MEDICAL MALPRACTICE AND LIABILITY RESEARCH

NIH GUIDE, Volume 22, Number 44, December 10, 1993



PA NUMBER:  PA-94-016



P.T. 34



Keywords:

  Health Care Economics 

  Health Insurance 



Agency for Health Care Policy and Research



PURPOSE



The purpose of this program announcement (PA) is to stimulate

research addressing medical malpractice and liability issues in the

context of current and contemplated Federal and State health care

reforms.  As efforts are made to achieve universal coverage and

curtail unnecessary expenditure while maintaining quality health

care, equitable and economic ways to deal with negligent care and

resolve malpractice disputes is essential.  This PA emphasizes a need

for research addressing key medical malpractice and liability issues

underlying reform efforts.



The Agency for Health Care Policy and Research (AHCPR) conducts and

supports research, demonstration projects, and evaluations of health

care services and systems delivering such services.  The AHCPR is the

focal point in the Department of Health and Human Services for

research on medical malpractice and liability.  Earlier studies

related to medical malpractice have contributed to the scientific

knowledge on which some current reform proposals are based.  The

AHCPR now announces a continued, refocused interest in the role that

medical malpractice and liability play in the U.S. health care

system.  The AHCPR plans to expand on previous work by supporting

research on medical malpractice and liability reform and related

issues as part of its efforts to examine the availability, quality,

and costs of health care services, and ways to improve the

effectiveness and appropriateness of health care delivery.



HEALTHY PEOPLE 2000



The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention priorities of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  Applications

responding to this PA could be related to many priority areas,

especially those involving surveillance and data systems.  Potential

applicants may obtain a copy of "Healthy People 2000" (Full Report:

Stock No. 017-001-00474-0 or Summary Report:  Stock No.

017-001-00473-1) through the Superintendent of Documents, Government

Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by domestic and foreign non-profit

organizations, public and private, including universities, units of

State and local government, non-profit firms, non-profit foundations,

and individuals.  Applications from minority and women investigators

are encouraged.



MECHANISM OF SUPPORT



This PA will use the research project grant (R01).  Responsibility

for the planning, direction, and execution of the proposed project

will be solely that of the applicant.  Most projects are expected to

vary from one to two years in length and, in rare cases, could extend

to three years due to the complexity or breadth of the subject area.

This PA is in effect through the October 1, 1996 receipt date.



RESEARCH OBJECTIVES



Background



The AHCPR convened a conference in February 1991 to examine research

priorities in medical, legal, and professional review aspects of

medical malpractice and liability and to refine a research agenda.

The conference provided a forum for discussion among professionals in

both public and private settings including health care providers and

administrators, legal practitioners, researchers, medical-legal

scholars, policymakers, professional licensure board representatives,

and quality improvement/risk management experts.  Participants

assessed the underlying problems associated with medical liability;

identified current and promising initiatives to address those

problems; assessed initiatives in terms of what is known regarding

their feasibility and effectiveness; and recommended strategies for

development of a medical liability research agenda.  The diverse

information needs and interests of health care providers, courts, and

professional reviewers are reflected in the areas recommended for

research:  (1) medical process research, (2) legal process research,

and (3) research on the professional review process. ["Issues in

Medical Liability:  A Working Conference," AHCPR Pub. No. 92-0011, a

report of the conference including summaries of working group

discussions and identified research issues, may be purchased from the

U.S. Government Printing Office, Superintendent of Documents, Mail

Stop: SSOP, Washington, DC 20402-9328 (telephone 202-783-3238).  ISBN

0-16-037820-6.  Applicants may also refer to the AHCPR Grant

Announcement on "Health Care Quality Improvement and Quality

Assurance Research".]



The current health care reform environment further focuses the

research priorities under this program announcement.  Malpractice

reforms under consideration by the Administration and Congress

include:  alternative dispute resolution mechanisms, certificates of

merit, limits on attorney fees, public access to National

Practitioner Data Bank information on repeat offenders, collateral

source offsets, periodic payment of awards, limits on damage awards,

use of clinical practice guidelines, and enterprise liability.  Some

States are already experimenting with these reforms.  Central

research questions to address problems associated with medical

malpractice and liability include:  What is the empirical evidence

that there are inequities and negative outcomes resulting from

malpractice and medical liability laws?  What aspects of provider

practice, professional review, and legal processes, including

motivations and actions of litigants, contribute to these problems?

What are the absolute and distributional effects of these problems

and (where applicable) proposed solutions in terms of cost, quality,

and access?  The answers to these questions may allow inferences to

be drawn about the effects of ongoing and contemplated reforms.  The

best applications will be structured to clearly draw such inferences.



The AHCPR will give high priority to the funding of research grant

applications focused specifically on medical malpractice and

liability issues in the context of health care reform.  Investigators

are encouraged to avoid primary data collection efforts and focus

instead on designs and methods that produce results more quickly,

such as using existing data, micro-simulation, and rigorous

syntheses.  Consideration will also be given to traditional legal

research (case law studies linking legal precedents with contemplated

reforms) and small demonstrations, if applicable.



Research Priority Areas



1.  Medical Process Research



Medical process research is directed toward improving patient

outcomes and quality of care, and reducing the risk of medical

injury.  Valid and reliable standards for reviewing and assessing

health care performance are viewed by many as not available, vague,

or capriciously applied in risk management and quality improvement

processes and legal fault determination.  The effectiveness of many

activities intended to change provider practices is unknown.

Providers may be unnecessarily anxious about risks of liability.

Many believe inequities in the liability determination process prompt

inappropriate provider behavior resulting in the provision of

unnecessary and inappropriate procedures and treatments thus driving

up health care costs (defensive medicine).  Practitioner-patient

relationships may be strained by communication problems because of

education deficits, language barriers, differing expectations, and a

lack of information about choices and alternatives.  Key research

questions include:



o  Are there reliable methods for identifying specific medical

outcomes that result in malpractice/liability?  Can certain types of

cases with significant risk of mismanagement or liability be

predicted or identified prospectively so as to mitigate risk?  Are

there correlations between payment decisions, outcomes of care,

patients' perceptions of quality, and claims?



o  What are the underlying causes and factors involved in substandard

medical practice and patterns of medical error? What provider

characteristics predict potentially risk-prone, substandard, or

unacceptable provider practice?



o  Does improved access to information and dissemination of medical

liability data improve medical, legal, and consumer decisionmaking?

Do changes in provider-patient communication practices reduce claims

of negligence?



o  Are clinical practice guidelines effective in changing provider

practice patterns, reducing adverse outcomes, and resolving claims?

How do clinical practice guidelines affect the frequency of

malpractice claims or the amount of awards?



o  What is the incidence, extent and cost of defensive medicine?  How

are practice patterns, malpractice experience, and liability

insurance premiums related?



2.  Legal Process Research



Legal process research is directed toward promoting more valid fault

determination and injury compensation, and towards reducing defensive

medicine practice and inappropriate use of medical technology.

Research on the connection between negligent medical care and legal

liability is essential in improving equitable fault determination and

standards for expert evidence in medical malpractice cases.  Some

commonly held beliefs about the current legal processes relating to

medical liability and malpractice are that:  lay juries are not

capable of fact-finding in complicated medical cases; procedural

rules and requirements for establishing legal causation are overly

complex and do not include the scientific methodology necessary for

accurate determination of medical causation; the legal process does

not effectively reject meritless claims, while significant numbers of

individuals injured by negligent medical care do not file claims; and

compensation awards to persons injured by negligent medical care are

not equitable, consistent, efficient, or predictable.  There is

currently little empirical evaluation of legal reforms designed to

promote more valid fault determination and equitable and timely

injury compensation; and reduce the incentives for defensive medicine

practice and inappropriate use of medical technology.  The

application of scientific medical information in the legal process

needs further investigation, including examination of standards for

medical expertise used in the liability determination process.  Key

research questions include:



o  What effects do specific tort reforms or combinations of tort

reform have on health care cost, quality, and access?



o  How do tort reforms affect the frequency of malpractice claims or

the amount of awards?



o  What are the barriers to claims by negligently injured patients?

What factors influence an injured patient's decision of whether or

not to file a malpractice claim?



o  How can the determination of economic and non-economic awards be

more objectively and equitably calculated?  What are the effects of

no-fault models of injury compensation and alternative dispute

resolution mechanisms?



o  What effects do enterprise liability (substituting liability on

the part of the institution or health plan for physician liability)

have on quality improvement and risk management, reductions in

defensive medicine, and the cost, efficiency, and equity of dispute

resolution?



3.  Research on the Professional Review Process



Research on the professional review process is directed toward

improving the security of and liability for confidential review

activities, developing equitable and valid standards of quality and

performance measures, and developing methods for effective

professional monitoring and discipline.  Many practitioners question

the fairness of standards used in the professional review process.

Fear of legal consequences may inhibit participation and action in

peer review activities, and hinder the sharing of information on

adverse outcomes or claims data.  Valid and reliable standards for

reviewing and assessing professional performance are not available,

vague, or erratically applied.  The role and effectiveness of

incentives or sanctions in changing provider practice patterns have

not been determined.  Key research questions include:



o  How effective are current State board interventions in the

professional review and disciplinary process?  Do professional review

incentives and sanctions change provider practice patterns?  How

effective are disciplinary and nonpunitive interventions (e.g.,

continuing education, re-training programs) in reducing risk-related

practices?



o  What are the most effective incentives for participation in risk

management and peer review activities?



o  How can laws be designed to effectively deal with issues of

confidentiality and immunity from liability for peer review

activities and records?



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING INCLUSION OF WOMEN AND

MINORITIES IN RESEARCH STUDY POPULATIONS



The AHCPR requires all applicants for research grants to include

minority populations and women in study populations so that research

findings can be of benefit to all persons in the population under

study.  Special emphasis must be placed on including minorities and

women in studies of conditions which disproportionately affect them.

This policy is intended to apply to males and females of all ages.

If women or minorities are excluded or inadequately represented in

research, a clear and compelling rationale must be provided.  The

AHCPR will not award grants for applications which do not comply.  If

the required information is not contained in the application, the

application will be returned without review.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of

the study. This information should be included in the form PHS 398 in

Sections 1-4 of the Research Plan AND summarized in Section 5, Human

Subjects.



Applicants are urged to assess carefully the feasibility of including

the broadest possible representation of minority groups.  However,

AHCPR recognizes that it may not be feasible or appropriate in all

research projects to include representation of the full array of

United States racial/ethnic minority populations (i.e., Native

Americans, Asian/Pacific Islanders, African Americans, Hispanics).

Where appropriate, the applicant must provide the rationale for

studies on single minority population groups.



The usual policies concerning research on human subjects, subscribed

to by NIH and AHCPR, also apply.



For foreign awards, the policy on inclusion of women applies fully.

Since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including

minorities.



Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the

selected study population is inadequate, it will be considered a

scientific weakness or deficiency in the study design and will be

reflected in assigning the priority score to the application.



APPLICATION PROCEDURES



Applications are to be submitted on the grants application form PHS

398 (rev. 9/91) and will be accepted at the standard application

deadlines as indicated in the application kit.  State and local

governments may use Form PHS 5161 and must submit an original and two

copies of the application.



Application kits are available at most institutional offices of

sponsored research; from the Office of Grants Information, Division

of Research Grants, National Institutes of Health, Westwood Building,

Room 449, Bethesda, MD 20892, telephone 301/710-0267; and from the

Office of Management, Scientific Review Branch, Agency for Health

Care Policy and Research, Suite 602, 2101 East Jefferson Street,

Rockville, MD 20852, telephone 301/594-1449.  The title and number of

the PA must be typed in Section 2a on the face page of the

application.



The completed original application and five legible copies must be

sent or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



The Division of Research Grants (DRG) will not accept any application

in response to this announcement that is essentially the same as one

currently pending initial review, unless the applicant withdraws the

pending application.  The DRG will not accept any application that is

essentially the same as one already reviewed.  This does not preclude

the submission of substantial revisions of applications already

reviewed, but such applications must include an introduction

addressing the previous critique.



Applicants are encouraged to apply by the earliest possible

submission date listed in the application kit.



REVIEW CONSIDERATIONS



Upon receipt, applications will be reviewed for completeness;

incomplete applications will be returned to applicants without

further considerations.  The review criteria for these applications

are considerations of scientific and technical excellence, which

include:  adequacy of the method to carry out the project;

availability of the data or the proposed plan to collect the data

required for the project; qualifications and experience of the

Principal Investigator and proposed staff; adequacy of the plan for

organizing and carrying out the project; reasonableness of the

proposed budget; and adequacy of the facilities and resources

available to the applicant.



Applications will be evaluated in accordance with the criteria stated

above for scientific/technical merit by an appropriate peer review

group.  Applications recommended for funding consideration by the

peer review group and that request total direct costs in excess of

$50,000 may be reviewed by an appropriate National Advisory Council

for policy relevance and research value.  Funding will be based on

recommendations from the peer review and AHCPR's Advisory Council.



AWARD CRITERIA



Applications will compete for available funds with all other

applications.  The following will be considered in making funding

decisions:  quality of the proposed project as determined by peer

review, availability of funds, and program balance among research

areas of the announcement.  The anticipated dates of award for

applications are 10 months from the date of submission.  The AHCPR is

particularly interested in funding policy-relevant applications that

can be completed within one to two years.



INQUIRIES



Those considering applying in response to this PA are strongly

encouraged to discuss the project with AHCPR program administrators

in advance of formal submission.  The AHCPR welcomes the opportunity

to clarify any issues or questions from potential applicants.  Direct

inquiries regarding programmatic issues to:



David C. Hsia, J.D., M.D., M.P.H.

Center for General Health Services Extramural Research

Agency for Health Care Policy and Research

2101 East Jefferson Street, Suite 502

Rockville, MD  20852

Telephone:  (301) 594-1354, ext. 118



Direct inquiries regarding fiscal matters to:



Ralph Sloat

Grants Management Office

Agency for Health Care Policy and Research

2101 East Jefferson Street, Suite 601

Rockville, MD  20852

Telephone:  (301) 594-1447



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance No. 93.226.  Awards are made under authorization of the

Public Health Service Act, Title IX, as amended and administered

under PHS grants policies and Federal Regulations 42 CFR Part 67,

Subpart A, and 45 CFR Part 74 (45 CFR Part 92 for State and local

governments).  This program is not subject to the intergovernmental

review requirements of Executive Order 12372.



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