[Senate Report 109-111]
[From the U.S. Government Publishing Office]
Calendar No. 178
109th Congress Report
SENATE
1st Session 109-111
======================================================================
WIRED FOR HEALTH CARE QUALITY ACT
_______
July 27, 2005.--Ordered to be printed
_______
Mr. Enzi, from the Committee on Health, Education, Labor, and Pensions,
submitted the following
R E P O R T
[To accompany S. 1418]
The Committee on Health, Education, Labor, and Pensions, to
which was referred the bill (S. 1418) 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..........................4
V. Cost estimate...................................................13
VI. Application of law to the legislative branch....................16
VII. Regulatory impact statement.....................................16
VIII.Section-by-section analysis.....................................16
IX. Changes in existing law.........................................18
I. Purpose and Summary
The purpose of S. 1418, 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.'' Most
importantly, the bill protects the privacy and security of
health information. The bill also permanently establishes the
Office of the National Coordinator within the Office of the
Secretary for Health and Human Services. The bill also
formalizes the role of private entities in the standards-
setting process by directing the Secretary to establish and
chair the public-private American Health Information
Collaborative. 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 a quality
measurement system in collaboration with other key Federal
agencies. The bill also calls for two studies, one examining
the variation among State laws that relate to the licensure,
registration, and certification of medical professionals, and
the other examining methods to create efficient reimbursement
incentives for improving health care quality. 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
The Institute of Medicine estimates that medical errors
kill 45,000 to 98,000 Americans each year in hospitals.
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 healthcare
today--medical errors, inconsistent quality, and rising costs--
can be addressed through the effective application of available
health information technology linking all elements of the
health care system and using the system to report performance
against quality measures. Information sharing networks have the
potential to enable decision support any where at any time,
thus improving the quality of health care and reducing costs.
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 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 healthcare better, safer and more efficient by
accelerating the widespread adoption of interoperable health
information technology and quality measurement across our
healthcare system.
Interoperability is a shared goal across the health care
industry by payers, providers, vendors, and consumers. 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, 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 and policy-setting process by directing the
Secretary to establish and chair the public-private American
Health Information Collaborative, which shall be composed of
representatives of the public and private sectors.
The committee aims to facilitate the development and
national implementation of an interoperable health IT
infrastructure that ensures patients' individually identifiable
health information is secure and protected; improves health
care quality, reduces medical errors, and advances the delivery
of appropriate, evidence-based medical care; reduces health
care costs resulting from inefficiency, medical errors,
inappropriate care, and incomplete information; ensures
appropriate information to guide medical decisions is available
at the time and place of care; promotes a more effective
marketplace, greater competition, and increased choice through
the wider availability of accurate information on health care
costs, quality, and outcomes; improves the coordination of care
and information among hospitals, laboratories, physician
offices, and other ambulatory care providers through an
effective infrastructure for the secure and authorized exchange
of health care information; improves public health reporting
and facilitates the early identification and rapid response to
public health threats and emergencies, including bioterror
events and infectious disease outbreaks; and promotes
prevention of chronic diseases.
For the last 2 years, HHS has supported its health
information technology initiatives without specific lines of
authorization. The committee believes it is critical to give
HHS specificauthorization but also provide the Secretary with
flexibility to determine what is effective and to allocate that money
accordingly.
The committee agrees that an investment in health
information technology now will decrease healthcare 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
On July 18, 2005, Senators Enzi, Kennedy, Frist, Clinton,
Alexander, Dodd, Burr, Harkin, Isakson, Milkulski, 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
held an executive session to consider S. 1418. After accepting
a substitute amendment offered by Senator Enzi by unanimous
voice vote, the committee approved S. 1418, as amended, by
unanimous voice vote.
IV. Explanation of Bill and Committee Views
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 at the Department of Health and Human Services. 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.
This bill will permanently establish the Office in the
Department. The duties of the Office include serving as a
member of the public-private American Health Information
Collaborative, serving as the primary advisor to the Secretary
and the President on the health information technology policies
and programs of 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 of patient health
information and the electronic exchange of health information.
The Office will report to Congress on actions taken by the
Federal Government and private entities to facilitate the
electronic exchange of health information and describe barriers
to the adoption of, and make recommendations to achieve full
implementation of, a nationwide electronic health information
system. The bill allows the Office to accept the detail of
Federal employees from other Federal agencies to assist in
their activities.
The bill also specifies that an additional purpose of the
Office is to coordinate and develop a nationwide interoperable
health information technology infrastructure that promotes the
prevention of chronic disease. The committee believes the
United States cannot address rising health care costs without
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 $1.4
trillion 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 legislation authorizes $5 million for each of fiscal
years 2006 and 2007 for personnel compensation for the Office.
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.
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 legislation formalizes involvement of private entities
in the standards-setting process by directing the Secretary to
establish and chair the public-private American Health
Information Collaborative, which the bill specifies be composed
of representatives of the public and private sectors.
It is the purpose of the Collaborative to advise the
Secretary and recommend specific actions 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
Collaborative serve a dual purpose of recommending standards
for the electronic exchange of health information and ongoing
modifications to these standards and recommending uniform
national policies facilitating the widespread adoption of
interoperable health information. Given the unusually sensitive
nature of health information and the complexity of the
technical standards and policies needed to guide its use, it is
imperative that a single entity be responsible for decisions
related to both domains so they can be closely integrated. The
Collaborative's policy recommendations are essential to the
success of widespread adoption of interoperable health
information technology. While the Collaborative will be the
authority regarding matters in both domains, it may establish
working groups within the Collaborative.
The Collaborative shall, among other things, advance and
develop recommendations for the following issues: Protection of
health information through appropriate privacy and
securitypractices; measures to prevent unauthorized access to health
information; methods to facilitate secure patient access to health
information; the ongoing harmonization of industry-wide health
information technology standards; recommendations for a nationwide
health information technology infrastructure; the identification and
prioritization of specific use cases for which health information
technology is valuable, beneficial, and feasible; recommendations for
the establishment of an entity to ensure the continuation of the
functions of the Collaborative; and other policies determined
appropriate by the Collaborative.
The committee finds great value for patients in viewing
their own health records. In developing uniform, interoperable
standards for health information, the Collaborative should
examine standards for patient review and secure access of their
health information. This would enhance the ability of patients
to manage their own health care. It would reduce duplication of
services and allow patients to be better health care consumers.
Patients can play an important role in reducing medical errors,
preventing over utilization of services, and improving quality.
The Collaborative 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 Collaborative should seek existing
solutions and minimal modifications, creating new solutions
only as a last resort. 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
Collaborative will ultimately depend on whether those who are
affected by standards and policies were able to participate in
the decision-making 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
Collaborative.
The Collaborative shall be composed of the Secretary (who
shall serve as the chairperson), the Secretary of Defense, the
Secretary of Veterans Affairs, the Secretary of Commerce, the
National Coordinator for Health Information Technology, and
representatives of other relevant agencies, as determined
appropriate by the Secretary. Representatives from each of the
following categories shall be appointed by the Secretary from
nominations submitted by the public: consumer and patient
organizations, experts in health information privacy and
security, health care providers, health insurance plans or
other third-party payers, standards development organizations,
information technology vendors, purchasers and employers, and
State or local government agencies or Indian tribes or tribal
organizations.
In appointing members, the Secretary shall select
individuals with expertise in health information privacy,
health information security, health care quality and patient
safety, data exchange and health information technology
standards. Each representative should be a key decision-maker
in his or her field and should have broad support from peers
and related professional organizations.
Members shall serve 2-year terms, and those who are not
considered full-time Federal employees will be paid a daily
rate plus per diem. Private-sector members who serve as special
government employees will be subject to financial disclosure
and conflict of interest requirements. Some private-sector
members may serve as industry representatives and will not be
special government employees.
Because the legislation specifies that the Federal Advisory
Committee Act (FACA) shall apply to the Collaborative (except
that the term provided shall be 5 years), the Collaborative
governance and administration will be transparent and
accountable. The bill deems recommended by the Collaborative
the standards adopted by the Consolidated Health Informatics
Initiative. The bill also directs the Collaborative, 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 Secretary to provide for the adoption
by the Federal Government of any standard or standards
recommended by the Collaborative within 60 days after the
issuance of such recommendation. The bill specifies the
Secretary of Health and Human Services, 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 healthcare services, as in the
Federal Employee Health Benefits Plan or Medicare Advantage
Plans, 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 Collaborative in order to create a
nationwide interoperable health information technology
infrastructure.
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 bill requires the Secretary annually to submit a report
to Congress that describes actions taken to achieve a
nationwide system for the exchange of health information,
describes barriers to the adoption of such a nationwide system,
contains recommendations to achieve full implementation of a
nationwide system, and contains a plan for the establishment of
an entity to ensure the continuation of the functions of the
Collaborative.
The legislation authorizes $4 million for each of fiscal
years 2006 and 2007 for operating the Collaborative.
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 Collaborative.
The adoption of standards is an important component of
establishing consistent and common content and communication
between health information technology systems. However,
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 Collaborative,
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.
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 guides and a
certification process. This committee believes this bill
addresses those factors in a way that appropriately
incorporates involvement of both the public and private
sectors.
The committee recognizes that the other 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 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. Less than 20 percent of
physicians in office practice and of hospitals currently use
simple electronic health records.
In order to address the health information technology
``adoption gap'' in the United States, S. 1418 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. The bill leaves to the discretion of the Secretary
the allocation of the authorization 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 of the
Department of Health and Human Services. Grant recipients must
provide matching funds equal to $1 for each $3 of Federal funds
provided under the grant.
The bill defines health care providers as hospitals,
skilled nursing facilities, home health entities, health care
clinics, federally qualified health centers, group practices,
pharmacists, pharmacies, laboratories, physicians, health
facilities operated by or pursuant to a contract with the
Indian Health Service, rural health clinics, and other entities
determined appropriate by the Secretary.
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 rural, frontier and other 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.
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 toreport their performance on a set of quality-of-
care measures to be 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 of the Department of Health and Human Services with a
strategic plan that criteria 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 dollar 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
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 their performance on a set of quality-of-care measures
to be 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 loan 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. An incentive for private entities to
contribute voluntarily to the loan program in their State is
that 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 healthcare 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 healthcare 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
healthcare 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 provides for one non-renewable local or
regional health information technology plan grant per entity.
The Federal Government must lead the effort to develop and
implement a nationwide interoperable health information
technology infrastructure through the adoption, certification,
and implementation of standards in conjunction with, and
inextricably linked to, the adoption and reporting of quality
measures integrated into the technology infrastructure. While
it is the intent of the committee that Federal resources
provided through these non-renewable grants be used to jump-
start local or regional health information technology plans
that can demonstrate sustainability beyond the grant period, it
is not the intention of the committee that these non-renewable
grants be limited to a single year or that the Secretary's
authority to negotiate the timeframe or grant amount be
restricted.
The legislation authorizes $116 million in fiscal year 2006
and $141 million for fiscal year 2007 for the three grant
sections. The bill leaves to the discretion of the Secretary
the allocation of the authorization among the three programs.
The committee is dedicated to fiscal responsibility.
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 prescribing for instance.
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 when they
graduate and begin practicing on their own. 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 legislation authorizes 5 million dollars for fiscal year
2007 for this section.
State laws and regulatory bodies determine the requirements
for licensure of health professionals that seek to practice
within their jurisdiction. The committee strongly believes that
the licensureof health professionals should remain within the
jurisdiction of States. Thirty-four [34] states have laws or
regulations in place which speak to the treatment of patients remotely,
usually through telemedicine. Yet most existing licensure requirements
do not speak to the full range of issues presented through telemedicine
and similar technologies. Therefore, this bill directs the Secretary to
conduct a review of the licensure requirements of States and the
related issues that licensure bodies confront as a nationwide
interoperable electronic health information system is developed.
The bill also reauthorizes Telemedicine Incentive Grants
through 2010. These grants were established to encourage state
licensure bodies to address remote treatment issues.
This legislation directs the Secretary of Health and Human
Services, in consultation with the Secretary of Defense,
Secretary of Veterans Affairs, and the heads of other relevant
Federal agencies to develop or adopt a quality measurement
system that includes measures to assess the effectiveness,
timeliness, patient self-management, patient centeredness,
efficiency, and safety of care received by patients, as
recommended by the Institute of Medicine. In developing the
quality measurement system, the legislation requires the
Secretary to give priority to measures with the greatest impact
for improving quality and efficiency, measures that may be
rapidly implemented, and measures that help consumers and
patients make informed decisions about their care.
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 measurement system,
the Secretary shall enter an arrangement with a private entity
to receive advice and recommendations with regard to the
development and updating of the quality measurement system. The
committee intends the development and updating of the quality
measurement system 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 adopted through the development and updating of the
quality measurement system. To that end, the legislation allows
the Secretary to establish collaborative agreements with
private entities to encourage the use of the measures adopted
by the Secretary and to foster uniformity between measures
utilized by the Federal Government and private entities to
minimize administrative burden on healthcare providers.
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.
Because the committee believes that protecting the privacy
and security of health information is the most important aspect
of creating an interoperable health information infrastructure,
the bill clarifies that the Health Insurance Portability and
Accountability Act of 1996 privacy and security laws and
regulations that apply to health information also apply to
health information stored or transmitted in electronic format.
The bill also directs the Secretary to study reimbursement
incentives for improving the quality of care at Federally
qualified health centers and other sites where reimbursement is
paid primarily on a cost basis, rather than through a
prospective payment system.
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 legislation requires the Secretary
to establish a health IT technical assistance toll-free
telephone number or Internet site.
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
U.S. Congress,
Congressional Budget Office,
Washington, DC, July 26, 2005.
Hon. Mike B. Enzi,
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. 1418, 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,
Elizabeth M. Robinson
(For Douglas Holtz-Eakin, Director).
Enclosure.
S. 1418--Wired for Health Care Quality Act
Summary: CBO estimates that implementing S. 1418 would cost
$40 million in 2006 and $652 million over the 2006-2010 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. 1418 would amend the Public Health
Service Act (PHSA) to codify the establishment and
responsibilities of those entities. In addition, the bill would
authorize appropriation of funding for grants to facilitate the
widespread adoption of certain health information technology.
S. 1418 would authorize the appropriation of $125 million in
2006, $155 million in 2007, and such sums as necessary for 2008
through 2010 for those activities.
S. 1418 also would require the Agency for Healthcare
Research and Quality (AHRQ) to establish a Center for Best
Practices to provide technical assistance to support the
adoption of health information technology, and it would extend
through 2010 authorization for a program to provide
telemedicine grants.
S. 1418 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
Any costs to State, local or tribal governments as a result of
participating in the grant programs would be incurred
voluntarily.
Estimated cost to the Federal Government: The estimated
cost of S. 1418 is shown in the following table. The costs of
this legislation fall within budget function 550 (health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-----------------------------------------------
2005 2006 2007 2008 2009 2010
----------------------------------------------------------------------------------------------------------------
SPENDING SUBJECT TO APPROPRIATION
Spending under Current Law:
Estimated Budget Authority\1\............................... 20 0 0 0 0 0
Estimated Outlays........................................... 4 14 2 0 0 0
Proposed Changes:
Estimated Authorization Level............................... 0 133 163 166 169 172
Estimated Outlays........................................... 0 40 125 156 164 167
Spending under S. 1418:
Estimated Authorization Level\1\............................ 20 133 163 166 169 172
Estimated Outlays........................................... 4 54 127 156 164 167
----------------------------------------------------------------------------------------------------------------
\1\ The 2005 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. 1418 would amend the Public Health
Service act to add title 29-- which would deal with health
information technology and quality--and to create a Center for
Best Practices and extend authorization for a program to
provide telemedicine grants. For this estimate, CBO assumes
that S. 1418 will be enacted near the end of fiscal year 2005,
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 $40
million in 2006 and $652 over the 2006-2010 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 $20
million is available in 2005 for the activities of ONCHIT and
AHIC ($3 million from funds appropriated to the Secretary and
$17 million from funds reprogrammed from other activities).
S. 1418 would add title 29 to the Public Health Service Act
to codify the establishment and responsibilities of ONCHIT and
AHIC. (It would change the name of the latter organization to
the American Health Information Collaborative). The bill would
establish several grant programs to promote the adoption of
health information technology.
For activities under title 29, S. 1418 would authorize the
appropriation of $125 million in 2006, $155 million in 2007,
and such sums as necessary in 2008 through 2010. Of the amounts
specified in 2006 and 2007, $5 million would be for ONCHIT in
each year; $4 million a year would be for AHIC; and the
remaining $116 million in 2006 and $146 million in 2007 would
be for the grant programs.
The bill would establish 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 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. The President's
budget request for fiscal year 2006 included $50 million for a
similar program. That program, which is in the request-for-
proposal stage, would provide funding and oversight through
contracts, rather than grants.
Other provisions
In addition to adding title 29 to the Public Health Service
Act, S. 1418 would amend that act to establish a Center for
Best Practices to provide technical assistance to support the
adoption of health information technology, and it would extend
through 2010 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). Based on
information provided by the Department of Health and Human
Services, CBO estimates that implementing those provisions
would require additional appropriations in 2006 through 2010 of
$3 million a year for the Center and $5 million a year for
HRSA.
Intergovernmental and private-sector impact: S. 1418
contains no intergovernmental or private-sector mandates as
defined in UMRA. The bill would not require any action on the
part of State, local, or tribal governments, but it would
provide grant money to public health entities that wish to
implement health record transfer systems. Therefore, CBO
assumes that any costs to those entities as a result of
participating in the grant programs would be incurred
voluntarily.
Estimate prepared by: Federal Costs: Tom Bradley. Impact on
State, Local, and Tribal Governments: Leo Lex and Ian Rudge.
Impact on the Private Sector: Peter Richmond.
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 XXIX--Health Information Technology and Quality''
Section 2901. Definitions
``Healthcare Provider,'' ``Health Information,'' ``Health
Insurance Plan,'' ``Laboratory,'' ``Pharmacist,'' ``Qualified
Health Information Technology,'' and ``State''
Section 2902. Office of the National Coordinator for Health
Information Technology
Establishes the Office of the National Coordinator within
the Office of the Secretary for Health and Human Services
Section 2903. American Health Information Collaborative
The Secretary of HHS shall establish and serve as the
Chairman of the FACA compliant, public-private American Health
Information Collaborative. The Collaborative shall be comprised
of members representing the Federal Government and private
entities. The Collaborative shall--
Serve as a forum for the participation of a broad range of
stakeholders to provide input on achieving interoperability of
health information technology;
Recommend to the Secretary uniform national standard and
policies for adoption by the Federal Government and voluntary
adoption by private entities to support the widespread adoption
of health information technology; and
Review existing standards (including content,
communication, and security standards), identify deficiencies,
omissions, duplication and overlap in existing standards and
recommend new standards and necessary modifications for the
electronic exchange of health information for adoption by the
Federal Government and voluntary adoption by private entities
to support the widespread adoption of health information
technology.
Upon receipt of recommendations from the Collaborative, the
Secretary of Health and Human Services, the Secretary of
Veterans Affairs, and the Secretary of Defense, in
collaboration with representatives of other relevant Federal
agencies, shall jointly review and the Secretary shall provide
for the adoption by the Federal Government of any standard or
standards contained in such recommendation. One year after
enactment, no Federal agency shall expend Federal fundsfor the
purchase of health information technology that is not compliant with
the applicable standards adopted by the Federal Government.
Section 2904. Implementation and certification of standards
The Secretary, based on recommendations of the
Collaborative shall develop criteria to--
Ensure uniform and consistent implementation of any
standards for the electronic exchange of health information;
and
Ensure and certify that hardware, software, and support
services that claim to be in compliance with any standard have
established and maintain such compliance.
The Secretary may recognize a private entity to assist in
the implementation and certification of the standards adopted
by the Federal Government, and the Secretary may accept
recommendations on the development of criteria from a Federal
agency or a private entity.
Section 2905. Grants to facilitate the widespread adoption
of interoperable health information technology
The Secretary may award competitive, matching grants to
eligible entities to facilitate the widespread adoption of
health information technology;
The Secretary may award competitive, matching grants to
states interested in establishing state programs for loans to
healthcare providers for purchasing qualified health
information technology. To qualify for this federal ``seed
money'' for their own loan programs, States must match each
dollar of federal funds with a dollar of state contributions.
States must ensure that providers receiving such loans are
purchasing information technology that is consistent with
standards adopted by the Federal Government; and
There is authorized to be appropriated $125 million in FY
2006 and $155 million in FY 2007 and such sums as necessary
from FY 2008 through 2010.
Section 2906. Demonstration program to integrate
information technology into clinical education
The Secretary may award competitive grants to carry out
demonstration projects to develop academic curricula
integrating qualified health information technology systems in
the clinical education of health professionals.
Section 2907. Licensure and the electronic exchange of
health information
Instructs the Secretary to study state laws for the
licensure, registration, and certification of medical
professionals and, within one year, issue a report with
recommendations for the harmonization of such laws.
Reauthorizes, through FY2010, grants to state licensing boards
to develop policies that reduce the statutory and regulatory
barriers to telemedicine (PHS Act Section 330L).
Section 2908. Quality measurement system
The bill directs the Secretary to develop and periodically
update a quality measurement system for assessing the quality
of care patients receive. The legislation also requires the
Secretary, in implementing such system, to take into account
the recommendations of public-private entities that involve
health care representatives and others interested in the
quality of care. The bill requires the Secretary, by July 1,
2006, to have in place an arrangement with a private nonprofit
entity to provide advice and recommendations on developing and
updating the quality measurement system, and specifies the
membership of such entity.
Section 2909. Ensuring privacy and security
The HIPAA and Social Security statutes and regulations
regarding privacy, confidentiality, and security of health
information shall apply to everything in this act.
Section 2910. Study of reimbursement incentives
The Secretary shall carry out, or contract with a private
entity to carry out, a study that examines methods to create
efficient reimbursement incentives for improving healthcare
quality in community Federally qualified health centers, rural
health clinics, and free clinics.
Section 3. Health information technology resource center
Amends the Public Health Service Act and establishes a
Health Information Technology Resource Center to provide
technical assistance and develop best practices to support and
accelerate efforts to adopt, implement, and effectively use
interoperable health information technology.
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. TELEMEDICINE; INCENTIVE GRANTS REGARDING COORDINATION AMONG
STATES.
(a) In General.-- * * *
(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] 2006 through 2010.
* * * * * * *
SEC. 914. INFORMATION SYSTEMS FOR HEALTH CARE IMPROVEMENT.
(a) In General.-- * * *
* * * * * * *
(c) Facilitating Public Access to Information.-- * * *
* * * * * * *
(d) Health Information Technology Resource Center.--
(a) In general.--The Secretary, acting through the
Director, shall develop a Health Information Technology
Resource 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 section 2903 and 2908.
(2) health information technology resource center.--
(A) In general.--The Center shall support
activities to meet goals, including--
(i) providing for the widespread
adoption of interoperable health
information technology;
(ii) providing 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;
(iii) the development of solutions to
barriers to the exchange of electronic
health information; or
(iv) 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.
(B) Purposes.--The purpose of the Center is
to--
(i) provide a forum for the exchange
of knowledge and experience;
(ii) accelerate the transfer of
lessons learned from existing public
and private sector initiatives,
including those currently receiving
Federal financial support; and
(iii) assemble, analyze, and widely
disseminate evidence and experience
related to the adoption,
implementation, and effective use of
interoperable health information
technology.
(C) 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.
(3) Technical assistance telephone number or
website.--The Secretary shall establish a toll-free
telephone number or Internet website to provide health
care providers and patients with a single point of
contact to--
(A) learn about Federal grants and technical
assistance services related to interoperable
health information technology;
(B) learn about qualified health information
technology and the quality measurement system
adopted by the Federal Government under
sections 2903 and 2908;
(C) learn about regional and local health
information networks for assistance with health
information technology; and
(D) disseminate additional information
determined by the Secretary.
(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.
* * * * * * *
TITLE XXVIII--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC
HEALTH EMERGENCIES
Subtitle A--National Preparedness and Response Planning, Coordinating,
and Reporting
SEC. 2801. NATIONAL PREPAREDNESS PLAN.
(a) In general.--
(1) Preparedness and response regarding public health
emergencies.-- * * *
* * * * * * *
Subtitle B--Emergency Preparedness and Response
SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO
BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES.
(a) Assistant Secretary for Public Health Emergency
Preparedness.--
(1) In general.-- * * *
* * * * * * *
TITLE XXIX--HEALTH INFORMATION TECHNOLOGY AND QUALITY
SEC. 2901. DEFINITIONS.
In this title:
(1) 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 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.
(2) Health information.--The term ``health
information'' has the meaning given such term in
section 1171(4) of the Social Security Act.
(3) Health insurance plan.--The term ``health
insurance plan'' means--
(A) a health insurance issuer (as defined in
section 2791(b)(2));
(B) a group health plan (as defined in
section 2791(a)(1)); and
(C) a health maintenance organization (as
defined in section 2791(b)(3)).
(4) Laboratory.--The term ``laboratory'' has the
meaning given that term in section 353.
(5) Pharmacist.--The term ``pharmacist'' has the
meaning given that term in section 804 of the Federal
Food, Drug, and Cosmetic Act.
(6) 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) incorporates decision support to reduce
medical errors and enhance health care quality;
(D) complies with the standards adopted by
the Federal Government under section 2903; and
(E) allows for the reporting of quality
measures under section 2908.
(7) 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.
SEC. 2902. OFFICE OF THE NATIONAL COORDINATOR OF HEALTH INFORMATION
TECHNOLOGY.
(a) Office of National Health Information Technology.--
There is established within the Office of the Secretary an
Office of the National Coordinator of Health Information
Technology (referred to in this section as the ``Office''). The
Office shall be headed by a National Coordinator who shall be
appointed by the President, in consultation with the Secretary,
and shall report directly to the Secretary.
(b) Purpose.--It shall be the purpose of the Office to
coordinate and oversee programs and activities to develop a
nationwide interoperable health information technology
infrastructure that--
(1) ensures that patients' health information is
secure and protected;
(2) improves health care quality, reduces medical
errors, and advances the delivery of patient-centered
medical care;
(3) reduces health care costs resulting from
inefficiency, medical errors, inappropriate care, and
incomplete information;
(4) ensures that appropriate information to help
guide medical decisions is available at the time and
place of care;
(5) promotes a more effective marketplace, greater
competition, and increased choice through the wider
availability of accurate information on health care
costs, quality, and outcomes;
(6) improves the coordination of care and information
among hospitals, laboratories, physician offices, and
other entities through an effective infrastructure for
the secure and authorized exchange of health care
information;
(7) improves public health reporting and facilitates
the early identification and rapid response to public
health threats and emergencies, including bioterror
events and infectious disease outbreaks;
(8) facilitates health research; and
(9) promotes prevention of chronic diseases.
(c) Duties of the National Coordinator.--The National
Coordinator shall--
(1) serve as a member of the public-private American
Health Information Collaborative established under
section 2903;
(2) serve as the principal advisor to the Secretary
concerning the development, application, and use of
health information technology, and coordinate and
oversee the health information technology programs of
the Department;
(3) facilitate the adoption of a nationwide,
interoperable system for the electronic exchange of
health information;
(4) ensure the adoption and implementation of
standards for the electronic exchange of health
information to reduce cost and improve health care
quality;
(5) ensure that health information technology policy
and programs of the Department are coordinated with
those of relevant executive branch agencies (including
Federal commissions) with a goal of avoiding
duplication of efforts and of helping to ensure that
each agency undertakes health information technology
activities primarily within the areas of its greatest
expertise and technical capability;
(6) to the extent permitted by law, coordinate
outreach and consultation by the relevant executive
branch agencies (including Federal commissions) with
public and private parties of interest, including
consumers, payers, employers, hospitals and other
health care providers, physicians, community health
centers, laboratories, vendors and other stakeholders;
(7) advise the President regarding specific Federal
health information technology programs; and
(8) submit the reports described under section
2903(i) (excluding paragraph (4) of such section).
(d) Detail of Federal Employees.--
(1) In general.--Upon the request of the National
Coordinator, the head of any Federal agency is
authorized to detail, with or without reimbursement
from the Office, any of the personnel of such agency to
the Office to assist it in carrying out its duties
under this section.
(2) Effect of detail.--Any detail of personnel under
paragraph (1) shall--
(A) not interrupt or otherwise affect the
civil service status or privileges of the
Federal employee; and
(B) be in addition to any other staff of the
Department employed by the National
Coordinator.
(3) Acceptance of detailees.--Notwithstanding any
other provision of law, the Office may accept detailed
personnel from other Federal agencies without regard to
whether the agency described under paragraph (1) is
reimbursed.
(e) Rule of Construction.--Nothing in this section shall be
construed to require the duplication of Federal efforts with
respect to the establishment of the Office, regardless of
whether such efforts were carried out prior to or after the
enactment of this title.
(f) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $5,000,000 for
fiscal year 2006, $5,000,000 for fiscal year 2007, and such
sums as may be necessary for each of fiscal years 2008 through
2010.
SEC. 2903. AMERICAN HEALTH INFORMATION COLLABORATIVE.
(a) Purpose.--The Secretary shall establish the public-
private American Health Information Collaborative (referred to
in this section as the ``Collaborative'') to--
(1) advise the Secretary and recommend specific
actions to achieve a nationwide interoperable health
information technology infrastructure;
(2) serve as a forum for the participation of a broad
range of stakeholders to provide input on achieving the
interoperability of health information technology; and
(3) recommend standards (including content,
communication, and security standards) for the
electronic exchange of health information (including
for the reporting of quality data under section 2908)
for adoption by the Federal Government and voluntary
adoption by private entities.
(b) Composition.--
(1) In general.--The Collaborative shall be composed
of--
(A) the Secretary, who shall serve as the
chairperson of the Collaborative;
(B) the Secretary of Defense, or his or her
designee;
(C) the Secretary of Veterans Affairs, or his
or her designee;
(D) the Secretary of Commerce, or his or her
designee;
(E) the National Coordinator for Health
Information Technology;
(F) representatives of other relevant Federal
agencies, as determined appropriate by the
Secretary; and
(G) representatives from each of the
following categories to be appointed by the
Secretary from nominations submitted by the
public--
(i) consumer and patient
organizations;
(ii) experts in health information
privacy and security;
(iii) health care providers;
(iv) health insurance plans or other
third party payors;
(v) standards development
organizations;
(vi) information technology vendors;
(vii) purchasers or employers; and
(viii) State or local government
agencies or Indian tribe or tribal
organizations.
(2) Considerations.--In appointing members under
paragraph (1)(G), the Secretary shall select
individuals with expertise in--
(A) health information privacy;
(B) health information security;
(C) health care quality and patient safety,
including those individuals with experience in
utilizing health information technology to
improve health care quality and patient safety;
(D) data exchange; and
(E) developing health information technology
standards and new health information
technology.
(3) Participation.--Membership and procedures of the
Collaborative shall ensure a balance among various
sectors of the healthcare system so that no single
sector unduly influences the recommendations of the
Collaborative.
(4) Terms.--Members appointed under paragraph (1)(G)
shall serve for 2 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.
(c) Recommendations and Policies.-- Not later than 1 year
after the date of enactment of this title, and annually
thereafter, the Collaborative shall recommend to the Secretary
uniform national policies for adoption by the Federal
Government and voluntary adoption by private entities to
support the widespread adoption of health information
technology, including--
(1) protection of health information through privacy
and security practices;
(2) measures to prevent unauthorized access to health
information;
(3) methods to facilitate secure patient access to
health information;
(4) fostering the public understanding of health
information technology;
(5) the ongoing harmonization of industry-wide health
information technology standards;
(6) recommendations for a nationwide interoperable
health information technology infrastructure;
(7) the identification and prioritization of specific
use cases for which health information technology is
valuable, beneficial, and feasible;
(8) recommendations for the establishment of an
entity to ensure the continuation of the functions of
the Collaborative; and
(9) other policies (including recommendations for
incorporating health information technology into the
provision of care and the organization of the health
care workplace) determined to be necessary by the
Collaborative.
(d) Standards.--
(1) Existing standards.--The standards adopted by the
Consolidated Health Informatics Initiative shall be
deemed to have been recommended by the Collaborative
under this section.
(2) First year review.--Not later than 1 year after
the date of enactment of this title, the Collaborative
shall--
(A) review existing standards (including
content, communication, and security standards)
for the electronic exchange of health
information, including such standards adopted
by the Secretary under paragraph (2)(A);
(B) identify deficiencies and omissions in
such existing standards; and
(C) identify duplication and overlap in such
existing standards;
and recommend new standards and modifications to such
existing standards as necessary.
(3) Ongoing review.--Beginning 1 year after the date
of enactment of this title, and annually thereafter,
the Collaborative shall--
(A) review existing standards (including
content, communication, and security standards)
for the electronic exchange of health
information, including such standards adopted
by the Secretary under paragraph (2)(A);
(B) identify deficiencies and omissions in
such existing standards; and
(C) identify duplication and overlap in such
existing standards;
and recommend new standards and modifications to such
existing standards as necessary.
(4) Limitation.--The standards and timeframe for
adoption described in this section shall be consistent
with any standards developed pursuant to the Health
Insurance Portability and Accountability Act of 1996.
(e) Federal Action.--Not later than 60 days after the
issuance of a recommendation from the Collaborative under
subsection (d)(2), the Secretary of Health and Human Services,
the Secretary of Veterans Affairs, and the Secretary of
Defense, in collaboration with representatives of other
relevant Federal agencies, as determined appropriate by the
Secretary, shall jointly review such recommendations. The
Secretary shall provide for the adoption by the Federal
Government of any standard or standards contained in such
recommendation.
(f) Coordination of Federal Spending.--Not later than 1
year after the adoption by the Federal Government of a
recommendation as provided for in subsection (e), and in
compliance with chapter 113 of title 40, United States Code, no
Federal agency shall expend Federal funds for the purchase of
any form of health information technology or 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 under subsection (e).
(g) Coordination of Federal Data Collection.--Not later
than 3 years after the adoption by the Federal Government of a
recommendation as provided for in subsection (e), all Federal
agencies collecting health data for the purposes of quality
reporting, surveillance, epidemiology, adverse event reporting,
research, or for other purposes determined appropriate by the
Secretary, shall comply with standards adopted under subsection
(e).
(h) Voluntary Adoption.--
(1) In general.--Any standards adopted by the Federal
Government under subsection (e) shall be voluntary with
respect to private entities.
(2) 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 adopted by the Federal Government
under section 2903 with respect to activities not
related to the contract.
(3) Limitation.--Private entities that enter into a
contract with the Federal Government shall adopt the
standards adopted by the Federal Government under
section 2903 for the purpose of activities under such
Federal contract.
(i) Reports.--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, on an annual basis, a report that--
(1) describes the specific actions that have been
taken by the Federal Government and private entities to
facilitate the adoption of an interoperable
nationwidesystem for the electronic exchange of health information;
(2) describes barriers to the adoption of such a
nationwide system;
(3) contains recommendations to achieve full
implementation of such a nationwide system; and
(4) contains a plan and progress toward the
establishment of an entity to ensure the continuation
of the functions of the Collaborative.
(j) Application of FACA.--The Federal Advisory Committee
Act (5 U.S.C. App.) shall apply to the Collaborative, except
that the term provided for under section 14(a)(2) shall be 5
years.
(k) Rule of Construction.--Nothing in this section shall be
construed to require the duplication of Federal efforts with
respect to the establishment of the Collaborative, regardless
of whether such efforts were carried out prior to or after the
enactment of this title.
(l) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, $4,000,000 for
fiscal year 2006, $4,000,000 for fiscal year 2007, and such
sums as may be necessary for each of fiscal years 2008 through
2010.
SEC. 2904. IMPLEMENTATION AND CERTIFICATION OF HEALTH INFORMATION
STANDARDS.
(a) Implementation.--
(1) In general.--The Secretary, based upon the
recommendations of the Collaborative, shall develop
criteria to ensure uniform and consistent
implementation of any standards for the electronic
exchange of health information voluntarily adopted by
private entities in technical conformance with such
standards adopted under this title.
(2) Implementation assistance.--The Secretary may
recognize a private entity or entities to assist
private entities in the implementation of the standards
adopted under this title using the criteria developed
by the Secretary under this section.
(b) Certification.--
(1) In general.--The Secretary, based upon the
recommendations of the Collaborative, shall develop
criteria to ensure and certify that hardware and
software that claim to be in compliance with any
standard for the electronic exchange of health
information adopted under this title have established
and maintained such compliance in technical conformance
with such standards.
(2) Certification assistance.--The Secretary may
recognize a private entity or entities to assist in the
certification described under paragraph (1) using the
criteria developed by the Secretary under this section.
(c) Delegation Authority.--The Secretary, through
consultation with the Collaborative, may accept recommendations
on the development of the criteria under subsections (a) and
(b) from a Federal agency or private entity.
SEC. 2905. GRANTS TO FACILITATE THE WIDESPREAD ADOPTION OF
INTEROPERABLE HEALTH INFORMATION TECHNOLOGY.
(a) Competitive Grants To Facilitate the Widespread
Adoption of Health Information 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) be a--
(i) not for profit hospital;
(ii) individual or group practice; or
(iii) another health care provider
not described in clause (i) or (ii);
(D) adopt the standards adopted by the
Federal Government under section 2903;
(E) implement the measurement system adopted
under section 2908 and report to the Secretary
on such measures;
(F) demonstrate significant financial need;
and
(G) provide matching funds in accordance with
paragraph (4).
(3) Use of funds.--Amounts received under a grant
under this subsection shall be used to facilitate the
purchase and enhance the utilization of qualified
health information technology systems.
(4) Matching requirement.--To be eligible for a grant
under this subsection an entity shall contribute non-
Federal contributions to the costs of carryingout 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 are located in
rural, frontier, and other underserved areas as
determined by the Secretary;
(B) eligible entities that will link, to the
extent practicable, the qualified health
information system to local or regional health
information plan or plans; and
(C) with respect to an entity described in
subsection (a)(2)(C)(iii), a nonprofit health
care provider.
(b) Competitive Grants to States for the Development of
State Loan Programs To Facilitate the Widespread 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 section. A grant to a
State 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 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 such loans--
(i) link, to the extent practicable,
the qualified health information system
to a local or regional health
information network; and
(ii) consult 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;
(E) require that health care providers
receiving such loans adopt the standards
adopted by the Federal Government under section
2903;
(F) require that health care providers
receiving such loans implement the measurement
system adopted under section 2908 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; and
(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.
(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
facilitate the purchase and enhance the
utilization of qualified healthinformation
technology and training of personnel in the use of such technology.
(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 loan
was awarded, and each loan shall be
fully amortized not later than 10 years
after the date of the loan.
(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 otherwise not
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
cashtoward 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 non-federal
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,
protocols, and other requirements adopted by the
Secretary under sections 2903 and 2908.
(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) physicians (as defined in section
1861(r) of the Social Security Act),
including physicians that provide
services to low income and underserved
populations;
(ii) hospitals (including hospitals
that provide services to low income and
underserved populations);
(iii) pharmacists or pharmacies;
(iv) health insurance plans;
(v) 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);
(vi) rural health clinics (as defined
in section 1861(aa) of the Social
Security Act);
(vii) patient or consumer
organizations;
(viii) employers; 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
paragraph (2)(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 2903;
(G) require that health care providers
receiving such grants implement the measurement
system adopted under section 2908 and report to
the Secretary on such measures;
(H) facilitate the electronic exchange of
health information within the local or regional
area and among local and regional areas;
(I) prepare and submit to the Secretary an
application in accordance with paragraph (3);
and
(J) agree to provide matching funds in
accordance with paragraph (5).
(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 adopted under
section 2903 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
2908;
(iv) a plan that describes provisions
to encourage the implementation of the
electronic exchange of health
information by all physicians,
including single physician practices
and small physician groups
participating in the health information
plan;
(v) a plan to ensure the privacy and
security of personal 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; and
(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; and
(viii) if 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) Determination 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;
(4) a description of the efforts of recipients under
this section to facilitate secure patient access to
health information; and
(5) other information as required by the Secretary.
(e) Requirement To Achieve Quality Improvement.--The
Secretary shall annually evaluate the activities conducted
under this section and shall, in awarding grants, implement the
lessons learned from such evaluation in a manner so that awards
made subsequent to each such evaluation are made in a manner
that, in the determination of the Secretary, will result in the
greatest improvement in quality measurement systems under
section 2908.
(f) Limitation.--An eligible entity may only receive one
non-renewable grant under subjection (a), one non-renewable
grant under subsection (b), and one non-renewable grand under
subsection (c).
(g) Authorization of Appropriations.--
(1) In general.--For the purpose of carrying out this
section, there is authorized to be appropriated
$116,000,000 for fiscal year 2006, $141,000,000 for
fiscal year 2007, and such sums as may be necessary for
each of fiscal years 2008 through 2010.
(2) Availability.--Amounts appropriated under
paragraph (1) shall remain available through fiscal
year 2010.
SEC. 2906. DEMONSTRATION PROGRAM TO INTEGRATE INFORMATION TECHNOLOGY
INTO CLINICAL EDUCATION.
(a) In General.--The Secretary may award grants 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. 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 shall--
(1) submit to the Secretary an application at such
time, in such manner, and containing such information
as the Secretary may require;
(2) submit to the Secretary a strategic plan for
integrating qualified health information technology
inthe clinical education of health professionals and for ensuring the
consistent utilization of decision support software to reduce medical
errors and enhance health care quality;
(3) be--
(A) a health professions school;
(B) a school of nursing; or
(C) an institution with a graduate medical
education program;
(4) 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,
the efficiency of health care delivery, and in
increasing the likelihood that graduates of the grantee
will adopt and incorporate health information
technology, and implement the quality measurement
system adopted under section 2908, in the delivery of
health care services; and
(5) provide matching funds in accordance with
subsection (c).
(c) Use of Funds.--
(1) In general.--With respect to a grant under
subsection (a), an eligible entity shall--
(A) use grant funds in collaboration with 2
or more disciplines; and
(B) use grant funds to integrate qualified
health information technology into community-
based clinical education.
(2) Limitation.--An eligible entity shall not use
amounts received under 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 this section only if the entity 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, $5,000,000 for
fiscal year 2007, and such sums as may be necessary for each of
fiscal years 2008 through 2010.
(h) Sunset.--This section shall not apply after September
30, 2010.
SEC. 2907. LICENSURE AND THE ELECTRONIC EXCHANGE OF HEALTH INFORMATION.
(a) In General.--The Secretary shall carry out, or contract
with a private entity to carry out, a study that examines--
(1) the variation among State laws that relate to the
licensure, registration, and certification of medical
professionals; and
(2) how such variation among State laws impacts the
secure electronic exchange of health information--
(A) among the States; and
(B) between the States and the Federal
Government.
(b) Report and Recommendations.--Not later than 1 year
after the date of enactment of this title, the Secretary shall
publish a report that--
(1) describes the results of the study carried out
under subsection (a); and
(2) makes recommendations to States regarding the
harmonization of State laws based on the results of
such study.
SEC. 2908. QUALITY MEASUREMENT SYSTEMS.
(a) In General.--The Secretary, in consultation with the
Secretary of Veterans Affairs, the Secretary of Defense, and
representatives of other relevant Federal agencies, as
determined appropriate by the Secretary, shall develop or adopt
a quality measurement system, including measures to assess that
effectiveness, timeliness, patient self-management,patient
centeredness, efficiency, and safety, for the purpose of measuring the
quality of care patients receive.
(b) Requirements.--The Secretaries shall ensure that the
quality measurement system developed under subsection (a)
comply with the following:
(1) Measures.--
(A) In general.--Subject to subparagraph (B),
the Secretaries shall select measures of
quality to be used by the Secretaries under the
systems.
(B) Requirements.--In selecting the measures
to be used under each system pursuant to
subparagraph (A), the Secretaries shall, to the
extent feasible, ensure that--
(i) such measures are evidence based,
reliable and valid;
(ii) such measures include measures
of process, structure, patient
experience, efficiency, and equity; and
(iii) such measures include measures
of overuse, underuse, and misuse of
health care items and services.
(2) Priorities.--In developing the system under
subsection (a), the Secretaries shall ensure that
priority is given to--
(A) measures with the greatest potential
impact for improving the quality and efficiency
of care provided under Federal programs;
(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;
and
(C) measures which may inform health care
decisions made by consumers and patients.
(3) Weights of measures.--The Secretaries shall
assign weights to the measures used by the Secretaries
under each system established under subsection (a).
(4) Risk adjustment.--The Secretaries shall establish
procedures to account for differences in patient health
status, patient characteristics, and geographic
location. To the extent practicable, such procedures
shall recognize existing procedures.
(5) Maintenance.--The Secretaries shall, as
determined appropriate, but in no case more often than
once during each 12-month period, update the quality
measurement systems developed under subsection (a),
including through--
(A) the addition of more accurate and precise
measures under the systems and the retirement
of existing outdated measures under the
systems; and
(B) the refinement of the weights assigned to
measures under the systems.
(c) Required Considerations in Developing and Updating the
Systems.--In developing and updating the quality measurement
systems under this section, the Secretaries shall--
(1) consult with, and take into account the
recommendations of, the entity that the Secretaries has
an arrangement with under subsection (e);
(2) consult with representatives of health care
providers, consumers, employers, and other individuals
and groups that are interested in the quality of health
care; and
(3) take into account--
(A) any demonstration or pilot program
conducted by the Secretaries relating to
measuring and rewarding quality and efficiency
of care;
(B) any existing activities conducted by the
Secretaries relating to measuring and rewarding
quality and efficiency;
(C) any existing activities conducted by
private entities including health insurance
plans and payors; and
(D) the report by the Institute of Medicine
of the National Academy of Sciences under
section 238(b) of the Medicare Prescription
Drug, Improvement, and Modernization Act of
2003.
(d) Required Considerations in Implementing the Systems.--
In implementing the quality measurement systems under this
section, the Secretaries shall take into account the
recommendations of public-private entities--
(1) that are established to examine issues of data
collection and reporting, including the feasibility of
collecting and reporting data on measures; and
(2) that involve representatives of health care
providers, consumers, employers, and other individuals
and groups that are interested in quality of care.
(e) Arrangement With an Entity To Provide Advice and
Recommendations.--
(1) Arrangement.--On and after July 1, 2006, the
Secretaries shall have in place an arrangement with an
entity that meets the requirements described in
paragraph (2) under which such entityprovides the
Secretary with advice on, and recommendations with respect to, the
development and updating of the quality measurement systems under this
section, including the assigning of weights to the measures under
subsection (b)(2).
(2) Requirements described.--The requirements
described in this paragraph are the following:
(A) The entity is a private nonprofit entity
governed by an executive director and a board.
(B) The members of the entity include
representatives of--
(i) health insurance plans and
providers with experience in the care
of individuals with multiple complex
chronic conditions or groups
representing such health insurance
plans and providers;
(ii) groups representing patients and
consumers;
(iii) purchasers and employers or
groups representing purchasers or
employers;
(iv) organizations that focus on
quality improvement as well as the
measurement and reporting of quality
measures;
(v) State government health programs;
(vi) 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
(vii) individuals or entities
involved in the development and
establishment of standards and
certification for health information
technology systems and clinical data.
(C) The membership of the entity is
representative of individuals with experience
with urban health care issues and individuals
with experience with rural and frontier health
care issues.
(D) If the entity requires a fee for
membership, the entity shall provide assurances
to the Secretary that such fees are not a
substantial barrier to participation in the
entity's activities related to the arrangement
with the Secretary.
(E) The entity--
(i) permits any member described in
subparagraph (B) to vote on matters of
the entity related to the arrangement
with the Secretary under paragraph (1);
and
(ii) ensures that member voting
provides a balance among disparate
stakeholders, so that no member
organization described in subparagraph
(B) unduly influences the outcome.
(F) With respect to matters related to the
arrangement with the Secretary under paragraph
(1), the entity conducts its business in an
open and transparent manner and provides the
opportunity for public comment.
(G) The entity operates 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).
(f) Use of Quality Measurement System.--
(1) In general.--For purposes of activities conducted
or supported by the Secretary under thisAct, the
Secretary shall, to the extent practicable, adopt and utilize the
measurement system developed under this section.
(2) Collaborative agreements.--With respect to
activities conducted or supported by the Secretary
under this Act, the Secretary may establish
collaborative agreements with private entities,
including group health plans and health insurance
issuers, providers, purchasers, consumer organizations,
and entities receiving a grant under section 2905, to--
(A) encourage the use of the health care
quality measures adopted by the Secretary under
this section; and
(B) foster uniformity between the health care
quality measures utilized by private entities.
(3) Reporting.--The Secretary shall implement
procedures to enable the Department of Health and Human
Services to accept the electronic submission of data
for purposes of quality measurement using the quality
measurement system adopted under this section and using
the standards adopted by the Federal Government under
section 2903.
(g) Dissemination of Information.--Beginning on January 1,
2008, in order to make comparative quality information
available to health care consumers, health professionals,
public health officials, researchers, and other appropriate
individuals and entities, the Secretary shall provide for the
aggregation and analysis of quality measures collected under
section 2905 and the dissemination of recommendations and best
practices derived in part from such analysis.
(h) Technical Assistance.--The Secretary shall provide
technical assistance to public and private entities to enable
such entities to--
(1) implement and use evidence-based guidelines with
the greatest potential to improve health care quality,
efficiency, and patient safety; and
(2) establish mechanisms for the rapid dissemination
of information regarding evidence-based guidelines with
the greatest potential to improve health care quality,
efficiency, and patient safety.
SEC. 2909. ENSURING PRIVACY AND SECURITY.
Nothing in this title shall be construed to affect the
scope of substance of--
(1) section 264 of the Health Insurance Portability
and Accountability Act of 1996;
(2) sections 1171 through 1179 of the Social Security
Act; and
(3) any regulation issued pursuant to any such
section;
and such sections shall remain in effect.
SEC. 2910. STUDY OF REIMBURSEMENT INCENTIVES.
The Secretary shall carry out, or contract with a private
entity to carry out, a study that examines methods to create
efficient reimbursement incentives for improving health care
quality in Federally qualified health centers, rural health
clinics, and free clinics.
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