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) provide a clear explanation of the relation-
ship between care options and health outcomes; 
(6) provide ratings of both the quality of evi-
dence 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 disclose any conflicts of interest pertaining 
to the development of the clinical practice guideline, in-
cluding any conflict of interest pertaining to any instru-
ment, medicine, drug, or any other substance, device, or 
means included in the clinical practice guideline. Disclo-
sures to the Secretary by eligible professional organiza-
tions shall be made promptly, upon submission of the 
guidelines, and during every review of the guidelines. Dis-
closures shall include the following: 
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(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 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-
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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. 
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 fol-
lowing: 
‘‘§ 1370. Health care liability claims 
‘‘(a) DEFINITIONS.—In this section, the terms ‘appli-
cable 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 ac-
tion 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 
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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 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.’’. 
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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 
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.— 
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(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; 
(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 
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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 
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: 
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(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 
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-
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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-
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. 
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(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; 
(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 sum-
mary judgment in favor of the applicable eligible 
professional unless the claimant is able to show oth-
erwise 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 
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claimant is able to show otherwise by clear and con-
vincing 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 de-
fendant applicable eligible professional’s nonadher-
ence to the applicable standard was neither the 
cause in fact nor the proximate cause of the plain-
tiff’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 eligi-
ble professional to summary judgment unless the 
plaintiff is able to show by clear and convincing evi-
dence 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 guide-
lines submitted by an eligible professional organiza-
tion and includes employees and agents of a physi-
cian. 
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(2) APPROPRIATE
USE
CRITERIA.—The term 
‘‘appropriate use criteria’’ means established evi-
dence-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 de-
veloped statements based on the review of clinical 
evidence for assisting a health care provider to de-
termine the appropriate health care in specific clin-
ical circumstances. 
(4) ELIGIBLE PROFESSIONAL ORGANIZATION.— 
The term ‘‘eligible professional organization’’ means 
a national or State medical society or medical spe-
cialty 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, 
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or medical screenings, treatments, or transfer serv-
ices 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 organiza-
tion, 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 ac-
tion 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, defend-
ants, or other parties, or the number of causes of ac-
tion, in which the claimant alleges a health care li-
ability claim. 
(8) HEALTH
CARE
LIABILITY
CLAIM.—The 
term ‘‘health care liability claim’’ means a claim by 
any person against an applicable eligible profes-
sional, a health care provider, or a health care orga-
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nization 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 en-
tity 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 admin-
ister 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, reg-
istered, or certified, or exempted from such require-
ment by other statute or regulation. 
(11) 
SECRETARY.—The 
term 
‘‘Secretary’’ 
means the Secretary of Health and Human Services. 
Æ 
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