[House Report 113-683]
[From the U.S. Government Publishing Office]
113th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 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
_______
December 22, 2014.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Upton, from the Committee on Energy and Commerce,
submitted the following
R E P O R T
[To accompany H.R. 5214]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 5214) to require the Secretary of Health and
Human Services to provide for recommendations for the
development of patient care, having considered the same, report
favorably thereon with an amendment and recommend that the bill
as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 2
Background and Need for Legislation.............................. 3
Hearings......................................................... 3
Committee Consideration.......................................... 4
Committee Votes.................................................. 4
Committee Oversight Findings..................................... 5
Statement of General Performance Goals and Objectives............ 5
New Budget Authority, Entitlement Authority, and Tax Expenditures 5
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 5
Committee Cost Estimate.......................................... 5
Congressional Budget Office Estimate............................. 5
Federal Mandates Statement....................................... 6
Duplication of Federal Programs.................................. 6
Disclosure of Directed Rule Makings.............................. 6
Advisory Committee Statement..................................... 6
Applicability to Legislative Branch.............................. 6
Section-by-Section Analysis of the Legislation................... 6
Changes in Existing Law Made by the Bill, as Reported............ 7
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
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.
PURPOSE AND SUMMARY
H.R. 5214, a bill to streamline government recommendations
related to the development of clinical data registries, was
introduced on July 28, 2014, by Representative Pete Olson (R-
TX) and subsequently referred to the Committee on Energy and
Commerce.
The legislation would require the Secretary of Health and
Human Services (HHS) to provide for recommendations for the
development and use of clinical data registries that are
integrated with clinical practice guidelines and best practices
or standards of care.
BACKGROUND AND NEED FOR LEGISLATION
Clinical data registries present opportunities for the
collection and dissemination of clinical data that can be used
to improve the quality of care delivered, increase research and
surveillance opportunities for treatments and services, and
ease the burden of government and other payer requirements on
developers and providers.
Many sub-agencies within HHS have rules that relate to the
ways in which data registries can be used to facilitate
reporting and other administrative requirements. Qualified
clinical data registries (QCDR) are just one example and were
included as an authorized reporting mechanism available for the
Physician Quality Reporting System (PQRS) under the Medicare
Physician Fee Schedule beginning in 2014.\1\ A QCDR is a
Centers for Medicare and Medicaid Services (CMS)-approved
entity that collects medical and/or clinical data for the
purpose of patient and disease tracking to foster improvement
in the quality of care provided to patients.
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\1\CMS, Physician Quality Reporting System www.cms.gov.
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Unfortunately, these various sub-agencies do not always use
the same requirements related to the collection, dissemination,
and administration of registry data. Various payment rules and
agency publications oftentimes can offer contradictory
statements that needlessly increase the burden on those seeking
to operate and employ registries. The Committee believes such
duplication in many instances is unnecessary.
The legislation would seek to engage the Secretary in a
process of disseminating information on a set of
recommendations related to the form and function of registries.
Such a process would force HHS and its sub-agencies to rethink
the current piece-meal approach to registry requirements and
facilitate greater transparency for policymakers to ensure
government requirements are streamlined and efficient.
The Committee recognizes, however, that registries have
various users, audiences, and purposes (as is evidenced by the
multi-stake-holder developed Agency for Healthcare Research and
Quality User Guide and the American Medical Association's
National Quality Registry Network process). The Committee does
not intend for this new requirement in the legislation to limit
flexibility or stymie development of registries by forcing
current innovation into a one-size-fits all registry approach.
The Committee expects the Secretary will work to improve
coordination without sacrificing innovation.
HEARINGS
The Committee on Energy and Commerce has not held hearings
on the legislation.
COMMITTEE CONSIDERATION
On July 29 and 30, 2014, the full Committee met in open
markup session and approved H.R. 5214, as amended, by a record
vote of 25 yeas and 18 nays.
COMMITTEE VOTES
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto. A
motion by Mr. Upton to order H.R. 5214, reported to the House,
as amended, by a record vote of 25 yeas and 18 nays. The
following reflects the record votes taken during the Committee
consideration:
COMMITTEE ON ENERGY AND COMMERCE--113TH CONGRESS
ROLL CALL VOTE #47
Bill: H.R. 5214, 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
Amendment: A motion by Mr. Upton to order H.R. 5214
favorably reported to the House, as amended. (Final Passage),
Disposition: Agreed to, by a roll call vote of 25 yeas and 18
nays
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REPRESENTATIVE YEAS NAYS PRESENT REPRESENTATIVE YEAS NAYS PRESENT
----------------------------------------------------------------------------------------------------------------
Mr. Upton...................... X ........ ......... Mr. Waxman....... ........ X .........
Mr. Hall....................... X ........ ......... Mr. Dingell...... ........ ........ .........
Mr. Barton..................... X ........ ......... Mr. Pallone...... ........ X .........
Mr. Whitfield.................. ........ ........ ......... Mr. Rush......... ........ ........ .........
Mr. Shimkus.................... X ........ ......... Ms. Eshoo........ ........ X .........
Mr. Pitts...................... X ........ ......... Mr. Engel........ ........ X .........
Mr. Walden..................... X ........ ......... Mr. Green........ ........ X .........
Mr. Terry...................... X ........ ......... Ms. DeGette...... ........ X .........
Mr. Rogers..................... ........ ........ ......... Mrs. Capps....... ........ X .........
Mr. Murphy..................... X ........ ......... Mr. Doyle........ ........ X .........
Mr. Burgess.................... X ........ ......... Ms. Schakowsky... ........ ........ .........
Mrs. Blackburn................. X ........ ......... Mr. Matheson..... ........ X .........
Mr. Gingrey.................... X ........ ......... Mr. Butterfield.. ........ X .........
Mr. Scalise.................... ........ ........ ......... Mr. Barrow....... ........ X .........
Mr. Latta...................... X ........ ......... Ms. Matsui....... ........ ........ .........
Mrs. McMorris Rodgers.......... ........ ........ ......... Ms. Christensen.. ........ ........ .........
Mr. Harper..................... X ........ ......... Ms. Castor....... ........ X .........
Mr. Lance...................... X ........ ......... Mr. Sarbanes..... ........ X .........
Mr. Cassidy.................... X ........ ......... Mr. McNerney..... ........ X .........
Mr. Guthrie.................... X ........ ......... Mr. Braley....... X ........ .........
Mr. Olson...................... X ........ ......... Mr. Welch........ ........ X .........
Mr. McKinley................... X ........ ......... Mr. Lujan........ ........ X .........
Mr. Gardner.................... X ........ ......... Mr. Tonko........ ........ X .........
Mr. Pompeo..................... ........ ........ ......... Mr. Yarmuth...... ........ X .........
Mr. Kinzinger.................. X ........ .........
Mr. Griffith................... X ........ .........
Mr. Bilirakis.................. X ........ .........
Mr. Johnson.................... X ........ .........
Mr. Long....................... X ........ .........
Mrs. Ellmers................... ........ ........ .........
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COMMITTEE OVERSIGHT FINDINGS
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has not held oversight
or legislative hearings on this legislation.
STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES
The goal of the legislation is to streamline the various
governmental reporting requirements related to clinical data
registries for the purpose of supporting registry development
and use by requiring the Secretary to publish one set of
recommendations.
NEW BUDGET AUTHORITY, ENTITLEMENT AUTHORITY, AND TAX EXPENDITURES
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
5214 would result in no new or increased budget authority,
entitlement authority, or tax expenditures or revenues.
EARMARK, LIMITED TAX BENEFITS, AND LIMITED TARIFF BENEFITS
In compliance with clause 9(e), 9(f), and 9(g) of rule XXI
of the House of Representatives, the Committee finds that H.R.
5214 contains no earmarks, limited tax benefits, or limited
tariff benefits.
COMMITTEE COST ESTIMATE
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
CONGRESSIONAL BUDGET OFFICE ESTIMATE
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, September 10, 2014.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Chairman: The Congressional Budget Office has prepared
the enclosed cost estimate for H.R. 5214, 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.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Amber G.
Marcellino.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
H.R. 5214--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
H.R. 5214 would require the Secretary of Health and Human
Services to make recommendations for the development and use of
clinical data registries for the improvement of patient care.
The legislation would direct the Secretary to post such
recommendations on the agency's website.
CBO estimates that implementing the bill would have no
significant effect on spending subject to appropriation.
Enacting H.R. 5214 would not affect direct spending or
revenues; therefore, pay-as-you-go procedures do not apply.
H.R. 5214 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act and
would not affect the budget of state, local, or tribal
governments.
The CBO staff contact for this estimate is Amber G.
Marcellino. The estimate was approved by Holly Harvey, Deputy
Assistant Director for Budget Analysis.
FEDERAL MANDATES STATEMENT
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
DUPLICATION OF FEDERAL PROGRAMS
No provision of H.R. 5214 establishes or reauthorizes a
program of the Federal Government known to be duplicative of
another Federal program.
DISCLOSURE OF DIRECTED RULE MAKINGS
The Committee estimates that enacting H.R. 5214 would not
direct specific rule making within the meaning of 5 U.S.C. 551.
ADVISORY COMMITTEE STATEMENT
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
APPLICABILITY TO LEGISLATIVE BRANCH
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
SECTION-BY-SECTION ANALYSIS OF THE LEGISLATION
Section 1. Recommendations for development and use of clinical data
registries
Section 1 would require the Secretary of HHS to consult
with clinical experts and make recommendations for the use of
clinical data registries to improve patient care. Specifically,
the bill directs the Secretary to include in the
recommendations: (1) standards to allow exchange of information
between electronic health records and registries, (2) how
registries can be used to evaluate models and methods of care,
(3) how registries can be used to monitor the safety and
efficacy of products approved by the Food and Drug
Administration, (4) how registry data can inform health care
professionals on the prevention of disease and how educational
resources derived from registry data can be disseminated, and
(5) how registries can promote preventive health care.
CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED
This legislation does not amend any existing Federal
statute.
[all]