‘‘(ii) the entity may not implement 
any quality and efficiency arrangement 
under subsection (i) for that year. 
‘‘(k) WAIVERS.— 
‘‘(1) IN GENERAL.—The Secretary shall waive 
such provisions of this title and title XI as may be 
necessary to carry out the program, including the 
following: 
‘‘(A) With respect to authorizing quality 
and efficiency arrangements between qualified 
entities and providers of services and suppliers, 
section 1877(a) (relating to physician self-refer-
ral), paragraphs (1) and (2) of sections 
1128A(b) (relating to the gainsharing civil 
money penalties), and paragraphs (1) and (2) 
of section 1128B(b) (relating to the anti-kick-
back statute). 
‘‘(B) Section 1128A(a)(5) of the Act (re-
lating to the inducement civil money penalties). 
‘‘(C) Section 1861(i) (relating to the 3-day 
acute hospitalization prerequisite before eligi-
bility for post-hospital extended care services). 
‘‘(D) With respect to home health serv-
ices— 
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‘‘(i) 
sections 
1814(a)(2)(C) 
and 
1835(a)(2)(A) (relating to the requirement 
that an individual be confined to home in 
order to be eligible for benefits for home 
health services); 
‘‘(ii) limitations on the amount, fre-
quency, and duration on home health serv-
ices; and 
‘‘(iii) prohibitions of free preoperative 
home safety assessments by home health 
agencies for patients scheduled to undergo 
surgery (such as under Advisory Opinion 
No. 06–01 of the Inspector General of the 
Department of Health and Human Serv-
ices). 
‘‘(2) AUTHORITY TO MODIFY WAIVERS UNDER 
CERTAIN CIRCUMSTANCES.— 
‘‘(A) IN GENERAL.—In the case of a quali-
fied entity with respect to which one or more 
waivers under paragraph (1) is in effect, if 
upon a review of the performance or an audit 
of the entity the Secretary finds a pattern of 
deficiencies or harm to applicable beneficiaries, 
the Secretary may modify or revoke any such 
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waiver at any time as applied to that qualified 
entity. 
‘‘(B) TERMINATION OF CERTAIN WAIVERS 
IN THE CASE OF EXCESS SHARED LOSSES.— 
‘‘(i) IN
GENERAL.—Subject to the 
process described in clause (ii), in the case 
of a qualified entity that has selected the 
payment model under subsection (g) and 
has gross shared losses exceeding the cap 
under subsection (g)(2)(C)(iv) with respect 
to an applicable condition, the Secretary 
shall terminate waivers described in para-
graphs (1)(C) and (1)(D) with respect to 
such qualified entity and applicable condi-
tion. 
‘‘(ii) 
PRE-TERMINATION
NOTICE.— 
The Secretary shall establish a process 
whereby a qualified entity is furnished no-
tice of any deficiency that may give rise to 
a termination of waivers under clause (i) 
not later than 6 months before the pro-
posed effective date of the termination. 
‘‘(l) INDEPENDENT EVALUATION AND REPORTS ON 
PROGRAM.— 
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‘‘(1) INDEPENDENT
EVALUATION.—The Sec-
retary shall conduct an independent evaluation of 
the impact of providing bundled payments to quali-
fied entities under this section. Such evaluation shall 
include an examination of the extent to which the 
bundling of payments this section have resulted in— 
‘‘(A) improved health outcomes; 
‘‘(B) improved access to care for applicable 
beneficiaries; 
‘‘(C) reduced spending under this title; and 
‘‘(D) improvement in performance on qual-
ity 
measures 
selected 
under 
subsection 
(j)(1)(A). 
‘‘(2) REPORTS.— 
‘‘(A) INTERIM
REPORT.—Not later than 
March 1, 2019, the Secretary shall submit to 
Congress a report on the initial results of the 
independent evaluation conducted under para-
graph (1). 
‘‘(B) FINAL
REPORT.—Not later than 
March 1, 2021, the Secretary shall submit to 
Congress a report on the final results of the 
independent evaluation conducted under para-
graph (1) and may include recommendations 
for the expansion of bundled payment meth-
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odologies and applicable conditions under this 
section as the Secretary determines to be appro-
priate.’’. 
Æ 
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