[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 663 Engrossed in House (EH)]
1st Session
H. R. 663
_______________________________________________________________________
AN ACT
To amend title IX of the Public Health Service Act to provide for the
improvement of patient safety and to reduce the incidence of events
that adversely affect patient safety, and for other purposes.
108th CONGRESS
1st Session
H. R. 663
_______________________________________________________________________
AN ACT
To amend title IX of the Public Health Service Act to provide for the
improvement of patient safety and to reduce the incidence of events
that adversely affect patient safety, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Patient Safety and
Quality Improvement Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings and purposes.
TITLE I--PATIENT SAFETY AND QUALITY IMPROVEMENT
Sec. 101. Amendments to Public Health Service Act.
Sec. 102. Promoting the diffusion and interoperability of information
technology systems involved with health
care delivery.
Sec. 103. Required use of product identification technology.
Sec. 104. Grants for electronic prescription programs.
Sec. 105. Grants to hospitals and other health care providers for
information technologies.
Sec. 106. Authorization of appropriations for grants under sections 104
and 105.
TITLE II--MEDICAL INFORMATION TECHNOLOGY ADVISORY BOARD.
Sec. 201. Medical Information Technology Advisory Board.
SEC. 2. FINDINGS AND PURPOSES.
(a) Findings.--The Congress finds as follows:
(1) In 1999, the Institute of Medicine released a report
entitled ``To Err Is Human'' that described medical errors as
the 8th leading cause of death in the United States, with as
many as 98,000 people dying as a result of medical errors each
year.
(2) To address these deaths and injuries due to medical
errors, the health care system must identify and learn from
such errors so that systems of care can be improved.
(3) Myriad public and private patient safety initiatives
have begun. The Quality Interagency Coordination Task Force has
recommended steps to improve patient safety that may be taken
by each Federal agency involved in health care and activities
relating to these steps are ongoing.
(4) The Department of Health and Human Services has
initiated several patient safety projects. The Joint Commission
on Accreditation of Healthcare Organizations issued a patient
safety standard that went into effect on July 1, 2001, and the
peer review organizations are conducting ongoing studies of
clinical performance measurement of care delivered to
beneficiaries under the medicare program under title XVIII of
the Social Security Act.
(5) Several steps can be taken now to improve patient
safety. For example, according to the Centers for Disease
Control and Prevention, hand washing is the single most
important means of preventing the spread of infection. Repeated
studies indicate that lack of or improper hand washing still
contributes significantly to disease transmission in health
care settings. Working with experts from the private sector,
the Centers for Disease Control and Prevention has drafted
``Guidelines for Hand Hygiene in Healthcare Settings'' setting
forth recommendations to promote improved hand hygiene
practices and reduce transmission of pathogenic microorganisms
to patients and personnel in health care settings.
(6) According to the Centers for Disease Control and
Prevention, nosocomial infections affect approximately 2
million patients annually in acute care facilities in the
United States at an estimated direct patient care cost of
approximately $3.5 billion each year.
(7) The Congress encourages the continuation and
acceleration of private sector efforts to take immediate steps
to improve patient safety and recognizes the need for action in
the public sector to complement these efforts.
(8) The research on patient safety unequivocally calls for
a learning environment, where providers will feel safe to
report health care errors, in order to improve patient safety.
(9) Voluntary data gathering systems are more supportive
than mandatory systems in creating the learning environment
referred to in paragraph (8) as stated in the Institute of
Medicine's report.
(10) Promising patient safety reporting systems have been
established throughout the United States, and the best ways to
structure and use these systems are currently being determined,
largely through projects funded by the Agency for Healthcare
Research and Quality.
(11) Many organizations currently collecting patient safety
information have expressed a need for protections that will
allow them to review protected information so that they may
collaborate in the development and implementation of patient
safety improvement strategies. Currently, the State peer review
protections provide inadequate conditions to allow the sharing
of information to promote patient safety.
(12) In 2001, the Institute of Medicine released a report
entitled ``Crossing the Quality Chasm'' that found that the
United States health care system does not consistently deliver
high-quality care to patients.
(b) Purposes.--The purposes of this Act are--
(1) to encourage a culture of safety and quality in the
United States health care system by providing for a health care
errors reporting system that both protects information and
improves patient safety and quality of health care; and
(2) to ensure accountability by raising standards and
expectations for continuous quality improvements in patient
safety through the actions of the Secretary of Health and Human
Services.
TITLE I--PATIENT SAFETY AND QUALITY IMPROVEMENT
SEC. 101. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.
(a) In General.--Title IX of the Public Health Service Act (42
U.S.C. 299 et seq.) is amended--
(1) in section 912(c), by inserting ``, in accordance with
part C,'' after ``The Director shall'';
(2) by redesignating part C as part D;
(3) by redesignating sections 921 through 928, as sections
931 through 938, respectively;
(4) in section 938(1) (as so redesignated), by striking
``921'' and inserting ``931''; and
(5) by inserting after part B the following:
``PART C--PATIENT SAFETY IMPROVEMENT
``SEC. 921. DEFINITIONS.
``In this part:
``(1) Identifiable information.--The term `identifiable
information' means information that is presented in a form and
manner that allows the identification of any provider, patient,
or reporter of patient safety work product. With respect to
patients, such information includes any individually
identifiable health information as that term is defined in the
regulations promulgated pursuant to section 264(c) of the
Health Insurance Portability and Accountability Act of 1996
(Public Law 104-191; 110 Stat. 2033).
``(2) Nonidentifiable information.--The term
`nonidentifiable information' means information that is
presented in a form and manner that prevents the identification
of any provider, patient, or reporter of patient safety work
product. With respect to patients, such information must be de-
identified consistent with the regulations promulgated pursuant
to section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191; 110 Stat.
2033).
``(3) Patient safety evaluation system.--The term `patient
safety evaluation system' means a process that involves the
collection, management, or analysis of information for
submission to or by a patient safety organization.
``(4) Patient safety organization.--The term `patient
safety organization' means a private or public organization or
component thereof that is certified, through a process to be
determined by the Secretary under section 925, to perform each
of the following activities:
``(A) The conduct, as the organization or
component's primary activity, of efforts to improve
patient safety and the quality of health care delivery.
``(B) The collection and analysis of patient safety
work product that is submitted by providers.
``(C) The development and dissemination of
evidence-based information to providers with respect to
improving patient safety, such as recommendations,
protocols, or information regarding best practices.
``(D) The utilization of patient safety work
product to carry out activities limited to those
described under this paragraph and for the purposes of
encouraging a culture of safety and of providing direct
feedback and assistance to providers to effectively
minimize patient risk.
``(E) The maintenance of confidentiality with
respect to identifiable information.
``(F) The provision of appropriate security
measures with respect to patient safety work product.
``(G) The submission of nonidentifiable information
to the Agency consistent with standards established by
the Secretary under section 923(b) for any National
Patient Safety Database.
``(5) Patient safety work product.--
``(A) The term `patient safety work product' means
any document or communication (including any
information, report, record, memorandum, analysis,
deliberative work, statement, or root cause analysis)
that--
``(i) except as provided in subparagraph
(B), is developed by a provider for the purpose
of reporting to a patient safety organization,
and is reported to a patient safety
organization;
``(ii) is created by a patient safety
organization; or
``(iii) would reveal the deliberations or
analytic process of a patient safety evaluation
system (as defined in paragraph (3)).
``(B)(i) Patient safety work product described in
subparagraph (A)(i)--
``(I) does not include any separate
information described in clause (ii); and
``(II) shall not be construed to include
such separate information merely by reason of
inclusion of a copy of the document or
communication involved in a submission to, or
the fact of submission of such a copy to, a
patient safety organization.
``(ii) Separate information described in this
clause is a document or communication (including a
patient's medical record or any other patient or
hospital record) that is developed or maintained, or
exists, separately from any patient safety evaluation
system.
``(C) Information available from sources other than
a patient safety work product under this section may be
discovered or admitted in a civil or administrative
proceeding, if discoverable or admissible under
applicable law.
``(6) Provider.--The term `provider' means--
``(A) an individual or entity licensed or otherwise
authorized under State law to provide health care
services, including--
``(i) a hospital, nursing facility,
comprehensive outpatient rehabilitation
facility, home health agency, and hospice
program;
``(ii) a physician, physician assistant,
nurse practitioner, clinical nurse specialist,
certified nurse midwife, nurse anesthetist,
psychologist, certified social worker,
registered dietitian or nutrition professional,
physical or occupational therapist, or other
individual health care practitioner;
``(iii) a pharmacist; and
``(iv) a renal dialysis facility,
ambulatory surgical center, pharmacy, physician
or health care practitioner's office, long-term
care facility, behavioral health residential
treatment facility, clinical laboratory, or
community health center; or
``(B) any other person or entity specified in
regulations by the Secretary after public notice and
comment.
``SEC. 922. PRIVILEGE FOR PATIENT SAFETY WORK PRODUCT.
``(a) Privilege.--Notwithstanding any other provision of law and
subject to subsection (c), patient safety work product shall not be--
``(1) subject to a civil or administrative subpoena or
order;
``(2) subject to discovery in connection with a civil or
administrative proceeding;
``(3) subject to disclosure pursuant to section 552 of
title 5, United States Code (commonly known as the Freedom of
Information Act), or any other similar Federal or State law;
``(4) required to be admitted as evidence or otherwise
disclosed in any State or Federal civil or administrative
proceeding; or
``(5) if the patient safety work product is identifiable
information and is received by a national accreditation
organization in its capacity as a patient safety organization--
``(A) used by a national accreditation organization
in an accreditation action against the provider that
reported the information;
``(B) shared by such organization with its survey
team; or
``(C) required as a condition of accreditation by a
national accreditation association.
``(b) Reporter Protection.--
``(1) In general.--A provider may not use against an
individual in an adverse employment action described in
paragraph (2) the fact that the individual in good faith
reported information--
``(A) to the provider with the intention of having
the information reported to a patient safety
organization; or
``(B) directly to a patient safety organization.
``(2) Adverse employment action.--For purposes of this
subsection, an `adverse employment action' includes--
``(A) the failure to promote an individual or
provide any other employment-related benefit for which
the individual would otherwise be eligible;
``(B) an adverse evaluation or decision made in
relation to accreditation, certification,
credentialing, or licensing of the individual; and
``(C) a personnel action that is adverse to the
individual concerned.
``(3) Remedies.--Any provider that violates this subsection
shall be subject to a civil monetary penalty of not more than
$20,000 for each such violation involved. Such penalty shall be
imposed and collected in the same manner as civil money
penalties under subsection (a) of section 1128A of the Social
Security Act are imposed and collected.
``(c) Disclosures.--Nothing in this section prohibits any of the
following disclosures:
``(1) Voluntary disclosure of nonidentifiable information.
``(2) Voluntary disclosure of identifiable information by a
provider or patient safety organization, if such disclosure--
``(A) is authorized by the provider for the
purposes of improving quality and safety;
``(B) is to an entity or person subject to the
requirements of section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (Public Law
104-191; 110 Stat. 2033), or any regulation promulgated
under such section; and
``(C) is not in conflict with such section or any
regulation promulgated under such section.
``(3) Disclosure as required by law by a provider to the
Food and Drug Administration, or on a voluntary basis by a
provider to a federally established patient safety program,
with respect to an Administration-regulated product or activity
for which that entity has responsibility, for the purposes of
activities related to the quality, safety, or effectiveness of
such Administration-regulated product or activity.
``(4) Disclosures of patient safety work product in
accordance with this part by a provider to a patient safety
organization.
``(d) Effect of Transfer, Disclosure.--The following shall not be
treated as a waiver of any privilege or protection established under
this part:
``(1) The transfer of any patient safety work product
between a provider and a patient safety organization.
``(2) Disclosure of patient safety work product as
described in subsection (c).
``(3) The unauthorized disclosure of patient safety work
product.
``(e) Penalty.--
``(1) Prohibition.--Except as provided in this part, and
subject to paragraphs (2) and (4), it shall be unlawful for any
person to disclose patient safety work product in violation of
this section, if such disclosure constitutes a negligent or
knowing breach of confidentiality.
``(2) Relation to hipaa.--The penalty under paragraph (3)
for a disclosure in violation of paragraph (1) does not apply
if the person would be subject to a penalty under section
264(c) of the Health Insurance Portability and Accountability
Act of 1996 (Public Law 104-191; 110 Stat. 2033), or any
regulation promulgated under such section, for the same
disclosure.
``(3) Amount.--Any person who violates paragraph (1) shall
be subject to a civil monetary penalty of not more than $10,000
for each such violation involved. Such penalty shall be imposed
and collected in the same manner as civil money penalties under
subsection (a) of section 1128A of the Social Security Act are
imposed and collected.
``(4) Subsequent disclosure.--Paragraph (1) applies only to
the first person that breaches confidentiality with respect to
particular patient safety work product.
``(f) Relation to HIPAA.--
``(1) In general.--For purposes of applying the regulations
promulgated pursuant to section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (Public Law 104-191;
110 Stat. 2033)--
``(A) patient safety organizations shall be treated
as business associates; and
``(B) activities of such organizations described in
section 921(4) in relation to a provider are deemed to
be health care operations (as defined in such
regulations) of the provider.
``(2) Rule of construction.--Nothing in this section shall
be construed to alter or affect the implementation of such
regulations or such section 264(c).
``(g) No Limitation of Other Privileges.--Nothing in this section
shall be construed to affect privileges, including peer review and
confidentiality protections, that are otherwise available under Federal
or State laws.
``(h) No Limitation on Contracts.--Nothing in this section shall be
construed to limit the power of a provider and a patient safety
organization, or a patient safety organization and the Agency or any
National Patient Safety Database, consistent with the provisions of
this Act and other applicable law, to enter into a contract requiring
greater confidentiality or delegating authority to make an authorized
disclosure.
``(i) Relation to State Reporting Requirements.--Nothing in this
part shall be construed as preempting or otherwise affecting any State
law requiring a provider to report information, including information
described in section 921(5)(B), that is not patient safety work
product.
``(j) Continuation of Privilege.--Patient safety work product of an
organization that is certified as a patient safety organization shall
continue to be privileged and confidential, in accordance with this
section, if the organization's certification is terminated or revoked
or if the organization otherwise ceases to qualify as a patient safety
organization.
``(k) Reports on Strategies To Improve Patient Safety.--
``(1) Draft report.--Not later than the date that is 18
months after any National Patient Safety Database is
operational, the Secretary, in consultation with the Director,
shall prepare a draft report on effective strategies for
reducing medical errors and increasing patient safety. The
draft report shall include any measure determined appropriate
by the Secretary to encourage the appropriate use of such
strategies, including use in any federally funded programs. The
Secretary shall make the draft report available for public
comment and submit the draft report to the Institute of
Medicine for review.
``(2) Final report.--Not later than 1 year after the date
described in paragraph (1), the Secretary shall submit a final
report to the Congress that includes, in an appendix, any
findings by the Institute of Medicine concerning research on
the strategies discussed in the draft report and any
modifications made by the Secretary based on such findings.
``SEC. 923. NATIONAL PATIENT SAFETY DATABASE.
``(a) Authority.--
``(1) In general.--In conducting activities under this
part, the Secretary shall provide for the establishment and
maintenance of a database to receive relevant nonidentifiable
patient safety work product, and may designate entities to
collect relevant nonidentifiable patient safety work product
that is voluntarily reported by patient safety organizations
upon the request of the Secretary. Any database established or
designated under this paragraph may be referred to as a
`National Patient Safety Database'.
``(2) Use of information.--Information reported to any
National Patient Safety Database shall be used to analyze
national and regional statistics, including trends and patterns
of health care errors. The information resulting from such
analyses may be included in the annual quality reports prepared
under section 913(b)(2).
``(3) Advisory role.--The Secretary shall provide
scientific support to patient safety organizations, including
the dissemination of methodologies and evidence-based
information related to root causes and quality improvement.
``(b) Standards.--In establishing or designating a database under
subsection (a)(1), the Secretary shall, in consultation with
representatives of patient safety organizations, the provider
community, and the health information technology industry, determine
common formats for the voluntary reporting of nonidentifiable patient
safety work product, including necessary elements, common and
consistent definitions, and a standardized computer interface for the
processing of the work product. To the extent practicable, such
standards shall be consistent with the administrative simplification
provisions of part C of title XI of the Social Security Act.
``(c) Certain Methodologies for Collection.--The Secretary shall
ensure that the methodologies for the collection of nonidentifiable
patient safety work product for any National Patient Safety Database
include the methodologies developed or recommended by the Patient
Safety Task Force of the Department of Health and Human Services.
``(d) Facilitation of Information Exchange.--To the extent
practicable, the Secretary may facilitate the direct link of
information between providers and patient safety organizations and
between patient safety organizations and any National Patient Safety
Database.
``(e) Restriction on Transfer.--Only nonidentifiable information
may be transferred to any National Patient Safety Database.
``SEC. 924. TECHNICAL ASSISTANCE.
``(a) In General.--The Secretary, acting through the Director,
may--
``(1) provide technical assistance to patient safety
organizations, and to States with reporting systems for health
care errors; and
``(2) provide guidance on the type of data to be
voluntarily submitted to any National Patient Safety Database.
``(b) Annual Meetings.--Assistance provided under subsection (a)
may include annual meetings for patient safety organizations to discuss
methodology, communication, information collection, or privacy
concerns.
``SEC. 925. CERTIFICATION OF PATIENT SAFETY ORGANIZATIONS.
``(a) In General.--Not later than 6 months after the date of
enactment of the Patient Safety and Quality Improvement Act, the
Secretary shall establish a process for certifying patient safety
organizations.
``(b) Process.--The process established under subsection (a) shall
include the following:
``(1) Certification of patient safety organizations by the
Secretary or by such other national or State governmental
organizations as the Secretary determines appropriate.
``(2) If the Secretary allows other governmental
organizations to certify patient safety organizations under
paragraph (1), the Secretary shall establish a process for
approving such organizations. Any such approved organization
shall conduct certifications and reviews in accordance with
this section.
``(3) A review of each certification under paragraph (1)
(including a review of compliance with each criterion in this
section and any related implementing standards as determined by
the Secretary through rulemaking) not less often than every 3
years, as determined by the Secretary.
``(4) Revocation of any such certification by the Secretary
or other such governmental organization that issued the
certification, upon a showing of cause.
``(c) Criteria.--A patient safety organization must meet the
following criteria as conditions of certification:
``(1) The mission of the patient safety organization is to
conduct activities that are to improve patient safety and the
quality of health care delivery and is not in conflict of
interest with the providers that contract with the patient
safety organization.
``(2) The patient safety organization has appropriately
qualified staff, including licensed or certified medical
professionals.
``(3) The patient safety organization, within any 2 year
period, contracts with more than 1 provider for the purpose of
receiving and reviewing patient safety work product.
``(4) The patient safety organization is not a component of
a health insurer or other entity that offers a group health
plan or health insurance coverage.
``(5) The patient safety organization is managed,
controlled, and operated independently from any provider that
contracts with the patient safety organization for reporting
patient safety work product.
``(6) To the extent practical and appropriate, the patient
safety organization collects patient safety work product from
providers in a standardized manner that permits valid
comparisons of similar cases among similar providers.
``(d) Additional Criteria for Component Organizations.--If a
patient safety organization is a component of another organization, the
patient safety organization must, in addition to meeting the criteria
described in subsection (c), meet the following criteria as conditions
of certification:
``(1) The patient safety organization maintains patient
safety work product separately from the rest of the
organization, and establishes appropriate security measures to
maintain the confidentiality of the patient safety work
product.
``(2) The patient safety organization does not make an
unauthorized disclosure under this Act of patient safety work
product to the rest of the organization in breach of
confidentiality.
``(3) The mission of the patient safety organization does
not create a conflict of interest with the rest of the
organization.''.
(b) Authorization of Appropriations.--Section 937 of the Public
Health Service Act (as redesignated by subsection (a)) is amended by
adding at the end the following:
``(e) Patient Safety and Quality Improvement.--For the purpose of
carrying out part C, there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 2004 through 2008.''.
SEC. 102. PROMOTING THE DIFFUSION AND INTEROPERABILITY OF INFORMATION
TECHNOLOGY SYSTEMS INVOLVED WITH HEALTH CARE DELIVERY.
(a) Voluntary Standards.--
(1) In general.--Not later than 18 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services (in this section referred to as the ``Secretary'')
shall--
(A) develop or adopt voluntary national standards
that promote the interoperability of information
technology systems involved with health care delivery,
including but not limited to computerized physician
order entry;
(B) in developing or adopting such standards, take
into account--
(i) the ability of such systems to capture
and aggregate clinically specific data to
enable evidence-based medicine and other
applications that promote the electronic
exchange of patient medical record information;
and
(ii) the cost that meeting such standards
would have on providing health care in the
United States and the increased efficiencies in
providing such care achieved under the
standards;
(C) in developing or adopting such standards and to
the extent practicable, test the efficacy, usability,
and scalability of proposed interoperability standards
within a variety of clinical settings, including an
urban academic medical center, a rural hospital, a
community health center, and a community hospital; and
(D) submit a report to the Congress containing
recommendations on such standards.
(2) Consultation.--In developing or adopting standards
under paragraph (1)(A), the Secretary shall consider the
recommendations of the National Committee on Vital Health
Statistics for the standardization of message formatting,
coding, and vocabulary for interoperability of information
technology systems involved with health care delivery. The
Secretary shall consult with representatives of the health
information technology industry and the provider community who
are involved with the development of interoperability
standards.
(b) Updates.--The Secretary shall provide for the ongoing review
and periodic updating of the standards developed under subsection (a).
SEC. 103. REQUIRED USE OF PRODUCT IDENTIFICATION TECHNOLOGY.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is
amended--
(1) in section 502, by adding at the end the following:
``(w) If it is a drug or biological product, unless it includes a
unique product identifier for the drug or biological product as
required by regulations under section 510(q).''; and
(2) in section 510, by adding at the end the following:
``(q)(1) The Secretary shall issue, and may periodically revise,
regulations requiring the manufacturer of any drug or biological
product that is subject to regulation by the Food and Drug
Administration, or the packager or labeler of a drug or biological
product that is subject to regulation by the Food and Drug
Administration, to include a unique product identifier on the packaging
of the drug or biological product.
``(2) For purposes of this subsection, the term `unique product
identifier' means an identification that--
``(A) is affixed by the manufacturer, labeler, or packager
to each drug or biological product described in paragraph (1)
at each packaging level;
``(B) uniquely identifies the item and meets the standards
required by this section; and
``(C) can be read by a scanning device or other technology
acceptable to the Secretary.
``(3) A unique product identifier required by regulations issued or
revised under paragraph (1) shall be based on--
``(A) the National Drug Code maintained by the Food and
Drug Administration;
``(B) commercially accepted standards established by
organizations that are accredited by the American National
Standards Institute, such as the Health Industry Business
Communication Council or the Uniform Code Council; or
``(C) other identification formats that the Secretary deems
appropriate.
``(4) The Secretary may, at the Secretary's discretion, waive the
requirements of this section, or add additional provisions that are
necessary to safeguard the public health.''.
SEC. 104. GRANTS FOR ELECTRONIC PRESCRIPTION PROGRAMS.
(a) Grants.--
(1) In general.--The Secretary of Health and Human Services
(in this section referred to as the ``Secretary'') may make
grants to qualified practitioners for the purpose of
establishing electronic prescription programs.
(2) Matching funds.--
(A) In general.--With respect to the costs of
establishing an electronic prescription program, a
condition for the receipt of a grant under paragraph
(1) is that the qualified practitioner involved agree
to make available (directly or through donations from
public or private entities) non-Federal contributions
toward such costs in an amount that is not less than 50
percent of such costs.
(B) Determination of amount contributed.--Non-
Federal contributions required in subparagraph (A) 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 non-
Federal contributions.
(b) Study.--
(1) In general.--The Secretary, acting through the Director
of the Agency for Healthcare Research and Quality, shall
support a study to assess existing scientific evidence
regarding the effectiveness and cost-effectiveness of the use
of electronic prescription programs intended to improve the
efficiency of prescription ordering and the safe and effective
use of prescription drugs. The study shall address the
following:
(A) The ability of such programs to reduce medical
errors and improve the quality and safety of patient
care.
(B) The impact of the use of such programs on
physicians, pharmacists, and patients, including such
factors as direct and indirect costs, changes in
productivity, and satisfaction.
(C) The effectiveness of strategies for overcoming
barriers to the use of electronic prescription
programs.
(2) Report.--The Secretary shall ensure that, not later
than 18 months after the date of the enactment of this Act, a
report containing the findings of the study under paragraph (1)
is submitted to the appropriate committees of the Congress.
(3) Dissemination of findings.--The Secretary shall
disseminate the findings of the study under paragraph (1) to
appropriate public and private entities.
(c) Development of Model.--The Secretary, acting through the
Director of the Agency for Healthcare Research and Quality, may develop
an Internet-based mathematical model that simulates the cost and
effectiveness of electronic prescription programs for qualified
practitioners. The model may be designed to allow qualified
practitioners to estimate, through an interactive interface, the impact
of electronic prescribing on their practices, including the reduction
in drug-related health care errors.
(d) Definitions.--For purposes of this section:
(1) The term ``electronic prescription program''--
(A) means a program for the electronic submission
and processing of prescriptions; and
(B) includes the hardware (including computers and
other electronic devices) and software programs for the
electronic submission of prescriptions to pharmacies,
the processing of such submissions by pharmacies, and
decision-support programs.
(2) The term ``qualified practitioner'' means a
practitioner licensed by law to administer or dispense
prescription drugs.
SEC. 105. GRANTS TO HOSPITALS AND OTHER HEALTH CARE PROVIDERS FOR
INFORMATION TECHNOLOGIES.
(a) In General.--The Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall make grants to
hospitals and other health care providers (but not more than 1 grant to
any 1 hospital or provider) to pay the costs of acquiring or
implementing information technologies whose purposes are--
(1) to improve quality of care and patient safety; and
(2) to reduce adverse events and health care complications
resulting from medication errors.
(b) Special Consideration.--In making grants under subsection (a),
the Secretary shall give special consideration to applicants who seek
to promote the following:
(1) Interoperability across hospital services or
departments using standards developed or adopted by the
Secretary under section 102.
(2) Electronic communication of patient data across the
spectrum of health care delivery.
(3) Computerized physician order entry or bar coding
applications.
(4) Electronic communication of patient data in hospitals
that provide services to underserved or low-income populations.
(5) Improved clinical decisionmaking through acquisition
and implementation of decision-support technologies.
(c) Certain Grant Conditions.--A condition for the receipt of a
grant under subsection (a) is that the applicant involved meet the
following requirements:
(1) The applicant agrees to carry out a program to measure,
analyze, and report patient safety and medical errors at the
hospital or other health care provider involved, to submit to
the Secretary a description of the methodology that will be
used, and to have such program in effect as soon as practicable
after the application for the grant is approved, without regard
to whether information technologies under the grant have been
implemented.
(2) The applicant has arranged for an evaluation that
addresses the effectiveness and cost-effectiveness of the
information technology for which the grant is provided and its
impact on the quality and safety of patient care, submitted the
evaluation plan to the Secretary, and received approval from
the Secretary of the applicant's methodology.
(3) The applicant has or is developing a patient safety
evaluation system (as that term is defined in section 921 of
the Public Health Service Act (as amended by section 101)) for
reporting health care errors to a patient safety organization.
(4) The applicant agrees to provide the Secretary with such
information as the Secretary may require regarding the use of
funds under this program or its impact.
(5) The applicant provides assurances satisfactory to the
Secretary that any information technology planned, acquired, or
implemented with grant funds under this section will be part of
an information program that--
(A) carries out the purposes described in
subsection (a); and
(B) is comprehensive or will be expanded to become
comprehensive, regardless of whether Federal assistance
is available for such expansion.
(d) Technical Assistance to Grantees.--The Secretary, acting
through the Director of the Agency for Healthcare Research and Quality,
shall provide technical assistance to applicants and grantees to ensure
the appropriate evaluation of the information technologies for which
grants are awarded under this section, such as--
(1) reviewing and providing technical assistance on the
applicant's proposed evaluation;
(2) developing mechanisms to ensure ongoing communications
between grantees and evaluators to facilitate the
identification and resolution of problems as they arise, ensure
mutual learning, and promote the rapid dissemination of
information;
(3) reviewing the interim and final reports required under
subsection (e); and
(4) disseminating evidence-based information in interim and
final reports to patient safety organizations, as appropriate.
(e) Evaluation Reports by Grantee.--A condition for the receipt of
a grant under subsection (a) is that the applicant agree to submit an
interim and a final report to the Secretary in accordance with this
subsection.
(1) Interim report.--Not later than 1 year after the
implementation of information technologies under the grant is
completed, the applicant will submit an interim report to the
Secretary describing the initial effectiveness of such
technologies in carrying out the purposes described in
subsection (a).
(2) Final report.--Not later than 3 years after the
implementation of information technologies under the grant is
completed, the applicant will submit a final report to the
Secretary describing the effectiveness and cost-effectiveness
of such technologies and addressing other issues determined to
be important in carrying out the purposes described in
subsection (a).
(3) Relation to disbursement of grant.--In disbursing a
grant under subsection (a), the Secretary shall withhold \1/3\
of the grant until the grantee submits to the Secretary the
report required in paragraph (1).
(f) Reports by Secretary.--
(1) Interim reports.--
(A) In general.--Through the fiscal year preceding
the fiscal year in which the final report under
paragraph (2) is prepared, the Secretary shall submit
to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate periodic reports on
the grant program under subsection (a). Such reports
shall be submitted not less frequently than once each
fiscal year, beginning with fiscal year 2004.
(B) Contents.--A report under subparagraph (A)
shall include information on--
(i) the number of grants made;
(ii) the nature of the projects for which
funding is provided under the grant program;
(iii) the geographic distribution of grant
recipients; and
(iv) such other matters as the Secretary
determines appropriate.
(2) Final report.--Not later than 180 days after the date
on which the last of the reports is due under subsection
(e)(2), the Secretary shall submit a final report to the
committees referred to in paragraph (1)(A) on the grant program
under subsection (a), together with such recommendations for
legislation and administrative action as the Secretary
determines appropriate.
(g) Definitions.--For purposes of this section:
(1) The term ``costs'', with respect to information
technologies referred to in subsection (a), includes total
expenditures incurred for--
(A) purchasing, leasing, and installing computer
software and hardware, including hand-held computer
technologies;
(B) making improvements to existing computer
software and hardware; and
(C) purchasing or leasing communications
capabilities necessary for clinical data access,
storage, and exchange.
(2) The term ``health care provider'' has the same meaning
given to the term ``provider'' in section 921 of the Public
Health Services Act (as amended by this Act).
(h) Termination of Grant Authorities.--The authority of the
Secretary to make grants under subsection (a) terminates upon the
expiration of fiscal year 2011.
(i) Matching Funds.--
(1) In general.--With respect to the costs of a grant to be
carried out under this section, such grant may be made only if
the applicant agrees to make available (directly or through
donations from public or private entities) non-Federal
contributions toward such costs in an amount that is not less
than 50 percent of such costs ($1 for each $1 of Federal funds
provided in the grant).
(2) Determination of amounts contributed.--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.
SEC. 106. AUTHORIZATION OF APPROPRIATIONS FOR GRANTS UNDER SECTIONS 104
AND 105.
For the purpose of carrying out sections 104 and 105, there are
authorized to be appropriated $25,000,000 for each of fiscal years 2004
and 2005.
TITLE II--MEDICAL INFORMATION TECHNOLOGY ADVISORY BOARD.
SEC. 201. MEDICAL INFORMATION TECHNOLOGY ADVISORY BOARD.
Title XI of the Social Security Act is amended by adding at the end
the following new section:
``medical information technology advisory board
``Sec. 1180. (a) Establishment.--
``(1) In general.--Not later than 3 months after the date
of the enactment of this section, the Secretary shall appoint
an advisory board to be known as the `Medical Information
Technology Advisory Board' (in this section referred to as the
`MITAB').
``(2) Chairman.--The Secretary shall designate one member
as chairman. The chairman shall be an individual affiliated
with an organization having expertise creating American
National Standards Institute (ANSI) accepted standards in
health care information technology and a member of the National
Committee for Vital and Health Statistics.
``(b) Composition.--
``(1) In general.--The MITAB shall consist of not more than
17 members that include--
``(A) experts from the fields of medical
information, information technology, medical continuous
quality improvement, medical records security and
privacy, individual and institutional health care
clinical providers, health researchers, and health care
purchasers;
``(B) one or more staff experts from each of the
following: the Centers for Medicare & Medicaid
Services, the Agency for Healthcare Research and
Quality, and the Institute of Medicine of the National
Academy of Sciences;
``(C) representatives of private organizations with
expertise in medical infomatics;
``(D) a representative of a teaching hospital; and
``(E) one or more representatives of the health
care information technology industry.
``(2) Terms of appointment.--The term of any appointment
under paragraph (1) to the MITAB shall be for the life of the
MITAB.
``(3) Meetings.--The MITAB shall meet at the call of its
chairman or a majority of its members.
``(4) Vacancies.--A vacancy on the MITAB shall be filled in
the same manner in which the original appointment was made not
later than 30 days after the MITAB is given notice of the
vacancy and shall not affect the power of the remaining members
to execute the duties of the MITAB.
``(5) Compensation.--Members of the MITAB shall receive no
additional pay, allowances, or benefits by reason of their
service on the MITAB.
``(6) Expenses.--Each member of the MITAB shall receive
travel expenses and per diem in lieu of subsistence in
accordance with sections 5702 and 5703 of title 5, United
States Code.
``(c) Duties.--
``(1) In general.--The MITAB shall on an ongoing basis
advise, and make recommendations to, the Secretary regarding
medical information technology, including the following:
``(A) The best current practices in medical
information technology.
``(B) Methods for the adoption (not later than 2
years after the date of the enactment of this section)
of a uniform health care information system interface
between and among old and new computer systems.
``(C) Recommendations for health care vocabulary,
messaging, and other technology standards (including a
common lexicon for computer technology) necessary to
achieve the interoperability of health care information
systems for the purposes described in subparagraph (E).
``(D) Methods of implementing--
``(i) health care information technology
interoperability standardization; and
``(ii) records security.
``(E) Methods to promote information exchange among
health care providers so that long-term compatibility
among information systems is maximized, in order to do
one or more of the following:
``(i) To maximize positive outcomes in
clinical care--
``(I) by providing decision support
for diagnosis and care; and
``(II) by assisting in the
emergency treatment of a patient
presenting at a facility where there is
no medical record for the patient.
``(ii) To contribute to (and be consistent
with) the development of the patient assessment
instrument provided for under section 545 of
the Medicare, Medicaid, and SCHIP Benefits
Improvement and Protection Act of 2000, and to
assist in minimizing the need for new and
different records as patients move from
provider to provider.
``(iii) To reduce or eliminate the need for
redundant records, paperwork, and the
repetitive taking of patient histories and
administering of tests.
``(iv) To minimize medical errors, such as
administration of contraindicated drugs.
``(v) To provide a compatible information
technology architecture that facilitates future
quality and cost-saving needs and that avoids
the financing and development of information
technology systems that are not readily
compatible.
``(2) Reports.--
``(A) Initial report.--No later than 18 months
after the date of the enactment of this section, the
MITAB shall submit to Congress and the Secretary an
initial report concerning the matters described in
paragraph (1). The report shall include--
``(i) the practices described in paragraph
(1)(A), including the status of health care
information technology standards being
developed by private sector and public-private
groups;
``(ii) recommendations for accelerating the
development of common health care terminology
standards;
``(iii) recommendations for completing
development of health care information system
messaging standards; and
``(iv) progress toward meeting the deadline
described in paragraph (1)(B) for adoption of
methods described in such paragraph.
``(B) Subsequent reports.--During each of the 2
years after the year in which the report is submitted
under subparagraph (A), the MITAB shall submit to
Congress and the Secretary an annual report relating to
additional recommendations, best practices, results of
information technology improvements, analyses of
private sector efforts to implement the
interoperability standards established in section 102
of the Patient Safety and Quality Improvement Act, and
such other matters as may help ensure the most rapid
dissemination of best practices in health care
information technology.
``(d) Staff and Support Services.--
``(1) Executive director.--
``(A) Appointment.--The Chairman shall appoint an
executive director of the MITAB.
``(B) Compensation.--The executive director shall
be paid the rate of basic pay for level V of the
Executive Schedule.
``(2) Staff.--With the approval of the MITAB, the executive
director may appoint such personnel as the executive director
considers appropriate.
``(3) Applicability of civil service laws.--The staff of
the MITAB shall be appointed without regard to the provisions
of title 5, United States Code, governing appointments in the
competitive service, and shall be paid without regard to the
provisions of chapter 51 and subchapter III of chapter 53 of
such title (relating to classification and General Schedule pay
rates).
``(4) Experts and consultants.--With the approval of the
MITAB, the executive director may procure temporary and
intermittent services under section 3109(b) of title 5, United
States Code.
``(e) Powers.--
``(1) Hearings and other activities.--For the purpose of
carrying out its duties, the MITAB may hold such hearings and
undertake such other activities as the MITAB determines to be
necessary to carry out its duties.
``(2) Detail of federal employees.--Upon the request of the
MITAB, the head of any Federal agency is authorized to detail,
without reimbursement, any of the personnel of such agency to
the MITAB to assist the MITAB in carrying out its duties. Any
such detail shall not interrupt or otherwise affect the civil
service status or privileges of the Federal employee.
``(3) Technical assistance.--Upon the request of the MITAB,
the head of a Federal agency shall provide such technical
assistance to the MITAB as the MITAB determines to be necessary
to carry out its duties.
``(4) Obtaining information.--The MITAB may secure directly
from any Federal agency information necessary to enable it to
carry out its duties, if the information may be disclosed under
section 552 of title 5, United States Code. Upon request of the
Chairman of the MITAB, the head of such agency shall furnish
such information to the MITAB.
``(f) Termination.--The MITAB shall terminate 30 days after the
date of submission of its final report under subsection (c)(2)(B).
``(g) Applicability of FACA.--The provisions of the Federal
Advisory Committee Act (5 U.S.C. App.) shall apply to the MITAB.
``(h) Funding.--There are authorized to be appropriated such sums
as are necessary for each fiscal year to carry out this section.''.
Passed the House of Representatives March 12, 2003.
Attest:
Clerk.