1.Short title; table of
contents
(a)This Act may be cited
as the Comprehensive Medical
Malpractice Reform Act of 2009
.
(b)The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents.
Title I—Health care malpractice liability reform
Sec. 101. Cap on non-economic damages.
Sec. 102. Sanctions for meritless actions and
pleadings.
Sec. 103. Performance standards applicable to State medical
boards.
Sec. 104. Interstate patient reporting and physician tracking
database.
Sec. 105. Definitions.
Title II—Health care malpractice liability mediation
programs
Sec. 201. Grants to States and health care entities for
mediation programs.
Sec. 202. Training and assistance for mediation
programs.
Sec. 203. Authorization of appropriations.
Title III—Voluntary reporting of medical safety
incidents
Subtitle A—Reporting by individuals involved in the provision
of health care
Sec. 301. Amendments to Public
Health Service Act.
Subtitle B—Liability protection in good-Faith
reporting
Sec. 311. Liability protection for health care providers in
good-faith reporting to State medical boards.
Title IV—Insurance reform
Sec. 401. Uniform State requirements regarding proposed rate
increases.
Sec. 402. Reduction in premiums paid by physicians for medical
malpractice insurance coverage.
Sec. 403. Effective date.
Title V—Exclusion of pharmaceuticals and devices from liability
reforms
Sec. 501. Exclusion of pharmaceuticals and devices.
<enum>I</enum><header>Health care
malpractice liability reform</header>
<section id="HDB9D97A130A74B63AD0308AA8F0A516A"><enum>101.</enum><header>Cap on
non-economic damages</header>
<subsection id="HEEF8CE7A797243B9AA94E07CED075A4F"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">When an individual is
injured or dies as the result of health care malpractice, a person entitled to
recover non-economic damages from a health care provider responsible for that
malpractice may not recover such damages, in the aggregate from all such
providers, in an amount more than $250,000, adjusted for inflation from 1975 as
provided in subsection (b). This limitation applies separately to each person
entitled to recover such damages.</text>
</subsection><subsection id="H2E1032A6DD4C4277A76DA6CAF73BB883"><enum>(b)</enum><header>Adjustment for
inflation from 1975</header>
<paragraph id="HEC52973ABBD74A4B925223F26D7C410E"><enum>(1)</enum><header>Publication by
Secretary of Labor</header><text>On or about December 1 of each year, the
Secretary of Labor shall publish in the Federal Register a dollar amount
determined by adjusting the dollar amount specified in subsection (a) according
to the adjustments in the Consumer Price Index of the Bureau of Labor
Statistics of the Department of Labor for the period beginning on or about
October 1, 1975, and ending on or about October 1 of that year.</text>
</paragraph><paragraph id="H90F569DE46CA4EE6ADC972693E44BBC5"><enum>(2)</enum><header>Applicability</header><text>For
purposes of subsection (a), the dollar amount that applies to a calendar year
is the dollar amount published on or about December 1 of the preceding
year.</text>
</paragraph><paragraph id="H33DCE11AB666458D98267482335FBCBF"><enum>(3)</enum><header>Estimation</header><text>Congress
estimates that the dollar amount that would apply to calendar year 2005 would
be approximately $878,000, though the dollar amount published under paragraph
(1), rather than the estimation in this paragraph, is to be applied.</text>
</paragraph></subsection><subsection id="H21907FBBEB014F48A1C832A4397E9E05"><enum>(c)</enum><header>Applicability</header>
<paragraph id="H184B85CF495D434CA75CE2AE76271F74"><enum>(1)</enum><header>In
general</header><text>Subject to paragraph (2), this section applies whenever
the amount of a recovery is made final in a calendar year after the date of the
enactment of this Act. In applying the dollar amount to a recovery, all
recoveries made final (whether before or after the date of the enactment of
this Act) are included in the aggregate.</text>
</paragraph><paragraph id="HEB06BD96847C4767A8C4D0B4C46E9197"><enum>(2)</enum><header>Not applicable
when State board not in compliance</header><text display-inline="yes-display-inline">During a period in which a State medical
board is not in compliance with the voluntary performance standards developed
under section 103 or is failing to submit the information described in
paragraphs (2) and (3)(A) of section 104(b) (as determined by the Secretary
under section 103 or 104, respectively), the limitation in subsection (a) does
not apply to liability arising under the law of that State.</text>
</paragraph></subsection><subsection id="H668D5D6BC6A64804A74676C144CF3168"><enum>(d)</enum><header>Relationship to
State law</header><text>This section operates on a case-by-case basis to
provide a maximum recovery and to prevent State law from providing a recovery
above that maximum. It does not prevent State law from providing a recovery
below that maximum.</text>
</subsection></section><section id="H7D72140D987D45F18518915383D08BCA"><enum>102.</enum><header>Sanctions for
meritless actions and pleadings</header>
<subsection id="HE0C65354E8C04C998B65B0E5C699989C"><enum>(a)</enum><header>Signature
required</header><text display-inline="yes-display-inline">Every pleading,
written motion, and other paper in any medical malpractice action shall be
signed by at least 1 attorney of record in the attorney's individual name, or,
if the party is not represented by an attorney, shall be signed by the party.
Each paper shall state the signer's address and telephone number, if any. An
unsigned paper shall be stricken unless omission of the signature is corrected
promptly after being called to the attention of the attorney or party.</text>
</subsection><subsection id="HFC037D82691341D4A23B3F916DFDEB95"><enum>(b)</enum><header>Certificate of
merit</header>
<paragraph id="H69DCCFF338B74E2A97D99E628A29E99A"><enum>(1)</enum><header>In
general</header><text>A medical malpractice action shall be dismissed unless
the attorney or unrepresented party presenting the complaint certifies that, to
the best of the person's knowledge, information, and belief, formed after an
inquiry reasonable under the circumstances—</text>
<subparagraph id="H890E3F15404D41899EAADBC99154D60F"><enum>(A)</enum><text>it is not being
presented for any improper purpose, such as to harass or to cause unnecessary
delay or needless increase in the cost of litigation;</text>
</subparagraph><subparagraph id="H4D1553512384465483DF75587F91B64F"><enum>(B)</enum><text>the claims and
other legal contentions therein are warranted by existing law or by a
nonfrivolous argument for the extension, modification, or reversal of existing
law or the establishment of new law; and</text>
</subparagraph><subparagraph id="H7C98948831E6429DA90BE21E3D5814C1"><enum>(C)</enum><text>the allegations
and other factual contentions have evidentiary support or, if specifically so
identified, are likely to have evidentiary support after a reasonable
opportunity for further investigation and discovery.</text>
</subparagraph></paragraph><paragraph id="H8B83E8D3FCE34814A3EE4FF772DACCF2"><enum>(2)</enum><header>Paper considered
to be a certification</header><text>By presenting to the court (whether by
signing, filing, submitting, or later advocating) a pleading, written motion,
or other paper, an attorney or unrepresented party is certifying that to the
best of the person's knowledge, information and belief, formed after an inquiry
reasonable under the circumstances—</text>
<subparagraph id="HFDD88B3008874BC184E8356190B9D1D9"><enum>(A)</enum><text>it is not being
presented for any improper purpose, such as to harass or to cause unnecessary
delay or needless increase in the cost of litigation;</text>
</subparagraph><subparagraph id="HE05F656E4CD6490C95B92994EC1F36FA"><enum>(B)</enum><text>the claims,
defenses, and other legal contentions therein are warranted by existing law or
by a nonfrivolous argument for the extension, modification, or reversal of
existing law or the establishment of new law; and</text>
</subparagraph><subparagraph id="HDFA90FB326EE423C86DD3F7CD5505F6E"><enum>(C)</enum><text>the allegations
and other factual contentions have evidentiary support or, if specifically so
identified, are reasonable based on a lack of information or belief.</text>
</subparagraph></paragraph></subsection><subsection id="HA088F88CB97C42A8AC7457AB197E7801"><enum>(c)</enum><header>Mandatory
sanctions</header>
<paragraph id="HB7161E4B2D164E1D969CB1F96683C865"><enum>(1)</enum><header>First
violation</header><text>If, after notice and a reasonable opportunity to
respond, a court, upon motion or upon its own initiative, determines that
subsection (b) has been violated, the court shall find each attorney or party
in violation in contempt of court and shall require the payment of costs and
attorneys fees. The court may also impose additional appropriate sanctions,
such as striking the pleadings, dismissing the suit, and sanctions plus
interest, upon the person in violation, or upon both such person and such
person's attorney or client (as the case may be).</text>
</paragraph><paragraph id="H65B4FC7D2FA84A72853F12BC5149E984"><enum>(2)</enum><header>Second
violation</header><text>If, after notice and a reasonable opportunity to
respond, a court, upon motion or upon its own initiative, determines that
subsection (b) has been violated and that the attorney or party with respect to
which the determination was made has committed one previous violation of
subsection (b) before this or any other court, the court shall find each such
attorney or party in contempt of court and shall require the payment of costs
and attorneys fees, and require such person in violation (or both such person
and such person's attorney or client (as the case may be)) to pay a monetary
fine. The court may also impose additional appropriate sanctions, such as
striking the pleadings, dismissing the suit and sanctions plus interest, upon
such person in violation, or upon both such person and such person's attorney
or client (as the case may be).</text>
</paragraph><paragraph id="HD222474C964D43048262C427D02139E7"><enum>(3)</enum><header>Third and
subsequent violations</header><text>If, after notice and a reasonable
opportunity to respond, a court, upon motion or upon its own initiative,
determines that subsection (b) has been violated and that the attorney or party
with respect to which the determination was made has committed more than one
previous violation of subsection (b) before this or any other court, the court
shall find each such attorney or party in contempt of court, refer each such
attorney to one or more appropriate State bar associations for disciplinary
proceedings, require the payment of costs and attorneys fees, and require such
person in violation (or both such person and such person's attorney or client
(as the case may be)) to pay a monetary fine. The court may also impose
additional appropriate sanctions, such as striking the pleadings, dismissing
the suit, and sanctions plus interest, upon such person in violation, or upon
both such person and such person's attorney or client (as the case may
be).</text>
</paragraph></subsection><subsection id="HE22F6C71D6384ED08B1871FA12461CCE"><enum>(d)</enum><header>Central tracking
database</header><text display-inline="yes-display-inline">The Attorney General
shall establish and maintain a central tracking database reporting system to
which courts are to report violations of subsection (b). The database shall
include all identifying information with respect to the attorney or the party
(if not represented by an attorney). The Attorney General shall permit courts
to consult the database to determine the extent to which an attorney or party
has violated subsection (b) previously.</text>
</subsection></section><section id="HD3CF2311365B49A091A59AB752E8F206"><enum>103.</enum><header>Performance
standards applicable to State medical boards</header>
<subsection id="H4333AD9CE0BB4F1E84BBEFE00B80402D"><enum>(a)</enum><header>Development</header><text>Not
later than 1 year after the date of the enactment of this Act, the Secretary of
Health and Human Services, in consultation with the Federation of State Medical
Boards, shall develop and make publicly available voluntary performance
standards applicable to State medical boards.</text>
</subsection><subsection id="H0CF13718A7B24BEBBB3F0BFB84C4A620"><enum>(b)</enum><header>Contents</header><text display-inline="yes-display-inline">In developing performance standards under
this section, the Secretary shall include standards to require the
following:</text>
<paragraph id="H59B3E588158547958E247D1ACEF082E0"><enum>(1)</enum><text>Processing patient
complaints within a specified limited period of time.</text>
</paragraph><paragraph id="H99B7B7C0F218471FB77BE7DC544DBE59"><enum>(2)</enum><text>Maintaining a
website or toll-free telephone number to enable a patient submitting a
complaint to track the status of the complaint.</text>
</paragraph><paragraph id="H559B46979AB6497C8DBE673DE4E00599"><enum>(3)</enum><text>Maintaining an
adequate level of staff for the activities of the State medical board.</text>
</paragraph><paragraph id="HA1E8A836BD0949D3A6DB5BCB5E3AD0ED"><enum>(4)</enum><text>Ensuring that
staff are qualified.</text>
</paragraph><paragraph id="H7086576787064FCD8953870C9CCDC314"><enum>(5)</enum><text>Making the
following information available to the public for physicians:</text>
<subparagraph id="H09B32726F3334F74816622D939866CCA"><enum>(A)</enum><text>Each physician’s
education and training.</text>
</subparagraph><subparagraph id="H78DE856A30564490B219DA17B257E69B"><enum>(B)</enum><text>Each physician’s
medical specialties.</text>
</subparagraph><subparagraph id="H320E63CE971442188C5DD0ACD3912E7B"><enum>(C)</enum><text>For each physician
a description of medical malpractice claims paid, hospital disciplinary actions
taken, criminal convictions occurring, and disciplinary actions taken by the
State medical board, within the previous 10 years.</text>
</subparagraph><subparagraph id="H2CB7A0F36A3B4814871D499B55C14918"><enum>(D)</enum><text>At the option of a
State medical board, each physician’s professional demographics (such as
business address, insurance plan and hospital affiliations, and available
translation services), professional or community awards received, and research
or other professional publications.</text>
</subparagraph></paragraph><paragraph id="HB6ED0D0EE68B4351BB1ED1C33A98A579"><enum>(6)</enum><text>Issuing an annual
report that includes aggregate disciplinary statistics, including—</text>
<subparagraph id="H4831D6C7C2D54CCA88AF7E814254C024"><enum>(A)</enum><text>statistics on the
number and type of complaints received; and</text>
</subparagraph><subparagraph id="HB5DC479FC4F54D80849D932700D9F3C9"><enum>(B)</enum><text>with respect to
physicians, statistics on the number and type of complaints received,
disaggregated by the medical school and graduate medical education program
completed by the physicians involved.</text>
</subparagraph></paragraph><paragraph id="H6BB2DB3F5B544B7BB9642FA10F2F77D6"><enum>(7)</enum><text>Such other issues
as the Secretary determines appropriate.</text>
</paragraph></subsection><subsection id="H717D6DA8F77D4B3BA63160E3DC585A26"><enum>(c)</enum><header>Determination
required</header><text>For the period beginning 3 years after the date of the
enactment of this Act, the Secretary shall determine whether the State medical
board of each State is in compliance with the voluntary performance standards
developed under subsection (a).</text>
</subsection><subsection id="HE43FD9B7F0194D6CAF60E96E26658B52"><enum>(d)</enum><header>Determination of
noncompliance</header><text>Before making a determination under subsection (c)
that a State medical board is not in compliance with the voluntary performance
standards developed under subsection (a), the Secretary shall—</text>
<paragraph id="H620806AFA5B242569833DAD81621ECB6"><enum>(1)</enum><text>propose a
determination of noncompliance;</text>
</paragraph><paragraph id="HCD9CDB59628A431D94D45F004805C72A"><enum>(2)</enum><text>identify the
reasons for such noncompliance; and</text>
</paragraph><paragraph id="H08F14FC5FE5846E587C78EA293AABAD1"><enum>(3)</enum><text>give the State
medical board an opportunity to correct such noncompliance.</text>
</paragraph></subsection><subsection id="H716C0C27506F42DA81E36A6171D7F151"><enum>(e)</enum><header>Revision of
determinations</header><text>The Secretary shall periodically review and, as
necessary, revise determinations of compliance and noncompliance under
subsection (c).</text>
</subsection><subsection id="H3401ED9AF458498FA10824B5EC37369B"><enum>(f)</enum><header>Report by
Secretary</header><text>Not later than 5 years after the date of the enactment
of this Act, and annually thereafter, the Secretary shall submit a report to
the Congress on the activities of the Secretary under this section, including a
listing of the State medical boards determined by the Secretary to be in
compliance or not in compliance with the voluntary standards developed under
subsection (a).</text>
</subsection></section><section id="H8F5EF3FA463E44FB8AD11377BAD4DA27"><enum>104.</enum><header>Interstate
patient reporting and physician tracking database</header>
<subsection id="H9294A0F5E1274473A1E549C4A9CFA55D"><enum>(a)</enum><header>Establishment</header><text>The
Secretary of Health and Human Services shall establish and maintain an
interstate patient reporting and physician tracking database (in this section
referred to as the <quote>database</quote>) .</text>
</subsection><subsection id="H378499A2CFB247058A3B60BEF79F1E66"><enum>(b)</enum><header>Database
contents</header>
<paragraph id="HB6555C2605A349EBA528258A9DD314D1"><enum>(1)</enum><header>In
general</header><text>The database shall consist of information about
physicians voluntarily submitted to the database by—</text>
<subparagraph id="H200D8181CED94398A3353C2E025E2FBC"><enum>(A)</enum><text>State medical
boards; and</text>
</subparagraph><subparagraph id="H21AFBBB95B1D41A5B59741EFAFD2A6B0"><enum>(B)</enum><text>patients.</text>
</subparagraph></paragraph><paragraph id="HD2F592D23C9F4EC9957DBBAA35C569C0"><enum>(2)</enum><header>Submissions by
State medical boards</header><text>The database shall encourage the State
medical board of each State to submit, with respect to each physician licensed
by the State, the following:</text>
<subparagraph id="HADAC0D7251524ADDA827F368E30C4EF4"><enum>(A)</enum><text>The physician’s
identity.</text>
</subparagraph><subparagraph id="H76D7D943BBCC4D5CAB4B6942D7F4F0F9"><enum>(B)</enum><text>The physician’s
education and training.</text>
</subparagraph><subparagraph id="H1378A80D6F5A42B4A6C94F4DD50C9626"><enum>(C)</enum><text>The physician’s
medical specialties.</text>
</subparagraph><subparagraph id="HD587C3526EEC479094EE75F9373E502F"><enum>(D)</enum><text display-inline="yes-display-inline">A description of medical malpractice claims
paid, hospital disciplinary actions taken, criminal convictions occurring, and
disciplinary actions taken by the State medical board, within the previous 10
years.</text>
</subparagraph></paragraph><paragraph id="H577611F79721403F81E8980CD41DA780"><enum>(3)</enum><header>Patient
complaints</header><text display-inline="yes-display-inline">The database
shall—</text>
<subparagraph id="H4DDD3D29CCDE488FB2A76C4CD4ADF1D6"><enum>(A)</enum><text>encourage the
State medical board of each State to submit, with respect to each physician
licensed by the State, a description of pending patient complaints about the
physician; and</text>
</subparagraph><subparagraph id="H6B86268AA3FD45A5B2C2577B816EE94B"><enum>(B)</enum><text>allow patients to
submit complaints about physicians directly to the database.</text>
</subparagraph></paragraph></subsection><subsection id="H9AE9CB7DD6784FADA8E8AE1D63283CAE"><enum>(c)</enum><header>Availability of
information</header>
<paragraph id="HB4B9060CFF1A41F4839EBD66D68B4730"><enum>(1)</enum><header>In
general</header><text>The information submitted to the database pursuant to
subsection (b)(2) shall be available to the public, including by means of the
Internet and a toll-free telephone number.</text>
</paragraph><paragraph id="H571B56F7AA694D4E85A6C8490EDDD832"><enum>(2)</enum><header>Patient
complaints</header>
<subparagraph id="H5CE24AB6C2EB446AB83D980C11FE7F35"><enum>(A)</enum><header>Confidentiality</header><text display-inline="yes-display-inline">Any patient complaint about a physician
submitted to the database shall be kept confidential and shall not be subject
to disclosure under section 552 of title 5, United States Code. Except as
provided in subparagraph (B), the database may disclose information derived
from such a patient complaint only if the information is not individually
identifiable.</text>
</subparagraph><subparagraph id="H8F8F9922618648D9AFBC847A7F7E0E7C"><enum>(B)</enum><header>Tracking patient
complaints</header><text>The database shall—</text>
<clause id="HEEEE75D6E4BF49F882915CF9FA87233E"><enum>(i)</enum><text>assign a tracking
number to each patient complaint submitted to the database pursuant to
subsection (b)(3);</text>
</clause><clause id="H5170F3B0D72146E19234FDFD724E2AD0"><enum>(ii)</enum><text>provide notice
and a description of each patient complaint submitted pursuant to subsection
(b)(3)(B) to the applicable State medical board; and</text>
</clause><clause id="HFA6ED321167748F9B271A0811A21E5B1"><enum>(iii)</enum><text>allow the
patient making any complaint submitted to the database pursuant to subsection
(b)(3) to track the status of the complaint, including by means of the Internet
and a toll-free telephone number.</text>
</clause></subparagraph><subparagraph id="HF86ED477147148FEB3C6D03BE01F3B25"><enum>(C)</enum><header>Analysis</header><text>Subject
to subparagraph (A), the Secretary of Health and Human Services shall conduct
analysis of patient complaints submitted to the database, including complaints
that do not result in disciplinary action, and use the data and conclusions
derived from such analysis to provide timely public health safety information
to health care consumers and practitioners.</text>
</subparagraph></paragraph></subsection><subsection id="H95A6D2FBCC2644DB937266FA4029EC5D"><enum>(d)</enum><header>Technical
assistance</header><text>The Secretary of Health and Human Services shall
provide technical assistance to States to facilitate the exchange of
information between State medical boards and the database.</text>
</subsection><subsection display-inline="no-display-inline" id="H6F5D64046D424909AEE628D02849CA38"><enum>(e)</enum><header>Determination
required</header><text display-inline="yes-display-inline">For the period
beginning 3 years after the date of the enactment of this Act, the Secretary
shall determine whether the State medical board of each State is failing to
submit the information described in subsections (b)(2) and (b)(3)(A).</text>
</subsection><subsection id="H4639C81EA2E34706A376F4D6AF3A842B"><enum>(f)</enum><header>Determination of
noncompliance</header><text>Before making a determination under subsection (e)
that a State medical board is failing to submit such information, the Secretary
shall—</text>
<paragraph id="H5936E7182D4946868FEBB5FD6BB4CE09"><enum>(1)</enum><text>propose a
determination of noncompliance;</text>
</paragraph><paragraph id="H7619C590095241BD9DDA9048CE6362C7"><enum>(2)</enum><text>identify the
reasons for such noncompliance; and</text>
</paragraph><paragraph id="H1D04D26562344F7FB0FD22CD80E31016"><enum>(3)</enum><text>give the State
medical board an opportunity to correct such noncompliance.</text>
</paragraph></subsection><subsection id="H2BF799B0529740CEBB6CFCFE3D6C6105"><enum>(g)</enum><header>Revision of
determinations</header><text>The Secretary shall periodically review and, as
necessary, revise determinations of compliance and noncompliance under
subsection (e).</text>
</subsection><subsection id="H9B47A65654414F6C82827C4D0406A803"><enum>(h)</enum><header>Assessment</header><text>Not
later than 3 years after the date of the enactment of this Act, the Secretary
shall—</text>
<paragraph id="H7129EF57E8D9469092482C33D6CB92E3"><enum>(1)</enum><text>conduct an
assessment of the database, including an assessment of the value of the
database to patients and the effect of the database on physicians; and</text>
</paragraph><paragraph id="HC2B16E159BBD46E0A0D6BB6CADB3E9CF"><enum>(2)</enum><text>submit a report to
the Congress on the results of the assessment, including any recommendations
for improvement of the database.</text>
</paragraph></subsection></section><section id="H9A5B562A256E48BBB253183671273462"><enum>105.</enum><header>Definitions</header><text display-inline="no-display-inline">In this title:</text>
<paragraph id="HB047DF73BF0E474A8D8EC86D8B603DA3"><enum>(1)</enum><text display-inline="yes-display-inline">The term <term>State medical board</term>
means a State entity responsible for licensing physicians or a subdivision of
such an entity.</text>
</paragraph><paragraph id="H69BB04A1177C457E8EB3622CD495107C"><enum>(2)</enum><text>The term
<term>health care malpractice</term> means the negligence or other fault of a
health care provider.</text>
</paragraph><paragraph id="HC1DE5068434C429CA51D96BEFAAC84A1"><enum>(3)</enum><text>The term
<term>health care provider</term> means—</text>
<subparagraph id="H7B98A464C8554AC4A290D056B6CB89AD"><enum>(A)</enum><text>any individual who
is engaged in the delivery of health care services in a State and who is
required by State law or regulation to be licensed or certified by the State to
engage in the delivery of such services in the State; and</text>
</subparagraph><subparagraph id="HDEC9414199714E4A9C4C8EAAB03B70C3"><enum>(B)</enum><text>any entity that is
engaged in the delivery of health care services in a State and that, if it is
required by State law or regulation to be licensed or certified by the State to
engage in the delivery of such services in the State, is so licensed.</text>
</subparagraph></paragraph><paragraph id="H43C139A889E34B3E986CDBC261FCE40E"><enum>(4)</enum><text>The term
<term>State</term> includes the District of Columbia, the Commonwealth of
Puerto Rico, and other territories and possessions of the United States.</text>
</paragraph></section><enum>II</enum><header>Health care
malpractice liability mediation programs</header>
<section id="H9758EEA15F114AFC997FB0F1BE76F5F3"><enum>201.</enum><header>Grants to
States and health care entities for mediation programs</header>
<subsection id="H4CD6D9FFD73F490CB31F8F6EFA149C36"><enum>(a)</enum><header>Grants
authorized</header><text>From amounts made available to carry out this section,
the Attorney General shall carry out a program under which the Attorney General
makes grants to States and health care entities to carry out mediation programs
described in subsection (b).</text>
</subsection><subsection id="HB75978E6B51C443DAE602DDAA833CE6B"><enum>(b)</enum><header>Mediation
programs</header><text>A mediation program referred to in subsection (a) is a
program, based on the Rush model, under which an allegation that an individual
has been injured or has died as the result of health care malpractice is
mediated by those parties consenting to do so in an effort to resolve the
matter without litigation.</text>
</subsection><subsection id="H2B4898542851471C9D97901D753B252C"><enum>(c)</enum><header>Rush
model</header><text>For purposes of this section, a program is based on the
Rush model if the program satisfies each of the following:</text>
<paragraph id="HA4248514457D4F308E20DDF64016C113"><enum>(1)</enum><text display-inline="yes-display-inline">Participation by the parties in the
mediation is voluntary.</text>
</paragraph><paragraph id="H7EE4FB179AA04035A2F624D00CFBE892"><enum>(2)</enum><text>The mediator is
neutral, having no interest in or power to determine the outcome of the
proceedings.</text>
</paragraph><paragraph id="H1073307665B74094B4C71F69E0F04CA3"><enum>(3)</enum><text>The site of the
mediation conference is held in a neutral setting, one that the parties
mutually agree upon.</text>
</paragraph><paragraph id="H8C534D122B024548A475ED84B57A218E"><enum>(4)</enum><text display-inline="yes-display-inline">At the commencement of a mediation, the
parties enter into a mediation agreement that—</text>
<subparagraph id="H24E8737378F1497FA810249EE822C2A7"><enum>(A)</enum><text>states that the
parties—</text>
<clause id="H562CDAF03B2B4DA69B05D44FE69D8016"><enum>(i)</enum><text>will
not request or subpoena the mediator to testify or produce any documents or
other information in any proceeding related to the mediation; and</text>
</clause><clause id="HE327B1991C10422ABD0A8A26AD47A5EC"><enum>(ii)</enum><text>will defend and
indemnify the mediator in connection with any summons or subpoena arising out
of the mediation proceeding;</text>
</clause></subparagraph><subparagraph id="H770A3CEA8D3A464894D53404B09974D7"><enum>(B)</enum><text>provides for
confidentiality of the mediation proceedings; and</text>
</subparagraph><subparagraph id="H01B151D6983D491F85D3EBEE2F599979"><enum>(C)</enum><text display-inline="yes-display-inline">states that any apology or expression of
remorse by a health care provider or other entity at any time during the
mediation proceedings will be kept confidential and will not be used in any
subsequent legal proceeding.</text>
</subparagraph></paragraph><paragraph id="H13DCEF53CA5A471BBCA0BEE7BA21E039"><enum>(5)</enum><text display-inline="yes-display-inline">The program is similar to the mediation
program carried out as of January 1, 2005, at Rush-Presbyterian-St. Luke’s
Medical Center in Chicago, Illinois.</text>
</paragraph></subsection><subsection id="H9BBEFD217E76416199E9E0460D865EF7"><enum>(d)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="H9835844F89FC48C4B30AF60EE577A0BB"><enum>(1)</enum><text>The term
<term>health care entity</term> means an entity covered by section
105(3)(B).</text>
</paragraph><paragraph id="HC5D591A2890A4A28A0821935436FD7B8"><enum>(2)</enum><text>The term
<term>health care malpractice</term> has the meaning given such term in section
105.</text>
</paragraph><paragraph id="H78F75E0F2F184E08874A8DA9ECA28F6A"><enum>(3)</enum><text>The term
<term>State</term> has the meaning given such term in section 105.</text>
</paragraph></subsection></section><section id="H7597D44EE9844CB79209F8D9982ADFA3"><enum>202.</enum><header>Training and
assistance for mediation programs</header><text display-inline="no-display-inline">From amounts made available to carry out
this section, the Attorney General shall carry out a program under which the
Attorney General provides training and assistance to recipients of grant
amounts under section 201 to carry out mediation programs under that
section.</text>
</section><section id="H6E556339B8A3473287EEA94A13145CD3"><enum>203.</enum><header>Authorization
of appropriations</header><text display-inline="no-display-inline">There are
authorized to be appropriated to the Attorney General such sums as may be
necessary to carry out sections 201 and 202.</text>
</section><enum>III</enum><header>Voluntary
reporting of medical safety incidents</header>
<subtitle id="H9F4A91A6233C480B8928FC39547F0376"><enum>A</enum><header>Reporting by
individuals involved in the provision of health care</header>
<section id="H490B56B5ABDF4DC7B45A1ED36BEA3585"><enum>301.</enum><header>Amendments to
<act-name parsable-cite="PHSA">Public Health Service Act</act-name></header>
<subsection id="H333F8641973D485BBE0CDF65284F6AE5"><enum>(a)</enum><header>In
general</header><text>Title IX of the <act-name parsable-cite="PHSA">Public
Health Service Act</act-name> (42 U.S.C. 299 et seq.) is amended—</text>
<paragraph id="HA4D082D755CF47F79AAD96C7CB3AFC16"><enum>(1)</enum><text>in section 912(c),
by inserting <quote>, in accordance with part C,</quote> after <quote>The
Director shall</quote>;</text>
</paragraph><paragraph id="HF98E7F3FC62E42E8B6E14B27A743F948"><enum>(2)</enum><text>by redesignating
part C as part D;</text>
</paragraph><paragraph id="HF97BBF836E714AC7ADF31306951E5789"><enum>(3)</enum><text>by redesignating
sections 921 through 928, as sections 931 through 938, respectively;</text>
</paragraph><paragraph id="H222D89001E9B430A8978DB12AE496C53"><enum>(4)</enum><text>in section 938(1)
(as so redesignated), by striking <quote>921</quote> and inserting
<quote>931</quote>; and</text>
</paragraph><paragraph id="H11A704F060C44631A82798847426A34D"><enum>(5)</enum><text>by inserting after
part B the following:</text>
<quoted-block id="H37E6BDDFD5904677A8C98B6B6E32105F">
<part id="H48E142D5B6514E3C9939EFA642E542E2"><enum>C</enum><header>Patient safety
improvement</header>
<section id="HE02EA20F24CA41ABAB11540511A5D28F"><enum>921.</enum><header>Definitions</header><text display-inline="no-display-inline">In this part:</text>
<paragraph id="H069FEFC857ED46CA94A675CBDD508295"><enum>(1)</enum><header>Identifiable
information</header><text>The term <term>identifiable information</term> means
information that is presented in a form and manner that allows the
identification of any provider, patient, or reporter of patient safety work
product. With respect to patients, such information includes any individually
identifiable health information as that term is defined in the regulations
promulgated pursuant to section 264(c) of the <act-name parsable-cite="HIPAA">Health Insurance Portability and Accountability Act of
1996</act-name> (Public Law 104–191; 110 Stat. 2033).</text>
</paragraph><paragraph id="H0CBEE8AFBF7944F4B9941C15B0846C8B"><enum>(2)</enum><header>Nonidentifiable
information</header><text>The term <term>nonidentifiable information</term>
means information that is presented in a form and manner that prevents the
identification of any provider, patient, or reporter of patient safety work
product. With respect to patients, such information must be de-identified
consistent with the regulations promulgated pursuant to section 264(c) of the
<act-name parsable-cite="HIPAA">Health Insurance Portability and Accountability
Act of 1996</act-name> (Public Law 104–191; 110 Stat. 2033).</text>
</paragraph><paragraph id="HDA1610DC6CC64318A06970013C078F28"><enum>(3)</enum><header>Patient safety
evaluation system</header><text>The term <term>patient safety evaluation
system</term> means a process that involves the collection, management, or
analysis of information for submission to or by a patient safety
organization.</text>
</paragraph><paragraph id="HEE12A6DA9C914796879F831527905B59"><enum>(4)</enum><header>Patient safety
organization</header><text>The term <term>patient safety organization</term>
means a private or public organization or component thereof that is certified,
through a process to be determined by the Secretary under section 925, to
perform each of the following activities:</text>
<subparagraph id="HE50F2E4160464F6589F4AA986B4A4F36"><enum>(A)</enum><text>The conduct, as
the organization or component’s primary activity, of efforts to improve patient
safety and the quality of health care delivery.</text>
</subparagraph><subparagraph id="H5ECD17BC635549C891ED35095D6D9F95"><enum>(B)</enum><text>The collection and
analysis of patient safety work product that is submitted by providers.</text>
</subparagraph><subparagraph id="HA746E2CBACCE420B9D81B986902C27B1"><enum>(C)</enum><text>The development
and dissemination of evidence-based information to providers with respect to
improving patient safety, such as recommendations, protocols, or information
regarding best practices.</text>
</subparagraph><subparagraph id="H1C21CE0509E442A6BCF501FE7EF7F67C"><enum>(D)</enum><text>The utilization of
patient safety work product to carry out activities limited to those described
under this paragraph and for the purposes of encouraging a culture of safety
and of providing direct feedback and assistance to providers to effectively
minimize patient risk.</text>
</subparagraph><subparagraph id="H3D758760B6714926834B6D2FAB551386"><enum>(E)</enum><text>The maintenance of
confidentiality with respect to identifiable information.</text>
</subparagraph><subparagraph id="HEBC5D282728147D98F939590DDEB086C"><enum>(F)</enum><text>The provision of
appropriate security measures with respect to patient safety work
product.</text>
</subparagraph><subparagraph id="H586D19DBA3BC4AC3A9973A76CF15B54E"><enum>(G)</enum><text>The submission of
nonidentifiable information to the Agency consistent with standards established
by the Secretary under section 923(b) for any National Patient Safety
Database.</text>
</subparagraph></paragraph><paragraph id="H5079C122CAF2458C8C96653DC946761A"><enum>(5)</enum><header>Patient safety
work product</header>
<subparagraph id="H2739B2F08C9949D69CE661655A946B1D"><enum>(A)</enum><text>The term
<term>patient safety work product</term> means any document or communication
(including any information, report, record, memorandum, analysis, deliberative
work, statement, or root cause analysis) that—</text>
<clause id="H03CF6F8776264C6EBC66BC84949827E6"><enum>(i)</enum><text>except as provided
in subparagraph (B), is developed by a provider for the purpose of reporting to
a patient safety organization, and is reported to a patient safety
organization;</text>
</clause><clause id="HE51C93FA949C43CFB303550BDE30E06B"><enum>(ii)</enum><text>is created by a
patient safety organization; or</text>
</clause><clause id="HA02868BB2B6C44F3B71480FA554019A3"><enum>(iii)</enum><text>would reveal the
deliberations or analytic process of a patient safety evaluation system (as
defined in paragraph (3)).</text>
</clause></subparagraph><subparagraph id="H54B53DD1CFF24458B7713DC9E8EB8575"><enum>(B)</enum><clause commented="no" display-inline="yes-display-inline" id="H15B2C5DEAD10495E9F3D8FBB08B02B34"><enum>(i)</enum><text>Patient safety work
product described in subparagraph (A)(i)—</text>
<subclause id="HC8F819DD878B404EB57766E4D351CA78" indent="up1"><enum>(I)</enum><text>does not include any separate information
described in clause (ii); and</text>
</subclause><subclause id="H22FCC58056804CE58C50A6BED3E2900B" indent="up1"><enum>(II)</enum><text>shall not be construed to include such
separate information merely by reason of inclusion of a copy of the document or
communication involved in a submission to, or the fact of submission of such a
copy to, a patient safety organization.</text>
</subclause></clause><clause id="H21DD0659731841DCAD80EAAD5CD947FC" indent="up1"><enum>(ii)</enum><text>Separate information described in
this clause is a document or communication (including a patient’s medical
record or any other patient or hospital record) that is developed or
maintained, or exists, separately from any patient safety evaluation
system.</text>
</clause></subparagraph><subparagraph id="HA0C49FD6D3914258925D0848287ABBAB"><enum>(C)</enum><text>Information
available from sources other than a patient safety work product under this
section may be discovered or admitted in a civil or administrative proceeding,
if discoverable or admissible under applicable law.</text>
</subparagraph></paragraph><paragraph id="H35B2F76DA90D4A27A394C0B1D868429E"><enum>(6)</enum><header>Provider</header><text>The
term <term>provider</term> means—</text>
<subparagraph id="H3D3CA8E4698D42ADB81F8D149141BC95"><enum>(A)</enum><text>an individual or
entity licensed or otherwise authorized under State law to provide health care
services, including—</text>
<clause id="H4CB7776D8AC64194807C27C041EEB1F8"><enum>(i)</enum><text>a
hospital, nursing facility, comprehensive outpatient rehabilitation facility,
home health agency, and hospice program;</text>
</clause><clause id="HDE393D5EFFDF46BCB103F3A56E274D93"><enum>(ii)</enum><text>a
physician, physician assistant, nurse practitioner, clinical nurse specialist,
certified nurse midwife, nurse anesthetist, psychologist, certified social
worker, registered dietitian or nutrition professional, physical or
occupational therapist, or other individual health care practitioner;</text>
</clause><clause id="HA5410CFDA1D846DB9FE0DC8D6331306B"><enum>(iii)</enum><text>a pharmacist;
and</text>
</clause><clause id="H4537A271EDCB460BA7AA3B469B790917"><enum>(iv)</enum><text>a
renal dialysis facility, ambulatory surgical center, pharmacy, physician or
health care practitioner’s office, long-term care facility, behavioral health
residential treatment facility, clinical laboratory, or community health
center; or</text>
</clause></subparagraph><subparagraph id="HEBA5851419BC40D086AD50944A01543D"><enum>(B)</enum><text>any other person
or entity specified in regulations by the Secretary after public notice and
comment.</text>
</subparagraph></paragraph></section><section id="H78ECBA27BFEA433AA86F7BA61E845EFC"><enum>922.</enum><header>Privilege for
patient safety work product</header>
<subsection id="H3FEFAAB55CA3433E9AE0176015F64933"><enum>(a)</enum><header>Privilege</header><text>Notwithstanding
any other provision of law and subject to subsection (c), patient safety work
product shall not be—</text>
<paragraph id="H1FC78BF5FB6C41FCA159C8094EA45B36"><enum>(1)</enum><text>subject to a civil
or administrative subpoena or order;</text>
</paragraph><paragraph id="H91A8B3FDE44841F2BDD2E2610AB0A0B5"><enum>(2)</enum><text>subject to
discovery in connection with a civil or administrative proceeding;</text>
</paragraph><paragraph id="HC6E79BBAFDB14806818CB26949A219DC"><enum>(3)</enum><text>subject to
disclosure pursuant to section 552 of title 5, United States Code (commonly
known as the Freedom of Information Act), or any other similar Federal or State
law;</text>
</paragraph><paragraph id="H3B793C42E4F249D9B8E70B62DBEA4ED2"><enum>(4)</enum><text>required to be
admitted as evidence or otherwise disclosed in any State or Federal civil or
administrative proceeding; or</text>
</paragraph><paragraph id="HEE633C49DFA84C9696E9B09DE54833A9"><enum>(5)</enum><text>if the patient
safety work product is identifiable information and is received by a national
accreditation organization in its capacity as a patient safety
organization—</text>
<subparagraph id="H2807E5FF8D5B49E7BEF623B71C22C2BC"><enum>(A)</enum><text>used by a national
accreditation organization in an accreditation action against the provider that
reported the information;</text>
</subparagraph><subparagraph id="HC7D9C7751CA649B1B5749571F18A476C"><enum>(B)</enum><text>shared by such
organization with its survey team; or</text>
</subparagraph><subparagraph id="HE8303062F92A4FAC9ADD89D8BFFC9272"><enum>(C)</enum><text>required as a
condition of accreditation by a national accreditation association.</text>
</subparagraph></paragraph></subsection><subsection id="HF6EA082A8E474BC1BB2836D95756CA05"><enum>(b)</enum><header>Reporter
protection</header>
<paragraph id="HA634A9E0F3A149DB92F4E15665E65E9A"><enum>(1)</enum><header>In
general</header><text>A provider may not use against an individual in an
adverse employment action described in paragraph (2) the fact that the
individual in good faith reported information—</text>
<subparagraph id="HA478927E57F34B53A7F62ED9E4FD557A"><enum>(A)</enum><text>to the provider
with the intention of having the information reported to a patient safety
organization; or</text>
</subparagraph><subparagraph id="H4B9A22BF0A4D43E18531342FD8721F37"><enum>(B)</enum><text>directly to a
patient safety organization.</text>
</subparagraph></paragraph><paragraph id="HC954C11C9A4D41EA8A365B860F8CF2B0"><enum>(2)</enum><header>Adverse
employment action</header><text>For purposes of this subsection, an
<quote>adverse employment action</quote> includes—</text>
<subparagraph id="H4180C82B4F1543F2B0FD90F6AC7E53A1"><enum>(A)</enum><text>the failure to
promote an individual or provide any other employment-related benefit for which
the individual would otherwise be eligible;</text>
</subparagraph><subparagraph id="HE38886FCD3CA47D2BE48EC06B4F2F11B"><enum>(B)</enum><text>an adverse
evaluation or decision made in relation to accreditation, certification,
credentialing, or licensing of the individual; and</text>
</subparagraph><subparagraph id="H8051AFEA78374D1480B3F9FC8C246CEC"><enum>(C)</enum><text>a personnel action
that is adverse to the individual concerned.</text>
</subparagraph></paragraph><paragraph id="HF1215FA875C14EE8A2EB9BC71E4F0C9D"><enum>(3)</enum><header>Remedies</header><text>Any
provider that violates this subsection shall be subject to a civil monetary
penalty of not more than $20,000 for each such violation involved. Such penalty
shall be imposed and collected in the same manner as civil money penalties
under subsection (a) of section 1128A of the <act-name parsable-cite="SSA">Social Security Act</act-name> are imposed and
collected.</text>
</paragraph></subsection><subsection id="H4E5F425060C442DAAEE7E99C3F5B5746"><enum>(c)</enum><header>Disclosures</header><text>Nothing
in this section prohibits any of the following disclosures:</text>
<paragraph id="HE21BA8A13C014C259980AB92BE3CBB5B"><enum>(1)</enum><text>Voluntary
disclosure of nonidentifiable information.</text>
</paragraph><paragraph id="H40CF5DAB41B04A499FF34AE4E8A91660"><enum>(2)</enum><text>Voluntary
disclosure of identifiable information by a provider or patient safety
organization, if such disclosure—</text>
<subparagraph id="H98A27C7552834BE0B3AA1F0855512658"><enum>(A)</enum><text>is authorized by
the provider for the purposes of improving quality and safety;</text>
</subparagraph><subparagraph id="H083D8A47F45C4241B42DF9E45BD5726E"><enum>(B)</enum><text>is to an entity or
person subject to the requirements of section 264(c) of the
<act-name parsable-cite="HIPAA">Health Insurance Portability and Accountability
Act of 1996</act-name> (Public Law 104–191; 110 Stat. 2033), or any regulation
promulgated under such section; and</text>
</subparagraph><subparagraph id="HE7BE28E66DAB418D9B9A6C6950F8BAB8"><enum>(C)</enum><text>is not in conflict
with such section or any regulation promulgated under such section.</text>
</subparagraph></paragraph><paragraph id="H7E9FC501618D402FB50ACBC34D0797CA"><enum>(3)</enum><text>Disclosure as
required by law by a provider to the Food and Drug Administration, or on a
voluntary basis by a provider to a federally established patient safety
program, with respect to an Administration-regulated product or activity for
which that entity has responsibility, for the purposes of activities related to
the quality, safety, or effectiveness of such Administration-regulated product
or activity.</text>
</paragraph><paragraph id="HF0947627DF0247BFA5C9544AB26A5B4D"><enum>(4)</enum><text>Disclosures of
patient safety work product in accordance with this part by a provider to a
patient safety organization.</text>
</paragraph></subsection><subsection id="HB648C53A53A7488798649921B1C781A9"><enum>(d)</enum><header>Effect of
transfer, disclosure</header><text>The following shall not be treated as a
waiver of any privilege or protection established under this part:</text>
<paragraph id="H2C2EC4CB02D7434FB4F3F9589110AB27"><enum>(1)</enum><text>The transfer of
any patient safety work product between a provider and a patient safety
organization.</text>
</paragraph><paragraph id="HA8EB40C0F6934BACB68899496B3BC9B8"><enum>(2)</enum><text>Disclosure of
patient safety work product as described in subsection (c).</text>
</paragraph><paragraph id="H1D013E64939E4170BFC9D6FC9FA331CC"><enum>(3)</enum><text>The unauthorized
disclosure of patient safety work product.</text>
</paragraph></subsection><subsection id="H13E2A0CB99DD4D4CBC33A0EC0B8C5949"><enum>(e)</enum><header>Penalty</header>
<paragraph id="H8141B64462E74C7CB95B20751A6F2D2E"><enum>(1)</enum><header>Prohibition</header><text>Except
as provided in this part, and subject to paragraphs (2) and (4), it shall be
unlawful for any person to disclose patient safety work product in violation of
this section, if such disclosure constitutes a negligent or knowing breach of
confidentiality.</text>
</paragraph><paragraph id="HEB30DDF26B6A4917A478E8B290A7C42C"><enum>(2)</enum><header>Relation to
HIPAA</header><text>The penalty under paragraph (3) for a disclosure in
violation of paragraph (1) does not apply if the person would be subject to a
penalty under section 264(c) of the <act-name parsable-cite="HIPAA">Health
Insurance Portability and Accountability Act of 1996</act-name> (Public Law
104–191; 110 Stat. 2033), or any regulation promulgated under such section, for
the same disclosure.</text>
</paragraph><paragraph id="HFB1E7EFDB69B4C2581FCE8C4294FBEAE"><enum>(3)</enum><header>Amount</header><text>Any
person who violates paragraph (1) shall be subject to a civil monetary penalty
of not more than $10,000 for each such violation involved. Such penalty shall
be imposed and collected in the same manner as civil money penalties under
subsection (a) of section 1128A of the <act-name parsable-cite="SSA">Social
Security Act</act-name> are imposed and collected.</text>
</paragraph><paragraph id="HBB164123CE5242A7916E63552C3B55AD"><enum>(4)</enum><header>Subsequent
disclosure</header><text>Paragraph (1) applies only to the first person that
breaches confidentiality with respect to particular patient safety work
product.</text>
</paragraph></subsection><subsection id="H5C6ABC71AD6A4427BAF8B0E1EC7A5CE2"><enum>(f)</enum><header>Relation to
HIPAA</header>
<paragraph id="H4161247A7D74481897C7D8259DA3C667"><enum>(1)</enum><header>In
general</header><text>For purposes of applying the regulations promulgated
pursuant to section 264(c) of the <act-name parsable-cite="HIPAA">Health
Insurance Portability and Accountability Act of 1996</act-name> (Public Law
104–191; 110 Stat. 2033)—</text>
<subparagraph id="H2E167A83BF42478FB335D75130B20F4F"><enum>(A)</enum><text>patient safety
organizations shall be treated as business associates; and</text>
</subparagraph><subparagraph id="HE9D0F366CD2443BF829E2BE5BF5C860E"><enum>(B)</enum><text>activities of such
organizations described in section 921(4) in relation to a provider are deemed
to be health care operations (as defined in such regulations) of the
provider.</text>
</subparagraph></paragraph><paragraph id="H585D4E9C72AE47CAA84F29AE4D043FBB"><enum>(2)</enum><header>Rule of
construction</header><text>Nothing in this section shall be construed to alter
or affect the implementation of such regulations or such section 264(c).</text>
</paragraph></subsection><subsection id="HB46667148908496D965E144123302D6D"><enum>(g)</enum><header>No limitation of
other privileges</header><text>Nothing in this section shall be construed to
affect privileges, including peer review and confidentiality protections, that
are otherwise available under Federal or State laws.</text>
</subsection><subsection id="HDA5DD39980B34D9BA785246DF6C45EC7"><enum>(h)</enum><header>No limitation on
contracts</header><text>Nothing in this section shall be construed to limit the
power of a provider and a patient safety organization, or a patient safety
organization and the Agency or any National Patient Safety Database, consistent
with the provisions of this Act and other applicable law, to enter into a
contract requiring greater confidentiality or delegating authority to make an
authorized disclosure.</text>
</subsection><subsection id="H47EEC4A77E24448E824E4B7D745FE6F6"><enum>(i)</enum><header>Relation to
State reporting requirements</header><text>Nothing in this part shall be
construed as preempting or otherwise affecting any State law requiring a
provider to report information, including information described in section
921(5)(B), that is not patient safety work product.</text>
</subsection><subsection id="HCD51A3BD65134F9FB133C120276BE81C"><enum>(j)</enum><header>Continuation of
privilege</header><text>Patient safety work product of an organization that is
certified as a patient safety organization shall continue to be privileged and
confidential, in accordance with this section, if the organization’s
certification is terminated or revoked or if the organization otherwise ceases
to qualify as a patient safety organization.</text>
</subsection><subsection id="HCB2AB04C584C492BBF29FA7E135CCF12"><enum>(k)</enum><header>Reports on
strategies To improve patient safety</header>
<paragraph id="H96340C68491F4257910E0CDCD192A2D7"><enum>(1)</enum><header>Draft
report</header><text>Not later than the date that is 18 months after any
National Patient Safety Database is operational, the Secretary, in consultation
with the Director, shall prepare a draft report on effective strategies for
reducing medical errors and increasing patient safety. The draft report shall
include any measure determined appropriate by the Secretary to encourage the
appropriate use of such strategies, including use in any federally funded
programs. The Secretary shall make the draft report available for public
comment and submit the draft report to the Institute of Medicine for
review.</text>
</paragraph><paragraph id="H1D23F031C6F54906B9755B86774A93AF"><enum>(2)</enum><header>Final
report</header><text>Not later than 1 year after the date described in
paragraph (1), the Secretary shall submit a final report to the Congress that
includes, in an appendix, any findings by the Institute of Medicine concerning
research on the strategies discussed in the draft report and any modifications
made by the Secretary based on such findings.</text>
</paragraph></subsection></section><section id="HB1844E7D8C4541718C6D0EAAD97E1255"><enum>923.</enum><header>National
Patient Safety Database</header>
<subsection id="H3860CBEA795B46F6BCFFD985B076ADA3"><enum>(a)</enum><header>Authority</header>
<paragraph id="H943324888D53410FAA06A3BC912C7313"><enum>(1)</enum><header>In
general</header><text>In conducting activities under this part, the Secretary
shall provide for the establishment and maintenance of a database to receive
relevant nonidentifiable patient safety work product, and may designate
entities to collect relevant nonidentifiable patient safety work product that
is voluntarily reported by patient safety organizations upon the request of the
Secretary. Any database established or designated under this paragraph may be
referred to as a <quote>National Patient Safety Database</quote>.</text>
</paragraph><paragraph id="HFF3BF2113174422D8E739D11F94749C7"><enum>(2)</enum><header>Use of
information</header><text>Information reported to any National Patient Safety
Database shall be used to analyze national and regional statistics, including
trends and patterns of health care errors. The information resulting from such
analyses may be included in the annual quality reports prepared under section
913(b)(2).</text>
</paragraph><paragraph id="HBF984FE1BEB042E89AE77DA2AE97DC79"><enum>(3)</enum><header>Advisory
role</header><text>The Secretary shall provide scientific support to patient
safety organizations, including the dissemination of methodologies and
evidence-based information related to root causes and quality
improvement.</text>
</paragraph></subsection><subsection id="H2623866BCD714B3D95D78620D52B0BE6"><enum>(b)</enum><header>Standards</header><text>In
establishing or designating a database under subsection (a)(1), the Secretary
shall, in consultation with representatives of patient safety organizations,
the provider community, and the health information technology industry,
determine common formats for the voluntary reporting of nonidentifiable patient
safety work product, including necessary elements, common and consistent
definitions, and a standardized computer interface for the processing of the
work product. To the extent practicable, such standards shall be consistent
with the administrative simplification provisions of part C of title XI of the
<act-name parsable-cite="SSA">Social Security Act</act-name>.</text>
</subsection><subsection id="H470DC404254145A6B4F6C230691730D3"><enum>(c)</enum><header>Certain
methodologies for collection</header><text>The Secretary shall ensure that the
methodologies for the collection of nonidentifiable patient safety work product
for any National Patient Safety Database include the methodologies developed or
recommended by the Patient Safety Task Force of the Department of Health and
Human Services.</text>
</subsection><subsection id="H956ED8AB75CB4ED8A09E881A5A67432C"><enum>(d)</enum><header>Facilitation of
information exchange</header><text>To the extent practicable, the Secretary may
facilitate the direct link of information between providers and patient safety
organizations and between patient safety organizations and any National Patient
Safety Database.</text>
</subsection><subsection id="H2C9C124852814839B5B2D9A347CC9EB8"><enum>(e)</enum><header>Restriction on
transfer</header><text>Only nonidentifiable information may be transferred to
any National Patient Safety Database.</text>
</subsection></section><section id="H2E5B4A288287424AA3439B090C5F333A"><enum>924.</enum><header>Technical
assistance</header>
<subsection id="H4E87BB3A520B4292ADBE44973B634F7D"><enum>(a)</enum><header>In
general</header><text>The Secretary, acting through the Director, may—</text>
<paragraph id="HE41098ED0FB94CFE941992C58C61A048"><enum>(1)</enum><text>provide technical
assistance to patient safety organizations, and to States with reporting
systems for health care errors; and</text>
</paragraph><paragraph id="HFB90B60AB312482296C82724483DB9EB"><enum>(2)</enum><text>provide guidance
on the type of data to be voluntarily submitted to any National Patient Safety
Database.</text>
</paragraph></subsection><subsection id="H3F1C5D4CF4C14FE88B3A5EA9D147A93B"><enum>(b)</enum><header>Annual
meetings</header><text>Assistance provided under subsection (a) may include
annual meetings for patient safety organizations to discuss methodology,
communication, information collection, or privacy concerns.</text>
</subsection></section><section id="HF62DD13CE74B45939FED3F82EEAE363A"><enum>925.</enum><header>Certification
of patient safety organizations</header>
<subsection id="H8B4AD92CD3084B718398545C0ACC79EA"><enum>(a)</enum><header>In
general</header><text>Not later than 6 months after the date of enactment of
the Patient Safety and Quality Improvement Act, the Secretary shall establish a
process for certifying patient safety organizations.</text>
</subsection><subsection id="HEB4AE4A422D64864BE4C573B171E467D"><enum>(b)</enum><header>Process</header><text>The
process established under subsection (a) shall include the following:</text>
<paragraph id="HB329ACB797194033B466D6B6AA7D2ACA"><enum>(1)</enum><text>Certification of
patient safety organizations by the Secretary or by such other national or
State governmental organizations as the Secretary determines
appropriate.</text>
</paragraph><paragraph id="HFF9F09F53DCF48A58BF4EF8C8E679113"><enum>(2)</enum><text>If the Secretary
allows other governmental organizations to certify patient safety organizations
under paragraph (1), the Secretary shall establish a process for approving such
organizations. Any such approved organization shall conduct certifications and
reviews in accordance with this section.</text>
</paragraph><paragraph id="H0F12536B22C640B597ED9DDD2367BE23"><enum>(3)</enum><text>A review of each
certification under paragraph (1) (including a review of compliance with each
criterion in this section and any related implementing standards as determined
by the Secretary through rulemaking) not less often than every 3 years, as
determined by the Secretary.</text>
</paragraph><paragraph id="H474CAC00AE3D4DD49786DF9541066EE8"><enum>(4)</enum><text>Revocation of any
such certification by the Secretary or other such governmental organization
that issued the certification, upon a showing of cause.</text>
</paragraph></subsection><subsection id="H074686F0875040A38F73D47B294FFC0D"><enum>(c)</enum><header>Criteria</header><text>A
patient safety organization must meet the following criteria as conditions of
certification:</text>
<paragraph id="H659B623305E6468A95B58D77F9E1C74F"><enum>(1)</enum><text>The mission of the
patient safety organization is to conduct activities that are to improve
patient safety and the quality of health care delivery and is not in conflict
of interest with the providers that contract with the patient safety
organization.</text>
</paragraph><paragraph id="HD5C425C7BB59489CAA5B98A464551416"><enum>(2)</enum><text>The patient safety
organization has appropriately qualified staff, including licensed or certified
medical professionals.</text>
</paragraph><paragraph id="H990DAB7BB2334D1793A20FCD5FC1C152"><enum>(3)</enum><text>The patient safety
organization, within any 2-year period, contracts with more than 1 provider for
the purpose of receiving and reviewing patient safety work product.</text>
</paragraph><paragraph id="H4094C5A8B7864256801C322F899245D5"><enum>(4)</enum><text>The patient safety
organization is not a component of a health insurer or other entity that offers
a group health plan or health insurance coverage.</text>
</paragraph><paragraph id="HA5E61891B322400194FA23CA3602D730"><enum>(5)</enum><text>The patient safety
organization is managed, controlled, and operated independently from any
provider that contracts with the patient safety organization for reporting
patient safety work product.</text>
</paragraph><paragraph id="HCE072176DF2348458A15C112B9C87F31"><enum>(6)</enum><text>To the extent
practical and appropriate, the patient safety organization collects patient
safety work product from providers in a standardized manner that permits valid
comparisons of similar cases among similar providers.</text>
</paragraph></subsection><subsection id="HEC4DCFE31C494874BCCC833ECAC79F3A"><enum>(d)</enum><header>Additional
criteria for component organizations</header><text>If a patient safety
organization is a component of another organization, the patient safety
organization must, in addition to meeting the criteria described in subsection
(c), meet the following criteria as conditions of certification:</text>
<paragraph id="H74322D0228414666B4082CC5FB5B571A"><enum>(1)</enum><text>The patient safety
organization maintains patient safety work product separately from the rest of
the organization, and establishes appropriate security measures to maintain the
confidentiality of the patient safety work product.</text>
</paragraph><paragraph id="H76A79556F891491A929348F1B314B1CB"><enum>(2)</enum><text>The patient safety
organization does not make an unauthorized disclosure under this Act of patient
safety work product to the rest of the organization in breach of
confidentiality.</text>
</paragraph><paragraph id="H77DA2FC516D84C5E826844744CBAF1A2"><enum>(3)</enum><text>The mission of the
patient safety organization does not create a conflict of interest with the
rest of the
organization.</text>
</paragraph></subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection id="H601D5ECBE33846DD9DEA45D8BD5EFD19"><enum>(b)</enum><header>Authorization of
appropriations</header><text>Section 937 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (as redesignated by
subsection (a)) is amended by adding at the end the following:</text>
<quoted-block act-name="Public Health Service Act" id="H51BB521AB63F4203BCE21276F41DB9AF">
<subsection id="H6384B671A1AF485DAF1611C37D28A0F8"><enum>(e)</enum><header>Patient safety
and quality improvement</header><text>For the purpose of carrying out part C,
there are authorized to be appropriated such sums as may be necessary for each
of the fiscal years 2010 through
2014.</text>
</subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section></subtitle><subtitle id="H5FF091550BD84765B51EB0634BCC8F69"><enum>B</enum><header>Liability
protection in good-Faith reporting</header>
<section id="HD8C2B232759B47FEB424082ABC151B8C"><enum>311.</enum><header>Liability
protection for health care providers in good-faith reporting to State medical
boards</header>
<subsection id="H838CCC4196004E8F8CA8DC9C58F1A384"><enum>(a)</enum><header>In
general</header><text>Notwithstanding any other provision of law, no health
care provider providing information (including by making a report, filing
charges, or presenting evidence) to a State medical board regarding the
competence or professional conduct of a physician shall be held, by reason of
having provided such information, to be liable in damages under any law of the
United States or of any State (or political subdivision thereof) unless such
information is false and the person providing the information knew that the
information was false.</text>
</subsection><subsection id="H7B1B6764FC774AEF8254FB916F9E8A11"><enum>(b)</enum><header>Attorney
fees</header><text>If a health care provider establishes in a civil action that
the health care provider is not liable in damages because of the application of
subsection (a), the court shall award to the provider any attorney fees and
costs incurred by the provider in establishing the application of subsection
(a).</text>
</subsection><subsection id="H80C26052EC584408A26AD6A7E4232272"><enum>(c)</enum><header>Definition</header><text>In
this section, the term <term>State medical board</term> means a State entity
responsible for licensing physicians or a subdivision of such an entity.</text>
</subsection></section></subtitle><enum>IV</enum><header>Insurance
reform</header>
<section id="HB3EBAA9642024939838D42CEACB94887"><enum>401.</enum><header>Uniform State
requirements regarding proposed rate increases</header>
<subsection id="H06D896AD8410446581E7D54CA4E3FE9E"><enum>(a)</enum><header>In
general</header><text>The Congress intends that each State have in effect laws
or regulations providing that—</text>
<paragraph id="HE278308DFAD04E158D46D36AA77B22CE"><enum>(1)</enum><text>a
provider of medical malpractice insurance in the State may not implement any
increase in the rate for such insurance that would result in such rate
increasing more than a certain percentage, as specified in such laws or
regulations, within a certain period of time, as specified in such laws or
regulations, unless, before such increase takes effect—</text>
<subparagraph id="HF39A66F1E4F34096BB5EE323E49BD10D"><enum>(A)</enum><text>the provider
submits to an appropriate State agency a description and justification of the
rate increase; and</text>
</subparagraph><subparagraph id="HC12C4A1CDEFA42CB8AE33921814F16EB"><enum>(B)</enum><text>such agency makes
a determination that the increase is justified; and</text>
</subparagraph></paragraph><paragraph id="H94DBD45E154043038457BC77EE3D1C8E"><enum>(2)</enum><text>any determination
referred to in paragraph (1)(B) regarding an increase in medical malpractice
insurance rates is made pursuant to an administrative hearing held by the
appropriate State agency; and</text>
</paragraph><paragraph id="HF17FB1E35BAC41AD9AFCF07171840428"><enum>(3)</enum><text>any individual or
institution that is involved in the provision of health care and is licensed by
the State to provide such care has standing, in any administrative proceeding
of the State regarding a proposed increase in the rate for medical malpractice
insurance (including a hearing referred to in paragraph (2)), to challenge such
increase.</text>
</paragraph></subsection><subsection id="HBD581C3FF5D24D1DAD2E744B3D6840D9"><enum>(b)</enum><header>Report</header><text>Not
later than 2 years after the date of the enactment of this Act, the Secretary
of Health and Human Services shall—</text>
<paragraph id="H16FCDC26A494433DB6904A3E4ECD03F7"><enum>(1)</enum><text>conduct and
complete a survey of the laws and regulations of the States to determine the
extent to which the States have in effects laws or regulations described in
subsection (a); and</text>
</paragraph><paragraph id="H030AA83A00E34031AC26A1861CCD2E06"><enum>(2)</enum><text>submit a report to
the Congress setting forth the results of the survey, describing such laws and
regulations of the various States, and describing the extent of the uniformity
of such laws and regulations.</text>
</paragraph></subsection><subsection id="H4EC15D7F10EF4B48B6D02F1FF8FDDDAC"><enum>(c)</enum><header>Definition</header><text>For
purposes of this section, the term <term>State</term> has the meaning given
such term in section 105.</text>
</subsection><subsection id="HD37F0D16E0F248D28A7FFD30FF0E6ED4"><enum>(d)</enum><header>Effective
date</header><text>This section shall take effect on the date of the enactment
of this Act.</text>
</subsection></section><section display-inline="no-display-inline" id="H28AE134591154170A206D8B68329D4C0"><enum>402.</enum><header>Reduction in
premiums paid by physicians for medical malpractice insurance coverage</header>
<subsection id="HE0B8C1D80F0341A6B78BFFF7D60A3808"><enum>(a)</enum><header>In
general</header><text>Not later than 180 days after the date of the enactment
of this Act, each medical malpractice liability insurance company shall—</text>
<paragraph id="H89186C2221B243A0935BD966A581A7C3"><enum>(1)</enum><text>develop a
reasonable estimate of the annual amount of financial savings that will be
achieved by the company as a result of section 101;</text>
</paragraph><paragraph id="H81B722BC58BC4C27ABEB3604CC77994C"><enum>(2)</enum><text>develop and
implement a plan to annually dedicate at least 50 percent of such annual
savings to reduce the amount of premiums that the company charges physicians
for medical malpractice liability coverage; and</text>
</paragraph><paragraph id="H8BD84D8F29FA49DEB9E2BCAAFE6367EC"><enum>(3)</enum><text>submit to the
Secretary of Health and Human Services (in this subsection referred to as the
<quote>Secretary</quote>) a written certification that the company has complied
with paragraphs (1) and (2).</text>
</paragraph></subsection><subsection id="HD8209461B4874E3A95B6329C217F99A1"><enum>(b)</enum><header>Reports</header><text>Not
later than one year after the date of the enactment of this Act and annually
thereafter, each medical malpractice liability insurance company shall submit
to the Secretary a report that identifies the percentage by which the company
has reduced medical malpractice coverage premiums relative to the date of the
enactment of this Act.</text>
</subsection><subsection id="H29E37EBFC9DA4A7CA9F18CD96F78E098"><enum>(c)</enum><header>Enforcement</header><text>A
medical malpractice liability insurance company that violates a provision of
this section is liable to the United States for a civil penalty in an amount
assessed by the Secretary, not to exceed $11,000 for each such violation. The
provisions of paragraphs (3) through (5) of section 303(g) of the Federal Food,
Drug, and Cosmetic Act apply to such a civil penalty to the same extent and in
the same manner as such paragraphs apply to a civil penalty under such
section.</text>
</subsection><subsection id="HD92D186AE41C45299C413774DF52666C"><enum>(d)</enum><header>Definition</header><text>For
purposes of this section, the term <term>medical malpractice liability
insurance company</term> means an entity in the business of providing an
insurance policy under which the entity makes payment in settlement (or partial
settlement) of, or in satisfaction of a judgment in, a medical malpractice
action or claim.</text>
</subsection></section><section id="H9EF81816A1CB4A9B84D51BCBAA752D47"><enum>403.</enum><header>Effective
date</header><text display-inline="no-display-inline">Except as provided in
section 401(d), this title shall take effect 1 year after the date of the
enactment of this Act.</text>
</section><enum>V</enum><header>Exclusion of
pharmaceuticals and devices from liability reforms</header>
<section id="H61AB7421E3E142079A04ADD8F5D311B5"><enum>501.</enum><header>Exclusion of
pharmaceuticals and devices</header><text display-inline="no-display-inline">For purposes of title I and II of this Act,
the manufacturer or distributor of a pharmaceutical or device is not a health
care provider, and health care malpractice does not include responsibility
based on products liability.</text>
</section>