[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1475 Introduced in Senate (IS)]

114th CONGRESS
  1st Session
                                S. 1475

To provide for the creation of a safe harbor for defendants in medical 
  malpractice actions who demonstrate adherence to clinical practice 
                              guidelines.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              June 2, 2015

  Mr. Barrasso (for himself and Mrs. Capito) introduced the following 
    bill; 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 
                              guidelines.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    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.
    (b) Maintenance.--
            (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.

SEC. 3. DEVELOPMENT.

    (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) 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) 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 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 to the 
Secretary by eligible professional organizations shall be made 
promptly, upon submission of the guidelines, and during every review of 
the guidelines. Disclosures shall include the following:
            (1) Scientific methodology and evidence that supports 
        clinical practice guidelines.
            (2) Outside collaborators.
            (3) Endorsements.

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:
``Sec. 1370. Health care liability claims
    ``(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:

``1370. Health care liability claims.''.

SEC. 8. 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) 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;
                            (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.
    (d) Results of Review.--
            (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.

SEC. 10. DEFINITIONS.

    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) 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 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.
            (8) 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.
            (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) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
                                 <all>