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 Energy 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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Comprehensive Medical Malpractice Reform Act of 

6 2005’’. 

7 (b) TABLE OF CONTENTS.—The table of contents of 

8 this Act is as follows:

Sec. 1. Short title; table of contents. 
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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 insurance 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 mandated 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 insurance coverage. 

Sec. 403. Effective date. 

TITLE V—EXCLUSION OF PHARMACEUTICALS AND DEVICES 

FROM LIABILITY REFORMS 

Sec. 501. Exclusion of pharmaceuticals and devices.

1 TITLE I—HEALTH CARE MAL2 PRACTICE LIABILITY RE3 FORM 

4 SEC. 101. CAP ON NON-ECONOMIC DAMAGES. 

5 (a) IN GENERAL.—When an individual is injured or 

6 dies as the result of health care malpractice, a person enti7 tled to recover non-economic damages from a health care 
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1 provider responsible for that malpractice may not recover 

2 such damages, in the aggregate from all such providers, 

3 in an amount more than $250,000, adjusted for inflation 

4 from 1975 as provided in subsection (b). This limitation 

5 applies separately to each person entitled to recover such 

6 damages. 

7 (b) ADJUSTMENT FOR INFLATION FROM 1975.—

8 (1) PUBLICATION BY SECRETARY OF LABOR.—

9 On or about December 1 of each year, the Secretary 

10 of Labor shall publish in the Federal Register a dol11 lar amount determined by adjusting the dollar 

12 amount specified in subsection (a) according to the 

13 adjustments in the Consumer Price Index of the Bu14 reau of Labor Statistics of the Department of Labor 

15 for the period beginning on or about October 1, 

16 1975, and ending on or about October 1 of that 

17 year. 

18 (2) APPLICABILITY.—For purposes of sub19 section (a), the dollar amount that applies to a cal20 endar year is the dollar amount published on or 

21 about December 1 of the preceding year. 

22 (3) ESTIMATION.—Congress estimates that the 

23 dollar amount that would apply to calendar year 

24 2005 would be approximately $878,000, though the 

25 dollar amount published under paragraph (1), rather 
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1 than the estimation in this paragraph, is to be ap2 plied. 

3 (c) APPLICABILITY.—

4 (1) IN GENERAL.—Subject to paragraph (2), 

5 this section applies whenever the amount of a recov6 ery is made final in a calendar year after the date 

7 of the enactment of this Act. In applying the dollar 

8 amount to a recovery, all recoveries made final 

9 (whether before or after the date of the enactment 

10 of this Act) are included in the aggregate. 

11 (2) NOT APPLICABLE WHEN STATE BOARD NOT

12 IN COMPLIANCE.—During a period in which a State 

13 medical board is not in compliance with the vol14 untary performance standards developed under sec15 tion 104 or is failing to submit the information de16 scribed in paragraphs (2) and (3)(A) of section 

17 105(b) (as determined by the Secretary under sec18 tion 104 or 105, respectively), the limitation in sub19 section (a) does not apply to liability arising under 

20 the law of that State. 

21 (d) RELATIONSHIP TO STATE LAW.—This section op22 erates on a case-by-case basis to provide a maximum re23 covery and to prevent State law from providing a recovery 

24 above that maximum. It does not prevent State law from 

25 providing a recovery below that maximum. 
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1 SEC. 102. REDUCTION IN PREMIUMS PAID BY PHYSICIANS 

2 FOR MEDICAL MALPRACTICE INSURANCE 

3 COVERAGE. 

4 (a) IN GENERAL.—Not later than 180 days after the 

5 date of the enactment of this Act, each medical mal6 practice liability insurance company shall—

7 (1) develop a reasonable estimate of the annual 

8 amount of financial savings that will be achieved by 

9 the company as a result of this section; 

10 (2) develop and implement a plan to annually 

11 dedicate at least 50 percent of such annual savings 

12 to reduce the amount of premiums that the company 

13 charges physicians for medical malpractice liability 

14 coverage; and 

15 (3) submit to the Secretary of Health and 

16 Human Services (in this subsection referred to as 

17 the ‘‘Secretary’’) a written certification that the 

18 company has complied with subparagraphs (A) and 

19 (B). 

20 (b) REPORTS.—Not later than one year after the date 

21 of the enactment of this Act and annually thereafter, each 

22 medical malpractice liability insurance company shall sub23 mit to the Secretary a report that identifies the percentage 

24 by which the company has reduced medical malpractice 

25 coverage premiums relative to the date of the enactment 

26 of this Act. 
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1 (c) ENFORCEMENT.—A medical malpractice liability 

2 insurance company that violates a provision of this sub3 section is liable to the United States for a civil penalty 

4 in an amount assessed by the Secretary, not to exceed 

5 $11,000 for each such violation. The provisions of para6 graphs (3) through (5) of section 303(g) of the Federal 

7 Food, Drug, and Cosmetic Act apply to such a civil pen8 alty to the same extent and in the same manner as such 

9 paragraphs apply to a civil penalty under such section. 

10 (d) DEFINITION.—For purposes of this subsection, 

11 the term ‘‘medical malpractice liability insurance com12 pany’’ means an entity in the business of providing an in13 surance policy under which the entity makes payment in 

14 settlement (or partial settlement) of, or in satisfaction of 

15 a judgment in, a medical malpractice action or claim. 

16 SEC. 103. SANCTIONS FOR MERITLESS ACTIONS AND 

17 PLEADINGS. 

18 (a) SIGNATURE REQUIRED.—Every pleading, written 

19 motion, and other paper in any medical malpractice action 

20 shall be signed by at least 1 attorney of record in the at21 torney’s individual name, or, if the party is not rep22 resented by an attorney, shall be signed by the party. Each 

23 paper shall state the signer’s address and telephone num24 ber, if any. An unsigned paper shall be stricken unless 
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1 omission of the signature is corrected promptly after being 

2 called to the attention of the attorney or party. 

3 (b) CERTIFICATE OF MERIT.—

4 (1) IN GENERAL.—A medical malpractice action 

5 shall be dismissed unless the attorney or unrepre6 sented party presenting the complaint certifies that, 

7 to the best of the person’s knowledge, information, 

8 and belief, formed after an inquiry reasonable under 

9 the circumstances—

10 (A) it is not being presented for any im11 proper purpose, such as to harass or to cause 

12 unnecessary delay or needless increase in the 

13 cost of litigation; 

14 (B) the claims and other legal contentions 

15 therein are warranted by existing law or by a 

16 nonfrivolous argument for the extension, modi17 fication, or reversal of existing law or the estab18 lishment of new law; and 

19 (C) the allegations and other factual con20 tentions have evidentiary support or, if specifi21 cally so identified, are likely to have evidentiary 

22 support after a reasonable opportunity for fur23 ther investigation and discovery. 

24 (2) PAPER CONSIDERED TO BE A CERTIFI25 CATION.—By presenting to the court (whether by 
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1 signing, filing, submitting, or later advocating) a 

2 pleading, written motion, or other paper, an attorney 

3 or unrepresented party is certifying that to the best 

4 of the person’s knowledge, information and belief, 

5 formed after an inquiry reasonable under the cir6 cumstances—

7 (A) it is not being presented for any im8 proper purpose, such as to harass or to cause 

9 unnecessary delay or needless increase in the 

10 cost of litigation; 

11 (B) the claims, defenses, and other legal 

12 contentions therein are warranted by existing 

13 law or by a nonfrivolous argument for the ex14 tension, modification, or reversal of existing law 

15 or the establishment of new law; and 

16 (C) the allegations and other factual con17 tentions have evidentiary support or, if specifi18 cally so identified, are reasonable based on a 

19 lack of information or belief. 

20 (c) MANDATORY SANCTIONS.—

21 (1) FIRST VIOLATION.—If, after notice and a 

22 reasonable opportunity to respond, a court, upon 

23 motion or upon its own initiative, determines that 

24 subsection (b) has been violated, the court shall find 

25 each attorney or party in violation in contempt of 
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1 court and shall require the payment of costs and at2 torneys fees. The court may also impose additional 

3 appropriate sanctions, such as striking the plead4 ings, dismissing the suit, and sanctions plus interest, 

5 upon the person in violation, or upon both such per6 son and such person’s attorney or client (as the case 

7 may be). 

8 (2) SECOND VIOLATION.—If, after notice and a 

9 reasonable opportunity to respond, a court, upon 

10 motion or upon its own initiative, determines that 

11 subsection (b) has been violated and that the attor12 ney or party with respect to which the determination 

13 was made has committed one previous violation of 

14 subsection (b) before this or any other court, the 

15 court shall find each such attorney or party in con16 tempt of court and shall require the payment of 

17 costs and attorneys fees, and require such person in 

18 violation (or both such person and such person’s at19 torney or client (as the case may be)) to pay a mon20 etary fine. The court may also impose additional ap21 propriate sanctions, such as striking the pleadings, 

22 dismissing the suit and sanctions plus interest, upon 

23 such person in violation, or upon both such person 

24 and such person’s attorney or client (as the case 

25 may be). 
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1 (3) THIRD AND SUBSEQUENT VIOLATIONS.—If, 

2 after notice and a reasonable opportunity to re3 spond, a court, upon motion or upon its own initia4 tive, determines that subsection (b) has been vio5 lated and that the attorney or party with respect to 

6 which the determination was made has committed 

7 more than one previous violation of subsection (b) 

8 before this or any other court, the court shall find 

9 each such attorney or party in contempt of court, 

10 refer each such attorney to one or more appropriate 

11 State bar associations for disciplinary proceedings, 

12 require the payment of costs and attorneys fees, and 

13 require such person in violation (or both such person 

14 and such person’s attorney or client (as the case 

15 may be)) to pay a monetary fine. The court may 

16 also impose additional appropriate sanctions, such as 

17 striking the pleadings, dismissing the suit, and sanc18 tions plus interest, upon such person in violation, or 

19 upon both such person and such person’s attorney or 

20 client (as the case may be). 

21 (d) CENTRAL TRACKING DATABASE.—The Attorney 

22 General shall establish and maintain a central tracking 

23 database reporting system to which courts are to report 

24 violations of subsection (b). The database shall include all 

25 identifying information with respect to the attorney or the 
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1 party (if not represented by an attorney). The Attorney 

2 General shall permit courts to consult the database to de3 termine the extent to which an attorney or party has vio4 lated subsection (b) previously. 

5 SEC. 104. PERFORMANCE STANDARDS APPLICABLE TO 

6 STATE MEDICAL BOARDS. 

7 (a) DEVELOPMENT.—Not later than 1 year after the 

8 date of the enactment of this Act, the Secretary of Health 

9 and Human Services, in consultation with the Federation 

10 of State Medical Boards, shall develop and make publicly 

11 available voluntary performance standards applicable to 

12 State medical boards. 

13 (b) CONTENTS.—In developing performance stand14 ards under this section, the Secretary shall include stand15 ards to require the following: 

16 (1) Processing patient complaints within a spec17 ified limited period of time. 

18 (2) Maintaining a website or toll-free telephone 

19 number to enable a patient submitting a complaint 

20 to track the status of the complaint. 

21 (3) Maintaining an adequate level of staff for 

22 the activities of the State medical board. 

23 (4) Ensuring that staff are qualified. 

24 (5) Making the following information available 

25 to the public for physicians: 
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1 (A) Each physician’s education and train2 ing. 

3 (B) Each physician’s medical specialties. 

4 (C) For each physician a description of 

5 medical malpractice claims paid, hospital dis6 ciplinary actions taken, criminal convictions oc7 curring, and disciplinary actions taken by the 

8 State medical board, within the previous 10 

9 years. 

10 (D) At the option of a State medical 

11 board, each physician’s professional demo12 graphics (such as business address, insurance 

13 plan and hospital affiliations, and available 

14 translation services), professional or community 

15 awards received, and research or other profes16 sional publications. 

17 (6) Issuing an annual report that includes ag18 gregate disciplinary statistics, including—

19 (A) statistics on the number and type of 

20 complaints received; and 

21 (B) with respect to physicians, statistics on 

22 the number and type of complaints received, 

23 disaggregated by the medical school and grad24 uate medical education program completed by 

25 the physicians involved. 
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1 (7) Such other issues as the Secretary deter2 mines appropriate. 

3 (c) DETERMINATION REQUIRED.—For the period be4 ginning 3 years after the date of the enactment of this 

5 Act, the Secretary shall determine whether the State med6 ical board of each State is in compliance with the vol7 untary performance standards developed under subsection 

8 (a). 

9 (d) DETERMINATION OF NONCOMPLIANCE.—Before 

10 making a determination under subsection (c) that a State 

11 medical board is not in compliance with the voluntary per12 formance standards developed under subsection (a), the 

13 Secretary shall—

14 (1) propose a determination of noncompliance; 

15 (2) identify the reasons for such noncompliance; 

16 and 

17 (3) give the State medical board an opportunity 

18 to correct such noncompliance. 

19 (e) REVISION OF DETERMINATIONS.—The Secretary 

20 shall periodically review and, as necessary, revise deter21 minations of compliance and noncompliance under sub22 section (c). 

23 (f) REPORT BY SECRETARY.—Not later than 5 years 

24 after the date of the enactment of this Act, and annually 

25 thereafter, the Secretary shall submit a report to the Con-
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1 gress on the activities of the Secretary under this section, 

2 including a listing of the State medical boards determined 

3 by the Secretary to be in compliance or not in compliance 

4 with the voluntary standards developed under subsection 

5 (a). 

6 SEC. 105. INTERSTATE PATIENT REPORTING AND PHYSI7 CIAN TRACKING DATABASE. 

8 (a) ESTABLISHMENT.—The Secretary of Health and 

9 Human Services shall establish and maintain an interstate 

10 patient reporting and physician tracking database (in this 

11 section referred to as the ‘‘database’’) . 

12 (b) DATABASE CONTENTS.—

13 (1) IN GENERAL.—The database shall consist of 

14 information about physicians voluntarily submitted 

15 to the database by—

16 (A) State medical boards; and 

17 (B) patients. 

18 (2) SUBMISSIONS BY STATE MEDICAL

19 BOARDS.—The database shall encourage the State 

20 medical board of each State to submit, with respect 

21 to each physician licensed by the State, the fol22 lowing: 

23 (A) The physician’s identity. 

24 (B) The physician’s education and train25 ing. 
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1 (C) The physician’s medical specialties. 

2 (D) A description of medical malpractice 

3 claims paid, hospital disciplinary actions taken, 

4 criminal convictions occurring, and disciplinary 

5 actions taken by the State medical board, with6 in the previous 10 years. 

7 (3) PATIENT COMPLAINTS.—The database 

8 shall—

9 (A) encourage the State medical board of 

10 each State to submit, with respect to each phy11 sician licensed by the State, a description of 

12 pending patient complaints about the physician; 

13 and 

14 (B) allow patients to submit complaints 

15 about physicians directly to the database. 

16 (c) AVAILABILITY OF INFORMATION.—

17 (1) IN GENERAL.—The information submitted 

18 to the database pursuant to subsection (b)(2) shall 

19 be available to the public, including by means of the 

20 Internet and a toll-free telephone number. 

21 (2) PATIENT COMPLAINTS.—

22 (A) CONFIDENTIALITY.—Any patient com23 plaint about a physician submitted to the data24 base shall be kept confidential and shall not be 

25 subject to disclosure under section 552 of title 
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1 5, United States Code. Except as provided in 

2 subparagraph (B), the database may disclose 

3 information derived from such a patient com4 plaint only if the information is not individually 

5 identifiable. 

6 (B) TRACKING PATIENT COMPLAINTS.—

7 The database shall—

8 (i) assign a tracking number to each 

9 patient complaint submitted to the data10 base pursuant to subsection (b)(3); 

11 (ii) provide notice and a description of 

12 each patient complaint submitted pursuant 

13 to subsection (b)(3)(B) to the applicable 

14 State medical board; and 

15 (iii) allow the patient making any 

16 complaint submitted to the database pur17 suant to subsection (b)(3) to track the sta18 tus of the complaint, including by means of 

19 the Internet and a toll-free telephone num20 ber. 

21 (C) ANALYSIS.—Subject to subparagraph 

22 (A), the Secretary of Health and Human Serv23 ices shall conduct analysis of patient complaints 

24 submitted to the database, including complaints 

25 that do not result in disciplinary action, and 
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1 use the data and conclusions derived from such 

2 analysis to provide timely public health safety 

3 information to health care consumers and prac4 titioners. 

5 (d) TECHNICAL ASSISTANCE.—The Secretary of 

6 Health and Human Services shall provide technical assist7 ance to States to facilitate the exchange of information 

8 between State medical boards and the database. 

9 (e) DETERMINATION REQUIRED.—For the period be10 ginning 3 years after the date of the enactment of this 

11 Act, the Secretary shall determine whether the State med12 ical board of each State is failing to submit the informa13 tion described in subsections (b)(2) and (b)(3)(A). 

14 (f) DETERMINATION OF NONCOMPLIANCE.—Before 

15 making a determination under subsection (e) that a State 

16 medical board is failing to submit such information, the 

17 Secretary shall—

18 (1) propose a determination of noncompliance; 

19 (2) identify the reasons for such noncompliance; 

20 and 

21 (3) give the State medical board an opportunity 

22 to correct such noncompliance. 

23 (g) REVISION OF DETERMINATIONS.—The Secretary 

24 shall periodically review and, as necessary, revise deter-
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1 minations of compliance and noncompliance under sub2 section (e). 

3 (h) ASSESSMENT.—Not later than 3 years after the 

4 date of the enactment of this Act, the Secretary shall—

5 (1) conduct an assessment of the database, in6 cluding an assessment of the value of the database 

7 to patients and the effect of the database on physi8 cians; and 

9 (2) submit a report to the Congress on the re10 sults of the assessment, including any recommenda11 tions for improvement of the database. 

12 SEC. 106. REPORT ON MODIFICATION OF MALPRACTICE 

13 PROCEDURES RELATING TO MANDATED 

14 CARE UNDER EMTALA. 

15 (a) ANALYSIS.—The Secretary of Health and Human 

16 Services shall conduct a study on alternatives to the 

17 present medical malpractice litigation and compensation 

18 process in resolving health care malpractice claims arising 

19 out of a screening examination or treatment provided to 

20 comply with the requirements of section 1867 of the Social 

21 Security Act (42 U.S.C. 1395dd), commonly referred to 

22 as EMTALA. 

23 (b) REPORT.—Not later than 2 years after the date 

24 of the enactment of this Act, the Secretary shall submit 

25 to the Congress a report on the study conducted under 
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1 subsection (a). The Secretary shall include in such report 

2 alternatives to medical malpractice litigation and com3 pensation, including medical liability insurance premium 

4 tax credits, no-fault medical liability insurance, and med5 ical malpractice health courts. 

6 SEC. 107. DEFINITIONS. 

7 In this title: 

8 (1) The term ‘‘State medical board’’ means a 

9 State entity responsible for licensing physicians or a 

10 subdivision of such an entity. 

11 (2) The term ‘‘health care malpractice’’ means 

12 the negligence or other fault of a health care pro13 vider. 

14 (3) The term ‘‘health care provider’’ means—

15 (A) any individual who is engaged in the 

16 delivery of health care services in a State and 

17 who is required by State law or regulation to be 

18 licensed or certified by the State to engage in 

19 the delivery of such services in the State; and 

20 (B) any entity that is engaged in the deliv21 ery of health care services in a State and that, 

22 if it is required by State law or regulation to be 

23 licensed or certified by the State to engage in 

24 the delivery of such services in the State, is so 

25 licensed. 
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1 (4) The term ‘‘State’’ includes the District of 

2 Columbia, the Commonwealth of Puerto Rico, and 

3 other territories and possessions of the United 

4 States. 

5 TITLE II—HEALTH CARE MAL6 PRACTICE LIABILITY MEDI7 ATION PROGRAMS 

8 SEC. 201. GRANTS TO STATES AND HEALTH CARE ENTITIES 

9 FOR MEDIATION PROGRAMS. 

10 (a) GRANTS AUTHORIZED.—From amounts made 

11 available to carry out this section, the Attorney General 

12 shall carry out a program under which the Attorney Gen13 eral makes grants to States and health care entities to 

14 carry out mediation programs described in subsection (b). 

15 (b) MEDIATION PROGRAMS.—A mediation program 

16 referred to in subsection (a) is a program, based on the 

17 Rush model, under which an allegation that an individual 

18 has been injured or has died as the result of health care 

19 malpractice is mediated by those parties consenting to do 

20 so in an effort to resolve the matter without litigation. 

21 (c) RUSH MODEL.—For purposes of this section, a 

22 program is based on the Rush model if the program satis23 fies each of the following: 

24 (1) Participation by the parties in the medi25 ation is voluntary. 
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1 (2) At the commencement of a mediation, the 

2 parties enter into a mediation agreement that—

3 (A) states that the parties—

4 (i) will not request or subpoena the 

5 mediator to testify or produce any docu6 ments or other information in any pro7 ceeding related to the mediation; and 

8 (ii) will defend and indemnify the me9 diator in connection with any summons or 

10 subpoena arising out of the mediation pro11 ceeding; 

12 (B) provides for confidentiality of the me13 diation proceedings; and 

14 (C) states that any apology or expression 

15 of remorse by a health care provider or other 

16 entity at any time during the mediation pro17 ceedings will be kept confidential and will not 

18 be used in any subsequent legal proceeding. 

19 (3) The program is similar to the mediation 

20 program carried out as of January 1, 2005, at 

21 Rush-Presbyterian-St. Luke’s Medical Center in Chi22 cago, Illinois. 

23 (d) DEFINITIONS.—In this section: 

24 (1) The term ‘‘health care entity’’ means an en25 tity covered by section 105(3)(B). 
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1 (2) The term ‘‘health care malpractice’’ has the 

2 meaning given such term in section 105. 

3 (3) The term ‘‘State’’ has the meaning given 

4 such term in section 105. 

5 SEC. 202. TRAINING AND ASSISTANCE FOR MEDIATION 

6 PROGRAMS. 

7 From amounts made available to carry out this sec8 tion, the Attorney General shall carry out a program 

9 under which the Attorney General provides training and 

10 assistance to recipients of grant amounts under section 

11 201 to carry out mediation programs under that section. 

12 SEC. 203. AUTHORIZATION OF APPROPRIATIONS. 

13 There are authorized to be appropriated to the Attor14 ney General such sums as may be necessary to carry out 

15 sections 201 and 202. 

16 TITLE III—VOLUNTARY REPORT17 ING OF MEDICAL SAFETY IN18 CIDENTS 

19 Subtitle A—Reporting by Individ20 uals Involved in the Provision 

21 of Health Care 

22 SEC. 301. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT. 

23 (a) IN GENERAL.—Title IX of the Public Health 

24 Service Act (42 U.S.C. 299 et seq.) is amended—
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1 (1) in section 912(c), by inserting ‘‘, in accord2 ance with part C,’’ after ‘‘The Director shall’’; 

3 (2) by redesignating part C as part D; 

4 (3) by redesignating sections 921 through 928, 

5 as sections 931 through 938, respectively; 

6 (4) in section 938(1) (as so redesignated), by 

7 striking ‘‘921’’ and inserting ‘‘931’’; and 

8 (5) by inserting after part B the following: 

9 ‘‘PART C—PATIENT SAFETY IMPROVEMENT 

10 ‘‘SEC. 921. DEFINITIONS. 

11 ‘‘In this part: 

12 ‘‘(1) IDENTIFIABLE INFORMATION.—The term 

13 ‘identifiable information’ means information that is 

14 presented in a form and manner that allows the 

15 identification of any provider, patient, or reporter of 

16 patient safety work product. With respect to pa17 tients, such information includes any individually 

18 identifiable health information as that term is de19 fined in the regulations promulgated pursuant to 

20 section 264(c) of the Health Insurance Portability 

21 and Accountability Act of 1996 (Public Law 104–

22 191; 110 Stat. 2033). 

23 ‘‘(2) NONIDENTIFIABLE INFORMATION.—The 

24 term ‘nonidentifiable information’ means informa25 tion that is presented in a form and manner that 
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1 prevents the identification of any provider, patient, 

2 or reporter of patient safety work product. With re3 spect to patients, such information must be de-iden4 tified consistent with the regulations promulgated 

5 pursuant to section 264(c) of the Health Insurance 

6 Portability and Accountability Act of 1996 (Public 

7 Law 104–191; 110 Stat. 2033). 

8 ‘‘(3) PATIENT SAFETY EVALUATION SYSTEM.—

9 The term ‘patient safety evaluation system’ means a 

10 process that involves the collection, management, or 

11 analysis of information for submission to or by a pa12 tient safety organization. 

13 ‘‘(4) PATIENT SAFETY ORGANIZATION.—The 

14 term ‘patient safety organization’ means a private or 

15 public organization or component thereof that is cer16 tified, through a process to be determined by the 

17 Secretary under section 925, to perform each of the 

18 following activities: 

19 ‘‘(A) The conduct, as the organization or 

20 component’s primary activity, of efforts to im21 prove patient safety and the quality of health 

22 care delivery. 

23 ‘‘(B) The collection and analysis of patient 

24 safety work product that is submitted by pro25 viders. 
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1 ‘‘(C) The development and dissemination 

2 of evidence-based information to providers with 

3 respect to improving patient safety, such as rec4 ommendations, protocols, or information re5 garding best practices. 

6 ‘‘(D) The utilization of patient safety work 

7 product to carry out activities limited to those 

8 described under this paragraph and for the pur9 poses of encouraging a culture of safety and of 

10 providing direct feedback and assistance to pro11 viders to effectively minimize patient risk. 

12 ‘‘(E) The maintenance of confidentiality 

13 with respect to identifiable information. 

14 ‘‘(F) The provision of appropriate security 

15 measures with respect to patient safety work 

16 product. 

17 ‘‘(G) The submission of nonidentifiable in18 formation to the Agency consistent with stand19 ards established by the Secretary under section 

20 923(b) for any National Patient Safety Data21 base. 

22 ‘‘(5) PATIENT SAFETY WORK PRODUCT.—

23 ‘‘(A) The term ‘patient safety work prod24 uct’ means any document or communication 

25 (including any information, report, record, 
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1 memorandum, analysis, deliberative work, state2 ment, or root cause analysis) that—

3 ‘‘(i) except as provided in subpara4 graph (B), is developed by a provider for 

5 the purpose of reporting to a patient safety 

6 organization, and is reported to a patient 

7 safety organization; 

8 ‘‘(ii) is created by a patient safety or9 ganization; or 

10 ‘‘(iii) would reveal the deliberations or 

11 analytic process of a patient safety evalua12 tion system (as defined in paragraph (3)). 

13 ‘‘(B)(i) Patient safety work product de14 scribed in subparagraph (A)(i)—

15 ‘‘(I) does not include any separate in16 formation described in clause (ii); and 

17 ‘‘(II) shall not be construed to include 

18 such separate information merely by rea19 son of inclusion of a copy of the document 

20 or communication involved in a submission 

21 to, or the fact of submission of such a copy 

22 to, a patient safety organization. 

23 ‘‘(ii) Separate information described in this 

24 clause is a document or communication (includ25 ing a patient’s medical record or any other pa-
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1 tient or hospital record) that is developed or 

2 maintained, or exists, separately from any pa3 tient safety evaluation system. 

4 ‘‘(C) Information available from sources 

5 other than a patient safety work product under 

6 this section may be discovered or admitted in a 

7 civil or administrative proceeding, if discover8 able or admissible under applicable law. 

9 ‘‘(6) PROVIDER.—The term ‘provider’ means—

10 ‘‘(A) an individual or entity licensed or 

11 otherwise authorized under State law to provide 

12 health care services, including—

13 ‘‘(i) a hospital, nursing facility, com14 prehensive outpatient rehabilitation facil15 ity, home health agency, and hospice pro16 gram; 

17 ‘‘(ii) a physician, physician assistant, 

18 nurse practitioner, clinical nurse specialist, 

19 certified nurse midwife, nurse anesthetist, 

20 psychologist, certified social worker, reg21 istered dietitian or nutrition professional, 

22 physical or occupational therapist, or other 

23 individual health care practitioner; 

24 ‘‘(iii) a pharmacist; and 
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1 ‘‘(iv) a renal dialysis facility, ambula2 tory surgical center, pharmacy, physician 

3 or health care practitioner’s office, long4 term care facility, behavioral health resi5 dential treatment facility, clinical labora6 tory, or community health center; or 

7 ‘‘(B) any other person or entity specified 

8 in regulations by the Secretary after public no9 tice and comment. 

10 ‘‘SEC. 922. PRIVILEGE FOR PATIENT SAFETY WORK PROD11 UCT. 

12 ‘‘(a) PRIVILEGE.—Notwithstanding any other provi13 sion of law and subject to subsection (c), patient safety 

14 work product shall not be—

15 ‘‘(1) subject to a civil or administrative sub16 poena or order; 

17 ‘‘(2) subject to discovery in connection with a 

18 civil or administrative proceeding; 

19 ‘‘(3) subject to disclosure pursuant to section 

20 552 of title 5, United States Code (commonly known 

21 as the Freedom of Information Act), or any other 

22 similar Federal or State law; 

23 ‘‘(4) required to be admitted as evidence or oth24 erwise disclosed in any State or Federal civil or ad25 ministrative proceeding; or 
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1 ‘‘(5) if the patient safety work product is identi2 fiable information and is received by a national ac3 creditation organization in its capacity as a patient 

4 safety organization—

5 ‘‘(A) used by a national accreditation orga6 nization in an accreditation action against the 

7 provider that reported the information; 

8 ‘‘(B) shared by such organization with its 

9 survey team; or 

10 ‘‘(C) required as a condition of accredita11 tion by a national accreditation association. 

12 ‘‘(b) REPORTER PROTECTION.—

13 ‘‘(1) IN GENERAL.—A provider may not use 

14 against an individual in an adverse employment ac15 tion described in paragraph (2) the fact that the in16 dividual in good faith reported information—

17 ‘‘(A) to the provider with the intention of 

18 having the information reported to a patient 

19 safety organization; or 

20 ‘‘(B) directly to a patient safety organiza21 tion. 

22 ‘‘(2) ADVERSE EMPLOYMENT ACTION.—For 

23 purposes of this subsection, an ‘adverse employment 

24 action’ includes—
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1 ‘‘(A) the failure to promote an individual 

2 or provide any other employment-related benefit 

3 for which the individual would otherwise be eli4 gible; 

5 ‘‘(B) an adverse evaluation or decision 

6 made in relation to accreditation, certification, 

7 credentialing, or licensing of the individual; and 

8 ‘‘(C) a personnel action that is adverse to 

9 the individual concerned. 

10 ‘‘(3) REMEDIES.—Any provider that violates 

11 this subsection shall be subject to a civil monetary 

12 penalty of not more than $20,000 for each such vio13 lation involved. Such penalty shall be imposed and 

14 collected in the same manner as civil money pen15 alties under subsection (a) of section 1128A of the 

16 Social Security Act are imposed and collected. 

17 ‘‘(c) DISCLOSURES.—Nothing in this section pro18 hibits any of the following disclosures: 

19 ‘‘(1) Voluntary disclosure of nonidentifiable in20 formation. 

21 ‘‘(2) Voluntary disclosure of identifiable infor22 mation by a provider or patient safety organization, 

23 if such disclosure—

24 ‘‘(A) is authorized by the provider for the 

25 purposes of improving quality and safety; 
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1 ‘‘(B) is to an entity or person subject to 

2 the requirements of section 264(c) of the 

3 Health Insurance Portability and Accountability 

4 Act of 1996 (Public Law 104–191; 110 Stat. 

5 2033), or any regulation promulgated under 

6 such section; and 

7 ‘‘(C) is not in conflict with such section or 

8 any regulation promulgated under such section. 

9 ‘‘(3) Disclosure as required by law by a pro10 vider to the Food and Drug Administration, or on 

11 a voluntary basis by a provider to a federally estab12 lished patient safety program, with respect to an Ad13 ministration-regulated product or activity for which 

14 that entity has responsibility, for the purposes of ac15 tivities related to the quality, safety, or effectiveness 

16 of such Administration-regulated product or activity. 

17 ‘‘(4) Disclosures of patient safety work product 

18 in accordance with this part by a provider to a pa19 tient safety organization. 

20 ‘‘(d) EFFECT OF TRANSFER, DISCLOSURE.—The fol21 lowing shall not be treated as a waiver of any privilege 

22 or protection established under this part: 

23 ‘‘(1) The transfer of any patient safety work 

24 product between a provider and a patient safety or25 ganization. 
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1 ‘‘(2) Disclosure of patient safety work product 

2 as described in subsection (c). 

3 ‘‘(3) The unauthorized disclosure of patient 

4 safety work product. 

5 ‘‘(e) PENALTY.—

6 ‘‘(1) PROHIBITION.—Except as provided in this 

7 part, and subject to paragraphs (2) and (4), it shall 

8 be unlawful for any person to disclose patient safety 

9 work product in violation of this section, if such dis10 closure constitutes a negligent or knowing breach of 

11 confidentiality. 

12 ‘‘(2) RELATION TO HIPAA.—The penalty under 

13 paragraph (3) for a disclosure in violation of para14 graph (1) does not apply if the person would be sub15 ject to a penalty under section 264(c) of the Health 

16 Insurance Portability and Accountability Act of 

17 1996 (Public Law 104–191; 110 Stat. 2033), or any 

18 regulation promulgated under such section, for the 

19 same disclosure. 

20 ‘‘(3) AMOUNT.—Any person who violates para21 graph (1) shall be subject to a civil monetary penalty 

22 of not more than $10,000 for each such violation in23 volved. Such penalty shall be imposed and collected 

24 in the same manner as civil money penalties under 
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1 subsection (a) of section 1128A of the Social Secu2 rity Act are imposed and collected. 

3 ‘‘(4) SUBSEQUENT DISCLOSURE.—Paragraph 

4 (1) applies only to the first person that breaches 

5 confidentiality with respect to particular patient 

6 safety work product. 

7 ‘‘(f) RELATION TO HIPAA.—

8 ‘‘(1) IN GENERAL.—For purposes of applying 

9 the regulations promulgated pursuant to section 

10 264(c) of the Health Insurance Portability and Ac11 countability Act of 1996 (Public Law 104–191; 110 

12 Stat. 2033)—

13 ‘‘(A) patient safety organizations shall be 

14 treated as business associates; and 

15 ‘‘(B) activities of such organizations de16 scribed in section 921(4) in relation to a pro17 vider are deemed to be health care operations 

18 (as defined in such regulations) of the provider. 

19 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in 

20 this section shall be construed to alter or affect the 

21 implementation of such regulations or such section 

22 264(c). 

23 ‘‘(g) NO LIMITATION OF OTHER PRIVILEGES.—

24 Nothing in this section shall be construed to affect privi25 leges, including peer review and confidentiality protec-
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1 tions, that are otherwise available under Federal or State 

2 laws. 

3 ‘‘(h) NO LIMITATION ON CONTRACTS.—Nothing in 

4 this section shall be construed to limit the power of a pro5 vider and a patient safety organization, or a patient safety 

6 organization and the Agency or any National Patient 

7 Safety Database, consistent with the provisions of this Act 

8 and other applicable law, to enter into a contract requiring 

9 greater confidentiality or delegating authority to make an 

10 authorized disclosure. 

11 ‘‘(i) RELATION TO STATE REPORTING REQUIRE12 MENTS.—Nothing in this part shall be construed as pre13 empting or otherwise affecting any State law requiring a 

14 provider to report information, including information de15 scribed in section 921(5)(B), that is not patient safety 

16 work product. 

17 ‘‘(j) CONTINUATION OF PRIVILEGE.—Patient safety 

18 work product of an organization that is certified as a pa19 tient safety organization shall continue to be privileged 

20 and confidential, in accordance with this section, if the or21 ganization’s certification is terminated or revoked or if the 

22 organization otherwise ceases to qualify as a patient safety 

23 organization. 

24 ‘‘(k) REPORTS ON STRATEGIES TO IMPROVE PA25 TIENT SAFETY.—
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1 ‘‘(1) DRAFT REPORT.—Not later than the date 

2 that is 18 months after any National Patient Safety 

3 Database is operational, the Secretary, in consulta4 tion with the Director, shall prepare a draft report 

5 on effective strategies for reducing medical errors 

6 and increasing patient safety. The draft report shall 

7 include any measure determined appropriate by the 

8 Secretary to encourage the appropriate use of such 

9 strategies, including use in any federally funded pro10 grams. The Secretary shall make the draft report 

11 available for public comment and submit the draft 

12 report to the Institute of Medicine for review. 

13 ‘‘(2) FINAL REPORT.—Not later than 1 year 

14 after the date described in paragraph (1), the Sec15 retary shall submit a final report to the Congress 

16 that includes, in an appendix, any findings by the 

17 Institute of Medicine concerning research on the 

18 strategies discussed in the draft report and any 

19 modifications made by the Secretary based on such 

20 findings. 

21 ‘‘SEC. 923. NATIONAL PATIENT SAFETY DATABASE. 

22 ‘‘(a) AUTHORITY.—

23 ‘‘(1) IN GENERAL.—In conducting activities 

24 under this part, the Secretary shall provide for the 

25 establishment and maintenance of a database to re-
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1 ceive relevant nonidentifiable patient safety work 

2 product, and may designate entities to collect rel3 evant nonidentifiable patient safety work product 

4 that is voluntarily reported by patient safety organi5 zations upon the request of the Secretary. Any data6 base established or designated under this paragraph 

7 may be referred to as a ‘National Patient Safety 

8 Database’. 

9 ‘‘(2) USE OF INFORMATION.—Information re10 ported to any National Patient Safety Database 

11 shall be used to analyze national and regional statis12 tics, including trends and patterns of health care er13 rors. The information resulting from such analyses 

14 may be included in the annual quality reports pre15 pared under section 913(b)(2). 

16 ‘‘(3) ADVISORY ROLE.—The Secretary shall 

17 provide scientific support to patient safety organiza18 tions, including the dissemination of methodologies 

19 and evidence-based information related to root 

20 causes and quality improvement. 

21 ‘‘(b) STANDARDS.—In establishing or designating a 

22 database under subsection (a)(1), the Secretary shall, in 

23 consultation with representatives of patient safety organi24 zations, the provider community, and the health informa25 tion technology industry, determine common formats for 
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1 the voluntary reporting of nonidentifiable patient safety 

2 work product, including necessary elements, common and 

3 consistent definitions, and a standardized computer inter4 face for the processing of the work product. To the extent 

5 practicable, such standards shall be consistent with the 

6 administrative simplification provisions of part C of title 

7 XI of the Social Security Act. 

8 ‘‘(c) CERTAIN METHODOLOGIES FOR COLLECTION.—

9 The Secretary shall ensure that the methodologies for the 

10 collection of nonidentifiable patient safety work product 

11 for any National Patient Safety Database include the 

12 methodologies developed or recommended by the Patient 

13 Safety Task Force of the Department of Health and 

14 Human Services. 

15 ‘‘(d) FACILITATION OF INFORMATION EXCHANGE.—

16 To the extent practicable, the Secretary may facilitate the 

17 direct link of information between providers and patient 

18 safety organizations and between patient safety organiza19 tions and any National Patient Safety Database. 

20 ‘‘(e) RESTRICTION ON TRANSFER.—Only nonidentifi21 able information may be transferred to any National Pa22 tient Safety Database. 

23 ‘‘SEC. 924. TECHNICAL ASSISTANCE. 

24 ‘‘(a) IN GENERAL.—The Secretary, acting through 

25 the Director, may—
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1 ‘‘(1) provide technical assistance to patient 

2 safety organizations, and to States with reporting 

3 systems for health care errors; and 

4 ‘‘(2) provide guidance on the type of data to be 

5 voluntarily submitted to any National Patient Safety 

6 Database. 

7 ‘‘(b) ANNUAL MEETINGS.—Assistance provided 

8 under subsection (a) may include annual meetings for pa9 tient safety organizations to discuss methodology, commu10 nication, information collection, or privacy concerns. 

11 ‘‘SEC. 925. CERTIFICATION OF PATIENT SAFETY ORGANIZA12 TIONS. 

13 ‘‘(a) IN GENERAL.—Not later than 6 months after 

14 the date of enactment of the Patient Safety and Quality 

15 Improvement Act, the Secretary shall establish a process 

16 for certifying patient safety organizations. 

17 ‘‘(b) PROCESS.—The process established under sub18 section (a) shall include the following: 

19 ‘‘(1) Certification of patient safety organiza20 tions by the Secretary or by such other national or 

21 State governmental organizations as the Secretary 

22 determines appropriate. 

23 ‘‘(2) If the Secretary allows other governmental 

24 organizations to certify patient safety organizations 

25 under paragraph (1), the Secretary shall establish a 
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1 process for approving such organizations. Any such 

2 approved organization shall conduct certifications 

3 and reviews in accordance with this section. 

4 ‘‘(3) A review of each certification under para5 graph (1) (including a review of compliance with 

6 each criterion in this section and any related imple7 menting standards as determined by the Secretary 

8 through rulemaking) not less often than every 3 

9 years, as determined by the Secretary. 

10 ‘‘(4) Revocation of any such certification by the 

11 Secretary or other such governmental organization 

12 that issued the certification, upon a showing of 

13 cause. 

14 ‘‘(c) CRITERIA.—A patient safety organization must 

15 meet the following criteria as conditions of certification: 

16 ‘‘(1) The mission of the patient safety organiza17 tion is to conduct activities that are to improve pa18 tient safety and the quality of health care delivery 

19 and is not in conflict of interest with the providers 

20 that contract with the patient safety organization. 

21 ‘‘(2) The patient safety organization has appro22 priately qualified staff, including licensed or certified 

23 medical professionals. 

24 ‘‘(3) The patient safety organization, within any 

25 2 year period, contracts with more than 1 provider 
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1 for the purpose of receiving and reviewing patient 

2 safety work product. 

3 ‘‘(4) The patient safety organization is not a 

4 component of a health insurer or other entity that 

5 offers a group health plan or health insurance cov6 erage. 

7 ‘‘(5) The patient safety organization is man8 aged, controlled, and operated independently from 

9 any provider that contracts with the patient safety 

10 organization for reporting patient safety work prod11 uct. 

12 ‘‘(6) To the extent practical and appropriate, 

13 the patient safety organization collects patient safety 

14 work product from providers in a standardized man15 ner that permits valid comparisons of similar cases 

16 among similar providers. 

17 ‘‘(d) ADDITIONAL CRITERIA FOR COMPONENT ORGA18 NIZATIONS.—If a patient safety organization is a compo19 nent of another organization, the patient safety organiza20 tion must, in addition to meeting the criteria described 

21 in subsection (c), meet the following criteria as conditions 

22 of certification: 

23 ‘‘(1) The patient safety organization maintains 

24 patient safety work product separately from the rest 

25 of the organization, and establishes appropriate se-
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1 curity measures to maintain the confidentiality of 

2 the patient safety work product. 

3 ‘‘(2) The patient safety organization does not 

4 make an unauthorized disclosure under this Act of 

5 patient safety work product to the rest of the orga6 nization in breach of confidentiality. 

7 ‘‘(3) The mission of the patient safety organiza8 tion does not create a conflict of interest with the 

9 rest of the organization.’’. 

10 (b) AUTHORIZATION OF APPROPRIATIONS.—Section 

11 937 of the Public Health Service Act (as redesignated by 

12 subsection (a)) is amended by adding at the end the fol13 lowing: 

14 ‘‘(e) PATIENT SAFETY AND QUALITY IMPROVE15 MENT.—For the purpose of carrying out part C, there are 

16 authorized to be appropriated such sums as may be nec17 essary for each of the fiscal years 2006 through 2010.’’. 

18 Subtitle B—Liability Protection in 

19 Good-faith Reporting 

20 SEC. 311. LIABILITY PROTECTION FOR HEALTH CARE PRO21 VIDERS IN GOOD-FAITH REPORTING TO 

22 STATE MEDICAL BOARDS. 

23 (a) IN GENERAL.—Notwithstanding any other provi24 sion of law, no health care provider providing information 

25 (including by making a report, filing charges, or pre-
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1 senting evidence) to a State medical board regarding the 

2 competence or professional conduct of a physician shall 

3 be held, by reason of having provided such information, 

4 to be liable in damages under any law of the United States 

5 or of any State (or political subdivision thereof) unless 

6 such information is false and the person providing the in7 formation knew that the information was false. 

8 (b) ATTORNEY FEES.—If a health care provider es9 tablishes in a civil action that the health care provider is 

10 not liable in damages because of the application of sub11 section (a), the court shall award to the provider any at12 torney fees and costs incurred by the provider in estab13 lishing the application of subsection (a). 

14 (c) DEFINITION.—In this section, the term ‘‘State 

15 medical board’’ means a State entity responsible for li16 censing physicians or a subdivision of such an entity. 

17 TITLE IV—INSURANCE REFORM 

18 SEC. 401. UNIFORM STATE REQUIREMENTS REGARDING 

19 PROPOSED RATE INCREASES. 

20 (a) IN GENERAL.—The Congress intends that each 

21 State have in effect laws or regulations providing that—

22 (1) a provider of medical malpractice insurance 

23 in the State may not implement any increase in the 

24 rate for such insurance that would result in such 

25 rate increasing more than a certain percentage, as 
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1 specified in such laws or regulations, within a cer2 tain period of time, as specified in such laws or reg3 ulations, unless, before such increase takes effect—

4 (A) the provider submits to an appropriate 

5 State agency a description and justification of 

6 the rate increase; and 

7 (B) such agency makes a determination 

8 that the increase is justified; and 

9 (2) any determination referred to in paragraph 

10 (1)(B) regarding an increase in medical malpractice 

11 insurance rates is made pursuant to an administra12 tive hearing held by the appropriate State agency; 

13 and 

14 (3) any individual or institution that is involved 

15 in the provision of health care and is licensed by the 

16 State to provide such care has standing, in any ad17 ministrative proceeding of the State regarding a pro18 posed increase in the rate for medical malpractice 

19 insurance (including a hearing referred to in para20 graph (2)), to challenge such increase. 

21 (b) REPORT.—Not later than 2 years after the date 

22 of the enactment of this Act, the Secretary of Health and 

23 Human Services shall—

24 (1) conduct and complete a survey of the laws 

25 and regulations of the States to determine the extent 
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1 to which the States have in effects laws or regula2 tions described in subsection (a); and 

3 (2) submit a report to the Congress setting 

4 forth the results of the survey, describing such laws 

5 and regulations of the various States, and describing 

6 the extent of the uniformity of such laws and regula7 tions. 

8 (c) DEFINITION.—For purposes of this section, the 

9 term ‘‘State’’ has the meaning given such term in section 

10 105. 

11 (d) EFFECTIVE DATE.—This section shall take effect 

12 on the date of the enactment of this Act. 

13 SEC. 402. REDUCTION IN PREMIUMS PAID BY PHYSICIANS 

14 FOR MEDICAL MALPRACTICE INSURANCE 

15 COVERAGE. 

16 (a) IN GENERAL.—Not later than 180 days after the 

17 date of the enactment of this Act, each medical mal18 practice liability insurance company shall—

19 (1) develop a reasonable estimate of the annual 

20 amount of financial savings that will be achieved by 

21 the company as a result of section 101; 

22 (2) develop and implement a plan to annually 

23 dedicate at least 50 percent of such annual savings 

24 to reduce the amount of premiums that the company 
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1 charges physicians for medical malpractice liability 

2 coverage; and 

3 (3) submit to the Secretary of Health and 

4 Human Services (in this subsection referred to as 

5 the ‘‘Secretary’’) a written certification that the 

6 company has complied with paragraphs (1) and (2). 

7 (b) REPORTS.—Not later than one year after the date 

8 of the enactment of this Act and annually thereafter, each 

9 medical malpractice liability insurance company shall sub10 mit to the Secretary a report that identifies the percentage 

11 by which the company has reduced medical malpractice 

12 coverage premiums relative to the date of the enactment 

13 of this Act. 

14 (c) ENFORCEMENT.—A medical malpractice liability 

15 insurance company that violates a provision of this section 

16 is liable to the United States for a civil penalty in an 

17 amount assessed by the Secretary, not to exceed $11,000 

18 for each such violation. The provisions of paragraphs (3) 

19 through (5) of section 303(g) of the Federal Food, Drug, 

20 and Cosmetic Act apply to such a civil penalty to the same 

21 extent and in the same manner as such paragraphs apply 

22 to a civil penalty under such section. 

23 (d) DEFINITION.—For purposes of this section, the 

24 term ‘‘medical malpractice liability insurance company’’ 

25 means an entity in the business of providing an insurance 
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1 policy under which the entity makes payment in settlement 

2 (or partial settlement) of, or in satisfaction of a judgment 

3 in, a medical malpractice action or claim. 

4 SEC. 403. EFFECTIVE DATE. 

5 Except as provided in section 401(d), this title shall 

6 take effect 1 year after the date of the enactment of this 

7 Act. 

8 TITLE V—EXCLUSION OF PHAR9 MACEUTICALS AND DEVICES 

10 FROM LIABILITY REFORMS 

11 SEC. 501. EXCLUSION OF PHARMACEUTICALS AND DE12 VICES. 

13 For purposes of title I and II of this Act, the manu14 facturer or distributor of a pharmaceutical or device is not 

15 a health care provider, and health care malpractice does 

16 not include responsibility based on products liability.

Æ