H. R. 3590—601 
‘‘(A) submit to the Secretary, the State long-term care 
ombudsman, residents of the facility, and the legal rep-
resentatives of such residents or other responsible parties, 
written notification 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 
‘‘(ii) in the case of a facility where the Secretary 
terminates the facility’s participation under this title, 
not later than the date that the Secretary determines 
appropriate; 
‘‘(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 residents of the facility by a 
specified date prior to closure that has been approved by 
the State, including 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 another facility or an alternative 
home and community-based setting. 
‘‘(B) CONTINUATION
OF
PAYMENTS
UNTIL
RESIDENTS 
RELOCATED.—The Secretary may, as the Secretary deter-
mines appropriate, continue to make payments under this 
title with respect to residents of a facility that has sub-
mitted a notification under paragraph (1) during the period 
beginning on the date such notification 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 participation 
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 sub-
section (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).’’. 
(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 Secretary shall 
terminate’’ and inserting ‘‘the Secretary, subject to section 
1128I(h), shall terminate’’; and 
(2) in the second sentence, by striking ‘‘subsection (c)(2)’’ 
and inserting ‘‘subsection (c)(2) and section 1128I(h)’’.
H. R. 3590—602 
(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 CULTURE 
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 (including the development of resources for facili-
ties 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.— 
(1) GRANT AWARD.—Under each demonstration project con-
ducted under this section, the Secretary shall award 1 or more 
grants to facility-based settings for the development of best 
practices described in subsection (a) with respect to the dem-
onstration 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 
impairment, 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 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 completion 
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
H. R. 3590—603 
inserting ‘‘(including, in the case of initial training and, if 
the Secretary determines appropriate, in the case of ongoing 
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 serv-
ices 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 ‘‘(including, in the case of initial training and, if 
the Secretary determines appropriate, in the case of ongoing 
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 adding at the end the following 
flush sentence: 
‘‘Such term includes an individual who provides such serv-
ices through an agency or under a contract with the 
facility.’’. 
(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 Na-
tional and State Background Checks on 
Direct 
Patient 
Access 
Employees 
of 
Long-term Care Facilities and Providers 
SEC. 6201. NATIONWIDE PROGRAM FOR NATIONAL AND STATE BACK-
GROUND 
CHECKS 
ON 
DIRECT 
PATIENT 
ACCESS 
EMPLOYEES OF LONG-TERM CARE FACILITIES AND PRO-
VIDERS. 
(a) IN GENERAL.—The Secretary of Health and Human Services 
(in this section referred to as the ‘‘Secretary’’), shall establish a 
program to identify efficient, effective, and economical procedures 
for long term care facilities or providers to conduct background 
checks on prospective direct patient access employees on a nation-
wide basis (in this subsection, such program shall be referred to 
as the ‘‘nationwide program’’). Except for the following modifica-
tions, 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 Mod-
ernization Act of 2003 (Public Law 108–173; 117 Stat. 2257), 
including the prohibition 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 section 
307: 
(1) AGREEMENTS.—
H. R. 3590—604 
(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 agreements with each State— 
(i) that the Secretary has entered into an agree-
ment with under such subsection (c)(1), but only in 
the case where such agreement did not require the 
State to conduct background checks under the program 
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 CRITERIA.—The selection 
criteria required under subsection (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 back-
ground checks on the prospective employee through such 
means as the Secretary determines appropriate, efficient, 
and effective that utilize a search of State-based abuse 
and neglect registries and databases, including the abuse 
and 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 pro-
ceedings in the State that may contain disqualifying 
information about prospective employees (such as pro-
ceedings conducted by State professional licensing and dis-
ciplinary boards and State Medicaid Fraud Control Units), 
and Federal criminal history records, including a finger-
print check using the Integrated Automated Fingerprint 
Identification 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 direct patient access employee of a long-term 
care facility or provider is convicted of a crime following 
the initial criminal history background check conducted
H. R. 3590—605 
with respect to such employee, and the employee’s finger-
prints match the prints on file with the State law enforce-
ment department, the department will immediately inform 
the State and the State will immediately inform the long- 
term care facility or provider which employs the direct 
patient access employee of such conviction; and 
(C) require that criminal history background checks 
conducted under the nationwide program remain valid for 
a period of time specified by the Secretary. 
(4) STATE
REQUIREMENTS.—An agreement entered into 
under paragraph (1) shall require that a participating State— 
(A) be responsible for monitoring compliance with the 
requirements of the nationwide program; 
(B) have procedures in place to— 
(i) conduct screening and criminal history back-
ground checks under the nationwide program in accord-
ance with the requirements of this section; 
(ii) monitor compliance by long-term care facilities 
and providers with the procedures and requirements 
of the nationwide program; 
(iii) as appropriate, provide for a provisional period 
of employment by a long-term care facility or provider 
of a direct patient access employee, not to exceed 60 
days, pending completion of the required criminal his-
tory 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 
supervision); 
(iv) provide an independent process by which a 
provisional employee or an employee may appeal or 
dispute the accuracy of the information obtained in 
a background check performed under the nationwide 
program, including the specification of criteria for 
appeals for direct patient access employees found to 
have disqualifying information which shall include 
consideration of the passage of time, extenuating cir-
cumstances, demonstration of rehabilitation, and rel-
evancy of the particular disqualifying 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 history 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 criminal history records, including a 
fingerprint check of such records; 
(II) overseeing the design of appropriate pri-
vacy and security safeguards for use in the review 
of the results of any State or national criminal 
history background checks conducted regarding a
H. R. 3590—606 
prospective direct patient access employee to deter-
mine 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 background check the results of such 
review; and 
(IV) in the case of an employee with a convic-
tion for a relevant crime that is subject to reporting 
under section 1128E of the Social Security Act 
(42 U.S.C. 1320a–7e), reporting the existence of 
such conviction to the database established under 
that section; 
(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 patient access employee of a long-term care 
facility or provider is convicted of a crime following 
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— 
(I) the department will immediately inform 
the State agency designated under clause (v) and 
such agency will immediately inform the facility 
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 employee 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 application sub-
mitted by a State under paragraph (1)(A)(iii), the State 
shall guarantee, with respect to the costs to be incurred 
by the State in carrying out the nationwide 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 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 paragraph (1)(A) shall be 3 times the 
amount that the State guarantees to make available 
under clause (i), except that in no case may the pay-
ment amount exceed $3,000,000. 
(B) PREVIOUSLY PARTICIPATING STATES.—
H. R. 3590—607 
(i) IN GENERAL.—As part of the application sub-
mitted by a State under paragraph (1)(B)(iii), the State 
shall guarantee, with respect to the costs to be incurred 
by the State in carrying out the nationwide 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 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 paragraph (1)(B) shall be 3 times the 
amount that the State guarantees to make available 
under clause (i), except that in no case may the pay-
ment amount exceed $1,500,000. 
(6) DEFINITIONS.—Under the nationwide program: 
(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 purposes of conducting the pro-
gram in such State. 
(B) DISQUALIFYING INFORMATION.—The term ‘‘disquali-
fying information’’ means a conviction for a relevant crime 
or a finding of patient or resident abuse. 
(C) FINDING
OF
PATIENT
OR
RESIDENT
ABUSE.—The 
term ‘‘finding of patient or resident 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 employee has com-
mitted— 
(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 participating 
State may specify for purposes of conducting the pro-
gram in such State. 
(D) DIRECT
PATIENT
ACCESS
EMPLOYEE.—The term 
‘‘direct patient access employee’’ means any individual who 
has access to a patient or resident of a long-term care 
facility or provider through employment or through a con-
tract 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 purposes of the nationwide program. Such 
term does not include a volunteer unless the volunteer 
has duties that are equivalent to the duties of a direct 
patient access employee and those duties involve (or may 
involve) one-on-one contact with a patient or resident of 
the long-term care facility or provider. 
(E) LONG-TERM CARE FACILITY OR PROVIDER.—The term 
‘‘long-term care facility or provider’’ means the following 
facilities or providers which receive payment for services 
under title XVIII or XIX of the Social Security Act:
H. R. 3590—608 
(i) A skilled nursing facility (as defined in section 
1819(a) of the Social Security 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 defined in section 
1861(dd)(1) of such Act (42 U.S.C. 1395x(dd)(1))). 
(v) A long-term care hospital (as described in sec-
tion 
1886(d)(1)(B)(iv) 
of 
such 
Act 
(42 
U.S.C. 
1395ww(d)(1)(B)(iv))). 
(vi) A provider of personal care services. 
(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 section 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 appropriate. 
(7) EVALUATION AND REPORT.— 
(A) EVALUATION.— 
(i) IN
GENERAL.—The Inspector General of the 
Department of Health and Human Services shall con-
duct an evaluation of the nationwide program. 
(ii) INCLUSION OF SPECIFIC TOPICS.—The evaluation 
conducted under clause (i) shall include the following: 
(I) A review of the various procedures imple-
mented by participating States for long-term care 
facilities or providers, including staffing agencies, 
to conduct background checks of direct patient 
access employees under the nationwide program 
and identification 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 extent to which 
conducting such background checks leads to any 
unintended consequences, including a reduction in 
the available workforce for long-term care facilities 
or providers. 
(IV) An assessment of the impact of the nation-
wide program on reducing the number of incidents 
of neglect, abuse, and misappropriation of resident 
property to the extent practicable. 
(V) An evaluation of other aspects of the 
nationwide program, as determined appropriate by 
the Secretary. 
(B) REPORT.—Not later than 180 days after the comple-
tion of the nationwide program, the Inspector General of 
the Department of Health and Human Services shall
H. R. 3590—609 
submit a report 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 Secretary 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 paragraph (1). 
Such amount shall remain available until expended. 
(B) RESERVATION OF FUNDS FOR CONDUCT OF EVALUA-
TION.—The 
Secretary 
may 
reserve 
not 
more 
than 
$3,000,000 of the amount transferred under subparagraph 
(A) to provide for the conduct of the evaluation under 
subsection (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 Gov-
ernors established under subsection (f). 
‘‘(2) COMPARATIVE
CLINICAL
EFFECTIVENESS
RESEARCH; 
RESEARCH.— 
‘‘(A) IN
GENERAL.—The terms ‘comparative clinical 
effectiveness research’ and ‘research’ mean research evalu-
ating and comparing health outcomes and the clinical 
effectiveness, risks, and benefits of 2 or more medical treat-
ments, services, and items described in subparagraph (B). 
‘‘(B) MEDICAL
TREATMENTS, 
SERVICES, 
AND
ITEMS 
DESCRIBED.—The medical treatments, services, and items 
described in this subparagraph are health care interven-
tions, protocols for treatment, care management, and 
delivery, procedures, medical devices, diagnostic tools, 
pharmaceuticals (including drugs and biologicals), integra-
tive 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 ‘conflict of interest’ 
means an association, including a financial or personal associa-
tion, that have the potential to bias or have the appearance
H. R. 3590—610 
of biasing an individual’s decisions in matters related to the 
Institute 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 receive 
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 preceding 
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 addition to any direct financial benefit deriving from 
the results or findings of a study conducted under this 
section. 
‘‘(b) PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE.— 
‘‘(1) ESTABLISHMENT.—There is authorized to be established 
a nonprofit corporation, to be known as the ‘Patient-Centered 
Outcomes Research Institute’ (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 Institute shall be 
subject to the provisions of this section, and, to the extent 
consistent with this section, to the District of Columbia Non-
profit Corporation Act. 
‘‘(3) FUNDING
OF
COMPARATIVE
CLINICAL
EFFECTIVENESS 
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 Institute 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 con-
cerning the manner in which diseases, disorders, and other health 
conditions 
can 
effectively 
and 
appropriately 
be 
prevented, 
diagnosed, treated, monitored, and managed through research and 
evidence synthesis that considers variations in patient subpopula-
tions, and the dissemination of research findings with respect to 
the relative health outcomes, clinical effectiveness, and appropriate-
ness 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 PRIORITIES.—The Institute 
shall identify national priorities for research, taking into 
account factors of disease incidence, prevalence, and burden 
in the United States (with emphasis on chronic conditions), 
gaps in evidence in terms of clinical outcomes, practice
H. R. 3590—611 
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 associated with a health 
care treatment, strategy, or health conditions, as well as 
patient needs, outcomes, and preferences, the relevance 
to patients and clinicians in making informed health 
decisions, and priorities in the National Strategy 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 update a research project 
agenda for research to address the priorities identified 
under subparagraph (A), taking into consideration the 
types of research that might address each priority and 
the relative value (determined based on the cost of con-
ducting research compared to the potential usefulness of 
the information produced by research) associated with the 
different types of research, and such other factors as the 
Institute determines appropriate. 
‘‘(2) CARRYING OUT RESEARCH PROJECT AGENDA.— 
‘‘(A) RESEARCH.—The Institute shall carry out the 
research project agenda established under paragraph (1)(B) 
in accordance with the methodological standards adopted 
under paragraph (9) using methods, including the following: 
‘‘(i) Systematic reviews and assessments of existing 
and future research and evidence including original 
research conducted subsequent to the date of the enact-
ment of this section. 
‘‘(ii) Primary research, such as randomized clinical 
trials, molecularly informed trials, and observational 
studies. 
‘‘(iii) Any other methodologies recommended 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 accordance with the 
research project agenda established under para-
graph (1)(B), the Institute shall enter into con-
tracts for the management of funding and conduct 
of research in accordance with the following: 
‘‘(aa) Appropriate agencies and instrumen-
talities of the Federal Government. 
‘‘(bb) Appropriate academic research, pri-
vate sector research, or study-conducting enti-
ties. 
‘‘(II) PREFERENCE.—In entering into contracts 
under subclause (I), the Institute shall give pref-
erence 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 governing 
statutes of such Agency or Institutes.
H. R. 3590—612 
‘‘(ii) CONDITIONS
FOR
CONTRACTS.—A contract 
entered into under this subparagraph 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 
managed or conducted under such contract; 
‘‘(II) comply with the methodological standards 
adopted under paragraph (9) with respect to such 
research; 
‘‘(III) consult with the expert advisory panels 
for clinical trials and rare disease appointed under 
clauses (ii) and (iii), respectively, of paragraph 
(4)(A); 
‘‘(IV) subject to clause (iv), permit a researcher 
who conducts original 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 research; 
‘‘(VI) comply with the requirements of the 
Institute for making the 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 research agenda adopted under paragraph (2). 
‘‘(iii) COVERAGE
OF
COPAYMENTS
OR
COINSUR-
ANCE.—A contract entered into under this subpara-
graph 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 validity of a research 
project, such as in the case where the research project 
must be blinded. 
‘‘(iv) 
REQUIREMENTS
FOR
PUBLICATION
OF 
RESEARCH.—Any research published under clause 
(ii)(IV) shall be within the bounds of and entirely con-
sistent with the evidence and findings produced under 
the contract with the Institute under this subpara-
graph. If the Institute determines that those require-
ments are not met, the Institute shall not enter into 
another contract with the agency, instrumentality, or 
entity which managed or conducted such research for 
a period determined appropriate by the Institute (but 
not less than 5 years). 
‘‘(C) REVIEW AND UPDATE OF EVIDENCE.—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,
H. R. 3590—613 
or quality of life preferences and include members of such 
subpopulations as subjects in the research as feasible and 
appropriate. 
‘‘(E) 
DIFFERENCES
IN
TREATMENT
MODALITIES.— 
Research shall be designed, as appropriate, to take into 
account different characteristics of treatment modalities 
that may affect 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 appro-
priate 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 net-
works 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 obtain data from Federal, State, or private entities, 
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 accord-
ance with laws and regulations governing the release and 
use of such data, including applicable confidentiality and 
privacy standards. 
‘‘(4) APPOINTING EXPERT ADVISORY PANELS.— 
‘‘(A) APPOINTMENT.— 
‘‘(i) IN
GENERAL.—The Institute may appoint 
permanent or ad hoc expert advisory panels as deter-
mined appropriate to assist in identifying research 
priorities and establishing the research project agenda 
under paragraph (1) and for other purposes. 
‘‘(ii) EXPERT
ADVISORY
PANELS
FOR
CLINICAL 
TRIALS.—The Institute shall appoint expert advisory 
panels in carrying out randomized clinical trials under 
the research 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, including important 
patient subgroups and other parameters of the 
research. Such panels shall be available as a resource 
for technical questions that may arise during the con-
duct of such research. 
‘‘(iii) EXPERT ADVISORY PANEL FOR RARE DISEASE.— 
In the case of a research study for rare disease, the 
Institute shall appoint an expert advisory panel for 
purposes of assisting in the design of the research 
study and determining the relative value and feasi-
bility of conducting the research study. 
‘‘(B) 
COMPOSITION.—An 
expert 
advisory 
panel 
appointed under subparagraph (A) shall include representa-
tives of practicing and research clinicians, patients, and 
experts in scientific and health services research, health 
services delivery, and evidence-based medicine who have 
experience in the relevant topic, and as appropriate, experts
H. R. 3590—614 
in integrative health and primary prevention strategies. 
The Institute may include a technical expert of each manu-
facturer 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
REPRESENTA-
TIVES.—The Institute shall provide support and resources to 
help patient and consumer representatives effectively partici-
pate on the Board and expert advisory panels appointed by 
the Institute under paragraph (4). 
‘‘(6) ESTABLISHING METHODOLOGY COMMITTEE.— 
‘‘(A) IN
GENERAL.—The Institute shall establish a 
standing methodology committee to carry out the functions 
described in subparagraph (C). 
‘‘(B) APPOINTMENT
AND
COMPOSITION.—The method-
ology committee established under subparagraph (A) shall 
be composed of not more than 15 members appointed by 
the Comptroller 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, 
comparative 
clinical 
effectiveness 
research, biostatistics, genomics, and research methodolo-
gies. Stakeholders with such expertise may be appointed 
to the methodology committee. In addition to the members 
appointed under the first sentence, the Directors of the 
National Institutes of Health and the Agency for 
Healthcare Research and Quality (or their designees) shall 
each be included as members of the methodology com-
mittee. 
‘‘(C) FUNCTIONS.—Subject to subparagraph (D), the 
methodology committee shall work to develop and improve 
the science and methods of comparative clinical effective-
ness research by, not later than 18 months after the 
establishment of the Institute, directly or through sub-
contract, developing and periodically updating the fol-
lowing: 
‘‘(i) Methodological standards for research. Such 
methodological standards shall provide specific criteria 
for internal validity, generalizability, feasibility, and 
timeliness of research and for health outcomes meas-
ures, risk adjustment, and other relevant aspects of 
research and assessment with respect to the design 
of research. Any methodological standards developed 
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 
relevant experts, stakeholders, and decisionmakers, 
and shall provide opportunities for public comment. 
Such standards shall also include methods by which 
patient subpopulations can be accounted for and evalu-
ated in different types of research. As appropriate, 
such standards shall build on existing work on meth-
odological standards for defined categories of health 
interventions and for each of the major categories of