary is receiving 
renal dialysis services from a facility that 
participates in such Organization. 
‘‘(iii) PARITY
IN
NOTIFICATION.—In 
the case that an eligible participating pro-
vider that is part of an Organization par-
ticipates 
in 
notifying 
Program-eligible 
beneficiaries about the Program under this 
subparagraph, such notification shall be 
provided in the same manner to all Pro-
gram-eligible beneficiaries to which, pursu-
ant to clause (ii), such eligible partici-
pating provider may provide information, 
materials, and assistance described in such 
clause. 
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‘‘(E) 
PROGRAM-ELIGIBLE
BENEFICIARY 
GRIEVANCE AND APPEAL RIGHTS.—Program-el-
igible beneficiaries participating in the Program 
under this section shall have grievance and ap-
peal rights and procedures consistent with those 
rights and procedures established under sub-
sections (f) and (g) of section 1852. 
‘‘(e) ESRD FEE-FOR-SERVICE INTEGRATED CARE 
PROGRAM MONTHLY PAYMENT AND CLAIMS PROCESSING 
MECHANISM.— 
‘‘(1) IN GENERAL.—For each Program-eligible 
beneficiary receiving care through an Organization, 
the Secretary shall make a monthly prospective pay-
ment in accordance with payment rates that would 
be determined under section 1853(a)(1)(H). 
‘‘(2) APPLICATION
OF
HEALTH
STATUS
RISK 
ADJUSTMENT METHODOLOGY.—The Secretary shall 
adjust the monthly prospective payment to an Orga-
nization under this subsection in the same manner 
in which the payment amount to a Medicare Advan-
tage plan is adjusted under section 1853(a)(1)(C). 
‘‘(3) TREATMENT OF AND PAYMENT FOR KID-
NEY ACQUISITION COSTS.— 
‘‘(A) EXCLUDING COSTS FOR KIDNEY AC-
QUISITIONS FROM MA BENCHMARK.—The Sec-
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retary shall adjust the payment amount to an 
Organization to exclude from such payment 
amount the Secretary’s estimate of the stand-
ardized costs for payments for organ acquisi-
tions for kidney transplants in the area involved 
for the year. 
‘‘(B) FFS TREATMENT OF AND PAYMENT 
FOR KIDNEY ACQUISITIONS.—An Organization 
shall provide all benefits described in subsection 
(b)(2)(A)(i), except for kidney acquisition costs. 
Payment for kidney acquisition costs covered 
under this title furnished to a Program-eligible 
beneficiary shall be made in accordance with 
this title and in such amounts as would other-
wise be made and determined for such items 
and services provided to such a beneficiary not 
participating in the Program under this section. 
‘‘(4) TREATMENT OF AND PAYMENT FOR HOS-
PICE CARE.— 
‘‘(A) IN GENERAL.—An agreement under 
this section shall require an Organization to in-
form each Program-eligible beneficiary who is 
assigned to or elects an ESRD Fee-For-Service 
Integrated Care Model offered by the Organiza-
tion about the availability of hospice care if— 
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‘‘(i) a hospice program participating 
under this title is located within the Orga-
nization’s service area; or 
‘‘(ii) it is common practice to refer pa-
tients to hospice programs outside such 
service area. 
‘‘(B) PAYMENT.—If a Program-eligible 
beneficiary who is assigned to or elects an 
ESRD Fee-For-Service Integrated Care Model 
offered by an Organization with an agreement 
under this section makes an election under sec-
tion 1812(d)(1) to receive hospice care from a 
particular hospice program— 
‘‘(i) payment for the care furnished to 
the Program-eligible beneficiary shall be 
made by the Secretary to the hospice pro-
gram elected by the Program-eligible bene-
ficiary; 
‘‘(ii) payment for other services for 
which the Program-eligible beneficiary in-
dividual is eligible notwithstanding the 
Program-eligible beneficiary’s election of 
hospice care under section 1812(d)(1), in-
cluding services not related to the Pro-
gram-eligible beneficiary’s terminal illness, 
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shall be made by the Secretary to the Or-
ganization or the provider or supplier of 
the service instead of the monthly prospec-
tive payment determined under subsection 
(f); and 
‘‘(iii) the Secretary shall continue to 
make monthly payments to the Organiza-
tion in an amount equal to the value of 
benefits and services determined under 
subsection (b)(2)(A)(ii)(IV). 
‘‘(5) APPLICATION OF CMI CLAIMS PROCESSING 
FRAMEWORK.— 
‘‘(A) IN GENERAL.—Under the Program, 
the Secretary shall apply a claims processing 
framework based on those that the Center for 
Medicare and Medicaid Innovation applies 
under various direct contracting models under 
section 1115A such that— 
‘‘(i) providers of services and suppliers 
serving Program-eligible beneficiaries con-
tinue to submit claims to a medicare ad-
ministrative contractor; 
‘‘(ii) the Secretary forwards claims to 
the Organization for payment; and 
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‘‘(iii) the Organization pays providers 
of services and suppliers an amount equal 
to the amount that they would otherwise 
receive under the original Medicare Fee- 
For-Service program plus any additional 
amount to which the provider may be eligi-
ble under subsection (b)(2)(A)(v) of this 
section. 
‘‘(B) APPLICATION OF BALANCE BILLING 
LIMITATIONS.—Section 1852(a)(2)(A) (relating 
to payments made by an MA organization to a 
non-contract provider of services), section 
1852(k)(1) (relating to limitations on balance 
billing), and section 1866(a)(1)(o) (relating to 
payments made by an MA organization to a 
non-contract supplier) shall apply to the Pro-
gram. 
‘‘(C) PAYMENTS FOR GRADUATE MEDICAL 
EDUCATION.—Section 1886(d)(11) and section 
1886(h)(3)(D) (relating to payments for grad-
uate medical education) shall apply to Organi-
zations and providers of services under the Pro-
gram. 
‘‘(6) NO EFFECT ON MA ESRD RATE SETTING 
OR RISK ADJUSTMENT MODEL.—To ensure the in-
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tegrity of the Medicare Advantage end stage renal 
disease rate setting process and risk adjustment fac-
tors applied to Medicare Advantage end stage renal 
disease rates, claims paid on behalf of Program-eligi-
ble beneficiaries shall not be included in neither the 
determination of such rates nor the development of 
such risk adjustment factors. 
‘‘(7) AGREEMENT BETWEEN A STATE AND OR-
GANIZATION FOR MEDICAID BENEFITS.—In the case 
that a State and Organization enter into a mutual 
agreement under which the Organization coordinates 
benefits under title XIX for Program-eligible bene-
ficiaries eligible for benefits under this title and title 
XIX such mutual agreement shall specify the pay-
ment from the State for providing or arranging for 
the provision of such benefits. 
‘‘(8) AFFIRMATION OF STATE OBLIGATIONS TO 
PAY
PREMIUM
AND
COST-SHARING
AMOUNTS.—A 
State shall continue to make medical assistance 
under the State plan under title XIX available for 
the duration of the Program for Medicare cost-shar-
ing (as defined in section 1905(p)(3)) under this 
title for qualified Medicare beneficiaries described in 
section 1905(p)(1) and other individuals who are 
Program-eligible beneficiaries assigned to or who 
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elect an Organization and entitled to medical assist-
ance for premiums and such cost-sharing under the 
State plan under title XIX in an amount equal to 
the amount of medical assistance that would be 
made available by such State if such Program-eligi-
ble beneficiaries were not participating in the Pro-
gram under this section. 
‘‘(f) WAIVER AUTHORITY.— 
‘‘(1) IN GENERAL.—The Secretary shall waive 
those requirements waived under section 1899 deter-
mined by the Secretary to be relevant and necessary 
for the operation of the Program under this section 
and may waive, as necessary, such additional re-
quirements that have been or may be waived based 
on authority established under section 1115A for 
purposes of models tested by the Centers for Medi-
care and Medicaid Innovation in order to carry out 
the Program under this section. 
‘‘(2) NOTICE OF WAIVERS.—Not later than 3 
months after the date of enactment of this section, 
the Secretary shall publish a notice of waivers that 
will apply in connection with the Program. The no-
tice shall include the specific conditions that an Or-
ganization must meet to qualify for each waiver, and 
commentary explaining the waiver requirements. 
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‘‘(g) REPORT.—Not later than December 31, 2025, 
the Medicare Payment Advisory Commission shall submit 
to Congress an interim report on the Program.’’. 
(b) RULES OF CONSTRUCTION.— 
(1) USE OF MEDICARE SUPPLEMENTAL POLICY 
UNDER
AN
ESRD
FEE-FOR-SERVICE
INTEGRATED 
CARE
MODEL.—Nothing in the provisions of, or 
amendments made by, this Act shall be construed to 
prevent a Program-eligible beneficiary assigned to, 
or who elects, an ESRD Fee-For-Service Integrated 
Care Model offered by an Organization with an 
agreement under this section from enrolling in or 
continuing enrollment in a medicare supplemental 
policy available to such Program-eligible beneficiary 
or receiving benefits under such medicare supple-
mental policy throughout the duration of the Pro-
gram-eligible beneficiary’s participation in an ESRD 
Fee-For-Service Integrated Care model offered by an 
Organizations with an agreement under this section. 
(2) APPLICATION OF STATE RULES REGARDING 
ISSUANCE OF MEDICARE SUPPLEMENTAL POLICIES 
TO INDIVIDUAL UNDER AGE 65.—Nothing in the pro-
visions of, or amendments made by, this Act shall be 
construed to establish a Federal requirement on an 
issuer of a medicare supplemental policy to offer 
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such medicare supplemental policy to individuals 
under age 65. 
(3) CONTINUED
AVAILABILITY
OF
MEDICARE 
SUPPLEMENTAL POLICIES TO INDIVIDUALS UNDER 
AGE 65.—Nothing in the provisions of, or amend-
ments made by, this Act shall be construed to affect 
a State’s authority to require an issuer of a medi-
care supplemental policy to offer such medicare sup-
plemental policy to individual. 
(c) GAO STUDY AND REPORT ON PAYMENT ADE-
QUACY FOR PEDIATRIC ESRD SERVICES.— 
(1) STUDY ON PAYMENT FOR PEDIATRIC ESRD 
SERVICES.—The Comptroller General of the United 
States shall conduct a study to examine the accuracy 
of pediatric data reported to the Centers for Medi-
care & Medicaid Services as part of the ESRD pro-
spective payment system. The study shall evaluate 
whether the organizations described in section 
1866G of the Social Security Act, as added by sub-
section (a), and the existing prospective payment 
system accurately capture and reimburse costs of pe-
diatric dialysis care and include an analysis of the 
following factors that influence such costs: 
(A) Increased acuity of nursing care com-
pared to adult dialysis patients, especially for 
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smaller and younger pediatric hemodialysis pa-
tients. 
(B) Need for developmental and behavioral 
specialists, including child life specialists. 
(C) Need for more frequent assessment by 
pediatric dieticians to adjust formulas and diet 
for the specialized growth and nutrition require-
ments of children treated with dialysis. 
(D) Need for social workers, school liai-
sons, and other trained individuals designated 
to help families navigate challenging psycho-
social situations and to coordinate with schools 
to ensure school attendance and optimize school 
performance among pediatric dialysis patients. 
(E) Need for a broader array of dialysis 
supplies, including different-sized dialyzers, tub-
ing, and peritoneal fluid bags to accommodate 
care provided infants through young adults. 
(2) REPORT.—Not later than 18 months after 
the date of the enactment of this Act, the Comp-
troller General shall submit to Congress a report 
containing the results of the study conducted under 
paragraph (1), together with recommendations for 
such legislation and administrative action as the 
Comptroller General determines appropriate. 
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(d) GAO STUDY AND REPORT ON THE IMPACT OF 
RACE-BASED CORRECTION OF EGFR ON REFERRAL OF 
ESRD PATIENTS FOR TRANSPLANT EVALUATION.— 
(1) STUDY ON IMPACT OF RACE-BASED COR-
RECTION
OF
EGFR
ON
REFERRAL
OF
ESRD
PA-
TIENTS
FOR
TRANSPLANT
EVALUATION.—The 
Comptroller General of the United States shall con-
duct a study to examine the impact of race-based 
correction of the estimated glomerular filtration rate 
(referred to in this subsection as ‘‘eGFR’’) on the 
referral of ESRD patients for transplant evaluation. 
(2) REPORT.—Not later than 18 months after 
the date of enactment of this Act, the Comptroller 
General shall submit to Congress a report containing 
the results of the study conducted under paragraph 
(1), together with recommendations for such legisla-
tion and administrative action as the Comptroller 
General determines appropriate. 
Æ 
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