I 
109TH CONGRESS 
1ST SESSION H. R. 2657
To provide comprehensive reform regarding medical malpractice. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 26, 2005
Mr. BAIRD (for himself, Mr. MORAN of Virginia, and Mr. RUPPERSBERGER) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce, and in addition to the Committee on the Judiciary, 
for a period to be subsequently determined by the Speaker, in each case 
for consideration of such provisions as fall within the jurisdiction of the 
committee concerned 
A BILL 
To provide comprehensive reform regarding medical 
malpractice.
Be it enacted by the Senate and House of Representa-
tives 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 
‘‘Comprehensive Medical Malpractice Reform Act of 
2005’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows:
Sec. 1. Short title; table of contents.
TITLE I—HEALTH CARE MALPRACTICE LIABILITY REFORM 
Sec. 101. Cap on non-economic damages. 
Sec. 102. Reduction in premiums paid by physicians for medical malpractice in-
surance coverage. 
Sec. 103. Sanctions for meritless actions and pleadings. 
Sec. 104. Performance standards applicable to State medical boards. 
Sec. 105. Interstate patient reporting and physician tracking database. 
Sec. 106. Report on modification of malpractice procedures relating to man-
dated care under EMTALA. 
Sec. 107. Definitions. 
TITLE II—HEALTH CARE MALPRACTICE LIABILITY MEDIATION 
PROGRAMS 
Sec. 201. Grants to States and health care entities for mediation programs. 
Sec. 202. Training and assistance for mediation programs. 
Sec. 203. Authorization of appropriations. 
TITLE III—VOLUNTARY REPORTING OF MEDICAL SAFETY 
INCIDENTS 
Subtitle A—Reporting by individuals involved in the provision of health care 
Sec. 301. Amendments to Public Health Service Act. 
Subtitle B—Liability protection in good-faith reporting 
Sec. 311. Liability protection for health care providers in good-faith reporting 
to State medical boards. 
TITLE IV—INSURANCE REFORM 
Sec. 401. Uniform state requirements regarding proposed rate increases. 
Sec. 402. Reduction in premiums paid by physicians for medical malpractice in-
surance coverage. 
Sec. 403. Effective date. 
TITLE V—EXCLUSION OF PHARMACEUTICALS AND DEVICES 
FROM LIABILITY REFORMS 
Sec. 501. Exclusion of pharmaceuticals and devices.
TITLE I—HEALTH CARE MAL-
PRACTICE 
LIABILITY 
RE-
FORM 
SEC. 101. CAP ON NON-ECONOMIC DAMAGES. 
(a) IN GENERAL.—When an individual is injured or 
dies as the result of health care malpractice, a person enti-
tled to recover non-economic damages from a health care
provider responsible for that malpractice may not recover 
such damages, in the aggregate from all such providers, 
in an amount more than $250,000, adjusted for inflation 
from 1975 as provided in subsection (b). This limitation 
applies separately to each person entitled to recover such 
damages. 
(b) ADJUSTMENT FOR INFLATION FROM 1975.—
(1) PUBLICATION BY SECRETARY OF LABOR.—
On or about December 1 of each year, the Secretary 
of Labor shall publish in the Federal Register a dol-
lar amount determined by adjusting the dollar 
amount specified in subsection (a) according to the 
adjustments in the Consumer Price Index of the Bu-
reau of Labor Statistics of the Department of Labor 
for the period beginning on or about October 1, 
1975, and ending on or about October 1 of that 
year. 
(2) APPLICABILITY.—For purposes of sub-
section (a), the dollar amount that applies to a cal-
endar year is the dollar amount published on or 
about December 1 of the preceding year. 
(3) ESTIMATION.—Congress estimates that the 
dollar amount that would apply to calendar year 
2005 would be approximately $878,000, though the 
dollar amount published under paragraph (1), rather
than the estimation in this paragraph, is to be ap-
plied. 
(c) APPLICABILITY.—
(1) IN GENERAL.—Subject to paragraph (2), 
this section applies whenever the amount of a recov-
ery is made final in a calendar year after the date 
of the enactment of this Act. In applying the dollar 
amount to a recovery, all recoveries made final 
(whether before or after the date of the enactment 
of this Act) are included in the aggregate. 
(2) NOT APPLICABLE WHEN STATE BOARD NOT 
IN COMPLIANCE.—During a period in which a State 
medical board is not in compliance with the vol-
untary performance standards developed under sec-
tion 104 or is failing to submit the information de-
scribed in paragraphs (2) and (3)(A) of section 
105(b) (as determined by the Secretary under sec-
tion 104 or 105, respectively), the limitation in sub-
section (a) does not apply to liability arising under 
the law of that State. 
(d) RELATIONSHIP TO STATE LAW.—This section op-
erates on a case-by-case basis to provide a maximum re-
covery and to prevent State law from providing a recovery 
above that maximum. It does not prevent State law from 
providing a recovery below that maximum.
SEC. 102. REDUCTION IN PREMIUMS PAID BY PHYSICIANS 
FOR 
MEDICAL 
MALPRACTICE 
INSURANCE 
COVERAGE. 
(a) IN GENERAL.—Not later than 180 days after the 
date of the enactment of this Act, each medical mal-
practice liability insurance company shall—
(1) develop a reasonable estimate of the annual 
amount of financial savings that will be achieved by 
the company as a result of this section; 
(2) develop and implement a plan to annually 
dedicate at least 50 percent of such annual savings 
to reduce the amount of premiums that the company 
charges physicians for medical malpractice liability 
coverage; and 
(3) submit to the Secretary of Health and 
Human Services (in this subsection referred to as 
the ‘‘Secretary’’) a written certification that the 
company has complied with subparagraphs (A) and 
(B). 
(b) REPORTS.—Not later than one year after the date 
of the enactment of this Act and annually thereafter, each 
medical malpractice liability insurance company shall sub-
mit to the Secretary a report that identifies the percentage 
by which the company has reduced medical malpractice 
coverage premiums relative to the date of the enactment 
of this Act.
(c) ENFORCEMENT.—A medical malpractice liability 
insurance company that violates a provision of this sub-
section is liable to the United States for a civil penalty 
in an amount assessed by the Secretary, not to exceed 
$11,000 for each such violation. The provisions of para-
graphs (3) through (5) of section 303(g) of the Federal 
Food, Drug, and Cosmetic Act apply to such a civil pen-
alty to the same extent and in the same manner as such 
paragraphs apply to a civil penalty under such section. 
(d) DEFINITION.—For purposes of this subsection, 
the term ‘‘medical malpractice liability insurance com-
pany’’ means an entity in the business of providing an in-
surance policy under which the entity makes payment in 
settlement (or partial settlement) of, or in satisfaction of 
a judgment in, a medical malpractice action or claim. 
SEC. 103. SANCTIONS FOR MERITLESS ACTIONS AND 
PLEADINGS. 
(a) SIGNATURE REQUIRED.—Every pleading, written 
motion, and other paper in any medical malpractice action 
shall be signed by at least 1 attorney of record in the at-
torney’s individual name, or, if the party is not rep-
resented by an attorney, shall be signed by the party. Each 
paper shall state the signer’s address and telephone num-
ber, 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.—
(1) IN GENERAL.—A medical malpractice action 
shall be dismissed unless the attorney or unrepre-
sented party presenting the complaint certifies that, 
to the best of the person’s knowledge, information, 
and belief, formed after an inquiry reasonable under 
the circumstances—
(A) it is not being presented for any im-
proper purpose, such as to harass or to cause 
unnecessary delay or needless increase in the 
cost of litigation; 
(B) the claims and other legal contentions 
therein are warranted by existing law or by a 
nonfrivolous argument for the extension, modi-
fication, or reversal of existing law or the estab-
lishment of new law; and 
(C) the allegations and other factual con-
tentions have evidentiary support or, if specifi-
cally so identified, are likely to have evidentiary 
support after a reasonable opportunity for fur-
ther investigation and discovery. 
(2) PAPER
CONSIDERED
TO
BE
A
CERTIFI-
CATION.—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 cir-
cumstances—
(A) it is not being presented for any im-
proper purpose, such as to harass or to cause 
unnecessary delay or needless increase in the 
cost of litigation; 
(B) the claims, defenses, and other legal 
contentions therein are warranted by existing 
law or by a nonfrivolous argument for the ex-
tension, modification, or reversal of existing law 
or the establishment of new law; and 
(C) the allegations and other factual con-
tentions have evidentiary support or, if specifi-
cally 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 at-
torneys fees. The court may also impose additional 
appropriate sanctions, such as striking the plead-
ings, dismissing the suit, and sanctions plus interest, 
upon the person in violation, or upon both such per-
son 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 attor-
ney 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 con-
tempt 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 at-
torney or client (as the case may be)) to pay a mon-
etary fine. The court may also impose additional ap-
propriate 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 AND SUBSEQUENT VIOLATIONS.—If, 
after notice and a reasonable opportunity to re-
spond, a court, upon motion or upon its own initia-
tive, determines that subsection (b) has been vio-
lated 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 sanc-
tions plus interest, upon such person in violation, or 
upon both such person and such person’s attorney or 
client (as the case may be). 
(d) CENTRAL TRACKING DATABASE.—The Attorney 
General shall establish and maintain a central tracking 
database reporting system to which courts are to report 
violations of subsection (b). The database shall include all 
identifying information with respect to the attorney or the
party (if not represented by an attorney). The Attorney 
General shall permit courts to consult the database to de-
termine the extent to which an attorney or party has vio-
lated subsection (b) previously. 
SEC. 104. PERFORMANCE STANDARDS APPLICABLE TO 
STATE MEDICAL BOARDS. 
(a) DEVELOPMENT.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services, in consultation with the Federation 
of State Medical Boards, shall develop and make publicly 
available voluntary performance standards applicable to 
State medical boards. 
(b) CONTENTS.—In developing performance stand-
ards under this section, the Secretary shall include stand-
ards to require the following: 
(1) Processing patient complaints within a spec-
ified limited period of time. 
(2) Maintaining a website or toll-free telephone 
number to enable a patient submitting a complaint 
to track the status of the complaint. 
(3) Maintaining an adequate level of staff for 
the activities of the State medical board. 
(4) Ensuring that staff are qualified. 
(5) Making the following information available 
to the public for physicians:
(A) Each physician’s education and train-
ing. 
(B) Each physician’s medical specialties. 
(C) For each physician a description of 
medical malpractice claims paid, hospital dis-
ciplinary actions taken, criminal convictions oc-
curring, and disciplinary actions taken by the 
State medical board, within the previous 10 
years. 
(D) At the option of a State medical 
board, each physician’s professional demo-
graphics (such as business address, insurance 
plan and hospital affiliations, and available 
translation services), professional or community 
awards received, and research or other profes-
sional publications. 
(6) Issuing an annual report that includes ag-
gregate disciplinary statistics, including—
(A) statistics on the number and type of 
complaints received; and 
(B) with respect to physicians, statistics on 
the number and type of complaints received, 
disaggregated by the medical school and grad-
uate medical education program completed by 
the physicians involved.
(7) Such other issues as the Secretary deter-
mines appropriate. 
(c) DETERMINATION REQUIRED.—For the period be-
ginning 3 years after the date of the enactment of this 
Act, the Secretary shall determine whether the State med-
ical board of each State is in compliance with the vol-
untary performance standards developed under subsection 
(a). 
(d) DETERMINATION OF NONCOMPLIANCE.—Before 
making a determination under subsection (c) that a State 
medical board is not in compliance with the voluntary per-
formance standards developed under subsection (a), the 
Secretary shall—
(1) propose a determination of noncompliance; 
(2) identify the reasons for such noncompliance; 
and 
(3) give the State medical board an opportunity 
to correct such noncompliance. 
(e) REVISION OF DETERMINATIONS.—The Secretary 
shall periodically review and, as necessary, revise deter-
minations of compliance and noncompliance under sub-
section (c). 
(f) REPORT BY SECRETARY.—Not later than 5 years 
after the date of the enactment of this Act, and annually 
thereafter, the Secretary shall submit a report to the Con-
gress on the activities of the Secretary under this section, 
including a listing of the State medical boards determined 
by the Secretary to be in compliance or not in compliance 
with the voluntary standards developed under subsection 
(a). 
SEC. 105. INTERSTATE PATIENT REPORTING AND PHYSI-
CIAN TRACKING DATABASE. 
(a) ESTABLISHMENT.—The Secretary of Health and 
Human Services shall establish and maintain an interstate 
patient reporting and physician tracking database (in this 
section referred to as the ‘‘database’’) . 
(b) DATABASE CONTENTS.—
(1) IN GENERAL.—The database shall consist of 
information about physicians voluntarily submitted 
to the database by—
(A) State medical boards; and 
(B) patients. 
(2) 
SUBMISSIONS
BY
STATE
MEDICAL 
BOARDS.—The database shall encourage the State 
medical board of each State to submit, with respect 
to each physician licensed by the State, the fol-
lowing: 
(A) The physician’s identity. 
(B) The physician’s education and train-
ing.
(C) The physician’s medical specialties. 
(D) A description of medical malpractice 
claims paid, hospital disciplinary actions taken, 
criminal convictions occurring, and disciplinary 
actions taken by the State medical board, with-
in the previous 10 years. 
(3) 
PATIENT
COMPLAINTS.—The 
database 
shall—
(A) encourage the State medical board of 
each State to submit, with respect to each phy-
sician licensed by the State, a description of 
pending patient complaints about the physician; 
and 
(B) allow patients to submit complaints 
about physicians directly to the database. 
(c) AVAILABILITY OF INFORMATION.—
(1) IN GENERAL.—The information submitted 
to the database pursuant to subsection (b)(2) shall 
be available to the public, including by means of the 
Internet and a toll-free telephone number. 
(2) PATIENT COMPLAINTS.—
(A) CONFIDENTIALITY.—Any patient com-
plaint about a physician submitted to the data-
base shall be kept confidential and shall not be 
subject to disclosure under section 552 of title
5, United States Code. Except as provided in 
subparagraph (B), the database may disclose 
information derived from such a patient com-
plaint only if the information is not individually 
identifiable. 
(B) TRACKING
PATIENT
COMPLAINTS.—
The database shall—
(i) assign a tracking number to each 
patient complaint submitted to the data-
base pursuant to subsection (b)(3); 
(ii) provide notice and a description of 
each patient complaint submitted pursuant 
to subsection (b)(3)(B) to the applicable 
State medical board; and 
(iii) allow the patient making any 
complaint submitted to the database pur-
suant to subsection (b)(3) to track the sta-
tus of the complaint, including by means of 
the Internet and a toll-free telephone num-
ber. 
(C) ANALYSIS.—Subject to subparagraph 
(A), the Secretary of Health and Human Serv-
ices shall conduct analysis of patient complaints 
submitted to the database, including complaints 
that do not result in disciplinary action, and
use the data and conclusions derived from such 
analysis to provide timely public health safety 
information to health care consumers and prac-
titioners. 
(d) TECHNICAL
ASSISTANCE.—The Secretary of 
Health and Human Services shall provide technical assist-
ance to States to facilitate the exchange of information 
between State medical boards and the database. 
(e) DETERMINATION REQUIRED.—For the period be-
ginning 3 years after the date of the enactment of this 
Act, the Secretary shall determine whether the State med-
ical board of each State is failing to submit the informa-
tion described in subsections (b)(2) and (b)(3)(A). 
(f) DETERMINATION OF NONCOMPLIANCE.—Before 
making a determination under subsection (e) that a State 
medical board is failing to submit such information, the 
Secretary shall—
(1) propose a determination of noncompliance; 
(2) identify the reasons for such noncompliance; 
and 
(3) give the State medical board an opportunity 
to correct such noncompliance. 
(g) REVISION OF DETERMINATIONS.—The Secretary 
shall periodically review and, as necessary, revise deter-
minations of compliance and noncompliance under sub-
section (e). 
(h) ASSESSMENT.—Not later than 3 years after the 
date of the enactment of this Act, the Secretary shall—
(1) conduct an assessment of the database, in-
cluding an assessment of the value of the database 
to patients and the effect of the database on physi-
cians; and 
(2) submit a report to the Congress on the re-
sults of the assessment, including any recommenda-
tions for improvement of the database. 
SEC. 106. REPORT ON MODIFICATION OF MALPRACTICE 
PROCEDURES 
RELATING 
TO 
MANDATED 
CARE UNDER EMTALA. 
(a) ANALYSIS.—The Secretary of Health and Human 
Services shall conduct a study on alternatives to the 
present medical malpractice litigation and compensation 
process in resolving health care malpractice claims arising 
out of a screening examination or treatment provided to 
comply with the requirements of section 1867 of the Social 
Security Act (42 U.S.C. 1395dd), commonly referred to 
as EMTALA. 
(b) REPORT.—Not later than 2 years after the date 
of the enactment of this Act, the Secretary shall submit 
to the Congress a report on the study conducted under
subsection (a). The Secretary shall include in such report 
alternatives to medical malpractice litigation and com-
pensation, including medical liability insurance premium 
tax credits, no-fault medical liability insurance, and med-
ical malpractice health courts. 
SEC. 107. DEFINITIONS. 
In this title: 
(1) The term ‘‘State medical board’’ means a 
State entity responsible for licensing physicians or a 
subdivision of such an entity. 
(2) The term ‘‘health care malpractice’’ means 
the negligence or other fault of a health care pro-
vider. 
(3) The term ‘‘health care provider’’ means—
(A) any individual who is engaged in the 
delivery of health care services in a State and 
who is required by State law or regulation to be 
licensed or certified by the State to engage in 
the delivery of such services in the State; and 
(B) any entity that is engaged in the deliv-
ery of health care services in a State and that, 
if it is required by State law or regulation to be 
licensed or certified by the State to engage in 
the delivery of such services in the State, is so 
licensed.
(4) The term ‘‘State’’ includes the District of 
Columbia, the Commonwealth of Puerto Rico, and 
other territories and possessions of the United 
States. 
TITLE II—HEALTH CARE MAL-
PRACTICE 
LIABILITY 
MEDI-
ATION PROGRAMS 
SEC. 201. GRANTS TO STATES AND HEALTH CARE ENTITIES 
FOR MEDIATION PROGRAMS. 
(a) GRANTS AUTHORIZED.—From amounts made 
available to carry out this section, the Attorney General 
shall carry out a program under which the Attorney Gen-
eral makes grants to States and health care entities to 
carry out mediation programs described in subsection (b). 
(b) MEDIATION PROGRAMS.—A mediation program 
referred to in subsection (a) is a program, based on the 
Rush model, under which an allegation that an individual 
has been injured or has died as the result of health care 
malpractice is mediated by those parties consenting to do 
so in an effort to resolve the matter without litigation. 
(c) RUSH MODEL.—For purposes of this section, a 
program is based on the Rush model if the program satis-
fies each of the following: 
(1) Participation by the parties in the medi-
ation is voluntary.
(2) At the commencement of a mediation, the 
parties enter into a mediation agreement that—
(A) states that the parties—
(i) will not request or subpoena the 
mediator to testify or produce any docu-
ments or other information in any pro-
ceeding related to the mediation; and 
(ii) will defend and indemnify the me-
diator in connection with any summons or 
subpoena arising out of the mediation pro-
ceeding; 
(B) provides for confidentiality of the me-
diation proceedings; and 
(C) states that any apology or expression 
of remorse by a health care provider or other 
entity at any time during the mediation pro-
ceedings will be kept confidential and will not 
be used in any subsequent legal proceeding. 
(3) The program is similar to the mediation 
program carried out as of January 1, 2005, at 
Rush-Presbyterian-St. Luke’s Medical Center in Chi-
cago, Illinois. 
(d) DEFINITIONS.—In this section: 
(1) The term ‘‘health care entity’’ means an en-
tity covered by section 105(3)(B).
(2) The term ‘‘health care malpractice’’ has the 
meaning given such term in section 105. 
(3) The term ‘‘State’’ has the meaning given 
such term in section 105. 
SEC. 202. TRAINING AND ASSISTANCE FOR MEDIATION 
PROGRAMS. 
From amounts made available to carry out this sec-
tion, the Attorney General shall carry out a program 
under which the Attorney General provides training and 
assistance to recipients of grant amounts under section 
201 to carry out mediation programs under that section. 
SEC. 203. AUTHORIZATION OF APPROPRIATIONS. 
There are authorized to be appropriated to the Attor-
ney General such sums as may be necessary to carry out 
sections 201 and 202. 
TITLE III—VOLUNTARY REPORT-
ING OF MEDICAL SAFETY IN-
CIDENTS 
Subtitle A—Reporting by Individ-
uals Involved in the Provision 
of Health Care 
SEC. 301. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT. 
(a) IN GENERAL.—Title IX of the Public Health 
Service Act (42 U.S.C. 299 et seq.) is amended—
(1) in section 912(c), by inserting ‘‘, in accord-
ance with part C,’’ after ‘‘The Director shall’’; 
(2) by redesignating part C as part D; 
(3) by redesignating sections 921 through 928, 
as sections 931 through 938, respectively; 
(4) in section 938(1) (as so redesignated), by 
striking ‘‘921’’ and inserting ‘‘931’’; and 
(5) by inserting after part B the following: 
‘‘PART C—PATIENT SAFETY IMPROVEMENT 
‘‘SEC. 921. DEFINITIONS. 
‘‘In this part: 
‘‘(1) IDENTIFIABLE INFORMATION.—The term 
‘identifiable information’ means information that is 
presented in a form and manner that allows the 
identification of any provider, patient, or reporter of 
patient safety work product. With respect to pa-
tients, such information includes any individually 
identifiable health information as that term is de-
fined in the regulations promulgated pursuant to 
section 264(c) of the Health Insurance Portability 
and Accountability Act of 1996 (Public Law 104–
191; 110 Stat. 2033). 
‘‘(2) NONIDENTIFIABLE
INFORMATION.—The 
term ‘nonidentifiable information’ means informa-
tion that is presented in a form and manner that
prevents the identification of any provider, patient, 
or reporter of patient safety work product. With re-
spect to patients, such information must be de-iden-
tified consistent with the regulations promulgated 
pursuant to section 264(c) of the Health Insurance 
Portability and Accountability Act of 1996 (Public 
Law 104–191; 110 Stat. 2033). 
‘‘(3) PATIENT SAFETY EVALUATION SYSTEM.—
The term ‘patient safety evaluation system’ means a 
process that involves the collection, management, or 
analysis of information for submission to or by a pa-
tient safety organization. 
‘‘(4) PATIENT
SAFETY
ORGANIZATION.—The 
term ‘patient safety organization’ means a private or 
public organization or component thereof that is cer-
tified, through a process to be determined by the 
Secretary under section 925, to perform each of the 
following activities: 
‘‘(A) The conduct, as the organization or 
component’s primary activity, of efforts to im-
prove patient safety and the quality of health 
care delivery. 
‘‘(B) The collection and analysis of patient 
safety work product that is submitted by pro-
viders.
‘‘(C) The development and dissemination 
of evidence-based information to providers with 
respect to improving patient safety, such as rec-
ommendations, protocols, or information re-
garding best practices. 
‘‘(D) The utilization of patient safety work 
product to carry out activities limited to those 
described under this paragraph and for the pur-
poses of encouraging a culture of safety and of 
providing direct feedback and assistance to pro-
viders to effectively minimize patient risk. 
‘‘(E) The maintenance of confidentiality 
with respect to identifiable information. 
‘‘(F) The provision of appropriate security 
measures with respect to patient safety work 
product. 
‘‘(G) The submission of nonidentifiable in-
formation to the Agency consistent with stand-
ards established by the Secretary under section 
923(b) for any National Patient Safety Data-
base. 
‘‘(5) PATIENT SAFETY WORK PRODUCT.—
‘‘(A) The term ‘patient safety work prod-
uct’ means any document or communication 
(including any information, report, record,
memorandum, analysis, deliberative work, state-
ment, or root cause analysis) that—
‘‘(i) except as provided in subpara-
graph (B), is developed by a provider for 
the purpose of reporting to a patient safety 
organization, and is reported to a patient 
safety organization; 
‘‘(ii) is created by a patient safety or-
ganization; or 
‘‘(iii) would reveal the deliberations or 
analytic process of a patient safety evalua-
tion system (as defined in paragraph (3)). 
‘‘(B)(i) Patient safety work product de-
scribed in subparagraph (A)(i)—
‘‘(I) does not include any separate in-
formation described in clause (ii); and 
‘‘(II) shall not be construed to include 
such separate information merely by rea-
son of inclusion of a copy of the document 
or communication involved in a submission 
to, or the fact of submission of such a copy 
to, a patient safety organization. 
‘‘(ii) Separate information described in this 
clause is a document or communication (includ-
ing a patient’s medical record or any other pa-
tient or hospital record) that is developed or 
maintained, or exists, separately from any pa-
tient safety evaluation system. 
‘‘(C) Information available from sources 
other than a patient safety work product under 
this section may be discovered or admitted in a 
civil or administrative proceeding, if discover-
able or admissible under applicable law. 
‘‘(6) PROVIDER.—The term ‘provider’ means—
‘‘(A) an individual or entity licensed or 
otherwise authorized under State law to provide 
health care services, including—
‘‘(i) a hospital, nursing facility, com-
prehensive outpatient rehabilitation facil-
ity, home health agency, and hospice pro-
gram; 
‘‘(ii) a physician, physician assistant, 
nurse practitioner, clinical nurse specialist, 
certified nurse midwife, nurse anesthetist, 
psychologist, certified social worker, reg-
istered dietitian or nutrition professional, 
physical or occupational therapist, or other 
individual health care practitioner; 
‘‘(iii) a pharmacist; and
‘‘(iv) a renal dialysis facility, ambula-
tory surgical center, pharmacy, physician 
or health care practitioner’s office, long-
term care facility, behavioral health resi-
dential treatment facility, clinical labora-
tory, or community health center; or 
‘‘(B) any other person or entity specified 
in regulations by the Secretary after public no-
tice and comment. 
‘‘SEC. 922. PRIVILEGE FOR PATIENT SAFETY WORK PROD-
UCT. 
‘‘(a) PRIVILEGE.—Notwithstanding any other provi-
sion of law and subject to subsection (c), patient safety 
work product shall not be—
‘‘(1) subject to a civil or administrative sub-
poena or order; 
‘‘(2) subject to discovery in connection with a 
civil or administrative proceeding; 
‘‘(3) subject to disclosure pursuant to section 
552 of title 5, United States Code (commonly known 
as the Freedom of Information Act), or any other 
similar Federal or State law; 
‘‘(4) required to be admitted as evidence or oth-
erwise disclosed in any State or Federal civil or ad-
ministrative proceeding; or
‘‘(5) if the patient safety work product is identi-
fiable information and is received by a national ac-
creditation organization in its capacity as a patient 
safety organization—
‘‘(A) used by a national accreditation orga-
nization in an accreditation action against the 
provider that reported the information; 
‘‘(B) shared by such organization with its 
survey team; or 
‘‘(C) required as a condition of accredita-
tion by a national accreditation association. 
‘‘(b) REPORTER PROTECTION.—
‘‘(1) IN
GENERAL.—A provider may not use 
against an individual in an adverse employment ac-
tion described in paragraph (2) the fact that the in-
dividual in good faith reported information—
‘‘(A) to the provider with the intention of 
having the information reported to a patient 
safety organization; or 
‘‘(B) directly to a patient safety organiza-
tion. 
‘‘(2) ADVERSE
EMPLOYMENT
ACTION.—For 
purposes of this subsection, an ‘adverse employment 
action’ includes—
‘‘(A) the failure to promote an individual 
or provide any other employment-related benefit 
for which the individual would otherwise be eli-
gible; 
‘‘(B) an adverse evaluation or decision 
made in relation to accreditation, certification, 
credentialing, or licensing of the individual; and 
‘‘(C) a personnel action that is adverse to 
the individual concerned. 
‘‘(3) REMEDIES.—Any provider that violates 
this subsection shall be subject to a civil monetary 
penalty of not more than $20,000 for each such vio-
lation involved. Such penalty shall be imposed and 
collected in the same manner as civil money pen-
alties under subsection (a) of section 1128A of the 
Social Security Act are imposed and collected. 
‘‘(c) DISCLOSURES.—Nothing in this section pro-
hibits any of the following disclosures: 
‘‘(1) Voluntary disclosure of nonidentifiable in-
formation. 
‘‘(2) Voluntary disclosure of identifiable infor-
mation by a provider or patient safety organization, 
if such disclosure—
‘‘(A) is authorized by the provider for the 
purposes of improving quality and safety;
‘‘(B) is to an entity or person subject to 
the requirements of section 264(c) of the 
Health Insurance Portability and Accountability 
Act of 1996 (Public Law 104–191; 110 Stat. 
2033), or any regulation promulgated under 
such section; and 
‘‘(C) is not in conflict with such section or 
any regulation promulgated under such section. 
‘‘(3) Disclosure as required by law by a pro-
vider to the Food and Drug Administration, or on 
a voluntary basis by a provider to a federally estab-
lished patient safety program, with respect to an Ad-
ministration-regulated product or activity for which 
that entity has responsibility, for the purposes of ac-
tivities related to the quality, safety, or effectiveness 
of such Administration-regulated product or activity. 
‘‘(4) Disclosures of patient safety work product 
in accordance with this part by a provider to a pa-
tient safety organization. 
‘‘(d) EFFECT OF TRANSFER, DISCLOSURE.—The fol-
lowing shall not be treated as a waiver of any privilege 
or protection established under this part: 
‘‘(1) The transfer of any patient safety work 
product between a provider and a patient safety or-
ganization.
‘‘(2) Disclosure of patient safety work product 
as described in subsection (c). 
‘‘(3) The unauthorized disclosure of patient 
safety work product. 
‘‘(e) PENALTY.—
‘‘(1) PROHIBITION.—Except as provided in this 
part, and subject to paragraphs (2) and (4), it shall 
be unlawful for any person to disclose patient safety 
work product in violation of this section, if such dis-
closure constitutes a negligent or knowing breach of 
confidentiality. 
‘‘(2) RELATION TO HIPAA.—The penalty under 
paragraph (3) for a disclosure in violation of para-
graph (1) does not apply if the person would be sub-
ject to a penalty under section 264(c) of the Health 
Insurance Portability and Accountability Act of 
1996 (Public Law 104–191; 110 Stat. 2033), or any 
regulation promulgated under such section, for the 
same disclosure. 
‘‘(3) AMOUNT.—Any person who violates para-
graph (1) shall be subject to a civil monetary penalty 
of not more than $10,000 for each such violation in-
volved. Such penalty shall be imposed and collected 
in the same manner as civil money penalties under
subsection (a) of section 1128A of the Social Secu-
rity Act are imposed and collected. 
‘‘(4) SUBSEQUENT
DISCLOSURE.—Paragraph 
(1) applies only to the first person that breaches 
confidentiality with respect to particular patient 
safety work product. 
‘‘(f) RELATION TO HIPAA.—
‘‘(1) IN GENERAL.—For purposes of applying 
the regulations promulgated pursuant to section 
264(c) of the Health Insurance Portability and Ac-
countability Act of 1996 (Public Law 104–191; 110 
Stat. 2033)—
‘‘(A) patient safety organizations shall be 
treated as business associates; and 
‘‘(B) activities of such organizations de-
scribed in section 921(4) in relation to a pro-
vider are deemed to be health care operations 
(as defined in such regulations) of the provider. 
‘‘(2) RULE
OF
CONSTRUCTION.—Nothing in 
this section shall be construed to alter or affect the 
implementation of such regulations or such section 
264(c). 
‘‘(g) NO LIMITATION
OF OTHER PRIVILEGES.—
Nothing in this section shall be construed to affect privi-
leges, including peer review and confidentiality protec-
tions, that are otherwise available under Federal or State 
laws. 
‘‘(h) NO LIMITATION ON CONTRACTS.—Nothing in 
this section shall be construed to limit the power of a pro-
vider and a patient safety organization, or a patient safety 
organization and the Agency or any National Patient 
Safety Database, consistent with the provisions of this Act 
and other applicable law, to enter into a contract requiring 
greater confidentiality or delegating authority to make an 
authorized disclosure. 
‘‘(i) RELATION
TO STATE REPORTING REQUIRE-
MENTS.—Nothing in this part shall be construed as pre-
empting or otherwise affecting any State law requiring a 
provider to report information, including information de-
scribed in section 921(5)(B), that is not patient safety 
work product. 
‘‘(j) CONTINUATION OF PRIVILEGE.—Patient safety 
work product of an organization that is certified as a pa-
tient safety organization shall continue to be privileged 
and confidential, in accordance with this section, if the or-
ganization’s certification is terminated or revoked or if the 
organization otherwise ceases to qualify as a patient safety 
organization. 
‘‘(k) REPORTS
ON STRATEGIES
TO IMPROVE PA-
TIENT SAFETY.—
‘‘(1) DRAFT REPORT.—Not later than the date 
that is 18 months after any National Patient Safety 
Database is operational, the Secretary, in consulta-
tion with the Director, shall prepare a draft report 
on effective strategies for reducing medical errors 
and increasing patient safety. The draft report shall 
include any measure determined appropriate by the 
Secretary to encourage the appropriate use of such 
strategies, including use in any federally funded pro-
grams. The Secretary shall make the draft report 
available for public comment and submit the draft 
report to the Institute of Medicine for review. 
‘‘(2) FINAL REPORT.—Not later than 1 year 
after the date described in paragraph (1), the Sec-
retary shall submit a final report to the Congress 
that includes, in an appendix, any findings by the 
Institute of Medicine concerning research on the 
strategies discussed in the draft report and any 
modifications made by the Secretary based on such 
findings. 
‘‘SEC. 923. NATIONAL PATIENT SAFETY DATABASE. 
‘‘(a) AUTHORITY.—
‘‘(1) IN
GENERAL.—In conducting activities 
under this part, the Secretary shall provide for the 
establishment and maintenance of a database to re-
ceive relevant nonidentifiable patient safety work 
product, and may designate entities to collect rel-
evant nonidentifiable patient safety work product 
that is voluntarily reported by patient safety organi-
zations upon the request of the Secretary. Any data-
base established or designated under this paragraph 
may be referred to as a ‘National Patient Safety 
Database’. 
‘‘(2) USE OF INFORMATION.—Information re-
ported to any National Patient Safety Database 
shall be used to analyze national and regional statis-
tics, including trends and patterns of health care er-
rors. The information resulting from such analyses 
may be included in the annual quality reports pre-
pared under section 913(b)(2). 
‘‘(3) ADVISORY
ROLE.—The Secretary shall 
provide scientific support to patient safety organiza-
tions, including the dissemination of methodologies 
and evidence-based information related to root 
causes and quality improvement. 
‘‘(b) STANDARDS.—In establishing or designating a 
database under subsection (a)(1), the Secretary shall, in 
consultation with representatives of patient safety organi-
zations, the provider community, and the health informa-
tion technology industry, determine common formats for
the voluntary reporting of nonidentifiable patient safety 
work product, including necessary elements, common and 
consistent definitions, and a standardized computer inter-
face for the processing of the work product. To the extent 
practicable, such standards shall be consistent with the 
administrative simplification provisions of part C of title 
XI of the Social Security Act. 
‘‘(c) CERTAIN METHODOLOGIES FOR COLLECTION.—
The Secretary shall ensure that the methodologies for the 
collection of nonidentifiable patient safety work product 
for any National Patient Safety Database include the 
methodologies developed or recommended by the Patient 
Safety Task Force of the Department of Health and 
Human Services. 
‘‘(d) FACILITATION OF INFORMATION EXCHANGE.—
To the extent practicable, the Secretary may facilitate the 
direct link of information between providers and patient 
safety organizations and between patient safety organiza-
tions and any National Patient Safety Database. 
‘‘(e) RESTRICTION ON TRANSFER.—Only nonidentifi-
able information may be transferred to any National Pa-
tient Safety Database. 
‘‘SEC. 924. TECHNICAL ASSISTANCE. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director, may—
‘‘(1) provide technical assistance to patient 
safety organizations, and to States with reporting 
systems for health care errors; and 
‘‘(2) provide guidance on the type of data to be 
voluntarily submitted to any National Patient Safety 
Database. 
‘‘(b) 
ANNUAL
MEETINGS.—Assistance 
provided 
under subsection (a) may include annual meetings for pa-
tient safety organizations to discuss methodology, commu-
nication, information collection, or privacy concerns. 
‘‘SEC. 925. CERTIFICATION OF PATIENT SAFETY ORGANIZA-
TIONS. 
‘‘(a) IN GENERAL.—Not later than 6 months after 
the date of enactment of the Patient Safety and Quality 
Improvement Act, the Secretary shall establish a process 
for certifying patient safety organizations. 
‘‘(b) PROCESS.—The process established under sub-
section (a) shall include the following: 
‘‘(1) Certification of patient safety organiza-
tions by the Secretary or by such other national or 
State governmental organizations as the Secretary 
determines appropriate. 
‘‘(2) If the Secretary allows other governmental 
organizations to certify patient safety organizations 
under paragraph (1), the Secretary shall establish a
process for approving such organizations. Any such 
approved organization shall conduct certifications 
and reviews in accordance with this section. 
‘‘(3) A review of each certification under para-
graph (1) (including a review of compliance with 
each criterion in this section and any related imple-
menting standards as determined by the Secretary 
through rulemaking) not less often than every 3 
years, as determined by the Secretary. 
‘‘(4) Revocation of any such certification by the 
Secretary or other such governmental organization 
that issued the certification, upon a showing of 
cause. 
‘‘(c) CRITERIA.—A patient safety organization must 
meet the following criteria as conditions of certification: 
‘‘(1) The mission of the patient safety organiza-
tion is to conduct activities that are to improve pa-
tient safety and the quality of health care delivery 
and is not in conflict of interest with the providers 
that contract with the patient safety organization. 
‘‘(2) The patient safety organization has appro-
priately qualified staff, including licensed or certified 
medical professionals. 
‘‘(3) The patient safety organization, within any 
2 year period, contracts with more than 1 provider
for the purpose of receiving and reviewing patient 
safety work product. 
‘‘(4) The patient safety organization is not a 
component of a health insurer or other entity that 
offers a group health plan or health insurance cov-
erage. 
‘‘(5) The patient safety organization is man-
aged, controlled, and operated independently from 
any provider that contracts with the patient safety 
organization for reporting patient safety work prod-
uct. 
‘‘(6) To the extent practical and appropriate, 
the patient safety organization collects patient safety 
work product from providers in a standardized man-
ner that permits valid comparisons of similar cases 
among similar providers. 
‘‘(d) ADDITIONAL CRITERIA FOR COMPONENT ORGA-
NIZATIONS.—If a patient safety organization is a compo-
nent of another organization, the patient safety organiza-
tion must, in addition to meeting the criteria described 
in subsection (c), meet the following criteria as conditions 
of certification: 
‘‘(1) The patient safety organization maintains 
patient safety work product separately from the rest 
of the organization, and establishes appropriate se-
curity measures to maintain the confidentiality of 
the patient safety work product. 
‘‘(2) The patient safety organization does not 
make an unauthorized disclosure under this Act of 
patient safety work product to the rest of the orga-
nization in breach of confidentiality. 
‘‘(3) The mission of the patient safety organiza-
tion does not create a conflict of interest with the 
rest of the organization.’’. 
(b) AUTHORIZATION OF APPROPRIATIONS.—Section 
937 of the Public Health Service Act (as redesignated by 
subsection (a)) is amended by adding at the end the fol-
lowing: 
‘‘(e) PATIENT SAFETY
AND QUALITY IMPROVE-
MENT.—For the purpose of carrying out part C, there are 
authorized to be appropriated such sums as may be nec-
essary for each of the fiscal years 2006 through 2010.’’. 
Subtitle B—Liability Protection in 
Good-faith Reporting 
SEC. 311. LIABILITY PROTECTION FOR HEALTH CARE PRO-
VIDERS 
IN 
GOOD-FAITH 
REPORTING 
TO 
STATE MEDICAL BOARDS. 
(a) IN GENERAL.—Notwithstanding any other provi-
sion of law, no health care provider providing information 
(including by making a report, filing charges, or pre-
senting evidence) to a State medical board regarding the 
competence or professional conduct of a physician shall 
be held, by reason of having provided such information, 
to be liable in damages under any law of the United States 
or of any State (or political subdivision thereof) unless 
such information is false and the person providing the in-
formation knew that the information was false. 
(b) ATTORNEY FEES.—If a health care provider es-
tablishes in a civil action that the health care provider is 
not liable in damages because of the application of sub-
section (a), the court shall award to the provider any at-
torney fees and costs incurred by the provider in estab-
lishing the application of subsection (a). 
(c) DEFINITION.—In this section, the term ‘‘State 
medical board’’ means a State entity responsible for li-
censing physicians or a subdivision of such an entity. 
TITLE IV—INSURANCE REFORM 
SEC. 401. UNIFORM STATE REQUIREMENTS REGARDING 
PROPOSED RATE INCREASES. 
(a) IN GENERAL.—The Congress intends that each 
State have in effect laws or regulations providing that—
(1) a provider of medical malpractice insurance 
in the State may not implement any increase in the 
rate for such insurance that would result in such 
rate increasing more than a certain percentage, as
specified in such laws or regulations, within a cer-
tain period of time, as specified in such laws or reg-
ulations, unless, before such increase takes effect—
(A) the provider submits to an appropriate 
State agency a description and justification of 
the rate increase; and 
(B) such agency makes a determination 
that the increase is justified; and 
(2) any determination referred to in paragraph 
(1)(B) regarding an increase in medical malpractice 
insurance rates is made pursuant to an administra-
tive hearing held by the appropriate State agency; 
and 
(3) any individual or institution that is involved 
in the provision of health care and is licensed by the 
State to provide such care has standing, in any ad-
ministrative proceeding of the State regarding a pro-
posed increase in the rate for medical malpractice 
insurance (including a hearing referred to in para-
graph (2)), to challenge such increase. 
(b) REPORT.—Not later than 2 years after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall—
(1) conduct and complete a survey of the laws 
and regulations of the States to determine the extent
to which the States have in effects laws or regula-
tions described in subsection (a); and 
(2) submit a report to the Congress setting 
forth the results of the survey, describing such laws 
and regulations of the various States, and describing 
the extent of the uniformity of such laws and regula-
tions. 
(c) DEFINITION.—For purposes of this section, the 
term ‘‘State’’ has the meaning given such term in section 
105. 
(d) EFFECTIVE DATE.—This section shall take effect 
on the date of the enactment of this Act. 
SEC. 402. REDUCTION IN PREMIUMS PAID BY PHYSICIANS 
FOR 
MEDICAL 
MALPRACTICE 
INSURANCE 
COVERAGE. 
(a) IN GENERAL.—Not later than 180 days after the 
date of the enactment of this Act, each medical mal-
practice liability insurance company shall—
(1) develop a reasonable estimate of the annual 
amount of financial savings that will be achieved by 
the company as a result of section 101; 
(2) develop and implement a plan to annually 
dedicate at least 50 percent of such annual savings 
to reduce the amount of premiums that the company
charges physicians for medical malpractice liability 
coverage; and 
(3) submit to the Secretary of Health and 
Human Services (in this subsection referred to as 
the ‘‘Secretary’’) a written certification that the 
company has complied with paragraphs (1) and (2). 
(b) REPORTS.—Not later than one year after the date 
of the enactment of this Act and annually thereafter, each 
medical malpractice liability insurance company shall sub-
mit to the Secretary a report that identifies the percentage 
by which the company has reduced medical malpractice 
coverage premiums relative to the date of the enactment 
of this Act. 
(c) ENFORCEMENT.—A medical malpractice liability 
insurance company that violates a provision of this section 
is liable to the United States for a civil penalty in an 
amount assessed by the Secretary, not to exceed $11,000 
for each such violation. The provisions of paragraphs (3) 
through (5) of section 303(g) of the Federal Food, Drug, 
and Cosmetic Act apply to such a civil penalty to the same 
extent and in the same manner as such paragraphs apply 
to a civil penalty under such section. 
(d) DEFINITION.—For purposes of this section, the 
term ‘‘medical malpractice liability insurance company’’ 
means an entity in the business of providing an insurance
policy under which the entity makes payment in settlement 
(or partial settlement) of, or in satisfaction of a judgment 
in, a medical malpractice action or claim. 
SEC. 403. EFFECTIVE DATE. 
Except as provided in section 401(d), this title shall 
take effect 1 year after the date of the enactment of this 
Act. 
TITLE V—EXCLUSION OF PHAR-
MACEUTICALS AND DEVICES 
FROM LIABILITY REFORMS 
SEC. 501. EXCLUSION OF PHARMACEUTICALS AND DE-
VICES. 
For purposes of title I and II of this Act, the manu-
facturer or distributor of a pharmaceutical or device is not 
a health care provider, and health care malpractice does 
not include responsibility based on products liability.
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