1.This Act may be cited as the
National Knee and Hip Replacement
Registry Act of 2009
.
2.
(a)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)Such registry
shall be subject to the policies and procedures developed under
section 3(a).
3.Knee and hip
replacement registry policies and procedures
(a)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)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.
4.Activities of the
registry
(a)Data collection
and storageBeginning 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)The head of the registry shall conduct data analysis to
fulfil the purpose of the registry under
section 2.
(c)
(1)Provision of
data to providersAt 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 manufacturersAt
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 researchersThe 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 entitiesTo 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)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)Federal departments and agencies shall provide
relevant data to the registry at the request of the head of the registry under
paragraph (1).
(f)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)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.
5.Safety monitoring
and reporting
(a)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)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.
6.Department of
Health and Human Services collection of information from providers and other
entities
(a)Modification of
required dataThe 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
participationIn 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.
7.Oversight of the
registry
(a)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 participationThe
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.
8.Authorization of
appropriationsThere is
authorized to be appropriated to carry out this Act, such sums as are necessary
for fiscal years 2010 through 2019.