I

103D CONGRESS

2D SESSION H. R. 4856

To improve the Nation’s health care by creating a comprehensive medical

malpractice prevention program through the creation of independent,

publicly accountable State medical boards and more stringent licensing

and discipline procedures; to empower health consumers by mandating

reporting of certain information regarding health care providers and

professionals and by enhancing informed individual choice regarding

health care services by providing certain information to consumers; and

for other purposes.

IN THE HOUSE OF REPRESENTATIVES

JULY 28, 1994

Mr. NADLER introduced the following bill; which was referred to the

Committee on Energy and Commerce

A BILL

To improve the Nation’s health care by creating a comprehensive medical malpractice prevention program

through the creation of independent, publicly accountable

State medical boards and more stringent licensing and

discipline procedures; to empower health consumers by

mandating reporting of certain information regarding

health care providers and professionals and by enhancing

informed individual choice regarding health care services

by providing certain information to consumers; and for

other purposes.
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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 ‘‘Patient Safety Act of 1994’’.

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

7 this Act is as follows:

Sec. 1. Short title; table of contents.

TITLE I—GENERAL PROVISIONS

Sec. 101. Findings and purpose.

Sec. 102. Preemption.

Sec. 103. Effective date.

Sec. 104. Definitions.

TITLE II—CREATION OF INDEPENDENT AND EFFECTIVE STATE

MEDICAL BOARDS

Sec. 201. Requirements for State medical boards.

Sec. 202. Guidelines for investigations.

Sec. 203. Disciplinary hearings.

Sec. 204. Disciplinary actions.

Sec. 205. Disclosure of disciplinary actions.

Sec. 206. Federal assumption of responsibilities.

TITLE III—REQUIREMENTS FOR HEALTH CARE PROFESSIONALS

AND PROVIDERS

Sec. 301. Renewal of license required every 2 years.

Sec. 302. Reporting requirements.

Sec. 303. Reexamination required after 6 years.

Sec. 304. Audits.

Sec. 305. Mandatory medical malpractice insurance.

Sec. 306. Study of medical negligence.

TITLE IV—PUBLIC ACCESS TO PRACTITIONER DATA BANK

Sec. 401. Providing public access to the national practitioner data bank.

8 TITLE I—GENERAL PROVISIONS

9 SEC. 101. FINDINGS AND PURPOSE.

10 (a) FINDINGS.—The Congress finds and declares

11 that—
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1 (1) there are a large number of avoidable

2 deaths and injuries in the Nation caused by medical

3 negligence and malpractice;

4 (2) the identity of health care professionals re5 sponsible for medical negligence should be revealed

6 to the public and they should be subject to discipline

7 by the appropriate State medical boards;

8 (3) despite the large number of consumers in9 jured by medical malpractice each year, fewer than

1 10 ⁄2 of 1 percent of the Nation’s health care profes11 sionals face any serious State sanctions each year;

12 (4) the purpose of State medical boards is to

13 protect the public from the unprofessional, improper

14 and incompetent practice of medicine;

15 (5) most State medical boards are not ade16 quately disciplining health care professionals and

17 when they do, most of their efforts focus on offenses

18 other than medical negligence, with revocations or

19 suspensions of licenses rarely occurring;

20 (6) among the reasons why the State medical

21 boards are unwilling or unable to identify and dis22 cipline negligent health care professions are that the

23 boards lack adequate funding, staffing, investigative

24 and disciplinary powers and because the boards are
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1 dominated by health care professionals who are re2 luctant to discipline their colleagues;

3 (7) medical malpractice lawsuits are a nec4 essary adjunct to State disciplinary proceedings, but

5 they are not a substitute for them, since it is govern6 ment, through its licensure of health care profes7 sionals, that must ensure that high-quality health

8 care is delivered to the public;

9 (8) health care consumers have very little infor10 mation available to them regarding the quality of

11 their health care providers and professionals;

12 (9) in order to make informed choices between

13 health care providers and professionals, consumers

14 need access to more information about their health

15 care providers and professionals, including discipli16 nary and malpractice records; and

17 (10) more and better information to health care

18 consumers about their health care providers and pro19 fessionals and more and better discipline of incom20 petent and negligent health care professionals will

21 alleviate the medical malpractice crisis and improve

22 the quality of health care in the Nation by helping

23 consumers to choose between health care providers

24 and professionals and by removing the licenses of
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1 those health care professionals who are a danger to

2 the public health and welfare.

3 (b) PURPOSE.—It is the purpose of this Act—

4 (1) to create a national program of medical

5 malpractice prevention by requiring State medical

6 boards to be controlled by members of the public

7 and not of the profession being monitored;

8 (2) to ensure that State medical boards are

9 more effective in identifying and disciplining incom10 petent, unethical, and negligent health care profes11 sionals by ensuring that such boards are adequately

12 staffed and funded to fulfill their purpose of permit13 ting only qualified and fit individuals to practice

14 medicine;

15 (3) to provide ready access to consumers of in16 formation regarding their health care providers and

17 professionals; and

18 (4) to ensure that all health care professionals

19 remain abreast of new information regarding the ef20 ficacy of medical tests and procedures and to assist

21 in the identification of incompetent health care pro22 fessionals, thereby reducing the incidence of the

23 practice of unnecessary medicine and the incidence

24 of preventable injuries to patients.
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1 SEC. 102. PREEMPTION.

2 The provisions of this Act shall preempt State law

3 only to the extent that the Secretary finds that State law

4 does not protect the health and safety of patients in the

5 State at least as effectively as the provisions of this Act.

6 SEC. 103. DEFINITIONS.

7 As used in this Act:

8 (1) HEALTH CARE PROVIDER.—The term

9 ‘‘health care provider’’ means any organization or

10 institution that is engaged in the delivery of health

11 care services in a State and that is required by the

12 laws or regulations of the State to be licensed or cer13 tified by the State to engage in the delivery of such

14 services in the State.

15 (2) HEALTH CARE PROFESSIONAL OR LI16 CENSEE.—The terms ‘‘health care professional’’ and

17 ‘‘licensee’’ mean an individual who provides health

18 care services in a State and who is required by the

19 laws or regulations of the State to be licensed or cer20 tified by the State to provide such services in the

21 State.

22 (3) INJURY.—The term ‘‘injury’’ means any ill23 ness, disease, or other harm that is the subject of

24 a quality of care complaint or a medical malpractice

25 claim.
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1 (4) QUALITY OF CARE COMPLAINT.—The term

2 ‘‘quality of health care complaint’’ means a claim in

3 which the claimant alleges to a State medical board

4 or any entity of the Federal Government which sanc5 tions health care professionals that injury was

6 caused by the provision of (or the failure to provide)

7 health care services.

8 (5) MEDICAL MALPRACTICE ACTION.—The term

9 ‘‘medical malpractice action’’ means a civil action

10 (other than an action in which the plaintiff’s sole al11 legation is an allegation of an intentional tort)

12 brought in a State or Federal court against a health

13 care provider or health care professional (regardless

14 of the theory of liability on which the action is

15 based) in which the plaintiff alleges a medical mal16 practice claim.

17 (6) MEDICAL MALPRACTICE CLAIM.—The term

18 ‘‘medical malpractice claim’’ means a claim in which

19 an individual alleges that injury was caused by the

20 provision of (or the failure to provide) health care

21 services.

22 (7) SECRETARY.—The term ‘‘Secretary’’ means

23 the Secretary of Health and Human Services.

24 (8) STATE.—The term ‘‘State’’ means the 50

25 States, the District of Columbia, Puerto Rico, the
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1 Virgin Islands, Guam, American Samoa, and the

2 Northern Mariana Islands.

3 (9) STATE MEDICAL BOARD.—The term ‘‘State

4 medical board’’ means the entity (as determined by

5 a State) with responsibility for the disciplining or li6 censing of health care professionals, and includes a

7 subdivision of such an entity.

8 SEC. 104. EFFECTIVE DATE.

9 This Act shall take effect January 1, 1996.

10 TITLE II—CREATION OF INDE11 PENDENT AND EFFECTIVE

12 STATE MEDICAL BOARDS

13 SEC. 201. REQUIREMENTS FOR STATE MEDICAL BOARDS.

14 (a) IN GENERAL.—Each State medical board shall

15 meet the following requirements:

16 (1) COMPOSITION.—Not less than 51 percent of

17 the members of a State medical board shall be pub18 lic members with no current or previous significant

19 business, professional, or pecuniary connection with

20 a health care professional, medical education facility,

21 or health care provider (other than as a patient or

22 potential patient), in accordance with regulations of

23 the Secretary. The number of members of the board

24 shall be based on the State’s physician population

25 (as prescribed by the Secretary), except that in no
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1 event may a board have fewer than 12 members.

2 The Chairperson and Vice-Chairperson of the board

3 shall be public members.

4 (2) TERM OF SERVICE.—Each member of the

5 board shall serve a term of 3 years.

6 (3) CONSUMER ASSISTANCE UNIT.—

7 (A) IN GENERAL.—A special consumer as8 sistance unit shall be created within the board

9 to deal directly with complainants. The staff of

10 the unit shall consist of consumer protection of11 ficers with medical or social work background.

12 (B) TOLL-FREE HOTLINE.—The consumer

13 assistance unit shall operate a toll-free phone

14 number through which the unit—

15 (i) shall advise the public of any hear16 ing pending pursuant to formal charges

17 filed against a health care professional,

18 any summary suspension or other discipli19 nary action taken by the board against a

20 health care professional, and the charges

21 (excluding patient identifying information)

22 against the professional on which such

23 hearing or action is based (in a manner

24 that does not disclose the identity of an in25 dividual patient);
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1 (ii) accept consumer complaints about

2 suspected health care professional mis3 conduct (other than complaints over billing

4 disputes); and

5 (iii) provide information to consumers

6 on health care professionals, including the

7 date the professional was first licensed, the

8 registration status of the professional, the

9 professional’s hospital affiliations, and the

10 names of other States in which the profes11 sional holds a license.

12 (C) POSTING REQUIREMENT.—The toll13 free phone number described in subparagraph

14 (B) shall be conspicuously posted by all health

15 care providers and professionals in the State

16 and shall be added to any printed materials dis17 tributed to the public by the board, together

18 with a clear statement that the number is not

19 to be used for filing complaints over billing dis20 putes.

21 (4) DISCLOSURE OF INFORMATION TO NA22 TIONAL PRACTITIONER DATA BANK.—Each State

23 medical board shall report the information received

24 under title III to the Secretary in accordance with
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1 section 424 of the Health Care Quality Improvement

2 Act of 1986.

3 (b) ADDITIONAL STATE REQUIREMENTS.—

4 (1) OVERSIGHT PANEL.—As prescribed by the

5 Secretary, each State shall establish an oversight

6 panel to independently assess and audit the State

7 medical board process and hear appeals from com8 plainants whose claims have been dismissed by State

9 medical boards. The panel shall consist of 7 mem10 bers appointed by the Governor and shall include not

11 more than 2 physicians.

12 (2) FUNDING.—Each State shall ensure that

13 the State medical boards are fully supported by the

14 revenues generated from their activities, including

15 fees, charges, and reimbursed costs. The health care

16 professional licensing fees charged in the State may

17 not be less than $500 annually. All revenues gen18 erated by this fee shall be used exclusively for State

19 medical board activities.

20 SEC. 202. GUIDELINES FOR INVESTIGATIONS.

21 (a) MANDATORY INVESTIGATION OF CERTAIN RE22 PORTS AND NATIONAL PRACTITIONER DATA BANK IN23 FORMATION.—

24 (1) IN GENERAL.—Upon receipt of reports pur25 suant to section 302 of the Health Care Quality Im-
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1 provement Act, and upon querying the National

2 Practitioner Data Bank while performing its reg3 istration or reregistration functions, the State medi4 cal board shall investigate any evidence which ap5 pears to show that a health care professional is or

6 may be medically incompetent, has engaged in un7 professional conduct, or is mentally or physically un8 able to engage safely in the performance of health

9 care services.

10 (2) SPECIFIC GROUNDS FOR INVESTIGA11 TIONS.—In addition to other information the report12 ing of which may constitute grounds for an inves13 tigation, receipt of reports disclosing the following

14 information may be grounds for instituting an inves15 tigation with respect to a health care professional:

16 (A) Quality of care complaints or medical

17 malpractice actions brought against the health

18 care professional.

19 (B) Payments in settlement (or partial set20 tlement) of, or in satisfaction of a judgment or

21 arbitration award in, a medical malpractice ac22 tion or claim.

23 (C) Professional liability insurance can24 cellations for reasons related to liability claims
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1 or actions brought against the health care pro2 fessional.

3 (D) Sanctions or disciplinary actions taken

4 against the health care professional by another

5 State or jurisdiction, a peer review body, a

6 health care provider, or a medical or profes7 sional association or society.

8 (E) The failure of the professional to meet

9 the requirements of section 302(b) (relating to

10 annual reports to health care consumers).

11 (F) The filing of a report by a medical ex12 aminer under section 302(c) indicating that a

13 death may have been the result of the profes14 sional’s negligence or incompetence.

15 (G) The failure of the professional to meet

16 the requirements of section 401(b) (relating to

17 providing information to patients on rights es18 tablished under title IV).

19 (b) INVESTIGATORY POWERS AND PROCEDURES.—

20 (1) IN GENERAL.—The State shall ensure that

21 the State medical boards are given sufficient powers

22 and follow certain procedural guidelines sufficient to

23 ensure efficient and effective performance of their

24 investigatory duties.
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1 (2) STAFFING.—The Secretary shall establish

2 guidelines for the duties of and qualifications for

3 staff positions of State medical boards, addressing

4 the appropriate separation of investigatory and adju5 dicatory functions. The Board’s staff may include,

6 but need not be limited to—

7 (A) an executive director,

8 (B) 1 or more hearing officers trained to

9 conduct hearings (whose decision shall be re10 viewed, approved, modified, or disapproved by

11 the Board), and

12 (C) 1 or more investigators trained in the

13 investigation of medical and related health care

14 practice.

15 (3) INVESTIGATIVE POWERS.—The State shall

16 ensure that the State medical boards have at least

17 the following investigative powers:

18 (A) The power to subpoena documents and

19 individuals possessing information relevant to

20 investigations:

21 (B) The power to swear in witnesses.

22 (C) The power to require professional com23 petency examinations upon reasonable suspicion

24 of incompetence. For purposes of this clause, a
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1 single act of alleged negligence may serve as a

2 reasonable suspicion of incompetence.

3 (D) To the extent necessary to complete an

4 investigation, the power to conduct an unan5 nounced on-site review of the licensee’s entire

6 practice, including but not limited to a com7 prehensive review of patient records of the li8 censee and such office records of the licensee as

9 are relevant to the investigation, and a review

10 of procedures and safeguards in the offices.

11 (E) The power to obtain the involuntary,

12 temporary, and summary suspension of a li13 censee from practice who poses an imminent

14 threat to patient health.

15 (F) The power to order immediate super16 vision of certain procedures by another licensee.

17 (G) The power to require the licensee to

18 submit to 1 or more physical or mental exami19 nations.

20 (H) The power to order drug testing of the

21 licensee.

22 (4) PROCEDURAL GUIDELINES.—The State

23 shall ensure that State medical boards adhere to the

24 following procedures:
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1 (A) All investigations of cases alleging pa2 tient harm and conducted pursuant to this sec3 tion shall be completed within 90 days of the

4 receipt of the report initiating the investigation,

5 except that such deadline may be extended for

6 reasonable cause.

7 (B) In conducting an investigation of a li8 censee, the State medical board shall, at no

9 cost, query the National Practitioner Data

10 Bank for all available information relating to

11 the professional competence and conduct of the

12 licensee.

13 SEC. 203. DISCIPLINARY HEARINGS.

14 (a) GROUNDS FOR HEARING.—If following an inves15 tigation, the State medical board finds there is probable

16 cause to believe that a health care professional has pro17 vided substandard treatment, has engaged in unpro18 fessional conduct, is medically incompetent or is mentally

19 or physically unable to engage safely in the performance

20 of health care services, a disciplinary hearing shall be con21 ducted in accordance with procedures established by State

22 law (consistent with the requirements of subsection (b)).

23 (b) REQUIREMENTS FOR HEARING.—

24 (1) TIMING.—A disciplinary hearing with re25 spect to a health care professional shall be held
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1 promptly after the conclusion of the State medical

2 board’s investigation of the health care professional,

3 and a decision shall be rendered not later than 60

4 days following completion of the hearing (except that

5 such deadline may be extended for reasonable

6 cause).

7 (2) POWERS OF BOARD.—In conducting a dis8 ciplinary hearing with respect to a health care pro9 fessional, the State medical board may subpoena

10 documents and individuals possessing relevant infor11 mation and may swear in witnesses.

12 (3) EVIDENTIARY STANDARD.—The decision

13 under a disciplinary hearing shall be based on the

14 preponderance of the evidence.

15 (4) DISSEMINATION OF INFORMATION.—The

16 State medical board shall make summaries of ongo17 ing disciplinary proceedings available to the public,

18 except that such summaries shall not include any in19 formation that may disclose the identity of, or iden20 tifying information on, an individual patient.

21 SEC. 204. DISCIPLINARY ACTIONS.

22 (a) PENALTIES DESCRIBED.—The penalties that may

23 be imposed on a health care professional by a State medi24 cal board are as follows:

25 (1) Revocation or suspension of a license.
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1 (2) Restriction or limitation of the extent,

2 scope, or type of practice, if such limitation is con3 ducted under the presence and guidance of a super4 vising licensee.

5 (3) Imposition of an administrative fine of at

6 least $1,000 for each count or separate offense.

7 (4) Issuance of a warning or reprimand.

8 (5) Probation with or without conditions (such

9 as submission to treatment, attendance at continu10 ing education courses, reexamination, or practice

11 only under the presence and guidance of a super12 vising licensee).

13 (6) Assessment of the reasonable costs of inves14 tigation, hearing, and review, and the costs of proba15 tion supervision.

16 (b) SUMMARY LICENSE SUSPENSION.—

17 (1) IN GENERAL.—The State medical board

18 may suspend the license of a health care professional

19 without the opportunity for a prior hearing if the

20 board finds that at least one of the following condi21 tions exists:

22 (A) The individual’s continued practice

23 creates a clear and present danger to public

24 health.
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1 (B) The individual has been found or has

2 pleaded guilty to a felony charge within the

3 State or in another jurisdiction relating to the

4 individual’s professional activities.

5 (C) The individual’s license has been sus6 pended or revoked in another jurisdiction, with7 out regard to whether such suspension or rev8 ocation has occurred or is pending.

9 (2) TIMING FOR FORMAL HEARING.—After the

10 summary suspension of a license pursuant to para11 graph (1), the State medical board shall hold a for12 mal hearing as soon as practicable following the

13 summary suspension (but in no event later than 90

14 days after such summary suspension).

15 (c) NOTIFICATION OF PATIENTS.—Any health care

16 professional subject to probation or a restriction or limita17 tion on the scope of practice shall notify patients of such

18 probation, restriction, or limitation.

19 (d) TERMINATION OF SANCTION.—

20 (1) NO STAY OF SUSPENSION OR REVOCATION

21 DURING APPEAL.—Under no circumstances may a

22 board stay the suspension or revocation of a license

23 pending an appeal, and the licensee may not resume

24 practice unless and until the penalty is overturned

25 upon such appeal.
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1 (2) MINIMUM PERIOD OF REVOCATION.—After

2 revocation of a license by a State medical board, a

3 health care professional may not petition for rein4 statement for at least a 3-year period.

5 (3) IMPOSITION OF CONDITIONS.—The State

6 medical board may condition the restoration of a

7 suspended or revoked license or the removal of limi8 tations on a license upon the health care professional

9 obtaining minimum results on one or more physical,

10 mental, or professional competency examinations.

11 SEC. 205. DISCLOSURE OF DISCIPLINARY ACTIONS.

12 (a) IN GENERAL.—

13 (1) PUBLICATION OF NEWSLETTER.—State

14 medical boards shall report regularly (but not less

15 often than monthly) in a published newsletter all

16 final disciplinary actions taken and formal charges

17 filed after State medical board investigation of a

18 complaint, including the names of the professionals

19 involved, a description of the acts or omissions sub20 ject to discipline or listed as the formal charge and

21 the nature of the actions taken.

22 (2) ANNUAL REPORTS.—State medical boards

23 shall publish annual reports compiling statistics on

24 disciplinary actions taken during a year (in accord25 ance with criteria established by the Secretary).
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1 (b) DISSEMINATION OF DISCIPLINARY ACTION RE2 PORTS.—The reports published under subsection (a) shall

3 be widely disseminated to the public (free of charge) by

4 advertising their availability through the news media, and

5 shall be forwarded to—

6 (1) health care providers in the State;

7 (2) the Secretary;

8 (3) the Medicare peer review organization serv9 ing geographic areas in the State under title XVIII

10 of the Social Security Act;

11 (4) entities offering medical malpractice insur12 ance within the State; and

13 (5) Federal depository libraries.

14 SEC. 206. FEDERAL ASSUMPTION OF RESPONSIBILITIES.

15 (a) DETERMINATION OF STATE COMPLIANCE.—Not

16 later than October 1 of each year (beginning with 1995),

17 the Secretary shall determine whether a State’s medical

18 board meets the requirements of this title and title III for

19 the following calendar year.

20 (b) FEDERAL ASSUMPTION OF RESPONSIBILITY.—If

21 the Secretary determines that a State medical board does

22 not meet the requirements of this title and title III for

23 a year—

24 (1) the Secretary shall carry out all functions of

25 the board in the State during the year; and
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1 (2) the State shall reimburse the Secretary (at

2 such time and in such manner as the Secretary may

3 require) for the costs incurred by the Secretary dur4 ing the year as a result of the application of para5 graph (1).

6 TITLE III—REQUIREMENTS FOR

7 HEALTH CARE PROFES8 SIONALS AND PROVIDERS

9 SEC. 301. RENEWAL OF LICENSE REQUIRED EVERY 2

10 YEARS.

11 (a) IN GENERAL.—Every 2 years, each health care

12 professional and health care provider shall demonstrate to

13 the satisfaction of the State medical board the profes14 sional’s continuing qualification for medical licensing.

15 (b) SIGNATURE REQUIRED.—An application for re16 registration of a license submitted under this section shall

17 be signed by the applicant and notarized, and shall contain

18 a statement of the applicant affirming (under penalty of

19 perjury) that the information provided is true to the best

20 of the applicant’s knowledge.

21 SEC. 302. REPORTING REQUIREMENTS.

22 (a) RENEWAL OF LICENSE.—

23 (1) IN GENERAL.—As a condition of the re24 newal of a license under section 301, at the time of

25 reregistration a health care professional or health
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1 care provider shall report (on a form prescribed and

2 promulgated by the Secretary) the following infor3 mation:

4 (A) Any pending investigation or prelimi5 nary or final action taken against the licensee

6 by—

7 (i) any jurisdiction or authority

8 (whether in the United States or a foreign

9 nation) which licenses or authorizes the

10 practice of medicine;

11 (ii) any peer review body;

12 (iii) any health care provider;

13 (iv) any professional medical society

14 or association;

15 (v) any law enforcement agency;

16 (vi) any court; or

17 (vii) any governmental agency,

18 for acts or conduct which may constitute

19 grounds for disciplinary action described in sec20 tion 204.

21 (B) Any pending medical malpractice claim

22 which has been filed against the licensee.

23 (C) Any adverse judgment, settlement, or

24 award against the licensee arising from a medi25 cal malpractice claim.
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1 (D) The licensee’s voluntary surrender of a

2 license or authorization to practice medicine in

3 any jurisdiction (including military, public

4 health, and foreign) or voluntary limitation on

5 the scope of services which the licensee would

6 otherwise be authorized to provide under the li7 cense.

8 (E) Any denial to the licensee of a license

9 or authorization to practice medicine by any ju10 risdiction (including military, public health, and

11 foreign).

12 (F) The licensee’s removal from the medi13 cal staff of any health care provider or limita14 tion of staff privileges at such a provider

15 (whether voluntary or involuntary), if such re16 moval or limitation occurred while the licensee

17 was under formal or informal investigation by

18 the provider or a committee thereof for any rea19 son related to possible medical incompetence,

20 unprofessional conduct, or mental or physical

21 inability to safely perform health care services.

22 (G) The licensee’s resignation or with23 drawal from a national, State, or county medi24 cal society, association, or organization (wheth25 er voluntary or involuntary) if that action oc-
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1 curred while the licensee was under formal or

2 informal investigation or review by that body

3 for any reason related to possible medical in4 competence, unprofessional conduct, or mental

5 or physical inability to safely perform health

6 care services.

7 (H) Whether the licensee has been treated

8 for an alcohol or chemical substance problem

9 during the 5-year period preceding the submis10 sion of the report.

11 (I) Any denial or restriction of the licens12 ee’s privileges to prescribe controlled sub13 stances.

14 (J) Whether the licensee has had any

15 physical injury or disease or mental disability

16 within the reregistration period which could

17 reasonably be expected to affect the licensee’s

18 ability to safely perform health care services.

19 (K) The licensee’s completion of continuing

20 medical education or other forms of professional

21 maintenance or evaluation, including specialty

22 board certification or recertification, within the

23 reregistration period, including participation in

24 malpractice prevention programs required by a

25 State medical board.
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1 (L) Any loss or restriction of medical mal2 practice insurance coverage in any jurisdiction

3 (including military, public health and foreign).

4 (M) Any name change or change of home

5 or professional address.

6 (N) In the case of a health care profes7 sional, the information contained in the profes8 sional’s annual report made available to con9 sumers under subsection (b)(2).

10 (2) REVIEW OF REPORTS SUBMITTED.—

11 (A) IN GENERAL.—The State medical

12 board shall review the information reported by

13 a licensee under paragraph (1) to determine

14 whether reregistration of a medical license to

15 the licensee is appropriate and whether an in16 vestigation or disciplinary action should be initi17 ated against the licensee.

18 (B) FALSE OR INCOMPLETE REPORTING.—

19 A licensee who knowingly and willfully submits

20 false or incomplete information on an applica21 tion for license reregistration shall be subject to

22 disciplinary action, including civil money pen23 alties.

24 (b) ANNUAL REPORTS TO CONSUMERS.—

25 (1) HEALTH CARE PROVIDERS.—
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1 (A) IN GENERAL.—Each health care pro2 vider shall make an annual report (in such form

3 and manner as the Secretary prescribes) avail4 able free of charge to all health care consumers

5 in the provider’s service area.

6 (B) CONTENTS OF REPORT.—The annual

7 report referred to in subparagraph (A) shall in8 clude—

9 (i) a list of all health services which

10 the provider is licensed to offer;

11 (ii) a list of all routine preoperative

12 and other medical tests frequently per13 formed by the provider, together with the

14 cost of such tests;

15 (iii) the number and types of quality

16 of care complaints and medical malpractice

17 actions claims decided or settled against

18 the provider for the year, including the

19 identity of all health care professionals

20 named in the complaints and claims;

21 (iv) a list of the names and addresses

22 of the members of the provider’s board of

23 trustees (if any), the provider’s chief ad24 ministrator, chief medical officer, and chief

25 nursing administrator;
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1 (v) the provider’s accreditation status

2 and any contingencies on accreditation,

3 Medicare certification, or licensure and a

4 description of all plans and current efforts

5 to correct deficiencies resulting in any such

6 contingencies; and

7 (vi) such other information as the

8 Secretary may require.

9 (2) HEALTH CARE PROFESSIONALS.—

10 (A) IN GENERAL.—Each health care pro11 fessional shall make an annual report (in such

12 form and manner as the Secretary prescribes)

13 available free of charge to all members of the

14 public health care consumers in the profes15 sional’s service area.

16 (B) CONTENTS OF REPORT.—The report

17 referred to in subparagraph (A) shall include—

18 (i) information regarding the profes19 sional’s education, experience, qualifica20 tions, certification by a board recognized

21 by the Board of American Medical Special22 ties, and license to provide health care

23 services, including a list of the States in

24 which such professional is licensed and any

25 limitations on such professional’s licenses;
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1 (ii) any disciplinary actions relating to

2 the scope of the professional’s practice

3 taken against the professional by any

4 health care provider, State medical board,

5 the Federal Government, or medical ac6 creditation or certification organization;

7 (iii) any quality of care complaints or

8 medical malpractice claims decided or set9 tled against the professional;

10 (iv) a disclosure of any ownership in11 terest the professional may have in any

12 health care provider, laboratory, or sup13 plier of health care items; and

14 (v) such other information as the Sec15 retary may require.

16 (3) RETROACTIVE REPORTING.—The initial an17 nual report made under this subsection by a health

18 care professional or provider shall include informa19 tion for the 3 years prior to date the report is made.

20 (c) SPECIAL REQUIREMENTS FOR MEDICAL EXAMIN21 ERS.—

22 (1) INITIAL REPORT ON DEATHS RESULTING

23 FROM PROVIDER NEGLIGENCE.—Each medical ex24 aminer shall file a report with the State medical

25 board upon receiving information (based on findings
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1 that were reached by or documented and approved

2 by a board-certified or board-eligible pathologist) in3 dicating that a death may be the result of a health

4 care professional’s or provider’s negligence or incom5 petence, and shall include in the report the name of

6 the decedent, date and place of death, attending

7 physician, and all other relevant information avail8 able.

9 (2) AUTOPSY.—Not later than 90 days after fil10 ing the report described in paragraph (1), a medical

11 examiner shall file with the State medical board cop12 ies of the medical examiner’s report, autopsy proto13 col, and all other relevant information available.

14 (d) SANCTIONS FOR FAILURE TO REPORT.—Any

15 health care provider or professional who knowingly and

16 willfully fails to comply with the reporting requirements

17 of this section shall be subject, in addition to other pen18 alties that may be prescribed by law, to a civil monetary

19 penalty of not more than $10,000 for each such failure.

20 SEC. 303. REEXAMINATION REQUIRED AFTER 6 YEARS.

21 (a) IN GENERAL.—Each State medical board shall

22 require a health care professional licensed by the board

23 to be reexamined every 6 years as a condition of licensure.

24 (b) CLINICAL PERFORMANCE EVALUATIONS FOR

25 CERTAIN LICENSEES.—A State medical board may re-
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1 quire a licensee to undergo a clinical performance evalua2 tion as part of the licensee’s reexamination under this sec3 tion if—

4 (1) the licensee practices exclusively in a private

5 office setting; or

6 (2) a medical malpractice claim has been filed

7 against the licensee since the licensee’s most recent

8 reexamination.

9 (c) REVIEW OF PATIENT MEDICAL RECORDS.—In

10 the case of a licensee described in subsection (b)(1), the

11 State medical board may conduct a review of the medical

12 records of the licensee’s patients as part of the reexamina13 tion under this section.

14 SEC. 304. AUDITS.

15 (a) PERFORMANCE AUDITS.—On a regular basis, a

16 State medical board shall conduct audits of the office17 based practices of licensees to assess performance and im18 prove practices. In furtherance of this audit function,

19 State medical boards shall be granted the authority to

20 subpoena office-based and provider-based patient records.

21 (b) PHARMACY AUDITS.—On an annual basis, State

22 medical boards shall conduct audits of a randomly selected

23 sample of pharmacy records to detect illegal drug diversion

24 and other misuse or overprescribing of controlled sub25 stances.
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1 SEC. 305. MANDATORY MEDICAL MALPRACTICE INSUR2 ANCE.

3 A State medical board may not issue or renew the

4 license of a health care professional or provider unless the

5 professional or provider certifies that the professional or

6 provider is covered under malpractice insurance in an

7 amount determined by the Secretary.

8 SEC. 306. STUDY OF MEDICAL NEGLIGENCE.

9 (a) STUDY.—The Secretary shall conduct (either di10 rectly or through contract) a national interdisciplinary

11 study modeled on the Harvard Medical Practice Study to

12 evaluate—

13 (1) the incidence of injuries regulating from

14 medical interventions and the percentage of such in15 juries that resulted from the negligence or fault of

16 a health care professional or health care provider;

17 (2) appropriate measures of the costs of medi18 cal expenses, lost wages, and lost household produc19 tion to individuals who suffer medical injuries and

20 their families, and the compensation provided for

21 such losses under the current medical injury com22 pensation system; and

23 (3) appropriate methods to prevent the occur24 rence of medical negligence.

25 (b) ACCESS TO RECORDS.—The Secretary shall have

26 the power to examine the medical records of patients of
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1 a health care provider or health care professional (in a

2 manner that does not disclose the identity of, or identify3 ing information on, any individual patient) to the extent

4 necessary to conduct the study under subsection (a).

5 (c) REPORT.—Not later than 3 years after the date

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

7 a report to Congress on the study conducted under sub8 section (a).

9 TITLE IV—PUBLIC ACCESS TO

10 PRACTITIONER DATA BANK

11 SEC. 401. PROVIDING PUBLIC ACCESS TO THE NATIONAL

12 PRACTITIONER DATA BANK.

13 Section 427(a) of the Health Care Quality Improve14 ment Act of 1986 (42 U.S.C. 11137(a)) is amended—

15 (1) by redesignating subsections (b), (c), and

16 (d) as subsections (c), (d), and (e); and

17 (2) by inserting after subsection (a) the follow18 ing new subsection:

19 ‘‘(b) AVAILABILITY OF INFORMATION TO THE PUB20 LIC.—

21 ‘‘(1) IN GENERAL.—Not later than 30 days

22 after the date of the enactment of this subsection

23 and every 6 months thereafter, the Secretary shall

24 publish and make available to the public the follow25 ing information reported under this part:
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1 ‘‘(A) Information reported under section

2 421, except the following:

3 ‘‘(i) The social security number of the

4 physician or practitioner.

5 ‘‘(ii) Information disclosing the iden6 tity of the patient involved in such inci7 dent.

8 ‘‘(B) Information reported under section

9 422(a).

10 ‘‘(C) Information reported under section

11 423 (a) and (b).

12 ‘‘(2) DISSEMINATION.—The Secretary shall—

13 ‘‘(A) disseminate the information described

14 in paragraph (1) to public libraries without

15 charge; and

16 ‘‘(B) establish a 24-hour toll-free hotline

17 through which individuals may obtain such in18 formation.’’.

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