115th CONGRESS 1st Session |
To provide for the creation of a safe harbor for defendants in medical malpractice actions who demonstrate adherence to clinical practice guidelines.
March 16, 2017
Mr. Barr (for himself, Mr. Cuellar, Mr. Roe of Tennessee, Mr. Palazzo, Mr. Pittenger, Mr. Allen, Mr. Rouzer, Mr. Moolenaar, Mr. Smith of Texas, Mr. Dunn, Mr. Austin Scott of Georgia, Mr. Stewart, and Mr. Carter of Georgia) 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
To provide for the creation of a safe harbor for defendants in medical malpractice actions who demonstrate adherence to clinical practice guidelines.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
This Act may be cited as the “Saving Lives, Saving Costs Act”.
SEC. 2. 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, may submit such guidelines to the Secretary. Not later than 6 months after the last day for submitting such guidelines, the Secretary shall select and designate one or more eligible professional organizations to provide and maintain such clinical practice guidelines on behalf of the Secretary. Not later 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, publication, and updating of such clinical practice guidelines.
(1) PERIODIC REVIEW.—Not later than 5 years after the Secretary enters into an agreement with each eligible professional organization under subsection (a), and every 5 years thereafter, the Secretary shall review the clinical practice guidelines of such organization and shall, as necessary, enter into agreements with additional eligible professional organizations, as appropriate, in accordance with subsection (a).
(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 for review by the Secretary.
(3) NOTIFICATION REQUIRED FOR CERTAIN UPDATES.—An amendment under paragraph (2) may not add, materially change, or remove a guideline from a set of guidelines, unless notification of such update is made available to applicable eligible professionals.
(a) Guideline standards.—The Secretary shall ensure that, to the extent practicable, the development of clinical practice guidelines are guided by the Standards for Developing Trustworthy Clinical Practice Guidelines of the Institute of Medicine and—
(1) are developed through a transparent process that minimizes conflicts of interest;
(2) are 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) are based on a systematic review of the existing evidence;
(5) except in the case of diagnostic guidelines, provide a clear explanation of the relationship between care options and health outcomes;
(6) except in the case of diagnostic guidelines, provide ratings of both the quality of evidence and strength of recommendation;
(7) are 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 follow that particular eligible professional organization’s conflict of interest protocol.
SEC. 4. No liability for guideline producers.
Neither an eligible professional organization nor the participants in its guideline development and approval process, may be held liable for any injury alleged to be caused by adhering to a clinical practice guideline to which they contributed.
SEC. 5. Internet publication of guidelines.
The Secretary shall publish on the Internet through the National Guideline Clearinghouse or other appropriate sites or sources, all clinical practice guidelines, 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 (Public Law 104–191).
SEC. 6. State flexibility and protection of States’ rights.
(a) Limitation.—This Act shall not preempt or supersede any State or Federal law that—
(1) imposes procedural or substantive protections for health care providers and health care organizations from liability, loss, or damages greater than such protections provided by this title; or
(2) creates a cause of action related to the provision of health care goods or services.
(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.
SEC. 7. Federal cause of action.
(a) In general.—Chapter 85 of title 28, United States Code, is amended by adding at the end the following:
“(a) Definitions.—In this section, the terms ‘applicable eligible professional’, ‘health care goods or services’, ‘health care liability action’, ‘health care liability claim’, ‘health care organization’, and ‘health care provider’ have the meaning given such terms in section 10 of the Saving Lives, Saving Costs Act.
“(b) Jurisdiction of claims.—The district courts shall have original jurisdiction of a health care liability action against an applicable eligible professional, health care provider, or health care organization.
“(c) Substantive law.—The substantive law for decision in a health care liability action brought under subsection (b) shall be derived from the law, including choice of law principles, of the State in which the provision of, use of, or payment for (or the failure to provide, use, or pay for) health care goods or services giving rise to the health care liability claim occurred unless such law is inconsistent with or preempted by Federal law.”.
(b) Technical and conforming amendment.—The table of sections for chapter 85 of title 28, United States Code, is amended by adding at the end the following:
Section 1441 of title 28, United States Code, is amended by adding at the end the following:
“(g) Certain actions against medical professionals.— (1) A health care liability action brought in a State court against an applicable eligible professional, health care provider, 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 pending.
“(2) In this subsection, the terms ‘applicable eligible professional’, ‘health care liability action’, ‘health care organization’, and ‘health care provider’ have the meaning given such terms in section 10 of the Saving Lives, Saving Costs Act.”.
SEC. 9. Mandatory review by independent medical panel.
(a) In general.—If, in any health care liability action removed to Federal court pursuant to section 1441(g) of title 28, United States Code, against an applicable eligible professional, health care provider, or health care organization, the applicable eligible professional, health care provider, or health care organization alleges, in response to a filing of the claimant, that the applicable eligible professional, health care provider, or health care organization 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, appointed in accordance with paragraph (5).
(2) REQUIREMENTS FOR MEMBER ELIGIBILITY.—
(A) IN GENERAL.—To be eligible to serve on an independent medical review panel, a member shall—
(i) be an experienced physician certified by a board recognized by the American Board of Medical Specialties or the American Osteopathic Association Bureau of Osteopathic Specialists;
(ii) 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
(iii) be approved by his or her specialty society.
(B) REGIONAL PREFERENCE.—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, 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 that, under certain circumstances, it may be appropriate for a physician to depart from the recommendations in clinical practice guidelines in the care of individual patients.
(5) SELECTION OF MEMBERS.—Each member of the independent medical review 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 independent medical review panel shall be shared 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, subject to the provisions of subsection (b)(4).
(2) 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 26 of the Federal Rules of Civil Procedure, any medical records that would be discoverable if the lawsuit advances to trial, and the applicable prescribed clinical practice guidelines.
(3) 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 result, or that the patient died.
(4) 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 liability, but 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.
(1) IN GENERAL.—Not later than 60 days after all members of the independent medical review 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 there are any applicable clinical practice guidelines to the health care liability action that substantively pertains to the injury suffered by the claimant.
(B) Whether the applicable eligible professional has alleged adherence to any such guideline.
(C) Whether the applicable eligible professional adhered to any such guideline.
(D) Whether there is a reasonable probability that—
(i) the applicable eligible professional violated the applicable clinical practice guideline;
(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 independent medical review panel made any finding under paragraph (2)(D) that there was no reasonable probability of the matters described in clauses (i) through (iii), 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) of paragraph (2) 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 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 case.
In this Act:
(1) 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 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) DIAGNOSTIC GUIDELINE.—The term “diagnostic guideline” means a clinical practice guideline that provides recommendation regarding the utility of diagnosis procedures for a specific clinical scenario.
(5) ELIGIBLE PROFESSIONAL ORGANIZATION.—The term “eligible professional organization” means a national or State medical society or medical specialty society.
(6) 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.
(7) 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.
(8) HEALTH CARE LIABILITY ACTION.—The term “health care liability action” means a civil action against an applicable eligible professional, 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.
(9) HEALTH CARE LIABILITY CLAIM.—The term “health care liability claim” means a claim by any person against an applicable eligible professional, 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 or 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.
(10) 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.
(11) 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.
(12) SECRETARY.—The term “Secretary” means the Secretary of Health and Human Services.