zations, and physicians and other en-
tities referred to in such section. 
‘‘(II) REFERENCE
FOR
ADDI-
TIONAL
PROVISION.—For the provi-
sion relating to limitations on balance 
billing against Organizations for serv-
ices covered under this title furnished 
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; 
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‘‘(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. 
‘‘(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, and respond in writing to such 
input. 
‘‘(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 
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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 
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 (VI). 
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‘‘(II) Health risk and other as-
sessments to determine the physical, 
psychosocial, nutrition, language, cul-
tural, and other needs of Program-eli-
gible beneficiaries enrolled in the Or-
ganization involved. 
‘‘(III) 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. 
‘‘(IV) Coordination and delivery 
of non-clinical services, such as trans-
portation, aimed at improving the ad-
herence of Program-eligible bene-
ficiaries enrolled in the Organization 
with care recommendations. 
‘‘(V) Services, such as transplant 
evaluation and vascular access care. 
‘‘(VI) In the case of an individual 
who, while enrolled in the Organiza-
tion, receives confirmation that a kid-
ney transplant is imminent, the provi-
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sion by an interdisciplinary care team 
described in subclause (I) of coun-
seling services to such individual on 
preparation for and potential chal-
lenges surrounding such transplant. 
‘‘(VII) 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). 
‘‘(VIII) Use of patient reminder 
systems. 
‘‘(IX) Education programs for 
patients, families, and caregivers. 
‘‘(X) Use of health care advice 
resources, such as nurse advice lines. 
‘‘(XI) Use of team-based health 
care delivery models that provide com-
prehensive and continuous medical 
care, such as medical homes. 
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‘‘(XII) Co-location of providers 
and services. 
‘‘(XIII) Use of a demonstrated 
capacity to share electronic health 
record information across sites of 
care. 
‘‘(XIV) 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. 
‘‘(XV) Other services, strategies, 
and approaches identified by the Or-
ganization to improve care coordina-
tion and delivery. 
‘‘(iii) 
REQUIREMENTS.—The 
Sec-
retary may not approve an ESRD Inte-
grated Care Strategy of an Organization 
unless under such Strategy the Organiza-
tion— 
‘‘(I) provides services to Pro-
gram-eligible beneficiaries enrolled in 
the Organization through a com-
prehensive, multidisciplinary health 
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and social services delivery system 
which integrates acute and long-term 
care services pursuant to regulations; 
and 
‘‘(II) specifies the covered items 
and services that will not be provided 
directly by the Organization, and to 
arrange for delivery of those items 
and services through contracts meet-
ing the requirements of regulations. 
‘‘(3) REQUIREMENT FOR CAPITAL RESERVES.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
enter into contracts under this section only with 
Organizations that demonstrate sufficient cap-
ital reserves, measured as a percentage of 
capitated payments and consistent with require-
ments established by the State in which the Or-
ganization operates. 
‘‘(B) ALTERNATIVE MECHANISM TO DEM-
ONSTRATE CAPACITY TO BEAR RISK.—An Orga-
nization shall be considered to meet the require-
ment in subparagraph (A) if the Organization 
includes at least one eligible participating pro-
vider or eligible participating partner that— 
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‘‘(i) is licensed as a risk-bearing entity 
or deemed by a State as able to bear risk; 
and 
‘‘(ii) chooses to bear risk as a condi-
tion of partnership in such Organization. 
‘‘(4) BENEFICIARY PROTECTIONS.— 
‘‘(A) CONTINUITY OF CARE.—To provide 
for continuity of care, each contract entered 
into with an Organization under this section 
shall provide for a transition period during 
which a Program-eligible beneficiary who is 
first enrolled in the Organization or who elects 
to opt out of the Program or otherwise disenroll 
from the Organization maintains access to eligi-
ble participating providers furnishing items or 
services to such beneficiary immediately before 
such enrollment or election for purposes of re-
ceipt of such items or services. Payment for 
such items or services covered under this title 
furnished to such Program-eligible beneficiary 
during such transition period shall be made in 
accordance with this title and in such amounts 
as would otherwise be determined for such 
items and services provided to such a bene-
ficiary not enrolled under the Program. 
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‘‘(B) ANTIDISCRIMINATION.—Each con-
tract entered into with an Organization under 
this section shall provide that each eligible par-
ticipating provider of such Organization may 
not deny, limit, or condition the furnishing of 
services, or affect the quality of services fur-
nished, under this title to Program-eligible 
beneficiaries on whether or not such a bene-
ficiary is enrolled with the Organization. 
‘‘(C) QUALITY ASSURANCE; PATIENT SAFE-
GUARDS.—Each contract entered into with an 
Organization under this section shall require 
that such Organization have in effect at a min-
imum— 
‘‘(i) a written plan of quality assur-
ance and improvement, and procedures im-
plementing such plan, in accordance with 
regulations; and 
‘‘(ii) written safeguards of the rights 
of Program-eligible beneficiaries enrolled in 
the Organization (including a patient bill 
of rights and procedures for grievances 
and appeals) in accordance with regula-
tions and with other requirements of this 
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title and Federal and State law that are 
designed for the protection of patients. 
‘‘(D) OVERSIGHT.—The Secretary shall 
oversee the marketing and assignment practices 
of each Organization entering into a contract 
under this section as part of the approval proc-
ess of Organizations under this section. 
‘‘(5) NON-APPLICATION
OF
CERTAIN
PROVI-
SIONS OF LAW.—For purposes of sections 162(m)(6) 
and 414(m) of the Internal Revenue Code of 1986 
and section 9010 of the Patient Protection and Af-
fordable Care Act (26 U.S.C. 4001 note prec.), in 
the case of an eligible participating provider that es-
tablishes an Organization or that enters into a part-
nership, ownership, or co-ownership agreement to es-
tablish an Organization, or an Organization with a 
contract under this section, risk-based payments in 
exchange for providing medical care shall not be con-
sidered premiums for health insurance coverage. 
‘‘(6) TREATMENT AS MEDICARE ADVANCED AL-
TERNATIVE PAYMENT MODEL.—Alternative care de-
livery models under the Program shall be treated 
under this title as an advanced alternative payment 
model. 
‘‘(c) PROGRAM OPERATION AND SCOPE.— 
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‘‘(1) IN GENERAL.—Not later than 6 months 
after the date of enactment of this section, the Sec-
retary shall establish a process through which an 
Organization can apply to offer one or more ESRD 
Integrated Care Models. Such application shall in-
clude information on at least the following: 
‘‘(A) 
The 
estimated 
average 
revenue 
amount described in subsection (b)(2)(A)(ii)(II) 
for the Organization to deliver benefits de-
scribed in subsection (b)(2)(A). 
‘‘(B) Any benefits offered by the Organiza-
tion beyond those described in such subsection. 
‘‘(C) A listing of network providers of serv-
ices and supplier. 
‘‘(D) Information on the expertise of net-
work providers of services and suppliers in serv-
ing ESRD patients. 
‘‘(E) A description of the ESRD Inte-
grated Care Strategy of the Organization de-
scribed in subsection (b)(2)(D). 
‘‘(2) PROGRAM
INITIATION.—The Secretary 
shall initiate the Program such that Organizations 
begin serving Program-eligible beneficiaries not later 
than January 1, 2018. 
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‘‘(3) CONTRACT
AWARD
AND
PERIOD.—The 
Secretary shall enter into contracts for an initial pe-
riod of not less than 5 years with all Organizations 
that meet Program requirements. 
‘‘(4) ALLOWANCE FOR LARGER SERVICE AREAS 
AND EXPANSION OF SERVICE AREAS.—Organizations 
shall demonstrate in their application that the pro-
posed service area has the capacity to serve Pro-
gram-eligible beneficiaries through an adequate pro-
vider network and is reflective of the communities in 
which beneficiaries live, work, and obtain health care 
services. 
‘‘(5) CONTRACT
TERMINATION
AND
SUSPEN-
SION.— 
‘‘(A) IN
GENERAL.—The Secretary may 
terminate a contract with an Organization 
under this section if the Secretary determines 
that an Organization has failed to meet quality 
requirements described in subsection (b) or 
(e)(2)(C)(iii) or violates other terms of the con-
tract. 
‘‘(B) INSUFFICIENT BENEFICIARY PARTICI-
PATION.—The Secretary shall, in the case of an 
Organization with a contract under this section 
with respect to which, for any period of at least 
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30 consecutive days during a year for which 
such contract applies, fewer than 50 percent of 
the total number of Program-eligible bene-
ficiaries served by the Organization receive ben-
efits through the Organization under this sec-
tion— 
‘‘(i) suspend such contract for the re-
mainder of such year; and 
‘‘(ii) provide for the Organization to 
return any prospective payments made to 
the Organization under this section for 
items and services not provided pursuant 
to clause (i). 
‘‘(C) REMEDY AND APPEALS PROCESS.— 
Prior to the Secretary terminating or sus-
pending a contract with an Organization under 
this section, the Secretary shall afford such Or-
ganization sufficient opportunity to remedy any 
contract violations and appeal a contract termi-
nation. 
‘‘(D) 
PROGRAM-ELIGIBLE
BENEFICIARY 
NOTICE
AT
TIME
OF
CONTRACT
TERMI-
NATION.—Each contract under this section with 
an Organization shall require the Organization 
to provide (and pay for) written notice in ad-
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vance of the contract’s termination or suspen-
sion, as well as a description of alternatives for 
obtaining benefits under this title, to each Pro-
gram-eligible beneficiary assigned to or who 
elected to receive benefits through the Organi-
zation under this section. 
‘‘(6) PROGRAM
EXPANSION.—The Secretary 
may, through rulemaking, expand the duration and 
scope of the Program under this section, to the ex-
tent determined appropriate by the Secretary, if— 
‘‘(A) 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 patient 
care without increasing spending under 
this title; 
‘‘(B) the Chief Actuary of the Centers for 
Medicare & Medicaid Services certifies that 
such expansion would reduce (or would not re-
sult in any increase in) net program spending 
under this title; and 
‘‘(C) the Secretary determines that such 
expansion would not deny or limit the coverage 
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or provision of benefits under this title for ap-
plicable individuals. 
‘‘(d) IDENTIFICATION OF PROGRAM-ELIGIBLE BENE-
FICIARIES.—The Secretary shall establish a process for 
the initial and ongoing identification of Program-eligible 
beneficiaries. 
‘‘(e) PROGRAM-ELIGIBLE BENEFICIARIES ASSIGNED 
INTO AN ESRD INTEGRATED CARE ORGANIZATION OPEN 
NETWORK MODEL.— 
‘‘(1) ASSIGNMENT.— 
‘‘(A) IN GENERAL.—Under the Program, 
subject to the succeeding provisions of this 
paragraph, the Secretary shall, upon the Sec-
retary identifying a beneficiary as a Program- 
eligible beneficiary, assign all such Program-eli-
gible beneficiary to an open network model of-
fered by an Organization that includes the di-
alysis facility at which the Program-eligible ben-
eficiary primarily receives renal dialysis serv-
ices. 
‘‘(B) 
PROGRAM-ELIGIBLE
BENEFICIARY 
NOTIFICATION OF ASSIGNMENT.— 
‘‘(i) IN GENERAL.—Upon assignment 
of a Program-eligible beneficiary to an Or-
ganization, the Secretary shall provide to 
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the Organization written notification of 
such assignment of such Program-eligible 
beneficiary and not later than 15 business 
days after the date of receipt of such noti-
fication, the Organization shall provide 
written notice of such assignment to the 
Program-eligible beneficiary. 
‘‘(ii) OPT-OUT PERIOD AND CHANGES 
UPON
INITIAL
ASSIGNMENT.—The Sec-
retary shall provide for a 75-day period be-
ginning on the date on which the assign-
ment of a Program-eligible beneficiary into 
an open network model offered by an Or-
ganization becomes effective during which 
a Program-eligible beneficiary may— 
‘‘(I) opt out of the Program; 
‘‘(II) make a one-time change of 
assignment into an open network 
model offered by a different Organiza-
tion; or 
‘‘(III) elect a preferred network 
model offered by the same or different 
Organization. 
‘‘(C) ADDITIONAL OPT-IN POPULATION.— 
An individual who, without application of clause 
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(iv) of subsection (a)(2)(C), would be treated as 
a Program-eligible beneficiary, may elect to en-
roll in an Organization under the Program 
under this section if such individual agrees to 
receive renal dialysis services primarily from a 
facility that participates in such Organization. 
For purposes of this section (other than sub-
paragraphs (A) and (B) of this paragraph, 
paragraph (2), and subsection (d)), an indi-
vidual making an election pursuant to the pre-
vious sentence shall be treated as a Program-el-
igible beneficiary. 
‘‘(D) DEEMED RE-ENROLLMENT.—A Pro-
gram-eligible beneficiary assigned under this 
paragraph to an ESRD Integrated Care Model 
offered by an Organization with respect to a 
year is deemed, unless the individual elects oth-
erwise under this paragraph, to have elected to 
continue such assignment with respect to the 
subsequent year. 
‘‘(E) ADDITIONAL OPPORTUNITY TO OPT 
OUT OR ELECT DIFFERENT MODEL OR ORGANI-
ZATION.—On the date that is one year after the 
effective date of the initial assignment of a Pro-
gram-eligible beneficiary to an open network 
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model offered by an Organization (and annually 
thereafter), a Program-eligible beneficiary shall 
be given the opportunity to— 
‘‘(i) opt out of the Program; 
‘‘(ii) make a one-time change of as-
signment into an open network model of-
fered by a different Organization; or 
‘‘(iii) elect a preferred network model 
offered by the same or different Organiza-
tion. 
‘‘(F) CHANGE
IN
PRINCIPAL
DIAGNOSIS 
OPT OUT.—In addition to any other period dur-
ing which a Program-eligible beneficiary may, 
pursuant to this paragraph, opt out of the Pro-
gram, in the case of a Program-eligible bene-
ficiary who, after assignment under this para-
graph, is diagnosed with a principal diagnosis 
(as defined by the Secretary) other than end- 
stage renal disease, such individual shall be 
given the opportunity to opt out of the Program 
during such period as specified by the Sec-
retary. 
‘‘(G) SPECIAL
ELECTION
PERIODS.—The 
Secretary shall offer Program-eligible bene-
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‘‘(3) PROGRAM-ELIGIBLE BENEFICIARY APPEAL 
RIGHTS.—Program-eligible beneficiaries enrolled in 
an Organization shall have the same right to appeal 
any denial of benefits under this title as such a Pro-
gram-eligible beneficiary would have under this title 
if such Program-eligible beneficiary were not so en-
rolled. 
‘‘(f) PAYMENT.— 
‘‘(1) IN GENERAL.—For each Program-eligible 
beneficiary receiving care through an Organization, 
the Secretary shall make a monthly capitated pay-
ment in accordance with payment rates that would 
be determined under section 1853(a)(1)(H), as ad-
justed pursuant to paragraph (2). 
‘‘(2) APPLICATION
OF
HEALTH
STATUS
RISK 
ADJUSTMENT METHODOLOGY.—The Secretary shall 
adjust the payment amount to an Organization 
under this subsection in the same manner in which 
the payment amount to a Medicare Advantage plan 
is adjusted under section 1853(a)(1)(C). 
‘‘(3) PAYMENT FOR PART D BENEFITS.—In the 
case where an Organization elects to offer part D 
prescription drug coverage under the Program under 
this section, payments to the Organization for such 
benefits provided to Program-eligible beneficiaries by 
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the Organization shall be made in the same manner 
and amounts as those payments would be made in 
the case of an organization with a contract under 
such part. 
‘‘(4) AGREEMENT
WITH
STATE
MEDICAID 
AGENCY.—In the event of an Organization that 
elects to cover benefits under title XIX for Program- 
eligible beneficiaries eligible for benefits under this 
title and title XIX such Organization shall enter into 
an agreement with the State Medicaid agency to 
provide benefits, or arrange for benefits to be pro-
vided, for which such beneficiaries are entitled to re-
ceive medical assistance under title XIX and to re-
ceive payment from the State for providing or ar-
ranging for the provision of such benefits. 
‘‘(5) AFFIRMATION OF STATE OBLIGATIONS TO 
PAY PREMIUM AND COST-SHARING AMOUNTS.— 
‘‘(A) IN GENERAL.—A State shall continue 
to make medical assistance under the State 
plan under title XIX available in the amount 
described in subparagraph (B) for the duration 
of the Program for cost-sharing (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 Pro-
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gram-eligible beneficiaries enrolled in an Orga-
nization and entitled to medical assistance for 
premiums and such cost-sharing under the 
State plan under title XIX. 
‘‘(B) AMOUNTS
MADE
AVAILABLE
FOR 
COST-SHARING.—For purposes of subparagraph 
(A): 
‘‘(i) IN GENERAL.—Subject to clause 
(ii), the amount of medical assistance de-
scribed in this clause to be made available 
for cost-sharing pursuant to subparagraph 
(A) for an individual described in such 
subparagraph entitled to medical assist-
ance for such cost-sharing under a State 
plan under title XIX shall be equal to the 
amount of medical assistance that would 
be made available under such State plan as 
in effect as of January 1, 2016. 
‘‘(ii) AMOUNTS
IN
THE
CASE
OF
A 
STATE
THAT
INCREASES
PAYMENTS
FOR 
COST-SHARING.—If a State increases the 
amount of medical assistance made avail-
able under the State plan under title XIX 
for cost-sharing described in subparagraph 
(A) after such date, such increased 
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amounts shall be made available under 
subparagraph (A) for the remaining dura-
tion of the Program. 
‘‘(g) WAIVER AUTHORITY.— 
‘‘(1) IN GENERAL.—In order to carry out the 
Program under this section, the Secretary shall 
waive those requirements waived under section 1899 
and may waive such additional requirements con-
sistent with those waived under programs adminis-
tered through the Center for Medicare and Medicaid 
Innovation as may be necessary. 
‘‘(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.’’. 
(b) CONFORMING AMENDMENT RELATING TO BAL-
ANCED BILLING.—Section 1866(a)(1)(O) of the Social Se-
curity Act (42 U.S.C. 1395cc(a)(1)(O)) is amended— 
(1) by inserting ‘‘with an ESRD Integrated 
Care Organization under section 1866F,’’ after 
‘‘with a PACE provider under section 1894 or 
1934,’’; 
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(2) by inserting ‘‘or ESRD Integrated Care Or-
ganization’’ after ‘‘in the case of a PACE provider’’; 
(3) by striking ‘‘or PACE program eligible indi-
viduals enrolled with the PACE provider’’ and in-
serting ‘‘, Program-eligible beneficiaries enrolled in 
the ESRD Integrated Care Organization, or PACE 
program eligible individuals enrolled with the PACE 
provider’’; and 
(4) by inserting ‘‘(or in the case of a Program- 
eligible beneficiary enrolled in the ESRD Integrated 
Care Organization, the amounts that would be made 
in accordance with payment rates that would be de-
termined under section 1853(a)(1)(H))’’ after ‘‘the 
amounts that would be made’’. 
Æ 
VerDate Sep 11 2014 
00:09 Sep 08, 2016
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E:\BILLS\H5942.IH
H5942
emcdonald on DSK9F6TC42PROD with BILLS