Saving Lives, Saving Costs Act - Establishes a framework for health care liability lawsuits to undergo review by independent medical review panels if health care professionals (practicing physicians or their agents or employees) allege adherence to applicable clinical practice guidelines in the provision of health care goods or services.
Requires the Secretary of Health and Human Services (HHS) to publish clinical practice guidelines that have been provided and maintained by national or state medical societies or medical specialty societies designated by the Secretary. Sets forth standards for the development of guidelines, including related to transparency, the composition of the panel, and the review of existing evidence.
Declares that this Act does 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 under this Act nor does it create a cause of action or preempt any defenses otherwise available.
Allows a defendant to remove any health care liability action brought in a state court to a district court.
Requires an independent medical review in health care liability actions if the eligible professionals allege that they adhered to applicable clinical practice guideline. Sets forth procedures for the use of the panel's findings at trial. Enables defendants to recover costs and attorneys' fees from plaintiffs if the defendants prevail subsequent to preliminary findings in their favor.
[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.
<all>
Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on the Constitution and Civil Justice.
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