National Medical Error Disclosure and Compensation Act or the National MEDiC Act - Amends the Public Health Service Act to require the Secretary of Health and Human Services to establish the Office of Patient Safety and Health Care Quality to improve patient safety and reduce medical errors across the health care system.
Requires the Director of the Office to establish and maintain a National Patient Safety Database to receive nonidentifiable patient safety work product.
Requires the Secretary, acting through the Director, to establish the National Medical Error Disclosure and Compensation (MEDiC) Program to provide for the confidential disclosure of medical errors and patient safety events, reduce preventable medical errors, ensure patient access to fair compensation for medical injury due to medical error, negligence, or malpractice, and reduce the cost of medical liability for health care providers. Requires Program participants to: (1) spend savings from the Program on reducing medical liability premiums or on activities to reduce medical errors; (2) report to a patient safety officer any medical error or patient safety event or any legal action related to the medical liability of a health care provider; (3) report to the patient any medical error that resulted in harm; and (4) offer to negotiate compensation with the patient and offer to provide an apology.
Requires the Director to award grants to facilitate the reporting, collection, and analysis of patient safety data and the development and dissemination of training guidelines and other recommendations to reduce medical errors and improve patient safety and quality of care.
Requires the Director to analyze: (1) patient safety data to determine performance and systems standards, tools, and best practices for health care providers; (2) the medical liability insurance market to determine legal costs related to medical liability, factors leading to such legal costs, and the success of any state reforms; and (3) patient safety data to examine cases that were not successfully negotiated through the Program.
[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1784 Introduced in Senate (IS)]
109th CONGRESS
1st Session
S. 1784
To amend the Public Health Service Act to promote a culture of safety
within the health care system through the establishment of a National
Medical Error Disclosure and Compensation Program.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 28, 2005
Mrs. Clinton (for herself and Mr. Obama) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to promote a culture of safety
within the health care system through the establishment of a National
Medical Error Disclosure and Compensation Program.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``National Medical Error Disclosure
and Compensation Act'' or the ``National MEDiC Act''.
SEC. 2. FINDINGS.
Congress makes the following findings:
(1) In 1999, the Institute of Medicine released a report
entitled ``To Err is Human'' that found medical errors to be
the eighth leading cause of death in the United States, with as
many as 98,000 people dying each year as a result of medical
errors.
(2) To reduce deaths and injuries due to medical errors,
the health care system must identify and learn how to prevent
such errors so that health care quality can be improved.
(3) The goals of the liability system are to identify
causes of medical error, remediate those causes to prevent
reoccurrence, and to compensate those injured by medical
negligence. Studies have shown, however, that only one medical
malpractice claim is filed for every 8 medical injuries, and
the average duration of malpractice claim resolution is between
4 and 8 years. Thus, the current health care liability system
has been found to be an inefficient and sometimes ineffective
mechanism for initiating or resolving claims of medical error,
medical negligence, or malpractice.
(4) The current liability system has also been shown to be
a deterrent to the timely sharing of information among health
care professionals, as well as between health care
professionals and patients, which impedes efforts to improve
patient safety and quality of care.
(5) Solutions to the patient safety, litigation, and
medical liability insurance problems have been elusive. A
middle ground solution that meets the basic needs of all
stakeholders including patients, health care providers,
insurers, purchasers, and attorneys is desperately needed.
(6) Some hospital systems and private medical liability
insurance companies have adopted a policy of robust disclosure
of medical errors, apologies for such errors, and early
compensation for patient injury. For example, a Department of
Veterans Affairs hospital in Lexington, Kentucky, the
University of Michigan Health System, and the private insurer
Copic Insurance Company in Colorado have adopted such policies
and have reported significantly decreased legal expenses and
smaller claim payouts. Overall, these policies have resulted in
fewer numbers of malpractice suits being filed, more patients
being compensated for injuries, greater patient trust and
satisfaction, and significantly reduced administrative and
legal defense costs for providers, insurers, and hospitals
where such policies are in place.
SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.
(a) In General.--Title IX of the Public Health Service Act (42
U.S.C. 299 et seq.), as amended by the Patient Safety and Quality
Improvement Act of 2005 (Public Law 109-41), is amended--
(1) by redesignating part D as part E;
(2) by redesignating sections 931 through 938 as sections
941 through 948, respectively;
(3) in section 948(1) (as so redesignated), by striking
``931'' and inserting ``941''; and
(4) by inserting after part C the following:
``PART D--MEDICAL ERROR DISCLOSURE AND COMPENSATION
``SEC. 931. DEFINITIONS.
``In this part:
``(1) Database.--The term `Database' means the National
Patient Safety Database established under section 934.
``(2) Health care provider.--The term `health care
provider' means a person or entity licensed or otherwise
authorized under State law to provide health care services,
including--
``(A) a hospital, health plan, community clinic,
nursing facility, comprehensive rehabilitation
facility, home health agency, hospice program, renal
dialysis facility, ambulatory surgical center,
pharmacy, doctor's or health care practitioner's
office, long-term care facility, behavior health
residential treatment facility, clinical laboratory, or
health center;
``(B) a doctor, nurse, physician assistant, nurse
practitioner, clinical nurse specialist, certified
nurse anesthetist, certified nurse midwife,
psychologist, certified social worker, registered
dietitian or nutrition professional, physical or
occupational therapist, pharmacist, or other individual
health care practitioner; and
``(C) any other health care professional specified
in regulations promulgated by the Secretary.
``(3) Identifiable patient safety work product.--The term
`identifiable patient safety work product' means patient safety
work product that--
``(A) is presented in a form and manner that allows
the identification of any provider that is a subject of
the work product, or any providers that participate in
activities that are a subject of the work product;
``(B) constitutes individually identifiable health
information as that term is defined in the regulations
promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996;
or
``(C) is presented in a form and manner that allows
the identification of an individual who reported
information in the manner specified in section 922(e)
or 935.
``(4) Medical error.--The term `medical error' means an
unexpected occurrence involving death or serious physical or
psychological injury, or the risk of such injury, including any
process variation of which recurrence may carry significant
chance of a serious adverse outcome.
``(5) Nonidentifiable patient safety work product.--The
term `nonidentifiable patient safety work product' has the
meaning given such term in section 921.
``(6) Office.--The term `Office' means the Office of
Patient Safety and Health Care Quality established under
section 933, which shall be a certified patient safety
organization as defined under part C.
``(7) Patient safety data.--The term `patient safety data'
means information requested by the Director of the Office to be
submitted by the patient safety officer of a Program
participant as described in section 935(e).
``(8) Patient safety event.--The term `patient safety
event' means an occurrence, incident, or process that either
contributes to, or has the potential to contribute to, a
patient injury or degrades the ability of health care providers
to provide the appropriate standard of care.
``(9) Patient safety officer.--The term `patient safety
officer' means the individual designated by a Program
participant as being responsible for ensuring that the
conditions for participation in the Program are met.
``(10) Patient safety organization.--The term `patient
safety organization' has the meaning given such term in section
921.
``(11) Patient safety work product.--The term `patient
safety work product' has the meaning given such term in section
921.
``(12) Program.--The term `Program' means the National
Medical Error Disclosure and Compensation (MEDiC) Program,
established under section 935.
``(13) Program participant.--The term `Program participant'
means a participant that meets the requirements of section
935(b).
``(14) Root cause analysis.--The term `root cause analysis'
means an examination or investigation of an occurrence, event,
or incident to determine if a preventable medical error took
place or the standard of care was not followed and to identify
the causal factors that led to such occurrence, event, or
incident.
``SEC. 932. PURPOSE AND GOALS.
``It is the purpose of this part to promote a culture of safety
within hospitals, health systems, clinics, and other sites of health
care, through the establishment of a National Medical Error Disclosure
and Compensation (MEDiC) Program (referred to in this part as the
`Program'). It shall be a goal of the Program to--
``(1) improve the quality of health care by encouraging
open communication between patients and health care providers
about medical errors and other patient safety events;
``(2) reduce rates of preventable medical errors;
``(3) ensure patients have access to fair compensation for
medical injury due to medical error, negligence, or
malpractice; and
``(4) reduce the cost of medical liability insurance for
doctors, hospitals, health systems, and other health care
providers.
``SEC. 933. OFFICE OF PATIENT SAFETY AND HEALTH CARE QUALITY.
``(a) In General.--The Secretary shall establish within the Office
of the Secretary, an Office of Patient Safety and Health Care Quality
to collaborate with the Director of the Agency for Health Care Research
and Quality to improve patient safety and reduce medical error across
the health care system. The Office shall be headed by a Director to be
appointed by the Secretary.
``(b) Activities.--The activities of the Office shall be deemed
patient safety activities, as defined in section 921.
``(c) Duties.--The Director of the Office shall--
``(1) establish and administer the Program;
``(2) determine who is eligible for participation in the
Program in accordance with section 935;
``(3) develop a standardized application to be submitted by
interested parties for entry into the Program;
``(4) oversee the application process for entry into the
Program under section 935 and provide technical assistance to
Program applicants and Program participants;
``(5) contract with an independent entity for the purpose
of evaluating the Program at least once every two years, with
the results of such evaluations being disseminated to Program
participants, Congress, and the public;
``(6) establish and maintain, in consultation with patient
safety organizations, health care quality organizations, health
care providers, and the health information technology industry,
a National Patient Safety Database as provided for in section
934 to receive nonidentifiable patient safety work product as
described in the reporting requirements for Program
participants under section 935(c)(10);
``(7) determine and adopt a standardized patient safety
taxonomy, necessary elements, common and consistent
definitions, and standardized formats for the electronic
reporting of patient safety data to the Database as described
in section 934(e);
``(8) survey Federal, State, and local requirements for the
reporting of patient safety data and work to streamline and
reduce duplication of such requirements;
``(9) grant patient safety organizations, researchers, and
other qualified individuals and institutions access to the
Database as determined appropriate through the evaluation of
completed applications submitted to the Office for such
purpose;
``(10) analyze, directly or through a contract with a
patient safety organization, all data entered into the Database
and provide Program participants, Congress, and the public with
medical error trend reports and other analyses as determined
appropriate by the Director on a quarterly basis;
``(11) develop, directly or through a contract with a
patient safety organization, safety and training
recommendations for health care providers that focus on the
reduction of medical errors, improved patient safety, and
increased quality of care on at least a yearly basis;
``(12) maintain a publicly accessible Internet website to
provide patients and health care providers with information
concerning the Program and the Database;
``(13) conduct, directly or through a contract, the
National MEDiC Accountability Study, as described in section
937, the Medical Liability Insurance Study, as described in
section 938, and a study to reduce the incidence of lawsuits
not related to medical error, as described in section 939; and
``(14) perform any other duties for the administration of
the Program as determined necessary by the Secretary.
``(d) Authorization of Appropriations.--There are authorized to be
appropriated, such sums as may be necessary for each fiscal year to
carry out the activities of the Office.
``SEC. 934. NATIONAL PATIENT SAFETY DATABASE.
``(a) In General.--The Director of the Office shall, in accordance
with section 933(c)(6), establish a National Patient Safety Database
that shall--
``(1) adopt standardized patient safety taxonomy in
consultation with the Joint Commission on Accreditation of the
Healthcare Organizations and other entities with relevant
expertise;
``(2) include necessary elements, common and consistent
definitions, and a standardized electronic interface for the
entry and processing of the data by Program participants, as
developed by the Director in consultation with patient safety
organizations, health care providers, and the health
information technology industry;
``(3) allow for the comprehensive collection and analysis
of the patient safety data required to be submitted by all
Program participants as described in section 935(e); and
``(4) include patient safety data required to be submitted
by Program participants as described in section 935(e) as
nonidentifiable patient safety work product and privileged and
confidential in accordance with section 922.
``(b) Limitation.--Information submitted to the Database shall be
confidential and protected from disclosure in accordance with the
regulations promulgated under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2 note).
``(c) Access.--Access to the patient safety data contained within
the Database shall only be provided through application to and approval
by the Director.
``SEC. 935. NATIONAL MEDICAL ERROR DISCLOSURE AND COMPENSATION (MEDIC)
PROGRAM.
``(a) Establishment.--The Secretary, acting through the Director of
the Office, shall establish a National Medical Error Disclosure and
Compensation (MEDiC) Program to provide for the confidential disclosure
of medical errors and patient safety events in order to improve patient
safety and health care quality, reduce rates of preventable medical
errors, ensure patient access to fair compensation for medical injury
due to medical error, negligence, or malpractice, and reduce the cost
of medical liability for doctors, hospitals, health systems, and other
health care providers.
``(b) Eligible Participants.--To be eligible to participate in the
Program an entity shall--
``(1)(A) be a health care provider as defined in section
931(2)(A);
``(B)(i) provide, in whole or part, medical malpractice
insurance for doctors and other designated health care
providers, including--
``(I) mutual insurance companies;
``(II) privately held or publically traded
liability insurance companies;
``(III) self-insured hospitals;
``(IV) captive insurance companies or providers
covered by captive insurance companies; and
``(V) risk-retention groups and any other
alternative malpractice insurance mechanisms; or
``(ii) in the case of a Program participant that is a
medical liability insurer, provide to all, or a subset of, the
insured of such insurer, an opportunity to participate in the
Program; or
``(C) be any other entity determined to be eligible by the
Director;
``(2) designate a patient safety officer to ensure that the
conditions of participation described in subsection (c) are
met;
``(3) submit a completed application to the Office at such
time, in such manner, and containing such information as the
Director may require; and
``(4) agree to comply with the conditions of participation
under subsection (c).
``(c) Conditions of Participation.--A Program participant shall,
directly or indirectly--
``(1) submit a comprehensive plan, as part of the
application for participation in the Program, to reduce the
incidence of medical errors and improve patient safety;
``(2) submit cost analysis statements, in such manner as
determined by the Director, for the 2 fiscal years prior to the
year of expected entry into the Program at the time of
application and at the end of every year of participation in
the Program, that outline all real and projected costs and
savings related to the liability coverage and legal defense
costs of doctors and other health care providers;
``(3) allocate an amount equal to not less than 50 percent
of the projected annual savings for the first year of
participation in the Program, not less than 40 percent of the
actual savings reported for the second year, and not less than
30 percent of the actual savings reported for the third and
each subsequent year of participation to--
``(A) in the case of a Program participant that is
a medical liability insurer, the reduction of medical
liability premiums for doctors or other designated
health care providers as defined in section 931; or
``(B) in the case of a Program participant that is
a health care provider as defined in section 931(2)(A),
activities that result in the reduction of medical
errors or that otherwise improve patient safety;
``(4) require health care providers included in the Program
by the Program participant and as outlined in the Program
participant application, to submit to the patient safety
officer a report of--
``(A) any incident or occurrence involving a
patient that is thought to either be a medical error or
patient safety event; and
``(B) any legal action related to the medical
liability of a health care provider;
``(5) ensure that the reports filed under paragraph (4) are
submitted to the Database in a standardized format as
designated by the Director;
``(6) where appropriate, ensure that a root cause analysis
of any report submitted to the patient safety officer as
described in paragraph (4) is performed within 90 days of the
filing of a report under such paragraph;
``(7) ensure that if a patient was harmed or injured as the
result of a medical error, or as a result of the relevant
standard of care not being followed, an account of the incident
or occurrence, as described in paragraph (4)(A) shall be
disclosed to the patient not later than 5 business days after
the completion of root cause analysis;
``(8) disclose information contained in any report
submitted to the patient safety officer as described in
paragraph (4)(A) upon the request of the patient with respect
to whom the report has been filed;
``(9) offer, at the time of disclosure of an incident or
occurrence in which it was determined that a patient was harmed
or injured as a result of medical error or as a result of the
relevant standard of care not being followed, to--
``(A) negotiate compensation with the patient
involved in accordance with subsection (d);
``(B) provide, at the discretion of the health care
provider involved, an apology or expression of remorse;
and
``(C) share, where practicable, any efforts the
health care provider will undertake to prevent
reoccurrence; and
``(10) prepare and submit entries to the Database as
required by the Director of the Office and in accordance with
subsection (e).
``(d) Negotiations.--
``(1) Terms.--If at the time of the disclosure of an
incident or occurrence in which it was determined that a
patient was harmed or injured as a result of medical error or
as a result of the relevant standard of care not being
followed, a patient elects to enter into an agreement for
negotiations with a Program participant as provided for in
subsection (c)(9), such negotiations shall, at a minimum,
provide for the following:
``(A) The confidentiality of the proceedings.
``(B) An agreement that any apology or expression
of remorse by a doctor or other designated health care
provider at any time during the negotiations shall be
kept confidential and shall not be used in any
subsequent legal proceedings as an admission of guilt
if such negotiations end without an offer of
compensation that is acceptable to both parties.
``(C) Written notification of a patient's right to
legal counsel, which shall include an affirmative
declaration that no coercive or otherwise inappropriate
action was taken to dissuade a patient from utilizing
counsel for the negotiations.
``(2) Neutral third party mediator.--Both parties may agree
to the use of a neutral third party mediator to facilitate the
negotiation of the terms of the settlement.
``(3) Timeframe for negotiations.--With respect to
negotiations under paragraph (1), the parties shall agree that
if an agreement on the terms of compensation is not reached
within 6 months from the date of the disclosure required under
subsection (c)(7) to the patient--
``(A) the patient may proceed directly to the
judicial system for a resolution of the issues
involved; or
``(B) the parties may sign an extension of the
agreement to provide an additional 3-month negotiation
period.
``(4) Payment.--Upon reaching an agreement under this
subsection, the Program participant shall provide the
negotiated compensation to the patient within an agreed upon
timeframe.
``(5) Finality.--Upon receipt of the final payment of the
accepted settlement as negotiated under this subsection, the
patient shall agree to the final settlement of the incident
described in the report and findings of the root cause analysis
under subsection (c)(7), and further litigation with respect to
such matter shall be prohibited in Federal or State court.
``(e) Submission of Patient Safety Data.--
``(1) In general.--All entries into the Database shall--
``(A) contain only non-identifiable patient safety
work product;
``(B) be in a standardized electronic format to be
determined by the Director; and
``(C) if related to a single occurrence or
incident, be given a common identifier to link entries
of related data.
``(2) Reporting requirements.--The patient safety officer
of a Program participant shall be required to prepare and enter
into the Database--
``(A) reports, containing only nonidentifiable
patient safety work product, filed by a health care
provider under subsection (c)(4) and a summary of the
findings of the root cause analysis with respect to
such report within 5 business days of the completion of
the root cause analysis;
``(B) the terms of any agreement reached through
negotiations under subsection (d);
``(C) any awards given by a Program participant to
a patient as compensation for harm or injury whether
obtained through negotiations under subsection (d) or
by other means;
``(D) any disciplinary actions taken against a
health care provider as a result of involvement in any
incident or occurrence involving a patient that is
thought to be a medical error or patient safety event,
or legal action for which a report under subsection
(c)(4) was filed; or
``(E) other data as determined appropriate by the
Director.
``(3) Privilege and confidentiality.--The provisions of
section 922 shall apply to patient safety data submitted under
this subsection.
``SEC. 936. NATIONAL MEDIC GRANT PROGRAM.
``(a) In General.--The Director of the Office shall award grants--
``(1) to Program participants, to enable such participants
to--
``(A) develop and implement communication programs
to help health care providers disclose medical errors
and other patient safety events to patients; and
``(B) procure information technology products,
including hardware, software, and support services, to
facilitate the reporting, collection, and analysis of
patient safety data as required under this part; and
``(2) to patient safety organizations and qualified
institutions or individuals, to enable the--
``(A) tracking and analysis of local and regional
patient safety trends; and
``(B) development and dissemination of training
guidelines and other recommendations for doctors and
other designated health care providers that focus on
methods to reduce medical errors and improve patient
safety and quality of care.
``(b) Application.--To be eligible to receive a grant under this
section, a Program participant, patient safety organization, or
qualified institution or individuals shall submit to the Director of
the Office an application at such time, in such manner, and containing
such information as the Director may require.
``(c) Authorization of Appropriations.--
``(1) In general.--There are authorized to be appropriated,
such sums as may be necessary to carry out this section.
``(2) Reserves.--The Secretary shall reserve 20 percent of
the funds appropriated under paragraph (1) to provide funding
to Program participants if the Secretary determines that the
total costs of the cases handled under the Program for the year
exceed the total costs that would have been incurred if such
cases had not been handled under the Program.
``SEC. 937. THE NATIONAL MEDIC ACCOUNTABILITY STUDY.
``(a) In General.--The Director of the Office shall conduct,
directly or through a contract with patient safety organizations or
qualified individuals or institutions, an analysis of the patient
safety data in the Database and other available data to determine
performance and systems standards, tools, and best practices (including
peer-review) for doctors and other health care providers necessary to
prevent medical errors, improve patient safety, and increase
accountability within the health care system. Such analysis shall also
consider the value of increasing the transparency of the patient safety
data to include the identity of health care providers and provide
recommendations for improvements to the peer review process.
``(b) Report and Recommendations.--Not later than 2 years after the
date of enactment of the National MEDiC Act, the Director of the Office
shall submit to Congress and make available to States, State medical
boards, and the public a report that describes the results of the study
carried out under subsection (a) and contains recommendations for
Congress based on the findings of the report.
``SEC. 938. MEDICAL LIABILITY INSURANCE STUDY.
``(a) In General.--The Director of the Office shall conduct,
directly or through contract with patient safety organizations or
qualified individuals or institutions, an analysis of the medical
liability insurance market that distinguishes between types of carriers
to determine historic and current legal costs related to medical
liability, factors leading to increased legal costs related to medical
liability, and which, if any, State medical liability insurance reforms
have led to stabilization or reduction in medical liability premiums.
``(b) Report and Recommendations.--Not later than 2 years after the
date of enactment of the National MEDiC Act, the Director of the Office
shall submit to Congress and make available to the States, State
insurance regulators, and the public a report that describes the
results of the study carried out under subsection (a) and contains
recommendations for Congress based on the findings of the report.
``SEC. 939. STUDY TO REDUCE THE INCIDENCE OF LAWSUITS NOT RELATED TO
MEDICAL ERROR.
``(a) In General.--The Director of the Office shall conduct,
directly or through a contract with patient safety organizations or
qualified individuals and institutions, an analysis of the patient
safety data in the Database to examine cases that were not successfully
negotiated through the Program, or of which the parties (including
providers and patients) chose not to participate in the Program and to
determine the reasons, trends, and impact on the Program participants
and patients.
``(b) Report and Recommendations.--
``(1) In general.--Not later than 5 years after the date of
enactment of the National MEDiC Act, the Director of the Office
shall submit to Congress and make available to the States, and
the public a report that describes the results of the study
carried out under subsection (a) and contains recommendations
for Congress based on the findings of the report.
``(2) Interim reports.--The Director of the Office shall
submit periodic interim reports to Congress (and make such
reports available to the States and the public) before the
submission on the report under paragraph (1) that describes the
progress and findings made in carrying out the study under
subsection (a).
``SEC. 940. AUTHORIZATION OF APPROPRIATIONS.
``There are authorized to be appropriated, such sums as may be
necessary to carry out this part.''.
(b) Conforming Amendment.--Section 921(7)(A)(i)(II) is amended by
inserting ``, including activities under section 935(e)'' after
``patient safety activities''.
<all>
Introduced in Senate
Sponsor introductory remarks on measure. (CR S10599)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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