by noncontract providers of services 
and 
suppliers, 
see 
section 
1866(a)(1)(O). 
‘‘(C) QUALITY AND REPORTING REQUIRE-
MENTS.— 
‘‘(i) CLINICAL MEASURES.—Under the 
Program, the Secretary shall— 
‘‘(I) require each participating 
Organization to submit to the Sec-
retary data on clinical measures con-
sistent with those measures submitted 
by organizations participating in the 
Comprehensive ESRD Care Initiative 
operated by the Center for Medicare 
and Medicaid Innovation as of Octo-
ber 1, 2016, to assess the quality of 
care provided; 
‘‘(II) establish requirements for 
participating Organizations to report 
to the Secretary, in a form and man-
ner specified by the Secretary, infor-
mation on such measures; and 
‘‘(III) establish quality perform-
ance standards on such measures to 
assess the quality of care. 
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‘‘(ii) 
REQUIREMENT
FOR
STAKE-
HOLDER
INPUT.—In developing require-
ments and standards under subclauses (II) 
and (III) of clause (i), the Secretary shall 
request and consider input from a stake-
holder board, at least one nephrologist, 
other suppliers and providers of services, 
renal dialysis facilities, and beneficiary ad-
vocates. 
‘‘(iii) ADDITIONAL ASSESSMENTS AND 
REPORTING
REQUIREMENTS.—The 
Sec-
retary shall assess the extent to which an 
Organization delivers integrated and pa-
tient-centered care through analysis of in-
formation obtained from Program-eligible 
beneficiaries enrolled in the Organization 
through surveys, such as the In-Center 
Hemodialysis Consumer Assessment of 
Healthcare Providers and Systems. 
‘‘(D) REQUIREMENTS
FOR
ESRD
INTE-
GRATED CARE STRATEGY.— 
‘‘(i) IN
GENERAL.—An Organization 
seeking a contract under this section to 
offer one or more ESRD Integrated Care 
Models must develop and submit for the 
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Secretary’s approval, subject to clauses (ii) 
and (iii), an ESRD Integrated Care Strat-
egy. 
‘‘(ii) 
ESRD 
INTEGRATED
CARE 
STRATEGY.—In assessing an ESRD Inte-
grated Care Strategy under clause (i), the 
Secretary shall consider the extent to 
which the Strategy includes elements, such 
as the following: 
‘‘(I) Interdisciplinary care teams 
led by at least one nephrologist, and 
comprised of registered nurses, social 
workers, renal dialysis facility man-
agers, and other representatives from 
alternative settings described in sub-
clause (VIII). 
‘‘(II) A decision process for care 
plans and care management that in-
cludes the nephrologist and other 
practitioners responsible for direct de-
livery of care to Program-eligible 
beneficiaries enrolled in the Organiza-
tion involved. 
‘‘(III) Health risk and other as-
sessments to determine the physical, 
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psychosocial, nutrition, language, cul-
tural, and other needs of Program-eli-
gible beneficiaries enrolled in the Or-
ganization involved. 
‘‘(IV) Development and at least 
annual updating of individualized care 
plans that incorporate at least the 
medical, social, and functional needs, 
preferences, and care goals of Pro-
gram-eligible beneficiaries enrolled in 
the Organization. 
‘‘(V) Coordination and delivery of 
non-clinical services, such as transpor-
tation, aimed at improving the adher-
ence of Program-eligible beneficiaries 
enrolled in the Organization with care 
recommendations. 
‘‘(VI) Services, such as trans-
plant evaluation, palliative care, eval-
uation for hospice eligibility, and vas-
cular access care. 
‘‘(VII) In the case of an indi-
vidual who, while enrolled in the Or-
ganization, receives confirmation that 
a kidney transplant is imminent, the 
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provision by an interdisciplinary care 
team described in subclause (I) of 
counseling services to such individual 
on preparation for and potential chal-
lenges surrounding such transplant. 
‘‘(VIII) Delivery of benefits and 
services in alternative settings, such 
as the home of the Program-eligible 
beneficiary enrolled in the Organiza-
tion, in coordination with the provider 
or other appropriate stakeholder in-
volved in such delivery serving on an 
interdisciplinary care team described 
in subclause (I). 
‘‘(IX) Use of patient reminder 
systems. 
‘‘(X) Education programs for pa-
tients, families, and caregivers. 
‘‘(XI) Use of health care advice 
resources, such as nurse advice lines. 
‘‘(XII) Use of team-based health 
care delivery models that provide com-
prehensive and continuous medical 
care, such as medical homes. 
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‘‘(XIII) Co-location of providers 
and services. 
‘‘(XIV) Use of a demonstrated 
capacity to share electronic health 
record information across sites of 
care. 
‘‘(XV) Use of programs to pro-
mote 
better 
adherence 
to 
rec-
ommended treatment regimens by in-
dividuals, including by addressing bar-
riers to access to care by such individ-
uals. 
‘‘(XVI) Defined protocols to fa-
cilitate the transition of pediatric pa-
tients into adult end stage renal dis-
ease care, developed in conjunction 
with the pediatric nephrology commu-
nity. 
‘‘(XVII) Other services, strate-
gies, and approaches identified by the 
Organization to improve care coordi-
nation and delivery. 
‘‘(iii) 
REQUIREMENTS.—The 
Sec-
retary may not approve an ESRD Inte-
grated Care Strategy of an Organization 
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