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 subsequently 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘National Knee and 

5 Hip Replacement Registry Act of 2009’’. 

6 SEC. 2. ESTABLISHMENT. 

7 (a) IN GENERAL.—Not later than 3 years after the 

8 date of the enactment of this Act, the Secretary of Health 

9 and Human Services shall establish within the Agency for 

10 Healthcare Research and Quality a national knee and hip 


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1 replacement registry (referred to in this Act as the ‘‘reg2 istry’’) for the purpose of identifying predictors (including 

3 patient co-morbidities, conditions, and characteristics; fea4 tures of the prostheses; and surgical technique) that may 

5 lead to poor outcomes in knee and hip replacement sur6 geries in order to assist health care providers in medical 

7 and surgical decision-making, improve patient care and 

8 outcomes generally, detect poorly performing prostheses 

9 and surgical techniques, and reduce the number of knee 

10 and hip replacement revision surgeries required nation11 wide. 

12 (b) POLICIES AND PROCEDURES.—Such registry 

13 shall be subject to the policies and procedures developed 

14 under section 3(a). 

15 SEC. 3. KNEE AND HIP REPLACEMENT REGISTRY POLICIES 

16 AND PROCEDURES. 

17 (a) POLICIES AND PROCEDURES.—Not later than 3 

18 years after the date of the enactment of this Act, the Ad19 ministrator of the Centers for Medicare and Medicaid 

20 Services, in coordination with the Director of the Agency 

21 for Healthcare Research and Quality, shall develop policies 

22 and procedures for the development and maintenance of 

23 the registry under section 2. The policies and procedures 

24 shall address— 


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1 (1) the scope of data collection to be conducted 

2 by the registry to conform with the purpose of the 

3 registry as defined in section 2; 

4 (2) the core data set to be used by the registry; 

5 (3) policies to be used by the registry to— 

6 (A) ensure scientific rigor in data collec7 tion and analysis; 

8 (B) avoid bias in the analysis of data; 

9 (C) ensure that analysis of the data col10 lected can be generalizable to the population of 

11 people getting knee and hip replacements; 

12 (D) protect, to the extent practicable, 

13 trade secrets of manufacturers of knee and hip 

14 replacement prostheses and related products; 

15 and 

16 (E) protect patient privacy; and 

17 (4) guidelines for data collection that— 

18 (A) incorporate, to the extent practicable, 

19 the recommendations and feedback of stake20 holders, including— 

21 (i) orthopedic practitioners and pro22 viders, such as hospitals, surgeons, nurses, 

23 and other practitioners and providers; 


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1 (ii) manufacturers of knee and hip re2 placement prostheses and related products; 

3 and 

4 (iii) patient and consumer groups; 

5 (B) balance the importance and usefulness 

6 of potential findings resulting from the collec7 tion of data by the registry with the feasibility 

8 and administrative burden on collecting such 

9 data; 

10 (C) allow the registry to use, to the extent 

11 practicable, data that is collected through exist12 ing Federal reporting requirements; and 

13 (D) rely, to the extent practicable, on the 

14 voluntary submission of data on both Medicare 

15 and non-Medicare patients by practitioners and 

16 providers. 

17 (b) INTERAGENCY COOPERATION.—In developing of 

18 the policies and procedures under subsection (a), the Ad19 ministrator of the Centers for Medicare and Medicaid 

20 Services shall consult with the heads of the Agency for 

21 Healthcare Research and Quality, the Food and Drug Ad22 ministration, the National Institutes of Health, and the 

23 Office of the National Coordinator for Health Information 

24 Technology. 


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1 SEC. 4. ACTIVITIES OF THE REGISTRY. 

2 (a) DATA COLLECTION AND STORAGE.—Beginning 

3 not later than 5 years after the date of the enactment of 

4 this Act, the head of the registry shall collect and store 

5 data related to knee and hip replacements (including in6 formation related to prosthetic devices and surgical proce7 dures consistent with the policies and procedures under 

8 section 3(a) in the registry established under subsection 

9 (a) of section 2). 

10 (b) DATA ANALYSIS.—The head of the registry shall 

11 conduct data analysis to fulfil the purpose of the registry 

12 under section 2. 

13 (c) ACCESS TO DATA.— 

14 (1) PROVISION OF DATA TO PROVIDERS.—At 

15 least one time per year, beginning not later than 6 

16 years after the date of enactment of this Act, the 

17 head of the registry shall provide data to health care 

18 providers to allow them to evaluate their perform19 ance, relative to their peers, in— 

20 (A) conducting knee and hip replacement 

21 surgeries; and 

22 (B) providing care related to such sur23 geries. 

24 (2) PROVISION OF DATA TO MANUFACTUR25 ERS.—At least one time per year, beginning not 

26 later than 7 years after the date of the enactment 


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1 of this Act, the head of the registry shall provide 

2 data to manufacturers of knee and hip replacement 

3 prostheses and related products to allow such manu4 facturers to evaluate the safety and performance of 

5 their products relative to similar products available 

6 on the market. 

7 (3) USE OF REGISTRY BY RESEARCHERS.—The 

8 head of the registry shall develop a process to allow 

9 outside researchers to apply to use individually iden10 tifiable data that is contained in the registry to con11 duct longitudinal studies consistent with the purpose 

12 of the registry under section 2. 

13 (d) COORDINATION WITH FDA, NIH, AND OTHER

14 HHS ENTITIES.—To avoid duplication in data collection 

15 and analysis, the head of the registry shall coordinate ac16 tivities of the registry with— 

17 (1) comparative effectiveness research con18 ducted by— 

19 (A) the Agency for Healthcare Research 

20 and Quality; 

21 (B) the National Institutes of Health; and 

22 (C) the Office of the Secretary of Health 

23 and Human Services; and 

24 (2) postmarket surveillance activities conducted 

25 by the Food and Drug Administration. 


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1 (e) COLLECTION OF REGISTRY INFORMATION FROM

2 FEDERAL DEPARTMENTS AND AGENCIES.— 

3 (1) REQUESTS BY THE REGISTRY.—The head 

4 of the registry may request data from Federal de5 partments and agencies if the collection of such data 

6 by the entity established under section 2 conforms 

7 with the policies and procedures under section 3. 

8 (2) AGENCY OBLIGATIONS.—Federal depart9 ments and agencies shall provide relevant data to 

10 the registry at the request of the head of the reg11 istry under paragraph (1). 

12 (f) PUBLIC FEEDBACK.—Not later than 2 years after 

13 beginning to collect data under subsection (a) and at the 

14 end of each subsequent 2-year period, in order to enhance 

15 the registry’s ability to achieve the purpose of the registry 

16 under section 2 and update policies and procedures under 

17 section 3, the head of the registry, in consultation with 

18 the Center for Medicare and Medicaid Services, the Food 

19 and Drug Administration, the Agency for Healthcare Re20 search and Quality, the Office of the National Coordinator 

21 of Health Information Technology, and the National Insti22 tutes of Health shall seek feedback from— 

23 (1) orthopedic providers, such as hospitals, sur24 geons, nurses, and other practitioners; 


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1 (2) manufacturers of knee and hip replacement 

2 prostheses and related products; 

3 (3) patient and consumer groups; and 

4 (4) public health experts and epidemiologist. 

5 (g) PUBLIC REPORT.—Beginning not later than six 

6 years after enactment, the head of the registry shall pub7 lish and make publically available an annual report that 

8 contains— 

9 (1) an overview of the data collected by under 

10 subsection (a); 

11 (2) the findings resulting from any analysis of 

12 such data conducted by the registry; and 

13 (3) any other information that the head of the 

14 registry determines is appropriate. 

15 SEC. 5. SAFETY MONITORING AND REPORTING. 

16 (a) SAFETY MONITORING.—The Agency for 

17 Healthcare Research and Quality and the Food and Drug 

18 Administration shall use the data in the registry and any 

19 analysis of such data conducted by the registry or by other 

20 entities to monitor and evaluate the safety of knee and 

21 hip replacement procedures and devices. 

22 (b) REPORT.—Not later than 6 years after the date 

23 of the enactment of this Act and annually thereafter, the 

24 Agency for Healthcare Research and Quality, in consulta25 tion with Food and Drug Administration, shall submit a 


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1 report to the Secretary of Health and Human Services and 

2 Congress containing recommendations on changes in pol3 icy and health care provider practices that could enhance 

4 the safety of knee and hip replacements. 

5 SEC. 6. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

6 COLLECTION OF INFORMATION FROM PRO7 VIDERS AND OTHER ENTITIES. 

8 (a) MODIFICATION OF REQUIRED DATA.—The Sec9 retary of Health and Human Services may modify the in10 formation required to be reported under administrative 

11 data sets under title XVIII of the Social Security Act (42 

12 U.S.C. 1395 et seq.) (including data that is required to 

13 be submitted by Medicare Advantage organizations and 

14 quality improvement organizations) to the extent the Sec15 retary, in consultation with the head of the registry, deter16 mines that the modification would result in the reporting 

17 of information that would be useful in carrying out the 

18 purpose of the registry under section 2. 

19 (b) CONDITION OF PARTICIPATION.—In the case that 

20 two consecutive reports submitted under section 7(a) con21 clude that the level of provider participation in the registry 

22 is insufficient to achieve the purpose of the registry under 

23 section 2, the Secretary of Health and Human Services 

24 may require providers of services (as defined under section 

25 1861(u) of the Social Security Act (42 U.S.C. 1395x(u))) 


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1 and physicians and other suppliers (as defined in sub2 sections (r) and (d) of section 1861 of the Social Security 

3 Act (42 U.S.C. 1395x(r) and (d)), respectively) to report 

4 relevant information directly to the registry as a condition 

5 of participation in the Medicare program under section 

6 1866 and 1842(h) of the Social Security Act (42 U.S.C. 

7 1395cc and 42 U.S.C. 1395u(h)), respectively. 

8 SEC. 7. OVERSIGHT OF THE REGISTRY. 

9 (a) IN GENERAL.—Not later than 1 year after the 

10 date the registry begins collecting data under section 4(a) 

11 and the end of each subsequent 2-year period, the Comp12 troller General of the United States shall submit to Con13 gress a report on the progress of the registry in achieving 

14 the purposes of the registry under section 2. 

15 (b) INFORMATION ON PROVIDER PARTICIPATION.— 

16 The report under subsection (a) shall include information 

17 on the number of providers participating in the registry 

18 and an analysis of whether that level of provider participa19 tion is sufficient to achieve the purposes of the registry 

20 under section 2. 

21 SEC. 8. AUTHORIZATION OF APPROPRIATIONS. 

22 There is authorized to be appropriated to carry out 

23 this Act, such sums as are necessary for fiscal years 2010 

24 through 2019. 

Æ 


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