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•AMDT. NO. 2786 
ownership or investment interest (or to an enti-
ty or individual at the request of or designated 
on behalf of a physician holding such an owner-
ship or investment interest), including the infor-
mation described in clauses (i) through (viii) of 
paragraph (1)(A), except that in applying such 
clauses, ‘physician’ shall be substituted for ‘cov-
ered recipient’ each place it appears. 
‘‘(D) Any other information regarding the 
ownership or investment interest the Secretary 
determines appropriate. 
‘‘(b) PENALTIES FOR NONCOMPLIANCE.— 
‘‘(1) FAILURE TO REPORT.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B) except as provided in paragraph (2), 
any applicable manufacturer or applicable 
group purchasing organization that fails to sub-
mit information required under subsection (a) 
in a timely manner in accordance with rules or 
regulations promulgated to carry out such sub-
section, shall be subject to a civil money penalty 
of not less than $1,000, but not more than 
$10,000, for each payment or other transfer of 
value or ownership or investment interest not 
reported as required under such subsection. 
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•AMDT. NO. 2786 
Such penalty shall be imposed and collected in 
the same manner as civil money penalties under 
subsection (a) of section 1128A are imposed 
and collected under that section. 
‘‘(B) LIMITATION.—The total amount of 
civil money penalties imposed under subpara-
graph (A) with respect to each annual submis-
sion of information under subsection (a) by an 
applicable manufacturer or applicable group 
purchasing 
organization 
shall 
not 
exceed 
$150,000. 
‘‘(2) KNOWING FAILURE TO REPORT.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), any applicable manufacturer or ap-
plicable group purchasing organization that 
knowingly fails to submit information required 
under subsection (a) in a timely manner in ac-
cordance with rules or regulations promulgated 
to carry out such subsection, shall be subject to 
a civil money penalty of not less than $10,000, 
but not more than $100,000, for each payment 
or other transfer of value or ownership or in-
vestment interest not reported as required 
under such subsection. Such penalty shall be 
imposed and collected in the same manner as 
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•AMDT. NO. 2786 
civil money penalties under subsection (a) of 
section 1128A are imposed and collected under 
that section. 
‘‘(B) LIMITATION.—The total amount of 
civil money penalties imposed under subpara-
graph (A) with respect to each annual submis-
sion of information under subsection (a) by an 
applicable manufacturer or applicable group 
purchasing 
organization 
shall 
not 
exceed 
$1,000,000. 
‘‘(3) USE OF FUNDS.—Funds collected by the 
Secretary as a result of the imposition of a civil 
money penalty under this subsection shall be used to 
carry out this section. 
‘‘(c) PROCEDURES FOR SUBMISSION OF INFORMA-
TION AND PUBLIC AVAILABILITY.— 
‘‘(1) IN GENERAL.— 
‘‘(A) ESTABLISHMENT.—Not later than 
October 1, 2011, the Secretary shall establish 
procedures— 
‘‘(i) for applicable manufacturers and 
applicable group purchasing organizations 
to submit information to the Secretary 
under subsection (a); and 
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•AMDT. NO. 2786 
‘‘(ii) for the Secretary to make such 
information submitted available to the pub-
lic. 
‘‘(B) DEFINITION OF TERMS.—The proce-
dures established under subparagraph (A) shall 
provide for the definition of terms (other than 
those terms defined in subsection (e)), as ap-
propriate, for purposes of this section. 
‘‘(C) PUBLIC
AVAILABILITY.—Except as 
provided in subparagraph (E), the procedures 
established under subparagraph (A)(ii) shall en-
sure that, not later than September 30, 2013, 
and on June 30 of each calendar year beginning 
thereafter, the information submitted under 
subsection (a) with respect to the preceding cal-
endar year is made available through an Inter-
net website that— 
‘‘(i) is searchable and is in a format 
that is clear and understandable; 
‘‘(ii) contains information that is pre-
sented by the name of the applicable man-
ufacturer or applicable group purchasing 
organization, the name of the covered re-
cipient, the business address of the covered 
recipient, the specialty of the covered re-
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•AMDT. NO. 2786 
cipient, the value of the payment or other 
transfer of value, the date on which the 
payment or other transfer of value was 
provided to the covered recipient, the form 
of the payment or other transfer of value, 
indicated (as appropriate) under subsection 
(a)(1)(A)(v), the nature of the payment or 
other transfer of value, indicated (as ap-
propriate) under subsection (a)(1)(A)(vi), 
and the name of the covered drug, device, 
biological, or medical supply, as applicable; 
‘‘(iii) contains information that is able 
to be easily aggregated and downloaded; 
‘‘(iv) contains a description of any en-
forcement actions taken to carry out this 
section, including any penalties imposed 
under subsection (b), during the preceding 
year; 
‘‘(v) contains background information 
on industry-physician relationships; 
‘‘(vi) in the case of information sub-
mitted with respect to a payment or other 
transfer of value described in subpara-
graph (E)(i), lists such information sepa-
rately from the other information sub-
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•AMDT. NO. 2786 
mitted under subsection (a) and designates 
such separately listed information as fund-
ing for clinical research; 
‘‘(vii) contains any other information 
the Secretary determines would be helpful 
to the average consumer; 
‘‘(viii) does not contain the National 
Provider Identifier of the covered recipient, 
and 
‘‘(ix) subject to subparagraph (D), 
provides the applicable manufacturer, ap-
plicable group purchasing organization, or 
covered recipient an opportunity to review 
and submit corrections to the information 
submitted with respect to the applicable 
manufacturer, applicable group purchasing 
organization, or covered recipient, respec-
tively, for a period of not less than 45 days 
prior to such information being made 
available to the public. 
‘‘(D) CLARIFICATION OF TIME PERIOD FOR 
REVIEW AND CORRECTIONS.—In no case may 
the 45-day period for review and submission of 
corrections to information under subparagraph 
(C)(ix) prevent such information from being 
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•AMDT. NO. 2786 
made available to the public in accordance with 
the dates described in the matter preceding 
clause (i) in subparagraph (C). 
‘‘(E) DELAYED
PUBLICATION
FOR
PAY-
MENTS
MADE
PURSUANT
TO
PRODUCT
RE-
SEARCH OR DEVELOPMENT AGREEMENTS AND 
CLINICAL INVESTIGATIONS.— 
‘‘(i) IN GENERAL.—In the case of in-
formation submitted under subsection (a) 
with respect to a payment or other transfer 
of value made to a covered recipient by an 
applicable manufacturer pursuant to a 
product research or development agree-
ment for services furnished in connection 
with research on a potential new medical 
technology or a new application of an ex-
isting medical technology or the develop-
ment of a new drug, device, biological, or 
medical supply, or by an applicable manu-
facturer in connection with a clinical inves-
tigation regarding a new drug, device, bio-
logical, or medical supply, the procedures 
established under subparagraph (A)(ii) 
shall provide that such information is 
made available to the public on the first 
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•AMDT. NO. 2786 
date described in the matter preceding 
clause (i) in subparagraph (C) after the 
earlier of the following: 
‘‘(I) The date of the approval or 
clearance of the covered drug, device, 
biological, or medical supply by the 
Food and Drug Administration. 
‘‘(II) Four calendar years after 
the date such payment or other trans-
fer of value was made. 
‘‘(ii) CONFIDENTIALITY OF INFORMA-
TION
PRIOR
TO
PUBLICATION.—Informa-
tion described in clause (i) shall be consid-
ered confidential and shall not be subject 
to disclosure under section 552 of title 5, 
United States Code, or any other similar 
Federal, State, or local law, until on or 
after the date on which the information is 
made available to the public under such 
clause. 
‘‘(2) CONSULTATION.—In establishing the pro-
cedures under paragraph (1), the Secretary shall 
consult with the Inspector General of the Depart-
ment of Health and Human Services, affected indus-
try, consumers, consumer advocates, and other inter-
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•AMDT. NO. 2786 
ested parties in order to ensure that the information 
made available to the public under such paragraph 
is presented in the appropriate overall context. 
‘‘(d) ANNUAL REPORTS AND RELATION TO STATE 
LAWS.— 
‘‘(1) ANNUAL
REPORT
TO
CONGRESS.—Not 
later than April 1 of each year beginning with 2013, 
the Secretary shall submit to Congress a report that 
includes the following: 
‘‘(A) The information submitted under 
subsection (a) during the preceding year, aggre-
gated for each applicable manufacturer and ap-
plicable group purchasing organization that 
submitted such information during such year 
(except, in the case of information submitted 
with respect to a payment or other transfer of 
value described in subsection (c)(1)(E)(i), such 
information shall be included in the first report 
submitted to Congress after the date on which 
such information is made available to the public 
under such subsection). 
‘‘(B) A description of any enforcement ac-
tions taken to carry out this section, including 
any penalties imposed under subsection (b), 
during the preceding year. 
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•AMDT. NO. 2786 
‘‘(2) ANNUAL REPORTS TO STATES.—Not later 
than September 30, 2013 and on June 30 of each 
calendar year thereafter, the Secretary shall submit 
to States a report that includes a summary of the 
information submitted under subsection (a) during 
the preceding year with respect to covered recipients 
in the State (except, in the case of information sub-
mitted with respect to a payment or other transfer 
of value described in subsection (c)(1)(E)(i), such in-
formation shall be included in the first report sub-
mitted to States after the date on which such infor-
mation is made available to the public under such 
subsection). 
‘‘(3) RELATION TO STATE LAWS.— 
‘‘(A) IN GENERAL.—In the case of a pay-
ment or other transfer of value provided by an 
applicable manufacturer that is received by a 
covered recipient (as defined in subsection (e)) 
on or after January 1, 2012, subject to sub-
paragraph (B), the provisions of this section 
shall preempt any statute or regulation of a 
State or of a political subdivision of a State 
that requires an applicable manufacturer (as so 
defined) to disclose or report, in any format, 
the type of information (as described in sub-
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•AMDT. NO. 2786 
section (a)) regarding such payment or other 
transfer of value. 
‘‘(B) NO PREEMPTION OF ADDITIONAL RE-
QUIREMENTS.—Subparagraph (A) shall not 
preempt any statute or regulation of a State or 
of a political subdivision of a State that re-
quires the disclosure or reporting of informa-
tion— 
‘‘(i) not of the type required to be dis-
closed or reported under this section; 
‘‘(ii) 
described 
in 
subsection 
(e)(10)(B), except in the case of informa-
tion described in clause (i) of such sub-
section; 
‘‘(iii) by any person or entity other 
than an applicable manufacturer (as so de-
fined) or a covered recipient (as defined in 
subsection (e)); or 
‘‘(iv) to a Federal, State, or local gov-
ernmental agency for public health surveil-
lance, investigation, or other public health 
purposes or health oversight purposes. 
‘‘(C) Nothing in subparagraph (A) shall be 
construed to limit the discovery or admissibility 
of information described in such subparagraph 
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•AMDT. NO. 2786 
in a criminal, civil, or administrative pro-
ceeding. 
‘‘(4) CONSULTATION.—The Secretary shall con-
sult with the Inspector General of the Department 
of Health and Human Services on the implementa-
tion of this section. 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) APPLICABLE GROUP PURCHASING ORGANI-
ZATION.—The term ‘applicable group purchasing or-
ganization’ means a group purchasing organization 
(as defined by the Secretary) that purchases, ar-
ranges for, or negotiates the purchase of a covered 
drug, device, biological, or medical supply which is 
operating in the United States, or in a territory, 
possession, or commonwealth of the United States. 
‘‘(2) APPLICABLE MANUFACTURER.—The term 
‘applicable manufacturer’ means a manufacturer of 
a covered drug, device, biological, or medical supply 
which is operating in the United States, or in a ter-
ritory, possession, or commonwealth of the United 
States. 
‘‘(3) CLINICAL
INVESTIGATION.—The term 
‘clinical investigation’ means any experiment involv-
ing 1 or more human subjects, or materials derived 
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•AMDT. NO. 2786 
‘‘(8) KNOWINGLY.—The term ‘knowingly’ has 
the meaning given such term in section 3729(b) of 
title 31, United States Code. 
‘‘(9) MANUFACTURER
OF
A
COVERED
DRUG, 
DEVICE, BIOLOGICAL, OR
MEDICAL
SUPPLY.—The 
term ‘manufacturer of a covered drug, device, bio-
logical, or medical supply’ means any entity which is 
engaged in the production, preparation, propagation, 
compounding, or conversion of a covered drug, de-
vice, biological, or medical supply (or any entity 
under common ownership with such entity which 
provides assistance or support to such entity with re-
spect to the production, preparation, propagation, 
compounding, conversion, marketing, promotion, 
sale, or distribution of a covered drug, device, bio-
logical, or medical supply). 
‘‘(10) PAYMENT
OR
OTHER
TRANSFER
OF 
VALUE.— 
‘‘(A) IN GENERAL.—The term ‘payment or 
other transfer of value’ means a transfer of 
anything of value. Such term does not include 
a transfer of anything of value that is made in-
directly to a covered recipient through a third 
party in connection with an activity or service 
in the case where the applicable manufacturer 
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•AMDT. NO. 2786 
is unaware of the identity of the covered recipi-
ent. 
‘‘(B) EXCLUSIONS.—An applicable manu-
facturer shall not be required to submit infor-
mation under subsection (a) with respect to the 
following: 
‘‘(i) A transfer of anything the value 
of which is less than $10, unless the aggre-
gate amount transferred to, requested by, 
or designated on behalf of the covered re-
cipient by the applicable manufacturer dur-
ing the calendar year exceeds $100. For 
calendar years after 2012, the dollar 
amounts specified in the preceding sen-
tence shall be increased by the same per-
centage as the percentage increase in the 
consumer price index for all urban con-
sumers (all items; U.S. city average) for 
the 12-month period ending with June of 
the previous year. 
‘‘(ii) Product samples that are not in-
tended to be sold and are intended for pa-
tient use. 
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•AMDT. NO. 2786 
‘‘(iii) Educational materials that di-
rectly benefit patients or are intended for 
patient use. 
‘‘(iv) The loan of a covered device for 
a short-term trial period, not to exceed 90 
days, to permit evaluation of the covered 
device by the covered recipient. 
‘‘(v) Items or services provided under 
a contractual warranty, including the re-
placement of a covered device, where the 
terms of the warranty are set forth in the 
purchase or lease agreement for the cov-
ered device. 
‘‘(vi) A transfer of anything of value 
to a covered recipient when the covered re-
cipient is a patient and not acting in the 
professional capacity of a covered recipient. 
‘‘(vii) Discounts (including rebates). 
‘‘(viii) In-kind items used for the pro-
vision of charity care. 
‘‘(ix) A dividend or other profit dis-
tribution from, or ownership or investment 
interest in, a publicly traded security and 
mutual fund (as described in section 
1877(c)). 
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•AMDT. NO. 2786 
‘‘(x) In the case of an applicable man-
ufacturer who offers a self-insured plan, 
payments for the provision of health care 
to employees under the plan. 
‘‘(xi) In the case of a covered recipi-
ent who is a licensed non-medical profes-
sional, a transfer of anything of value to 
the covered recipient if the transfer is pay-
ment solely for the non-medical profes-
sional services of such licensed non-medical 
professional. 
‘‘(xii) In the case of a covered recipi-
ent who is a physician, a transfer of any-
thing of value to the covered recipient if 
the transfer is payment solely for the serv-
ices of the covered recipient with respect to 
a civil or criminal action or an administra-
tive proceeding. 
‘‘(11) PHYSICIAN.—The term ‘physician’ has 
the meaning given that term in section 1861(r).’’. 
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•AMDT. NO. 2786 
SEC. 6003. DISCLOSURE REQUIREMENTS FOR IN-OFFICE 
ANCILLARY SERVICES EXCEPTION TO THE 
PROHIBITION ON PHYSICIAN SELF-REFER-
RAL FOR CERTAIN IMAGING SERVICES. 
(a) IN GENERAL.—Section 1877(b)(2) of the Social 
Security Act (42 U.S.C. 1395nn(b)(2)) is amended by 
adding at the end the following new sentence: ‘‘Such re-
quirements shall, with respect to magnetic resonance im-
aging, computed tomography, positron emission tomog-
raphy, and any other designated health services specified 
under subsection (h)(6)(D) that the Secretary determines 
appropriate, include a requirement that the referring phy-
sician inform the individual in writing at the time of the 
referral that the individual may obtain the services for 
which the individual is being referred from a person other 
than a person described in subparagraph (A)(i) and pro-
vide such individual with a written list of suppliers (as 
defined in section 1861(d)) who furnish such services in 
the area in which such individual resides.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
this section shall apply to services furnished on or after 
January 1, 2010. 
SEC. 6004. PRESCRIPTION DRUG SAMPLE TRANSPARENCY. 
Part A of title XI of the Social Security Act (42 
U.S.C. 1301 et seq.), as amended by section 6002, is 
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•AMDT. NO. 2786 
amended by inserting after section 1128G the following 
new section: 
‘‘SEC. 1128H. REPORTING OF INFORMATION RELATING TO 
DRUG SAMPLES. 
‘‘(a) IN GENERAL.—Not later than April 1 of each 
year (beginning with 2012), each manufacturer and au-
thorized distributor of record of an applicable drug shall 
submit to the Secretary (in a form and manner specified 
by the Secretary) the following information with respect 
to the preceding year: 
‘‘(1) In the case of a manufacturer or author-
ized distributor of record which makes distributions 
by mail or common carrier under subsection (d)(2) 
of section 503 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 353), the identity and quantity 
of drug samples requested and the identity and 
quantity of drug samples distributed under such 
subsection during that year, aggregated by— 
‘‘(A) the name, address, professional des-
ignation, and signature of the practitioner mak-
ing the request under subparagraph (A)(i) of 
such subsection, or of any individual who makes 
or signs for the request on behalf of the practi-
tioner; and 
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•AMDT. NO. 2786 
‘‘(B) for which payment is available under 
title XVIII or a State plan under title XIX or 
XXI (or a waiver of such a plan). 
‘‘(2) AUTHORIZED DISTRIBUTOR OF RECORD.— 
The term ‘authorized distributor of record’ has the 
meaning given that term in subsection (e)(3)(A) of 
such section. 
‘‘(3) MANUFACTURER.—The term ‘manufac-
turer’ has the meaning given that term for purposes 
of subsection (d) of such section.’’. 
SEC. 
6005. 
PHARMACY 
BENEFIT 
MANAGERS 
TRANS-
PARENCY REQUIREMENTS. 
Part A of title XI of the Social Security Act (42 
U.S.C. 1301 et seq.) is amended by inserting after section 
1150 the following new section: 
‘‘SEC. 1150A. PHARMACY BENEFIT MANAGERS TRANS-
PARENCY REQUIREMENTS. 
‘‘(a) PROVISION OF INFORMATION.—A health bene-
fits plan or any entity that provides pharmacy benefits 
management services on behalf of a health benefits plan 
(in this section referred to as a ‘PBM’) that manages pre-
scription drug coverage under a contract with— 
‘‘(1) a PDP sponsor of a prescription drug plan 
or an MA organization offering an MA–PD plan 
under part D of title XVIII; or 
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•AMDT. NO. 2786 
‘‘(2) a qualified health benefits plan offered 
through an exchange established by a State under 
section 1311 of the Patient Protection and Afford-
able Care Act, 
shall provide the information described in subsection (b) 
to the Secretary and, in the case of a PBM, to the plan 
with which the PBM is under contract with, at such times, 
and in such form and manner, as the Secretary shall speci-
fy. 
‘‘(b) INFORMATION DESCRIBED.—The information 
described in this subsection is the following with respect 
to services provided by a health benefits plan or PBM for 
a contract year: 
‘‘(1) The percentage of all prescriptions that 
were provided through retail pharmacies compared 
to mail order pharmacies, and the percentage of pre-
scriptions for which a generic drug was available and 
dispensed (generic dispensing rate), by pharmacy 
type (which includes an independent pharmacy, 
chain pharmacy, supermarket pharmacy, or mass 
merchandiser pharmacy that is licensed as a phar-
macy by the State and that dispenses medication to 
the general public), that is paid by the health bene-
fits plan or PBM under the contract. 
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•AMDT. NO. 2786 
‘‘(2) The aggregate amount, and the type of re-
bates, discounts, or price concessions (excluding 
bona fide service fees, which include but are not lim-
ited to distribution service fees, inventory manage-
ment fees, product stocking allowances, and fees as-
sociated with administrative services agreements and 
patient care programs (such as medication compli-
ance programs and patient education programs))that 
the PBM negotiates that are attributable to patient 
utilization under the plan, and the aggregate amount 
of the rebates, discounts, or price concessions that 
are passed through to the plan sponsor, and the 
total number of prescriptions that were dispensed. 
‘‘(3) The aggregate amount of the difference 
between the amount the health benefits plan pays 
the PBM and the amount that the PBM pays retail 
pharmacies, and mail order pharmacies, and the 
total number of prescriptions that were dispensed. 
‘‘(c) CONFIDENTIALITY.—Information disclosed by a 
health benefits plan or PBM under this section is con-
fidential and shall not be disclosed by the Secretary or 
by a plan receiving the information, except that the Sec-
retary may disclose the information in a form which does 
not disclose the identity of a specific PBM, plan, or prices 
charged for drugs, for the following purposes: 
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•AMDT. NO. 2786 
‘‘(1) As the Secretary determines to be nec-
essary to carry out this section or part D of title 
XVIII. 
‘‘(2) To permit the Comptroller General to re-
view the information provided. 
‘‘(3) To permit the Director of the Congres-
sional Budget Office to review the information pro-
vided. 
‘‘(4) To States to carry out section 1311 of the 
Patient Protection and Affordable Care Act. 
‘‘(d) PENALTIES.—The provisions of subsection 
(b)(3)(C) of section 1927 shall apply to a health benefits 
plan or PBM that fails to provide information required 
under subsection (a) on a timely basis or that knowingly 
provides false information in the same manner as such 
provisions apply to a manufacturer with an agreement 
under that section.’’. 
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•AMDT. NO. 2786 
Subtitle B—Nursing Home 
Transparency and Improvement 
PART I—IMPROVING TRANSPARENCY OF 
INFORMATION 
SEC. 6101. REQUIRED DISCLOSURE OF OWNERSHIP AND 
ADDITIONAL DISCLOSABLE PARTIES INFOR-
MATION. 
(a) IN GENERAL.—Section 1124 of the Social Secu-
rity Act (42 U.S.C. 1320a–3) is amended by adding at 
the end the following new subsection: 
‘‘(c) REQUIRED DISCLOSURE OF OWNERSHIP AND 
ADDITIONAL DISCLOSABLE PARTIES INFORMATION.— 
‘‘(1) DISCLOSURE.—A facility shall have the in-
formation described in paragraph (2) available— 
‘‘(A) during the period beginning on the 
date of the enactment of this subsection and 
ending on the date such information is made 
available to the public under section 6101(b) of 
the Patient Protection and Affordable Care Act 
for submission to the Secretary, the Inspector 
General of the Department of Health and 
Human Services, the State in which the facility 
is located, and the State long-term care om-
budsman in the case where the Secretary, the 
Inspector General, the State, or the State long- 
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•AMDT. NO. 2786 
term care ombudsman requests such informa-
tion; and 
‘‘(B) beginning on the effective date of the 
final regulations promulgated under paragraph 
(3)(A), for reporting such information in ac-
cordance with such final regulations. 
Nothing in subparagraph (A) shall be construed as 
authorizing a facility to dispose of or delete informa-
tion described in such subparagraph after the effec-
tive date of the final regulations promulgated under 
paragraph (3)(A). 
‘‘(2) INFORMATION DESCRIBED.— 
‘‘(A) IN GENERAL.—The following infor-
mation is described in this paragraph: 
‘‘(i) The information described in sub-
sections (a) and (b), subject to subpara-
graph (C). 
‘‘(ii) The identity of and information 
on— 
‘‘(I) each member of the gov-
erning body of the facility, including 
the name, title, and period of service 
of each such member; 
‘‘(II) each person or entity who is 
an officer, director, member, partner, 
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•AMDT. NO. 2786 
trustee, or managing employee of the 
facility, including the name, title, and 
period of service of each such person 
or entity; and 
‘‘(III) each person or entity who 
is an additional disclosable party of 
the facility. 
‘‘(iii) The organizational structure of 
each additional disclosable party of the fa-
cility and a description of the relationship 
of each such additional disclosable party to 
the facility and to one another. 
‘‘(B) SPECIAL RULE WHERE INFORMATION 
IS
ALREADY
REPORTED
OR
SUBMITTED.—To 
the extent that information reported by a facil-
ity to the Internal Revenue Service on Form 
990, information submitted by a facility to the 
Securities and Exchange Commission, or infor-
mation otherwise submitted to the Secretary or 
any other Federal agency contains the informa-
tion described in clauses (i), (ii), or (iii) of sub-
paragraph (A), the facility may provide such 
Form or such information submitted to meet 
the requirements of paragraph (1). 
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•AMDT. NO. 2786 
‘‘(C) SPECIAL
RULE.—In applying sub-
paragraph (A)(i)— 
‘‘(i) with respect to subsections (a) 
and (b), ‘ownership or control interest’ 
shall include direct or indirect interests, in-
cluding such interests in intermediate enti-
ties; and 
‘‘(ii) subsection (a)(3)(A)(ii) shall in-
clude the owner of a whole or part interest 
in any mortgage, deed of trust, note, or 
other obligation secured, in whole or in 
part, by the entity or any of the property 
or assets thereof, if the interest is equal to 
or exceeds 5 percent of the total property 
or assets of the entirety. 
‘‘(3) REPORTING.— 
‘‘(A) IN
GENERAL.—Not later than the 
date that is 2 years after the date of the enact-
ment of this subsection, the Secretary shall pro-
mulgate final regulations requiring, effective on 
the date that is 90 days after the date on which 
such final regulations are published in the Fed-
eral Register, a facility to report the informa-
tion described in paragraph (2) to the Secretary 
in a standardized format, and such other regu-
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•AMDT. NO. 2786 
lations as are necessary to carry out this sub-
section. Such final regulations shall ensure that 
the facility certifies, as a condition of participa-
tion and payment under the program under 
title XVIII or XIX, that the information re-
ported by the facility in accordance with such 
final regulations is, to the best of the facility’s 
knowledge, accurate and current. 
‘‘(B) GUIDANCE.—The Secretary shall pro-
vide guidance and technical assistance to States 
on how to adopt the standardized format under 
subparagraph (A). 
‘‘(4) NO EFFECT ON EXISTING REPORTING RE-
QUIREMENTS.—Nothing in this subsection shall re-
duce, diminish, or alter any reporting requirement 
for a facility that is in effect as of the date of the 
enactment of this subsection. 
‘‘(5) DEFINITIONS.—In this subsection: 
‘‘(A) ADDITIONAL DISCLOSABLE PARTY.— 
The term ‘additional disclosable party’ means, 
with respect to a facility, any person or entity 
who— 
‘‘(i) exercises operational, financial, or 
managerial control over the facility or a 
part thereof, or provides policies or proce-
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•AMDT. NO. 2786 
dures for any of the operations of the facil-
ity, or provides financial or cash manage-
ment services to the facility; 
‘‘(ii) leases or subleases real property 
to the facility, or owns a whole or part in-
terest equal to or exceeding 5 percent of 
the total value of such real property; or 
‘‘(iii) provides management or admin-
istrative services, management or clinical 
consulting services, or accounting or finan-
cial services to the facility. 
‘‘(B) FACILITY.—The term ‘facility’ means 
a disclosing entity which is— 
‘‘(i) a skilled nursing facility (as de-
fined in section 1819(a)); or 
‘‘(ii) a nursing facility (as defined in 
section 1919(a)). 
‘‘(C) MANAGING
EMPLOYEE.—The term 
‘managing employee’ means, with respect to a 
facility, an individual (including a general man-
ager, business manager, administrator, director, 
or consultant) who directly or indirectly man-
ages, advises, or supervises any element of the 
practices, finances, or operations of the facility. 
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•AMDT. NO. 2786 
‘‘(D) ORGANIZATIONAL STRUCTURE.—The 
term ‘organizational structure’ means, in the 
case of— 
‘‘(i) a corporation, the officers, direc-
tors, and shareholders of the corporation 
who have an ownership interest in the cor-
poration which is equal to or exceeds 5 
percent; 
‘‘(ii) a limited liability company, the 
members and managers of the limited li-
ability company (including, as applicable, 
what percentage each member and man-
ager has of the ownership interest in the 
limited liability company); 
‘‘(iii) a general partnership, the part-
ners of the general partnership; 
‘‘(iv) a limited partnership, the gen-
eral partners and any limited partners of 
the limited partnership who have an own-
ership interest in the limited partnership 
which is equal to or exceeds 10 percent; 
‘‘(v) a trust, the trustees of the trust; 
‘‘(vi) an individual, contact informa-
tion for the individual; and 
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•AMDT. NO. 2786 
‘‘(vii) any other person or entity, such 
information as the Secretary determines 
appropriate.’’. 
(b) PUBLIC AVAILABILITY OF INFORMATION.—Not 
later than the date that is 1 year after the date on which 
the 
final 
regulations 
promulgated 
under 
section 
1124(c)(3)(A) of the Social Security Act, as added by sub-
section (a), are published in the Federal Register, the Sec-
retary of Health and Human Services shall make the in-
formation reported in accordance with such final regula-
tions available to the public in accordance with procedures 
established by the Secretary. 
(c) CONFORMING AMENDMENTS.— 
(1) IN GENERAL.— 
(A) SKILLED NURSING FACILITIES.—Sec-
tion 1819(d)(1) of the Social Security Act (42 
U.S.C. 1395i–3(d)(1)) is amended by striking 
subparagraph (B) and redesignating subpara-
graph (C) as subparagraph (B). 
(B) 
NURSING
FACILITIES.—Section 
1919(d)(1) of the Social Security Act (42 
U.S.C. 1396r(d)(1)) is amended by striking 
subparagraph (B) and redesignating subpara-
graph (C) as subparagraph (B). 
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•AMDT. NO. 2786 
(2) EFFECTIVE DATE.—The amendments made 
by paragraph (1) shall take effect on the date on 
which the Secretary makes the information described 
in subsection (b)(1) available to the public under 
such subsection. 
SEC. 6102. ACCOUNTABILITY REQUIREMENTS FOR SKILLED 
NURSING FACILITIES AND NURSING FACILI-
TIES. 
Part A of title XI of the Social Security Act (42 
U.S.C. 1301 et seq.), as amended by sections 6002 and 
6004, is amended by inserting after section 1128H the 
following new section: 
‘‘SEC. 1128I. ACCOUNTABILITY REQUIREMENTS FOR FACILI-
TIES. 
‘‘(a) DEFINITION OF FACILITY.—In this section, the 
term ‘facility’ means— 
‘‘(1) a skilled nursing facility (as defined in sec-
tion 1819(a)); or 
‘‘(2) a nursing facility (as defined in section 
1919(a)). 
‘‘(b) EFFECTIVE COMPLIANCE
AND ETHICS PRO-
GRAMS.— 
‘‘(1) REQUIREMENT.—On or after the date that 
is 36 months after the date of the enactment of this 
section, a facility shall, with respect to the entity 
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•AMDT. NO. 2786 
that operates the facility (in this subparagraph re-
ferred to as the ‘operating organization’ or ‘organi-
zation’), have in operation a compliance and ethics 
program that is effective in preventing and detecting 
criminal, civil, and administrative violations under 
this Act and in promoting quality of care consistent 
with regulations developed under paragraph (2). 
‘‘(2) DEVELOPMENT OF REGULATIONS.— 
‘‘(A) IN
GENERAL.—Not later than the 
date that is 2 years after such date of the en-
actment, the Secretary, working jointly with the 
Inspector General of the Department of Health 
and Human Services, shall promulgate regula-
tions for an effective compliance and ethics pro-
gram for operating organizations, which may 
include a model compliance program. 
‘‘(B) DESIGN
OF
REGULATIONS.—Such 
regulations with respect to specific elements or 
formality of a program shall, in the case of an 
organization that operates 5 or more facilities, 
vary with the size of the organization, such that 
larger organizations should have a more formal 
program and include established written policies 
defining the standards and procedures to be fol-
lowed by its employees. Such requirements may 
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•AMDT. NO. 2786 
specifically apply to the corporate level manage-
ment of multi unit nursing home chains. 
‘‘(C) EVALUATION.—Not later than 3 
years after the date of the promulgation of reg-
ulations under this paragraph, the Secretary 
shall complete an evaluation of the compliance 
and ethics programs required to be established 
under this subsection. Such evaluation shall de-
termine if such programs led to changes in defi-
ciency citations, changes in quality perform-
ance, or changes in other metrics of patient 
quality of care. The Secretary shall submit to 
Congress a report on such evaluation and shall 
include in such report such recommendations 
regarding changes in the requirements for such 
programs as the Secretary determines appro-
priate. 
‘‘(3) REQUIREMENTS
FOR
COMPLIANCE
AND 
ETHICS
PROGRAMS.—In this subsection, the term 
‘compliance and ethics program’ means, with respect 
to a facility, a program of the operating organization 
that— 
‘‘(A) has been reasonably designed, imple-
mented, and enforced so that it generally will be 
effective in preventing and detecting criminal, 
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•AMDT. NO. 2786 
civil, and administrative violations under this 
Act and in promoting quality of care; and 
‘‘(B) includes at least the required compo-
nents specified in paragraph (4). 
‘‘(4) REQUIRED COMPONENTS OF PROGRAM.— 
The required components of a compliance and ethics 
program of an operating organization are the fol-
lowing: 
‘‘(A) The organization must have estab-
lished compliance standards and procedures to 
be followed by its employees and other agents 
that are reasonably capable of reducing the 
prospect of criminal, civil, and administrative 
violations under this Act. 
‘‘(B) Specific individuals within high-level 
personnel of the organization must have been 
assigned overall responsibility to oversee compli-
ance with such standards and procedures and 
have sufficient resources and authority to as-
sure such compliance. 
‘‘(C) The organization must have used due 
care not to delegate substantial discretionary 
authority to individuals whom the organization 
knew, or should have known through the exer-
cise of due diligence, had a propensity to en-
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•AMDT. NO. 2786 
gage in criminal, civil, and administrative viola-
tions under this Act. 
‘‘(D) The organization must have taken 
steps to communicate effectively its standards 
and procedures to all employees and other 
agents, such as by requiring participation in 
training programs or by disseminating publica-
tions that explain in a practical manner what is 
required. 
‘‘(E) The organization must have taken 
reasonable steps to achieve compliance with its 
standards, such as by utilizing monitoring and 
auditing systems reasonably designed to detect 
criminal, civil, and administrative violations 
under this Act by its employees and other 
agents and by having in place and publicizing 
a reporting system whereby employees and 
other agents could report violations by others 
within the organization without fear of retribu-
tion. 
‘‘(F) The standards must have been con-
sistently enforced through appropriate discipli-
nary mechanisms, including, as appropriate, 
discipline of individuals responsible for the fail-
ure to detect an offense. 
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•AMDT. NO. 2786 
‘‘(G) After an offense has been detected, 
the organization must have taken all reasonable 
steps to respond appropriately to the offense 
and to prevent further similar offenses, includ-
ing any necessary modification to its program 
to prevent and detect criminal, civil, and admin-
istrative violations under this Act. 
‘‘(H) The organization must periodically 
undertake reassessment of its compliance pro-
gram to identify changes necessary to reflect 
changes within the organization and its facili-
ties. 
‘‘(c) QUALITY ASSURANCE AND PERFORMANCE IM-
PROVEMENT PROGRAM.— 
‘‘(1) IN GENERAL.—Not later than December 
31, 2011, the Secretary shall establish and imple-
ment a quality assurance and performance improve-
ment program (in this subparagraph referred to as 
the ‘QAPI program’) for facilities, including multi 
unit chains of facilities. Under the QAPI program, 
the Secretary shall establish standards relating to 
quality assurance and performance improvement 
with respect to facilities and provide technical assist-
ance to facilities on the development of best prac-
tices in order to meet such standards. Not later than 
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•AMDT. NO. 2786 
1 year after the date on which the regulations are 
promulgated under paragraph (2), a facility must 
submit to the Secretary a plan for the facility to 
meet such standards and implement such best prac-
tices, including how to coordinate the implementa-
tion of such plan with quality assessment and assur-
ance 
activities 
conducted 
under 
sections 
1819(b)(1)(B) and 1919(b)(1)(B), as applicable. 
‘‘(2) REGULATIONS.—The Secretary shall pro-
mulgate regulations to carry out this subsection.’’. 
SEC. 6103. NURSING HOME COMPARE MEDICARE WEBSITE. 
(a) SKILLED NURSING FACILITIES.— 
(1) IN GENERAL.—Section 1819 of the Social 
Security Act (42 U.S.C. 1395i–3) is amended— 
(A) by redesignating subsection (i) as sub-
section (j); and 
(B) by inserting after subsection (h) the 
following new subsection: 
‘‘(i) NURSING HOME COMPARE WEBSITE.— 
‘‘(1) INCLUSION
OF
ADDITIONAL
INFORMA-
TION.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
ensure that the Department of Health and 
Human Services includes, as part of the infor-
mation provided for comparison of nursing 
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•AMDT. NO. 2786 
homes on the official Internet website of the 
Federal Government for Medicare beneficiaries 
(commonly referred to as the ‘Nursing Home 
Compare’ Medicare website) (or a successor 
website), the following information in a manner 
that is prominent, updated on a timely basis, 
easily accessible, readily understandable to con-
sumers of long-term care services, and search-
able: 
‘‘(i) Staffing data for each facility (in-
cluding resident census data and data on 
the hours of care provided per resident per 
day) based on data submitted under sec-
tion 1128I(g), including information on 
staffing turnover and tenure, in a format 
that is clearly understandable to con-
sumers of long-term care services and al-
lows such consumers to compare dif-
ferences in staffing between facilities and 
State and national averages for the facili-
ties. Such format shall include— 
‘‘(I) concise explanations of how 
to interpret the data (such as a plain 
English explanation of data reflecting 
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•AMDT. NO. 2786 
‘nursing home staff hours per resident 
day’); 
‘‘(II) differences in types of staff 
(such as training associated with dif-
ferent categories of staff); 
‘‘(III) the relationship between 
nurse staffing levels and quality of 
care; and 
‘‘(IV) an explanation that appro-
priate staffing levels vary based on 
patient case mix. 
‘‘(ii) Links to State Internet websites 
with information regarding State survey 
and certification programs, links to Form 
2567 State inspection reports (or a suc-
cessor form) on such websites, information 
to guide consumers in how to interpret and 
understand such reports, and the facility 
plan of correction or other response to 
such report. Any such links shall be posted 
on a timely basis. 
‘‘(iii) The standardized complaint 
form developed under section 1128I(f), in-
cluding explanatory material on what com-
plaint forms are, how they are used, and 
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•AMDT. NO. 2786 
how to file a complaint with the State sur-
vey and certification program and the 
State long-term care ombudsman program. 
‘‘(iv) Summary information on the 
number, type, severity, and outcome of 
substantiated complaints. 
‘‘(v) The number of adjudicated in-
stances of criminal violations by a facility 
or the employees of a facility— 
‘‘(I) that were committed inside 
the facility; 
‘‘(II) with respect to such in-
stances of violations or crimes com-
mitted inside of the facility that were 
the violations or crimes of abuse, ne-
glect, and exploitation, criminal sexual 
abuse, or other violations or crimes 
that resulted in serious bodily injury; 
and 
‘‘(III) the number of civil mone-
tary penalties levied against the facil-
ity, employees, contractors, and other 
agents. 
‘‘(B) DEADLINE FOR PROVISION OF INFOR-
MATION.— 
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•AMDT. NO. 2786 
‘‘(i) IN
GENERAL.—Except as pro-
vided in clause (ii), the Secretary shall en-
sure that the information described in sub-
paragraph (A) is included on such website 
(or a successor website) not later than 1 
year after the date of the enactment of this 
subsection. 
‘‘(ii) 
EXCEPTION.—The 
Secretary 
shall ensure that the information described 
in subparagraph (A)(i) is included on such 
website (or a successor website) not later 
than the date on which the requirements 
under section 1128I(g) are implemented. 
‘‘(2) 
REVIEW
AND
MODIFICATION
OF 
WEBSITE.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
establish a process— 
‘‘(i) to review the accuracy, clarity of 
presentation, timeliness, and comprehen-
siveness of information reported on such 
website as of the day before the date of the 
enactment of this subsection; and 
‘‘(ii) not later than 1 year after the 
date of the enactment of this subsection, to 
modify or revamp such website in accord-
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•AMDT. NO. 2786 
ance with the review conducted under 
clause (i). 
‘‘(B) CONSULTATION.—In conducting the 
review under subparagraph (A)(i), the Sec-
retary shall consult with— 
‘‘(i) State long-term care ombudsman 
programs; 
‘‘(ii) consumer advocacy groups; 
‘‘(iii) provider stakeholder groups; and 
‘‘(iv) any other representatives of pro-
grams or groups the Secretary determines 
appropriate.’’. 
(2) TIMELINESS
OF
SUBMISSION
OF
SURVEY 
AND CERTIFICATION INFORMATION.— 
(A) IN GENERAL.—Section 1819(g)(5) of 
the Social Security Act (42 U.S.C. 1395i– 
3(g)(5)) is amended by adding at the end the 
following new subparagraph: 
‘‘(E) SUBMISSION OF SURVEY AND CER-
TIFICATION
INFORMATION
TO
THE
SEC-
RETARY.—In order to improve the timeliness of 
information made available to the public under 
subparagraph (A) and provided on the Nursing 
Home Compare Medicare website under sub-
section (i), each State shall submit information 
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•AMDT. NO. 2786 
respecting any survey or certification made re-
specting a skilled nursing facility (including any 
enforcement actions taken by the State) to the 
Secretary not later than the date on which the 
State sends such information to the facility. 
The Secretary shall use the information sub-
mitted under the preceding sentence to update 
the information provided on the Nursing Home 
Compare Medicare website as expeditiously as 
practicable but not less frequently than quar-
terly.’’. 
(B) EFFECTIVE
DATE.—The amendment 
made by this paragraph shall take effect 1 year 
after the date of the enactment of this Act. 
(3) SPECIAL FOCUS FACILITY PROGRAM.—Sec-
tion 1819(f) of the Social Security Act (42 U.S.C. 
1395i–3(f)) is amended by adding at the end the fol-
lowing new paragraph: 
‘‘(8) SPECIAL FOCUS FACILITY PROGRAM.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
conduct a special focus facility program for en-
forcement of requirements for skilled nursing 
facilities that the Secretary has identified as 
having substantially failed to meet applicable 
requirement of this Act. 
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•AMDT. NO. 2786 
‘‘(B) PERIODIC
SURVEYS.—Under such 
program the Secretary shall conduct surveys of 
each facility in the program not less than once 
every 6 months.’’. 
(b) NURSING FACILITIES.— 
(1) IN GENERAL.—Section 1919 of the Social 
Security Act (42 U.S.C. 1396r) is amended— 
(A) by redesignating subsection (i) as sub-
section (j); and 
(B) by inserting after subsection (h) the 
following new subsection: 
‘‘(i) NURSING HOME COMPARE WEBSITE.— 
‘‘(1) INCLUSION
OF
ADDITIONAL
INFORMA-
TION.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
ensure that the Department of Health and 
Human Services includes, as part of the infor-
mation provided for comparison of nursing 
homes on the official Internet website of the 
Federal Government for Medicare beneficiaries 
(commonly referred to as the ‘Nursing Home 
Compare’ Medicare website) (or a successor 
website), the following information in a manner 
that is prominent, updated on a timely basis, 
easily accessible, readily understandable to con-
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•AMDT. NO. 2786 
sumers of long-term care services, and search-
able: 
‘‘(i) Staffing data for each facility (in-
cluding resident census data and data on 
the hours of care provided per resident per 
day) based on data submitted under sec-
tion 1128I(g), including information on 
staffing turnover and tenure, in a format 
that is clearly understandable to con-
sumers of long-term care services and al-
lows such consumers to compare dif-
ferences in staffing between facilities and 
State and national averages for the facili-
ties. Such format shall include— 
‘‘(I) concise explanations of how 
to interpret the data (such as plain 
English explanation of data reflecting 
‘nursing home staff hours per resident 
day’); 
‘‘(II) differences in types of staff 
(such as training associated with dif-
ferent categories of staff); 
‘‘(III) the relationship between 
nurse staffing levels and quality of 
care; and 
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•AMDT. NO. 2786 
‘‘(IV) an explanation that appro-
priate staffing levels vary based on 
patient case mix. 
‘‘(ii) Links to State Internet websites 
with information regarding State survey 
and certification programs, links to Form 
2567 State inspection reports (or a suc-
cessor form) on such websites, information 
to guide consumers in how to interpret and 
understand such reports, and the facility 
plan of correction or other response to 
such report. Any such links shall be posted 
on a timely basis. 
‘‘(iii) The standardized complaint 
form developed under section 1128I(f), in-
cluding explanatory material on what com-
plaint forms are, how they are used, and 
how to file a complaint with the State sur-
vey and certification program and the 
State long-term care ombudsman program. 
‘‘(iv) Summary information on the 
number, type, severity, and outcome of 
substantiated complaints. 
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•AMDT. NO. 2786 
‘‘(v) The number of adjudicated in-
stances of criminal violations by a facility 
or the employees of a facility— 
‘‘(I) that were committed inside 
of the facility; and 
‘‘(II) with respect to such in-
stances of violations or crimes com-
mitted outside of the facility, that 
were violations or crimes that resulted 
in the serious bodily injury of an 
elder. 
‘‘(B) DEADLINE FOR PROVISION OF INFOR-
MATION.— 
‘‘(i) IN
GENERAL.—Except as pro-
vided in clause (ii), the Secretary shall en-
sure that the information described in sub-
paragraph (A) is included on such website 
(or a successor website) not later than 1 
year after the date of the enactment of this 
subsection. 
‘‘(ii) 
EXCEPTION.—The 
Secretary 
shall ensure that the information described 
in subparagraph (A)(i) is included on such 
website (or a successor website) not later 
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•AMDT. NO. 2786 
than the date on which the requirements 
under section 1128I(g) are implemented. 
‘‘(2) 
REVIEW
AND
MODIFICATION
OF 
WEBSITE.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
establish a process— 
‘‘(i) to review the accuracy, clarity of 
presentation, timeliness, and comprehen-
siveness of information reported on such 
website as of the day before the date of the 
enactment of this subsection; and 
‘‘(ii) not later than 1 year after the 
date of the enactment of this subsection, to 
modify or revamp such website in accord-
ance with the review conducted under 
clause (i). 
‘‘(B) CONSULTATION.—In conducting the 
review under subparagraph (A)(i), the Sec-
retary shall consult with— 
‘‘(i) State long-term care ombudsman 
programs; 
‘‘(ii) consumer advocacy groups; 
‘‘(iii) provider stakeholder groups; 
‘‘(iv) skilled nursing facility employees 
and their representatives; and 
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•AMDT. NO. 2786 
‘‘(v) any other representatives of pro-
grams or groups the Secretary determines 
appropriate.’’. 
(2) TIMELINESS
OF
SUBMISSION
OF
SURVEY 
AND CERTIFICATION INFORMATION.— 
(A) IN GENERAL.—Section 1919(g)(5) of 
the Social Security Act (42 U.S.C. 1396r(g)(5)) 
is amended by adding at the end the following 
new subparagraph: 
‘‘(E) SUBMISSION OF SURVEY AND CER-
TIFICATION
INFORMATION
TO
THE
SEC-
RETARY.—In order to improve the timeliness of 
information made available to the public under 
subparagraph (A) and provided on the Nursing 
Home Compare Medicare website under sub-
section (i), each State shall submit information 
respecting any survey or certification made re-
specting a nursing facility (including any en-
forcement actions taken by the State) to the 
Secretary not later than the date on which the 
State sends such information to the facility. 
The Secretary shall use the information sub-
mitted under the preceding sentence to update 
the information provided on the Nursing Home 
Compare Medicare website as expeditiously as 
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•AMDT. NO. 2786 
practicable but not less frequently than quar-
terly.’’. 
(B) EFFECTIVE
DATE.—The amendment 
made by this paragraph shall take effect 1 year 
after the date of the enactment of this Act. 
(3) SPECIAL FOCUS FACILITY PROGRAM.—Sec-
tion 1919(f) of the Social Security Act (42 U.S.C. 
1396r(f)) is amended by adding at the end of the 
following new paragraph: 
‘‘(10) SPECIAL FOCUS FACILITY PROGRAM.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
conduct a special focus facility program for en-
forcement of requirements for nursing facilities 
that the Secretary has identified as having sub-
stantially failed to meet applicable requirements 
of this Act. 
‘‘(B) PERIODIC
SURVEYS.—Under such 
program the Secretary shall conduct surveys of 
each facility in the program not less often than 
once every 6 months.’’. 
(c) AVAILABILITY OF REPORTS ON SURVEYS, CER-
TIFICATIONS, AND COMPLAINT INVESTIGATIONS.— 
(1) SKILLED
NURSING
FACILITIES.—Section 
1819(d)(1) of the Social Security Act (42 U.S.C. 
1395i–3(d)(1)), as amended by section 6101, is 
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•AMDT. NO. 2786 
amended by adding at the end the following new 
subparagraph: 
‘‘(C) AVAILABILITY OF SURVEY, CERTIFI-
CATION, AND COMPLAINT INVESTIGATION RE-
PORTS.—A skilled nursing facility must— 
‘‘(i) have reports with respect to any 
surveys, certifications, and complaint in-
vestigations made respecting the facility 
during the 3 preceding years available for 
any individual to review upon request; and 
‘‘(ii) post notice of the availability of 
such reports in areas of the facility that 
are prominent and accessible to the public. 
The facility shall not make available under 
clause (i) identifying information about com-
plainants or residents.’’. 
(2) NURSING FACILITIES.—Section 1919(d)(1) 
of the Social Security Act (42 U.S.C. 1396r(d)(1)), 
as amended by section 6101, is amended by adding 
at the end the following new subparagraph: 
‘‘(V) AVAILABILITY OF SURVEY, CERTIFI-
CATION, AND COMPLAINT INVESTIGATION RE-
PORTS.—A nursing facility must— 
‘‘(i) have reports with respect to any 
surveys, certifications, and complaint in-
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•AMDT. NO. 2786 
vestigations made respecting the facility 
during the 3 preceding years available for 
any individual to review upon request; and 
‘‘(ii) post notice of the availability of 
such reports in areas of the facility that 
are prominent and accessible to the public. 
The facility shall not make available under 
clause (i) identifying information about com-
plainants or residents.’’. 
(3) EFFECTIVE DATE.—The amendments made 
by this subsection shall take effect 1 year after the 
date of the enactment of this Act. 
(d) GUIDANCE TO STATES ON FORM 2567 STATE IN-
SPECTION REPORTS AND COMPLAINT INVESTIGATION RE-
PORTS.— 
(1) GUIDANCE.—The Secretary of Health and 
Human Services (in this subtitle referred to as the 
‘‘Secretary’’) shall provide guidance to States on 
how States can establish electronic links to Form 
2567 State inspection reports (or a successor form), 
complaint investigation reports, and a facility’s plan 
of correction or other response to such Form 2567 
State inspection reports (or a successor form) on the 
Internet website of the State that provides informa-
tion on skilled nursing facilities and nursing facili-
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•AMDT. NO. 2786 
ties and the Secretary shall, if possible, include such 
information on Nursing Home Compare. 
(2) REQUIREMENT.—Section 1902(a)(9) of the 
Social Security Act (42 U.S.C. 1396a(a)(9)) is 
amended— 
(A) by striking ‘‘and’’ at the end of sub-
paragraph (B); 
(B) by striking the semicolon at the end of 
subparagraph (C) and inserting ‘‘, and’’; and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(D) that the State maintain a consumer- 
oriented website providing useful information to 
consumers regarding all skilled nursing facili-
ties and all nursing facilities in the State, in-
cluding for each facility, Form 2567 State in-
spection reports (or a successor form), com-
plaint investigation reports, the facility’s plan of 
correction, and such other information that the 
State or the Secretary considers useful in as-
sisting the public to assess the quality of long 
term care options and the quality of care pro-
vided by individual facilities;’’. 
(3) DEFINITIONS.—In this subsection: 
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•AMDT. NO. 2786 
(A) NURSING FACILITY.—The term ‘‘nurs-
ing facility’’ has the meaning given such term 
in section 1919(a) of the Social Security Act 
(42 U.S.C. 1396r(a)). 
(B) SECRETARY.—The term ‘‘Secretary’’ 
means the Secretary of Health and Human 
Services. 
(C) SKILLED
NURSING
FACILITY.—The 
term ‘‘skilled nursing facility’’ has the meaning 
given such term in section 1819(a) of the Social 
Security Act (42 U.S.C. 1395i–3(a)). 
(e) DEVELOPMENT OF CONSUMER RIGHTS INFORMA-
TION PAGE ON NURSING HOME COMPARE WEBSITE.— 
Not later than 1 year after the date of enactment of this 
Act, the Secretary shall ensure that the Department of 
Health and Human Services, as part of the information 
provided for comparison of nursing facilities on the Nurs-
ing Home Compare Medicare website develops and in-
cludes a consumer rights information page that contains 
links to descriptions of, and information with respect to, 
the following: 
(1) The documentation on nursing facilities 
that is available to the public. 
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•AMDT. NO. 2786 
(2) General information and tips on choosing a 
nursing facility that meets the needs of the indi-
vidual. 
(3) General information on consumer rights 
with respect to nursing facilities. 
(4) The nursing facility survey process (on a 
national and State-specific basis). 
(5) On a State-specific basis, the services avail-
able through the State long-term care ombudsman 
for such State. 
SEC. 6104. REPORTING OF EXPENDITURES. 
Section 1888 of the Social Security Act (42 U.S.C. 
1395yy) is amended by adding at the end the following 
new subsection: 
‘‘(f) REPORTING
OF
DIRECT
CARE
EXPENDI-
TURES.— 
‘‘(1) IN GENERAL.—For cost reports submitted 
under this title for cost reporting periods beginning 
on or after the date that is 2 years after the date 
of the enactment of this subsection, skilled nursing 
facilities shall separately report expenditures for 
wages and benefits for direct care staff (breaking 
out (at a minimum) registered nurses, licensed pro-
fessional nurses, certified nurse assistants, and other 
medical and therapy staff). 
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•AMDT. NO. 2786 
‘‘(2) MODIFICATION OF FORM.—The Secretary, 
in consultation with private sector accountants expe-
rienced with Medicare and Medicaid nursing facility 
home cost reports, shall redesign such reports to 
meet the requirement of paragraph (1) not later 
than 1 year after the date of the enactment of this 
subsection. 
‘‘(3) CATEGORIZATION
BY
FUNCTIONAL
AC-
COUNTS.—Not later than 30 months after the date 
of the enactment of this subsection, the Secretary, 
working in consultation with the Medicare Payment 
Advisory Commission, the Medicaid and CHIP Pay-
ment and Access Commission, the Inspector General 
of the Department of Health and Human Services, 
and other expert parties the Secretary determines 
appropriate, shall take the expenditures listed on 
cost reports, as modified under paragraph (1), sub-
mitted by skilled nursing facilities and categorize 
such expenditures, regardless of any source of pay-
ment for such expenditures, for each skilled nursing 
facility into the following functional accounts on an 
annual basis: 
‘‘(A) Spending on direct care services (in-
cluding nursing, therapy, and medical services). 
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•AMDT. NO. 2786 
‘‘(B) Spending on indirect care (including 
housekeeping and dietary services). 
‘‘(C) Capital assets (including building and 
land costs). 
‘‘(D) Administrative services costs. 
‘‘(4) AVAILABILITY
OF
INFORMATION
SUB-
MITTED.—The Secretary shall establish procedures 
to make information on expenditures submitted 
under this subsection readily available to interested 
parties upon request, subject to such requirements 
as the Secretary may specify under the procedures 
established under this paragraph.’’. 
SEC. 6105. STANDARDIZED COMPLAINT FORM. 
(a) IN GENERAL.—Section 1128I of the Social Secu-
rity Act, as added and amended by this Act, is amended 
by adding at the end the following new subsection: 
‘‘(f) STANDARDIZED COMPLAINT FORM.— 
‘‘(1) DEVELOPMENT BY THE SECRETARY.—The 
Secretary shall develop a standardized complaint 
form for use by a resident (or a person acting on the 
resident’s behalf) in filing a complaint with a State 
survey and certification agency and a State long- 
term care ombudsman program with respect to a fa-
cility. 
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•AMDT. NO. 2786 
‘‘(2) COMPLAINT
FORMS
AND
RESOLUTION 
PROCESSES.— 
‘‘(A) COMPLAINT FORMS.—The State must 
make the standardized complaint form devel-
oped under paragraph (1) available upon re-
quest to— 
‘‘(i) a resident of a facility; and 
‘‘(ii) any person acting on the resi-
dent’s behalf. 
‘‘(B) COMPLAINT RESOLUTION PROCESS.— 
The State must establish a complaint resolution 
process in order to ensure that the legal rep-
resentative of a resident of a facility or other 
responsible party is not denied access to such 
resident or otherwise retaliated against if they 
have complained about the quality of care pro-
vided by the facility or other issues relating to 
the facility. Such complaint resolution process 
shall include— 
‘‘(i) procedures to assure accurate 
tracking of complaints received, including 
notification to the complainant that a com-
plaint has been received; 
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•AMDT. NO. 2786 
‘‘(ii) procedures to determine the like-
ly severity of a complaint and for the in-
vestigation of the complaint; and 
‘‘(iii) deadlines for responding to a 
complaint and for notifying the complain-
ant of the outcome of the investigation. 
‘‘(3) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed as preventing a 
resident of a facility (or a person acting on the resi-
dent’s behalf) from submitting a complaint in a 
manner or format other than by using the standard-
ized complaint form developed under paragraph (1) 
(including submitting a complaint orally).’’. 
(b) EFFECTIVE DATE.—The amendment made by 
this section shall take effect 1 year after the date of the 
enactment of this Act. 
SEC. 6106. ENSURING STAFFING ACCOUNTABILITY. 
Section 1128I of the Social Security Act, as added 
and amended by this Act, is amended by adding at the 
end the following new subsection: 
‘‘(g) SUBMISSION
OF
STAFFING
INFORMATION 
BASED ON PAYROLL DATA IN A UNIFORM FORMAT.—Be-
ginning not later than 2 years after the date of the enact-
ment of this subsection, and after consulting with State 
long-term care ombudsman programs, consumer advocacy 
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•AMDT. NO. 2786 
groups, provider stakeholder groups, employees and their 
representatives, and other parties the Secretary deems ap-
propriate, the Secretary shall require a facility to elec-
tronically submit to the Secretary direct care staffing in-
formation (including information with respect to agency 
and contract staff) based on payroll and other verifiable 
and auditable data in a uniform format (according to spec-
ifications established by the Secretary in consultation with 
such programs, groups, and parties). Such specifications 
shall require that the information submitted under the 
preceding sentence— 
‘‘(1) specify the category of work a certified em-
ployee performs (such as whether the employee is a 
registered nurse, licensed practical nurse, licensed 
vocational nurse, certified nursing assistant, thera-
pist, or other medical personnel); 
‘‘(2) include resident census data and informa-
tion on resident case mix; 
‘‘(3) include a regular reporting schedule; and 
‘‘(4) include information on employee turnover 
and tenure and on the hours of care provided by 
each category of certified employees referenced in 
paragraph (1) per resident per day. 
Nothing in this subsection shall be construed as pre-
venting the Secretary from requiring submission of such 
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•AMDT. NO. 2786 
information with respect to specific categories, such as 
nursing staff, before other categories of certified employ-
ees. Information under this subsection with respect to 
agency and contract staff shall be kept separate from in-
formation on employee staffing.’’. 
SEC. 6107. GAO STUDY AND REPORT ON FIVE-STAR QUAL-
ITY RATING SYSTEM. 
(a) STUDY.—The Comptroller General of the United 
States (in this section referred to as the ‘‘Comptroller 
General’’) shall conduct a study on the Five-Star Quality 
Rating System for nursing homes of the Centers for Medi-
care & Medicaid Services. Such study shall include an 
analysis of— 
(1) how such system is being implemented; 
(2) any problems associated with such system 
or its implementation; and 
(3) how such system could be improved. 
(b) REPORT.—Not later than 2 years 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 subsection (a), together with rec-
ommendations for such legislation and administrative ac-
tion as the Comptroller General determines appropriate. 
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•AMDT. NO. 2786 
PART II—TARGETING ENFORCEMENT 
SEC. 6111. CIVIL MONEY PENALTIES. 
(a) SKILLED NURSING FACILITIES.— 
(1) IN GENERAL.—Section 1819(h)(2)(B)(ii) of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395i– 
3(h)(2)(B)(ii)) is amended— 
(A) by striking ‘‘PENALTIES.—The Sec-
retary’’ and inserting ‘‘PENALTIES.— 
‘‘(I) IN
GENERAL.—Subject to 
subclause (II), the Secretary’’; and 
(B) by adding at the end the following new 
subclauses: 
‘‘(II) 
REDUCTION
OF
CIVIL 
MONEY PENALTIES IN CERTAIN CIR-
CUMSTANCES.—Subject to subclause 
(III), in the case where a facility self- 
reports and promptly corrects a defi-
ciency for which a penalty was im-
posed under this clause not later than 
10 calendar days after the date of 
such imposition, the Secretary may 
reduce the amount of the penalty im-
posed by not more than 50 percent. 
‘‘(III) PROHIBITIONS ON REDUC-
TION FOR CERTAIN DEFICIENCIES.— 
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•AMDT. NO. 2786 
‘‘(aa) 
REPEAT
DEFI-
CIENCIES.—The Secretary may 
not reduce the amount of a pen-
alty under subclause (II) if the 
Secretary had reduced a penalty 
imposed on the facility in the 
preceding year under such sub-
clause with respect to a repeat 
deficiency. 
‘‘(bb) CERTAIN OTHER DE-
FICIENCIES.—The Secretary may 
not reduce the amount of a pen-
alty under subclause (II) if the 
penalty is imposed on the facility 
for a deficiency that is found to 
result in a pattern of harm or 
widespread harm, immediately 
jeopardizes the health or safety 
of a resident or residents of the 
facility, or results in the death of 
a resident of the facility. 
‘‘(IV) COLLECTION
OF
CIVIL 
MONEY PENALTIES.—In the case of a 
civil money penalty imposed under 
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•AMDT. NO. 2786 
this clause, the Secretary shall issue 
regulations that— 
‘‘(aa) subject to item (cc), 
not later than 30 days after the 
imposition of the penalty, provide 
for the facility to have the oppor-
tunity to participate in an inde-
pendent informal dispute resolu-
tion process which generates a 
written record prior to the collec-
tion of such penalty; 
‘‘(bb) in the case where the 
penalty is imposed for each day 
of noncompliance, provide that a 
penalty may not be imposed for 
any day during the period begin-
ning on the initial day of the im-
position of the penalty and end-
ing on the day on which the in-
formal dispute resolution process 
under item (aa) is completed; 
‘‘(cc) may provide for the 
collection of such civil money 
penalty and the placement of 
such amounts collected in an es-
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•AMDT. NO. 2786 
(1) IN GENERAL.—Section 1919(h)(3)(C)(ii) of 
the Social Security Act (42 U.S.C. 1396r(h)(3)(C)) 
is amended— 
(A) by striking ‘‘PENALTIES.—The Sec-
retary’’ and inserting ‘‘PENALTIES.— 
‘‘(I) IN
GENERAL.—Subject to 
subclause (II), the Secretary’’; and 
(B) by adding at the end the following new 
subclauses: 
‘‘(II) 
REDUCTION
OF
CIVIL 
MONEY PENALTIES IN CERTAIN CIR-
CUMSTANCES.—Subject to subclause 
(III), in the case where a facility self- 
reports and promptly corrects a defi-
ciency for which a penalty was im-
posed under this clause not later than 
10 calendar days after the date of 
such imposition, the Secretary may 
reduce the amount of the penalty im-
posed by not more than 50 percent. 
‘‘(III) PROHIBITIONS ON REDUC-
TION FOR CERTAIN DEFICIENCIES.— 
‘‘(aa) 
REPEAT
DEFI-
CIENCIES.—The Secretary may 
not reduce the amount of a pen-
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•AMDT. NO. 2786 
imposition of the penalty, provide 
for the facility to have the oppor-
tunity to participate in an inde-
pendent informal dispute resolu-
tion process which generates a 
written record prior to the collec-
tion of such penalty; 
‘‘(bb) in the case where the 
penalty is imposed for each day 
of noncompliance, provide that a 
penalty may not be imposed for 
any day during the period begin-
ning on the initial day of the im-
position of the penalty and end-
ing on the day on which the in-
formal dispute resolution process 
under item (aa) is completed; 
‘‘(cc) may provide for the 
collection of such civil money 
penalty and the placement of 
such amounts collected in an es-
crow account under the direction 
of the Secretary on the earlier of 
the date on which the informal 
dispute resolution process under 
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•AMDT. NO. 2786 
item (aa) is completed or the 
date that is 90 days after the 
date of the imposition of the pen-
alty; 
‘‘(dd) may provide that such 
amounts collected are kept in 
such account pending the resolu-
tion of any subsequent appeals; 
‘‘(ee) in the case where the 
facility successfully appeals the 
penalty, may provide for the re-
turn of such amounts collected 
(plus interest) to the facility; and 
‘‘(ff) in the case where all 
such appeals are unsuccessful, 
may provide that some portion of 
such amounts collected may be 
used to support activities that 
benefit residents, including as-
sistance to support and protect 
residents of a facility that closes 
(voluntarily or involuntarily) or is 
decertified (including offsetting 
costs of relocating residents to 
home and community-based set-
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•AMDT. NO. 2786 
tings or another facility), projects 
that support resident and family 
councils and other consumer in-
volvement in assuring quality 
care in facilities, and facility im-
provement initiatives approved by 
the Secretary (including joint 
training of facility staff and sur-
veyors, technical assistance for 
facilities implementing quality as-
surance programs, the appoint-
ment of temporary management 
firms, and other activities ap-
proved by the Secretary).’’. 
(2) 
CONFORMING
AMENDMENT.—Section 
1919(h)(5)(8) of the Social Security Act (42 U.S.C. 
1396r(h)(5)(8)) is amended by inserting ‘‘(ii)(IV),’’ 
after ‘‘(i),’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect 1 year after the date of the 
enactment of this Act. 
SEC. 
6112. 
NATIONAL 
INDEPENDENT 
MONITOR 
DEM-
ONSTRATION PROJECT. 
(a) ESTABLISHMENT.— 
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•AMDT. NO. 2786 
(1) IN GENERAL.—The Secretary, in consulta-
tion with the Inspector General of the Department 
of Health and Human Services, shall conduct a dem-
onstration project to develop, test, and implement an 
independent monitor program to oversee interstate 
and large intrastate chains of skilled nursing facili-
ties and nursing facilities. 
(2) SELECTION.—The Secretary shall select 
chains of skilled nursing facilities and nursing facili-
ties described in paragraph (1) to participate in the 
demonstration project under this section from 
among those chains that submit an application to 
the Secretary at such time, in such manner, and 
containing such information as the Secretary may 
require. 
(3) DURATION.—The Secretary shall conduct 
the demonstration project under this section for a 2- 
year period. 
(4) IMPLEMENTATION.—The Secretary shall 
implement the demonstration project under this sec-
tion not later than 1 year after the date of the en-
actment of this Act. 
(b) REQUIREMENTS.—The Secretary shall evaluate 
chains selected to participate in the demonstration project 
under this section based on criteria selected by the Sec-
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•AMDT. NO. 2786 
retary, including where evidence suggests that a number 
of the facilities of the chain are experiencing serious safety 
and quality of care problems. Such criteria may include 
the evaluation of a chain that includes a number of facili-
ties participating in the ‘‘Special Focus Facility’’ program 
(or a successor program) or multiple facilities with a 
record of repeated serious safety and quality of care defi-
ciencies. 
(c) RESPONSIBILITIES.—An independent monitor 
that enters into a contract with the Secretary to partici-
pate in the conduct of the demonstration project under 
this section shall— 
(1) conduct periodic reviews and prepare root- 
cause quality and deficiency analyses of a chain to 
assess if facilities of the chain are in compliance 
with State and Federal laws and regulations applica-
ble to the facilities; 
(2) conduct sustained oversight of the efforts of 
the chain, whether publicly or privately held, to 
achieve compliance by facilities of the chain with 
State and Federal laws and regulations applicable to 
the facilities; 
(3) analyze the management structure, distribu-
tion of expenditures, and nurse staffing levels of fa-
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•AMDT. NO. 2786 
cilities of the chain in relation to resident census, 
staff turnover rates, and tenure; 
(4) report findings and recommendations with 
respect to such reviews, analyses, and oversight to 
the chain and facilities of the chain, to the Sec-
retary, and to relevant States; and 
(5) publish the results of such reviews, anal-
yses, and oversight. 
(d) IMPLEMENTATION OF RECOMMENDATIONS.— 
(1) RECEIPT OF FINDING BY CHAIN.—Not later 
than 10 days after receipt of a finding of an inde-
pendent monitor under subsection (c)(4), a chain 
participating in the demonstration project shall sub-
mit to the independent monitor a report— 
(A) outlining corrective actions the chain 
will take to implement the recommendations in 
such report; or 
(B) indicating that the chain will not im-
plement such recommendations, and why it will 
not do so. 
(2) RECEIPT
OF
REPORT
BY
INDEPENDENT 
MONITOR.—Not later than 10 days after receipt of 
a report submitted by a chain under paragraph (1), 
an independent monitor shall finalize its rec-
ommendations and submit a report to the chain and 
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•AMDT. NO. 2786 
facilities of the chain, the Secretary, and the State 
or States, as appropriate, containing such final rec-
ommendations. 
(e) COST OF APPOINTMENT.—A chain shall be re-
sponsible for a portion of the costs associated with the 
appointment of independent monitors under the dem-
onstration project under this section. The chain shall pay 
such portion to the Secretary (in an amount and in ac-
cordance with procedures established by the Secretary). 
(f) WAIVER AUTHORITY.—The Secretary may waive 
such requirements of titles XVIII and XIX of the Social 
Security Act (42 U.S.C. 1395 et seq.; 1396 et seq.) as 
may be necessary for the purpose of carrying out the dem-
onstration project under this section. 
(g) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated such sums as may be 
necessary to carry out this section. 
(h) DEFINITIONS.—In this section: 
(1) ADDITIONAL
DISCLOSABLE
PARTY.—The 
term ‘‘additional disclosable party’’ has the meaning 
given such term in section 1124(c)(5)(A) of the So-
cial Security Act, as added by section 4201(a). 
(2) FACILITY.—The term ‘‘facility’’ means a 
skilled nursing facility or a nursing facility. 
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•AMDT. NO. 2786 
(3) NURSING
FACILITY.—The term ‘‘nursing 
facility’’ has the meaning given such term in section 
1919(a) of the Social Security Act (42 U.S.C. 
1396r(a)). 
(4) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services, acting 
through the Assistant Secretary for Planning and 
Evaluation. 
(5) SKILLED
NURSING
FACILITY.—The term 
‘‘skilled nursing facility’’ has the meaning given such 
term in section 1819(a) of the Social Security Act 
(42 U.S.C. 1395(a)). 
(i) EVALUATION AND REPORT.— 
(1) EVALUATION.—The Secretary, in consulta-
tion with the Inspector General of the Department 
of Health and Human Services, shall evaluate the 
demonstration project conducted under this section. 
(2) REPORT.—Not later than 180 days after 
the completion of the demonstration project under 
this section, the Secretary shall submit to Congress 
a report containing the results of the evaluation con-
ducted under paragraph (1), together with rec-
ommendations— 
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•AMDT. NO. 2786 
(A) as to whether the independent monitor 
program should be established on a permanent 
basis; 
(B) if the Secretary recommends that such 
program be so established, on appropriate pro-
cedures and mechanisms for such establish-
ment; and 
(C) for such legislation and administrative 
action as the Secretary determines appropriate. 
SEC. 6113. NOTIFICATION OF FACILITY CLOSURE. 
(a) IN GENERAL.—Section 1128I of the Social Secu-
rity Act, as added and amended by this Act, is amended 
by adding at the end the following new subsection: 
‘‘(h) NOTIFICATION OF FACILITY CLOSURE.— 
‘‘(1) IN GENERAL.—Any individual who is the 
administrator of a facility must— 
‘‘(A) submit to the Secretary, the State 
long-term care ombudsman, residents of the fa-
cility, and the legal representatives of such resi-
dents or other responsible parties, written noti-
fication of an impending closure— 
‘‘(i) subject to clause (ii), not later 
than the date that is 60 days prior to the 
date of such closure; and 
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•AMDT. NO. 2786 
‘‘(ii) in the case of a facility where the 
Secretary terminates the facility’s partici-
pation under this title, not later than the 
date that the Secretary determines appro-
priate; 
‘‘(B) ensure that the facility does not 
admit any new residents on or after the date on 
which such written notification is submitted; 
and 
‘‘(C) include in the notice a plan for the 
transfer and adequate relocation of the resi-
dents of the facility by a specified date prior to 
closure that has been approved by the State, in-
cluding assurances that the residents will be 
transferred to the most appropriate facility or 
other setting in terms of quality, services, and 
location, taking into consideration the needs, 
choice, and best interests of each resident. 
‘‘(2) RELOCATION.— 
‘‘(A) IN GENERAL.—The State shall ensure 
that, before a facility closes, all residents of the 
facility have been successfully relocated to an-
other facility or an alternative home and com-
munity-based setting. 
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•AMDT. NO. 2786 
‘‘(B) CONTINUATION OF PAYMENTS UNTIL 
RESIDENTS RELOCATED.—The Secretary may, 
as the Secretary determines appropriate, con-
tinue to make payments under this title with re-
spect to residents of a facility that has sub-
mitted a notification under paragraph (1) dur-
ing the period beginning on the date such noti-
fication is submitted and ending on the date on 
which the resident is successfully relocated. 
‘‘(3) SANCTIONS.—Any individual who is the 
administrator of a facility that fails to comply with 
the requirements of paragraph (1)— 
‘‘(A) shall be subject to a civil monetary 
penalty of up to $100,000; 
‘‘(B) may be subject to exclusion from par-
ticipation in any Federal health care program 
(as defined in section 1128B(f)); and 
‘‘(C) shall be subject to any other penalties 
that may be prescribed by law. 
‘‘(4) PROCEDURE.—The provisions of section 
1128A (other than subsections (a) and (b) and the 
second sentence of subsection (f)) shall apply to a 
civil money penalty or exclusion under paragraph (3) 
in the same manner as such provisions apply to a 
penalty or proceeding under section 1128A(a).’’. 
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•AMDT. NO. 2786 
(b) 
CONFORMING
AMENDMENTS.—Section 
1819(h)(4) of the Social Security Act (42 U.S.C. 1395i– 
3(h)(4)) is amended— 
(1) in the first sentence, by striking ‘‘the Sec-
retary shall terminate’’ and inserting ‘‘the Secretary, 
subject to section 1128I(h), shall terminate’’; and 
(2) in the second sentence, by striking ‘‘sub-
section (c)(2)’’ and inserting ‘‘subsection (c)(2) and 
section 1128I(h)’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect 1 year after the date of the 
enactment of this Act. 
SEC. 6114. NATIONAL DEMONSTRATION PROJECTS ON CUL-
TURE CHANGE AND USE OF INFORMATION 
TECHNOLOGY IN NURSING HOMES. 
(a) IN GENERAL.—The Secretary shall conduct 2 
demonstration projects, 1 for the development of best 
practices in skilled nursing facilities and nursing facilities 
that are involved in the culture change movement (includ-
ing the development of resources for facilities to find and 
access funding in order to undertake culture change) and 
1 for the development of best practices in skilled nursing 
facilities and nursing facilities for the use of information 
technology to improve resident care. 
(b) CONDUCT OF DEMONSTRATION PROJECTS.— 
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•AMDT. NO. 2786 
(1) GRANT AWARD.—Under each demonstration 
project conducted under this section, the Secretary 
shall award 1 or more grants to facility-based set-
tings for the development of best practices described 
in subsection (a) with respect to the demonstration 
project involved. Such award shall be made on a 
competitive basis and may be allocated in 1 lump- 
sum payment. 
(2) CONSIDERATION
OF
SPECIAL
NEEDS
OF 
RESIDENTS.—Each demonstration project conducted 
under this section shall take into consideration the 
special needs of residents of skilled nursing facilities 
and nursing facilities who have cognitive impair-
ment, including dementia. 
(c) DURATION AND IMPLEMENTATION.— 
(1) DURATION.—The demonstration projects 
shall each be conducted for a period not to exceed 
3 years. 
(2) 
IMPLEMENTATION.—The 
demonstration 
projects shall each be implemented not later than 1 
year after the date of the enactment of this Act. 
(d) DEFINITIONS.—In this section: 
(1) NURSING
FACILITY.—The term ‘‘nursing 
facility’’ has the meaning given such term in section 
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•AMDT. NO. 2786 
1919(a) of the Social Security Act (42 U.S.C. 
1396r(a)). 
(2) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
(3) SKILLED
NURSING
FACILITY.—The term 
‘‘skilled nursing facility’’ has the meaning given such 
term in section 1819(a) of the Social Security Act 
(42 U.S.C. 1395(a)). 
(e) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated such sums as may be 
necessary to carry out this section. 
(f) REPORT.—Not later than 9 months after the com-
pletion of the demonstration project, the Secretary shall 
submit to Congress a report on such project, together with 
recommendations for such legislation and administrative 
action as the Secretary determines appropriate. 
PART III—IMPROVING STAFF TRAINING 
SEC. 6121. DEMENTIA AND ABUSE PREVENTION TRAINING. 
(a) SKILLED NURSING FACILITIES.— 
(1) IN GENERAL.—Section 1819(f)(2)(A)(i)(I) 
of the Social Security Act (42 U.S.C. 1395i– 
3(f)(2)(A)(i)(I)) is amended by inserting ‘‘(includ-
ing, in the case of initial training and, if the Sec-
retary determines appropriate, in the case of ongo-
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•AMDT. NO. 2786 
ing training, dementia management training, and 
patient abuse prevention training’’ before ‘‘, (II)’’. 
(2) CLARIFICATION OF DEFINITION OF NURSE 
AIDE.—Section 1819(b)(5)(F) of the Social Security 
Act (42 U.S.C. 1395i–3(b)(5)(F)) is amended by 
adding at the end the following flush sentence: 
‘‘Such term includes an individual who provides 
such services through an agency or under a 
contract with the facility.’’. 
(b) NURSING FACILITIES.— 
(1) IN GENERAL.—Section 1919(f)(2)(A)(i)(I) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1396r(f)(2)(A)(i)(I)) is amended by inserting ‘‘(in-
cluding, in the case of initial training and, if the 
Secretary determines appropriate, in the case of on-
going training, dementia management training, and 
patient abuse prevention training’’ before ‘‘, (II)’’. 
(2) CLARIFICATION OF DEFINITION OF NURSE 
AIDE.—Section 1919(b)(5)(F) of the Social Security 
Act (42 U.S.C. 1396r(b)(5)(F)) is amended by add-
ing at the end the following flush sentence: 
‘‘Such term includes an individual who provides 
such services through an agency or under a 
contract with the facility.’’. 
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•AMDT. NO. 2786 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect 1 year after the date of the 
enactment of this Act. 
Subtitle C—Nationwide Program 
for National and State Back-
ground Checks on Direct Pa-
tient Access Employees of Long- 
term Care Facilities and Pro-
viders 
SEC. 6201. NATIONWIDE PROGRAM FOR NATIONAL AND 
STATE BACKGROUND CHECKS ON DIRECT PA-
TIENT ACCESS EMPLOYEES OF LONG-TERM 
CARE FACILITIES AND PROVIDERS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services (in this section referred to as the ‘‘Sec-
retary’’), shall establish a program to identify efficient, ef-
fective, and economical procedures for long term care fa-
cilities or providers to conduct background checks on pro-
spective direct patient access employees on a nationwide 
basis (in this subsection, such program shall be referred 
to as the ‘‘nationwide program’’). Except for the following 
modifications, the Secretary shall carry out the nationwide 
program under similar terms and conditions as the pilot 
program under section 307 of the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003 (Pub-
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•AMDT. NO. 2786 
lic Law 108–173; 117 Stat. 2257), including the prohibi-
tion on hiring abusive workers and the authorization of 
the imposition of penalties by a participating State under 
subsection (b)(3)(A) and (b)(6), respectively, of such sec-
tion 307: 
(1) AGREEMENTS.— 
(A) NEWLY PARTICIPATING STATES.—The 
Secretary shall enter into agreements with each 
State— 
(i) that the Secretary has not entered 
into an agreement with under subsection 
(c)(1) of such section 307; 
(ii) that agrees to conduct background 
checks under the nationwide program on a 
Statewide basis; and 
(iii) that submits an application to the 
Secretary containing such information and 
at such time as the Secretary may specify. 
(B) CERTAIN PREVIOUSLY PARTICIPATING 
STATES.—The Secretary shall enter into agree-
ments with each State— 
(i) that the Secretary has entered into 
an agreement with under such subsection 
(c)(1), but only in the case where such 
agreement did not require the State to 
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•AMDT. NO. 2786 
conduct background checks under the pro-
gram established under subsection (a) of 
such section 307 on a Statewide basis; 
(ii) that agrees to conduct background 
checks under the nationwide program on a 
Statewide basis; and 
(iii) that submits an application to the 
Secretary containing such information and 
at such time as the Secretary may specify. 
(2) NONAPPLICATION
OF
SELECTION
CRI-
TERIA.—The selection criteria required under sub-
section (c)(3)(B) of such section 307 shall not apply. 
(3) REQUIRED FINGERPRINT CHECK AS PART 
OF CRIMINAL HISTORY BACKGROUND CHECK.—The 
procedures established under subsection (b)(1) of 
such section 307 shall— 
(A) require that the long-term care facility 
or provider (or the designated agent of the 
long-term care facility or provider) obtain State 
and national criminal history background 
checks on the prospective employee through 
such means as the Secretary determines appro-
priate, efficient, and effective that utilize a 
search of State-based abuse and neglect reg-
istries and databases, including the abuse and 
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•AMDT. NO. 2786 
neglect registries of another State in the case 
where a prospective employee previously resided 
in that State, State criminal history records, 
the records of any proceedings in the State that 
may contain disqualifying information about 
prospective employees (such as proceedings con-
ducted by State professional licensing and dis-
ciplinary boards and State Medicaid Fraud 
Control Units), and Federal criminal history 
records, including a fingerprint check using the 
Integrated Automated Fingerprint Identifica-
tion System of the Federal Bureau of Investiga-
tion; 
(B) require States to describe and test 
methods that reduce duplicative fingerprinting, 
including providing for the development of ‘‘rap 
back’’ capability by the State such that, if a di-
rect patient access employee of a long-term care 
facility or provider is convicted of a crime fol-
lowing the initial criminal history background 
check conducted with respect to such employee, 
and the employee’s fingerprints match the 
prints on file with the State law enforcement 
department, the department will immediately 
inform the State and the State will immediately 
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inform the long-term care facility or provider 
which employs the direct patient access em-
ployee of such conviction; and 
(C) require that criminal history back-
ground checks conducted under the nationwide 
program remain valid for a period of time speci-
fied by the Secretary. 
(4) STATE REQUIREMENTS.—An agreement en-
tered into under paragraph (1) shall require that a 
participating State— 
(A) be responsible for monitoring compli-
ance with the requirements of the nationwide 
program; 
(B) have procedures in place to— 
(i) conduct screening and criminal his-
tory background checks under the nation-
wide program in accordance with the re-
quirements of this section; 
(ii) monitor compliance by long-term 
care facilities and providers with the proce-
dures and requirements of the nationwide 
program; 
(iii) as appropriate, provide for a pro-
visional period of employment by a long- 
term care facility or provider of a direct 
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patient access employee, not to exceed 60 
days, pending completion of the required 
criminal history background check and, in 
the case where the employee has appealed 
the results of such background check, 
pending completion of the appeals process, 
during which the employee shall be subject 
to direct on-site supervision (in accordance 
with procedures established by the State to 
ensure that a long-term care facility or 
provider furnishes such direct on-site su-
pervision); 
(iv) provide an independent process by 
which a provisional employee or an em-
ployee may appeal or dispute the accuracy 
of the information obtained in a back-
ground check performed under the nation-
wide program, including the specification 
of criteria for appeals for direct patient ac-
cess employees found to have disqualifying 
information which shall include consider-
ation of the passage of time, extenuating 
circumstances, demonstration of rehabilita-
tion, and relevancy of the particular dis-
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qualifying information with respect to the 
current employment of the individual; 
(v) provide for the designation of a 
single State agency as responsible for— 
(I) overseeing the coordination of 
any State and national criminal his-
tory background checks requested by 
a long-term care facility or provider 
(or the designated agent of the long- 
term care facility or provider) utilizing 
a search of State and Federal crimi-
nal history records, including a finger-
print check of such records; 
(II) overseeing the design of ap-
propriate privacy and security safe-
guards for use in the review of the re-
sults of any State or national criminal 
history background checks conducted 
regarding a prospective direct patient 
access employee to determine whether 
the employee has any conviction for a 
relevant crime; 
(III) immediately reporting to 
the long-term care facility or provider 
that requested the criminal history 
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background check the results of such 
review; and 
(IV) in the case of an employee 
with a conviction for a relevant crime 
that is subject to reporting under sec-
tion 1128E of the Social Security Act 
(42 U.S.C. 1320a–7e), reporting the 
existence of such conviction to the 
database established under that sec-
tion; 
(vi) determine which individuals are 
direct patient access employees (as defined 
in paragraph (6)(B)) for purposes of the 
nationwide program; 
(vii) as appropriate, specify offenses, 
including convictions for violent crimes, for 
purposes of the nationwide program; and 
(viii) describe and test methods that 
reduce duplicative fingerprinting, including 
providing for the development of ‘‘rap 
back’’ capability such that, if a direct pa-
tient access employee of a long-term care 
facility or provider is convicted of a crime 
following the initial criminal history back-
ground check conducted with respect to 
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such employee, and the employee’s finger-
prints match the prints on file with the 
State law enforcement department— 
(I) the department will imme-
diately inform the State agency des-
ignated under clause (v) and such 
agency will immediately inform the fa-
cility or provider which employs the 
direct patient access employee of such 
conviction; and 
(II) the State will provide, or will 
require the facility to provide, to the 
employee a copy of the results of the 
criminal history background check 
conducted with respect to the em-
ployee at no charge in the case where 
the individual requests such a copy. 
(5) PAYMENTS.— 
(A) NEWLY PARTICIPATING STATES.— 
(i) IN GENERAL.—As part of the ap-
plication submitted by a State under para-
graph (1)(A)(iii), the State shall guar-
antee, with respect to the costs to be in-
curred by the State in carrying out the na-
tionwide program, that the State will make 
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available (directly or through donations 
from public or private entities) a particular 
amount of non-Federal contributions, as a 
condition of receiving the Federal match 
under clause (ii). 
(ii) FEDERAL MATCH.—The payment 
amount to each State that the Secretary 
enters into an agreement with under para-
graph (1)(A) shall be 3 times the amount 
that the State guarantees to make avail-
able under clause (i), except that in no 
case may the payment amount exceed 
$3,000,000. 
(B) 
PREVIOUSLY
PARTICIPATING 
STATES.— 
(i) IN GENERAL.—As part of the ap-
plication submitted by a State under para-
graph (1)(B)(iii), the State shall guar-
antee, with respect to the costs to be in-
curred by the State in carrying out the na-
tionwide program, that the State will make 
available (directly or through donations 
from public or private entities) a particular 
amount of non-Federal contributions, as a 
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condition of receiving the Federal match 
under clause (ii). 
(ii) FEDERAL MATCH.—The payment 
amount to each State that the Secretary 
enters into an agreement with under para-
graph (1)(B) shall be 3 times the amount 
that the State guarantees to make avail-
able under clause (i), except that in no 
case may the payment amount exceed 
$1,500,000. 
(6) DEFINITIONS.—Under the nationwide pro-
gram: 
(A) 
CONVICTION
FOR
A
RELEVANT 
CRIME.—The term ‘‘conviction for a relevant 
crime’’ means any Federal or State criminal 
conviction for— 
(i) any offense described in section 
1128(a) of the Social Security Act (42 
U.S.C. 1320a–7); or 
(ii) such other types of offenses as a 
participating State may specify for pur-
poses of conducting the program in such 
State. 
(B) DISQUALIFYING
INFORMATION.—The 
term ‘‘disqualifying information’’ means a con-
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viction for a relevant crime or a finding of pa-
tient or resident abuse. 
(C) FINDING OF PATIENT OR RESIDENT 
ABUSE.—The term ‘‘finding of patient or resi-
dent abuse’’ means any substantiated finding 
by a State agency under section 1819(g)(1)(C) 
or 1919(g)(1)(C) of the Social Security Act (42 
U.S.C. 1395i–3(g)(1)(C), 1396r(g)(1)(C)) or a 
Federal agency that a direct patient access em-
ployee has committed— 
(i) an act of patient or resident abuse 
or neglect or a misappropriation of patient 
or resident property; or 
(ii) such other types of acts as a par-
ticipating State may specify for purposes 
of conducting the program in such State. 
(D) 
DIRECT
PATIENT
ACCESS
EM-
PLOYEE.—The term ‘‘direct patient access em-
ployee’’ means any individual who has access to 
a patient or resident of a long-term care facility 
or provider through employment or through a 
contract with such facility or provider and has 
duties that involve (or may involve) one-on-one 
contact with a patient or resident of the facility 
or provider, as determined by the State for pur-
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poses of the nationwide program. Such term 
does not include a volunteer unless the volun-
teer has duties that are equivalent to the duties 
of a direct patient access employee and those 
duties involve (or may involve) one-on-one con-
tact with a patient or resident of the long-term 
care facility or provider. 
(E) LONG-TERM CARE FACILITY OR PRO-
VIDER.—The term ‘‘long-term care facility or 
provider’’ means the following facilities or pro-
viders which receive payment for services under 
title XVIII or XIX of the Social Security Act: 
(i) A skilled nursing facility (as de-
fined in section 1819(a) of the Social Secu-
rity Act (42 U.S.C. 1395i–3(a))). 
(ii) A nursing facility (as defined in 
section 1919(a) of such Act (42 U.S.C. 
1396r(a))). 
(iii) A home health agency. 
(iv) A provider of hospice care (as de-
fined in section 1861(dd)(1) of such Act 
(42 U.S.C. 1395x(dd)(1))). 
(v) A long-term care hospital (as de-
scribed in section 1886(d)(1)(B)(iv) of 
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such 
Act 
(42 
U.S.C. 
1395ww(d)(1)(B)(iv))). 
(vi) A provider of personal care serv-
ices. 
(vii) A provider of adult day care. 
(viii) A residential care provider that 
arranges for, or directly provides, long- 
term care services, including an assisted 
living facility that provides a level of care 
established by the Secretary. 
(ix) An intermediate care facility for 
the mentally retarded (as defined in sec-
tion 1905(d) of such Act (42 U.S.C. 
1396d(d))). 
(x) Any other facility or provider of 
long-term care services under such titles as 
the participating State determines appro-
priate. 
(7) EVALUATION AND REPORT.— 
(A) EVALUATION.— 
(i) IN GENERAL.—The Inspector Gen-
eral of the Department of Health and 
Human Services shall conduct an evalua-
tion of the nationwide program. 
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•AMDT. NO. 2786 
(ii) INCLUSION
OF
SPECIFIC
TOP-
ICS.—The 
evaluation 
conducted 
under 
clause (i) shall include the following: 
(I) A review of the various proce-
dures implemented by participating 
States for long-term care facilities or 
providers, including staffing agencies, 
to conduct background checks of di-
rect patient access employees under 
the nationwide program and identi-
fication of the most appropriate, effi-
cient, and effective procedures for 
conducting such background checks. 
(II) An assessment of the costs 
of conducting such background checks 
(including start up and administrative 
costs). 
(III) A determination of the ex-
tent to which conducting such back-
ground checks leads to any unin-
tended consequences, including a re-
duction in the available workforce for 
long-term care facilities or providers. 
(IV) An assessment of the impact 
of the nationwide program on reduc-
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•AMDT. NO. 2786 
ing the number of incidents of neglect, 
abuse, and misappropriation of resi-
dent property to the extent prac-
ticable. 
(V) An evaluation of other as-
pects of the nationwide program, as 
determined appropriate by the Sec-
retary. 
(B) REPORT.—Not later than 180 days 
after the completion of the nationwide program, 
the Inspector General of the Department of 
Health and Human Services shall submit a re-
port to Congress containing the results of the 
evaluation conducted under subparagraph (A). 
(b) FUNDING.— 
(1) NOTIFICATION.—The Secretary of Health 
and Human Services shall notify the Secretary of 
the Treasury of the amount necessary to carry out 
the nationwide program under this section for the 
period of fiscal years 2010 through 2012, except 
that in no case shall such amount exceed 
$160,000,000. 
(2) TRANSFER OF FUNDS.— 
(A) IN GENERAL.—Out of any funds in the 
Treasury not otherwise appropriated, the Sec-
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•AMDT. NO. 2786 
retary of the Treasury shall provide for the 
transfer to the Secretary of Health and Human 
Services of the amount specified as necessary to 
carry out the nationwide program under para-
graph (1). Such amount shall remain available 
until expended. 
(B) RESERVATION
OF
FUNDS
FOR
CON-
DUCT OF EVALUATION.—The Secretary may re-
serve not more than $3,000,000 of the amount 
transferred under subparagraph (A) to provide 
for the conduct of the evaluation under sub-
section (a)(7)(A). 
Subtitle D—Patient-Centered 
Outcomes Research 
SEC. 6301. PATIENT-CENTERED OUTCOMES RESEARCH. 
(a) IN GENERAL.—Title XI of the Social Security Act 
(42 U.S.C. 1301 et seq.) is amended by adding at the end 
the following new part: 
‘‘PART D—COMPARATIVE CLINICAL EFFECTIVENESS 
RESEARCH 
‘‘COMPARATIVE CLINICAL EFFECTIVENESS RESEARCH 
‘‘SEC. 1181. (a) DEFINITIONS.—In this section: 
‘‘(1) BOARD.—The term ‘Board’ means the 
Board of Governors established under subsection (f). 
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•AMDT. NO. 2786 
‘‘(2) COMPARATIVE CLINICAL EFFECTIVENESS 
RESEARCH; RESEARCH.— 
‘‘(A) IN GENERAL.—The terms ‘compara-
tive clinical effectiveness research’ and ‘re-
search’ mean research evaluating and com-
paring health outcomes and the clinical effec-
tiveness, risks, and benefits of 2 or more med-
ical treatments, services, and items described in 
subparagraph (B). 
‘‘(B) MEDICAL
TREATMENTS, SERVICES, 
AND
ITEMS
DESCRIBED.—The medical treat-
ments, services, and items described in this sub-
paragraph are health care interventions, proto-
cols for treatment, care management, and deliv-
ery, procedures, medical devices, diagnostic 
tools, pharmaceuticals (including drugs and 
biologicals), integrative health practices, and 
any other strategies or items being used in the 
treatment, management, and diagnosis of, or 
prevention of illness or injury in, individuals. 
‘‘(3) CONFLICT OF INTEREST.—The term ‘con-
flict of interest’ means an association, including a fi-
nancial or personal association, that have the poten-
tial to bias or have the appearance of biasing an in-
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•AMDT. NO. 2786 
dividual’s decisions in matters related to the Insti-
tute or the conduct of activities under this section. 
‘‘(4) REAL CONFLICT OF INTEREST.—The term 
‘real conflict of interest’ means any instance where 
a member of the Board, the methodology committee 
established under subsection (d)(6), or an advisory 
panel appointed under subsection (d)(4), or a close 
relative of such member, has received or could re-
ceive either of the following: 
‘‘(A) A direct financial benefit of any 
amount deriving from the result or findings of 
a study conducted under this section. 
‘‘(B) A financial benefit from individuals 
or companies that own or manufacture medical 
treatments, services, or items to be studied 
under this section that in the aggregate exceeds 
$10,000 per year. For purposes of the pre-
ceding sentence, a financial benefit includes 
honoraria, fees, stock, or other financial benefit 
and the current value of the member or close 
relative’s already existing stock holdings, in ad-
dition to any direct financial benefit deriving 
from the results or findings of a study con-
ducted under this section. 
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•AMDT. NO. 2786 
‘‘(b) PATIENT-CENTERED OUTCOMES RESEARCH IN-
STITUTE.— 
‘‘(1) ESTABLISHMENT.—There is authorized to 
be established a nonprofit corporation, to be known 
as the ‘Patient-Centered Outcomes Research Insti-
tute’ (referred to in this section as the ‘Institute’) 
which is neither an agency nor establishment of the 
United States Government. 
‘‘(2) APPLICATION OF PROVISIONS.—The Insti-
tute shall be subject to the provisions of this section, 
and, to the extent consistent with this section, to the 
District of Columbia Nonprofit Corporation Act. 
‘‘(3) FUNDING OF COMPARATIVE CLINICAL EF-
FECTIVENESS RESEARCH.—For fiscal year 2010 and 
each subsequent fiscal year, amounts in the Patient- 
Centered Outcomes Research Trust Fund (referred 
to in this section as the ‘PCORTF’) under section 
9511 of the Internal Revenue Code of 1986 shall be 
available, without further appropriation, to the Insti-
tute to carry out this section. 
‘‘(c) PURPOSE.—The purpose of the Institute is to 
assist patients, clinicians, purchasers, and policy-makers 
in making informed health decisions by advancing the 
quality and relevance of evidence concerning the manner 
in which diseases, disorders, and other health conditions 
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•AMDT. NO. 2786 
can effectively and appropriately be prevented, diagnosed, 
treated, monitored, and managed through research and 
evidence synthesis that considers variations in patient sub-
populations, and the dissemination of research findings 
with respect to the relative health outcomes, clinical effec-
tiveness, and appropriateness of the medical treatments, 
services, and items described in subsection (a)(2)(B). 
‘‘(d) DUTIES.— 
‘‘(1) IDENTIFYING RESEARCH PRIORITIES AND 
ESTABLISHING RESEARCH PROJECT AGENDA.— 
‘‘(A) 
IDENTIFYING
RESEARCH
PRIOR-
ITIES.—The Institute shall identify national 
priorities for research, taking into account fac-
tors of disease incidence, prevalence, and bur-
den in the United States (with emphasis on 
chronic conditions), gaps in evidence in terms of 
clinical outcomes, practice variations and health 
disparities in terms of delivery and outcomes of 
care, the potential for new evidence to improve 
patient health, well-being, and the quality of 
care, the effect on national expenditures associ-
ated with a health care treatment, strategy, or 
health conditions, as well as patient needs, out-
comes, and preferences, the relevance to pa-
tients and clinicians in making informed health 
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•AMDT. NO. 2786 
decisions, and priorities in the National Strat-
egy for quality care established under section 
399H of the Public Health Service Act that are 
consistent with this section. 
‘‘(B) ESTABLISHING
RESEARCH
PROJECT 
AGENDA.—The Institute shall establish and up-
date a research project agenda for research to 
address the priorities identified under subpara-
graph (A), taking into consideration the types 
of research that might address each priority 
and the relative value (determined based on the 
cost of conducting research compared to the po-
tential usefulness of the information produced 
by research) associated with the different types 
of research, and such other factors as the Insti-
tute determines appropriate. 
‘‘(2) CARRYING OUT RESEARCH PROJECT AGEN-
DA.— 
‘‘(A) 
RESEARCH.—The 
Institute 
shall 
carry out the research project agenda estab-
lished under paragraph (1)(B) in accordance 
with the methodological standards adopted 
under paragraph (9) using methods, including 
the following: 
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•AMDT. NO. 2786 
‘‘(i) Systematic reviews and assess-
ments of existing and future research and 
evidence including original research con-
ducted subsequent to the date of the enact-
ment of this section. 
‘‘(ii) Primary research, such as ran-
domized clinical trials, molecularly in-
formed trials, and observational studies. 
‘‘(iii) Any other methodologies rec-
ommended by the methodology committee 
established under paragraph (6) that are 
adopted by the Board under paragraph 
(9). 
‘‘(B) CONTRACTS FOR THE MANAGEMENT 
OF FUNDING AND CONDUCT OF RESEARCH.— 
‘‘(i) CONTRACTS.— 
‘‘(I) IN
GENERAL.—In accord-
ance with the research project agenda 
established under paragraph (1)(B), 
the Institute shall enter into contracts 
for the management of funding and 
conduct of research in accordance 
with the following: 
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•AMDT. NO. 2786 
‘‘(aa) Appropriate agencies 
and instrumentalities of the Fed-
eral Government. 
‘‘(bb) Appropriate academic 
research, private sector research, 
or study-conducting entities. 
‘‘(II) PREFERENCE.—In entering 
into contracts under subclause (I), the 
Institute shall give preference to the 
Agency for Healthcare Research and 
Quality and the National Institutes of 
Health, but only if the research to be 
conducted or managed under such 
contract is authorized by the gov-
erning statutes of such Agency or In-
stitutes. 
‘‘(ii) CONDITIONS FOR CONTRACTS.— 
A contract entered into under this sub-
paragraph shall require that the agency, 
instrumentality, or other entity— 
‘‘(I) abide by the transparency 
and conflicts of interest requirements 
under subsection (h) that apply to the 
Institute with respect to the research 
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•AMDT. NO. 2786 
managed or conducted under such 
contract; 
‘‘(II) comply with the methodo-
logical standards adopted under para-
graph (9) with respect to such re-
search; 
‘‘(III) consult with the expert ad-
visory panels for clinical trials and 
rare disease appointed under clauses 
(ii) and (iii), respectively, of para-
graph (4)(A); 
‘‘(IV) subject to clause (iv), per-
mit a researcher who conducts origi-
nal research under the contract for 
the agency, instrumentality, or other 
entity to have such research published 
in a peer-reviewed journal or other 
publication; 
‘‘(V) have appropriate processes 
in place to manage data privacy and 
meet ethical standards for the re-
search; 
‘‘(VI) comply with the require-
ments of the Institute for making the 
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•AMDT. NO. 2786 
information available to the public 
under paragraph (8); and 
‘‘(VII) comply with other terms 
and conditions determined necessary 
by the Institute to carry out the re-
search agenda adopted under para-
graph (2). 
‘‘(iii) COVERAGE OF COPAYMENTS OR 
COINSURANCE.—A contract entered into 
under this subparagraph may allow for the 
coverage of copayments or coinsurance, or 
allow for other appropriate measures, to 
the extent that such coverage or other 
measures are necessary to preserve the va-
lidity of a research project, such as in the 
case where the research project must be 
blinded. 
‘‘(iv) REQUIREMENTS
FOR
PUBLICA-
TION OF RESEARCH.—Any research pub-
lished under clause (ii)(IV) shall be within 
the bounds of and entirely consistent with 
the evidence and findings produced under 
the contract with the Institute under this 
subparagraph. If the Institute determines 
that those requirements are not met, the 
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Institute shall not enter into another con-
tract with the agency, instrumentality, or 
entity which managed or conducted such 
research for a period determined appro-
priate by the Institute (but not less than 
5 years). 
‘‘(C) REVIEW
AND
UPDATE
OF
EVI-
DENCE.—The Institute shall review and update 
evidence on a periodic basis as appropriate. 
‘‘(D) TAKING INTO ACCOUNT POTENTIAL 
DIFFERENCES.—Research shall be designed, as 
appropriate, to take into account the potential 
for differences in the effectiveness of health 
care treatments, services, and items as used 
with various subpopulations, such as racial and 
ethnic minorities, women, age, and groups of 
individuals with different comorbidities, genetic 
and molecular sub-types, or quality of life pref-
erences and include members of such sub-
populations as subjects in the research as fea-
sible and appropriate. 
‘‘(E) DIFFERENCES
IN
TREATMENT
MO-
DALITIES.—Research shall be designed, as ap-
propriate, to take into account different charac-
teristics of treatment modalities that may affect 
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research outcomes, such as the phase of the 
treatment modality in the innovation cycle and 
the impact of the skill of the operator of the 
treatment modality. 
‘‘(3) DATA COLLECTION.— 
‘‘(A) IN GENERAL.—The Secretary shall, 
with appropriate safeguards for privacy, make 
available to the Institute such data collected by 
the Centers for Medicare & Medicaid Services 
under the programs under titles XVIII, XIX, 
and XXI, as well as provide access to the data 
networks developed under section 937(f) of the 
Public Health Service Act, as the Institute and 
its contractors may require to carry out this 
section. The Institute may also request and ob-
tain data from Federal, State, or private enti-
ties, including data from clinical databases and 
registries. 
‘‘(B) USE OF DATA.—The Institute shall 
only use data provided to the Institute under 
subparagraph (A) in accordance with laws and 
regulations governing the release and use of 
such data, including applicable confidentiality 
and privacy standards. 
‘‘(4) APPOINTING EXPERT ADVISORY PANELS.— 
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‘‘(A) APPOINTMENT.— 
‘‘(i) IN GENERAL.—The Institute may 
appoint permanent or ad hoc expert advi-
sory panels as determined appropriate to 
assist in identifying research priorities and 
establishing the research project agenda 
under paragraph (1) and for other pur-
poses. 
‘‘(ii) EXPERT ADVISORY PANELS FOR 
CLINICAL TRIALS.—The Institute shall ap-
point expert advisory panels in carrying 
out randomized clinical trials under the re-
search project agenda under paragraph 
(2)(A)(ii). Such expert advisory panels 
shall advise the Institute and the agency, 
instrumentality, or entity conducting the 
research on the research question involved 
and the research design or protocol, includ-
ing important patient subgroups and other 
parameters of the research. Such panels 
shall be available as a resource for tech-
nical questions that may arise during the 
conduct of such research. 
‘‘(iii) EXPERT ADVISORY PANEL FOR 
RARE DISEASE.—In the case of a research 
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study for rare disease, the Institute shall 
appoint an expert advisory panel for pur-
poses of assisting in the design of the re-
search study and determining the relative 
value and feasibility of conducting the re-
search study. 
‘‘(B) COMPOSITION.—An expert advisory 
panel appointed under subparagraph (A) shall 
include representatives of practicing and re-
search clinicians, patients, and experts in sci-
entific and health services research, health serv-
ices delivery, and evidence-based medicine who 
have experience in the relevant topic, and as ap-
propriate, experts in integrative health and pri-
mary prevention strategies. The Institute may 
include a technical expert of each manufacturer 
or each medical technology that is included 
under the relevant topic, project, or category 
for which the panel is established. 
‘‘(5) SUPPORTING
PATIENT
AND
CONSUMER 
REPRESENTATIVES.—The Institute shall provide 
support and resources to help patient and consumer 
representatives effectively participate on the Board 
and expert advisory panels appointed by the Insti-
tute under paragraph (4). 
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•AMDT. NO. 2786 
‘‘(6) 
ESTABLISHING
METHODOLOGY
COM-
MITTEE.— 
‘‘(A) IN GENERAL.—The Institute shall es-
tablish a standing methodology committee to 
carry out the functions described in subpara-
graph (C). 
‘‘(B) APPOINTMENT AND COMPOSITION.— 
The methodology committee established under 
subparagraph (A) shall be composed of not 
more than 15 members appointed by the Comp-
troller General of the United States. Members 
appointed to the methodology committee shall 
be experts in their scientific field, such as 
health services research, clinical research, com-
parative clinical effectiveness research, bio-
statistics, genomics, and research methodolo-
gies. Stakeholders with such expertise may be 
appointed to the methodology committee. In ad-
dition to the members appointed under the first 
sentence, the Directors of the National Insti-
tutes of Health and the Agency for Healthcare 
Research and Quality (or their designees) shall 
each be included as members of the method-
ology committee. 
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‘‘(C) FUNCTIONS.—Subject to subpara-
graph (D), the methodology committee shall 
work to develop and improve the science and 
methods of comparative clinical effectiveness re-
search by, not later than 18 months after the 
establishment of the Institute, directly or 
through subcontract, developing and periodi-
cally updating the following: 
‘‘(i) Methodological standards for re-
search. Such methodological standards 
shall provide specific criteria for internal 
validity, generalizability, feasibility, and 
timeliness of research and for health out-
comes measures, risk adjustment, and 
other relevant aspects of research and as-
sessment with respect to the design of re-
search. Any methodological standards de-
veloped and updated under this subclause 
shall be scientifically based and include 
methods by which new information, data, 
or advances in technology are considered 
and incorporated into ongoing research 
projects by the Institute, as appropriate. 
The process for developing and updating 
such standards shall include input from 
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•AMDT. NO. 2786 
relevant experts, stakeholders, and deci-
sionmakers, and shall provide opportunities 
for public comment. Such standards shall 
also include methods by which patient sub-
populations can be accounted for and eval-
uated in different types of research. As ap-
propriate, such standards shall build on ex-
isting work on methodological standards 
for defined categories of health interven-
tions and for each of the major categories 
of comparative clinical effectiveness re-
search methods (determined as of the date 
of enactment of the Patient Protection and 
Affordable Care Act). 
‘‘(ii) A translation table that is de-
signed to provide guidance and act as a 
reference for the Board to determine re-
search methods that are most likely to ad-
dress each specific research question. 
‘‘(D) CONSULTATION
AND
CONDUCT
OF 
EXAMINATIONS.—The methodology committee 
may consult and contract with the Institute of 
Medicine of the National Academies and aca-
demic, nonprofit, or other private and govern-
mental entities with relevant expertise to carry 
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•AMDT. NO. 2786 
out activities described in subparagraph (C) 
and may consult with relevant stakeholders to 
carry out such activities. 
‘‘(E) REPORTS.—The methodology com-
mittee shall submit reports to the Board on the 
committee’s performance of the functions de-
scribed in subparagraph (C). Reports shall con-
tain recommendations for the Institute to adopt 
methodological standards developed and up-
dated by the methodology committee as well as 
other actions deemed necessary to comply with 
such methodological standards. 
‘‘(7) PROVIDING FOR A PEER-REVIEW PROCESS 
FOR PRIMARY RESEARCH.— 
‘‘(A) IN GENERAL.—The Institute shall en-
sure that there is a process for peer review of 
primary research described in subparagraph 
(A)(ii) of paragraph (2) that is conducted under 
such paragraph. Under such process— 
‘‘(i) evidence from such primary re-
search shall be reviewed to assess scientific 
integrity and adherence to methodological 
standards adopted under paragraph (9); 
and 
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•AMDT. NO. 2786 
‘‘(ii) a list of the names of individuals 
contributing to any peer-review process 
during the preceding year or years shall be 
made public and included in annual reports 
in accordance with paragraph (10)(D). 
‘‘(B) 
COMPOSITION.—Such 
peer-review 
process shall be designed in a manner so as to 
avoid bias and conflicts of interest on the part 
of the reviewers and shall be composed of ex-
perts in the scientific field relevant to the re-
search under review. 
‘‘(C) USE OF EXISTING PROCESSES.— 
‘‘(i) PROCESSES OF ANOTHER ENTI-
TY.—In the case where the Institute enters 
into a contract or other agreement with 
another entity for the conduct or manage-
ment of research under this section, the 
Institute may utilize the peer-review proc-
ess of such entity if such process meets the 
requirements under subparagraphs (A) and 
(B). 
‘‘(ii) PROCESSES
OF
APPROPRIATE 
MEDICAL
JOURNALS.—The Institute may 
utilize the peer-review process of appro-
priate medical journals if such process 
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•AMDT. NO. 2786 
meets the requirements under subpara-
graphs (A) and (B). 
‘‘(8) RELEASE OF RESEARCH FINDINGS.— 
‘‘(A) IN
GENERAL.—The Institute shall, 
not later than 90 days after the conduct or re-
ceipt of research findings under this part, make 
such research findings available to clinicians, 
patients, and the general public. The Institute 
shall ensure that the research findings— 
‘‘(i) convey the findings of research in 
a manner that is comprehensible and use-
ful to patients and providers in making 
health care decisions; 
‘‘(ii) fully convey findings and discuss 
considerations specific to certain sub-
populations, 
risk 
factors, 
and 
comorbidities, as appropriate; 
‘‘(iii) include limitations of the re-
search and what further research may be 
needed as appropriate; 
‘‘(iv) not be construed as mandates 
for 
practice 
guidelines, 
coverage 
rec-
ommendations, payment, or policy rec-
ommendations; and 
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•AMDT. NO. 2786 
‘‘(v) not include any data which would 
violate the privacy of research participants 
or any confidentiality agreements made 
with respect to the use of data under this 
section. 
‘‘(B) DEFINITION
OF
RESEARCH
FIND-
INGS.—In this paragraph, the term ‘research 
findings’ means the results of a study or assess-
ment. 
‘‘(9) ADOPTION.—Subject to subsection (h)(1), 
the Institute shall adopt the national priorities iden-
tified under paragraph (1)(A), the research project 
agenda established under paragraph (1)(B), the 
methodological standards developed and updated by 
the 
methodology 
committee 
under 
paragraph 
(6)(C)(i), and any peer-review process provided 
under paragraph (7) by majority vote. In the case 
where the Institute does not adopt such processes in 
accordance with the preceding sentence, the proc-
esses shall be referred to the appropriate staff or en-
tity within the Institute (or, in the case of the meth-
odological standards, the methodology committee) 
for further review. 
‘‘(10) ANNUAL REPORTS.—The Institute shall 
submit an annual report to Congress and the Presi-
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•AMDT. NO. 2786 
dent, and shall make the annual report available to 
the public. Such report shall contain— 
‘‘(A) a description of the activities con-
ducted under this section, research priorities 
identified under paragraph (1)(A) and methodo-
logical standards developed and updated by the 
methodology 
committee 
under 
paragraph 
(6)(C)(i) that are adopted under paragraph (9) 
during the preceding year; 
‘‘(B) the research project agenda and 
budget of the Institute for the following year; 
‘‘(C) any administrative activities con-
ducted by the Institute during the preceding 
year; 
‘‘(D) the names of individuals contributing 
to any peer-review process under paragraph (7), 
without identifying them with a particular re-
search project; and 
‘‘(E) any other relevant information (in-
cluding information on the membership of the 
Board, expert advisory panels, methodology 
committee, and the executive staff of the Insti-
tute, any conflicts of interest with respect to 
these individuals, and any bylaws adopted by 
the Board during the preceding year). 
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•AMDT. NO. 2786 
‘‘(e) ADMINISTRATION.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the Board shall carry out the duties of the Institute. 
‘‘(2) NONDELEGABLE DUTIES.—The activities 
described in subsections (d)(1) and (d)(9) are non-
delegable. 
‘‘(f) BOARD OF GOVERNORS.— 
‘‘(1) IN GENERAL.—The Institute shall have a 
Board of Governors, which shall consist of the fol-
lowing members: 
‘‘(A) 
The 
Director 
of 
Agency 
for 
Healthcare Research and Quality (or the Direc-
tor’s designee). 
‘‘(B) The Director of the National Insti-
tutes of Health (or the Director’s designee). 
‘‘(C) Seventeen members appointed, not 
later than 6 months after the date of enactment 
of this section, by the Comptroller General of 
the United States as follows: 
‘‘(i) 3 members representing patients 
and health care consumers. 
‘‘(ii) 5 members representing physi-
cians and providers, including at least 1 
surgeon, nurse, State-licensed integrative 
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•AMDT. NO. 2786 
health care practitioner, and representative 
of a hospital. 
‘‘(iii) 3 members representing private 
payers, of whom at least 1 member shall 
represent health insurance issuers and at 
least 1 member shall represent employers 
who self-insure employee benefits. 
‘‘(iv) 3 members representing pharma-
ceutical, device, and diagnostic manufac-
turers or developers. 
‘‘(v) 1 member representing quality 
improvement or independent health service 
researchers. 
‘‘(vi) 2 members representing the 
Federal Government or the States, includ-
ing at least 1 member representing a Fed-
eral health program or agency. 
‘‘(2) QUALIFICATIONS.—The Board shall rep-
resent a broad range of perspectives and collectively 
have scientific expertise in clinical health sciences re-
search, including epidemiology, decisions sciences, 
health economics, and statistics. In appointing the 
Board, the Comptroller General of the United States 
shall consider and disclose any conflicts of interest 
in accordance with subsection (h)(4)(B). Members of 
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•AMDT. NO. 2786 
the Board shall be recused from relevant Institute 
activities in the case where the member (or an im-
mediate family member of such member) has a real 
conflict of interest directly related to the research 
project or the matter that could affect or be affected 
by such participation. 
‘‘(3) TERMS; VACANCIES.—A member of the 
Board shall be appointed for a term of 6 years, ex-
cept with respect to the members first appointed, 
whose terms of appointment shall be staggered even-
ly over 2-year increments. No individual shall be ap-
pointed to the Board for more than 2 terms. Vacan-
cies shall be filled in the same manner as the origi-
nal appointment was made. 
‘‘(4) CHAIRPERSON AND VICE-CHAIRPERSON.— 
The Comptroller General of the United States shall 
designate a Chairperson and Vice Chairperson of the 
Board from among the members of the Board. Such 
members shall serve as Chairperson or Vice Chair-
person for a period of 3 years. 
‘‘(5) COMPENSATION.—Each member of the 
Board who is not an officer or employee of the Fed-
eral Government shall be entitled to compensation 
(equivalent to the rate provided for level IV of the 
Executive Schedule under section 5315 of title 5, 
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•AMDT. NO. 2786 
United States Code) and expenses incurred while 
performing the duties of the Board. An officer or 
employee of the Federal government who is a mem-
ber of the Board shall be exempt from compensa-
tion. 
‘‘(6) DIRECTOR
AND
STAFF; EXPERTS
AND 
CONSULTANTS.—The Board may employ and fix the 
compensation of an Executive Director and such 
other personnel as may be necessary to carry out the 
duties of the Institute and may seek such assistance 
and support of, or contract with, experts and con-
sultants that may be necessary for the performance 
of the duties of the Institute. 
‘‘(7) MEETINGS
AND
HEARINGS.—The Board 
shall meet and hold hearings at the call of the 
Chairperson or a majority of its members. Meetings 
not solely concerning matters of personnel shall be 
advertised at least 7 days in advance and open to 
the public. A majority of the Board members shall 
constitute a quorum, but a lesser number of mem-
bers may meet and hold hearings. 
‘‘(g) 
FINANCIAL
AND
GOVERNMENTAL
OVER-
SIGHT.— 
‘‘(1) CONTRACT
FOR
AUDIT.—The Institute 
shall provide for the conduct of financial audits of 
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•AMDT. NO. 2786 
the Institute on an annual basis by a private entity 
with expertise in conducting financial audits. 
‘‘(2) REVIEW AND ANNUAL REPORTS.— 
‘‘(A) REVIEW.—The Comptroller General 
of the United States shall review the following: 
‘‘(i) Not less frequently than on an 
annual basis, the financial audits con-
ducted under paragraph (1). 
‘‘(ii) Not less frequently than every 5 
years, the processes established by the In-
stitute, including the research priorities 
and the conduct of research projects, in 
order to determine whether information 
produced by such research projects is ob-
jective and credible, is produced in a man-
ner consistent with the requirements under 
this section, and is developed through a 
transparent process. 
‘‘(iii) Not less frequently than every 5 
years, the dissemination and training ac-
tivities and data networks established 
under section 937 of the Public Health 
Service Act, including the methods and 
products used to disseminate research, the 
types of training conducted and supported, 
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•AMDT. NO. 2786 
and the types and functions of the data 
networks established, in order to determine 
whether the activities and data are pro-
duced in a manner consistent with the re-
quirements under such section. 
‘‘(iv) Not less frequently than every 5 
years, the overall effectiveness of activities 
conducted under this section and the dis-
semination, training, and capacity building 
activities conducted under section 937 of 
the Public Health Service Act. Such review 
shall include an analysis of the extent to 
which research findings are used by health 
care decision-makers, the effect of the dis-
semination of such findings on reducing 
practice variation and disparities in health 
care, and the effect of the research con-
ducted and disseminated on innovation and 
the health care economy of the United 
States. 
‘‘(v) Not later than 8 years after the 
date of enactment of this section, the ade-
quacy and use of the funding for the Insti-
tute and the activities conducted under 
section 937 of the Public Health Service 
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•AMDT. NO. 2786 
Act, including a determination as to 
whether, based on the utilization of re-
search findings by public and private pay-
ers, funding sources for the Patient-Cen-
tered Outcomes Research Trust Fund 
under section 9511 of the Internal Rev-
enue Code of 1986 are appropriate and 
whether such sources of funding should be 
continued or adjusted. 
‘‘(B) ANNUAL REPORTS.—Not later than 
April 1 of each year, the Comptroller General 
of the United States shall submit to Congress 
a report containing the results of the review 
conducted under subparagraph (A) with respect 
to the preceding year (or years, if applicable), 
together with recommendations for such legisla-
tion and administrative action as the Comp-
troller General determines appropriate. 
‘‘(h) ENSURING TRANSPARENCY, CREDIBILITY, AND 
ACCESS.—The Institute shall establish procedures to en-
sure that the following requirements for ensuring trans-
parency, credibility, and access are met: 
‘‘(1) PUBLIC COMMENT PERIODS.—The Insti-
tute shall provide for a public comment period of not 
less than 45 days and not more than 60 days prior 
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•AMDT. NO. 2786 
to the adoption under subsection (d)(9) of the na-
tional 
priorities 
identified 
under 
subsection 
(d)(1)(A), the research project agenda established 
under subsection (d)(1)(B), the methodological 
standards developed and updated by the method-
ology committee under subsection (d)(6)(C)(i), and 
the peer-review process provided under paragraph 
(7), and after the release of draft findings with re-
spect to systematic reviews of existing research and 
evidence. 
‘‘(2) ADDITIONAL FORUMS.—The Institute shall 
support forums to increase public awareness and ob-
tain and incorporate public input and feedback 
through media (such as an Internet website) on re-
search priorities, research findings, and other duties, 
activities, or processes the Institute determines ap-
propriate. 
‘‘(3) PUBLIC
AVAILABILITY.—The Institute 
shall make available to the public and disclose 
through the official public Internet website of the In-
stitute the following: 
‘‘(A) Information contained in research 
findings as specified in subsection (d)(9). 
‘‘(B) The process and methods for the con-
duct of research, including the identity of the 
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•AMDT. NO. 2786 
entity and the investigators conducing such re-
search and any conflicts of interests of such 
parties, any direct or indirect links the entity 
has to industry, and research protocols, includ-
ing measures taken, methods of research and 
analysis, research results, and such other infor-
mation the Institute determines appropriate) 
concurrent with the release of research findings. 
‘‘(C) Notice of public comment periods 
under paragraph (1), including deadlines for 
public comments. 
‘‘(D) Subsequent comments received dur-
ing each of the public comment periods. 
‘‘(E) In accordance with applicable laws 
and processes and as the Institute determines 
appropriate, proceedings of the Institute. 
‘‘(4) DISCLOSURE
OF
CONFLICTS
OF
INTER-
EST.— 
‘‘(A) IN GENERAL.—A conflict of interest 
shall be disclosed in the following manner: 
‘‘(i) By the Institute in appointing 
members to an expert advisory panel under 
subsection (d)(4), in selecting individuals 
to contribute to any peer-review process 
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•AMDT. NO. 2786 
under subsection (d)(7), and for employ-
ment as executive staff of the Institute. 
‘‘(ii) By the Comptroller General in 
appointing members of the methodology 
committee under subsection (d)(6); 
‘‘(iii) By the Institute in the annual 
report under subsection (d)(10), except 
that, in the case of individuals contributing 
to any such peer review process, such de-
scription shall be in a manner such that 
those individuals cannot be identified with 
a particular research project. 
‘‘(B) MANNER OF DISCLOSURE.—Conflicts 
of interest shall be disclosed as described in 
subparagraph (A) as soon as practicable on the 
Internet web site of the Institute and of the 
Government Accountability Office. The informa-
tion disclosed under the preceding sentence 
shall include the type, nature, and magnitude of 
the interests of the individual involved, except 
to the extent that the individual recuses himself 
or herself from participating in the consider-
ation of or any other activity with respect to the 
study as to which the potential conflict exists. 
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•AMDT. NO. 2786 
‘‘(i) RULES.—The Institute, its Board or staff, shall 
be prohibited from accepting gifts, bequeaths, or donations 
of services or property. In addition, the Institute shall be 
prohibited from establishing a corporation or generating 
revenues from activities other than as provided under this 
section. 
‘‘(j) RULES OF CONSTRUCTION.— 
‘‘(1) COVERAGE.—Nothing in this section shall 
be construed— 
‘‘(A) to permit the Institute to mandate 
coverage, reimbursement, or other policies for 
any public or private payer; or 
‘‘(B) as preventing the Secretary from cov-
ering the routine costs of clinical care received 
by an individual entitled to, or enrolled for, ben-
efits under title XVIII, XIX, or XXI in the case 
where such individual is participating in a clin-
ical trial and such costs would otherwise be cov-
ered under such title with respect to the bene-
ficiary.’’. 
(b) DISSEMINATION AND BUILDING CAPACITY FOR 
RESEARCH.—Title IX of the Public Health Service Act 
(42 U.S.C. 299 et seq.), as amended by section 3606, is 
further amended by inserting after section 936 the fol-
lowing: 
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•AMDT. NO. 2786 
‘‘SEC. 937. DISSEMINATION AND BUILDING CAPACITY FOR 
RESEARCH. 
‘‘(a) IN GENERAL.— 
‘‘(1) DISSEMINATION.—The Office of Commu-
nication and Knowledge Transfer (referred to in this 
section as the ‘Office’) at the Agency for Healthcare 
Research and Quality (or any other relevant office 
designated by Agency for Healthcare Research and 
Quality), in consultation with the National Institutes 
of Health, shall broadly disseminate the research 
findings that are published by the Patient Centered 
Outcomes Research Institute established under sec-
tion 1181(b) of the Social Security Act (referred to 
in this section as the ‘Institute’) and other govern-
ment-funded research relevant to comparative clin-
ical effectiveness research. The Office shall create in-
formational tools that organize and disseminate re-
search findings for physicians, health care providers, 
patients, payers, and policy makers. The Office shall 
also develop a publicly available resource database 
that collects and contains government-funded evi-
dence and research from public, private, not-for 
profit, and academic sources. 
‘‘(2) REQUIREMENTS.—The Office shall provide 
for the dissemination of the Institute’s research find-
ings and government-funded research relevant to 
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•AMDT. NO. 2786 
comparative clinical effectiveness research to physi-
cians, health care providers, patients, vendors of 
health information technology focused on clinical de-
cision support, appropriate professional associations, 
and Federal and private health plans. Materials, fo-
rums, and media used to disseminate the findings, 
informational tools, and resource databases shall— 
‘‘(A) include a description of consider-
ations for specific subpopulations, the research 
methodology, and the limitations of the re-
search, and the names of the entities, agencies, 
instrumentalities, and individuals who con-
ducted any research which was published by the 
Institute; and 
‘‘(B) not be construed as mandates, guide-
lines, or recommendations for payment, cov-
erage, or treatment. 
‘‘(b) INCORPORATION
OF RESEARCH FINDINGS.— 
The Office, in consultation with relevant medical and clin-
ical associations, shall assist users of health information 
technology focused on clinical decision support to promote 
the timely incorporation of research findings disseminated 
under subsection (a) into clinical practices and to promote 
the ease of use of such incorporation. 
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•AMDT. NO. 2786 
‘‘(c) FEEDBACK.—The Office shall establish a proc-
ess to receive feedback from physicians, health care pro-
viders, patients, and vendors of health information tech-
nology focused on clinical decision support, appropriate 
professional associations, and Federal and private health 
plans about the value of the information disseminated and 
the assistance provided under this section. 
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall preclude the Institute from making its research 
findings publicly available as required under section 
1181(d)(8) of the Social Security Act. 
‘‘(e) TRAINING OF RESEARCHERS.—The Agency for 
Health Care Research and Quality, in consultation with 
the National Institutes of Health, shall build capacity for 
comparative clinical effectiveness research by establishing 
a grant program that provides for the training of research-
ers in the methods used to conduct such research, includ-
ing systematic reviews of existing research and primary 
research such as clinical trials. At a minimum, such train-
ing shall be in methods that meet the methodological 
standards adopted under section 1181(d)(9) of the Social 
Security Act. 
‘‘(f) BUILDING DATA
FOR RESEARCH.—The Sec-
retary shall provide for the coordination of relevant Fed-
eral health programs to build data capacity for compara-
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•AMDT. NO. 2786 
‘‘(i) an amount equivalent to the net 
revenues received in the Treasury from the 
fees imposed under subchapter B of chap-
ter 34 (relating to fees on health insurance 
and self-insured plans) for such fiscal year; 
and 
‘‘(ii) $150,000,000. 
‘‘(E) For each of fiscal years 2014, 2015, 
2016, 2017, 2018, and 2019— 
‘‘(i) an amount equivalent to the net 
revenues received in the Treasury from the 
fees imposed under subchapter B of chap-
ter 34 (relating to fees on health insurance 
and self-insured plans) for such fiscal year; 
and 
‘‘(ii) $150,000,000. 
The amounts appropriated under subpara-
graphs (A), (B), (C), (D)(ii), and (E)(ii) shall 
be transferred from the general fund of the 
Treasury, from funds not otherwise appro-
priated. 
‘‘(2) TRUST FUND TRANSFERS.—In addition to 
the amounts appropriated under paragraph (1), 
there shall be credited to the PCORTF the amounts 
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•AMDT. NO. 2786 
such plan) under title XIX of the Social Security 
Act or a child health plan under title XXI the name, 
national provider identifier, and other identifying in-
formation for any provider of medical or other items 
or services or supplier under the Medicare program 
under title XVIII or under the CHIP program under 
title XXI that is terminated from participation 
under that program within 30 days of the termi-
nation (and, with respect to all such providers or 
suppliers who are terminated from the Medicare pro-
gram on the date of enactment of this Act, within 
90 days of such date). 
(3) 
CONFORMING
AMENDMENT.—Section 
1902(a)(23) of the Social Security Act (42 U.S.C. 
1396a), is amended by inserting before the semi-
colon at the end the following: ‘‘or by a provider or 
supplier to which a moratorium under subsection 
(ii)(4) is applied during the period of such morato-
rium’’. 
(c) CHIP.—Section 2107(e)(1) of the Social Security 
Act (42 U.S.C. 1397gg(e)(1)), as amended by section 
2101(d), is amended— 
(1) 
by 
redesignating 
subparagraphs 
(D) 
through (M) as subparagraphs (E) through (N), re-
spectively; and 
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•AMDT. NO. 2786 
‘‘(II) The program under title 
XXI. 
‘‘(III) Health-related programs 
administered by the Secretary of Vet-
erans Affairs. 
‘‘(IV) Health-related programs 
administered by the Secretary of De-
fense. 
‘‘(V) The program of old-age, 
survivors, and disability insurance 
benefits established under title II. 
‘‘(VI) The Indian Health Service 
and the Contract Health Service pro-
gram. 
‘‘(ii) PRIORITY
FOR
INCLUSION
OF 
CERTAIN DATA.—Inclusion of the data de-
scribed in subclause (I) of such clause in 
the Integrated Data Repository shall be a 
priority. Data described in subclauses (II) 
through (VI) of such clause shall be in-
cluded in the Integrated Data Repository 
as appropriate. 
‘‘(B) DATA SHARING AND MATCHING.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall enter into agreements with the indi-
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•AMDT. NO. 2786 
agree on a final and complete list of which, if 
any, patents listed under paragraph (3) by the 
subsection (k) applicant or the reference prod-
uct sponsor shall be the subject of an action for 
patent infringement under paragraph (6), the 
provisions of paragraph (5) shall apply to the 
parties. 
‘‘(5) PATENT
RESOLUTION
IF
NO
AGREE-
MENT.— 
‘‘(A) NUMBER
OF
PATENTS.—The sub-
section (k) applicant shall notify the reference 
product sponsor of the number of patents that 
such applicant will provide to the reference 
product sponsor under subparagraph (B)(i)(I). 
‘‘(B) EXCHANGE OF PATENT LISTS.— 
‘‘(i) IN GENERAL.—On a date agreed 
to by the subsection (k) applicant and the 
reference product sponsor, but in no case 
later than 5 days after the subsection (k) 
applicant notifies the reference product 
sponsor under subparagraph (A), the sub-
section (k) applicant and the reference 
product sponsor shall simultaneously ex-
change— 
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•AMDT. NO. 2786 
U.S.C. 355c) is amended by adding at the end the 
following: 
‘‘(n) NEW ACTIVE INGREDIENT.— 
‘‘(1) NON-INTERCHANGEABLE BIOSIMILAR BIO-
LOGICAL
PRODUCT.—A biological product that is 
biosimilar to a reference product under section 351 
of the Public Health Service Act, and that the Sec-
retary has not determined to meet the standards de-
scribed in subsection (k)(4) of such section for inter-
changeability with the reference product, shall be 
considered to have a new active ingredient under 
this section. 
‘‘(2) INTERCHANGEABLE BIOSIMILAR BIOLOGI-
CAL PRODUCT.—A biological product that is inter-
changeable with a reference product under section 
351 of the Public Health Service Act shall not be 
considered to have a new active ingredient under 
this section.’’. 
(e) PRODUCTS PREVIOUSLY APPROVED UNDER SEC-
TION 505.— 
(1) REQUIREMENT TO FOLLOW SECTION 351.— 
Except as provided in paragraph (2), an application 
for a biological product shall be submitted under 
section 351 of the Public Health Service Act (42 
U.S.C. 262) (as amended by this Act). 
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