I 
115TH CONGRESS 
1ST SESSION H. R. 1565 
To provide for the creation of a safe harbor for defendants in medical 
malpractice actions who demonstrate adherence to clinical practice guidelines. 
IN THE HOUSE OF REPRESENTATIVES 
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 Com-
mittee on the Judiciary, for a period to be subsequently determined by 
the Speaker, in each case for consideration of such provisions as fall with-
in the jurisdiction of the committee concerned 
A BILL 
To provide for the creation of a safe harbor for defendants 
in medical malpractice actions who demonstrate adher-
ence to clinical practice guidelines. 
Be it enacted by the Senate and House of Representa-
tives 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’’. 
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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 organi-
zations that have established, published, maintained, and 
updated on a regular basis, clinical practice guidelines, in-
cluding when applicable, appropriate use criteria, that in-
corporate 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 organiza-
tions to provide and maintain such clinical practice guide-
lines on behalf of the Secretary. Not later than 6 months 
after designating each such eligible professional organiza-
tion, the Secretary shall enter into an agreement with each 
such eligible professional organization for maintenance, 
publication, and updating of such clinical practice guide-
lines. 
(b) MAINTENANCE.— 
(1) PERIODIC REVIEW.—Not later than 5 years 
after the Secretary enters into an agreement with 
each eligible professional organization under sub-
section (a), and every 5 years thereafter, the Sec-
retary shall review the clinical practice guidelines of 
such organization and shall, as necessary, enter into 
agreements with additional eligible professional orga-
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nizations, as appropriate, in accordance with sub-
section (a). 
(2) UPDATE BY ELIGIBLE PROFESSIONAL ORGA-
NIZATION.—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 Sec-
retary for review by the Secretary. 
(3) NOTIFICATION REQUIRED FOR CERTAIN UP-
DATES.—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 profes-
sionals. 
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, multi-
disciplinary panel of experts and representatives 
from key affected groups; 
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(3) take into consideration important patient 
subgroups and patient preferences, as appropriate; 
(4) are based on a systematic review of the ex-
isting evidence; 
(5) except in the case of diagnostic guidelines, 
provide a clear explanation of the relationship be-
tween 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 evi-
dence emerges; and 
(8) clearly identify any exceptions to the appli-
cation of the clinical practice guideline. 
(b) REQUIRED DISCLOSURES FROM ELIGIBLE PRO-
FESSIONAL ORGANIZATIONS.—Any person who is affili-
ated with an eligible professional organization and who di-
rectly 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 
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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 se-
lection of the guidelines in compliance with data disclosure 
standards in the Health Insurance Portability and Ac-
countability Act of 1996 (Public Law 104–191). 
SEC. 6. STATE FLEXIBILITY AND PROTECTION OF STATES’ 
RIGHTS. 
(a) LIMITATION.—This Act shall not preempt or su-
persede any State or Federal law that— 
(1) imposes procedural or substantive protec-
tions for health care providers and health care orga-
nizations from liability, loss, or damages greater 
than such protections provided by this title; or 
(2) creates a cause of action related to the pro-
vision 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 pro-
vision of State or Federal law. 
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States Code, is amended by adding at the end the fol-
lowing: 
‘‘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 PROFES-
SIONALS.—(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 em-
bracing the place where such action is pending. 
‘‘(2) In this subsection, the terms ‘applicable eligible 
professional’, ‘health care liability action’, ‘health care or-
ganization’, 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 ac-
tion removed to Federal court pursuant to section 1441(g) 
of title 28, United States Code, against an applicable eligi-
ble professional, health care provider, or health care orga-
nization, the applicable eligible professional, health care 
provider, or health care organization alleges, in response 
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to a filing of the claimant, that the applicable eligible pro-
fessional, 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 inde-
pendent medical review panel. 
(b) INDEPENDENT MEDICAL REVIEW PANEL.— 
(1) COMPOSITION.—An independent medical re-
view panel under this section shall be composed of 
3 members who are experts in the relevant field of 
clinical practice, appointed in accordance with para-
graph (5). 
(2) 
REQUIREMENTS
FOR
MEMBER
ELIGI-
BILITY.— 
(A) IN GENERAL.—To be eligible to serve 
on an independent medical review panel, a 
member shall— 
(i) be an experienced physician cer-
tified by a board recognized by the Amer-
ican Board of Medical Specialties or the 
American Osteopathic Association Bureau 
of Osteopathic Specialists; 
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(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 spe-
cialty society. 
(B) REGIONAL PREFERENCE.—When pos-
sible, 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 DETERMINA-
TIONS.—The members of the independent medical 
review panel shall acknowledge that, under certain 
circumstances, it may be appropriate for a physician 
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to depart from the recommendations in clinical prac-
tice 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 se-
lection 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 par-
ties, 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 find-
ing as to liability of the defendant applicable eligible 
professional shall deem the prescribed clinical prac-
tice guidelines as the standard of conduct, care, and 
skill expected of members of the medical profession 
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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 find-
ing based solely upon the pre-discovery evidence sub-
mitted 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 re-
view 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 RE-
VIEW PANEL.—No preliminary finding by the inde-
pendent medical review panel that the defendant ap-
plicable 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, opin-
ions, and conclusions of the review panel shall be ad-
missible as evidence in any and all subsequent pro-
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ceedings 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 profes-
sional has alleged adherence to any such guide-
line. 
(C) Whether the applicable eligible profes-
sional adhered to any such guideline. 
(D) Whether there is a reasonable prob-
ability that— 
(i) the applicable eligible professional 
violated the applicable clinical practice 
guideline; 
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