I 113th CONGRESS 2d Session H. R. 4106 IN THE HOUSE OF REPRESENTATIVES February 27, 2014 Mr. Barr (for himself and Mr. Bera of California ) introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on the Judiciary , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To provide for the development and dissemination of clinical practice guidelines and the establishment of a right of removal to Federal courts for defendants in medical malpractice actions involving a Federal payor, and for other purposes.

1. Short title This Act may be cited as the Saving Lives, Saving Costs Act . 2. Purposes The purposes of this Act are: (1) To offer physicians who document adherence to certain evidence-based clinical-practice guidelines, and, when applicable, appropriate use criteria, a safe harbor from medical-malpractice litigation. (2) To reduce the practice of defensive medicine and resulting health care costs. (3) To increase adherence to evidence-based clinical practice guidelines to reduce clinical variation in health care practice. (4) To improve quality of care and patient safety. (5) To permit organizations with relevant expertise to participate in the selection of clinical practice guidelines. (6) To permit professionals with relevant expertise to participate and benefit from liability reform. 3. Requirements for selection of clinical practice guidelines (a) Selection Not later than 6 months after the date of enactment of this Act, eligible professional organizations that have established, published, maintained and updated on a regular basis, clinical practice guidelines, including when applicable, appropriate use criteria, that incorporate best practices, shall submit to the Secretary those guidelines. Not later than 6 months after that submission date, the Secretary shall select and designate one or more of those eligible professional organizations to provide and maintain such clinical practice guidelines on behalf of the Secretary. To this end, not more than 6 months after designating each such eligible professional organization, the Secretary shall enter into an agreement with each such eligible professional organization for maintenance and updating of such clinical practice guidelines. (b) Maintenance (1) Periodic review Not later than 5 years after publication of guidelines, and every five years thereafter, the Secretary shall review the clinical practice guidelines and shall, as necessary, enter into agreements with eligible professional organizations. (2) 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, who shall review the amendments. (3) Notification required for certain updates In the case of an amendment under paragraph (2) that adds, materially changes, or removes a guideline from a set of guidelines, such update shall not apply under this subsection unless notification of such update is made available to applicable eligible professionals. 4. Development (a) Guideline standards To the extent possible, the development of clinical practice guidelines should be guided by the Institute of Medicine’s Standards for Developing Trustworthy Guidelines and should— (1) be developed through a transparent process that minimizes conflicts of interest; (2) be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups; (3) take into consideration important patient subgroups and patient preferences as appropriate; (4) be based on a systematic review of the existing evidence; (5) provide a clear explanation of the relationship between care options and health outcomes; (6) provide ratings of both the quality of evidence and strength of recommendation; (7) be reconsidered and revised when new evidence emerges; and (8) clearly identify any exceptions to the application of the clinical practice guideline. (b) 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 guideline, including any conflict of interest pertaining to any instrument, medicine, drug, or any other substance, device, or means included in the clinical practice guideline. Disclosures by eligible professional organizations shall be made promptly, upon submission of the guidelines, and during every review of the guidelines, to the Secretary. Disclosures shall additionally include the following: (1) Scientific methodology and evidence that supports clinical practice guidelines. (2) Outside collaborators. (3) Endorsements. 5. Internet publication of guidelines The Secretary of Health and Human Services shall publish all clinical practice guidelines on the Internet through the National Guideline Clearinghouse or other appropriate sites or sources, 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 1996. 6. State flexibility and protection of States’ rights (a) Limitation This Act shall not preempt or supersede any State or Federal law that imposes greater procedural or substantive protections for health care providers and health care organizations from liability, loss, or damages than those provided by this title or create a cause of action. (b) 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 law. 7. Right of removal Section 1441 of title 28, United States Code, is amended by adding at the end the following: (g) Certain actions against medical professionals (1) Any health care liability action brought in a State court against an applicable eligible professional or health care provider 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 pending. (2) For purposes of this subsection the terms applicable eligible professional , health care provider , health care liability action , and health care liability claim have the meaning given such term in section 10 of the Saving Lives, Saving Costs Act of 2014. . 8. Mandatory review by independent medical review panel (a) In general If, in any health care liability action against an applicable eligible professional, the applicable eligible professional alleges, in any response to the claimant’s filing, that the applicable eligible professional adhered to an applicable clinical practice guideline in the provision of health care goods or services to the claimant, then the court shall suspend further proceedings on the health care liability action prior to discovery proceedings, until the completion of a review of the action by an independent medical review panel. (b) Independent medical review panel (1) Composition An independent medical review panel under this section shall be composed of 3 members who are experts in the relevant field of clinical practice. (2) Requirements for member eligibility To be eligible to serve on an independent medical review panel, a member shall— (A) be an experienced physician certified by a board recognized by the American Board of Medical Specialties; (B) not earlier than 2 years prior to the date of selection to the board, have been in active medical practice or devoted a substantial portion of his or her time to teaching at an accredited medical school, or have been engaged in university-based research in relation to the medical care and type of treatment at issue; and (C) be approved by his or her specialty society. When possible, members should be from the region where the case in question originates to account for geographical practice variation. (3) No civil liability for members No civil action shall be brought in any court against any member for any act done, failure to act, or statement or opinion made, within the scope of his or her duties as a member of the independent medical review panel. (4) Considerations in making determinations The members of the independent medical review panel shall acknowledge the ability of physicians to depart from the recommendations in clinical practice guidelines, when appropriate, in the care of individual patients. (5) Selection of members Each member of the panel shall be jointly selected by the parties. A member whose selection one party does not concur in may not serve on the panel, except that, if, not later than 30 days after a response to the health care liability action is filed, 3 members have not been selected by the parties, the court shall appoint any remaining members. (6) Compensation of members The costs of compensation to the members of the panel shall be split between the parties equally, unless otherwise agreed to by the parties. (c) Terms of review A review by an independent medical review panel under this section shall comply with the following: (1) 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 conduct, care, and skill expected of members of the medical profession engaged in the defendant’s field of practice under the same or similar circumstances. (2) Record for review The review panel shall make a preliminary finding based solely upon the pre-discovery evidence submitted to it pursuant to Rule 26 of the Federal Rules of Civil Procedure and the applicable prescribed clinical practice guidelines. (3) Limitation The review panel shall not make a finding of negligence from the mere fact that a treatment or procedure was unsuccessful, failed to bring the best result or that the patient died. (4) Use at trial of work product of review panel No preliminary finding by the 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 liability. However, said findings, opinions and conclusions of the review panel shall be admissible as evidence in any and all subsequent proceedings before the court, including for purposes of motions for summary judgment and at trial. (d) Results of review (1) In general Not later than 60 days after all members of the panel have been selected, the panel shall complete a review of the record of the liability action and shall make a finding under this subsection. (2) Finding described A finding under this subsection shall include the following: (A) A determination of whether or not there are any applicable clinical practice guidelines to the health care liability action that substantively pertains to the injury suffered by the claimant. (B) If the applicable eligible professional has alleged adherence to any such guideline. (C) If the applicable eligible professional did adhere to any such guideline. (D) Whether there is a reasonable probability that— (i) the applicable eligible professional violated the applicable standard of care; (ii) that violation proximately caused the claimant’s alleged injury; and (iii) the claimant suffered damages as a result of the injury. (3) Use at trial The finding under this subsection may be received into evidence by the court. If the panel made any finding under paragraph (2)(D) that there was no reasonable probability, 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 evidence. If the panel made a finding under subparagraphs (A) through (C) that there was an applicable clinical practice guideline that the defendant adhered to, 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 evidence. 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 failure to conform to the required 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 case. 9. Recovery of Costs If the defendant applicable eligible professional prevails subsequent to a preliminary finding in his or her favor by the independent medical review panel, the defendant may recover costs and attorneys’ fees from the plaintiff. 10. Definitions In this Act: (1) applicable eligible professional The term applicable eligible professional means physicians practicing within clinical practice guidelines submitted by an eligible professional organization and includes employees and agents of a physician. (2) 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 margin. (3) 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 circumstances. (4) eligible professional organization The term eligible professional organization means a national or State medical society or medical specialty society. (5) 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 Act, premium tax credits under section 36B of the Internal Revenue Code of 1986 or cost-sharing reductions under section 1402 of the Patient Protection and Affordable Care Act, or medical screenings, treatments, or transfer services provided pursuant to section 1867 of the Social Security Act is not made by the individual or any non-Federal third party on behalf of the individual. (6) Health care goods or services The term health care goods or services means any goods or services provided by a health care organization, provider, or by any individual working under the supervision of a health care provider, that relates to the diagnosis, prevention, or treatment of any human disease or impairment, or the assessment or care of the health of human beings. (7) Health care liability action The term health care liability action means a civil action against a health care provider or a health care organization, regardless of the theory of liability on which the claim is based, or the number of plaintiffs, defendants, or other parties, or the number of causes of action, in which the claimant alleges a health care liability claim. (8) Health care liability claim The term health care liability claim means a claim by any person against a health care provider or a health care organization which is based upon the provision of, use of, or payment for (or the failure to provide, use, or pay for) health care goods services for which at least partial payment was made by a Federal payor or which was mandated by Federal law, regardless of the theory of liability on which the claim is based. (9) 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 plan, including any person or entity acting under a contract or arrangement with a health care organization to provide or administer any health benefit. (10) Health care provider The term health care provider means any person or entity required by State or Federal laws or regulations to be licensed, registered, or certified to provide health care services, and being either so licensed, registered, or certified, or exempted from such requirement by other statute or regulation. (11) performance period The term performance period means the period of time during which the final rule establishing a clinical practice guideline is in effect. (12) Secretary The term Secretary means the Secretary of Health and Human Services.