[Senate Report 110-187]
[From the U.S. Government Publishing Office]
Calendar No. 318
110th Congress Report
SENATE
1st Session 110-187
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WIRED FOR HEALTH CARE QUALITY ACT
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October 1, 2007.--Ordered to be printed
_______
Mr. Kennedy, from the Committee on Health, Education, Labor, and
Pensions, submitted the following
R E P O R T
[To accompany S. 1693]
The Committee on Health, Education, Labor, and Pensions, to
which was referred the bill (S. 1693) to enhance the adoption
of a nationwide interoperable health information technology
system and to improve the quality and reduce the costs of
health care in the United States, having considered the same,
reports favorably thereon with an amendment in the nature of a
substitute and recommends that the bill (as amended) do pass.
CONTENTS
Page
I. Purpose and Summary..............................................1
II. Background and Need for Legislation..............................2
III. Legislative History and Committee Action.........................3
IV. Explanation of Bill and Committee Views..........................3
V. Cost Estimate...................................................13
VI. Application of Law to the Legislative Branch....................17
VII. Regulatory Impact Statement.....................................17
VIII.Section-by-Section Analysis.....................................17
IX. Changes in Existing Law.........................................23
I. Purpose and Summary
The purpose of S. 1693, the ``Wired for Health Care Quality
Act'' is to enhance the adoption of a nationwide interoperable
health information technology system and to improve the quality
and reduce the cost of health care in the United States.
The bill amends the Public Health Service Act by adding a
new title, ``Health Information Technology and Quality''. The
bill enhances the use of health information technology to
improve health care quality, while protecting the privacy and
security of health information. The bill also establishes the
Office of the National Coordinator for Health Information
Technology within the Office of the Secretary for Health and
Human Services (referred to hereafter as ``the Secretary''),
and formalizes the role of private entities in the standards-
setting process by establishing the public-private Partnership
for Health Care Improvement. The bill also establishes the
American Health Information Community to provide advice to the
Secretary and Federal agencies concerning policy considerations
related to health information technology. The National
Coordinator will serve as member of both the Partnership and
the American Health Information Community, and will serve as a
liaison between those entities and the Federal government. The
bill authorizes three grant programs to facilitate the
widespread adoption of interoperable health information
technology. The legislation also authorizes competitive grants
to carry out demonstration projects to develop academic
curricula integrating qualified health information technology
systems in the clinical education of health professionals. In
order to improve health care quality, the bill tasks the
Secretary with developing and utilizing quality measures and
facilitates the analysis of large data sets to improve
measurement of quality and efficiency of health care. Finally,
the bill establishes a Health Information Technology Resource
Center within the Agency for Health Care Research and Quality
to provide technical assistance and develop best practices to
support and accelerate efforts to adopt, implement, and
effectively use interoperable health information technology.
II. Background and Need for Legislation
Studies by the Institute of Medicine and other expert
bodies have revealed serious problems with health care quality
and medical errors. Additionally, a RAND study stated that
adult Americans receive recommended care only 55 percent of the
time. Nearly 30 percent of health care spending is for
treatments that may not improve health status, may be
redundant, or may be inappropriate for the patient's condition
according to Dartmouth University researchers.
Some of the most serious challenges facing health care
today--medical errors, inconsistent quality, and rising costs--
can be addressed through the effective application of health
information technology linking all elements of the health care
system and using the system to improve information available to
physicians to improve quality, enhance preventive care, and
reduce errors.
In April 2004, the President signed an Executive Order
announcing his commitment to the promotion of health
information technology to lower costs, reduce medical errors,
improve quality of care, and provide better information for
patients and physicians. In particular, the President called
for widespread adoption of electronic health records and for
health information to follow patients throughout their care in
a seamless and secure manner.
This committee agrees that if we move from a paper-based
health care system to secure, interoperable electronic health
records, we will reduce mistakes and save lives, time and
money. This legislation will bring the government and the
private sector together to make health care better, safer and
more efficient by accelerating the widespread adoption of
interoperable health information technology and quality
measurement across our health care system.
Interoperability is a shared goal across the health care
industry. The national strategy for achieving interoperability
of digital health information calls for Federal agencies--who
pay more than one-third of all health care costs--to
collaborate with private entities in developing and adopting an
architecture, standards, implementation specifications, a
certification process, and a method of governance for ongoing
implementation of health IT. Once the market has structure,
patients, providers, medical professionals, and vendors will be
better able to innovate, create efficiencies, and improve care.
The legislation formalizes involvement of private entities
in the standards-setting process by establishing the
Partnership for Health Care Improvement, composed of
representatives of the public and private sectors. The National
Coordinator for Health Information Technology will serve as a
member of the Partnership.
The committee agrees that an investment in health
information technology now will decrease health care costs over
the long-term. This legislation targets Federal funding to
those who need the most help updating and advancing health
information technology.
III. Legislative History and Committee Action
The HELP Committee has a strong tradition of making
bipartisan progress on health information technology,
regardless of whether the chairmanship is held by a Republican
or a Democrat.
In the 109th Congress, Senators Enzi, Kennedy, Frist,
Clinton, Alexander, Dodd, Burr, Harkin, Isakson, Mikulski,
DeWine, Jeffords, Roberts, Bingaman, Murray, Bond, Hagel,
Martinez, Talent, Nelson (FL), and Obama introduced S. 1418,
the ``Wired for Health Care Quality Act.'' On July 20, 2005,
the committee reported that bill (as amended by a Chairman's
substitute) by unanimous voice vote. The bill was approved by
the full Senate by unanimous consent on November 18, 2005. The
House of Representatives also approved legislation on health
information technology in the 109th Congress, but the Senate
and House were unable to resolve the differences between the
two bills before the 109th Congress adjourned.
The committee's commitment to health IT continued in the
110th Congress. On June 26, 2007, Senators Kennedy, Enzi,
Clinton, Hatch, Obama, Alexander, Gregg, Isakson, Roberts, and
Burr introduced S. 1693, the ``Wired for Health Care Quality
Act''. On June 27, 2007, the committee held an executive
session to consider S. 1693. After accepting a substitute
amendment offered by Senator Kennedy and amendments offered by
Senator Reed and Senator Dodd by unanimous voice vote, the
committee approved S. 1693, as amended, by unanimous voice
vote.
IV. Explanation of Bill and Committee Views
OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY
In April 2004, by Executive Order, President George W. Bush
established the Office of the National Coordinator for Health
Information Technology, operating from the Office of the
Secretary. The Office is charged with developing a blueprint
for a nationwide interoperable health information technology
infrastructure and coordinating health information technology
policies and programs across the Federal Government.
The National Coordinator will serve as member of both the
Partnership and the American Health Information Community,
serving as the primary advisor to the Secretary, and will serve
as a liaison between those entities and the Federal Government,
ensuring the adoption of standards for the electronic exchange
of health information, and interacting with public and private
stakeholders. In carrying out the activities of the Office, the
National Coordinator shall work to ensure the security and
privacy of patient health information and the electronic
exchange of health information. Additionally, the Office of the
National Coordinator shall be responsible for ensuring that
health information technology initiatives are coordinated
across programs of the Department of Health and Human Services
as well as with other Federal agencies. The National
Coordinator shall also review Federal health information
technology investments to ensure investments are meeting
published objectives and at the request of the Office of
Management and Budget, shall provide advice and comments. The
committee encourages the Office of the National Coordinator for
Health Information Technology to work in collaboration with
programs and departments within the Department of Health and
Human Services, including the Office of Minority Health, Indian
Health Service, Office for Civil Rights, Administration on
Aging, and the Office of Disability, and with other Federal
agencies including the Department of Justice. The committee
encourages the National Coordinator to ensure that the
membership of boards, councils, partnerships, working groups,
and other entities created by and utilized by the Office are
representative of the diversity of the Nation's populations and
regions, and ensure a balance among various sectors of the
health care system so that no single sector unduly influences
the recommendations and outcomes. This is necessary to help
ensure wider adoption and utilization of health information
technology to improve health care quality and patient safety
for all population groups, including populations at risk for
health disparities, medically unserved and underserved
populations, and rural populations.
The bill also specifies that an additional responsibility
of the Office is to enhance the use of health information
technology to improve the quality of health care in the
prevention and treatment of chronic disease. The committee
believes the United States cannot address rising health care
costs without more focus on preventing chronic disease.
According to the Centers for Disease Control, the medical care
costs of people with chronic diseases account for more than 75
percent of the Nation's medical care costs. In addition,
chronic disease accounts for 70 percent of all death in the
United States. The committee believes adoption and promotion of
health information technology can lead to innovative
interventions to prevent disease and reduce health care costs.
The committee encourages reports to assess the impact of health
information technology in communities with health disparities
and to identify practices to increase the adoption of such
technology by health care providers in such communities.
The Secretary has begun undertaking the activities outlined
in this section of the legislation. It is the committee's
intent not to require the duplication of Federal efforts with
respect to the establishment of the Office.
QUALIFIED HEALTH INFORMATION TECHNOLOGY
The committee believes that the inclusion of decision
support in an interoperable health information technology
system is critical to reducing medical errors and improving the
quality of care patients receive. For that reason, the
committee included the incorporation of decision support in the
definition of qualified health information technology. The
definition clearly states that qualified health information
technology means a computerized system and it is the intent of
the committee that decision support be included in that system,
but the committee recognizes that each potential component
(hardware or software) of a comprehensive interoperable health
information technology system may not include a decision
support feature. It is not the intention of the committee to
restrict these components from participation in an
interoperable qualified health information technology system,
but rather to require that decision support be integrated
within the system and available to any user.
The committee recognizes that there are a variety of policy
and technical matters on which the recommendations and judgment
of non-government experts are especially important. The
technical challenges of implementing a nationwide health
information architecture are formidable, and require careful
consideration by those with special expertise in health care
and information technology. To provide this important technical
advice, the legislation establishes a private-sector
Partnership for Health Care Improvement.
Equally important are the major social and policy
considerations raised by broader use of health IT. These
include questions of privacy and security, inclusion of all
communities in the progress that health IT brings and the
bridging of digital divides that might otherwise hinder the
broader adoption of health IT. To provide advice to the Federal
Government on these and similar important policy matters, the
legislation establishes the American Health Information
Community, the membership of which reflects the broad variety
of perspectives needed to provide effective recommendations on
policy challenges associated with health IT.
The areas of interest served by the Partnership and
Community, though distinct, are clearly intertwined. For this
reason, the legislation provides mechanisms to ensure that the
deliberations of each body are informed by the other, and
provides that the National Coordinator will liaise between the
two.
PARTNERSHIP FOR HEALTH CARE IMPROVEMENT
The committee believes there are significant barriers to
widespread adoption of interoperable health information
technology. One of the primary barriers is the current lack of
agreed-upon standards and common implementation guidelines and
a certification process. The committee believes this bill
addresses those factors in a way that appropriately
incorporates involvement of both the public and private
sectors.
The legislation establishes the Partnership for Health Care
Improvement to recommend specific technical standards and
policies to achieve a nationwide interoperable health
information technology infrastructure, and to serve as a forum
for the participation of a broad range of stakeholders to
provide input on achieving the interoperability of health
information technology. It is the intent of the Committee to
ensure that the Partnership recommends standards for the
electronic exchange of health information and ongoing
modifications to these standards facilitating the widespread
adoption of interoperable health IT.
The Partnership shall strive for maximum cost-effectiveness
by building on existing standards and policy work, establishing
efficient processes and minimizing the negative economic impact
of any new requirements it defines. As a general principle, the
Partnership should seek existing solutions and minimal
modifications, creating new solutions only when truly needed.
Even so, some change will be required to ensure
interoperability. The extent of such change must be determined
using a defined process. To do so effectively requires close
and continuous interaction with standards development
organizations and other potential sources of relevant models
for its own work.
The process to identify and specify these standards and
policies must engage all affected stakeholders, as the
credibility and compliance with the decisions of the
Partnership will ultimately depend on whether those who are
affected by standards and policies were able to participate in
the decisionmaking process. It is the intent of the committee
to ensure a balance among all stakeholders, so that no member
organization unduly influences recommendations from the
Partnership.
AMERICAN HEALTH INFORMATION COMMUNITY
The American Health Information Community is established by
the legislation to provide policy advice on issues arising from
more widespread adoption of health IT. These include protecting
the privacy and security of information in electronic format,
fostering public understanding of health IT, and defining
appropriate uses of health IT, among other policy issues. The
Community's policy recommendations are essential to the success
of widespread adoption of interoperable health information
technology.
With respect to the American Health Information Community
policies, the committee encourages the entity to ensure the
application of appropriate uses of a nationwide health
information network including improving the quality of care in
rural and frontier communities, reducing health disparities,
and fostering the understanding of health information
technology among U.S. populations and subpopulations. Policies
must incorporate input from health care consumers.
ADOPTION AND EFFECT OF STANDARDS
The bill directs the Partnership, on an ongoing basis, to
recommend new standards for the electronic exchange of health
information and modifications to existing standards, identify
deficiencies and omissions in existing standards, and identify
duplication and overlap in existing standards. The bill directs
the President to provide for the adoption by the Federal
Government of any standard or implementation specification
recommended by the Partnership within 90 days after the
issuance of such recommendation. The bill specifies the
Secretary, the Secretary of Veterans Affairs, and the Secretary
of Defense, in collaboration with representatives of other
relevant Federal agencies, jointly review such recommendations.
The committee believes that when private entities contract
with the government to provide health care services, those
entities should be able to exchange interoperable information
with the Federal Government. To accomplish this under their
contracts, private entities must adopt the same standards as
the Federal Government. However, this requirement only applies
to the external exchange of information. The committee does not
intend for private entities to have to adopt the government's
standards for their internal business processes, even if those
processes ultimately support the exchange of information under
the contract.
Not later than 1 year after the adoption by the Federal
Government of a recommended standard, no Federal agency shall
expend Federal funds for the purchase of any form of health
information technology system for clinical care or for the
electronic retrieval, storage, or exchange of health
information that is not consistent with applicable standards
adopted by the Federal Government. The committee believes it is
critical that the Federal Government comply with the data
standards recommended by the Partnership in order to create a
nationwide interoperable health information technology
infrastructure. Pilot testing of standards is important to
ensuring that they are usable and practical. For this reason,
the committee included a provision to allow, but not require,
the pilot testing of any standard before its adoption.
The legislation requires the Secretary of HHS to implement
procedures to enable the Department to accept the electronic
submission of data. Participation in the electronic submission
of reports utilizing standards is voluntary for private
entities, but the Department shall permit such submission. The
provision is intended to provide private entities the option of
submitting data electronically so that reporting becomes simply
another function of an interoperable health information
technology system.
The adoption of standards is an important component of
establishing consistent and common content and communication
between health information technology systems and consistent
and common use of adopted standards is another vital piece of
establishing a nationwide interoperable health information
system. This bill directs the Secretary or his designee, based
upon the recommendation of the Partnership, to establish
criteria for the implementation and certification of standards
adopted by the Federal Government. Additionally, the bill
authorizes the Secretary to recognize a private entity to
assist with the development of criteria for the implementation
of the standards and certification of products for compliance
with the standards.
It is the committee's intent to work with the
Administration and ensure that this legislation complements
steps the Administration has taken towards ensuring
interoperable health IT by 2014.
IMPROVING THE QUALITY OF HEALTH CARE
The committee believes that the use of health information
technology will help to improve the quality of health care in
the prevention and management of chronic disease, improve
health care quality for all populations including rural and
frontier communities, medically underserved communities, and
communities at risk for health disparities. The committee
strongly believes that fostering the development and use of
health care quality measures will benefit from collaboration
with multi-stakeholder groups that reflect the diversity of the
U.S. population.
The Federal Government possesses a significant amount of
publicly financed information that could be used to
dramatically improve health care quality and making care more
affordable for all Americans. Several businesses and health
insurance plans in the private sector already utilize their own
data to compare and examine the cost and effectiveness of the
care their workers and beneficiaries are receiving. The
legislation expands this research effort by allowing qualified
organizations to access defined Federal health care data to
determine more effective and affordable health care solutions,
while placing a premium on the privacy and security of
patients. The bill authorizes the release of de-identified
patient data, reimbursement claims data and survey data
maintained by the programs administered by the Secretary to
qualified organizations, known as Quality Reporting
Organizations (QROs). QROs can then use this data to analyze
and develop reports on the cost and quality of health care
while including necessary safeguards to protect patient
privacy. These reports can be requested by private sector
organizations to measure health care quality and costs in a
community. Any reports or results derived from this data must
be released to the public within 1 year, including detailed
information on the methodology, standards and measures of
quality used in developing the reports.
In every instance beneficiary privacy is ensured by
requiring QROs to comply with the Health Insurance Portability
and Accountability Act (HIPAA) and the Privacy Act. To further
ensure beneficiary protection, the bill also requires a privacy
review by the Secretary of any analytical report prepared by a
QRO prior to its release.
In addition, the legislation ensures that the Secretary
permits researchers to access Federal health care data for
research provided they comply with appropriate criteria as
established by the Secretary.
This legislation directs the Secretary, to develop, adopt
and utilize quality measures for the purpose of measuring the
quality and efficiency of health care that patients receive.
The bill directs the Secretary to designate a single entity to
promote the development of quality measures and provide the
Secretary with advice and recommendations on the key elements
and priorities of a national system for health care performance
measurement. In carrying out its duties, the designated entity
shall ensure that such measures are evidence-based, reliable,
and valid and include measures of clinical process and
outcomes, patient experience, efficiency, and equity, as well
as measures to assess the effectiveness, timeliness, patient
self-management, patient centeredness, and safety of care
received by patients. Further, the bill directs the designated
entity to give priority to measures with the greatest impact
for improving performance and efficiency, measures that may be
rapidly implemented, measures that help consumers and patients
make informed decisions about their care, measures that apply
to multiple services furnished by different providers, measures
that can be integrated into the technology standards setting
and certification process.
The RAND Institute reports that patients receive care that
is appropriate to their condition only 55 percent of the time
and best clinical practices take, on average, 17 years to reach
the bedside. The committee finds that the development and
adoption of a quality measurement system and its integration
with the interoperable health information technology system
under this legislation is a critical step in eradicating these
deficiencies and improving the quality of health care that all
Americans receive.
In developing and updating the quality measures, the
Secretary shall enter an arrangement with a private entity to
receive advice and recommendations with regard to the
development and updating of quality measures. The committee
intends the development and updating of the quality measures to
recognize those established measurement sets that have gone
through a multi-stakeholder, open and accountable process and
are currently in use by both the Secretary and the private
sector, including the Health Plan Employer Data and Information
Set and the Consumer Assessment of Health Plans. It is the
intention of the committee to avoid the duplication of these
established measures and expects that the Secretary will adopt
these measure sets and additions to them. The committee intends
the widespread adoption and use of measures developed pursuant
to this legislation adopted through the development and
updating of the quality measurement system.
The legislation also requires reporting of quality measures
by entities receiving grants and loans and allows the Secretary
to aggregate, analyze and disseminate quality data for the
purposes of providing information to consumers, professionals,
officials and researchers.
LOWERING THE BARRIERS TO IMPLEMENTATION OF HEALTH IT
The committee recognizes that a major barrier to widespread
adoption of health information technology in the U.S. health
care system is the high cost of such technology. The typical
cost of purchasing a robust health information technology
system for a solo or group practitioner is estimated to be
thousands of dollars per provider. In addition to this, there
are typically ongoing system maintenance and management costs
that must be borne. In the hospital setting, costs vary widely.
Nonetheless, purchasing a robust health information technology
system, conducting training of personnel, integrating a new
health information technology system into legacy computerized
systems, and purchasing technical support services can cost
millions of dollars for a community hospital of average size.
Most experts estimate that the widespread adoption of
health information technology will result in a substantial cost
savings over time in our health care system. While providers
must bear the full cost of acquiring these systems, a large
part of these economic savings will accrue to health insurers
and large integrated health care systems, rather than to
physicians in office practices or smaller community hospitals.
Many physicians and community hospitals, community health
centers and other provider organizations operate with small
financial margins and have difficulty affording modern health
information technology systems for use in these clinical
settings. Because of the current cost and segmented
reimbursement, rates of adoption of modern health information
technology in the United States are very low.
In order to address the health information technology
``adoption gap'' in the United States, S.1693 authorizes three
grant programs that will carefully target financial support to
health care providers and consortia for the purpose of
facilitating the adoption of interoperable health information
technology. For the purposes of this act, within the definition
of health care provider, the term ``laboratory'' is intended to
include not-for-profit blood centers. The bill leaves to the
discretion of the Secretary the allocation of the funding among
the three programs.
In addition, the greatest improvements in quality of health
care and cost savings will be realized when all elements of the
health care system are electronically connected and speak a
common technical language--that is they are interoperable. For
this reason, each grant program requires that each grant
recipient acquire only qualified health information technology
systems that are capable of supporting common technical
standards and full interoperability and reporting performance
on quality measures adopted by the Federal Government under
this legislation.
The first grant program will award grants, on a competitive
basis, to health care providers to facilitate the purchase and
enhance the utilization of qualified health information
technology systems to improve the quality and efficiency of
health care. Awards will be made by the Secretary. Grant
recipients must provide matching funds equal to $1 for each $3
of Federal funds provided under the grant.
Because the committee recognizes the importance of
targeting scarce Federal resources where they are most needed,
this grant program will give preference to providers that may
be least likely to have the capital to acquire health
information technology in the absence of a grant--those that
are located in medically underserved areas. The committee also
recognizes that while there are immediate improvements in
quality of care and error reduction with the use of health
information technology such as electronic health records, the
full benefits of implementing such systems will only be
realized when individual provider's systems are all
interconnected and patient information will be available when
and where it is needed. Thus, this grant program will also give
preference to providers that will link, to the extent
practicable, their health information system to local or
regional health information systems. The bill also gives
preference to those grantees that enhance the development of a
``medical home'' for patients. For too many patients, care is
scattered and uncoordinated. Health IT offers the opportunity
to bring greater coordination and cohesion to medical
treatment, thus improving outcomes and reducing disparities.
In order to maximize the utility of health information
technology systems acquired under this grant program in
improving and measuring quality of care, grant recipients will
be required to report on quality measures adopted by the
Federal Government under this bill.
The second program will award grants on a competitive basis
to States for the establishment of State programs that will
offer loans to health care providers to facilitate the purchase
and enhance the utilization of qualified health information
technology. To be eligible to receive such a grant, States must
establish a State loan fund and submit an application to the
Secretary with a strategic plan for awarding loans to eligible
entities. State loan programs will be required to stipulate
that preference in awarding loans will be given to providers
who will link, to the extent practicable, their health
information system to local or regional health information
systems. States will be required to match $1 for every $1 of
Federal funds provided under the grant. The Secretary may give
preference to States that adopt value-based purchasing programs
to improve health care quality.
To maximize the likelihood that scarce Federal resources
will be spent on projects with the greatest likelihood of
success, recipients of loans will also be required to consult
as necessary with the Health Information Technology Resource
Center--established in this bill--that will provide technical
assistance and develop best practices to support and accelerate
efforts to adopt, implement, and use effectively interoperable
health information technology.
To maximize the utility of health information technology
systems acquired under this loan program in improving and
measuring quality of care, loan recipients will be required to
report on quality measures adopted by the Federal Government
under this bill.
States may use grant funds to make loans directly to
providers or may use funds to securitize additional loans or
bonds, thereby augmenting the total amount of capital available
in the program to lend to providers. In addition, State
programs may accept voluntary contributions from private
entities that may have a strong interest in expanding adoption
of health information technology among health care providers in
their State or local area. As an incentive for private entities
to contribute voluntarily to the loan program, programs may
publicize the names of private entities that make
contributions. The committee sees a positive marketing value
associated with this public recognition of responsible
corporate citizenship.
The third program allows the Secretary to award competitive
grants to implement regional or local health information
technology plans that improve health care quality and
efficiency through the use of interoperable health information
technology compliant with technology standards and the quality
measurement system. To receive a grant, eligible entities must
be comprised of a consortium of community stakeholders that
demonstrate financial need, adopt policies that demonstrate a
commitment to open and fair participation, and demonstrate a
commitment to improving the quality of health care through the
use of interoperable health information technology.
The committee finds that the development and implementation
of regional or local health information technology plans is a
critical strategy in the Nation's efforts to build a nationwide
interoperable health information technology infrastructure.
Community exchange of health information through regional or
local health information technology plans compliant with
standards will maximize the benefits that patients experience
from system-wide use of health IT and minimize costly
technology links and retrofitting that would be necessary if
health care stakeholders adopt health IT independent of an
interoperable regional or local health information technology
plan.
However, the committee recognizes that there may be
instances in which inclusion of all required stakeholders
outlined may not be possible and the legislation provides the
Secretary some flexibility in such cases. However, the
committee believes that only applications that demonstrate the
strongest commitment to a community-wide collaboration through
the most extensive partnering feasible be provided funding.
The legislation authorizes $139 million in fiscal year 2008
and 2009, to remain available until expended. The bill leaves
to the discretion of the Secretary the allocation of funding
authorized for this section among the three programs.
ENSURING THE PRIVACY OF HEALTH INFORMATION
Because the committee believes that protecting the privacy
and security of health information is an essential aspect of
creating an interoperable health information infrastructure,
the bill establishes several important privacy protections.
First, the bill recognizes that privacy protections under HIPAA
do not directly apply to one set of new entities that have
arisen as a result of new health IT. The bill thus applies the
regulations promulgated under HIPAA to these entities. The bill
also clarifies that individuals have a right, to the extent
provided under HIPAA, to inspect and obtain a copy of their
medical records in electronic format, and to have a covered
entity amend protected health information in an electronic
format--a provision that is especially helpful in guarding
against medical fraud.
The committee encourages the Office of the National
Coordinator for Health Information Technology to ensure that
the development and use of health information technology does
not adversely affect privacy. The committee encourages the
Office of the National Coordinator for Health Information
Technology to work with the Department of Justice and the
Office of Civil Rights in this effort.
INTEGRATION OF HEALTH IT INTO HEALTH CARE PRACTICE
Another barrier to widespread adoption of interoperable
health information is cultural. The committee recognizes that
many physicians and hospitals are hesitant to move from paper-
based systems to electronic systems. Some physicians have been
writing prescriptions by hand for many years and may resist
changing to electronic records and prescribing systems.
This committee believes that one way to address this
cultural barrier to the widespread adoption of health
information technology is to support teaching hospitals and
continuing education programs that integrate health information
technology in the clinical education of health care
professionals. The committee believes that exposing students
and residents to effective everyday uses of health IT will lead
to a greater adoption by these students and residents in their
future medical practice. The bill authorizes the Secretary to
award demonstration grants to health professions centers and
academic health centers to integrate health IT into clinical
education in community settings. To be eligible, grantees must
submit a strategic plan and provide matching funds of at least
$1 for every $2 of Federal funding. The Secretary is required
to evaluate the program and disseminate the results, and to
report annually to Congress. The bill also reauthorizes
Telemedicine Incentive Grants through 2010. These grants were
established to encourage State licensure bodies to address
remote treatment issues.
The bill also amends the Public Health Service Act and
directs the Secretary, acting through the Director of the
Agency for Health Care Research and Quality, to develop a
Health Information Technology Resource Center to provide
technical assistance and develop best practices to support and
accelerate the efforts of States and health care providers to
adopt, implement, and use effectively health information
technology that complies with the standards and quality
measurement system adopted by the Federal Government. The
committee believes it is important to provide a forum for the
exchange of knowledge and experience, accelerate the transfer
of lessons learned from existing public and private sector
initiatives, and assemble, analyze, and widely disseminate
evidence and experience related to the adoption,
implementation, and effective use of interoperable health
information technology. The Secretary has begun undertaking the
activities outlined in this section of the legislation. It is
the committee's intent not to require the duplication of
Federal efforts with respect to the establishment of the
Center.
The committee believes this legislation integrates
technology and quality to create a seamless, efficient health
care system for the 21st century. This legislation will help
facilitate the widespread adoption of electronic health records
to ultimately result in fewer mistakes, lower costs, better
care, and greater patient participation in their health and
well being.
V. Cost Estimate
Pursuant to Section 402 of the Congressional Budget Act of
1974, the committee estimates the cost of the legislation will
be equal to the amounts discussed in the following estimate
provided by the Congressional Budget Office.
July 25, 2007.
Hon. Edward M. Kennedy,
Chairman, Committee on Health, Education, Labor, and Pensions,
U.S. Senate, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for S. 1693, the Wired for
Health Care Quality Act.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Tom Bradley.
Sincerely,
Peter R. Orszag.
Enclosure.
S. 1693--Wired for Health Care Quality Act
Summary: CBO estimates that implementing S. 1693 would cost
$47 million in 2008 and $317 million over the 2008-12 period,
assuming appropriation of the necessary amounts. Enacting the
bill would have no effect on direct spending or revenues.
On April 27, 2004, the President issued Executive Order
13335, which established within the Office of the Secretary of
Health and Human Services (HHS) the position of National Health
Information Technology Coordinator. The Secretary subsequently
established the Office of the National Coordinator of Health
Information Technology (ONCHIT) and the American Health
Information Community (AHIC) to support the adoption of health
information technology. S. 1693 would amend the Public Health
Service Act (PHSA) to codify the establishment and
responsibilities of those entities. In addition, the bill would
authorize funding for grants to facilitate the widespread
adoption of certain health information technology. S. 1693
would authorize the appropriation of $150 million for 2008 and
$150 million for 2009 for those activities.
S. 1693 also would require the Agency for Healthcare
Research and Quality (AHRQ) to establish a Health Information
Technology Resource Center to provide technical assistance to
support the adoption of health information technology,
authorize AHRQ to award grants to develop and test quality
measures, and extend through 2009 authorization for a program
to provide telemedicine grants. CBO estimates that implementing
those provisions would require the appropriation of $11 million
for 2008 and $25 million over the 2008-12 period.
S. 1693 contains an intergovernmental mandate as defined in
the Unfunded Mandates Reform Act (UMRA) because it would limit
the application of State and local law. However, CBO estimates
that the net costs of the mandate would be minimal and far
below the threshold established in UMRA ($66 million in 2007,
as adjusted for inflation). In general, the bill would benefit
State, local, and tribal governments and any costs they incur
as a result of participating in the grant programs would result
from complying with conditions of Federal assistance. The bill
contains no private-sector mandates as defined in UMRA.
Estimated cost to the Federal Government: The estimated
cost of S. 1693 is shown in the following table. The costs of
this legislation fall within budget function 550 (health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-----------------------------------------------------------
2007 2008 2009 2010 2011 2012
----------------------------------------------------------------------------------------------------------------
SPENDING SUBJECT TO APPROPRIATION
Spending under Current Law:
Estimated Budget Authority \1\.................. 61 0 0 0 0 0
Estimated Outlays............................... 18 28 12 2 0 0
Proposed Changes:
Estimated Authorization Level................... 0 161 161 1 1 1
Estimated Outlays............................... 0 47 119 105 39 7
Spending under S. 1693:
Estimated Authorization Level \1\............... 61 161 161 1 1 1
Estimated Outlays............................... 18 75 131 107 39 7
----------------------------------------------------------------------------------------------------------------
\1\ The 2007 level is CBO's estimate of the funding for the activities of the Office of the National Coordinator
of Health Information Technology and the American Health Information Community, including funds reprogrammed
by the Secretary of Health and Human Services from other activities.
Basis of estimate: S. 1693 would amend the Public Health
Service Act to add title 30--which would deal with health
information technology and quality--and to create a Health
Information Technology Resource Center and extend authorization
for a program to provide telemedicine grants. For this
estimate, CBO assumes that S. 1693 will be enacted near the end
of fiscal year 2007, that the necessary amounts will be
appropriated each year, and that outlays will follow historical
patterns for similar activities of the Department of Health and
Human Services. CBO estimates that implementing those
provisions would cost $47 million in 2008 and $317 million over
the 2008-12 period.
Health Information Technology and Quality
The National Coordinator of Health Information Technology
serves as the senior advisor to the Secretary of HHS and the
President on all health information technology programs and
initiatives, and is responsible for:
Developing and maintaining a strategic plan
to guide the nationwide implementation of electronic
health records in both the public and private health
care sectors;
Coordinating spending by Federal agencies
for health information technology programs and
initiatives; and
Coordinating outreach activities to private
industry and serving as the catalyst for change in the
health care industry.
In June 2005, the Secretary announced the creation of the
American Health Information Community, a public-private
collaboration to provide a forum for public and private
interests to recommend specific actions that will accelerate
the widespread adoption of electronic records and other health
information technology. Based on information provided by the
Department of Health and Human Services, CBO estimates that $61
million is available in 2007 for the activities of ONCHIT and
AHIC ($42 million from funds appropriated to the Secretary and
$19 million from funds reprogrammed from other activities).
S. 1693 would add title 30 to the Public Health Service Act
to specify the responsibilities of ONCHIT, AHIC, and a new
organization--the Partnership for Health Care Improvement. The
current responsibilities of AHIC would be divided between AHIC
and the Partnership, with AHIC focusing on development of
policy and the Partnership focusing on the technical aspects of
developing and promoting the adoption of health information
technology.
The bill also would establish several grant programs to
promote the adoption of health information technology.
For most of the activities under title 30, S. 1693 would
specify the amounts authorized to be appropriated for fiscal
years 2008 and 2009: $5 million in each year for ONCHIT, $2
million in each year for the Partnership, $2 million in each
year for AHIC, and $141 million in each year for grant
programs. Those specified amounts total $150 million in each of
fiscal years 2008 and 2009. In addition, the bill would
authorize the Secretary, acting through AHRQ, to make grants to
support the development and testing of quality measures. CBO
estimates the necessary funding for those grants would amount
to $1 million for 2008 and $5 million over the 2008-12 period.
Thus, CBO estimates that the necessary funding for activities
under title 30 would total $151 million for fiscal year 2008
and $305 million over the 2008-12 period.
Of the $141 million in specified funding for grant programs
in each of fiscal years 2008 and 2009, $139 million a year
would be allocated to three grant programs--for health care
providers, States, and to implement regional or local plans for
the exchange of health information--to facilitate the adoption
of health information technology, and $2 million a year would
be allocated to a fourth grant program to develop academic
curricula integrating health information technology systems
into the clinical education of health professionals.
The bill would limit eligibility for the grants to health
care providers to providers that demonstrate significant
financial need. Those providers would be required to provide $1
of matching funds for every $3 of Federal grant funds, and they
could use the funds to purchase and enhance the utilization of
health information technology and for training personnel in the
use of the technology.
States would be eligible for grants that would fund the
establishment of State programs for loans to health care
providers to facilitate the purchase and use of health
information technology. States would have to provide $1 of
matching funds for every $1 of Federal grant funds.
The grants to implement regional or local plans for the
exchange of health information would require $1 of matching
funds for every $2 of Federal grant funds.
Other provisions
In addition to adding title 30 to the Public Health Service
Act, S. 1693 would amend that act to establish a Health
Information Technology Resource Center to provide technical
assistance to support the adoption of health information
technology, and it would extend through 2009 authorization for
a program to provide telemedicine grants. The Center would be
administered by AHRQ, and the telemedicine grants would be
administered by the Health Resources and Services
Administration (HRSA). CBO estimates that implementing those
provisions would require additional appropriations for 2008 and
2009 of $5 million a year for the Center and $5 million a year
for HRSA.
Intergovernmental and private-sector impact: S. 1693 would
deem an operator of a health information electronic database a
covered entity under the Health Insurance Portability and
Accountability Act (HIPAA). With some exceptions HIPAA preempts
State laws that impose standards less stringent than the
Federal standard. Therefore, State standards with respect to an
operator of a health information database that are less
stringent than the new Federal standard would be preempted by
the bill. That preemption would be an intergovernmental mandate
as defined in UMRA because it would limit the application of
State and local law. However, CBO estimates that the net costs
of the mandate would be minimal and far below the threshold
established in UMRA ($66 million in 2007, as adjusted for
inflation).
The bill also would authorize grants to States and public
health entities to assist them with purchasing information
technology systems to improve the delivery of health care.
Public institutions of higher education also would benefit from
grants authorized in the bill to develop academic curricula or
analyze data. Any costs those governments or institutions
incur, including matching funds, would result from complying
with conditions of Federal assistance.
The bill contains no private-sector mandates as defined in
UMRA.
Estimate prepared by: Federal costs: Tom Bradley; Impact on
state, local, and tribal governments: Lisa Ramirez-Branum;
Impact on the private sector: Stuart Hagen.
Estimate approved by: Peter H. Fontaine, Deputy Assistant
Director for Budget Analysis.
VI. Application of Law to the 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.
VII. Regulatory Impact Statement
Pursuant to the requirements of paragraph 11(b) of rule
XXVI of the Standing Rules of the Senate, the committee has
determined that the bill will not have a significant regulatory
impact.
VIII. Section-by-Section Analysis
Section 1. Short title
Wired for Health Care Quality Act.
Section 2. Improving Health Care Quality, Safety, and Efficiency
Amends the Public Health Service Act by adding at the end:
``Title XXX--Health Information Technology and Quality''.
Section 3001. Definitions
``Community,'' ``Health Care Provider,'' ``Health
Information,'' ``Health Plan,'' ``Individually Identifiable
Health Information,'' ``Laboratory,'' ``National Coordinator,''
``Partnership,'' ``Qualified Health Information Technology,''
and ``State''.
Section 3002. Office of the National Coordinator for Health Information
Technology
Section 3002 establishes within the office of the Secretary
an Office of the National Coordinator for Health Information
Technology and defines its responsibilities. The Office will
ensure coordination of health information technology
initiatives across programs of the Department of Health and
Human Services and related government agencies. It will create
a strategic plan for the implementation of an interoperable
health information technology infrastructure with the purpose
of reviewing Federal health information technology investments
with measurable outcome goals for health information technology
to assess progress within the Department of HHS and other
Federal agencies. It will review Federal purchases of health IT
to ensure compliance with the Partnership's plans for health
IT, as well as the implementation of health IT systems by other
organizations in order to draw lessons for other health care
providers. The Office will also study how to use these systems
to utilize health IT to improve quality of care and chronic
disease management. The Office will further work to increase
the penetration of health IT in communities with health
disparities. In order to publicize its activities, the Office
will maintain a Web site which publishes a schedule for the
assignment of significant use cases, recommendations of the
Community, quality measures, and identifies potential funding
sources for health information technology systems. The Office
will also devise a plan to replace itself after this section's
provisions sunset on September 30, 2014.
Section 3003. Partnership for Health Care Improvement; Standards and
technology
Section 3003 establishes the public-private Partnership for
Health Care Improvement comprised of individuals from the
public and private sectors. This Partnership shall recommend
standards, implementation specifications, and certification
criteria for electronic exchange of health information for
adoption by the Federal Government and voluntary adoption by
private entities. The Partnership will hold public hearings for
comment on its recommendations, and ensure that all its
recommendations are compliant with HIPAA in order to protect
patient privacy. In addition to issuing recommendations, the
Partnership will also serve as a forum for technical experts in
the field of health information technology. The governance
rules of the Partnership and information about its meetings
will be publicly available on a Web site maintained by the
Partnership.
Members of the Partnership will serve 3-year terms. The
membership will include representatives of consumer or patient
organizations, privacy experts, security experts, health care
providers, health insurance representatives, insurance
purchasers, and information technology vendors, with the
National Coordinator serving as the liaison among the parties
and to the Federal Government. The Majority Leader of the
Senate, the Minority Leader of the Senate, the Speaker of the
House, and the Minority Leader of the House will each appoint a
member of the Partnership. Partnership recommendations shall be
reviewed by the Secretaries of HHS, Veterans Affairs, Defense,
and related agencies. If appropriate, the President shall
provide for the Federal Government's adoption of the
recommendations.
Section 3004. American Health Information Community--Policies
Section 3004 creates a committee known as the American
Health Information Community, which makes recommendations on
policy issues related to health IT. These recommendations shall
be designed for adoption by the Federal Government and the
voluntary adoption by private entities. The recommendations of
the Community shall address the following issues among others:
1. Protection of patients' control of the
acquisition, use and release of their health
information;
2. Protection of individually identifiable health
information by notifying patients of wrongful
disclosure and by allowing patients to access their own
health information;
3. Identification of appropriate uses of the national
health information network, including collection of
quality data and public reporting, biosurveillance,
medical research, and drug safety;
4. Increasing the involvement of health care
providers and staff in health IT systems design and
implementation;
5. Fostering the public understanding of health
information technology; and
6. Promulgation of a strategy to use health IT to
improve chronic disease management.
All recommendations of the Community shall be consistent
with HIPAA to ensure the protection of patient privacy. The
Community will hold public hearings for comment on its
recommendations, and publish its findings in the Federal
Register and the Web site of the National Coordinator.
The membership of the Community will be chosen by a variety
of officials to represent a wide range of viewpoints. It will
be composed of three members appointed by the Secretary,
including one representative of DHHS. One will be appointed by
the Secretary of Veterans Affairs and represent DVA. The
majority and minority leaders of the Senate and the Speaker and
minority leader of the House of Representatives will each
appoint one member. Nine members will be appointed by the
Comptroller General to represent different parts of the health
care community, including representatives of health care
providers, consumer groups, insurance companies, technology
vendors and organized labor. There will also be experts in
privacy and security, improving health care in disadvantaged
areas, and health care quality measurement. All members serve
three year terms.
The Community will be able to draw both on outside
expertise and Federal resources. Outside entities shall advise
the Community on issues of health privacy and security, patient
safety, ethics, research data exchange, and information
technology standards. The Federal Government shall provide the
Community access to resources from the Library of Congress,
Federal agencies, and elected representatives. The Federal
Advisory Committee Act shall apply to the Community.
Two million dollars is authorized to be appropriated to
support the Community's activities in fiscal year 2008 and
fiscal year 2009. The provisions applying to the Community will
sunset on September 20, 2014.
Section 3005. Federal purchasing and data collection
Section 3005 prohibits the Federal Government from
purchasing health IT systems that do not comply with the
adopted recommendations of the Partnership. Within 3 years, the
Federal Government will also establish a common format for
reporting health information. However, all Federal standards
shall be voluntary with respect to private entities. Private
entities contracting with the Federal Government shall adopt
the government's standards for their activities under Federal
contract.
Section 3006. Quality and efficiency reports
Section 3006 provides that the government contract with
three Quality Reporting Organizations (QROs) to utilize Federal
health care data for the purpose of producing reports on health
care quality. The Secretary will draft regulations for QROs to
request heath quality reports in exchange for a reasonable fee.
These three outside organizations must have expertise in the
analysis of such data and have the technological infrastructure
appropriate to utilize Federal health IT standards. In order to
ensure patient privacy, the QROs must ensure patient privacy by
adhering to HIPAA standards in addition to those of sections
552 and 552a of U.S.C. Title 5. Moreover, these protections
continue to apply if the organization's contract with the
Federal Government is terminated. Researchers will be able to
access the information provided they comply with guidelines
established by the Secretary. The QROs are also required to
protect the security of patient data.
TITLE II--FACILITATING THE WIDESPREAD ADOPTION OF INTEROPERABLE HEALTH
INFORMATION TECHNOLOGY
Section 201. Facilitating the widespread adoption of interoperable
health information technology
Title XXX of the Public Health Service Act as created by
Section 101 is further amended by adding at the end the
following provisions:
Section 3008. Facilitating the widespread adoption of interoperable
health information technology
Section 3008 establishes three grant programs at HHS: a
grant program for health IT adoption in health care facilities,
a competitive grant program for State loan programs in health
IT, and a program to supply funds for the implementation of
regional and local health IT network. To fund these three
programs, $139 million is authorized to be appropriated. The
program for health provider IT adoption gives grants directly
to health care providers for four purposes: the purchase of
qualified health IT systems, personnel training in these
systems, increasing utilization of health IT and improving
chronic disease management. The State program allows States to
apply for grants to State qualified health IT loan funds to
match State contributions to these programs. They may not
directly duplicate other Federal spending in the bill. The
program for regional and local health IT allows a wide range of
entities to jointly apply for grants to produce regional and
local health IT networks. These entities may include health
care providers, health insurance companies, patient advocacy
groups, and others. These programs have four common eligibility
requirements:
1. Adoption of standards consistent with those
approved by the government;
2. Matching of Federal contributions with other
funds: $1 for every $3 of Federal contributions in
health IT adoption grants, $1 for every $1 of Federal
contributions in the State loan program, and $1 for
every $2 of Federal contributions in the local and
regional network program;
3. Notification of individuals if their health
information is wrongfully disclosed; and
4. Medical care delivery staff input in system
design.
Network grants have the following additional requirements:
1. Integrate stakeholders into local and regional
health IT networks when possible;
2. Practice of non-discrimination for all
stakeholders in the network;
3. Input of medical care delivery staff in systems
design;
4. Features to reduce barriers to provider
implementation of health IT; and
5. Draft plans to protect patient privacy and
security, to maintain compliance with Federal
standards, and to ensure the financial sustainability
of the networks.
Section 3009. Demonstration program to integrate information technology
into clinical education
Section 3009 establishes a demonstration program to give
grants to institutions of medical education in order to
integrate health IT into their curricula. These projects must
involve two or more medical disciplines and match 50 percent of
the Federal contribution with money from other sources. The
institutions must report to the Secretary within 1 year on the
effectiveness of the projects. Two million dollars is
authorized to be appropriated for this purpose in fiscal year
2008 and fiscal year 2009. The provisions of this program
sunset on September 30, 2012.
TITLE III--IMPROVING THE QUALITY OF HEALTH CARE
Section 301. Consensus process for the adoption of quality measures for
use in the Nationwide Interoperable Health Information
Technology Infrastructure
Title XXX of the Public Health Service Act, as amended by
section 201, is further amended by adding at the end the
following:
Section 3010. Fostering development and use of health quality measures
Section 3010 requires the Secretary of HHS to develop and
use health care quality measures for the purpose of measuring
the quality and efficiency of health care patients receive. The
Secretary shall designate an organization to promote the
development of quality measures and provide the Secretary with
advice and recommendations on the key elements and priorities
of a national system for health care performance measurement.
The organization will endorse national consensus quality
measures and recommend quality measures to the Secretary of HHS
for adoption and use. The organization will further coordinate
setting standards for the development and testing of quality
measures. The quality measures adopted by the Secretary will be
integrated into the Partnership's certification process. In
addition, the organization will also promote the development of
electronic health records that allow automatic collection,
aggregation and transmission of quality measurements.
The designated organization itself must be a private
nonprofit governed by a president and a board of directors
which represent health care providers, health plans, patients
or consumers, health care purchasers or employers, and health
care practitioners. The board of directors should have
experience with urban and rural health care issues, State and
local health programs, safety net and quality issues and be
experts in health information technology standards and
technology assessment. The organization will conduct business
in an open and transparent fashion which allows for public
comment.
The quality measures endorsed by the organization must be
evidence-based, and must include measures of clinical process
and outcomes, patient experience, efficiency, equity, patient
centeredness, patient self-management, safety, underuse and
overuse. Priority is given to quality measures with the
greatest potential for improving care, that may be implemented
rapidly, that inform patient choice, that can be integrated
into the certification process, that facilitate physician
decision-making using health IT, and that apply to multiple
health services. The organization shall establish procedures to
ensure appropriate risk adjustment and for the maintenance or
quality measures. The Secretary may award grants to
organizations to support the development and testing of quality
measures.
Section 3011. Adoption and use of quality measures; Reporting
In Section 3011, the Secretary is given the responsibility
of selecting quality measures for use and ensuring that these
measures are integrated into the bill's overall health IT
framework. The Secretary will decide which quality measures
shall be adopted from those recommended to him by multi-
stakeholder groups and endorsed by the designated organization.
Moreover, the Secretary shall ensure that all adopted measures
are integrated into the standards adopted pursuant to Section
3005. In addition, all quality measures are required to
complement quality measures for programs in Titles XVIII, XIX,
and XXI of the Social Security Act and not conflict with the
needs of programs under that title as determined by the
Administrator of the CMS.
The Secretary shall also devise regulations to allow the
distribution, aggregation and analysis of selected quality
measures.
TITLE IV--PRIVACY AND SECURITY
Section 401. Privacy and security
Title XXX of the Public Health Service Act, as amended by
section 301, is further amended by adding at the end the
following:
Section 3013. Ensuring privacy and security
Section 3013 introduces new privacy protections for health
IT. The section extends HIPAA privacy protections to cover
health records stored in certain health information electronic
databases. It further recognizes the right of individuals to
look at their health records stored in electronic form to the
extent provided under HIPAA. Victims of medical fraud are also
recognized as having the right to view the fraudulently entered
information and amend their records to the extent provided
under HIPAA.
TITLE V--MISCELLANEOUS PROVISIONS
Section 501. GAO study
Section 501 stipulates that within a year of an enactment,
the Comptroller General submit a report to Congress detailing
circumstances in which it is necessary and workable to require
health plans, health care clearinghouses, and health care
providers to notify parents of wrongful disclosure of
individually identifiable health information.
Section 502. Health Information Technology Resource Center
Section 502 amends Section 914 of the Public Health Service
Act to include a requirement that the Secretary develop a
Health Information Technology Resource Center to serve as a
forum to explore lessons learned from public or private sector
initiatives, assemble evidence concerning adoption of health
information technology, establish local and regional networks,
and provide for exchange of electronic health data.
Section 503. Facilitating the provision of telehealth services across
state lines
Section 503 reauthorizes section 330L of the Public Health
Service Act: Telemedicine; Incentive Grants Regarding
Coordination Among States. Section 330L allows the Secretary of
HHS to make grants to States that have adopted regional State
reciprocity agreements. Such sums as may be necessary are
authorized to be appropriated for fiscal year 2008 and fiscal
year 2009.
IX. Changes in Existing Law
In compliance with rule XXVI paragraph 12 of the Standing
Rules of the Senate, the following provides a print of the
statute or the part or section thereof to be amended or
replaced (existing law proposed to be omitted is enclosed in
black brackets, new matter is printed in italic, existing law
in which no change is proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
[SEC. 330L. [254C-18] TELEMEDICINE; INCENTIVE GRANTS REGARDING
COORDINATION AMONG STATES.
[(a) In General.--The Secretary may make grants to State
professional licensing boards to carry out programs under which
such licensing boards of various States cooperate to develop
and implement State policies that will reduce statutory and
regulatory barriers to telemedicine.
[(b) Authorization of Appropriations.--For the purpose of
carrying out subsection (a), there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2002 through 2006.]
SEC. 330L. TELEMEDICINE; INCENTIVE GRANTS REGARDING COORDINATION AMONG
STATES.
(a) Facilitating the Provision of Telehealth Services
Across State Lines.--The Secretary may make grants to States
that have adopted regional State reciprocity agreements for
practitioner licensure, in order to expedite the provision of
telehealth services across State lines.
(b) Authorization of Appropriations.--For the purpose of
carrying out subsection (a), there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2008 and 2009.
* * * * * * *
SEC. 914. [299B-3] INFORMATION SYSTEMS FOR HEALTH CARE IMPROVEMENT.
(a) In General.--* * *
* * * * * * *
(d) Health Information Technology Resource Center.--
(1) In general.--The Secretary, acting through the
Director, shall develop a Health Information Technology
Resource Center (referred to in this subsection as the
``Center'' to provide technical assistance and develop
best practices to support and accelerate efforts to
adopt, implement, and effectively use interoperable
health information technology in compliance with
sections 3003 and 3010.
(2) Purposes.--The purposes of the Center are to--
(A) provide a forum for the exchange of
knowledge and experience;
(B) accelerate the transfer of lessons
learned from existing public and private sector
initiatives, including those currently
receiving Federal financial support;
(C) assemble, analyze, and widely disseminate
evidence and experience related to the
adoption, implementation, and effective use of
interoperable health information technology;
(D) provide for the establishment of regional
and local health information networks to
facilitate the development of interoperability
across health care settings and improve the
quality of health care;
(E) provide for the development of solutions
to barriers to the exchange of electronic
health information; and
(F) conduct other activities identified by
the States, local, or regional health
information networks, or health care
stakeholders as a focus for developing and
sharing best practices.
(3) Support for activities.--To provide support for
the activities of the Center, the Director shall modify
the requirements, if necessary, that apply to the
National Resource Center for Health Information
Technology to provide the necessary infrastructure to
support the duties and activities of the Center and
facilitate information exchange across the public and
private sectors.
(4) Rule of construction.--Nothing in this subsection
shall be construed to require the duplication of
Federal efforts with respect to the establishment of
the Center, regardless of whether such efforts were
carried out prior to or after the enactment of this
subsection.
(e) Authorization of Appropriations.--There is authorized
to be appropriated, such sums as may be necessary for each of
fiscal years 2008 and 2009 to carry out this section.
* * * * * * *
TITLE XXIX--LIFESPAN RESPITE CARE
SEC. 2901. [300II] DEFINITIONS.
* * * * * * *
SEC. 2905. [300II-4] AUTHORIZATION OF APPROPRIATIONS.
* * * * * * *
TITLE XXX--HEALTH INFORMATION TECHNOLOGY AND QUALITY
SEC. 3001. DEFINITIONS; REFERENCE.
(a) In General.--In this title:
(1) Community.--The term ``Community'' means the
American Health Information Community established under
section 3004.
(2) Health care provider.--The term ``health care
provider'' means a hospital, skilled nursing facility,
home health entity, health care clinic, federally
qualified health center, group practice (as defined in
section 1877(h)(4) of the Social Security Act), a
pharmacist, a pharmacy, a laboratory, a physician (as
defined in section 1861(r) of the Social Security Act),
a practitioner (as defined in section 1842(b)(18)(CC)
of the Social Security Act), a health facility operated
by or pursuant to a contract with the Indian Health
Service, a rural health clinic, and any other category
of facility or clinician determined appropriate by the
Secretary.
(3) Health information.--The term ``health
information'' has the meaning given such term in
section 1171(4) of the Social Security Act.
(4) Health insurance plan.--
(A) In general.--The term ``health insurance
plan'' means--
(i) a health insurance issuer (as
defined in section 2791(b)(2));
(ii) a group health plan (as defined
in section 2791(a)(1)); and
(iii) a health maintenance
organization (as defined in section
2791(b)(3)); or
(iv) a safety net health plan.
(B) Safety net health plan.--The term
``safety net health plan'' means a managed care
organization, as defined in section as
1932(a)(1)(B)(i) of the Social Security Act--
(i) that is exempt from or not
subject to Federal income tax, or that
is owned by an entity or entities
exempt from or not subject to Federal
income tax; and
(ii) for which not less than 75
percent of the enrolled population
receives benefits under a Federal
health care program (as defined in
section 1128B(f)(1) of the Social
Security Act) or a health care plan or
program which is funded, in whole or in
part, by a State (other than a program
for government employees).
(C) References.--All references in this title
to ``health plan'' shall be deemed to be
references to ``health insurance plan.''
(5) Individually identifiable health information.--
The term ``individually identifiable health
information'' has the meaning given such term in
section 1171 of the Social Security Act.
(6) Laboratory.--The term ``laboratory'' has the
meaning given such term in section 353.
(7) National coordinator.--The term ``National
Coordinator'' means the National Coordinator of Health
Information Technology appointed pursuant to section
3002.
(8) Partnership.--The term ``Partnership'' means the
Partnership for Health Care Improvement established
under section 3003.
(9) Qualified health information technology.--The
term ``qualified health information technology'' means
a computerized system (including hardware and software)
that--
(A) protects the privacy and security of
health information;
(B) maintains and provides permitted access
to health information in an electronic format;
(C) with respect to individually identifiable
health information maintained in a designated
record set, preserves an audit trail of each
individual that has gained access to such
record set;
(D) incorporates decision support to reduce
medical errors and enhance health care quality;
(E) complies with the standards adopted by
the Federal Government under section 3003;
(F) has the ability to transmit and exchange
information to other health information
technology systems and, to the extent feasible,
public health information technology systems;
and
(G) allows for the reporting of quality
measures adopted under section 3010.
(10) State.--The term ``State'' means each of the
several States, the District of Columbia, Puerto Rico,
the Virgin Islands, Guam, American Samoa, and the
Northern Mariana Islands.
(b) References to Social Security Act.--Any reference in
this section to the Social Security Act shall be deemed to be a
reference to such Act as in effect on the date of enactment of
this title.
SEC. 3002. OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION
TECHNOLOGY.
(a) Establishment.--There is established within the office
of the Secretary, the Office of the National Coordinator of
Health Information Technology. The National Coordinator shall
be appointed by the Secretary in consultation with the
President, and shall report directly to the Secretary.
(b) Purpose.--The Office of the National Coordinator shall
be responsible for--
(1) ensuring that key health information technology
initiatives are coordinated across programs of the
Department of Health and Human Services;
(2) ensuring that health information technology
policies and programs of the Department of Health and
Human Services are coordinated with such policies and
programs of other relevant Federal agencies including
Federal commissions and advisory committees) with a
goal of avoiding duplication of efforts and of helping
to ensure that each agency undertakes activities
primarily within the areas of its greatest expertise
and technical capability;
(3) reviewing Federal health information technology
investments to ensure that Federal health information
technology programs are meeting the objectives of the
strategic plan published by the Office of the National
Coordinator of Health Information Technology to
establish a nationwide interoperable health information
technology infrastructure;
(4) providing comments and advice regarding specific
Federal health information technology programs, at the
request of Office of Management and Budget; and
(5) enhancing the use of health information
technology to improve the quality of health care in the
prevention and management of chronic disease and to
address population health.
(c) Role With Community and the Partnership.--The Office of
the National Coordinator shall--
(1) serve as an ex officio member of the Community,
and act as a liaison between the Federal Government and
the Community;
(2) serve as an ex officio member of the Partnership
and act as a liaison between the Federal Government and
the Partnership; and
(3) serve as a liaison between the Partnership and
the Community.
(d) Reports and Website.--The Office of the National
Coordinator shall--
(1) develop and publish a strategic plan for
implementing a nationwide interoperable health
information technology infrastructure;
(2) maintain and frequently update an Internet
website that--
(A) publishes the schedule for the assessment
of standards for significant use cases;
(B) publishes the recommendations of the
Community;
(C) publishes the recommendations of the
Partnership;
(D) publishes quality measures;
(E) identifies sources of funds that will be
made available to facilitate the purchase of,
or enhance the utilization of, health
information technology systems, either through
grants or technical assistance; and
(F) publishes a plan for a transition of any
functions of the Office of the National
Coordinator that should be continued after
September 30, 2014;
(3) prepare a report on the lessons learned from
major public and private health care systems that have
implemented health information technology systems,
including an explanation of whether the systems and
practices developed by such systems may be applicable
to and usable in whole or in part by other health care
providers; and
(4) assess the impact of health information
technology in communities with health disparities and
identify practices to increase the adoption of such
technology by health care providers in such
communities.
(e) Rule of Construction.--Nothing in this section shall be
construed as requiring the duplication of Federal efforts with
respect to the establishment of the Office of the National
Coordinator for Health Information Technology, regardless of
whether such efforts are carried out before or after the date
of the enactment of this title.
(f) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $5,000,000 for
each of fiscal years 2008 and 2009.
(g) Sunset.--The provisions of this section shall not apply
after September 30, 2014.
SEC. 3003. PARTNERSHIP FOR HEALTH CARE IMPROVEMENT-STANDARDS AND
TECHNOLOGY.
(a) Establishment.--
(1) In general.--There is established a public-
private Partnership for Health Care Improvement to--
(A) provide advice to the Secretary and the
Nation and recommend specific actions to
achieve a nationwide interoperable health
information technology infrastructure;
(B) make recommendations concerning
standards, implementation specifications, and
certification criteria for the electronic
exchange of health information (including for
the reporting of quality data under section
3010) for adoption by the Federal Government
and voluntary adoption by private entities;
(C) serve as a forum for the participation of
a broad range of stakeholders with specific
technical expertise in the development of
standards, implementation specifications, and
certification criteria to provide input on the
effective implementation of health information
technology
(D) develop and maintain an Internet web site
that--
(i) publishes established governance
rules (including a subsequent
appointment process);
(ii) publishes a business plan;
(iii) publishes meeting notices at
least 14 days prior to each meeting;
(iv) publishes meeting agendas at
least 7 days prior to each meeting; and
(v) publishes meeting materials at
least 3 days prior to each meeting.
(2) Limitation.--The Partnership shall not meet or
take any action until an advisory committee charter has
been filed with the Secretary and with the appropriate
committees of the Senate and House of Representatives
for the Community described in section 3004.
(b) Membership.--
(1) Appointments.--
(A) In general.--The Partnership shall be
composed of members to be appointed as follows:
(i) 2 members shall be appointed by
the Secretary.
(ii) member shall be appointed by the
majority leader of the Senate.
(iii) 1 member shall be appointed by
the minority leader of the Senate.
(iv) 1 member shall be appointed by
the Speaker of the House of
Representatives.
(v) 1 member shall be appointed by
the minority leader of the House of
Representatives.
(vi) Seven members shall be appointed
by the Comptroller General of whom--
(I) one member shall be a
representative of consumer or
patient organizations;
(II) one member shall be a
representative of organizations
with expertise in privacy;
(III) one member shall be a
representative of organizations
with expertise in security;
(IV) one member shall be a
representative of health care
providers;
(V) one member shall be a
representative of health plans
or other third party payers;
(VI) one member shall be a
representative of information
technology vendors; and
(VII) one member shall be a
representative of purchasers or
employers.
(B) National coordinator.--The National
Coordinator shall be a member of the
Partnership and act as a liaison among the
Partnership, the community, and the Federal
Government.
(2) Chairperson and vice chairperson.--The
Partnership shall designate one member to serve as the
chairperson and one member to serve as the vice
chairperson of the Partnership.
(3) Participation.--In appointing members under
paragraph (1)(A), and in developing the procedures for
conducting the activities of the Partnership, the
Partnership shall ensure a balance among various
sectors of the health care system so that no single
sector unduly influences the recommendations of the
Partnership.
(4) Terms.--Members appointed under paragraph (1)(A)
shall serve for 3 year terms, except that any member
appointed to fill a vacancy for an unexpired term shall
be appointed for the remainder of such term. A member
may serve for not to exceed 180 days after the
expiration of such member's term or until a successor
has been appointed.
(5) Outside involvement.--The Partnership shall
ensure an adequate opportunity for the participation of
outside advisors, including individuals with expertise
in--
(A) health information privacy;
(B) health information security;
(C) health care quality and patient safety,
including individuals with expertise in
utilizing health information technology to
improve health care quality and patient safety;
(D) medical and clinical research data
exchange; and
(E) developing health information technology
standards and new health information
technology.
(6) Quorum.--Two-thirds of the members of the
Partnership shall constitute a quorum for the purpose
of conducting votes.
(c) Standards and Implementation Specifications.--
(1) Schedule.--Not later than 90 days after the date
of enactment of this title, the Partnership shall
develop a schedule for the assessment of standards and
implementation specifications under this section. The
Partnership shall update such schedule annually. The
Secretary shall publish such schedule in the Federal
Register and on the Internet website of the Department
of Health and Human Services.
(2) First year recommendations.--Consistent with the
schedule published under paragraph (1) and not later
than 1 year after date of enactment of this title, the
Partnership shall recommend, and the Secretary shall
review, such standards and implementation
specifications.
(3) Ongoing recommendations.--The Partnership shall
review and modify, as appropriate but at least
annually, adopted standards and implementation
specifications and continue to recommend additional
standards and implementation specifications, consistent
with the schedule published pursuant to paragraph (1).
The Secretary shall review such modifications and
recommendations.
(4) Recognition of private entities.--The
Partnership, in consultation with the Secretary, may
recognize a private entity or entities for the purpose
of developing and updating standards and implementation
specifications to achieve uniform and consistent
implementation of the standards adopted by the
President under this title. Such entity or entities
shall make recommendations to the Partnership
consistent with this section.
(5) Publication.--All recommendations made by the
Partnership pursuant to this section shall be published
in the Federal Register and on the Internet website of
the Office of the National Coordinator.
(6) Pilot testing.--The Secretary may conduct, or
recognize a private entity or entities to conduct, a
pilot project to test the standards and implementation
specifications developed under this section in order to
provide for the efficient implementation of the
standards and implementation specifications described
in this subsection prior to issuing such
recommendations.
(7) Public input.--The Partnership shall conduct open
public meetings and develop a process to allow for
public comment on the schedule and recommendations
described in this section. Such process shall ensure
that such comments will be submitted within 30 days of
the publication of a recommendation under this section.
(8) Federal action.--Not later than 90 days after the
issuance of a recommendation from the Partnership under
this subsection, the Secretary, the Secretary of
Veterans Affairs, and the Secretary of Defense, in
collaboration with representatives of other relevant
Federal agencies as determined appropriate by the
President, shall jointly review such recommendation. If
appropriate, the President shall provide for the
adoption by the Federal Government of any standard or
implementation specification contained in such
recommendation. Such determination shall be published
in the Federal Register and on the Internet website of
the Office of the National Coordinator within 30 days
after such determination is made.
(9) Consistency.--The standards and implementation
specifications described in this subsection shall be
consistent with the standards for information
transactions and data elements developed pursuant to
the regulations promulgated under section 264(c) of the
Health Insurance Portability and Accountability Act of
1996.
(d) Certification.--
(1) Developing criteria.--The Partnership, in
consultation with the Secretary, may recognize a
private entity or entities for the purpose of
developing and recommending to the Partnership criteria
to certify that appropriate categories of health
information technology products that claim to be in
compliance with applicable standards and implementation
specifications adopted under this title have
established such compliance.
(2) Adoption of criteria.--The Secretary, based upon
the recommendations of the Partnership, shall review,
and if appropriate, adopt such criteria.
(3) Conducting certification.--The Secretary may
recognize a private entity or entities to conduct the
certifications described under paragraph (1) using the
criteria adopted by the Secretary under this
subsection.
(e) Rule of Construction.--Nothing in this section shall be
construed as disrupting existing activities described in
subsection (c) or (d).
(f) Requirement to Consider Recommendations.--In carrying
out the activities described in subsections (c) and (d), the
Partnership shall adopt and integrate the recommendations of
the Community that are adopted by the Secretary.
(g) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $2,000,000 for
each of the fiscal years 2008 and 2009.
SEC. 3004. AMERICAN HEALTH INFORMATION COMMUNITY--POLICIES.
(a) Establishment.--There is established a committee to be
known as the American Health Information Community. The
Community shall--
(1) provide advice to the Secretary and the heads of
any relevant Federal agencies concerning the policy
considerations related to health information
technology;
(2) not later than 1 year after the date of enactment
of this title, and annually thereafter, make
recommendations concerning a policy framework for the
development and adoption of a nationwide interoperable
health information technology infrastructure;
(3) not later than 1 year after the date of enactment
of this title, and annually thereafter, make
recommendation concerning national policies for
adoption by the Federal Government, and voluntary
adoption by private entities, to support the widespread
adoption of health information technology, including--
(A) the protection of individually
identifiable health information, including
policies concerning the individual's ability to
control the acquisition, uses, and disclosures
of individually identifiable health
information;
(B) methods to protect individually
identifiable health information from improper
use and disclosures and methods to notify
patients if their individually identifiable
health information is wrongfully disclosed;
(C) methods to facilitate secure access to
such individual's individually identifiable
health information;
(D) the appropriate uses of a nationwide
health information network including--
(i) the collection of quality data
and public reporting;
(ii) biosurveillance and public
health;
(iii) medical and clinical research;
and
(iv) drug safety;
(E) fostering the public understanding of
health information technology;
(F) strategies to enhance the use of health
information technology in preventing and
managing chronic disease;
(G) policies to incorporate the input of
employees of health care providers in the
design and implementation of health information
technology systems; and
(H) other policies determined to be necessary
by the Community; and
(4) serve as a forum for the participation of a broad
range of stakeholders to provide input on improving the
effective implementation of health information
technology systems.
(b) Publication.--All recommendations made by the Community
pursuant to this section shall be published in the Federal
Register and on the Internet website of the National
Coordinator. The Secretary shall review all recommendations and
determine which recommendations shall be endorsed by the
Federal Government and such determination shall be published on
the Internet website of the Office of the National Coordinator
within 30 days after the date on which such endorsement is
made.
(c) Membership.--
(1) In general.--The Community shall be composed of
members to be appointed as follows:
(A) 3 members shall be appointed by the
Secretary, 1 of whom shall be a representative
from the Department of Health and Human
Services.
(B) 1 member shall be appointed by the
Secretary of Veterans Affairs who shall
represent the Department of Veterans Affairs.
(C) 1 member shall be appointed by the
Secretary of Defense who shall represent the
Department of Defense.
(D) 1 member shall be appointed by the
majority leader of the Senate.
(E) 1 member shall be appointed by the
minority leader of the Senate.
(F) 1 member shall be appointed by the
Speaker of the House of Representatives.
(G) 1 member shall be appointed by the
minority leader of the House of
Representatives.
(H) Nine members shall be appointed by the
Comptroller General of whom--
(i) one member shall be advocates for
patients or consumers;
(ii) one member shall represent
health care providers;
(iii) one member shall be from a
labor organization representing health
care workers;
(iv) one member shall have expertise
in privacy and security;
(v) one member shall have expertise
in improving the health of vulnerable
populations;
(vi) one member shall represent
health plans or other third party
payers;
(vii) one member shall represent
information technology vendors;
(viii) one member shall represent
purchasers or employers; and
(ix) one member shall have expertise
in health care quality measurement and
reporting.
(2) Chairperson and vice chairperson.--The Community
shall designate one member to serve as the chairperson
and one member to serve as the vice chairperson of the
Community.
(3) National coordinator.--The National Coordinator
shall be a member of the Community and act as a liaison
among the Community, the partnership, and the Federal
Government.
(4) Participation.--The members of the Community
appointed under paragraph (1) shall represent a balance
among various sectors of the health care system so that
no single sector unduly influences the recommendations
of the Community.
(5) Terms.--
(A) In general.--The terms of members of the
Community shall be for 3 years except that the
Comptroller General shall designate staggered
terms for the members first appointed.
(B) Vacancies.--Any member appointed to fill
a vacancy in the membership of the Community
that occurs prior to the expiration of the term
for which the member's predecessor was
appointed shall be appointed only for the
remainder of that term. A member may serve
after the expiration of that member's term
until a successor has been appointed. A vacancy
in the Community shall be filled in the manner
in which the original appointment was made.
(6) Outside involvement.--The Community shall ensure
an adequate opportunity for the participation of
outside advisors, including individuals with expertise
in--
(A) health information privacy and security;
(B) improving the health of vulnerable
populations;
(C) health care quality and patient safety,
including individuals with expertise in
measurement and the use of health information
technology to capture data to improve health
care quality and patient safety;
(D) ethics;
(E) medical and clinical research data
exchange; and
(F) developing health information technology
standards and new health information
technology.
(7) Quorum.--Ten members of the Community shall
constitute a quorum for purposes of voting, but a
lesser number of members may meet and hold hearings.
(d) Federal Agencies.--
(1) Staff of other federal agencies.--Upon the
request of the Community, the head of any Federal
agency may detail, without reimbursement, any of the
personnel of such agency to the Community to assist in
carrying out the duties of the Community. Any such
detail shall not interrupt or otherwise affect the
civil service status or privileges of the Federal
employee involved.
(2) Technical assistance.--Upon the request of the
Community, the head of a Federal agency shall provide
such technical assistance to the Community as the
Community determines to be necessary to carry out its
duties.
(3) Other resources.--The Community shall have
reasonable access to materials, resources, statistical
data, and other information from the Library of
Congress and agencies and elected representatives of
the executive and legislative branches of the Federal
Government. The chairperson or vice chairperson of the
Community shall make requests for such access in
writing when necessary.
(e) Application of FACA.--The Federal Advisory Committee
Act (5 U.S.C. App.) shall apply to the Community, except that
the term provided for under section 14(a)(2) of such Act shall
be not longer than 7 years.
(f) Sunset.-- The provisions of this section shall not
apply after September 20, 2014.
(g) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $2,000,000 for
each of fiscal years 2008 and 2009.
SEC. 3005. FEDERAL PURCHASING AND DATA COLLECTION.
(a) Coordination of Federal Spending.--
(1) In general.--Not later than 1 year after the
adoption by the President of a recommendation under
section 3003(c)(6), a Federal agency shall not expend
Federal funds for the purchase of any new health
information technology or health information technology
system for clinical care or for the electronic
retrieval, storage, or exchange of health information
if such technology or system is not consistent with
applicable standards adopted by the Federal Government
under section 3003.
(2) Rule of construction.--Nothing in paragraph (1)
shall be construed to restrict the purchase of minor
(as determined by the Secretary) hardware or software
components in order to modify, correct a deficiency in,
or extend the life of existing hardware or software.
(b) Voluntary Adoption.--
(1) In general.--Any standards and implementation
specifications adopted by the Federal Government under
section 303(c)(6) shall be voluntary with respect to
private entities.
(2) Requirement.--Private entities that enter into a
contract with the Federal Government shall adopt the
standards and implementation specifications adopted by
the Federal Government under this section for the
purpose of activities under such Federal contract.
(3) Rule of construction.--Nothing in this section
shall be construed to require that a private entity
that enters into a contract with the Federal Government
adopt the standards and implementation specifications
adopted by the Federal Government under this section
with respect to activities not related to the contract.
(c) Coordination of Federal Data Collection.--Not later
than 3 years after the adoption by the Federal Government of a
recommendation as provided for in section 303(c)(6), all
Federal agencies collecting health data in an electronic format
for the purposes of quality reporting, surveillance,
epidemiology, adverse event reporting, research, or for other
purposes determined appropriate by the Secretary, shall comply
with the standards and implementation specifications adopted
under such subsection.
SEC. 3006. QUALITY AND EFFICIENCY REPORTS.
(a) Purpose.--The purpose of this section is to provide for
the development of reports based on Federal health care data
and private data that is publicly available or is provided by
the entity making the request for the report in order to--
(1) improve the quality and efficiency of health care
and advance health care research;
(2) enhance the education and awareness of consumers
for evaluating health care services; and
(3) provide the public with reports on national,
regional, and provider- and supplier-specific
performance, which may be in a provider- or supplier-
identifiable format.
(b) Procedures for the Development of Reports.--
(1) In general.--Notwithstanding section 552(b)(6) or
552a(b) of title 5, United States Code, not later than
12 months after the date of enactment of this section,
the Secretary, in accordance with the purpose described
in subsection (a), shall establish and implement
procedures under which an entity may submit a request
to a Quality Reporting Organization for the
Organization to develop a report based on--
(A) Federal health care data disclosed to the
Organization under subsection (c); and
(B) private data that is publicly available
or is provided to the Organization by the
entity making the request for the report.
(2) Definitions.--In this section:
(A) Federal health care data.--The term
``Federal health care data'' means--
(i) deidentified patient enrollment
data, reimbursement claims, and survey
data maintained by the Secretary or
entities under programs, contracts,
grants, or memoranda of understanding
administered by the Secretary; and
(ii) where feasible, other
deidentified patient enrollment data,
reimbursement claims, and survey data
maintained by the Federal Government or
entities under contract with the
Federal Government.
(B) Quality reporting organization.--The term
``Quality Reporting Organization'' means an
entity with a contract under subsection (d).
(c) Access to Federal Health Care Data.--
(1) In general.--The procedures established under
subsection (b)(1) shall provide for the secure
disclosure of Federal health care data to each Quality
Reporting Organization.
(2) Update of information.--Not less than every 6
months, the Secretary shall update the information
disclosed under paragraph (1) to Quality Reporting
Organizations.
(d) Quality Reporting Organizations.--
(1) In general.--
(A) Three contracts.--Subject to subparagraph
(B), the Secretary shall enter into a contract
with 3 private entities to serve as Quality
Reporting Organizations under which an entity
shall--
(i) store the Federal health care
data that is to be disclosed under
subsection (c); and
(ii) develop and release reports
pursuant to subsection (e).
(B) Additional contracts.--If the Secretary
determines that reports are not being developed
and released within 6 months of the receipt of
the request for the report, the Secretary shall
enter into contracts with additional private
entities in order to ensure that such reports
are developed and released in a timely manner.
(2) Qualifications.--The Secretary shall enter into a
contract with an entity under paragraph (1) only if the
Secretary determines that the entity--
(A) has the research capability to conduct
and complete reports under this section;
(B) has in place--
(i) an information technology
infrastructure to support the database
of Federal health care data that is to
be disclosed to the entity; and
(ii) operational standards to provide
security for such database;
(C) has experience with, and expertise on,
the development of reports on health care
quality and efficiency; and
(D) has a significant business presence in
the United States.
(3) Contract requirements.--Each contract with an
entity under paragraph (1) shall contain the following
requirements:
(A) Ensuring beneficiary privacy.--
(i) HIPAA.--The entity shall meet the
requirements imposed on a covered
entity for purposes of applying part C
of title XI and all regulatory
provisions promulgated thereunder,
including regulations (relating to
privacy) adopted pursuant to the
authority of the Secretary under
section 264(c) of the Health Insurance
Portability and Accountability Act of
1996 (42 U.S.C. 1320d-2 note).
(ii) Privacy.-- The entity shall
provide assurances that the entity will
not use the Federal health care data
disclosed under subsection (c) in a
manner that violates sections 552 or
552a of title 5, United States Code,
with regard to the privacy of and
individual's individually identifiable
health information.
(B) Proprietary information.--The entity
shall provide assurances that the entity will
not disclose any negotiated price concessions,
such as discounts, direct or indirect
subsidies, rebates, and direct or indirect
remunerations, obtained by health care
providers or suppliers or health care plans, or
any other proprietary cost information.
(C) Disclosure.--The entity shall disclose--
(i) any financial, reporting, or
contractual relationship between the
entity and any health care provider or
supplier or health care plan; and
(ii) if applicable, the fact that the
entity is managed, controlled, or
operated by any health care provider or
supplier or health care plan.
(D) Component of another organization.--If
the entity is a component of another
organization--
(i) the entity shall maintain Federal
health care data and reports separately
from the rest of the organization and
establish appropriate security measures
to maintain the confidentiality and
privacy of the Federal health care data
and reports; and
(ii) the entity shall not make an
unauthorized disclosure to the rest of
the organization of Federal health care
data or reports in breach of such
confidentiality and privacy
requirement.
(E) Termination or nonrenewal.--If a contract
under this section is terminated or not
renewed, the following requirements shall
apply:
(i) Confidentiality and privacy
protections.--The entity shall continue
to comply with the confidentiality and
privacy requirements under this section
with respect to all Federal health care
data disclosed to the entity and each
report developed by the entity.
(ii) Disposition of data and
reports.--The entity shall--
(I) return to the Secretary
all Federal health care data
disclosed to the entity and
each report developed by the
entity; or
(II) if returning the Federal
health care data and reports is
not practicable, destroy the
reports and Federal health care
data.
(4) Competitive procedures.--Competitive procedures
(as defined in section 4(5) of the Federal Procurement
Policy Act) shall be used to enter into contracts under
paragraph (1).
(5) Review of contract in the event of a merger or
acquisition.--The Secretary shall review the contract
with a Quality Reporting Organization under this
section in the event of a merger or acquisition of the
Organization in order to ensure that the requirements
under this section will continue to be met.
(e) Development and Release of Reports Based on Requests.--
(1) Request for a report.--
(A) Request.--
(i) In general.--The procedures
established under subsection (b)(1)
shall include a process for an entity
to submit a request to a Quality
Reporting Organization for a report
based on Federal health care data and
private data that is publicly available
or is provided by the entity making the
request for the report. Such request
shall comply with the purpose described
in subsection (a).
(ii) Request for specific
methodology.--The process described in
clause (i) shall permit an entity
making a request for a report to
request that a specific methodology,
including appropriate risk adjustment,
be used by the Quality Reporting
Organization in developing the report.
The Organization shall work with the
entity making the request to finalize
the methodology to be used.
(iii) Request for a specific qro.--
The process described in clause (i)
shall permit an entity to submit the
request for a report to any Quality
Reporting 0rganization.
(B) Release to public.--The procedures
established under subsection (b)(1) shall
provide that at the time a request for a report
is finalized under subparagraph (A) by a
Quality Reporting Organization, the
Organization shall make available to the
public, through the Internet website of the
Department of Health and Human Services and
other appropriate means, a brief description of
both the requested report and the methodology
to be used to develop such report.
(2) Development and release of report.--
(A) Development.--
(i) In general.--If the request for a
report complies with the purpose
described in subsection (a), the
Quality Reporting Organization may
develop the report based on the
request.
(ii) Requirement.--A report developed
under clause (i) shall include a
detailed description of the standards,
methodologies, and measures of quality
used in developing the report.
(B) Review of report by secretary to ensure
compliance with privacy requirement.--Prior to
a Quality Reporting Organization releasing a
report under subparagraph (C), the Secretary
shall review the report to ensure that the
report complies with the Federal regulations
(concerning the privacy of individually
identifiable beneficiary health information)
promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of
1996 and sections 552 or 552a of title 5,
United States Code, with regard to the privacy
of individually identifiable beneficiary health
information. The Secretary shall act within 30
business days of receiving such report.
(C) Release of report.--
(i) Release to entity making
request.--If the Secretary finds that
the report complies with the provisions
described in subparagraph (B), the
Quality Reporting Organization shall
release the report to the entity that
made the request for the report.
(ii) Release to public.--The
procedures established under subsection
(b)(1) shall provide for the following:
(I) Updated description.--At
the time of the release of a
report by a Quality Reporting
Organization under clause (i),
the entity shall make available
to the public, through the
Internet website of the
Department of Health and Human
Services and other appropriate
means, an updated brief
description of both the
requested report and the
methodology used to develop
such report.
(II) Complete report.--Not
later than 1 year after the
date of the release of a report
under clause (i), the report
shall be made available to the
public through the Internet
website of the Department of
Health and Human Services and
other appropriate means.
(f) Annual Review of Reports and Termination of
Contracts.--
(1) Annual review of reports.--The Comptroller
General of the United States shall review reports
released under subsection (e)(2)(C) to ensure that such
reports comply with the purpose described in subsection
(a) and annually submit a report to the Secretary on
such review.
(2) Termination of contracts.--The Secretary may
terminate a contract with a Quality Reporting
Organization if the Secretary determines that there is
a pattern of reports being released by the Organization
that do not comply with the purpose described in
subsection (a).
(g) Fees.--
(1) Fees for secretary.--The Secretary shall charge a
Quality Reporting Organization a fee for--
(A) disclosing the data under subsection (c);
and
(B) conducting the review under subsection
(e)(2)(B).
The Secretary shall ensure that such fees are
sufficient to cover the costs of the activities
described in subparagraph (A) and (B).
(2) Fees for qro.--
(A) In general.--Subject to subparagraphs (A)
and (B), a Quality Reporting Organization may
charge an entity making a request for a report
a reasonable fee for the development and
release of the report.
(B) Discount for small entities.--In the case
of an entity making a request for a report
(including a not-for-profit) that has annual
revenue that does not exceed $10,000,000, the
Quality Reporting Organization shall reduce the
reasonable fee charged to such entity under
subparagraph (A) by an amount equal to 10
percent of such fee.
(C) Increase for large entities that do not
agree to release reports within 6 months.--In
the case of an entity making a request for a
report that is not described in subparagraph
(B) and that does not agree to the report being
released to the public under clause (ii)(II) of
subsection (e)(2)(C) within 6 months of the
date of the release of the report to the entity
under clause (i) of such subsection, the
Quality Reporting Organization shall increase
the reasonable fee charged to such entity under
subparagraph (A) by an amount equal to 10
percent of such fee.
(D) Rule of construction.--Nothing in this
paragraph shall be construed to effect the
requirement that a report be released to the
public under clause (ii)(II) of subsection
(e)(2)(C)(ii)(II) by not later than 1 year
after the date of the release of the report to
the requesting entity under clause (i) of such
subsection.
(h) Coordination.--Not later than 1 year after the date of
enactment of this title, the Secretary shall submit a report
(including recommendations) to the appropriate committees of
Congress concerning the coordination of existing Federal health
care quality initiatives.
(i) Regulations.--Not later than 6 months after the date of
enactment of this section, the Secretary shall prescribe
regulations to carry out this section.
SEC. 3007. RESEARCH ACCESS TO HEALTH CARE DATA AND REPORTING ON
PERFORMANCE.
The Secretary shall permit researchers that meet criteria
used to evaluate the appropriateness of the release data for
research purpose (as established by the Secretary) to--
(1) have access to all Federal health care data (as
defined in section 3006(b)(2)(A)); and
(2) report on the performance of health care
providers and suppliers, including reporting in a
provider- or supplier-identfiable format.
* * * * * * *
SEC. 3008. FACILITATING THE WIDESPREAD ADOPTION OF INTEROPERABLE HEALTH
INFORMATION TECHNOLOGY.
(a) Competitive Grants for Adoption of Technology.--
(1) In general.--The Secretary may award competitive
grants to eligible entities to facilitate the purchase
and enhance the utilization of qualified health
information technology systems to improve the quality
and efficiency of health care.
(2) Eligibility.--To be eligible to receive a grant
under paragraph (1) an entity shall--
(A) submit to the Secretary an application at
such time, in such manner, and containing such
information as the Secretary may require;
(B) submit to the Secretary a strategic plan
for the implementation of data sharing and
interoperability measures;
(C) adopt the standards adopted by the
Federal Government under section 3005;
(D) implement the measures adopted under
section 3010 and report to the Secretary on
such measures;
(E) agree to notify individuals if their
individually identifiable health information is
wrongfully disclosed;
(F) take into account the input of employees
and staff who are directly involved in patient
care of such health care providers in the
design, implementation, and use of qualified
health information technology systems;
(G) demonstrate significant financial need;
(H) provide matching funds in accordance with
paragraph (4); and
(I) be a--
(i) public or not for profit
hospital;
(ii) federally qualified health
center (as defined in section
1861(aa)(4) of the Social Security
Act);
(iii) individual or group practice
(or a consortium thereof); or
(iv) another health care provider not
described in clause (i) or (ii);
that serves medically underserved
communities.
(3) Use of funds.--Amounts received under a grant
under this subsection shall be used to--
(A) facilitate the purchase of qualified
health information technology systems;
(B) train personnel in the use of such
systems;
(C) enhance the utilization of qualified
health information technology systems (which
may include activities to increase the
awareness among consumers of health care
privacy protections); or
(D) improve the prevention and management of
chronic disease.
(4) Matching requirement.--To be eligible for a grant
under this subsection an entity shall contribute non-
Federal contributions to the costs of carrying out the
activities for which the grant is awarded in an amount
equal to $1 for each $3 of Federal funds provided under
the grant.
(5) Preference in awarding grants.--In awarding
grants under this subsection the Secretary shall give
preference to--
(A) eligible entities that will improve the
degree to which such entity will link the
qualified health information system to local or
regional health information plan or plans; and
(B) with respect to awards made for the
purpose of providing care in an outpatient
medical setting, entities that organize their
practices as a patient-centered medical home.
(b) Competitive Grants for the Development of State Loan
Programs to Facilitate the Wide-spread Adoption of Health
Information Technology.--
(1) In general.--The Secretary may award competitive
grants to States for the establishment of State
programs for loans to health care providers to
facilitate the purchase and enhance the utilization of
qualified health information technology.
(2) Establishment of fund.--To be eligible to receive
a competitive grant under this subsection, a State
shall establish a qualified health information
technology loan fund (referred to in this subsection as
a ``State loan fund'' and comply with the other
requirements contained in this subsection. Amounts
received under a grant under this subsection shall be
deposited in the State loan fund established by the
State. No funds authorized by other provisions of this
title to be used for other purposes specified in this
title shall be deposited in any such State loan fund.
(3) Eligibility.--To be eligible to receive a grant
under paragraph (1) a State shall--
(A) submit to the Secretary an application at
such time, in such manner, and containing such
information as the Secretary may require;
(B) submit to the Secretary a strategic plan
in accordance with paragraph (4);
(C) establish a qualified health information
technology loan fund in accordance with
paragraph (2);
(D) require that health care providers
receiving loans under the grant--
(i) link, to the extent practicable,
the qualified health information system
to a local or regional health
information network;
(ii) consult, as needed, with the
Health Information Technology Resource
Center established in section 914(d) to
access the knowledge and experience of
existing initiatives regarding the
successful implementation and effective
use of health information technology;
(iii) agree to notify individuals if
their individually identifiable health
information is wrongfully disclosed;
and
(iv) take into account the input of
employees and staff who are directly
involved in patient care of such health
care providers in the design and
implementation and use of qualified
health information technology systems;
(E) require that health care providers
receiving loans under the grant adopt the
standards adopted by the Federal Government
under section 3005;
(F) require that health care providers
receiving loans under the grant implement the
measures adopted under section 3010 and report
to the Secretary on such measures; and
(G) provide matching funds in accordance with
paragraph (8).
(4) Strategic plan.--
(A) In general.--A State that receives a
grant under this subsection shall annually
prepare a strategic plan that identifies the
intended uses of amounts available to the State
loan fund of the State.
(B) Contents.--A strategic plan under
subparagraph (A) shall include--
(i) a list of the projects to be
assisted through the State loan fund in
the first fiscal year that begins after
the date on which the plan is
submitted;
(ii) a description of the criteria
and methods established for the
distribution of funds from the State
loan fund;
(iii) a description of the financial
status of the State loan fund and the
short-term and long-term goals of the
State loan fund; and
(iv) a description of the strategies
the State will use to address
challenges in the adoption of health
information technology due to limited
broadband access.
(5) Use of funds.--
(A) In general.--Amounts deposited in a State
loan fund, including loan repayments and
interest earned on such amounts, shall be used
only for awarding loans or loan guarantees, or
as a source of reserve and security for
leveraged loans, the proceeds of which are
deposited in the State loan fund established
under paragraph (1). Loans under this section
may be used by a health care provider to--
(i) facilitate the purchase of
qualified health information technology
systems;
(ii) enhance the utilization of
qualified health information technology
systems (which may include activities
to increase the awareness among
consumers of health care of privacy
protections and privacy rights); or
(iii) train personnel in the use of
such systems.
(B) Limitation.--Amounts received by a State
under this subsection may not be used--
(i) for the purchase or other
acquisition of any health information
technology system that is not a
qualified health information technology
system;
(ii) to conduct activities for which
Federal funds are expended under this
title, or the amendments made by the
Wired for Health Care Quality Act; or
(iii) for any purpose other than
making loans to eligible entities under
this section.
(6) Types of assistance.--Except as otherwise limited
by applicable State law, amounts deposited into a State
loan fund under this subsection may only be used for
the following:
(A) To award loans that comply with the
following:
(i) The interest rate for each loan
shall be less than or equal to the
market interest rate.
(ii) The principal and interest
payments on each loan shall commence
not later than 1 year after the date on
which the loan was awarded, and each
loan shall be fully amortized not later
than 10 years after such date.
(iii) The State loan fund shall be
credited with all payments of principal
and interest on each loan awarded from
the fund.
(B) To guarantee, or purchase insurance for,
a local obligation (all of the proceeds of
which finance a project eligible for assistance
under this subsection) if the guarantee or
purchase would improve credit market access or
reduce the interest rate applicable to the
obligation involved.
(C) As a source of revenue or security for
the payment of principal and interest on
revenue or general obligation bonds issued by
the State if the proceeds of the sale of the
bonds will be deposited into the State loan
fund.
(D) To earn interest on the amounts deposited
into the State loan fund.
(7) Administration of state loan funds.--
(A) Combined financial administration.--A
State may (as a convenience and to avoid
unnecessary administrative costs) combine, in
accordance with State law, the financial
administration of a State loan fund established
under this subsection with the financial
administration of any other revolving fund
established by the State if not otherwise
prohibited by the law under which the State
loan fund was established.
(B) Cost of administering fund.--Each State
may annually use not to exceed 4 percent of the
funds provided to the State under a grant under
this subsection to pay the reasonable costs of
the administration of the programs under this
section, including the recovery of reasonable
costs expended to establish a State loan fund
which are incurred after the date of enactment
of this title.
(C) Guidance and regulations.--The Secretary
shall publish guidance and promulgate
regulations as may be necessary to carry out
the provisions of this subsection, including--
(i) provisions to ensure that each
State commits and expends funds
allotted to the State under this
subsection as efficiently as possible
in accordance with this title and
applicable State laws; and
(ii) guidance to prevent waste,
fraud, and abuse.
(D) Private sector contributions.--
(i) In general.--A State loan fund
established under this subsection may
accept contributions from private
sector entities, except that such
entities may not specify the recipient
or recipients of any loan issued under
this subsection.
(ii) Availability of information.--A
State shall make publicly available the
identity of, and amount contributed by,
any private sector entity under clause
(i) and may issue letters of
commendation or make other awards (that
have no financial value) to any such
entity.
(8) Matching requirements.--
(A) In general.--The Secretary may not make a
grant under paragraph (1) to a State unless the
State agrees to make available (directly or
through donations from public or private
entities) non-Federal contributions in cash
toward the costs of the State program to be
implemented under the grant in an amount equal
to not less than $1 for each $1 of Federal
funds provided under the grant.
(B) Determination of amount of nonfederal
contribution.--In determining the amount of
non-Federal contributions that a State has
provided pursuant to subparagraph (A), the
Secretary may not include any amounts provided
to the State by the Federal Government.
(9) Preference in awarding grants.--The Secretary may
give a preference in awarding grants under this
subsection to States that adopt value-based purchasing
programs to improve health care quality.
(10) Reports.--The Secretary shall annually submit to
the Committee on Health, Education, Labor, and Pensions
and the Committee on Finance of the Senate, and the
Committee on Energy and Commerce and the Committee on
Ways and Means of the House of Representatives, a
report summarizing the reports received by the
Secretary from each State that receives a grant under
this subsection.
(c) Competitive Grants for the Implementation of Regional
or Local Health Information Technology Plans.--
(1) In general.--The Secretary may award competitive
grants to eligible entities to implement regional or
local health information plans to improve health care
quality and efficiency through the electronic exchange
of health information pursuant to the standards,
implementation specifications and certification
criteria, and other requirements adopted by the
Secretary under section 3010.
(2) Eligibility.--To be eligible to receive a grant
under paragraph (1) an entity shall--
(A) demonstrate financial need to the
Secretary;
(B) demonstrate that one of its principal
missions or purposes is to use information
technology to improve health care quality and
efficiency;
(C) adopt bylaws, memoranda of understanding,
or other charter documents that demonstrate
that the governance structure and
decisionmaking processes of such entity allow
for participation on an ongoing basis by
multiple stakeholders within a community,
including--
(i) health care providers (including
health care providers that provide
services to low income and underserved
populations);
(ii) pharmacists or pharmacies;
(iii) health plans;
(iv) health centers (as defined in
section 330(b)) and federally qualified
health centers (as defined in section
1861(aa)(4) of the Social Security Act)
and rural health clinics (as defined in
section 1861(aa) of the Social Security
Act), if such centers or clinics are
present in the community served by the
entity;
(v) patient or consumer organzations;
(vi) organizations dedicated to
improving the health of vulnerable
populations;
(vii) employers;
(viii) State or local health
departments; and
(ix) any other health care providers
or other entities, as determined
appropriate by the Secretary;
(D) demonstrate the participation, to the
extent practicable, of stakeholders in the
electronic exchange of health information
within the local or regional plan pursuant to
subparagraph (C);
(E) adopt nondiscrimination and conflict of
interest policies that demonstrate a commitment
to open, fair, and nondiscriminatory
participation in the health information plan by
all stakeholders;
(F) adopt the standards adopted by the
Secretary under section 3005;
(G) require that health care providers
receiving such grants--
(i) implement the measures adopted
under section 3010 and report to the
Secretary on such measures; and
(ii) take into account the input of
employees and staff who are directly
involved in patient care of such health
care providers in the design,
implementation, and use of health
information technology systems;
(H) agree to notify individuals if their
individually identifiable health information is
wrongfully disclosed;
(I) facilitate the electronic exchange of
health information within the local or regional
area and among local and regional areas;
(J) prepare and submit to the Secretary an
application in accordance with paragraph (3);
(K) agree to provide matching funds in
accordance with paragraph (5); and
(L) reduce barriers to the implementation of
health information technology by providers.
(3) Application.--
(A) In general.--To be eligible to receive a
grant under paragraph (1), an entity shall
submit to the Secretary an application at such
time, in such manner, and containing such
information as the Secretary may require.
(B) Required information.--At a minimum, an
application submitted under this paragraph
shall include--
(i) clearly identified short-term and
long-term objectives of the regional or
local health information plan;
(ii) a technology plan that complies
with the standards, implementation
specifications, and certification
criteria adopted under section
3003(c)(6) and that includes a
descriptive and reasoned estimate of
costs of the hardware, software,
training, and consulting services
necessary to implement the regional or
local health information plan;
(iii) a strategy that includes
initiatives to improve health care
quality and efficiency, including the
use and reporting of health care
quality measures adopted under section
3010;
(iv) a plan that describes provisions
to encourage the implementation of the
electronic exchange of health
information by all health care
providers participating in the health
information plan;
(v) a plan to ensure the privacy and
security of individually identifiable
health information that is consistent
with Federal and State law;
(vi) a governance plan that defines
the manner in which the stakeholders
shall jointly make policy and
operational decisions on an ongoing
basis;
(vii) a financial or business plan
that describes--
(I) the sustainability of the
plan;
(II) the financial costs and
benefits of the plan; and
(III) the entities to which
such costs and benefits will
accrue;
(viii) a description of whether the
State in which the entity resides has
received a grant under section 319D,
alone or as a part of a consortium, and
if the State has received such a grant,
how the entity will coordinate the
activities funded under such section
319D with the system under this
section; and
(ix) in the case of an applicant
entity that is unable to demonstrate
the participation of all stakeholders
pursuant to paragraph (2)(C), the
justification from the entity for any
such nonparticipation.
(4) Use of funds.--Amounts received under a grant
under paragraph (1) shall be used to establish and
implement a regional or local health information plan
in accordance with this subsection.
(5) Matching requirement.--
(A) In general.--The Secretary may not make a
grant under this subsection to an entity unless
the entity agrees that, with respect to the
costs to be incurred by the entity in carrying
out the infrastructure program for which the
grant was awarded, the entity will make
available (directly or through donations from
public or private entities) non-Federal
contributions toward such costs in an amount
equal to not less than 50 percent of such costs
($1 for each $2 of Federal funds provided under
the grant).
(B) Determinatiion of amount contributed.--
Non-Federal contributions required under
subparagraph (A) may be in cash or in kind,
fairly evaluated, including equipment,
technology, or services. Amounts provided by
the Federal Government, or services assisted or
subsidized to any significant extent by the
Federal Government, may not be included in
determining the amount of such non-Federal
contributions.
(d) Reports.--Not later than 1 year after the date on which
the first grant is awarded under this section, and annually
thereafter during the grant period, an entity that receives a
grant under this section shall submit to the Secretary a report
on the activities carried out under the grant involved. Each
such report shall include--
(1) a description of the financial costs and benefits
of the project involved and of the entities to which
such costs and benefits accrue;
(2) an analysis of the impact of the project on
health care quality and safety;
(3) a description of any reduction in duplicative or
unnecessary care as a result of the project involved;
and
(4) other information as required by the Secretary.
(e) Authorization of Appropriations.--
(1) In general.--For the purpose of carrying out this
section, there is authorized to be appropriated
$139,000,000 for fiscal year 2008 and $139,000,000 for
fiscal year 2009.
(2) Availability.--Amounts appropriated under
paragraph (1) shall remain available through fiscal
year 2012.
* * * * * * *
SEC. 3009. DEMONSTRATION PROGRAM TO INTEGRATE INFORMATION TECHNOLOGY
INTO CLINICAL EDUCATION.
(a) In General.--The Secretary may award grants to eligible
entities or consortia under this section to carry out
demonstration projects to develop academic curricula
integrating qualified health information technology systems in
the clinical education of health professionals or analyze
clinical data sets to discover quality measures. Such awards
shall be made on a competitive basis and pursuant to peer
review.
(b) Eligibility.--To be eligible to receive a grant under
subsection (a), an entity or consortium shall--
(1) submit to the Secretary an application at such
time, in such manner, and containing such information
as the Secretary may require;
(2) be or include--
(A) a health professions school;
(B) a school of nursing; or
(C) an institution with a graduate medical
education program;
(3) provide for the collection of data regarding the
effectiveness of the demonstration project to be funded
under the grant in improving the safety of patients and
the efficiency of health care delivery; and
(4) provide matching funds in accordance with
subsection (d).
(c) Use of Funds.--
(1) In general.--With respect to a grant under
subsection (a), an eligible entity or consortium shall
use amounts received under the grant in collaboration
with 2 or more disciplines.
(2) Limitation.--An eligible entity or consortium
shall not award a grant under subsection (a) to
purchase hardware, software, or services.
(d) Matching Funds.--
(1) In general.--The Secretary may award a grant to
an entity under or consortium this section only if the
entity of consortium agrees to make available non-
Federal contributions toward the costs of the program
to be funded under the grant in an amount that is not
less than $1 for each $2 of Federal funds provided
under the grant.
(2) Determination of amount contributed.--Non-Federal
contributions under paragraph (1) may be in cash or in
kind, fairly evaluated, including equipment or
services. Amounts provided by the Federal Government,
or services assisted or subsidized to any significant
extent by the Federal Government, may not be included
in determining the amount of such contributions.
(e) Evaluation.--The Secretary shall take such action as
may be necessary to evaluate the projects funded under this
section and publish, make available, and disseminate the
results of such evaluations on as wide a basis as is
practicable.
(f) Reports.--Not later than 1 year after the date of
enactment of this title, and annually thereafter, the Secretary
shall submit to the Committee on Health, Education, Labor, and
Pensions and the Committee on Finance of the Senate, and the
Committee on Energy and Commerce and the Committee on Ways and
Means of the House of Representatives a report that--
(1) describes the specific projects established under
this section; and
(2) contains recommendations for Congress based on
the evaluation conducted under subsection (e).
(g) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section, $2,000,000 for
each of fiscal years 2008 and 2009.
(h) Sunset.--This provisions of this section shall not
apply after September 30, 2012.
* * * * * * *
SEC. 3010. FOSTERING DEVELOPMENT AND USE OF HEALTH CARE QUALITY
MEASURES.
(a) In General.--The Secretary shall provide for the
development and use of health care quality measures (referred
to in this title as ``quality measures'') for the purpose of
measuring the quality and efficiency of health care that
patients receive.
(b) Designation of, and Arrangement With, Organization.--
(1) In general.--Not later than 90 days after the
date of enactment of this title, the Secretary shall
designate, and have in effect an arrangement with, a
single organization that meets the requirements of
subsection (c) under which such organization shall
promote the development of quality measures and provide
the Secretary with advice and recommendations on the
key elements and priorities of a national system for
healthcare performance measurement.
(2) Responsibilities.--The responsibilities to be
performed by the organization designated under
paragraph (1) (in this title referred to as the
``designated Organization'') shall include--
(A) establishing and managing an integrated
national strategy and process for setting
priorities and goals in establishing quality
measures;
(B) coordinating and harmonizing the
development and testing of such measures;
(C) establishing standards for the
development and testing of such measures;
(D) endorsing national consensus quality
measures;
(E) recommending, in collaboration with
multi-stakeholder groups, quality measures to
the Secretary for adoption and use;
(F) promoting the development and use of
electronic health records that contain the
functionality for automated collection,
aggregation, and transmission of performance
measurement information; and
(G) providing recommendations and advice to
the Partnership regarding the integration of
quality measures into the certification process
outlined under section 3003 and the Community
regarding national policies outlined under
section 3004.
(c) Requirements Described.--The requirements described in
this subsection are the following:
(1) Private entity.--The organization shall be a
private nonprofit entity that is governed by a board of
directors and an individual who is designated as
president and chief executive officer.
(2) Board membership.--The members of the board of
directors of the entity shall include representatives
of--
(A) health care providers or groups
representing providers;
(B) health plans or groups representing
health plans;
(C) patients or consumers enrolled in such
plans or groups representing individuals
enrolled in such plans;
(D) health care purchasers and employers or
groups representing purchasers or employers;
and
(E) organizations that develop health
information technology standards and new health
information technology.
(3) Other membership requirements.--The membership of
the board of directors of the entity shall be
representative of individuals with experience with--
(A) urban health care issues;
(B) safety net health care issues;
(C) rural or frontier health care issues;
(D) quality and safety issues;
(E) State or local health programs;
(F) individuals or entities skilled in the
conduct and interpretation of biomedical,
health services, and health economics research
and with expertise in outcomes and
effectiveness research and technology
assessment; and
(G) individuals or entities involved in the
development and establishment of standards and
certification for health information technology
systems and clinical data.
(4) Open and transparent.--With respect to matters
related to the arrangement with the Secretary under
subsection (a)(l), the organization shall conduct its
business in an open and transparent manner, and provide
the opportunity for public comment and ensure a balance
among disparate stakeholders, so that no member
organization unduly influences the work of the
organization.
(5) Voluntary consensus standards setting
organizations.--The organization shall operate as a
voluntary consensus standards setting organization as
defined for purposes of section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (Public
Law 104-113) and Office of Management and Budget
Revised Circular A-119 (published in the Federal
Register on February 10, 1998).
(6) Participation.--If the organization requires a
fee for membership, the organization shall ensure that
such fee is not a substantial barrier to participation
in the entity's activities related to the arrangement
with the Secretary.
(d) Requirements for Measures.--The quality measures
developed under this title shall comply with the following:
(1) Measures.--The designated organization, in
promoting the development of quality measures under
this title, shall ensure that such measures--
(A) are evidence-based, reliable, and valid;
(B) include--
(i) measures of clinical processes
and outcomes, patient experience,
efficiency, and equity; and
(ii) measures to assess
effectiveness, timeliness, patient
self-management, patient centeredness,
and safety; and
(C) include measures of underuse and overuse.
(2) Priorities.--In carrying out its responsibilities
under this section, the designated organization shall
ensure that priority is given to--
(A) measures with the greatest potential
impact for improving the performance and
efficiency of care;
(B) measures that may be rapidly implemented
by group health plans, health insurance
issuers, physicians, hospitals, nursing homes,
long-term care providers, and other providers;
(C) measures which may inform health care
decisions made by consumers and patients;
(D) measures that apply to multiple services
furnished by different providers during an
episode of care;
(E) measures that can be integrated into
certification process described in section
3003; and
(F) measures that may be integrated into the
decision support function of qualified health
information technology as defined by this
title.
(3) Risk adjustment.--The designated organization, in
consultation with performance measure developers and
other stakeholders, shall establish procedures to
ensure that quality measures take into account
differences in patient health status, patient
characteristics, and geographic location, as
appropriate.
(4) Maintenance.--The designated organization, in
consultation with owners and developers of quality
measures, shall require the owners or developers of
quality measures to update and enhance such measures,
including the development of more accurate and precise
specifications, and retire existing out-dated measures.
Such updating shall occur not more often than once
during each 12-month period, except in the case of
emergency circumstances requiring a more immediate
update to a measure.
(e) Grants for Performance Measure Development.--The
Secretary, acting through the Agency for Healthcare Research
and Quality, may award grants, in amounts not to exceed $50,000
each, to organizations to support the development and testing
of quality measures that meet the standards established by the
designated organization.
SEC. 3011. ADOPTION AND USE OF QUALITY MEASURES; REPORTING.
(a) In General.--For purposes of carrying out activities
authorized or required by this title to ensure the use of
quality measures and to foster uniformity between health care
quality measures utilized by private entities, the Secretary
shall--
(1) select quality measures for adoption and use,
from quality measures recommended by multi-stakeholder
groups and endorsed by the designated organization; and
(2) ensure that standards adopted under section 3005
integrate the quality measures endorsed, adopted, and
utilized under this section.
(b) Relationship With Programs Under the Social Security
Act.--The Secretary shall ensure that the quality measures
adopted under this section--
(1) complement quality measures developed by the
Secretary under programs administered by the Secretary
under the Social Security Act, including programs under
titles XVIII, XIX, and XXI of such Act; and
(2) do not conflict with the needs and priorities of
the programs under titles XVIII, XIX, and XXI of such
Act, as set forth by the Administrator of the Centers
for Medicare & Medicaid Services.
(c) Reporting.-- The Secretary shall implement procedures,
consistent with generally accepted standards, to enable the
Department of Health and Human Services to accept the
electronic submission of data for purposes of performance
measurement, including at the provider level, using the quality
measures developed, endorsed, and adopted pursuant to this
title.
(d) Dissemination of Information.--In order to make
comparative performance information available to health care
consumers, health professionals, public health officials,
oversight organizations, researchers, and other appropriate
individuals and entities, after consultation with multi-
stakeholder groups, the Secretary shall promulgate regulations
to provide for the dissemination, aggregation, and analysis of
quality measures collected pursuant to this title.
* * * * * * *
SEC. 3013. ENSURING PRIVACY AND SECURITY.
(a) Privacy Protections Apply to Health Information
Electronic Databases.--An operator of a health information
electronic database shall be deemed to be a ``covered entity''
for purposes of sections 1171 through 1179 of the Social
Security Act and the regulations promulgated under section
264(c) of the Health Insurance Portability and Accountability
Act of 1996 (42 U.S.C. 1320d-2 note) (referred to in this
section as the ``HIPAA privacy regulations'').
(b) Health Information Electronic Database Defined.--In
this section, the term ``operator of a health information
electronic database'' means an entity that--
(1) is constituted, organized, or chartered for the
primary purpose of maintaining or transmitting
protected health information in a designated record set
or sets;
(2) receives valuable consideration for maintaining
or transmitting protected health information in a
designated record set or sets; and
(3) is not a health plan, healthcare clearinghouse,
or healthcare provider who transmits any health
information in electronic form in connection with a
transaction referred to in section 1173(a)(1) of the
Social Security Act.
(c) Right of Individuals To Inspect Their Medical Records
Maintained in Electronic Format.--To the extent provided for
under the HIPAA privacy regulations with respect to protected
health information, an individual shall have a right of access
to inspect and obtain a copy of protected health information
about the individual stored in electronic format.
(d) Rights of Individuals Who Are Victims of Medical
Fraud.--To the extent provided for under the HIPAA privacy
regulations and under the conditions specified in such
regulations, with respect to protected health information, an
individual who is a victim of medical fraud or who believes
that there is an error in their protected health information
stored in an electronic format shall have the right--
(1) to have access to inspect and obtain a copy of
protected health information about the individual,
including the information fraudulently entered, in a
designated record set; and
(2) to have a covered entity amend protected health
information or a record about the individual, including
information fraudulently entered, in a designated
electronic record set for as long as the protected
health information is maintained in the designated
electronic record set to ensure that fraudulent and
inaccurate health information is not shared or re-
reported.
(e) Rule of Construction.--Nothing in this section shall be
construed to supercede or otherwise limit the provisions of any
contract that provides for the application of privacy
protections that are greater than the privacy protections
provided for under the regulations promulgated under section
264 of the Health Insurance Portability and Accountability Act
of 1996.
* * * * * * *