[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2813 Introduced in House (IH)]

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.

    Be it enacted by the Senate and House of Representatives 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 replacement registry (referred to in this Act as 
the ``registry'') for the purpose of identifying predictors (including 
patient co-morbidities, conditions, and characteristics; features of 
the prostheses; and surgical technique) that may lead to poor outcomes 
in knee and hip replacement surgeries 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 nationwide.
    (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 Administrator 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--
            (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 collection and 
                analysis;
                    (B) avoid bias in the analysis of data;
                    (C) ensure that analysis of the data collected 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 stakeholders, 
                including--
                            (i) orthopedic practitioners and providers, 
                        such as hospitals, surgeons, nurses, and other 
                        practitioners and providers;
                            (ii) manufacturers of knee and hip 
                        replacement prostheses and related products; 
                        and
                            (iii) patient and consumer groups;
                    (B) balance the importance and usefulness of 
                potential findings resulting from the collection 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 existing 
                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 Administrator 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 
Administration, the National Institutes of Health, and the Office of 
the National Coordinator for Health Information Technology.

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 information related to prosthetic devices and surgical 
procedures 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 
        performance, relative to their peers, in--
                    (A) conducting knee and hip replacement surgeries; 
                and
                    (B) providing care related to such surgeries.
            (2) Provision of data to manufacturers.--At least one time 
        per year, beginning not later than 7 years after the date of 
        the enactment 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 manufacturers 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 identifiable data that is 
        contained in the registry to conduct 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 activities of the registry with--
            (1) comparative effectiveness research conducted 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.
    (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 departments 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 departments and agencies 
        shall provide relevant data to the registry at the request of 
        the head of the registry 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 Research and Quality, the 
Office of the National Coordinator of Health Information Technology, 
and the National Institutes of Health shall seek feedback from--
            (1) orthopedic providers, such as hospitals, surgeons, 
        nurses, and other practitioners;
            (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 publish 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 consultation with Food and Drug Administration, shall 
submit a report to the Secretary of Health and Human Services and 
Congress containing recommendations on changes in policy 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 PROVIDERS AND OTHER ENTITIES.

    (a) Modification of Required Data.--The Secretary of Health and 
Human Services may modify the information 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 Secretary, in consultation with the 
head of the registry, determines 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) conclude 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))) and 
physicians and other suppliers (as defined in subsections (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 Comptroller General of the United States 
shall submit to Congress 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 participation 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.
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