I 

109TH CONGRESS 

1ST SESSION H. R. 3378 

To provide comprehensive reform regarding medical malpractice. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 21, 2005 

Mr. BAIRD (for himself, Mr. MORAN of Virginia, Mr. RUPPERSBERGER, and 

Mr. LIPINSKI) 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. Sanctions for meritless actions and pleadings. 

Sec. 103. Performance standards applicable to State medical boards. 

Sec. 104. Interstate patient reporting and physician tracking database. 

Sec. 105. 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 

8 provider responsible for that malpractice may not recover 
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1 such damages, in the aggregate from all such providers, 

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

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

4 applies separately to each person entitled to recover such 

5 damages. 

6 (b) ADJUSTMENT FOR INFLATION FROM 1975.— 

7 (1) PUBLICATION BY SECRETARY OF LABOR.— 

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

9 of Labor shall publish in the Federal Register a dol10 lar amount determined by adjusting the dollar 

11 amount specified in subsection (a) according to the 

12 adjustments in the Consumer Price Index of the Bu13 reau of Labor Statistics of the Department of Labor 

14 for the period beginning on or about October 1, 

15 1975, and ending on or about October 1 of that 

16 year. 

17 (2) APPLICABILITY.—For purposes of sub18 section (a), the dollar amount that applies to a cal19 endar year is the dollar amount published on or 

20 about December 1 of the preceding year. 

21 (3) ESTIMATION.—Congress estimates that the 

22 dollar amount that would apply to calendar year 

23 2005 would be approximately $878,000, though the 

24 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 103 or is failing to submit the information de16 scribed in paragraphs (2) and (3)(A) of section 

17 104(b) (as determined by the Secretary under sec18 tion 103 or 104, 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. SANCTIONS FOR MERITLESS ACTIONS AND 

2 PLEADINGS. 

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

4 motion, and other paper in any medical malpractice action 

5 shall be signed by at least 1 attorney of record in the at6 torney’s individual name, or, if the party is not rep7 resented by an attorney, shall be signed by the party. Each 

8 paper shall state the signer’s address and telephone num9 ber, if any. An unsigned paper shall be stricken unless 

10 omission of the signature is corrected promptly after being 

11 called to the attention of the attorney or party. 

12 (b) CERTIFICATE OF MERIT.— 

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

14 shall be dismissed unless the attorney or unrepre15 sented party presenting the complaint certifies that, 

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

17 and belief, formed after an inquiry reasonable under 

18 the circumstances— 

19 (A) it is not being presented for any im20 proper purpose, such as to harass or to cause 

21 unnecessary delay or needless increase in the 

22 cost of litigation; 

23 (B) the claims and other legal contentions 

24 therein are warranted by existing law or by a 

25 nonfrivolous argument for the extension, modi-
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1 fication, or reversal of existing law or the estab2 lishment of new law; and 

3 (C) the allegations and other factual con4 tentions have evidentiary support or, if specifi5 cally so identified, are likely to have evidentiary 

6 support after a reasonable opportunity for fur7 ther investigation and discovery. 

8 (2) PAPER CONSIDERED TO BE A CERTIFI9 CATION.—By presenting to the court (whether by 

10 signing, filing, submitting, or later advocating) a 

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

12 or unrepresented party is certifying that to the best 

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

14 formed after an inquiry reasonable under the cir15 cumstances— 

16 (A) it is not being presented for any im17 proper purpose, such as to harass or to cause 

18 unnecessary delay or needless increase in the 

19 cost of litigation; 

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

21 contentions therein are warranted by existing 

22 law or by a nonfrivolous argument for the ex23 tension, modification, or reversal of existing law 

24 or the establishment of new law; and 
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1 (C) the allegations and other factual con2 tentions have evidentiary support or, if specifi3 cally so identified, are reasonable based on a 

4 lack of information or belief. 

5 (c) MANDATORY SANCTIONS.— 

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

7 reasonable opportunity to respond, a court, upon 

8 motion or upon its own initiative, determines that 

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

10 each attorney or party in violation in contempt of 

11 court and shall require the payment of costs and at12 torneys fees. The court may also impose additional 

13 appropriate sanctions, such as striking the plead14 ings, dismissing the suit, and sanctions plus interest, 

15 upon the person in violation, or upon both such per16 son and such person’s attorney or client (as the case 

17 may be). 

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

19 reasonable opportunity to respond, a court, upon 

20 motion or upon its own initiative, determines that 

21 subsection (b) has been violated and that the attor22 ney or party with respect to which the determination 

23 was made has committed one previous violation of 

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

25 court shall find each such attorney or party in con-
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1 tempt of court and shall require the payment of 

2 costs and attorneys fees, and require such person in 

3 violation (or both such person and such person’s at4 torney or client (as the case may be)) to pay a mon5 etary fine. The court may also impose additional ap6 propriate sanctions, such as striking the pleadings, 

7 dismissing the suit and sanctions plus interest, upon 

8 such person in violation, or upon both such person 

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

10 may be). 

11 (3) THIRD AND SUBSEQUENT VIOLATIONS.—If, 

12 after notice and a reasonable opportunity to re13 spond, a court, upon motion or upon its own initia14 tive, determines that subsection (b) has been vio15 lated and that the attorney or party with respect to 

16 which the determination was made has committed 

17 more than one previous violation of subsection (b) 

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

19 each such attorney or party in contempt of court, 

20 refer each such attorney to one or more appropriate 

21 State bar associations for disciplinary proceedings, 

22 require the payment of costs and attorneys fees, and 

23 require such person in violation (or both such person 

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

25 may be)) to pay a monetary fine. The court may 
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1 also impose additional appropriate sanctions, such as 

2 striking the pleadings, dismissing the suit, and sanc3 tions plus interest, upon such person in violation, or 

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

5 client (as the case may be). 

6 (d) CENTRAL TRACKING DATABASE.—The Attorney 

7 General shall establish and maintain a central tracking 

8 database reporting system to which courts are to report 

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

10 identifying information with respect to the attorney or the 

11 party (if not represented by an attorney). The Attorney 

12 General shall permit courts to consult the database to de13 termine the extent to which an attorney or party has vio14 lated subsection (b) previously. 

15 SEC. 103. PERFORMANCE STANDARDS APPLICABLE TO 

16 STATE MEDICAL BOARDS. 

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

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

19 and Human Services, in consultation with the Federation 

20 of State Medical Boards, shall develop and make publicly 

21 available voluntary performance standards applicable to 

22 State medical boards. 

23 (b) CONTENTS.—In developing performance stand24 ards under this section, the Secretary shall include stand25 ards to require the following: 
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1 (1) Processing patient complaints within a spec2 ified limited period of time. 

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

4 number to enable a patient submitting a complaint 

5 to track the status of the complaint. 

6 (3) Maintaining an adequate level of staff for 

7 the activities of the State medical board. 

8 (4) Ensuring that staff are qualified. 

9 (5) Making the following information available 

10 to the public for physicians: 

11 (A) Each physician’s education and train12 ing. 

13 (B) Each physician’s medical specialties. 

14 (C) For each physician a description of 

15 medical malpractice claims paid, hospital dis16 ciplinary actions taken, criminal convictions oc17 curring, and disciplinary actions taken by the 

18 State medical board, within the previous 10 

19 years. 

20 (D) At the option of a State medical 

21 board, each physician’s professional demo22 graphics (such as business address, insurance 

23 plan and hospital affiliations, and available 

24 translation services), professional or community 
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1 awards received, and research or other profes2 sional publications. 

3 (6) Issuing an annual report that includes ag4 gregate disciplinary statistics, including— 

5 (A) statistics on the number and type of 

6 complaints received; and 

7 (B) with respect to physicians, statistics on 

8 the number and type of complaints received, 

9 disaggregated by the medical school and grad10 uate medical education program completed by 

11 the physicians involved. 

12 (7) Such other issues as the Secretary deter13 mines appropriate. 

14 (c) DETERMINATION REQUIRED.—For the period be15 ginning 3 years after the date of the enactment of this 

16 Act, the Secretary shall determine whether the State med17 ical board of each State is in compliance with the vol18 untary performance standards developed under subsection 

19 (a). 

20 (d) DETERMINATION OF NONCOMPLIANCE.—Before 

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

22 medical board is not in compliance with the voluntary per23 formance standards developed under subsection (a), the 

24 Secretary shall— 

25 (1) propose a determination of noncompliance; 
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1 (2) identify the reasons for such noncompliance; 

2 and 

3 (3) give the State medical board an opportunity 

4 to correct such noncompliance. 

5 (e) REVISION OF DETERMINATIONS.—The Secretary 

6 shall periodically review and, as necessary, revise deter7 minations of compliance and noncompliance under sub8 section (c). 

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

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

11 thereafter, the Secretary shall submit a report to the Con12 gress on the activities of the Secretary under this section, 

13 including a listing of the State medical boards determined 

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

15 with the voluntary standards developed under subsection 

16 (a). 

17 SEC. 104. INTERSTATE PATIENT REPORTING AND PHYSI18 CIAN TRACKING DATABASE. 

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

20 Human Services shall establish and maintain an interstate 

21 patient reporting and physician tracking database (in this 

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

23 (b) DATABASE CONTENTS.— 
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1 (1) IN GENERAL.—The database shall consist of 

2 information about physicians voluntarily submitted 

3 to the database by— 

4 (A) State medical boards; and 

5 (B) patients. 

6 (2) SUBMISSIONS BY STATE MEDICAL

7 BOARDS.—The database shall encourage the State 

8 medical board of each State to submit, with respect 

9 to each physician licensed by the State, the fol10 lowing: 

11 (A) The physician’s identity. 

12 (B) The physician’s education and train13 ing. 

14 (C) The physician’s medical specialties. 

15 (D) A description of medical malpractice 

16 claims paid, hospital disciplinary actions taken, 

17 criminal convictions occurring, and disciplinary 

18 actions taken by the State medical board, with19 in the previous 10 years. 

20 (3) PATIENT COMPLAINTS.—The database 

21 shall— 

22 (A) encourage the State medical board of 

23 each State to submit, with respect to each phy24 sician licensed by the State, a description of 
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1 pending patient complaints about the physician; 

2 and 

3 (B) allow patients to submit complaints 

4 about physicians directly to the database. 

5 (c) AVAILABILITY OF INFORMATION.— 

6 (1) IN GENERAL.—The information submitted 

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

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

9 Internet and a toll-free telephone number. 

10 (2) PATIENT COMPLAINTS.— 

11 (A) CONFIDENTIALITY.—Any patient com12 plaint about a physician submitted to the data13 base shall be kept confidential and shall not be 

14 subject to disclosure under section 552 of title 

15 5, United States Code. Except as provided in 

16 subparagraph (B), the database may disclose 

17 information derived from such a patient com18 plaint only if the information is not individually 

19 identifiable. 

20 (B) TRACKING PATIENT COMPLAINTS.— 

21 The database shall— 

22 (i) assign a tracking number to each 

23 patient complaint submitted to the data24 base pursuant to subsection (b)(3); 
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1 (ii) provide notice and a description of 

2 each patient complaint submitted pursuant 

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

4 State medical board; and 

5 (iii) allow the patient making any 

6 complaint submitted to the database pur7 suant to subsection (b)(3) to track the sta8 tus of the complaint, including by means of 

9 the Internet and a toll-free telephone num10 ber. 

11 (C) ANALYSIS.—Subject to subparagraph 

12 (A), the Secretary of Health and Human Serv13 ices shall conduct analysis of patient complaints 

14 submitted to the database, including complaints 

15 that do not result in disciplinary action, and 

16 use the data and conclusions derived from such 

17 analysis to provide timely public health safety 

18 information to health care consumers and prac19 titioners. 

20 (d) TECHNICAL ASSISTANCE.—The Secretary of 

21 Health and Human Services shall provide technical assist22 ance to States to facilitate the exchange of information 

23 between State medical boards and the database. 

24 (e) DETERMINATION REQUIRED.—For the period be25 ginning 3 years after the date of the enactment of this 
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1 Act, the Secretary shall determine whether the State med2 ical board of each State is failing to submit the informa3 tion described in subsections (b)(2) and (b)(3)(A). 

4 (f) DETERMINATION OF NONCOMPLIANCE.—Before 

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

6 medical board is failing to submit such information, the 

7 Secretary shall— 

8 (1) propose a determination of noncompliance; 

9 (2) identify the reasons for such noncompliance; 

10 and 

11 (3) give the State medical board an opportunity 

12 to correct such noncompliance. 

13 (g) REVISION OF DETERMINATIONS.—The Secretary 

14 shall periodically review and, as necessary, revise deter15 minations of compliance and noncompliance under sub16 section (e). 

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

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

19 (1) conduct an assessment of the database, in20 cluding an assessment of the value of the database 

21 to patients and the effect of the database on physi22 cians; and 

23 (2) submit a report to the Congress on the re24 sults of the assessment, including any recommenda25 tions for improvement of the database. 
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1 SEC. 105. DEFINITIONS. 

2 In this title: 

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

4 State entity responsible for licensing physicians or a 

5 subdivision of such an entity. 

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

7 the negligence or other fault of a health care pro8 vider. 

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

10 (A) any individual who is engaged in the 

11 delivery of health care services in a State and 

12 who is required by State law or regulation to be 

13 licensed or certified by the State to engage in 

14 the delivery of such services in the State; and 

15 (B) any entity that is engaged in the deliv16 ery of health care services in a State and that, 

17 if it 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, is so 

20 licensed. 

21 (4) The term ‘‘State’’ includes the District of 

22 Columbia, the Commonwealth of Puerto Rico, and 

23 other territories and possessions of the United 

24 States. 
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1 TITLE II—HEALTH CARE MAL2 PRACTICE LIABILITY MEDI3 ATION PROGRAMS 

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

5 FOR MEDIATION PROGRAMS. 

6 (a) GRANTS AUTHORIZED.—From amounts made 

7 available to carry out this section, the Attorney General 

8 shall carry out a program under which the Attorney Gen9 eral makes grants to States and health care entities to 

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

11 (b) MEDIATION PROGRAMS.—A mediation program 

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

13 Rush model, under which an allegation that an individual 

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

15 malpractice is mediated by those parties consenting to do 

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

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

18 program is based on the Rush model if the program satis19 fies each of the following: 

20 (1) Participation by the parties in the medi21 ation is voluntary. 

22 (2) The mediator is neutral, having no interest 

23 in or power to determine the outcome of the pro24 ceedings. 
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1 (3) The site of the mediation conference is held 

2 in a neutral setting, one that the parties mutually 

3 agree upon. 

4 (4) At the commencement of a mediation, the 

5 parties enter into a mediation agreement that— 

6 (A) states that the parties— 

7 (i) will not request or subpoena the 

8 mediator to testify or produce any docu9 ments or other information in any pro10 ceeding related to the mediation; and 

11 (ii) will defend and indemnify the me12 diator in connection with any summons or 

13 subpoena arising out of the mediation pro14 ceeding; 

15 (B) provides for confidentiality of the me16 diation proceedings; and 

17 (C) states that any apology or expression 

18 of remorse by a health care provider or other 

19 entity at any time during the mediation pro20 ceedings will be kept confidential and will not 

21 be used in any subsequent legal proceeding. 

22 (5) The program is similar to the mediation 

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

24 Rush-Presbyterian-St. Luke’s Medical Center in Chi25 cago, Illinois. 
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1 (d) DEFINITIONS.—In this section: 

2 (1) The term ‘‘health care entity’’ means an en3 tity covered by section 105(3)(B). 

4 (2) The term ‘‘health care malpractice’’ has the 

5 meaning given such term in section 105. 

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

7 such term in section 105. 

8 SEC. 202. TRAINING AND ASSISTANCE FOR MEDIATION 

9 PROGRAMS. 

10 From amounts made available to carry out this sec11 tion, the Attorney General shall carry out a program 

12 under which the Attorney General provides training and 

13 assistance to recipients of grant amounts under section 

14 201 to carry out mediation programs under that section. 

15 SEC. 203. AUTHORIZATION OF APPROPRIATIONS. 

16 There are authorized to be appropriated to the Attor17 ney General such sums as may be necessary to carry out 

18 sections 201 and 202. 
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1 TITLE III—VOLUNTARY REPORT2 ING OF MEDICAL SAFETY IN3 CIDENTS 

4 Subtitle A—Reporting by Individ5 uals Involved in the Provision 

6 of Health Care 

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

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

9 Service Act (42 U.S.C. 299 et seq.) is amended— 

10 (1) in section 912(c), by inserting ‘‘, in accord11 ance with part C,’’ after ‘‘The Director shall’’; 

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

13 (3) by redesignating sections 921 through 928, 

14 as sections 931 through 938, respectively; 

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

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

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

18 ‘‘PART C—PATIENT SAFETY IMPROVEMENT 

19 ‘‘SEC. 921. DEFINITIONS. 

20 ‘‘In this part: 

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

22 ‘identifiable information’ means information that is 

23 presented in a form and manner that allows the 

24 identification of any provider, patient, or reporter of 

25 patient safety work product. With respect to pa-
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1 tients, such information includes any individually 

2 identifiable health information as that term is de3 fined in the regulations promulgated pursuant to 

4 section 264(c) of the Health Insurance Portability 

5 and Accountability Act of 1996 (Public Law 104– 

6 191; 110 Stat. 2033). 

7 ‘‘(2) NONIDENTIFIABLE INFORMATION.—The 

8 term ‘nonidentifiable information’ means informa9 tion that is presented in a form and manner that 

10 prevents the identification of any provider, patient, 

11 or reporter of patient safety work product. With re12 spect to patients, such information must be de-iden13 tified consistent with the regulations promulgated 

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

15 Portability and Accountability Act of 1996 (Public 

16 Law 104–191; 110 Stat. 2033). 

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

18 The term ‘patient safety evaluation system’ means a 

19 process that involves the collection, management, or 

20 analysis of information for submission to or by a pa21 tient safety organization. 

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

23 term ‘patient safety organization’ means a private or 

24 public organization or component thereof that is cer25 tified, through a process to be determined by the 
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1 Secretary under section 925, to perform each of the 

2 following activities: 

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

4 component’s primary activity, of efforts to im5 prove patient safety and the quality of health 

6 care delivery. 

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

8 safety work product that is submitted by pro9 viders. 

10 ‘‘(C) The development and dissemination 

11 of evidence-based information to providers with 

12 respect to improving patient safety, such as rec13 ommendations, protocols, or information re14 garding best practices. 

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

16 product to carry out activities limited to those 

17 described under this paragraph and for the pur18 poses of encouraging a culture of safety and of 

19 providing direct feedback and assistance to pro20 viders to effectively minimize patient risk. 

21 ‘‘(E) The maintenance of confidentiality 

22 with respect to identifiable information. 

23 ‘‘(F) The provision of appropriate security 

24 measures with respect to patient safety work 

25 product. 
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1 ‘‘(G) The submission of nonidentifiable in2 formation to the Agency consistent with stand3 ards established by the Secretary under section 

4 923(b) for any National Patient Safety Data5 base. 

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

7 ‘‘(A) The term ‘patient safety work prod8 uct’ means any document or communication 

9 (including any information, report, record, 

10 memorandum, analysis, deliberative work, state11 ment, or root cause analysis) that— 

12 ‘‘(i) except as provided in subpara13 graph (B), is developed by a provider for 

14 the purpose of reporting to a patient safety 

15 organization, and is reported to a patient 

16 safety organization; 

17 ‘‘(ii) is created by a patient safety or18 ganization; or 

19 ‘‘(iii) would reveal the deliberations or 

20 analytic process of a patient safety evalua21 tion system (as defined in paragraph (3)). 

22 ‘‘(B)(i) Patient safety work product de23 scribed in subparagraph (A)(i)— 

24 ‘‘(I) does not include any separate in25 formation described in clause (ii); and 
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1 ‘‘(II) shall not be construed to include 

2 such separate information merely by rea3 son of inclusion of a copy of the document 

4 or communication involved in a submission 

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

6 to, a patient safety organization. 

7 ‘‘(ii) Separate information described in this 

8 clause is a document or communication (includ9 ing a patient’s medical record or any other pa10 tient or hospital record) that is developed or 

11 maintained, or exists, separately from any pa12 tient safety evaluation system. 

13 ‘‘(C) Information available from sources 

14 other than a patient safety work product under 

15 this section may be discovered or admitted in a 

16 civil or administrative proceeding, if discover17 able or admissible under applicable law. 

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

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

20 otherwise authorized under State law to provide 

21 health care services, including— 

22 ‘‘(i) a hospital, nursing facility, com23 prehensive outpatient rehabilitation facil24 ity, home health agency, and hospice pro25 gram; 
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1 ‘‘(ii) a physician, physician assistant, 

2 nurse practitioner, clinical nurse specialist, 

3 certified nurse midwife, nurse anesthetist, 

4 psychologist, certified social worker, reg5 istered dietitian or nutrition professional, 

6 physical or occupational therapist, or other 

7 individual health care practitioner; 

8 ‘‘(iii) a pharmacist; and 

9 ‘‘(iv) a renal dialysis facility, ambula10 tory surgical center, pharmacy, physician 

11 or health care practitioner’s office, long12 term care facility, behavioral health resi13 dential treatment facility, clinical labora14 tory, or community health center; or 

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

16 in regulations by the Secretary after public no17 tice and comment. 

18 ‘‘SEC. 922. PRIVILEGE FOR PATIENT SAFETY WORK PROD19 UCT. 

20 ‘‘(a) PRIVILEGE.—Notwithstanding any other provi21 sion of law and subject to subsection (c), patient safety 

22 work product shall not be— 

23 ‘‘(1) subject to a civil or administrative sub24 poena or order; 
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1 ‘‘(2) subject to discovery in connection with a 

2 civil or administrative proceeding; 

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

4 552 of title 5, United States Code (commonly known 

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

6 similar Federal or State law; 

7 ‘‘(4) required to be admitted as evidence or oth8 erwise disclosed in any State or Federal civil or ad9 ministrative proceeding; or 

10 ‘‘(5) if the patient safety work product is identi11 fiable information and is received by a national ac12 creditation organization in its capacity as a patient 

13 safety organization— 

14 ‘‘(A) used by a national accreditation orga15 nization in an accreditation action against the 

16 provider that reported the information; 

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

18 survey team; or 

19 ‘‘(C) required as a condition of accredita20 tion by a national accreditation association. 

21 ‘‘(b) REPORTER PROTECTION.— 

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

23 against an individual in an adverse employment ac24 tion described in paragraph (2) the fact that the in25 dividual in good faith reported information— 
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1 ‘‘(A) to the provider with the intention of 

2 having the information reported to a patient 

3 safety organization; or 

4 ‘‘(B) directly to a patient safety organiza5 tion. 

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

7 purposes of this subsection, an ‘adverse employment 

8 action’ includes— 

9 ‘‘(A) the failure to promote an individual 

10 or provide any other employment-related benefit 

11 for which the individual would otherwise be eli12 gible; 

13 ‘‘(B) an adverse evaluation or decision 

14 made in relation to accreditation, certification, 

15 credentialing, or licensing of the individual; and 

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

17 the individual concerned. 

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

19 this subsection shall be subject to a civil monetary 

20 penalty of not more than $20,000 for each such vio21 lation involved. Such penalty shall be imposed and 

22 collected in the same manner as civil money pen23 alties under subsection (a) of section 1128A of the 

24 Social Security Act are imposed and collected. 
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1 ‘‘(c) DISCLOSURES.—Nothing in this section pro2 hibits any of the following disclosures: 

3 ‘‘(1) Voluntary disclosure of nonidentifiable in4 formation. 

5 ‘‘(2) Voluntary disclosure of identifiable infor6 mation by a provider or patient safety organization, 

7 if such disclosure— 

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

9 purposes of improving quality and safety; 

10 ‘‘(B) is to an entity or person subject to 

11 the requirements of section 264(c) of the 

12 Health Insurance Portability and Accountability 

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

14 2033), or any regulation promulgated under 

15 such section; and 

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

17 any regulation promulgated under such section. 

18 ‘‘(3) Disclosure as required by law by a pro19 vider to the Food and Drug Administration, or on 

20 a voluntary basis by a provider to a federally estab21 lished patient safety program, with respect to an Ad22 ministration-regulated product or activity for which 

23 that entity has responsibility, for the purposes of ac24 tivities related to the quality, safety, or effectiveness 

25 of such Administration-regulated product or activity. 
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1 ‘‘(4) Disclosures of patient safety work product 

2 in accordance with this part by a provider to a pa3 tient safety organization. 

4 ‘‘(d) EFFECT OF TRANSFER, DISCLOSURE.—The fol5 lowing shall not be treated as a waiver of any privilege 

6 or protection established under this part: 

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

8 product between a provider and a patient safety or9 ganization. 

10 ‘‘(2) Disclosure of patient safety work product 

11 as described in subsection (c). 

12 ‘‘(3) The unauthorized disclosure of patient 

13 safety work product. 

14 ‘‘(e) PENALTY.— 

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

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

17 be unlawful for any person to disclose patient safety 

18 work product in violation of this section, if such dis19 closure constitutes a negligent or knowing breach of 

20 confidentiality. 

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

22 paragraph (3) for a disclosure in violation of para23 graph (1) does not apply if the person would be sub24 ject to a penalty under section 264(c) of the Health 

25 Insurance Portability and Accountability Act of 
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1 1996 (Public Law 104–191; 110 Stat. 2033), or any 

2 regulation promulgated under such section, for the 

3 same disclosure. 

4 ‘‘(3) AMOUNT.—Any person who violates para5 graph (1) shall be subject to a civil monetary penalty 

6 of not more than $10,000 for each such violation in7 volved. Such penalty shall be imposed and collected 

8 in the same manner as civil money penalties under 

9 subsection (a) of section 1128A of the Social Secu10 rity Act are imposed and collected. 

11 ‘‘(4) SUBSEQUENT DISCLOSURE.—Paragraph 

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

13 confidentiality with respect to particular patient 

14 safety work product. 

15 ‘‘(f) RELATION TO HIPAA.— 

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

17 the regulations promulgated pursuant to section 

18 264(c) of the Health Insurance Portability and Ac19 countability Act of 1996 (Public Law 104–191; 110 

20 Stat. 2033)— 

21 ‘‘(A) patient safety organizations shall be 

22 treated as business associates; and 

23 ‘‘(B) activities of such organizations de24 scribed in section 921(4) in relation to a pro-
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1 vider are deemed to be health care operations 

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

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

4 this section shall be construed to alter or affect the 

5 implementation of such regulations or such section 

6 264(c). 

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

8 Nothing in this section shall be construed to affect privi9 leges, including peer review and confidentiality protec10 tions, that are otherwise available under Federal or State 

11 laws. 

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

13 this section shall be construed to limit the power of a pro14 vider and a patient safety organization, or a patient safety 

15 organization and the Agency or any National Patient 

16 Safety Database, consistent with the provisions of this Act 

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

18 greater confidentiality or delegating authority to make an 

19 authorized disclosure. 

20 ‘‘(i) RELATION TO STATE REPORTING REQUIRE21 MENTS.—Nothing in this part shall be construed as pre22 empting or otherwise affecting any State law requiring a 

23 provider to report information, including information de24 scribed in section 921(5)(B), that is not patient safety 

25 work product. 
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1 ‘‘(j) CONTINUATION OF PRIVILEGE.—Patient safety 

2 work product of an organization that is certified as a pa3 tient safety organization shall continue to be privileged 

4 and confidential, in accordance with this section, if the or5 ganization’s certification is terminated or revoked or if the 

6 organization otherwise ceases to qualify as a patient safety 

7 organization. 

8 ‘‘(k) REPORTS ON STRATEGIES TO IMPROVE PA9 TIENT SAFETY.— 

10 ‘‘(1) DRAFT REPORT.—Not later than the date 

11 that is 18 months after any National Patient Safety 

12 Database is operational, the Secretary, in consulta13 tion with the Director, shall prepare a draft report 

14 on effective strategies for reducing medical errors 

15 and increasing patient safety. The draft report shall 

16 include any measure determined appropriate by the 

17 Secretary to encourage the appropriate use of such 

18 strategies, including use in any federally funded pro19 grams. The Secretary shall make the draft report 

20 available for public comment and submit the draft 

21 report to the Institute of Medicine for review. 

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

23 after the date described in paragraph (1), the Sec24 retary shall submit a final report to the Congress 

25 that includes, in an appendix, any findings by the 
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1 Institute of Medicine concerning research on the 

2 strategies discussed in the draft report and any 

3 modifications made by the Secretary based on such 

4 findings. 

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

6 ‘‘(a) AUTHORITY.— 

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

8 under this part, the Secretary shall provide for the 

9 establishment and maintenance of a database to re10 ceive relevant nonidentifiable patient safety work 

11 product, and may designate entities to collect rel12 evant nonidentifiable patient safety work product 

13 that is voluntarily reported by patient safety organi14 zations upon the request of the Secretary. Any data15 base established or designated under this paragraph 

16 may be referred to as a ‘National Patient Safety 

17 Database’. 

18 ‘‘(2) USE OF INFORMATION.—Information re19 ported to any National Patient Safety Database 

20 shall be used to analyze national and regional statis21 tics, including trends and patterns of health care er22 rors. The information resulting from such analyses 

23 may be included in the annual quality reports pre24 pared under section 913(b)(2). 
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1 ‘‘(3) ADVISORY ROLE.—The Secretary shall 

2 provide scientific support to patient safety organiza3 tions, including the dissemination of methodologies 

4 and evidence-based information related to root 

5 causes and quality improvement. 

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

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

8 consultation with representatives of patient safety organi9 zations, the provider community, and the health informa10 tion technology industry, determine common formats for 

11 the voluntary reporting of nonidentifiable patient safety 

12 work product, including necessary elements, common and 

13 consistent definitions, and a standardized computer inter14 face for the processing of the work product. To the extent 

15 practicable, such standards shall be consistent with the 

16 administrative simplification provisions of part C of title 

17 XI of the Social Security Act. 

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

19 The Secretary shall ensure that the methodologies for the 

20 collection of nonidentifiable patient safety work product 

21 for any National Patient Safety Database include the 

22 methodologies developed or recommended by the Patient 

23 Safety Task Force of the Department of Health and 

24 Human Services. 
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1 ‘‘(d) FACILITATION OF INFORMATION EXCHANGE.— 

2 To the extent practicable, the Secretary may facilitate the 

3 direct link of information between providers and patient 

4 safety organizations and between patient safety organiza5 tions and any National Patient Safety Database. 

6 ‘‘(e) RESTRICTION ON TRANSFER.—Only nonidentifi7 able information may be transferred to any National Pa8 tient Safety Database. 

9 ‘‘SEC. 924. TECHNICAL ASSISTANCE. 

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

11 the Director, may— 

12 ‘‘(1) provide technical assistance to patient 

13 safety organizations, and to States with reporting 

14 systems for health care errors; and 

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

16 voluntarily submitted to any National Patient Safety 

17 Database. 

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

19 under subsection (a) may include annual meetings for pa20 tient safety organizations to discuss methodology, commu21 nication, information collection, or privacy concerns. 

22 ‘‘SEC. 925. CERTIFICATION OF PATIENT SAFETY ORGANIZA23 TIONS. 

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

25 the date of enactment of the Patient Safety and Quality 
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1 Improvement Act, the Secretary shall establish a process 

2 for certifying patient safety organizations. 

3 ‘‘(b) PROCESS.—The process established under sub4 section (a) shall include the following: 

5 ‘‘(1) Certification of patient safety organiza6 tions by the Secretary or by such other national or 

7 State governmental organizations as the Secretary 

8 determines appropriate. 

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

10 organizations to certify patient safety organizations 

11 under paragraph (1), the Secretary shall establish a 

12 process for approving such organizations. Any such 

13 approved organization shall conduct certifications 

14 and reviews in accordance with this section. 

15 ‘‘(3) A review of each certification under para16 graph (1) (including a review of compliance with 

17 each criterion in this section and any related imple18 menting standards as determined by the Secretary 

19 through rulemaking) not less often than every 3 

20 years, as determined by the Secretary. 

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

22 Secretary or other such governmental organization 

23 that issued the certification, upon a showing of 

24 cause. 
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1 ‘‘(c) CRITERIA.—A patient safety organization must 

2 meet the following criteria as conditions of certification: 

3 ‘‘(1) The mission of the patient safety organiza4 tion is to conduct activities that are to improve pa5 tient safety and the quality of health care delivery 

6 and is not in conflict of interest with the providers 

7 that contract with the patient safety organization. 

8 ‘‘(2) The patient safety organization has appro9 priately qualified staff, including licensed or certified 

10 medical professionals. 

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

12 2 year period, contracts with more than 1 provider 

13 for the purpose of receiving and reviewing patient 

14 safety work product. 

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

16 component of a health insurer or other entity that 

17 offers a group health plan or health insurance cov18 erage. 

19 ‘‘(5) The patient safety organization is man20 aged, controlled, and operated independently from 

21 any provider that contracts with the patient safety 

22 organization for reporting patient safety work prod23 uct. 

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

25 the patient safety organization collects patient safety 
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1 work product from providers in a standardized man2 ner that permits valid comparisons of similar cases 

3 among similar providers. 

4 ‘‘(d) ADDITIONAL CRITERIA FOR COMPONENT ORGA5 NIZATIONS.—If a patient safety organization is a compo6 nent of another organization, the patient safety organiza7 tion must, in addition to meeting the criteria described 

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

9 of certification: 

10 ‘‘(1) The patient safety organization maintains 

11 patient safety work product separately from the rest 

12 of the organization, and establishes appropriate se13 curity measures to maintain the confidentiality of 

14 the patient safety work product. 

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

16 make an unauthorized disclosure under this Act of 

17 patient safety work product to the rest of the orga18 nization in breach of confidentiality. 

19 ‘‘(3) The mission of the patient safety organiza20 tion does not create a conflict of interest with the 

21 rest of the organization.’’. 

22 (b) AUTHORIZATION OF APPROPRIATIONS.—Section 

23 937 of the Public Health Service Act (as redesignated by 

24 subsection (a)) is amended by adding at the end the fol25 lowing: 
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1 ‘‘(e) PATIENT SAFETY AND QUALITY IMPROVE2 MENT.—For the purpose of carrying out part C, there are 

3 authorized to be appropriated such sums as may be nec4 essary for each of the fiscal years 2006 through 2010.’’. 

5 Subtitle B—Liability Protection in 

6 Good-faith Reporting 

7 SEC. 311. LIABILITY PROTECTION FOR HEALTH CARE PRO8 VIDERS IN GOOD-FAITH REPORTING TO 

9 STATE MEDICAL BOARDS. 

10 (a) IN GENERAL.—Notwithstanding any other provi11 sion of law, no health care provider providing information 

12 (including by making a report, filing charges, or pre13 senting evidence) to a State medical board regarding the 

14 competence or professional conduct of a physician shall 

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

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

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

18 such information is false and the person providing the in19 formation knew that the information was false. 

20 (b) ATTORNEY FEES.—If a health care provider es21 tablishes in a civil action that the health care provider is 

22 not liable in damages because of the application of sub23 section (a), the court shall award to the provider any at24 torney fees and costs incurred by the provider in estab25 lishing the application of subsection (a). 
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1 (c) DEFINITION.—In this section, the term ‘‘State 

2 medical board’’ means a State entity responsible for li3 censing physicians or a subdivision of such an entity. 

4 TITLE IV—INSURANCE REFORM 

5 SEC. 401. UNIFORM STATE REQUIREMENTS REGARDING 

6 PROPOSED RATE INCREASES. 

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

8 State have in effect laws or regulations providing that— 

9 (1) a provider of medical malpractice insurance 

10 in the State may not implement any increase in the 

11 rate for such insurance that would result in such 

12 rate increasing more than a certain percentage, as 

13 specified in such laws or regulations, within a cer14 tain period of time, as specified in such laws or reg15 ulations, unless, before such increase takes effect— 

16 (A) the provider submits to an appropriate 

17 State agency a description and justification of 

18 the rate increase; and 

19 (B) such agency makes a determination 

20 that the increase is justified; 

21 (2) any determination referred to in paragraph 

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

23 insurance rates is made pursuant to an administra24 tive hearing held by the appropriate State agency; 

25 and 
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1 (3) any individual or institution that is involved 

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

3 State to provide such care has standing, in any ad4 ministrative proceeding of the State regarding a pro5 posed increase in the rate for medical malpractice 

6 insurance (including a hearing referred to in para7 graph (2)), to challenge such increase. 

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

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

10 Human Services shall— 

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

12 and regulations of the States to determine the extent 

13 to which the States have in effects laws or regula14 tions described in subsection (a); and 

15 (2) submit a report to the Congress setting 

16 forth the results of the survey, describing such laws 

17 and regulations of the various States, and describing 

18 the extent of the uniformity of such laws and regula19 tions. 

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

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

22 105. 

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

24 on the date of the enactment of this Act. 
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1 SEC. 402. 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 section 101; 

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 paragraphs (1) and (2). 

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

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

21 medical malpractice liability insurance company shall sub22 mit to the Secretary a report that identifies the percentage 

23 by which the company has reduced medical malpractice 

24 coverage premiums relative to the date of the enactment 

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

2 insurance company that violates a provision of this section 

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

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

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

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

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

8 extent and in the same manner as such paragraphs apply 

9 to a civil penalty under such section. 

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

11 term ‘‘medical malpractice liability insurance company’’ 

12 means an entity in the business of providing an insurance 

13 policy under which the entity makes payment in settlement 

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

15 in, a medical malpractice action or claim. 

16 SEC. 403. EFFECTIVE DATE. 

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

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

19 Act. 
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1 TITLE V—EXCLUSION OF PHAR2 MACEUTICALS AND DEVICES 

3 FROM LIABILITY REFORMS 

4 SEC. 501. EXCLUSION OF PHARMACEUTICALS AND DE5 VICES. 

6 For purposes of title I and II of this Act, the manu7 facturer or distributor of a pharmaceutical or device is not 

8 a health care provider, and health care malpractice does 

9 not include responsibility based on products liability. 

Æ