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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4106 Introduced in House (IH)]

113th CONGRESS
  2d Session
                                H. R. 4106

 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.

_______________________________________________________________________

                    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.

    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. 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.

SEC. 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.

SEC. 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.

SEC. 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.

SEC. 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.

SEC. 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.''.

SEC. 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.

SEC. 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.

SEC. 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.
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