Better HEALTH Act of 2003 - Amends the Public Health Service Act to allow the Secretary of Health and Human Services, through the Administrator of the Health Resources and Services Administration, to award grants or contracts for geographic areas that have a shortage of health care professionals due to the costs of medical malpractice insurance.
Amends the Internal Revenue Code to provide a business tax credit for medical professional malpractice insurance according to a specified schedule.
Directs the Secretary of Health and Human Services, through the Health Resources and Services Administration, to make grants to eligible nonprofit hospitals and clinics to pay 15 percent of qualified medical malpractice insurance costs.
Prohibits any individual from bringing a medical malpractice liability action unless it is accompanied by the affidavit of a qualified specialist attesting to the reasonableness of the filing. Requires the attorney of a person filing such an action, or the individual if there is no attorney, to sign a certificate of merit attesting to the justified nature of the action.
Directs courts to impose sanctions for violations of the provisions pertaining to the certificate of merit, including to issue fines for multiple offenders.
Medical Malpractice Insurance Antitrust Act of 2003 - Declares that nothing in the McCarran-Ferguson Act shall be construed to permit commercial insurers to engage in any form of price fixing, bid rigging, or market allocations in connection with the conduct of the business of providing medical malpractice insurance.
Establishes an Independent Advisory Commission on Medical Malpractice Insurance.
Patient Safety Improvement and Medical Injury Reduction Act - Amends the Public Health Service Act to set forth that, with certain exceptions, patient safety information shall be privileged and confidential and not subject to specified disclosures. Allows health care professionals to waive such privileges. Declares that it is unlawful for any person to disclose patient safety information in violation of this Act (with specified exceptions).
Grants protection against adverse employment actions to individuals who report certain types of information to providers or patient safety organizations.
Requires the Director of the Agency for Healthcare Research and Quality to establish: (1) a Center for Quality Improvement and Patient Safety; (2) a National Patient Safety Database; and (3) a National Patient Safety Research Demonstration System.
Directs the Secretary of Health and Human Services to award grants to eligible entities to promote community partnerships for health care improvement among health care professionals, with the aim of improving the quality of medical care in communities.
Directs the Secretary to appoint a Medical Information Technology Advisory Board.
Allows the Secretary to make grants for: (1) computerized physician order entry systems; (2) informatics systems; and (3) patient safety research.
Amends provisions of the Federal Food, Drug, and Cosmetic Act to classify drugs and biological devices as misbranded unless they include a unique product identifier. Directs the Secretary to issue and periodically revise regulations to require the manufacturer of such a product, or its packager or labeler, to include such information on the packaging.
[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1374 Introduced in Senate (IS)]
108th CONGRESS
1st Session
S. 1374
To provide health care professionals with immediate relief from
increased medical malpractice insurance costs and to deal with the root
causes of the current medical malpractice insurance crisis.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 8, 2003
Mr. Durbin (for himself and Mr. Graham of South Carolina) introduced
the following bill; which was read twice and referred to the Committee
on Finance
_______________________________________________________________________
A BILL
To provide health care professionals with immediate relief from
increased medical malpractice insurance costs and to deal with the root
causes of the current medical malpractice insurance crisis.
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 ``Better HEALTH Act
of 2003''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--ENHANCING PATIENT ACCESS TO CARE THROUGH DIRECT ASSISTANCE
Sec. 101. Grants and contracts regarding health care professional
shortages.
Sec. 102. Health care professional assignments to trauma centers
through National Health Service Corps.
TITLE II--INCENTIVES FOR PARTICIPATION IN MEDICARE, MEDICAID, AND SCHIP
AND FINANCIAL ASSISTANCE FOR HEALTH CARE PROFESSIONALS
Sec. 201. Incentives for participation in medicare, medicaid, and
SCHIP.
Sec. 202. Credit for qualified expenditures for medical professional
malpractice insurance.
Sec. 203. Exclusion for loan payments under National Health Service
Corps loan repayment program.
TITLE III--LIMITING FRIVOLOUS MEDICAL MALPRACTICE SUITS
Sec. 301. Health care specialist affidavit.
Sec. 302. Sanctions for frivolous actions any pleadings.
Sec. 303. Applicability.
Sec. 304. Definitions.
TITLE IV--MEDICAL MALPRACTICE INSURANCE REFORM
Sec. 401. Short title.
Sec. 402. Prohibition on anti-competitive activities.
Sec. 403. Application to activities of State commissions of insurance
and other State insurance regulatory
bodies.
Sec. 404. Study on medical malpractice reinsurance.
TITLE V--INDEPENDENT ADVISORY COMMISSION ON MEDICAL MALPRACTICE
INSURANCE
Sec. 501. Establishment.
Sec. 502. Duties.
Sec. 503. Report.
Sec. 504. Membership.
Sec. 505. Director and staff; experts and consultants.
Sec. 506. Powers.
Sec. 507. Authorization of appropriations.
TITLE VI--REDUCING MEDICAL MALPRACTICE BY PREVENTING MEDICAL ERRORS
Sec. 601. Short title.
Sec. 602. Purpose.
Sec. 603. Patient safety improvements.
Sec. 604. Required use of product identification technology.
TITLE I--ENHANCING PATIENT ACCESS TO CARE THROUGH DIRECT ASSISTANCE
SEC. 101. GRANTS AND CONTRACTS REGARDING HEALTH CARE PROFESSIONAL
SHORTAGES.
Subpart I of part D of title III of the Public Health Service Act
(42 U.S.C. 254b et seq.) is amended by adding at the end the following:
``SEC. 330L. HEALTH CARE PROFESSIONAL SHORTAGES RESULTING FROM COSTS OF
MEDICAL MALPRACTICE INSURANCE.
``(a) In General.--The Secretary, acting through the Administrator
of the Health Resources and Services Administration, may make awards of
grants or contracts in accordance with this section for geographic
areas that, as determined by the Secretary, have a shortage of one or
more types of health care professionals as a result of the
professional's making the decision to cease or curtail providing health
care services in the geographic areas because of the costs of
maintaining medical malpractice insurance.
``(b) Recipients of Awards; Expenditure.--In accordance with such
criteria as the Secretary may establish:
``(1) Awards under subsection (a) may be made to health
care professionals who agree to provide health care services
(or to continue providing health care services, as the case may
be) in geographic areas described in such subsection for the
period during which payments under the awards are made to the
health care professionals.
``(2) Health care professionals who receive such awards may
expend the awards to assist the professionals with the costs of
maintaining medical malpractice insurance for providing health
care services in the geographic area for which the award is
made.
``(c) Definition.--For purposes of this section, the term `health
care professionals' means health care professionals, and organizations
that provide health care services (including hospitals, clinics, and
group practices), that meet applicable legal requirements to provide
the health care services involved.
``(d) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, $10,000,000 for fiscal year
2004, and such sums as may be necessary for each subsequent fiscal
year.''.
SEC. 102. HEALTH CARE PROFESSIONAL ASSIGNMENTS TO TRAUMA CENTERS
THROUGH NATIONAL HEALTH SERVICE CORPS.
Section 338H of the Public Health Service Act (42 U.S.C. 254q) is
amended by adding at the end the following:
``(d) Trauma Centers; Separate Authorization Regarding Shortages
Resulting From Costs of Medical Malpractice Insurance.--
``(1) In general.--For the purpose of assigning Corps
surgeons, obstetricians/gynecologists, and other health care
professionals to trauma centers in health care professional
shortage areas described in paragraph (2), there are authorized
to be appropriated $10,000,000 for fiscal year 2004, and such
sums as may be necessary for each of the fiscal years 2005
through 2007. Such authorization is in addition to any other
authorization of appropriations that is available for such
purpose.
``(2) Description of areas.--A health professional shortage
area referred to in paragraph (1) is such an area in which, as
determined by the Secretary, a medical facility in the area has
lost its designation as a trauma center or as a particular
level of trauma center, or is at significant risk of losing
such a designation, as a result of one or more surgeons,
obstetricians/gynecologists, or other health care professionals
making the decision to cease or curtail practicing at the
facility because of the costs of maintaining medical
malpractice insurance. For purposes of paragraph (1) the term
`trauma center' includes such a medical facility, the Secretary
may adjust the criteria for designation as a health
professional shortage area to the extent necessary to make
funds appropriated under paragraph (1) available with respect
to any medical facility to ensure that the facility does not
lose any such designation as a result of such decisions by
health care professionals.''.
TITLE II--INCENTIVES FOR PARTICIPATION IN MEDICARE, MEDICAID, AND SCHIP
AND FINANCIAL ASSISTANCE FOR HEALTH CARE PROFESSIONALS
SEC. 201. INCENTIVES FOR PARTICIPATION IN MEDICARE, MEDICAID, AND
SCHIP.
(a) In General.--Punitive damages may not be awarded in a medical
malpractice action against a qualified health professional, except upon
proof of an intentional act, such as voluntary intoxication or
impairment by a physician, sexual abuse or misconduct, assault and
battery, or falsification of records.
(b) Construction.--Subsection (a) shall not be construed to
establish a cause of action for punitive damages and shall not preempt
or supersede any other Federal or State law with respect to punitive
damages.
(c) Definitions.--In this section:
(1) Health care professional.--The term ``health care
professional'' means any individual who provides health care
services in a State and who is required by the laws or
regulations of the State to be licensed or certified by the
State to provide such services in the State.
(2) Medical malpractice action.--The term ``medical
malpractice action'' means an action in any Federal or State
court or against a qualified health care professional that--
(A) arises under the law of the State involved;
(B) alleges the failure of such health care
professional to adhere to the relevant professional
standard of care for the service and specialty
involved;
(C) alleges death or injury proximately caused by
such failure; and
(D) seeks monetary damages, whether compensatory or
punitive, as relief for such death or injury.
(3) Qualified health care professional.--The term
``qualified health care professional'' means a health care
professional--
(A) who is licensed in the State in which such
professional practices; and
(B) 25 percent or more of the patients of whom
receive benefits under title XVIII, XIX, and XXI of the
Social Security Act (42 U.S.C. 1395, 1396, and 1397aa
et seq.).
SEC. 202. CREDIT FOR QUALIFIED EXPENDITURES FOR MEDICAL PROFESSIONAL
MALPRACTICE INSURANCE.
(a) In General.--Subpart D of part IV of subchapter A of chapter 1
of the Internal Revenue Code of 1986 (relating to business tax credits)
is amended by adding at the end the following:
``SEC. 45G. CREDIT FOR EXPENDITURES FOR MEDICAL PROFESSIONAL
MALPRACTICE INSURANCE.
``(a) General Rule.--For purposes of section 38, in the case of a
taxpayer which is an eligible person, the medical malpractice insurance
expenditure tax credit determined under this section for a covered year
shall equal the applicable percentage of the qualified medical
malpractice insurance expenditures incurred by an eligible person
during the covered year.
``(b) Applicable Percentage.--For purposes of subsection (a), the
applicable percentage is--
``(1) in the case of an eligible person described in
subsection (c)(2)(A), 20 percent,
``(2) in the case of an eligible person described in
subsection (c)(2)(B), 10 percent, and
``(3) in the case of an eligible person described in
subsection (c)(2)(C), 15 percent.
``(c) Definitions.--In this section:
``(1) Covered year.--The term `covered year' means taxable
years beginning in 2004 and 2005.
``(2) Eligible person.--The term `eligible person' means--
``(A) any physician (as defined in section
213(d)(4)) who practices in any surgical specialty or
subspecialty, emergency medicine, obstetrics,
anesthesiology or who does intervention work which is
reflected in medical malpractice insurance
expenditures,
``(B) any physician (as so defined) who practices
in general medicine, allergy, dermatology, or
pathology, and
``(C) any hospital or clinic,
which meets applicable legal requirements to provide the health
care services involved.
``(3) Qualified medical malpractice insurance
expenditure.--The term `qualified medical malpractice insurance
expenditure' means so much of any professional insurance
premium, surcharge, payment or other cost or expense required
as a condition of State licensure which is incurred by an
eligible person in a covered year for the sole purpose of
providing or furnishing general medical malpractice liability
insurance for such eligible person as does not exceed twice the
Statewide average of such costs for similarly situated eligible
persons.
``(d) Special Rules.--
``(1) In general.--Except as provided in paragraph (2), the
credit determined under this section shall be claimed by the
eligible person incurring the qualified medical malpractice
insurance expenditure.
``(2) Certification.--Each State, through its board of
medical licensure and State board (or agency) regulating
insurance, annually shall provide such information to the
Secretary of Health and Human Services as is necessary to
permit the Secretary to calculate average costs for purposes of
subsection (c)(3) and to certify such average costs (rounded to
the nearest whole dollar) to the Secretary of the Treasury on
or before the 15th day of November of each year.
``(e) Effective Date.--This section shall apply to qualified
medical malpractice expenditures incurred after December 31, 2002.''.
(b) Credit Made Part of General Business Credit.--Section 38(b) of
the Internal Revenue Code of 1986 (relating to current year business
credit) is amended by striking ``plus'' at the end of paragraph (14),
by striking the period at the end of paragraph (15) and inserting ``,
plus'', and by adding at the end the following new paragraph:
``(16) the medical malpractice insurance expenditure tax
credit determined under section 45G(a).''.
(c) Limitation on Carryback.--Section 39(d) of the Internal Revenue
Code of 1986 (relating to transition rules) is amended by adding at the
end the following new paragraph:
``(11) No carryback of medical malpractice insurance
expenditure tax credit before effective date.--No portion of
the unused business credit for any taxable year which is
attributable to the credit determined under section 45G may be
carried back to any taxable year beginning before 2004.''.
(d) Denial of Double Benefit.--Section 280C of the Internal Revenue
Code of 1986 (relating to certain expenses for which credits are
allowable) is amended by adding at the end the following new
subsection:
``(d) Credit for Medical Malpractice Liability Insurance
Premiums.--
``(1) In general.--No deduction shall be allowed for that
portion of the qualified medical malpractice insurance
expenditures otherwise allowable as a deduction for the taxable
year which is equal to the amount of the credit allowable for
the taxable year under section 45G (determined without regard
to section 38(c)).
``(2) Controlled groups.--In the case of a corporation
which is a member of a controlled group of corporations (within
the meaning of section 41(f)(5)) or a trade or business which
is treated as being under common control with other trades or
business (within the meaning of section 41(f)(1)(B)), this
subsection shall be applied under rules prescribed by the
Secretary similar to the rules applicable under subparagraphs
(A) and (B) of section 41(f)(1).''.
(e) Grants to Non-Profit Hospitals and Clinics.--
(1) In general.--The Secretary of Health and Human
Services, acting through the Administrator of the Health
Resources and Services Administration, shall award grants to
eligible non-profit hospitals and clinics to assist such
hospitals and clinics in defraying qualified medical
malpractice insurance expenditures.
(2) Eligible non-profit hospital or clinic.--To be eligible
to receive a grant under paragraph (1) an entity shall--
(A) be a non-profit hospital or clinic;
(B) be unable to claim the tax credit described in
section 45G of the Internal Revenue Code of 1986 for
the year for which an application is submitted under
subparagraph (C); and
(C) prepare and submit to the Secretary of Health
and Human Services an application at such time, in such
manner, and containing such information as the
Secretary may require.
(3) Amount of grant.--The amount of a grant to a non-profit
hospital or clinic under paragraph (1) shall equal 15 percent
of the amount of the qualified medical malpractice insurance
expenditures of the hospital or clinic for the year involved.
(4) Qualified medical malpractice insurance expenditure.--
In this subsection, the term ``qualified medical malpractice
insurance expenditure'' means so much of any professional
insurance premium, surcharge, payment or other cost or expense
required as a condition of State licensure which is incurred by
a non-profit hospital or clinic in a year for the sole purpose
of providing or furnishing general medical malpractice
liability insurance for such hospital or clinic as does not
exceed twice the Statewide average of such costs for similarly
situated hospitals or clinics.
(5) Authorization of appropriations.--There are authorized to be
appropriated to carry out this subsection, such sums as may be
necessary for each of fiscal years 2004 and 2005.
(f) Clerical Amendment.--The table of sections for subpart D of
part IV of subchapter A of chapter 1 of the Internal Revenue Code of
1986 is amended by adding at the end the following new item:
``Sec. 45G. Credit for expenditures for
medical professional
malpractice insurance.''.
(g) Effective Date.--The amendments made by this section shall
apply to expenditures incurred after December 31, 2002.
SEC. 203. EXCLUSION FOR LOAN PAYMENTS UNDER NATIONAL HEALTH SERVICE
CORPS LOAN REPAYMENT PROGRAM.
(a) In General.--Section 117 of the Internal Revenue Code of 1986
is amended by adding at the end the following new subsection:
``(e) Loan Payments Under National Health Service Corps Loan
Repayment Program.--Gross income shall not include any amount received
under section 338B(g) of the Public Health Service Act.''.
(b) Effective Date.--The amendment made by subsection (a) shall
apply to amounts received by an individual in taxable years beginning
after December 31, 2002.
TITLE III--LIMITING FRIVOLOUS MEDICAL MALPRACTICE SUITS
SEC. 301. HEALTH CARE SPECIALIST AFFIDAVIT.
(a) Requiring Submission With Complaint.--No medical malpractice
liability action may be brought by any individual unless, at the time
the individual brings the action (except as provided in subsection
(b)(1)), it is accompanied by the affidavit of a qualified specialist
that includes the specialist's statement of belief that, based on a
review of the available medical record and other relevant material,
there is a reasonable and meritorious cause for the filing of the
action against the defendant.
(b) Extension in Certain Instances.--
(1) In general.--Subject to paragraph (2), subsection (a)
shall not apply with respect to an individual who brings a
medical malpractice liability action without submitting an
affidavit described in such subsection if, as of the time the
individual brings the action, the individual has been unable to
obtain adequate medical records or other information necessary
to prepare the affidavit.
(2) Deadline for submission where extension applies.--In
the case of an individual who brings an action for which
paragraph (1) applies, the action shall be dismissed unless the
individual (or the individual's attorney) submits the affidavit
described in subsection (a) not later than 90 days after
obtaining the information described in such subparagraph.
(c) Qualified Specialist Defined.--In subsection (a), the term
``qualified specialist'' means, with respect to a medical malpractice
liability action, a health care professional who is reasonably believed
by the individual bringing the action (or the individuals attorney)--
(1) to be knowledgeable in the relevant issues involved in
the action;
(2) to practice (or to have practiced) or to teach (or to
have taught) in the same area of health care or medicine that
is at issue in the action; and
(3) in the case of an action against a physician, to be
board certified in a specialty relating to that area of
medicine.
(d) Confidentiality of Specialist.--Upon a showing of good cause by
a defendant, the court may ascertain the identity of a specialist
referred to in subsection (a) while preserving confidentiality.
SEC. 302. SANCTIONS FOR FRIVOLOUS ACTIONS ANY PLEADINGS.
(a) Signature Required.--Every pleading, written motion, and other
paper in any medical malpractice liability action shall be signed by at
least 1 attorney of record in the attorney's individual name, or, if
the party is not represented by an attorney, shall be signed by the
party. Each paper shall state the signer's address and telephone
number, if any. An unsigned paper shall be stricken unless omission of
the signature is corrected promptly after being called to the attention
of the attorney or party.
(b) Certificate of Merit.--By presenting to the court (whether by
signing, filing, submitting, or later advocating) a pleading, written
motion, or other paper, an attorney or unrepresented party is
certifying that to the best of the person's knowledge, information and
belief, formed after an inquiry reasonable under the circumstances--
(1) it is not being presented for any improper purpose,
such as to harass or to cause unnecessary delay or needless
increase in the cost of litigation;
(2) the claims, defenses, and other legal contentions
therein are warranted by existing law or by a non frivolous
argument for the extension, modification, or reversal of
existing law or the establishment of new law; and
(3) the allegations and other factual contentions have
evidentiary support or, if specifically so identified, are
reasonable based on a lack of information or belief.
(c) Mandatory Sanctions.--
(1) First violation.--If, after notice and a reasonable
opportunity to respond, a court, upon motion or upon its own
initiative, determines that subsection (b) has been violated,
the court shall find each attorney or party in violation in
contempt of court and shall require the payment of costs and
attorneys fees. The court may also impose additional
appropriate sanctions, such as striking the pleadings,
dismissing the suit, and sanctions plus interest, upon the
person in violation, or upon both such person and such person's
attorney or client (as the case may be).
(2) Second violation.--If, after notice and a reasonable
opportunity to respond, a court, upon motion or upon its own
initiative, determines that subsection (b) has been violated
and that the attorney or party with respect to which the
determination was made has committed one previous violation of
subsection (b) before this or any other court, the court shall
find each such attorney or party in contempt of court and shall
require the payment of costs and attorneys fees, and require
such person in violation (or both such person and such person's
attorney or client (as the case may be)) to pay a monetary
fine. The court may also impose additional appropriate
sanctions, such as striking the pleadings, dismissing the suit
and sanctions plus interest, upon such person in violation, or
upon both such person and such person's attorney or client (as
the case may be).
(3) Third violations.--If, after notice and a reasonable
opportunity to respond, a court, upon motion or upon its own
initiative, determines that subsection (b) has been violated
and that the attorney or party with respect to which the
determination was made has committed more than one previous
violation of subsection (b) before this or any other court, the
court shall find each such attorney or party in contempt of
court, refer each such attorney to one or more appropriate
State bar associations for disciplinary proceedings, require
the payment of costs and attorneys fees, and require such
person in violation (or both such person and such person's
attorney, or client (as the case may be)) to pay a monetary
fine. The court may also impose additional appropriate
sanctions, such as striking the pleadings, dismissing the suit,
and sanctions plus interest, upon such person in violation, or
upon both such person and such person's attorney or client (as
the case may be).
SEC. 303. APPLICABILITY.
(a) In General.--This title shall apply with respect to any medical
malpractice liability action brought on or after the date of enactment
of this Act in any State or Federal court, except that this title shall
not apply to a claim or action for damages arising from a vaccine-
related injury or death to the extent that title XXI of the Public
Health Service Act applies to the claim or action.
(b) Effect of Sovereign Immunity and Choice of Law or Venue.--
Nothing in this title shall be construed to--
(1) waive or affect any defense of sovereign immunity
asserted by any State under any provision of law;
(2) waive or affect any defense of sovereign immunity
asserted by the United States;
(3) affect the applicability of any provision of the
Foreign Sovereign Immunities Act of 1976;
(4) preempt State choice-of-law rules with respect to
claims brought by a foreign nation or a citizen of a foreign
nation; or
(5) affect the right of any court to transfer venue or to
apply the law of a foreign nation or to dismiss a claim of a
foreign nation or of a citizen of a foreign nation on the
ground of inconvenient forum.
(c) Federal Court Jurisdiction Not Established on Federal Question
Grounds.--Nothing in this title shall be construed to establish any
jurisdiction in the district courts of the United States over medical
malpractice liability actions on the basis of section 1331 or 1337 of
title 28, United States Code.
SEC. 304. DEFINITIONS.
In this title:
(1) Health care professional.--The term ``health care
professional'' means any individual who provides health care
services in a State and who is required by the laws or
regulations of the State to be licensed or certified by the
State to provide such services in the State.
(2) Injury.--The term ``injury'' means any illness,
disease, or other harm that is the subject of a medical
malpractice liability action or a medical malpractice claim.
(3) Medical malpractice claim.--The term ``medical
malpractice claim'' means a claim against a health care
provider, a health care professional, or a blood or tissue bank
licensed or registered by the Food and Drug Administration in
which a claimant alleges that injury was caused by the
provision of (or the failure to provide) health care services,
except that such term does not include--
(A) any claim based on an allegation of an
intentional tort; or
(B) any claim based on an allegation that a product
is defective or unreasonably dangerous.
(4) Medical malpractice liability action.--The term
``medical malpractice liability action'' means a civil action
brought in a State or Federal court against a health care
provider, a health care professional, or a blood or tissue bank
licensed or registered by the Food and Drug Administration in
which the plaintiff alleges a medical malpractice claim.
(5) State.--The term ``State'' includes the District of
Columbia and any commonwealth, territory, or possession of the
United States.
TITLE IV--MEDICAL MALPRACTICE INSURANCE REFORM
SEC. 401. SHORT TITLE.
This title may be cited as the ``Medical Malpractice Insurance
Antitrust Act of 2003''.
SEC. 402. PROHIBITION ON ANTI-COMPETITIVE ACTIVITIES.
Notwithstanding any other provision of law, nothing in the Act of
March 9, 1945 (15 U.S.C. 1011 et seq., commonly known as the
``McCarran-Ferguson Act'') shall be construed to permit commercial
insurers to engage in any form of price fixing, bid rigging, or market
allocations in connection with the conduct of the business of providing
medical malpractice insurance.
SEC. 403. APPLICATION TO ACTIVITIES OF STATE COMMISSIONS OF INSURANCE
AND OTHER STATE INSURANCE REGULATORY BODIES.
This title does not apply to the information gathering and rate
setting activities of any State commissions of insurance, or any other
State regulatory body with authority to set insurance rates.
SEC. 404. STUDY ON MEDICAL MALPRACTICE REINSURANCE.
(a) In General.--The Secretary of the Treasury shall conduct a
study of the feasibility and efficacy of establishing a Federal
reinsurance fund for the payment of certain noneconomic damages in
medical malpractice action. Such study shall address--
(1) the advantages, if any, that a federally-administered
reinsurance fund would offer over private reinsurance;
(2) the level at which such fund should assume the
liability for payment of noneconomic damages in medical
malpractice actions;
(3) the administration of such payments of noneconomic
damages by the fund;
(4) whether such a fund should be financed through the
assessment of user fees on malpractice insurance issuers, and
if so, the amount of such fee, and how to calculate such fee
for each malpractice insurance issuer;
(5) whether individual malpractice insurance issuers should
be permitted to negotiate their own terms (relating to fees and
payments) with such fund; and
(6) whether such fund could use capital from the Federal
Judgment Fund for the first year in which the fund is
operating, and what the terms would be relating to the
repayment of such capital.
(b) Report.--Not later than 1 year after the date of enactment of
this Act, the Secretary of the Treasury shall submit to the appropriate
committees of Congress a report concerning the results of the study
conducted under subsection (a).
TITLE V--INDEPENDENT ADVISORY COMMISSION ON MEDICAL MALPRACTICE
INSURANCE
SEC. 501. ESTABLISHMENT.
(a) Findings.--The Congress finds as follows:
(1) The sudden rise in medical malpractice insurance
premiums in regions of the United States can threaten patient
access to health care professionals.
(2) Improving patient access to physicians and other health
care professionals is a national priority.
(b) Establishment.--There is established a national commission to
be known as the ``Independent Advisory Commission on Medical
Malpractice Insurance'' (in this title referred to as the
``Commission'').
SEC. 502. DUTIES.
(a) In General.--The Commission shall evaluate the causes and scope
of the recent and dramatic increases in medical malpractice insurance
premiums, including the correlation, if any, to changes in State tort
law regarding medical malpractice, and formulate additional proposals
to reduce such medical malpractice insurance premiums and make
recommendations to avoid any dramatic increases in medical malpractice
insurance premiums in the future.
(b) Considerations.--In formulating proposals under this section,
the Commission shall, at a minimum, consider the following:
(1) Alternatives to the current medical malpractice
liability system that would ensure adequate compensation for
patients, preserve access to health care professionals, and
improve health care safety and quality.
(2) Modifications of, and alternatives to, the existing
State and Federal regulations and oversight that affect, or
could affect, medical malpractice lines of insurance.
(3) State and Federal reforms that would more evenly
distribute the risk of medical malpractice across various
categories of professionals.
(4) The effect of Federal medical malpractice reinsurance
program administered by the Department of Health and Human
Services on medical malpractice insurance availability and
affordability.
(5) The effect on medical malpractice insurance
availability and affordability of a Federal medical malpractice
insurance program, administered by the Department of Health and
Human Services, to provide medical malpractice insurance based
on customary coverage terms and liability amounts in States
where such insurance is unavailable or is unavailable at
reasonable and customary terms, on medical malpractice
insurance availability and affordability.
(6) Programs that would reduce medical errors and increase
patient safety, including new innovations in technology and
management.
(7) The effect on medical malpractice insurance
availability and affordability of State policies under which--
(A) any health care professional licensed by the
State has standing in any State administrative
proceeding to challenge a proposed rate increase in
medical malpractice insurance; and
(B) a provider of medical malpractice insurance in
the State may not implement a rate increase in such
insurance unless the provider, at minimum, first
submits to the appropriate State agency a description
of the rate increase and a substantial justification
for the rate increase.
SEC. 503. REPORT.
(a) In General.--The Commission shall transmit to Congress--
(1) an initial report not later than 180 days after the
date of the initial meeting of the Commission; and
(2) a report not less than each year thereafter until the
Commission terminates.
(b) Contents.--Each report transmitted under this section shall
contain a detailed statement of the findings and conclusions of the
Commission, including proposals for addressing the current dramatic
increases in medical malpractice insurance rates and recommendations
for avoiding any such dramatic increases in the future.
(c) Voting and Reporting Requirements.--With respect to each
proposal or recommendation contained in the report submitted under
subsection (a), each member of the Commission shall vote on the
proposal or recommendation, and the Commission shall include, by
member, the results of that vote in the report.
SEC. 504. MEMBERSHIP.
(a) Number and Appointment.--The Commission shall be composed of 15
members appointed by the Comptroller General of the United States.
(b) Membership.--
(1) In general.--The membership of the Commission shall
include individuals with national recognition for their
expertise in health finance and economics, actuarial science,
medical malpractice insurance, insurance regulation, health
care law, health care policy, health care access, allopathic
and osteopathic physicians, other health care professionals of
health care services, patient advocacy, and other related
fields, who provide a mix of different professionals, broad geographic
representations, and a balance between urban and rural representatives.
(2) Inclusion.--The membership of the Commission shall
include the following:
(A) Two individuals with expertise in health
finance and economics, including one with expertise in
consumer protections in the area of health finance and
economics.
(B) Two individuals with expertise in medical
malpractice insurance, representing both commercial
insurance carriers and physician-sponsored insurance
carriers.
(C) An individual with expertise in State insurance
regulation and State insurance markets.
(D) An individual representing physicians.
(E) An individual with expertise in issues
affecting hospitals, nursing homes, nurses, and other
health care professionals.
(F) Two individuals representing patient interests.
(G) Two individuals with expertise in health care
law or health care policy.
(H) An individual with expertise in representing
patients in medical malpractice claims.
(3) Majority.--The total number of individuals who are
directly involved with the provision or management of medical
malpractice insurance, representing health care professionals,
or representing professionals in malpractice lawsuits, shall
not constitute a majority of the membership of the Commission.
(4) Ethical disclosure.--The Comptroller General of the
United States shall establish a system for public disclosure by
members of the Commission of financial or other potential
conflicts of interest relating to such members.
(c) Terms.--
(1) In general.--The terms of the members of the Commission
shall be for 3 years except that the Comptroller General of the
United States shall designate staggered terms for the members
first appointed.
(2) Vacancies.--Any member appointed to fill a vacancy
occurring before the expiration of the term for which the
member's predecessor was appointed shall be appointed only for
the remainder of that term. A member may serve after the
expiration of that member's term until a successor has taken
office. A vacancy in the Commission shall be filled in the
manner in which the original appointment was made.
(3) Compensation.--Members of the Commission shall be
compensated in accordance with section 1805(c)(4) of the Social
Security Act.
(4) Chairperson; vice chairperson.--The Comptroller General
of the United States shall designate at the time of appointment
a member of the Commission as Chairperson and a member as Vice
Chairperson. In the case of vacancy of the Chairpersonship or
Vice Chairpersonship, the Comptroller General may designate
another member for the remainder of that member's term.
(5) Meetings.--
(A) In general.--The Commission shall meet at the
call of the Chairperson.
(B) Initial meeting.--The Commission shall hold an
initial meeting not later than the date that is 1 year
after the date of the enactment of this title, or the date that is 3
months after the appointment of all the members of the Commission,
whichever occurs earlier.
SEC. 505. DIRECTOR AND STAFF; EXPERTS AND CONSULTANTS.
Subject to such review as the Comptroller General of the United
States deems necessary to assure the efficient administration of the
Commission, the Commission may--
(1) employ and fix the compensation of an Executive
Director (subject to the approval of the Comptroller General)
and such other personnel as may be necessary to carry out its
duties (without regard to the provisions of title 5, United
States Code, governing appointments in the competitive
service);
(2) seek such assistance and support as may be required in
the performance of its duties from appropriate Federal
departments and agencies;
(3) enter into contracts or make other arrangements, as may
be necessary for the conduct of the work of the Commission
(without regard to section 3709 of the Revised Statutes (41
U.S.C. 5));
(4) make advance, progress, and other payments which relate
to the work of the Commission;
(5) provide transportation and subsistence for persons
serving without compensation; and
(6) prescribe such rules and regulations as it deems
necessary with respect to the internal organization and
operation of the Commission.
SEC. 506. POWERS.
(a) Obtaining Official Data.--The Commission may secure directly
from any department or agency of the United States information
necessary to enable it to carry out this section. Upon request of the
Chairperson, the head of that department or agency shall furnish that
information to the Commission on an agreed upon schedule.
(b) Data Collection.--In order to carry out its functions, the
Commission shall--
(1) utilize existing information, both published and
unpublished, where possible, collected and assessed either by
its own staff or under other arrangements made in accordance
with this section;
(2) carry out, or award grants or contracts for, original
research and experimentation, where existing information is
inadequate; and
(3) adopt procedures allowing any interested party to
submit information for the Commission's use in making reports
and recommendations.
(c) Access of General Accounting Office to Information.--The
Comptroller General of the United States shall have unrestricted access
to all deliberations, records, and nonproprietary data of the
Commission, immediately upon request.
(d) Periodic Audit.--The Commission shall be subject to periodic
audit by the Comptroller General of the United States.
SEC. 507. AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--There are authorized to be appropriated such sums
as may be necessary to carry out this title for each of fiscal years
2004 through 2008.
(b) Requests for Appropriations.--The Commission shall submit
requests for appropriations in the same manner as the Comptroller
General of the United States submits requests for appropriations, but
amounts appropriated for the Commission shall be separate from amounts
appropriated for the Comptroller General.
TITLE VI--REDUCING MEDICAL MALPRACTICE BY PREVENTING MEDICAL ERRORS
SEC. 601. SHORT TITLE.
This title may be cited as the ``Patient Safety Improvement and
Medical Injury Reduction Act''.
SEC. 602. PURPOSE.
It is the purpose of this title to improve patient safety by
promoting the voluntary reporting of patient safety events and medical
errors and other measures.
SEC. 603. PATIENT SAFETY IMPROVEMENTS.
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 E;
(3) by redesignating sections 921 through 928, as sections
941 through 948, respectively;
(4) in section 948(1) (as so redesignated), by striking
``921'' and inserting ``941''; and
(5) by inserting after part B the following:
``PART C--PATIENT SAFETY IMPROVEMENT
``SEC. 921. DEFINITIONS.
``In this part:
``(1) Center.--The term `Center' means the Center for
Quality Improvement and Patient Safety established under
section 922(a).
``(2) Health care professional.--The term `health care
professional' means an individual or entity licensed or
otherwise authorized under State law to provide health care
services, including--
``(A) a hospital, nursing facility, comprehensive
outpatient rehabilitation facility, home health agency,
and hospice program;
``(B) a physician, physician assistant, nurse
practitioner, clinical nurse specialist, certified
nurse midwife, psychologist, certified social worker,
registered dietitian or nutrition professional,
physical or occupational therapist, or other individual
health care practitioner;
``(C) a pharmacist; and
``(D) 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.
``(3) Identifiable information.--The term `identifiable
information' means information that is presented in a form and
manner that allows the identification of any health care
professional, patient, or reporter of patient safety
information. 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).
``(4) National patient safety database.--The term `National
Patient Safety Database' means the database of nonidentifiable
information concerning patient safety that is coordinated by,
and developed in collaboration with, the Director under section
922(c)(3)(B).
``(5) National patient safety research demonstration
system.--The term `National Patient Safety Research
Demonstration System' means a system under which the Director
will enter into voluntary agreements with a geographically and
institutionally diverse group of eligible entities to collect
data for the purpose of conducting research on patient safety
under section 922(c)(3)(C).
``(6) Nonidentifiable information.--The term
`nonidentifiable information' means information that is
presented in a form and manner that prevents the identification
of any health care professional, patient, or reporter of
patient safety information. 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).
``(7) Patient safety information.--The term `patient safety
information' means any reports, records, memoranda, analyses,
deliberative work, statements, or root cause analyses that are
collected or developed to improve patient safety or health care
quality and that--
``(A) are developed by a health care professional
for the purpose of reporting to a patient safety
organization and that are reported on a timely basis to
such an organization; or
``(B) are collected or developed by a patient
safety organization or by the National Patient Safety
Database or National Patient Safety Research
Demonstration System, regardless of whether the
information is transmitted to the health care
professional that reported the original information.
``(8) 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 Director under section 925, to perform each
of the following activities:
``(A) The conduct, as the organization or
component's primary activity, of activities to improve
patient safety and the quality of health care delivery.
``(B) The collection and analysis of patient safety
information that is submitted by health care
professionals.
``(C) The development and dissemination of
evidence-based information to health care professionals
with respect to improving patient safety (such as
recommendations, protocols, or information regarding
best practices).
``(D) The utilization of patient safety information
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 health care professionals to
effectively minimize patient risk.
``(E) The maintenance of appropriate
confidentiality with respect to identifiable
information.
``(F) The provision of appropriate security
measures with respect to patient safety information.
``(G) The submission of nonidentifiable information
to the Agency consistent with standards established by
the Director under section 924 for the National Patient
Safety Database.
``SEC. 922. PRIVILEGE.
``(a) In General.--Notwithstanding any other provision of law,
patient safety information shall be privileged and confidential in
accordance with this section.
``(b) Scope of Privilege.--Subject to the succeeding provisions of
this section, such information shall not be--
``(1) subject to a civil or administrative subpoena;
``(2) subject to discovery in connection with a civil or
administrative proceeding;
``(3) disclosed 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; or
``(4) admitted as evidence or otherwise disclosed in any
Federal or State civil or administrative proceeding.
``(c) Exceptions to Privilege.--The privilege provided for under
this section shall not apply to--
``(1) records of a patient's medical diagnosis and
treatment, patient or hospital records, other primary health
care information or other documents, records, or data that
exist separately from the process of collecting or developing
information for the purposes of this part;
``(2) information merely by reason of its inclusion,
report, or the fact of its submission, to a patient safety
organization, the National Patient Safety Database, or the
National Patient Safety Research Demonstration System; and
``(3) information available from sources other than a
report or submission made under this part, which may be
discovered or admitted in a Federal or State civil or
administrative proceeding, if discoverable or admissible under
applicable Federal or State law.
``(d) Disclosures.--Nothing in this section shall be construed to
prohibit any of the following disclosures:
``(1) The disclosure of nonidentifiable information by a
health care professional, patient safety organization, or the
Director.
``(2) The disclosure of identifiable information by a
health care professional or patient safety organization, if
such disclosure--
``(A) is authorized by the professional 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) The disclosure of patient safety information by a
professional or patient safety organization to the Food and
Drug Administration.
``(e) Rules of Construction.--
``(1) In general.--Nothing in this section shall be
construed to limit or extend other privileges that are
available under Federal or State laws, including peer review
and confidentiality protections.
``(2) Construction regarding use of patient safety
information.--
``(A) Internal use permitted to improve patient
safety, quality, and efficiency.--Nothing in this part
shall be construed to limit a health care professional
from using patient safety information within the
professional to improve patient safety, health care
quality, or administrative efficiency of the
professional.
``(B) Treatment.--Information that is collected as
patient safety information is not disqualified from
being treated as patient safety information because of
its use for the purposes described in subparagraph (A)
and such use shall not constitute a waiver of any
privilege or protection established under this section
or under State law.
``(3) State mandatory reporting requirements.--Nothing in
this part shall be construed as preempting or otherwise
affecting any mandatory reporting requirement for health care
professionals under State law.
``(f) Application of Privacy Regulations.--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)--
``(1) patient safety organizations that collect or receive
identifiable information shall be treated as covered entities;
and
``(2) activities of such organizations described in section
923(b)(2)(A) in relation to a health care professional are
deemed to be health care operations of the professional.
Nothing in this section shall be construed to alter or affect the
implementation of such regulation or such section 264(c).
``(g) Waivers.--
``(1) In general.--Nothing in this part shall be construed
as precluding a health care professional from waiving the
privilege established under this section.
``(2) Limitation.--The disclosure of patient safety
information pursuant to this part shall not constitute a waiver
of any other Federal or State privilege.
``(h) Continuation of Privilege.--Patient safety information 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 until the information is otherwise disposed of in
accordance with section 925(g).
``(i) Penalty.--
``(1) Prohibition.--Except as provided in this part, and
subject to paragraph (2), it shall be unlawful for any person
to disclose patient safety information in violation of this
section.
``(2) Relation to hipaa.--The penalty under this subsection
for a disclosure described in paragraph (1) shall not apply if
the person making such disclosure is 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
such disclosure.
``(3) Amount.--Any person who violates paragraph (1) shall
be subject to a civil monetary penalty of not more than $25,000
for each such violation involved. Such penalty shall be imposed
and collected in the same manner as civil money penalties are
imposed and collected under subsection (a) of section 1128A of
the Social Security Act.
``(j) Survey and Report.--
``(1) Survey.--The Comptroller General of the United States
shall conduct a survey of State laws that relate to patient
safety information peer review systems, including laws that
establish an evidentiary privilege applicable to information
developed in such systems, and shall review the manner in which
such laws have been interpreted by the courts and the
effectiveness of such laws in promoting patient safety.
``(2) Report.--Not later than 9 months after the date of
enactment of this part, the Comptroller General shall prepare
and submit to Congress a report concerning the results of the
survey conducted under paragraph (1).
``SEC. 923. REPORTER PROTECTION.
``(a) In General.--A health care professional may not take an
adverse employment action, as described in subsection (b), against an
individual based upon the fact that the individual in good faith
reported--
``(1) to the professional with the intention of having it
reported to a patient safety organization, or
``(2) directly to a patient safety organization,
information that would constitute patient safety information if the
professional were to have submitted it on a timely basis to a patient
safety organization in accordance with this part.
``(b) Adverse Employment Action.--For purposes of this section, an
`adverse employment action' includes--
``(1) the failure to promote an individual or provide any
other employment-related benefit for which the individual would
otherwise be eligible;
``(2) an evaluation or decision made in relation to
accreditation, certification, credentialing or licensing of the
individual; and
``(3) a personnel action that is adverse to the individual
concerned.
``(c) Remedies.--The provisions of the first sentence of section
1128A(a) of the Social Security Act shall apply with respect to a
health care professional's violation of subsection (a) in the same
manner as they apply to an act referred to in section 1128A(a)(7) of
such Act.
``(d) Penalty.--Any person who violated the provisions of this
section shall be subject to a fine of not more than $25,000,
imprisonment for not more than 6 months, or both, per disclosure and
payment of the costs of prosecution.
``SEC. 924. CENTER FOR QUALITY IMPROVEMENT AND PATIENT SAFETY.
``(a) In General.--The Director shall establish a center to be
known as the Center for Quality Improvement and Patient Safety to carry
out the duties described in subsection (b).
``(b) Duties.--
``(1) In general.--The Center shall carry out the following
duties:
``(A) Conduct and support research, demonstrations,
and evaluations of the quality of health care and the
promotion of patient safety, and the measurement of
health care quality.
``(B) Develop, evaluate, and disseminate methods
for identifying and promoting effective patient safety
programs.
``(C) Provide for the certification and
recertification of patient safety organizations in
accordance with section 925.
``(D) Establish a National Patient Safety Database
to collect, support, and coordinate the analysis of
nonidentifiable information submitted to the Database
in accordance with subsection (d).
``(E) Establish a National Patient Safety Research
Demonstration System under which the Director will
enter into voluntary agreements with a geographically
and institutionally diverse group of eligible entities
to collect data for the purpose of conducting research
on patient safety.
``(F) Facilitate the development of consensus,
including through annual meetings, among health care
professionals, patients, and other interested parties
concerning patient safety and recommendations to
improve patient safety.
``(G) Provide technical assistance and support to
States that have (or are developing) medical errors
reporting systems, assist States in developing
standardized methods for data collection, and collect
data from State reporting systems for inclusion in the
National Patient Safety Database.
``(2) Consultation.--In carrying out the duties under
paragraph (1) (including the establishment of the Database),
the Director shall consult with and develop partnerships, as
appropriate, with health care organizations, health care
professionals, public and private sector entities, patient
safety organizations, health care consumers, and other relevant
experts to improve patient safety.
``(c) Implementation and Consultation.--In carrying out this
section, the Director shall--
``(1) facilitate the development of patient safety goals
and track the progress made in meeting those goals; and
``(2) ensure that information submitted by a patient safety
organization to the National Patient Safety Database, as
provided for under subsection (d), is comparable and useful for
research and analysis and that the research findings and
patient safety alerts that result from such analyses are
presented in clear and consistent formats that enhance the
usefulness of such alerts.
``(d) National Patient Safety Database.--
``(1) In general.--The Director shall--
``(A) establish a National Patient Safety Database
to collect nonidentifiable information concerning
patient safety that is reported on a voluntary basis
which shall be used to analyze national, regional, and
State trends and patterns in patient safety and medical
errors; and
``(B) establish common formats for the voluntary
reporting of information under subparagraph (A),
including the establishment of necessary data elements,
common and consistent definitions, and a standardized
computer interface for the processing of such data.
To the extent practicable, formats established under
subparagraph (A) shall be consistent with the administrative
simplification provisions of part C of title XI of the Social
Security Act.
``(2) Database.--In carrying out this subsection, the
Director--
``(A) shall establish and modify as necessary
criteria to determine the organizations that may
voluntarily contribute to, and the data that comprises,
the National Patient Safety Database;
``(B) shall ensure that the National Patient Safety
Database is only used by qualified entities or
individuals for purposes of research, education, and
enhancing patient safety as determined appropriate by
the Director in accordance with criteria applied by the
Director;
``(C) may enter into contracts for the
administration of the Database with private and public
entities with experience in the administration of
similar databases;
``(D) shall ensure that the methodologies for the
collection of nonidentifiable patient safety
information for the National Patient Safety Database
include the methodologies developed or recommended by
the Patient Safety Task Force of the Department of
Health and Human Services; and
``(E) may, to the extent practicable, facilitate
the direct link of information between health care
professionals and patient safety organizations and
between patient safety organizations and the National
Patient Safety Database.
``(3) National patient safety research demonstration
system.--
``(A) Establishment.--
``(i) In general.--Not later than 1 year
after the date of enactment of this part, the
Director shall establish a National Patient
Safety Research Demonstration System under
which the Director will enter into voluntary
agreements with a geographically and
institutionally diverse group of eligible
entities to collect information for the purpose
of conducting research on patient safety. The
Director may contract with other organizations
to carry out this paragraph.
``(ii) Purpose.--The purpose of the
demonstration system established under clause
(i) is to conduct targeted research on patient
safety and to test promising systems and
methods of improving patient safety.
``(iii) Number and types of
organizations.--In carrying out clause (i), the
Director shall determine the number and types
of health care organizations with which to
enter into agreements, as well as the types of
patient safety events the particular health
care organizations with which the Director
enters into an agreement should identify and
the types of analyses that such organizations
should perform.
``(B) Eligibility.--To be eligible to enter into an
agreement under subparagraph (A) an entity shall--
``(i) be a health care organization; and
``(ii) prepare and submit to the Director
an application at such time, in such manner,
and containing such information as the Director
may require.
``(C) Submission of reports.--
``(i) In general.--A health care
organization that enters into a voluntary
agreement under subparagraph (A) shall, with
respect to such organization, submit reports of
patient safety events, or reports of specific
types of patient safety events if so prescribed
by the agreement, and shall submit, if
prescribed by the agreement, root cause analyses concerning such events
(using standards developed by the Director), and corrective action
plans to the Director.
``(ii) Processing of information.--The
Director shall process the reports submitted
under clause (i) in the same manner as reports
are processed through the National Patient
Safety Database.
``(iii) Provision of recommendations.--The
Director shall provide feedback concerning
patient safety event reports directly to the
health care organizations that are
participating in the demonstration system under
this paragraph.
``(D) Technical assistance.--The Director shall
provide health care organizations participating in the
demonstration system under this paragraph with
technical support and may provide technology support,
including computer software and hardware, through the
patient safety improvement grants under section 932 and
section 934.
``(E) Evaluation.--Upon the expiration of the 5-
year period beginning on the date on which the
demonstration system is established under this
paragraph, the Director shall prepare and submit to the
Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of
the House of Representatives a report that includes--
``(i) information on the types of data
collected through the demonstration system;
``(ii) research conducted with data
collected through the demonstration system; and
``(iii) the identification of promising
systems and methods of reducing patient safety
events.
``(F) Rule of construction.--Nothing in this
paragraph shall be construed to preempt Federal or
State mandatory reporting or sentinel surveillance
systems in effect on the date of enactment of this
part, or Federal or State mandatory reporting or
sentinel surveillance systems developed after such date
of enactment.
``(e) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary for each fiscal year to
carry out this section.
``SEC. 925. PATIENT SAFETY ORGANIZATIONS.
``(a) Certification and Recertification.--
``(1) In general.--The initial certification and
recertification of a patient safety organization under section
924 shall be made under a process that is approved by the
Director and is consistent with criteria published by the
Director.
``(2) Revocation.--Such a certification or recertification
of a patient safety organization may be revoked by the Director
upon a showing of cause (including the disclosure of
information in violation of section 922).
``(3) Termination.--Such a certification provided for a
patient safety organization shall terminate (subject to
recertification) on the earlier of--
``(A) the date that is 3 years after the date on
which such certification was provided; or
``(B) the date on which the Director revokes the
certification.
``(b) Organization Requirements.--A patient safety organization
shall meet the following criteria as conditions for certification:
``(1) The mission of the organization shall be to conduct
activities to improve patient safety and the quality of health
care delivery.
``(2) The organization shall collect and analyze patient
safety information that is voluntarily reported by more than
one health care professional on a local, regional, State, or
national basis.
``(3) The organization shall have appropriately qualified
staff, including licensed or certified medical professionals.
``(4) The organization is managed, controlled, and operated
independently from health care professionals that report
patient safety information to it under this part, and the
organization--
``(A) does not have a material familial or
financial relationship (except for fees charged to
health care professionals) with any health care
professional from whom it receives patient safety
information;
``(B) does not otherwise have a conflict of
interest with such a health care professional (as
determined under regulations); and
``(C) is not a health insurer or other entity that
offers a group health plan or health insurance
coverage, or a component of such an entity.
``(5) The organization seeks to collect data from health
care professionals in a standardized manner that permits valid
comparisons of similar cases among similar health care
professionals.
``(6) The organization meets such other requirements as the
Director may by regulation require.
``(c) Limitation on Use of Patient Safety Information by Patient
Safety Organizations.--A patient safety organization may not use
patient safety information reported by a health care professional in
accordance with this part to take regulatory or enforcement actions it
otherwise performs (or is responsible for performing) in relation to
such professional.
``(d) Technical Assistance.--The Director may provide technical
assistance to patient safety organizations in providing recommendations
and advice to health care professionals reporting patient safety
information under this part. Such assistance shall include advice with
respect to methodology, communication, dissemination of information,
data collection, security, and confidentiality concerns.
``(e) Component Organizations.--If a patient safety organization is
a component of a larger organization, the patient safety organization
shall--
``(1) maintain patient safety information within the
component, separately from the rest of the larger organization,
and establish appropriate security measures to maintain the
confidentiality of the patient safety information;
``(2) not disclose patient safety information to the larger
organization; and
``(3) not create a conflict of interest with the larger
organization.
``(f) Construction.--Nothing in this part shall be construed to
limit or discourage the reporting of information relating to patient
safety within a health care professional.
``(g) Treatment of Information.--If an organization no longer
qualifies as a patient safety organization under this section, with
respect to any patient safety information that such organization
received from a health care professional, the organization shall comply
with one of the following:
``(1) With the approval of the professional and another
patient safety organization, the organization shall transfer
such information to such other organization.
``(2) If practicable, the organization shall return the
information to the professional.
``(3) The organization shall destroy the patient safety
information.
``PART D--PATIENT SAFETY IMPROVEMENT GRANTS
``SEC. 931. GRANTS FOR COMMUNITY PARTNERSHIPS FOR HEALTH CARE
IMPROVEMENT.
``(a) In General.--The Secretary shall award grants to eligible
entities to enable such entities to establish, enhance or improve
community partnerships for health care improvement among professionals
within a community for the purpose of improving the quality of medical
care, including the prescribing, dispensing, and use of prescription
drugs, within such community.
``(b) Eligible Entities.--To be eligible to receive a grant under
subsection (a) an entity shall--
``(1) be a--
``(A) hospital;
``(B) health care clinic;
``(C) skilled nursing facility;
``(D) non-profit entity, or component thereof,
established for the purpose of establishing, enhancing
or improving a community partnership for health care
improvement; or
``(E) consortium of any of the entities described
in subparagraphs (A) through (D); and
``(2) prepare and submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may reasonably require, including assurances
satisfactory to the Secretary that the community partnership
for health care improvement in connection with which the entity
is submitting the application does, at the time of application,
or will, within a reasonable amount of time from the date of
application, include the substantive participation of a broad
range of entities (that may include professionals, payers,
patients, and governmental entities) involved in the delivery
of health care within the community.
``(c) Limitations.--In carrying out subsection (a), the Secretary
shall not--
``(1) award any single entity more than $2,000,000 in any
single fiscal year; or
``(2) award grants under this section to any single entity
for more than 3 fiscal years.
``(d) Definition.--In this section, the term `community partnership
for health care improvement' means a formal cooperative arrangement
including health care facilities and nonprofit organizations within a
community that--
``(1) is entered into for the purpose of significantly
reducing the incidence of patient safety events or
significantly improving the quality of health care, including
the appropriate use of prescription drugs, at health care
facilities participating in such partnership using one or more
quantifiable indicators of such improvement;
``(2) collects quantifiable data on the incidence of
patient safety events or on the quality of health care in
connection with one or more specific medical procedures
conducted at the health care facilities participating in such
partnerships;
``(3) makes available to the health care facilities
participating in such partnership the data described in
paragraph (2); and
``(4) promotes cooperation and communication among
professionals employed by the health care facilities
participating in such partnership for the purposes described in
paragraph (1).
``(e) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $50,000,000 for fiscal year
2004, and such sums as may be necessary for each subsequent fiscal
year.
``SEC. 932. TECHNICAL STANDARDS FOR HEALTH CARE INFORMATION TECHNOLOGY
SYSTEMS.
``(a) In General.--By not later than 2 years after the date of the
enactment of this part, the Secretary shall develop or adopt (and shall
periodically review and update) voluntary, national standards--
``(1) that promote the interoperability of health care
information technology systems across all health care settings;
and
``(2) for computerized physician order entry systems,
including standards relating to--
``(A) data formats or other methods of encoding
medical information that facilitate transfer of data
among such systems;
``(B) the protection of the confidentiality of
individually identifiable health information contained
within such systems from unauthorized access or
disclosure;
``(C) procedures for issuing warnings when
prescribing errors may be imminent;
``(D) procedures for ensuring that recommendations
or warnings issued by such systems reflect good medical
practice; and
``(E) other matters determined appropriate by the
Secretary.
``(b) Cost and Increased Efficiency.--In promulgating regulations
to carry out this section, the Secretary shall take into account the
cost that meeting the standards under subsection (a) would have on
providing health care in the United States and the increased
efficiencies in providing such care achieved under the standards.
``(c) Consultation and Coordination.--The Secretary shall develop
and update the standards under subsection (a) in consultation with (and
with coordination between)--
``(1) the National Committee for Vital and Health
Statistics;
``(2) the Medical Information Technology Advisory Board
(established under section 933); and
``(3) the Secretary of Veterans Affairs and the Secretary
of Defense.
``(d) Dissemination.--The Secretary shall provide for the
dissemination of the standards developed and updated under this
section.
``(e) Limitation.--Effective beginning on the date that is 4 years
after the date of enactment of this part, the Secretary may not
purchase any health care information technology system unless such
system conforms to the standards developed or adopted under subsection
(a), to the extent that such standards have been developed or adopted.
``(f) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary for each fiscal year to
carry out this section.
``SEC. 933. MEDICAL INFORMATION TECHNOLOGY ADVISORY BOARD.
``(a) Establishment.--
``(1) In general.--Not later than 3 months after the date
of the enactment of this part, 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) Chairperson.--The Secretary shall designate one
member of the MITAB to serve as the chairperson. The
chairperson 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 professionals, 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 informatics;
``(D) a representative of a teaching hospital;
``(E) one or more representatives of the health
care information technology industry; and
``(F) a representative of an organization
representing health care consumers.
``(2) Terms of appointment.--The term of any appointment
under paragraph (1) to the MITAB shall be for 2 years. Such an
appointment may be renewed for one additional term.
``(3) Meetings.--The MITAB shall meet at the call of its
chairperson 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 part) 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 professionals 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
professional to professional.
``(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.--Not later than 18 months
after the date of the enactment of this part, 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 1184
of the Social Security 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 Chairperson 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
Chairperson 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) Testing.--The Secretary, in consultation with the MITAB,
shall test the efficacy, usability, and scalability, of standards
within a variety of clinical settings that may include a rural hospital
or community health center, a community hospital, a children's
hospital, and an urban academic center.
``(h) Applicability of FACA.--The provisions of the Federal
Advisory Committee Act (5 U.S.C. App.) shall apply to the MITAB.
``(i) Authorization of Appropriations.--There are authorized to be
appropriated to the Secretary of Health and Human Services such sums as
are necessary to carry out this section.
``SEC. 934. GRANTS FOR COMPUTERIZED PHYSICIAN ORDER ENTRY SYSTEMS.
``(a) In General.--The Secretary may award grants to eligible
entities to enable such entities to develop, install, or train
personnel in the use of, computerized physician order entry systems.
``(b) Eligibility.--To be eligible to receive a grant under
subsection (a), an entity shall--
``(1) be a nonprofit hospital, health care clinic,
community health center, skilled nursing facility, or other
nonprofit entity determined to be eligible by the Secretary;
``(2) prepare and submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may require, including a description of the
computerized medication prescribing system that the entity
intends to implement using amounts received under the grant;
and
``(3) provide assurances that are satisfactory to the
Secretary that any computerized physician order entry systems,
for which amounts are to be expended under an award made under
subsection (a), conform to the technical standards established
by the Secretary for such systems under section 932(a)(2).
``(c) Matching Requirement.--
``(1) In general.--The Secretary may not make a grant to an
entity under subsection (a) unless that entity agrees that,
with respect to the costs to be incurred by the entity in
carrying out the activities for which the grant is being
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 $1 for
each $2 of Federal funds provided under the grant.
``(2) Determination of amount contributed.--Non-Federal
contributions required in 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 non-Federal contributions.
``(d) 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 enactment of this part, 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.
``(e) Definitions.--In this section and section 932:
``(1) Computerized physician order entry system.--The term
`computerized physician order entry system' means an
information technology system that--
``(A) shall--
``(i) permit a qualified practitioner who
wishes to enter a medication order for a
patient to enter such order via a computer that
is linked to a database capable of accessing
the medical record of the patient who is
intended to receive such medication;
``(ii) incorporate prescribing error
prevention software so that a warning
(including documentation regarding the cause of
such warning) is generated by such system if a
medication order is entered that is likely to
lead to an adverse drug event; and
``(iii) require documented acknowledgment
that a qualified practitioner entering a
medication order that has generated the warning
described in clause (ii) has read the
appropriate documentation regarding the cause
of such warning prior to overriding such
warning; and
``(B) may allow for the electronic submission of
prescriptions to pharmacies or pharmacy benefit
managers and the processing of such submissions by
pharmacies.
``(2) Qualified practitioner.--The term `qualified
practitioner' means a practitioner licensed to administer
prescription drugs.
``(f) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $100,000,000 for fiscal year
2004, and such sums as may be necessary for each of fiscal years 2005
through 2008.
``SEC. 935. GRANTS FOR INFORMATICS SYSTEMS.
``(a) In General.--The Secretary may establish a program to make
grants to eligible entities for the purpose of assisting such entities
in offsetting the costs related to purchasing, leasing, licensing,
developing, and implementing standardized clinical health care
informatics systems, other than computerized prescriber order entry
systems, that are designed to improve patient safety and reduce adverse
events and health care complications resulting from medication errors.
``(b) Costs Defined.--In this section, the term `costs' includes
total expenditures incurred for--
``(1) purchasing, leasing, licensing, and installing
computer software and hardware;
``(2) making improvements to existing computer software and
hardware;
``(3) purchasing or leasing communications capabilities
necessary for clinical data access, storage, and exchange; and
``(4) providing education and training to eligible entity
staff on computer patient safety information systems.
``(c) Eligibility.--To be eligible to receive a grant under this
section, an entity shall--
``(1) be a hospital, health care clinic, community health
center, skilled nursing facility, patient safety organization,
or other entity determined to be eligible by the Secretary; and
``(2) prepare and submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may require, including a description of the type
of informatics system that the entity intends to implement
using amounts received under the grant.
``(d) Types of Imformatics Systems.--
``(1) In general.--Not later than 6 months after the date
of enactment of this part, the Secretary shall identify the
informatics systems, other than computerized physician order
entry systems, and other information technology or
telecommunications systems demonstrated to improve patient
safety and reduce adverse events and health care complications
resulting from medication errors, that may be adopted and
applied by eligible entities through funds under this section.
``(2) Systems.--The systems described in paragraph (1) may
include bar coding, software to collect and analyze medication
errors, clinical decision-support systems, software to detect
inappropriately prescribed drugs or doses, drug utilization
review programs, and disease management systems.
``(e) Matching Requirement.--
``(1) In general.--The Secretary may not make a grant to an
entity under subsection (a) unless that entity agrees that,
with respect to the costs to be incurred by the entity in
carrying out the activities for which the grant is being
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 $1 for
each $1 of Federal funds provided under the grant.
``(2) Determination of amount contributed.--Non-Federal
contributions required in 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 non-Federal contributions.
``(f) Additional Information.--An eligible entity receiving a grant
under this section shall furnish the Secretary with such information as
the Secretary may require to--
``(1) evaluate the project for which the grant is made,
including how the project has improved patient safety and has
reduced patient safety events and health care complications
resulting from medication errors; and
``(2) ensure that funding provided under the grant is
expended for the purposes for which it is made.
``(g) Reports.--
``(1) Interim reports.--
``(A) In general.--The Secretary shall submit, at
least annually, a report to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives on the grant program established under
this section.
``(B) Contents.--A report submitted pursuant to
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 5 years after the date
of enactment of this part, the Secretary shall submit a final
report to the committees referred to in paragraph (1)(A) on the
grant program.
``(h) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $50,000,000 for fiscal year
2004, and such sums as may be necessary for each subsequent fiscal
year.''.
``SEC. 936. GRANTS FOR PATIENT SAFETY RESEARCH.
``(a) In General.--The Secretary may conduct research and award
grants to promote research on patient safety.
``(b) Process.--The Secretary shall establish a formal process to
gather information on priorities, methodologies and approaches for
medical errors, including medication errors, and patient safety
research. In gathering such information, the Secretary shall ensure
that input is obtained from a wide range of individuals and
organizations who will use and can benefit from the availability of
such information.
``(c) Coordination.--The Secretary shall ensure that activities are
carried out under subsection (a) in cooperation and coordination with
existing research initiatives, programs, and activities.
``(d) Other Industries.--In carrying out this section, the
Secretary shall consider the experiences of other industries in
reducing errors within such industries and the processes that such
industries employ to reduce errors.
``(e) Issues.--The issues to be addressed with respect to the
research to be conducted and supported under this subsection may
include--
``(1) the types and causes of errors in the provision of
health care, both in the United States and internationally,
such as those identified by the reporting system developed by
the Linnaeus Collaboration and the United States Pharmacopeia;
``(2) the identification and comparison of trends in errors
in geographically and demographically diverse health care
facilities;
``(3) training requirements for health care professionals
to ensure that such professionals provide quality health care
generally, in specific settings, and for specific practices;
``(4) the development of effective communication methods
and tools between disciplines to improve patient safety;
``(5) the use of interdisciplinary teams to improve patient
safety;
``(6) the barriers to medical error reduction strategies;
``(7) the use of standardized processes in providing
medication, including the application of these processes in
demographically diverse health care facilities;
``(8) the application of a national standardized taxonomy
for medication errors;
``(9) the effect of educational programs on the consistent
application of standardized definitions, terminology, and
formats; and
``(10) other areas determined appropriate by the Secretary.
``(f) Eligibility.--To be eligible to receive a grant under
subsection (a), an entity shall--
``(1) be a patient safety organization, health care
professional, health care professional association, research
organization, university, or other entity determined to be
eligible by the Secretary; and
``(2) prepare and submit to the Secretary an application at
such time, in such manner, and containing such information as
the Secretary may require.
``(g) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section, $50,000,000 for fiscal year
2004, and such sums as may be necessary for each subsequent fiscal
year.''.
SEC. 604. 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:
``(u) 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(o).''; and
(2) in section 510, by adding at the end the following:
``(o)(1) The Secretary shall issue, and may periodically revise,
regulations requiring the manufacturer of any drug or biological
product, or the packager or labeler of a drug or biological product, 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);
``(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 subsection, or add additional provisions that are
necessary to safeguard the public health.''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Finance.
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