I 
111TH CONGRESS 
1ST SESSION H. R. 2813 
To establish a national knee and hip replacement registry. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 10, 2009 
Mr. PASCRELL (for himself and Mr. DOGGETT) introduced the following bill; 
which was referred to the Committee on Energy and Commerce, and in 
addition to the Committee on Ways and Means, for a period to be subse-
quently determined by the Speaker, in each case for consideration of such 
provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To establish a national knee and hip replacement registry. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘National Knee and 
Hip Replacement Registry Act of 2009’’. 
SEC. 2. ESTABLISHMENT. 
(a) IN GENERAL.—Not later than 3 years after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services shall establish within the Agency for 
Healthcare Research and Quality a national knee and hip 
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replacement registry (referred to in this Act as the ‘‘reg-
istry’’) for the purpose of identifying predictors (including 
patient co-morbidities, conditions, and characteristics; fea-
tures of the prostheses; and surgical technique) that may 
lead to poor outcomes in knee and hip replacement sur-
geries in order to assist health care providers in medical 
and surgical decision-making, improve patient care and 
outcomes generally, detect poorly performing prostheses 
and surgical techniques, and reduce the number of knee 
and hip replacement revision surgeries required nation-
wide. 
(b) POLICIES
AND PROCEDURES.—Such registry 
shall be subject to the policies and procedures developed 
under section 3(a). 
SEC. 3. KNEE AND HIP REPLACEMENT REGISTRY POLICIES 
AND PROCEDURES. 
(a) POLICIES AND PROCEDURES.—Not later than 3 
years after the date of the enactment of this Act, the Ad-
ministrator of the Centers for Medicare and Medicaid 
Services, in coordination with the Director of the Agency 
for Healthcare Research and Quality, shall develop policies 
and procedures for the development and maintenance of 
the registry under section 2. The policies and procedures 
shall address— 
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(1) the scope of data collection to be conducted 
by the registry to conform with the purpose of the 
registry as defined in section 2; 
(2) the core data set to be used by the registry; 
(3) policies to be used by the registry to— 
(A) ensure scientific rigor in data collec-
tion and analysis; 
(B) avoid bias in the analysis of data; 
(C) ensure that analysis of the data col-
lected can be generalizable to the population of 
people getting knee and hip replacements; 
(D) protect, to the extent practicable, 
trade secrets of manufacturers of knee and hip 
replacement prostheses and related products; 
and 
(E) protect patient privacy; and 
(4) guidelines for data collection that— 
(A) incorporate, to the extent practicable, 
the recommendations and feedback of stake-
holders, including— 
(i) orthopedic practitioners and pro-
viders, such as hospitals, surgeons, nurses, 
and other practitioners and providers; 
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(ii) manufacturers of knee and hip re-
placement prostheses and related products; 
and 
(iii) patient and consumer groups; 
(B) balance the importance and usefulness 
of potential findings resulting from the collec-
tion of data by the registry with the feasibility 
and administrative burden on collecting such 
data; 
(C) allow the registry to use, to the extent 
practicable, data that is collected through exist-
ing Federal reporting requirements; and 
(D) rely, to the extent practicable, on the 
voluntary submission of data on both Medicare 
and non-Medicare patients by practitioners and 
providers. 
(b) INTERAGENCY COOPERATION.—In developing of 
the policies and procedures under subsection (a), the Ad-
ministrator of the Centers for Medicare and Medicaid 
Services shall consult with the heads of the Agency for 
Healthcare Research and Quality, the Food and Drug Ad-
ministration, the National Institutes of Health, and the 
Office of the National Coordinator for Health Information 
Technology. 
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SEC. 4. ACTIVITIES OF THE REGISTRY. 
(a) DATA COLLECTION AND STORAGE.—Beginning 
not later than 5 years after the date of the enactment of 
this Act, the head of the registry shall collect and store 
data related to knee and hip replacements (including in-
formation related to prosthetic devices and surgical proce-
dures consistent with the policies and procedures under 
section 3(a) in the registry established under subsection 
(a) of section 2). 
(b) DATA ANALYSIS.—The head of the registry shall 
conduct data analysis to fulfil the purpose of the registry 
under section 2. 
(c) ACCESS TO DATA.— 
(1) PROVISION OF DATA TO PROVIDERS.—At 
least one time per year, beginning not later than 6 
years after the date of enactment of this Act, the 
head of the registry shall provide data to health care 
providers to allow them to evaluate their perform-
ance, relative to their peers, in— 
(A) conducting knee and hip replacement 
surgeries; and 
(B) providing care related to such sur-
geries. 
(2) PROVISION
OF
DATA
TO
MANUFACTUR-
ERS.—At least one time per year, beginning not 
later than 7 years after the date of the enactment 
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of this Act, the head of the registry shall provide 
data to manufacturers of knee and hip replacement 
prostheses and related products to allow such manu-
facturers to evaluate the safety and performance of 
their products relative to similar products available 
on the market. 
(3) USE OF REGISTRY BY RESEARCHERS.—The 
head of the registry shall develop a process to allow 
outside researchers to apply to use individually iden-
tifiable data that is contained in the registry to con-
duct longitudinal studies consistent with the purpose 
of the registry under section 2. 
(d) COORDINATION WITH FDA, NIH, AND OTHER 
HHS ENTITIES.—To avoid duplication in data collection 
and analysis, the head of the registry shall coordinate ac-
tivities of the registry with— 
(1) comparative effectiveness research con-
ducted by— 
(A) the Agency for Healthcare Research 
and Quality; 
(B) the National Institutes of Health; and 
(C) the Office of the Secretary of Health 
and Human Services; and 
(2) postmarket surveillance activities conducted 
by the Food and Drug Administration. 
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(e) COLLECTION OF REGISTRY INFORMATION FROM 
FEDERAL DEPARTMENTS AND AGENCIES.— 
(1) REQUESTS BY THE REGISTRY.—The head 
of the registry may request data from Federal de-
partments and agencies if the collection of such data 
by the entity established under section 2 conforms 
with the policies and procedures under section 3. 
(2) AGENCY
OBLIGATIONS.—Federal depart-
ments and agencies shall provide relevant data to 
the registry at the request of the head of the reg-
istry under paragraph (1). 
(f) PUBLIC FEEDBACK.—Not later than 2 years after 
beginning to collect data under subsection (a) and at the 
end of each subsequent 2-year period, in order to enhance 
the registry’s ability to achieve the purpose of the registry 
under section 2 and update policies and procedures under 
section 3, the head of the registry, in consultation with 
the Center for Medicare and Medicaid Services, the Food 
and Drug Administration, the Agency for Healthcare Re-
search and Quality, the Office of the National Coordinator 
of Health Information Technology, and the National Insti-
tutes of Health shall seek feedback from— 
(1) orthopedic providers, such as hospitals, sur-
geons, nurses, and other practitioners; 
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(2) manufacturers of knee and hip replacement 
prostheses and related products; 
(3) patient and consumer groups; and 
(4) public health experts and epidemiologist. 
(g) PUBLIC REPORT.—Beginning not later than six 
years after enactment, the head of the registry shall pub-
lish and make publically available an annual report that 
contains— 
(1) an overview of the data collected by under 
subsection (a); 
(2) the findings resulting from any analysis of 
such data conducted by the registry; and 
(3) any other information that the head of the 
registry determines is appropriate. 
SEC. 5. SAFETY MONITORING AND REPORTING. 
(a) 
SAFETY
MONITORING.—The 
Agency 
for 
Healthcare Research and Quality and the Food and Drug 
Administration shall use the data in the registry and any 
analysis of such data conducted by the registry or by other 
entities to monitor and evaluate the safety of knee and 
hip replacement procedures and devices. 
(b) REPORT.—Not later than 6 years after the date 
of the enactment of this Act and annually thereafter, the 
Agency for Healthcare Research and Quality, in consulta-
tion with Food and Drug Administration, shall submit a 
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report to the Secretary of Health and Human Services and 
Congress containing recommendations on changes in pol-
icy and health care provider practices that could enhance 
the safety of knee and hip replacements. 
SEC. 6. DEPARTMENT OF HEALTH AND HUMAN SERVICES 
COLLECTION OF INFORMATION FROM PRO-
VIDERS AND OTHER ENTITIES. 
(a) MODIFICATION OF REQUIRED DATA.—The Sec-
retary of Health and Human Services may modify the in-
formation required to be reported under administrative 
data sets under title XVIII of the Social Security Act (42 
U.S.C. 1395 et seq.) (including data that is required to 
be submitted by Medicare Advantage organizations and 
quality improvement organizations) to the extent the Sec-
retary, in consultation with the head of the registry, deter-
mines that the modification would result in the reporting 
of information that would be useful in carrying out the 
purpose of the registry under section 2. 
(b) CONDITION OF PARTICIPATION.—In the case that 
two consecutive reports submitted under section 7(a) con-
clude that the level of provider participation in the registry 
is insufficient to achieve the purpose of the registry under 
section 2, the Secretary of Health and Human Services 
may require providers of services (as defined under section 
1861(u) of the Social Security Act (42 U.S.C. 1395x(u))) 
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and physicians and other suppliers (as defined in sub-
sections (r) and (d) of section 1861 of the Social Security 
Act (42 U.S.C. 1395x(r) and (d)), respectively) to report 
relevant information directly to the registry as a condition 
of participation in the Medicare program under section 
1866 and 1842(h) of the Social Security Act (42 U.S.C. 
1395cc and 42 U.S.C. 1395u(h)), respectively. 
SEC. 7. OVERSIGHT OF THE REGISTRY. 
(a) IN GENERAL.—Not later than 1 year after the 
date the registry begins collecting data under section 4(a) 
and the end of each subsequent 2-year period, the Comp-
troller General of the United States shall submit to Con-
gress a report on the progress of the registry in achieving 
the purposes of the registry under section 2. 
(b) INFORMATION ON PROVIDER PARTICIPATION.— 
The report under subsection (a) shall include information 
on the number of providers participating in the registry 
and an analysis of whether that level of provider participa-
tion is sufficient to achieve the purposes of the registry 
under section 2. 
SEC. 8. AUTHORIZATION OF APPROPRIATIONS. 
There is authorized to be appropriated to carry out 
this Act, such sums as are necessary for fiscal years 2010 
through 2019. 
Æ 
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