[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5214 Reported in House (RH)]
Union Calendar No. 514
113th CONGRESS
2d Session
H. R. 5214
[Report No. 113-683]
To require the Secretary of Health and Human Services to provide for
recommendations for the development and use of clinical data registries
for the improvement of patient care.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 28, 2014
Mr. Olson introduced the following bill; which was referred to the
Committee on Energy and Commerce
December 22, 2014
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed
in italic]
[For text of introduced bill, see copy of bill as introduced on July
28, 2014]
_______________________________________________________________________
A BILL
To require the Secretary of Health and Human Services to provide for
recommendations for the development and use of clinical data registries
for the improvement of patient care.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. RECOMMENDATIONS FOR DEVELOPMENT AND USE OF CLINICAL DATA
REGISTRIES.
(a) In General.--Not later than one year after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
make recommendations for the development and use, when appropriate, of
clinical data registries that are integrated with clinical practice
guidelines and best practices or standards of care, including
recommendations designed to minimize duplication and burden on those
operating or reporting to such registries, for the improvement of
patient care. The Secretary shall make such recommendations available
to the public by posting them on a public Website of the Department of
Health and Human Services.
(b) Specific Recommendations.--Such recommendations, with respect
to such registries, shall include the following:
(1) Recommendations for a set of standards that, if adopted
by such registries, would allow for the bidirectional,
interoperable exchange of information between the electronic
health records of the reporting clinicians and such registries.
(2) Recommendations on how clinical registries, including
outcomes-based registries, may be developed and then used to
evaluate various care models and methods, including improved
clinical care coordination, and the impact of such models and
methods on the management of diseases as measured by
appropriate care parameters based on clinical practice
guidelines and best practices (such as A1C, blood pressure, and
cholesterol levels in the case of diabetes).
(3) Recommendations on how such registries should be
structured to facilitate--
(A) the recording and reporting of post-market data
for the purposes of monitoring safety and efficacy of
FDA-approved devices and drugs;
(B) the reporting of relevant clinical data to
satisfy attestation requirements for coverage of
prescribed devices; and
(C) coverage with evidence development policies for
devices under the Medicare program (such as improving
patient access to safe and effective glucose monitoring
systems).
(4) Recommendations on how data from such registries may be
used to inform physicians and other health care professionals
regarding clinical practices for the prevention of diseases
(such as diabetes and the precursor conditions of diabetes) and
appropriate methods for the dissemination of clinical practice
support tools and other educational resources that may be
derived from registry data.
(5) Recommendations for how registries can be used to
promote preventive health benefits such as screenings and the
Medicare annual wellness visits that may reduce the risk of
chronic diseases (such as obesity, osteoporosis, cardiovascular
disease, cancer, diabetes and their complications).
(c) Consultation With Clinical Experts.--The Secretary shall
consult with national medical specialty societies, patient groups,
technology vendors, and developers and manufacturers of drugs and
medical devices in the development of such recommendations as they
relate to the diseases that members of such societies manage and treat
(such as with endocrinologists with respect to recommendations relating
to diabetes and pre-diabetes conditions).
(d) Rule of Construction.--Nothing in this section may be construed
as--
(1) authorizing the Secretary of Health and Human Services
to take any action with regard to the recommendations made
under this section (other than making such recommendations
available to the public in the manner described in subsection
(a));
(2) limiting or interfering with the authority of a health
care practitioner to practice medicine or to prescribe or
administer a drug or device to an individual for a condition or
disease; or
(3) providing the Centers for Medicare & Medicaid Services
with authority to limit (or to encourage other individuals or
entities to limit) coverage under the Medicare program under
title XVIII of the Social Security Act for an item or service
furnished to an individual on account of the participation, or
lack of participation, of the individual in a registry or other
data collection system.
Union Calendar No. 514
113th CONGRESS
2d Session
H. R. 5214
[Report No. 113-683]
_______________________________________________________________________
A BILL
To require the Secretary of Health and Human Services to provide for
recommendations for the development and use of clinical data registries
for the improvement of patient care.
_______________________________________________________________________
December 22, 2014
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed