1.This Act may be cited as
the National Medical Error Disclosure and Compensation Act
or
the National MEDiC
Act
.
2.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.
3.Amendment to the
public health service act
(a)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:
DMedical Error
Disclosure and Compensation
931.In this part:
(1)The
term Database means the National Patient Safety Database
established under section 934.
(2)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 productThe 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)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 productThe term nonidentifiable
patient safety work product has the meaning given such term in section
921.
(6)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)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)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)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
organizationThe term patient safety organization
has the meaning given such term in section 921.
(11)Patient safety
work productThe term patient safety work product
has the meaning given such term in section 921.
(12)The term Program means the
National Medical Error Disclosure and Compensation (MEDiC) Program, established
under section 935.
(13)The term Program participant means a
participant that meets the requirements of section 935(b).
(14)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.
932.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.
933.Office of
Patient Safety and Health Care Quality
(a)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)The
activities of the Office shall be deemed patient safety activities, as defined
in section 921.
(c)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 appropriationsThere are authorized to be appropriated, such
sums as may be necessary for each fiscal year to carry out the activities of
the Office.
934.National
patient safety database
(a)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)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
to the patient safety data contained within the Database shall only be provided
through application to and approval by the Director.
935.National
Medical Error Disclosure and Compensation (MEDic) Program
(a)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)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
participationA 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)
(1)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 mediatorBoth 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
negotiationsWith 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)Upon
reaching an agreement under this subsection, the Program participant shall
provide the negotiated compensation to the patient within an agreed upon
timeframe.
(5)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)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)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
confidentialityThe provisions of section 922 shall apply to
patient safety data submitted under this subsection.
936.National MEDiC
Grant Program
(a)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)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)There are authorized to be appropriated, such sums as may
be necessary to carry out this section.
(2)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.
937.The National
MEDiC Accountability Study
(a)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
recommendationsNot 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.
938.Medical
liability insurance study
(a)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
recommendationsNot 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.
939.Study to
reduce the incidence of lawsuits not related to medical error
(a)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)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)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).
940.Authorization
of appropriationsThere are
authorized to be appropriated, such sums as may be necessary to carry out this
part.
.
(b)Section 921(7)(A)(i)(II) is amended by inserting
, including activities under section 935(e)
after patient
safety activities
.