109 HR 3378 IH: Comprehensive Medical Malpractice Reform Act of 2005
U.S. House of Representatives
2005-07-21
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EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.Short title; table of contents
(a)This Act may be cited as the Comprehensive Medical Malpractice Reform Act of 2005
.
(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="H3A2CCC7F150640118787927547731EC9"><enum>101.</enum><header>Cap on non-economic damages</header>
<subsection id="H029F8BAF16984121841664EDEC44E51E"><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="H9DA12D391C68470D85FCD1225FD297AA"><enum>(b)</enum><header>Adjustment for inflation from 1975</header>
<paragraph id="H860F5985E54C4E50B48E15E611C882B4"><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="H717ABFE468E7435EAE72EE6B76B9BEC9"><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="H89EA30DE1F15492BA418C1600D29404"><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="H8EECB6ACF5824EADAA996362C8C34EEF"><enum>(c)</enum><header>Applicability</header>
<paragraph id="H6731D85517944114B4FF0056B000079"><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="H457592D0819244A7A5FCD587881C8428"><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="HE5721E0500EA46E4936C8B7EDD33ED4E"><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="H77835621042A41478B28EF29002031B0"><enum>102.</enum><header>Sanctions for meritless actions and pleadings</header>
<subsection id="H824F6E60E6894F6FB56683296F3E96CE"><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="H95AC2231CF3F41F7A7FE72CEE8427DEF"><enum>(b)</enum><header>Certificate of merit</header>
<paragraph id="HACA57145B41E4394AC69081C9300E2D3"><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="HB501928A30FB403F9F08FDBF8E33E786"><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="HD9169383D7A74965BBBE16E6FC029A7"><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="H73FC6D65CF8E4311A8CD5972091D5237"><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="H547434E41AB1468BAF5FF0504A8FD7E"><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="H6FA18AB506964D7390F9D275A5E96754"><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="HF1F9856099F948E685EC007167E12D30"><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="HD31080B4278F4AB996BB435D1C1FB908"><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="H6B5CED28C634465B96159495F5C530C7"><enum>(c)</enum><header>Mandatory sanctions</header>
<paragraph id="H8A92DCF548C34B0987B4B8E2041336C5"><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="HEAB42A9F35564AF0B81E1F5E3F26AE5B"><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="H89348D4DC5A543BFAFB4FADE00DB4D39"><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="H4254AF05799D454093D9E69D3388C05E"><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="H48E5CA08A0E9460296894220FD330093"><enum>103.</enum><header>Performance standards applicable to State medical boards</header>
<subsection id="H2FF2462E636C48668460D9DD2E134251"><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="H46FBDB58C58D4D0100B0D7953FC14296"><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="H3661CA302F0E4357B23F32D79334AE79"><enum>(1)</enum><text>Processing patient complaints within a specified limited period of time.</text></paragraph>
<paragraph id="HF86641C1BB46451E99AFB21FD594F908"><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="H058613BC7E954C199B85B589597930D3"><enum>(3)</enum><text>Maintaining an adequate level of staff for the activities of the State medical board.</text></paragraph>
<paragraph id="H8644F2D916294F2AAD0093E4AC047E2F"><enum>(4)</enum><text>Ensuring that staff are qualified.</text></paragraph>
<paragraph id="H826237E71D8B45FB81DACBB0E92008B"><enum>(5)</enum><text>Making the following information available to the public for physicians:</text>
<subparagraph id="H63C4A5AEC7344EE0BE47B612A434B864"><enum>(A)</enum><text>Each physician’s education and training.</text></subparagraph>
<subparagraph id="H352372E1FC5D4DEB8B523FFD718CFC04"><enum>(B)</enum><text>Each physician’s medical specialties.</text></subparagraph>
<subparagraph id="H75B9E12E272C42A9A5B48899C3276E49"><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="H8B4BE5F896E242F5AF61D42CCE2EBA08"><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="H3096DD40E79B42F100CC35DAEAD125A7"><enum>(6)</enum><text>Issuing an annual report that includes aggregate disciplinary statistics, including—</text>
<subparagraph id="H89BDF8F4039D45E882ECE201E46E1569"><enum>(A)</enum><text>statistics on the number and type of complaints received; and</text></subparagraph>
<subparagraph id="H2FC8A26C1E6D49A7BC3E99C61F63276C"><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="H621A702B8FAB48E690B76020F2A0781E"><enum>(7)</enum><text>Such other issues as the Secretary determines appropriate.</text></paragraph></subsection>
<subsection id="HD13E8A6ED81B4DF68B446FFC6126226C"><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="H59E32A1F399F4023AB681B0394D3A78B"><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="H15431F16513B4306A594AB05EF5BC55E"><enum>(1)</enum><text>propose a determination of noncompliance;</text></paragraph>
<paragraph id="HB20B196B14854E04904D76A0D9C52651"><enum>(2)</enum><text>identify the reasons for such noncompliance; and</text></paragraph>
<paragraph id="H0CE478E7DB4444CD81605DCAFC9DB6AC"><enum>(3)</enum><text>give the State medical board an opportunity to correct such noncompliance.</text></paragraph></subsection>
<subsection id="H41031CA0C9834D4D9B9970C700DBBF65"><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="H9A3E427A74384D628521FF8FCC00CF20"><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="HC80413E549814B878BE9BA5498004F98"><enum>104.</enum><header>Interstate patient reporting and physician tracking database</header>
<subsection id="H3CE499EC84AE4F6E9BC32E00DB262EAE"><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="HDB89BC94470A4C21936943CA117F9597"><enum>(b)</enum><header>Database contents</header>
<paragraph id="H00518C107C5B4013A8E25F9552C2C9E6"><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="HBA44E2F1B15849568CD96B7CA6751DCF"><enum>(A)</enum><text>State medical boards; and</text></subparagraph>
<subparagraph id="H28C775FA1E614DE699FDCD4E00D2CA25"><enum>(B)</enum><text>patients.</text></subparagraph></paragraph>
<paragraph id="HBC1F8E4AE61844F69E000749F6AEC4D7"><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="H7D639D3BD88D44148EC72FF52BAEE29B"><enum>(A)</enum><text>The physician’s identity.</text></subparagraph>
<subparagraph id="H308271821EC541A7B01D1C1063147499"><enum>(B)</enum><text>The physician’s education and training.</text></subparagraph>
<subparagraph id="H656E50A0DB4D45109764B8A8A3959202"><enum>(C)</enum><text>The physician’s medical specialties.</text></subparagraph>
<subparagraph id="HB68E9C857236418CB5D3C0C80300EAF6"><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="H89077CC933484F609988BF3F6584FA2E"><enum>(3)</enum><header>Patient complaints</header><text display-inline="yes-display-inline">The database shall—</text>
<subparagraph id="HBCA36B071DC940468300964034B4AB41"><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="HBF992D2D20B14F7AB09100D4C41B299D"><enum>(B)</enum><text>allow patients to submit complaints about physicians directly to the database.</text></subparagraph></paragraph></subsection>
<subsection id="HF702A3E2EE3F4B86AFE31F657F76E847"><enum>(c)</enum><header>Availability of information</header>
<paragraph id="H7307CE87FC1D48C392B92D564BAD5D2B"><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="H1E895BB7EAC14607A5099F8F589943B3"><enum>(2)</enum><header>Patient complaints</header>
<subparagraph id="H127C77DF99194BA9B154AE3F9685CD7"><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 <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> 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="HE4E18A85DD9846F397EBFE7340D49D31"><enum>(B)</enum><header>Tracking patient complaints</header><text>The database shall—</text>
<clause id="HE4109E851647459AB546AA7B3F21EEF"><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="HC5A0552066DB4E81949906D34FF3B49E"><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="H077BC4E423064CA2AE1EF63782FC8BCD"><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="H451C8C2E024841E48FCBC1D541E3EF3F"><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="HCD782FE297634F9EA388163910A678D3"><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 id="HE5D85A9D99294578B21C7DD572C718AC" display-inline="no-display-inline"><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="H2506246E232548C19BF633CB27ED2DBC"><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="HBBB05C0107964EBBB6A2C1C39789D07D"><enum>(1)</enum><text>propose a determination of noncompliance;</text></paragraph>
<paragraph id="H22B262FEA20D46F5A7108E16F8D000EF"><enum>(2)</enum><text>identify the reasons for such noncompliance; and</text></paragraph>
<paragraph id="H9ADD849536394B388D77BFBF2626BF0"><enum>(3)</enum><text>give the State medical board an opportunity to correct such noncompliance.</text></paragraph></subsection>
<subsection id="H0BF6F3575A9C4FE8A9E8CBD9B4EC21EC"><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="HE05560E7FD7D41769EDAEFB48B82F9E5"><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="HAF87DA2352A64ED3963400C9D1ABC572"><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="HEFA616BA2967435CBE69924240ECB741"><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="H4896AABB29DE43E49BE309231B9DFC82"><enum>105.</enum><header>Definitions</header><text display-inline="no-display-inline">In this title:</text>
<paragraph id="HA4B37F1D52FB4660BA224134A5E51905"><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="H54B14F61F3C94BD29326998EC073C72D"><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="H3D632EB128784199AF88DBDE006D6E66"><enum>(3)</enum><text>The term <term>health care provider</term> means—</text>
<subparagraph id="HF853EAF133674BC0AEC8DFCAFE382763"><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="H3D6A013A8439416FB0301FA451E067E6"><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="H5B9508F4A850435ABC0297DD040059F1"><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="H8065C41C12FA449D9B38BCE1BB242300"><enum>201.</enum><header>Grants to States and health care entities for mediation programs</header>
<subsection id="H348371A86F494667A3F4138237888C1E"><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="HC97C9D2553E1440F9BC075B1EB79E00"><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="HCD8CFD1F2E3645FD0065281409175607"><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="H1C4DA24305DB4E238E40AF161FBF95D1"><enum>(1) </enum><text display-inline="yes-display-inline">Participation by the parties in the mediation is voluntary.</text></paragraph>
<paragraph id="HA551E210CFE64A7BB712BB06895421C9"><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="H421E04F5FB4B4820B0411220318900D7"><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="H42C7AF083DA24D26AED15FE2159DF120"><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="HD967B8D27CD04AADAD961BC17CE71B4C"><enum>(A)</enum><text>states that the parties—</text>
<clause id="HCE249BADD0724CF3A23E443843C2208D"><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="HB8ACAAFB20F04FF3B395107D5D9EEFEE"><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="H345A44304C3D4E7381E85FB7B4B3199E"><enum>(B)</enum><text>provides for confidentiality of the mediation proceedings; and</text></subparagraph>
<subparagraph id="H45C03458B75C449BAD14F1004BDBC490"><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="H02D2B14C1C114856B335630065A56CA8"><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="HDDBF8884F4AA431D9C49FDB04E835758"><enum>(d)</enum><header>Definitions</header><text>In this section:</text>
<paragraph id="HA64D6C19313F46B4BD04BC8CB1BBDE25"><enum>(1)</enum><text>The term <term>health care entity</term> means an entity covered by section 105(3)(B).</text></paragraph>
<paragraph id="H0083EF3985DA4E43B4DE32509BFE763D"><enum>(2)</enum><text>The term <term>health care malpractice</term> has the meaning given such term in section 105.</text></paragraph>
<paragraph id="H2AD6A13445AA4A38BB93AE89EF3785A2"><enum>(3)</enum><text>The term <term>State</term> has the meaning given such term in section 105.</text></paragraph></subsection></section>
<section id="H6C161D37B0D848278CCD165E9610A695"><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="HB27927BE3D4944358E9DE8098333BCB8"><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="HB721768015AC459E8297B12900655927"><enum>A</enum><header>Reporting by individuals involved in the provision of health care</header>
<section id="HD7A835001ADF498085A0A624429259E3"><enum>301.</enum><header>Amendments to <act-name parsable-cite="PHSA">Public Health Service Act</act-name></header>
<subsection id="H1EE383161A434B51BCE8403EE6D1A5C7"><enum>(a)</enum><header>In general</header><text>Title IX of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/299">42 U.S.C. 299 et seq.</external-xref>) is amended—</text>
<paragraph id="H308055904B4A4F5DA726363345BF5475"><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="H43BB6E61DA1642F89FE3C3C361905171"><enum>(2)</enum><text>by redesignating part C as part D;</text></paragraph>
<paragraph id="H8E94A9DDCB8F4477A6465CAD27054739"><enum>(3)</enum><text>by redesignating sections 921 through 928, as sections 931 through 938, respectively;</text></paragraph>
<paragraph id="H78D28BDCAE734AD780D5B189CC943E97"><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="H318FCD63C31249EEAC2C7727F8313E86"><enum>(5)</enum><text>by inserting after part B the following:</text>
<quoted-block id="HE7840B3A1D7E402C96DB38349F78E87">
<part id="HC58111A3193041D6AC04261E089CE055"><enum>C</enum><header>Patient safety improvement</header>
<section id="H3AF91D15ECDE4B028E77B0B8A42B5782"><enum>921.</enum><header>Definitions</header><text display-inline="no-display-inline">In this part:</text>
<paragraph id="H98D60E9640FA4D5491B77DA683754ED7"><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> (<external-xref legal-doc="public-law" parsable-cite="pl/104/191">Public Law 104–191</external-xref>; 110 Stat. 2033).</text></paragraph>
<paragraph id="H9779BA8D2C894D0A8BFC6F79428FAA6C"><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> (<external-xref legal-doc="public-law" parsable-cite="pl/104/191">Public Law 104–191</external-xref>; 110 Stat. 2033).</text></paragraph>
<paragraph id="HE14EDE232BA44862AE83E6EA5D0827D2"><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="HFE7F064BC5D24C85B8AF2B31CCC8C64E"><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="H4DB78CC7E1FD4C21896CD000BB3699C6"><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="HBC7FD41E7EB645E5AD11ECC3DD23FA03"><enum>(B)</enum><text>The collection and analysis of patient safety work product that is submitted by providers.</text></subparagraph>
<subparagraph id="HFADA15722B2048FCAD964DDA4DC0E0E6"><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="H94063DAE8B1343B0B22DCC906429EB69"><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="HA7FC2A4E26934F0B9C583EA3D8CF5384"><enum>(E)</enum><text>The maintenance of confidentiality with respect to identifiable information.</text></subparagraph>
<subparagraph id="H56553EDCE6454A94B1508907738BDC4B"><enum>(F)</enum><text>The provision of appropriate security measures with respect to patient safety work product.</text></subparagraph>
<subparagraph id="H83DE7347506F4FAE9E953F44C53B199D"><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="H952AE09194E6480488AC1653BC6D7C88"><enum>(5)</enum><header>Patient safety work product</header>
<subparagraph id="HAF517B0BD5884A45B075D14534715400"><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="HAF6E2AD583F746C19079D4EE8BAD374F"><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="H055691C11E8748CB8FB793C9A3783D36"><enum>(ii)</enum><text>is created by a patient safety organization; or</text></clause>
<clause id="H22C2CFC96F7C40D7BBB4514B72006061"><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="HB8D67091299548B1AFC3DC902DC4F5E"><enum>(B)</enum>
<clause display-inline="yes-display-inline" id="HFADC2B64D8D7492A9CD0B723BCB7C42"><enum>(i)</enum><text>Patient safety work product described in subparagraph (A)(i)—</text>
<subclause indent="clause" id="H6E497F423DEB4B30A08861E5ECFE311"><enum>(I)</enum><text>does not include any separate information described in clause (ii); and</text></subclause>
<subclause indent="clause" id="HEE63F7AF4B394BB7AC1F72F5789FA104"><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 indent="subparagraph" id="HB1D6AA91D6E241C700C9483785BBED66"><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="HF5BA0E641B0345BDAA6527E8AC1C2200"><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="H257D25AB3D7748259C399D004B9DA3D2"><enum>(6)</enum><header>Provider</header><text>The term <term>provider</term> means—</text>
<subparagraph id="HB92A14B4D60F4BCFB7C41679AAB852F9"><enum>(A)</enum><text>an individual or entity licensed or otherwise authorized under State law to provide health care services, including—</text>
<clause id="H2EF40B96BEAC441E9F177E2E2305C059"><enum>(i)</enum><text>a hospital, nursing facility, comprehensive outpatient rehabilitation facility, home health agency, and hospice program;</text></clause>
<clause id="H72A6BB4F48674294A7E400636F5BF0C2"><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="H5356A6A27F344100BADD0561DC15D54"><enum>(iii)</enum><text>a pharmacist; and</text></clause>
<clause id="H73BE8C1FBC2145A3B009FDCBEB876448"><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="H49E16E70258E43BF0074E14100B81052"><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="H92E11444F2B4484B95FF6CA195D2BF16"><enum>922.</enum><header>Privilege for patient safety work product</header>
<subsection id="H0CAAF84C425B4274BF38F6D4E9F0679C"><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="HFD547FE4E34247E49D648321DB464849"><enum>(1)</enum><text>subject to a civil or administrative subpoena or order;</text></paragraph>
<paragraph id="H272052E03854458EA365C06DA8CECB5D"><enum>(2)</enum><text>subject to discovery in connection with a civil or administrative proceeding;</text></paragraph>
<paragraph id="HC47E190A5B7F4C39B500BB73D2581641"><enum>(3)</enum><text>subject to disclosure pursuant to <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> 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="HB9E73AD5679D43EA9525B0AD61EFD300"><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="H83B804B8C39042C289138F3FCCC64E24"><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="HE9F2C15A421242FF8D4FA38F63676EFA"><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="H89E84710B9F44F1C923EABACB7ADAFEE"><enum>(B)</enum><text>shared by such organization with its survey team; or</text></subparagraph>
<subparagraph id="HD116FA22563A4FEFBB97A03EDAB6524"><enum>(C)</enum><text>required as a condition of accreditation by a national accreditation association.</text></subparagraph></paragraph></subsection>
<subsection id="H554615E2BAFD47DBA2C9F33FBAEFB95B"><enum>(b)</enum><header>Reporter protection</header>
<paragraph id="H28ABBCCD5D624606951B6F4FB02BF32B"><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="HE637699094BA4DCCBC1025578300B506"><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="H8E6B0D0BF17D405CBF5400BD5931BC02"><enum>(B)</enum><text>directly to a patient safety organization.</text></subparagraph></paragraph>
<paragraph id="H3D0E123F41AA45D497DFEE9FA81DAF4F"><enum>(2)</enum><header>Adverse employment action</header><text>For purposes of this subsection, an <quote>adverse employment action</quote> includes—</text>
<subparagraph id="HBDD8AD4F8EC3451185AF4055D4626CC"><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="H580305411FBD4DF49B328F02A2133C9F"><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="HF1B0BE6CA58C4871BD98D9D9217D358B"><enum>(C)</enum><text>a personnel action that is adverse to the individual concerned.</text></subparagraph></paragraph>
<paragraph id="HCFCDB5964C0A404A81E33E32566C91CA"><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="HE02DCDDCD4354ADEBF493BA7078300D1"><enum>(c)</enum><header>Disclosures</header><text>Nothing in this section prohibits any of the following disclosures:</text>
<paragraph id="HD6DDD242BC574A3A8B987494424C4532"><enum>(1)</enum><text>Voluntary disclosure of nonidentifiable information.</text></paragraph>
<paragraph id="HE0AAD3DF48114E61AFB255A7D4847CE"><enum>(2)</enum><text>Voluntary disclosure of identifiable information by a provider or patient safety organization, if such disclosure—</text>
<subparagraph id="H142331253E0D4727A91C66ED817DB9D3"><enum>(A)</enum><text>is authorized by the provider for the purposes of improving quality and safety;</text></subparagraph>
<subparagraph id="HF56150B32C374AD48DDEFFC4A501665F"><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> (<external-xref legal-doc="public-law" parsable-cite="pl/104/191">Public Law 104–191</external-xref>; 110 Stat. 2033), or any regulation promulgated under such section; and</text></subparagraph>
<subparagraph id="H1D12CD672D9C4241B54FD2993529FA03"><enum>(C)</enum><text>is not in conflict with such section or any regulation promulgated under such section.</text></subparagraph></paragraph>
<paragraph id="H092871E4B1D54FCB8868001BD9CA92B4"><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="H6F22368CC86B4DA4943CDA99136487FF"><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="H2C5BEC0DAE3F4D24965680F7FD689E1F"><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="HBE287D729BE7464DB1BD7DB23407126"><enum>(1)</enum><text>The transfer of any patient safety work product between a provider and a patient safety organization.</text></paragraph>
<paragraph id="H8F83D7F8430949DD94BC8809A7A6B63E"><enum>(2)</enum><text>Disclosure of patient safety work product as described in subsection (c).</text></paragraph>
<paragraph id="HEE4D5B0A3E3847BD862FCBE75000540"><enum>(3)</enum><text>The unauthorized disclosure of patient safety work product.</text></paragraph></subsection>
<subsection id="H7FB45C97A5324E54984BEBE0C02369A"><enum>(e)</enum><header>Penalty</header>
<paragraph id="H4141748C8D0C4C1895DE15DA2CA605E1"><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="HDC36277086134FF9AC6369F2723D7F14"><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> (<external-xref legal-doc="public-law" parsable-cite="pl/104/191">Public Law 104–191</external-xref>; 110 Stat. 2033), or any regulation promulgated under such section, for the same disclosure.</text></paragraph>
<paragraph id="H5E8218FBB95A4029AADAAD10E3A6FDF2"><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="H2E47BE1CE5EC484AAFE90069B42D14C5"><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="H744A365520FB45A1A3C12CAE64BF422B"><enum>(f)</enum><header>Relation to HIPAA</header>
<paragraph id="H4050FB06B0D147B69C4D06014708DB1B"><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> (<external-xref legal-doc="public-law" parsable-cite="pl/104/191">Public Law 104–191</external-xref>; 110 Stat. 2033)—</text>
<subparagraph id="H31D2BF4770B04213B7F4F4A754083379"><enum>(A)</enum><text>patient safety organizations shall be treated as business associates; and</text></subparagraph>
<subparagraph id="H9EAD5F5097E049B0AB6B1D21E28E68EE"><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="H047F41D5580E482794F8EC5705C29C75"><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="H913C839DB0174E979B0011D1C1F6127B"><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="HE7B500AAAFC94FB6A3E5F7673EF305A9"><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="H32094E0C779A430E96C7708CF335B18"><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="HCAAA3BBB8004490B98DBF1C55000945"><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="HECCF16BE784048C3B01413C1005C49EB"><enum>(k)</enum><header>Reports on strategies to improve patient safety</header>
<paragraph id="HE2484E5608FD476FA7248E2988D6D5CF"><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="H3E3A5B236D2A4BAFACC7192C08FA50BA"><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="H24A1F719A5BA42439FD546DB38F315D0"><enum>923.</enum><header>National Patient Safety Database</header>
<subsection id="H7841799278E0499EADC68969B4D24D09"><enum>(a)</enum><header>Authority</header>
<paragraph id="HA3230E5915BA44C0BF1EDE6D1F8B49DF"><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="H4E4FBA1553E148A89EA4919107008CA2"><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="HCC5EFB35F9F04CACB13FB9BC77E9864"><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="H201B59C8855243DCBDA87502E7AD1840"><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="H5E837AFE70424A6F8513D3AED1AB0254"><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="HDB80AABA0FE94DFEAA00BD3116FC4DEF"><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="H82AC8B32E05A4A5CBB9600485F5F73E"><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="H135C4638474746E18497EA43836B7CC7"><enum>924.</enum><header>Technical assistance</header>
<subsection id="H9E7F54E37A014A6F9717D68BC901919B"><enum>(a)</enum><header>In general</header><text>The Secretary, acting through the Director, may—</text>
<paragraph id="H9AC8B2BB93C24AD7B537DB247467432E"><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="H7AA15C26E56A45649E7B196DBADFEED9"><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="H2CE979124B3142E88D37628CA26379D0"><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="H69F71D06B19D4E4186E1D7B6E56805D6"><enum>925.</enum><header>Certification of patient safety organizations</header>
<subsection id="H79698C705C744AA991A21F17BC5DF35"><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="HC81A8151615D4CE4815BCE09553199B2"><enum>(b)</enum><header>Process</header><text>The process established under subsection (a) shall include the following:</text>
<paragraph id="H5DD836D9ABB149CFA967EB623D2E6F3D"><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="H2827A87D580145279BA604DFD080DE8D"><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="H26D3486134D949308B4210009218DC21"><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="HD71A85FBA7E34D86B5C34F43007E1BDC"><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="HFF4DECE6BCC144EBBADBBB00FAFD00CA"><enum>(c)</enum><header>Criteria</header><text>A patient safety organization must meet the following criteria as conditions of certification:</text>
<paragraph id="HDA49CA1B595C426B91A2CD53E1E3739"><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="HD646C736535343289EAA613036543643"><enum>(2)</enum><text>The patient safety organization has appropriately qualified staff, including licensed or certified medical professionals.</text></paragraph>
<paragraph id="H83C92CFFFE054D0A8E6C9D2E8E30BAC9"><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="H3BD3B2998B934AB08EC69000AF5FB33F"><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="H945BF3B0B8274F13966BD0BA708C6747"><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="H0542B6FF127641E995C71C87DDCD6302"><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="H7AB521CD35A74B9289C74606D006C49"><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="HACCFD22606CB445AB7FDAE926DE15DBB"><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="HA899D47E7C3740AF95DA27357966EA4D"><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="HAF676D25CFEA407AA8A5DC1A3E2C2C8"><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="H6C5F98EA4CE14BC2B40090CD71A4F81D"><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="HAE6607AB27CF4119BFF2F2CDC46337">
<subsection id="HBEF2A4043F6E4D249B63CE006EE088EC"><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 2006 through 2010.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section></subtitle>
<subtitle id="H9F6C329275334E45946E55D68B7C01DB"><enum>B</enum><header>Liability protection in good-faith reporting</header>
<section id="H58EE02E490714A2A88005C8CFCCBE1F0"><enum>311.</enum><header>Liability protection for health care providers in good-faith reporting to State medical boards</header>
<subsection id="H0BF9A6483FBF45ED85CDC589CAA5E6BC"><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="H2732E39447E74831BA31AD32F6EE32CB"><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="HC306FD89909C44BDB908EC364FF47DE3"><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="H6BD921F87B9B48BFA6D4E4B1BFDF5CBB"><enum>401.</enum><header>Uniform state requirements regarding proposed rate increases</header>
<subsection id="H69E2FA5308B14FBEAF141300772E35CA"><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="H537FDAC08CB04D8DBF7E402B80DDD650"><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="H53224A3BD56142C48301A9C635CF6E5"><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="H4DB80149104D4276A0F2243138CAD6E6"><enum>(B)</enum><text>such agency makes a determination that the increase is justified;</text></subparagraph></paragraph>
<paragraph id="H9C8437F21F054BF8B57338AF27FEA2D3"><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="H07A68C361E844A50A8840662E478BF2E"><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="HC8C9A6671DCA4014B73213D6E697A831"><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="H13105DB48EAF4F70B97437CCC5F7CBEB"><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="H1B367A6C19DE4683B8E04EE1E11E4336"><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="H95ACA8EF44544F079B3294114172D18F"><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="H30EB77F600AC493A874C59D97D00234B"><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 id="H529066C305174512B551C057424EDDEC" display-inline="no-display-inline"><enum>402.</enum><header>Reduction in premiums paid by physicians for medical malpractice insurance coverage</header>
<subsection id="HFC6D7BA955434496A439F6EB25E626C1"><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="H3FCC6875183142ADBA3BA58E6C310090"><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="H973D133E736F43BEA7A8E825AF8775FB"><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="HEDE4784F4AB041A0A2152C9D6D832161"><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="H11D7B3F9EEB948C2B9712461A999666F"><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="HB9A58DD8807B4C268498902D4675A607"><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="HC4BE11EBF91C48BAB31341BF6198FBDA"><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="H8E0FC8A6BCB04DA997C09BCC077EF8EF"><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="HB6E64CA5A0D640E685B46C4B9F6927B2"><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>