,,ii #aadth ,,congress #ast ,session ,s4 #adge ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #b1 #bjae,mr4 ,barrasso 7for himself and ,mrs4 ,capito7 introduced the following bill2 which was read twice and referred to the ,committee on the ,judiciary ,a ,,bill ,to provide for the creation of a safe harbor for defendants in medical malpractice actions who demonstrate adherence to clinical practice guidelines4 #a4 ,short title ,this ,act may be cited as the ,saving ,lives1 ,saving ,costs ,act4 #b4 ,requirements for selection of clinical practice guidelines 7a7 ,selection ,not later than #f months after the date of enactment of this ,act1 eligible professional organizations that have established1 published1 maintained1 and updated on a regular basis1 clinical practice guidelines1 including when applicable1 appropriate use criteria1 that incorporate best practices1 may submit such guidelines to the ,secretary4 ,not later than #f months after the last day for submitting such guidelines1 the ,secretary shall select and designate one or more eligible professional organizations to provide and maintain such clinical practice guidelines on behalf of the ,secretary4 ,not later than #f months after designating each such eligible professional organization1 the ,secretary shall enter into an agreement with each such eligible professional organization for maintenance1 publication1 and updating of such clinical practice guidelines4 7b7 ,maintenance 7#a7 ,periodic review ,not later than #e years after the ,secretary enters into an agreement with each eligible professional organization under subsection 7a71 and every #e years thereafter1 the ,secretary shall review the clinical practice guidelines of such organization and shall1 as necessary1 enter into agreements with additional eligible professional organizations1 as appropriate1 in accordance with subsection 7a74 7#b7 ,update by eligible professional organization ,an eligible professional organization that collaborated in the establishment of a clinical practice guideline may submit amendments to that clinical practice guideline at any time to the ,secretary for review by the ,secretary4 7#c7 ,notification required for certain updates ,an amendment under paragraph 7#b7 may not add1 materially change1 or remove a guideline from a set of guidelines1 unless notification of such update is made available to applicable eligible professionals4 #c4 ,development 7a7 ,guideline standards ,the ,secretary shall ensure that1 to the extent practicable1 the development of clinical practice guidelines are guided by the ,standards for ,developing ,trustworthy ,clinical ,practice ,guidelines of the ,institute of ,medicine and-- 7#a7 are developed through a transparent process that minimizes conflicts of interest2 7#b7 are developed by a knowledgeable1 multidisciplinary panel of experts and representatives from key affected groups2 7#c7 take into consideration important patient subgroups and patient preferences1 as appropriate2 7#d7 are based on a systematic review of the existing evidence2 7#e7 provide a clear explanation of the relationship between care options and health outcomes2 7#f7 provide ratings of both the quality of evidence and strength of recommendation2 7#g7 are reconsidered and revised when new evidence emerges2 and 7#h7 clearly identify any exceptions to the application of the clinical practice guideline4 7b7 ,required disclosures from eligible professional organizations ,any person who is affiliated with an eligible professional organization and who directly participated in the creation of a clinical practice guideline shall disclose any conflicts of interest pertaining to the development of the clinical practice guideline1 including any conflict of interest pertaining to any instrument1 medicine1 drug1 or any other substance1 device1 or means included in the clinical practice guideline4 ,disclosures to the ,secretary by eligible professional organizations shall be made promptly1 upon submission of the guidelines1 and during every review of the guidelines4 ,disclosures shall include the following3 7#a7 ,scientific methodology and evidence that supports clinical practice guidelines4 7#b7 ,outside collaborators4 7#c7 ,endorsements4 #d4 ,no liability for guideline producers ,neither an eligible professional organization nor the participants in its guideline development and approval process1 may be held liable for any injury alleged to be caused by adhering to a clinical practice guideline to which they contributed4 #e4 ,internet publication of guidelines ,the ,secretary shall publish on the ,internet through the ,national ,guideline ,clearinghouse or other appropriate sites or sources1 all clinical practice guidelines1 including all data and methodology used in the development and selection of the guidelines in compliance with data disclosure standards in the ,health ,insurance ,portability and ,accountability ,act of #aiif 7,public ,law #ajd-aia74 #f4 ,state flexibility and protection of ,states' rights 7a7 ,limitation ,this ,act shall not preempt or supersede any ,state or ,federal law that-- 7#a7 imposes procedural or substantive protections for health care providers and health care organizations from liability1 loss1 or damages greater than such protections provided by this title2 or 7#b7 creates a cause of action related to the provision of health care goods or services4 7b7 ,state ,flexibility ,no provision of this ,act shall be construed to preempt any defense available to a party in a health care liability action under any other provision of ,state or ,federal law4 #g4 ,federal cause of action 7a7 ,in general ,chapter #he of title #bh1 ,united ,states ,code1 is amended by adding at the end the following3 #acgj4 ,health care liability claims 7a7 ,definitions ,in this section1 the terms applicable eligible professional1 health care goods or services1 health care liability action1 health care liability claim1 health care organization1 and health care provider have the meaning given such terms in section #aj of the ,saving ,lives1 ,saving ,costs ,act4 7b7 ,jurisdiction of claims ,the district courts shall have original jurisdiction of a health care liability action against an applicable eligible professional1 health care provider1 or health care organization4 7c7 ,substantive law ,the substantive law for decision in a health care liability action brought under subsection 7b7 shall be derived from the law1 including choice of law principles1 of the ,state in which the provision of1 use of1 or payment for 7or the failure to provide1 use1 or pay for7 health care goods or services giving rise to the health care liability claim occurred unless such law is inconsistent with or preempted by ,federal law4 4 7b7 ,technical and conforming amendment ,the table of sections for chapter #he of title #bh1 ,united ,states ,code1 is amended by adding at the end the following3 #acgj4 ,health care liability claims4 4 #h4 ,right of removal ,section #adda of title #bh1 ,united ,states ,code1 is amended by adding at the end the following3 7g7 ,certain actions against medical professionals 7#a7 ,a health care liability action brought in a ,state court against an applicable eligible professional1 health care provider1 or health care organization may be removed by any defendant or the defendants to the district court of the ,united ,states for the district and division embracing the place where such action is pending4 7#b7 ,in this subsection1 the terms applicable eligible professional1 health care liability action1 health care organization1 and health care provider have the meaning given such terms in section #aj of the ,saving ,lives1 ,saving ,costs ,act4 4 #i4 ,mandatory review by independent medical panel 7a7 ,in general ,if1 in any health care liability action removed to ,federal court pursuant to section #adda7;g7 of title #bh1 ,united ,states ,code1 against an applicable eligible professional1 health care provider1 or health care organization1 the applicable eligible professional1 health care provider1 or health care organization alleges1 in response to a filing of the claimant1 that the applicable eligible professional1 health care provider1 or health care organization adhered to an applicable clinical practice guideline in the provision of health care goods or services to the claimant1 then the court shall suspend further proceedings on the health care liability action prior to discovery proceedings1 until the completion of a review of the action by an independent medical review panel4 7b7 ,independent medical review panel 7#a7 ,composition ,an independent medical review panel under this section shall be composed of #c members who are experts in the relevant field of clinical practice1 appointed in accordance with paragraph 7#e74 7#b7 ,requirements for member eligibility 7,a7 ,in general ,to be eligible to serve on an independent medical review panel1 a member shall-- 7i7 be an experienced physician certified by a board recognized by the ,american ,board of ,medical ,specialties2 7ii7 not earlier than #b years prior to the date of selection to the board1 have been in active medical practice or devoted a substantial portion of his or her time to teaching at an accredited medical school1 or have been engaged in university-based research in relation to the medical care and type of treatment at issue2 and 7iii7 be approved by his or her specialty society4 7,b7 ,regional preference ,when possible1 members should be from the region where the case in question originates to account for geographical practice variation4 7#c7 ,no civil liability for members ,no civil action shall be brought in any court against any member for any act1 failure to act1 or statement or opinion made1 within the scope of his or her duties as a member of the independent medical review panel4 7#d7 ,considerations in making determinations ,the members of the independent medical review panel shall acknowledge that1 under certain circumstances1 it may be appropriate for a physician to depart from the recommendations in clinical practice guidelines in the care of individual patients4 7#e7 ,selection of members ,each member of the independent medical review panel shall be jointly selected by the parties4 ,a member whose selection one party does not concur in may not serve on the panel1 except that1 if1 not later than #cj days after a response to the health care liability action is filed1 #c members have not been selected by the parties1 the court shall appoint any remaining members4 7#f7 ,compensation of members ,the costs of compensation to the members of the independent medical review panel shall be shared between the parties equally1 unless otherwise agreed to by the parties4 7c7 ,terms of review ,a review by an independent medical review panel under this section shall comply with the following3 7#a7 ,standard of conduct ,the mandatory independent medical review panel that is charged with the responsibility of making a preliminary finding as to liability of the defendant applicable eligible professional shall deem the prescribed clinical practice guidelines as the standard of conduct1 care1 and skill expected of members of the medical profession engaged in the defendant's field of practice under the same or similar circumstances1 subject to the provisions of subsection 7b77#d74 7#b7 ,record for review ,the independent medical review panel shall make a preliminary finding based solely upon the pre-discovery evidence submitted to it pursuant to ,rule #bf of the ,federal ,rules of ,civil ,procedure1 any medical records that would be discoverable if the lawsuit advances to trial1 and the applicable prescribed clinical practice guidelines4 7#c7 ,limitation ,the independent medical review panel shall not make a finding of negligence from the mere fact that a treatment or procedure was unsuccessful or failed to bring the best result1 or that the patient died4 7#d7 ,use at trial of work product of review panel ,no preliminary finding by the independent medical review panel that the defendant applicable eligible professional breached the standard of care as set forth under the prescribed clinical practice guidelines shall constitute negligence per se or conclusive evidence of liability1 but findings1 opinions1 and conclusions of the review panel shall be admissible as evidence in any and all subsequent proceedings before the court1 including for purposes of motions for summary judgment and at trial4 7d7 ,results of review 7#a7 ,in general ,not later than #fj days after all members of the independent medical review panel have been selected1 the panel shall complete a review of the record of the liability action and shall make a finding under this subsection4 7#b7 ,finding described ,a finding under this subsection shall include the following3 7,a7 ,a determination of whether there are any applicable clinical practice guidelines to the health care liability action that substantively pertains to the injury suffered by the claimant4 7,b7 ,whether the applicable eligible professional has alleged adherence to any such guideline4 7,c7 ,whether the applicable eligible professional adhered to any such guideline4 7,d7 ,whether there is a reasonable probability that-- 7i7 the applicable eligible professional violated the applicable clinical practice guideline2 7ii7 that violation proximately caused the claimant's alleged injury2 and 7iii7 the claimant suffered damages as a result of the injury4 7#c7 ,use at trial ,the finding under this subsection may be received into evidence by the court4 ,if the independent medical review panel made any finding under paragraph 7#b77;,d7 that there was no reasonable probability of the matters described in clauses 7i7 through 7iii71 the court may issue a summary judgment in favor of the applicable eligible professional unless the claimant is able to show otherwise by clear and convincing evidence4 ,if the panel made a finding under subparagraphs 7,a7 through 7,c7 of paragraph 7#b7 that there was an applicable clinical practice guideline that the defendant adhered to1 the court shall issue summary judgment in favor of the applicable eligible professional unless the claimant is able to show otherwise by clear and convincing evidence4 ,any preliminary finding that the defendant applicable eligible professional did not breach the standard of care as set forth under the prescribed medical practice guidelines or that the defendant applicable eligible professional's nonadherence to the applicable standard was neither the cause in fact nor the proximate cause of the plaintiff's injury or that the plaintiff did not incur any damages as a result shall be given deference by the court and shall entitle the defendant applicable eligible professional to summary judgment unless the plaintiff is able to show by clear and convincing evidence that the independent medical review panel was in error and that there is a genuine issue as to a material fact in the case4 #aj4 ,definitions ,in this ,act3 7#a7 ,applicable eligible professional ,the term applicable eligible professional means a physician practicing within clinical practice guidelines submitted by an eligible professional organization and includes employees and agents of a physician4 7#b7 ,appropriate use criteria ,the term appropriate use criteria means established evidence-based guidelines developed or endorsed by an eligible professional organization that specify when the health benefits of a procedure or service exceed the expected health risks by a significantly wide margin4 7#c7 ,clinical practice guideline ,the term clinical practice guideline means systematically developed statements based on the review of clinical evidence for assisting a health care provider to determine the appropriate health care in specific clinical circumstances4 7#d7 ,eligible professional organization ,the term eligible professional organization means a national or ,state medical society or medical specialty society4 7#e7 ,federal payor ,the term ,federal payor includes reimbursements made under the ,medicare program under title ,,xviii of the ,social ,security ,act or the ,medicaid program under title ,,xix of the ,social ,security ,act1 premium tax credits under section #cf;,b of the ,internal ,revenue ,code of #aihf or cost-sharing reductions under section #adjb of the ,patient ,protection and ,affordable ,care ,act1 or medical screenings1 treatments1 or transfer services provided pursuant to section #ahfg of the ,social ,security ,act is not made by the individual or any non-,federal third party on behalf of the individual4 7#f7 ,health care goods or services ,the term health care goods or services means any goods or services provided by a health care organization1 provider1 or by any individual working under the supervision of a health care provider1 that relates to the diagnosis1 prevention1 or treatment of any human disease or impairment1 or the assessment or care of the health of human beings4 7#g7 ,health care liability action ,the term health care liability action means a civil action against an applicable eligible professional1 a health care provider1 or a health care organization1 regardless of the theory of liability on which the claim is based1 or the number of plaintiffs1 defendants1 or other parties1 or the number of causes of action1 in which the claimant alleges a health care liability claim4 7#h7 ,health care liability claim ,the term health care liability claim means a claim by any person against an applicable eligible professional1 a health care provider1 or a health care organization which is based upon the provision of1 use of1 or payment for 7or the failure to provide1 use1 or pay for7 health care goods or services for which at least partial payment was made by a ,federal payor or which was mandated by ,federal law1 regardless of the theory of liability on which the claim is based4 7#i7 ,health care organization ,the term health care organization means any person or entity which is obligated to provide or pay for health benefits under any health plan1 including any person or entity acting under a contract or arrangement with a health care organization to provide or administer any health benefit4 7#aj7 ,health care provider ,the term health care provider means any person or entity required by ,state or ,federal laws or regulations to be licensed1 registered1 or certified to provide health care services1 and being either so licensed1 registered1 or certified1 or exempted from such requirement by other statute or regulation4 7#aa7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4