Library / Laws / 113th / hr / H.R. 2957 / Introduced in House
I
113th CONGRESS
1st Session
H. R. 2957
IN THE HOUSE OF REPRESENTATIVES
August 1, 2013
Mr. Murphy of
Pennsylvania (for himself, Mr.
Barber, Mr. Roe of
Tennessee, Mr. Burgess,
Mr. Cassidy,
Mr. Dent, Mr. Tiberi, Mrs.
Blackburn, Mr. Guthrie,
Mr. Bucshon, and
Mr. Marino) introduced the following
bill; which was referred to the Committee
on Energy and Commerce, and in addition to the Committee on
Ways and Means, 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 amend the Public Health Service Act and the Social
Security Act to extend health information technology assistance eligibility to
behavioral health, mental health, and substance abuse professionals and
facilities, and for other purposes.
1.
Short title
This Act may be cited as the
Behavioral Health Information
Technology Act of 2013.
2.
Extension of
health information technology assistance for behavioral and mental health and
substance abuse
Section
3000(3) of the Public Health Service Act (42 U.S.C. 300jj(3)) is amended by
inserting before and any other category the following:
behavioral and mental health professionals (as defined in section
331(a)(3)(E)(i)), a substance abuse professional, a psychiatric hospital (as
defined in section 1861(f) of the Social Security Act), a community mental
health center meeting the criteria specified in section 1913(c), a residential
or outpatient mental health or substance abuse treatment
facility,.
3.
Extension of
eligibility for medicare and Medicaid health information technology
implementation assistance
(a)
Payment
incentives for eligible professionals under medicare
Section 1848
of the Social Security Act (42 U.S.C. 1395w–4) is amended—
(1) in subsection
(a)(7)—
(A) in subparagraph
(E), by adding at the end the following new clause:
(iv)
Additional
eligible professional
The
term additional eligible professional means a clinical
psychologist providing qualified psychologist services (as defined in section
1861(ii)).
;
and
(B) by adding at the
end the following new subparagraph:
(F)
Application to
additional eligible professionals
The Secretary shall apply the provisions of
this paragraph with respect to an additional eligible professional in the same
manner as such provisions apply to an eligible professional, except in applying
subparagraph (A)—
(i) in
clause (i), the reference to 2015 shall be deemed a reference to 2019;
(ii) in clause (ii),
the references to 2015, 2016, and 2017 shall be deemed references to 2019,
2020, and 2021, respectively; and
(iii) in clause (iii),
the reference to 2018 shall be deemed a reference to
2022.
;
and
(2) in subsection
(o)—
(A) in paragraph (5),
by adding at the end the following new subparagraph:
(D)
Additional
eligible professional
The
term additional eligible professional means a clinical
psychologist providing qualified psychologist services (as defined in section
1861(ii)).
;
and
(B) by adding at the
end the following new paragraph:
(6)
Application to
additional eligible professionals
The Secretary shall apply the provisions of
this subsection with respect to an additional eligible professional in the same
manner as such provisions apply to an eligible professional, except in
applying—
(A) paragraph (1)(A)(ii), the reference to 2016
shall be deemed a reference to 2020;
(B) paragraph
(1)(B)(ii), the references to 2011 and 2012 shall be deemed references to 2015
and 2016, respectively;
(C) paragraph
(1)(B)(iii), the references to 2013 shall be deemed references to 2017;
(D) paragraph
(1)(B)(v), the references to 2014 shall be deemed references to 2018;
and
(E) paragraph (1)(E),
the reference to 2011 shall be deemed a reference to
2015.
.
(b)
Eligible
hospitals
Section 1886 of the Social Security Act (42 U.S.C.
1395ww) is amended—
(1) in subsection (b)(3)(B)(ix), by adding at
the end the following new subclause:
(V) The Secretary shall apply the provisions of
this subsection with respect to an additional eligible hospital (as defined in
subsection (n)(6)(C)) in the same manner as such provisions apply to an
eligible hospital, except in applying—
(aa) subclause (I),
the references to 2015, 2016, and 2017 shall be deemed references to 2019,
2020, and 2021, respectively; and
(bb) subclause (III),
the reference to 2015 shall be deemed a reference to
2019.
;
and
(2) in subsection
(n)—
(A) in paragraph (6),
by adding at the end the following new subparagraph:
(C)
Additional
eligible hospital
The term
additional eligible hospital means an inpatient hospital that is
a psychiatric hospital (as defined in section
1861(f)).
;
and
(B) by adding at the
end the following new paragraph:
(7)
Application to
additional eligible hospitals
The Secretary shall apply the provisions of
this subsection with respect to an additional eligible hospital in the same
manner as such provisions apply to an eligible hospital, except in
applying—
(A) paragraph
(2)(E)(ii), the references to 2013 and 2015 shall be deemed references to 2017
and 2019, respectively; and
(B) paragraph
(2)(G)(i), the reference to 2011 shall be deemed a reference to
2015.
.
(c)
Medicaid
providers
Section 1903(t) of the Social Security Act (42 U.S.C.
1396b(t)) is amended—
(1) in paragraph
(2)(B)—
(A) in clause (i), by
striking , or and inserting a semicolon;
(B) in clause (ii), by
striking the period and inserting a semicolon; and
(C) by adding after
clause (ii) the following new clauses:
(iii) a public
hospital that is principally a psychiatric hospital (as defined in section
1861(f));
(iv) a
private hospital that is principally a psychiatric hospital (as defined in
section 1861(f)) and that has at least 10 percent of its patient volume (as
estimated in accordance with a methodology established by the Secretary)
attributable to individuals receiving medical assistance under this
title;
(v) a community mental health center meeting
the criteria specified in section 1913(c) of the Public Health Service Act;
or
(vi) a
residential or outpatient mental health or substance abuse treatment facility
that—
(I) is accredited by the Joint Commission on
Accreditation of Healthcare Organizations, the Commission on Accreditation of
Rehabilitation Facilities, the Council on Accreditation, or any other national
accrediting agency recognized by the Secretary; and
(II) has at least 10
percent of its patient volume (as estimated in accordance with a methodology
established by the Secretary) attributable to individuals receiving medical
assistance under this title.
;
and
(2) in paragraph
(3)(B)—
(A) in clause (iv), by
striking and after the semicolon;
(B) in clause (v), by
striking the period and inserting ; and; and
(C) by adding at the
end the following new clause:
(vi) clinical
psychologist providing qualified psychologist services (as defined in section
1861(ii)), if such clinical psychologist is practicing in an outpatient clinic
that—
(I) is led by a
clinical psychologist; and
(II) is not otherwise
receiving payment under paragraph (1) as a Medicaid provider described in
paragraph
(2)(B).
.
(d)
Medicare
Advantage organizations
Section 1853 of the Social Security Act
(42 U.S.C. 1395w–23) is amended—
(1) in subsection
(l)—
(A) in paragraph
(1)—
(i) by
inserting or additional eligible professionals (as described in
paragraph (9)) after paragraph (2); and
(ii) by
inserting and additional eligible professionals before
under such sections;
(B) in paragraph
(3)(B)—
(i) in
clause (i) in the matter preceding subclause (I), by inserting or an
additional eligible professional described in paragraph (9) after
paragraph (2); and
(ii) in clause (ii)—
(I) in the matter
preceding subclause (I), by inserting or an additional eligible
professional described in paragraph (9) after paragraph
(2); and
(II) in subclause (I), by inserting or an
additional eligible professional, respectively, after eligible
professional;
(C) in paragraph (3)(C), by inserting
and additional eligible professionals after all eligible
professionals;
(D) in paragraph
(4)(D), by adding at the end the following new sentence: In the case
that a qualifying MA organization attests that not all additional eligible
professionals of the organization are meaningful EHR users with respect to an
applicable year, the Secretary shall apply the payment adjustment under this
paragraph based on the proportion of all such additional eligible professionals
of the organization that are not meaningful EHR users for such
year.;
(E) in paragraph (6)(A), by inserting
and, as applicable, each additional eligible professional described in
paragraph (9) after paragraph (2);
(F) in paragraph (6)(B), by inserting
and, as applicable, each additional eligible hospital described in
paragraph (9) after subsection (m)(1);
(G) in paragraph (7)(A), by inserting
and, as applicable, additional eligible professionals after
eligible professionals;
(H) in paragraph (7)(B), by inserting
and, as applicable, additional eligible professionals after
eligible professionals;
(I) in paragraph (8)(B), by inserting
and additional eligible professionals described in paragraph (9)
after paragraph (2); and
(J) by adding at the
end the following new paragraph:
(9)
Additional
eligible professional described
With respect to a qualifying MA
organization, an additional eligible professional described in this paragraph
is an additional eligible professional (as defined for purposes of section
1848(o)) who—
(A)
(i) is employed by the
organization; or
(ii)
(I) is employed by, or is a
partner of, an entity that through contract with the organization furnishes at
least 80 percent of the entity’s Medicare patient care services to enrollees of
such organization; and
(II) furnishes at least 80 percent of
the professional services of the additional eligible professional covered under
this title to enrollees of the organization; and
(B) furnishes, on
average, at least 20 hours per week of patient care
services.
;
and
(2) in subsection
(m)—
(A) in paragraph
(1)—
(i) by
inserting or additional eligible hospitals (as described in paragraph
(7)) after paragraph (2); and
(ii) by
inserting and additional eligible hospitals before under
such sections;
(B) in paragraph
(3)(A)(i), by inserting or additional eligible hospital after
eligible hospital;
(C) in paragraph
(3)(A)(ii), by inserting or an additional eligible hospital
after eligible hospital in each place it occurs;
(D) in paragraph
(3)(B)—
(i) in
clause (i), by inserting or an additional eligible hospital described in
paragraph (7) after paragraph (2); and
(ii) in clause (ii)—
(I) in the matter
preceding subclause (I), by inserting or an additional eligible hospital
described in paragraph (7) after paragraph (2);
and
(II) in subclause (I), by inserting or an
additional eligible hospital, respectively, after eligible
hospital;
(E) in paragraph
(4)(A), by inserting or one or more additional eligible hospitals (as
defined in section 1886(n)), as appropriate, after section
1886(n)(6)(A));
(F) in paragraph
(4)(D), by adding at the end the following new sentence: In the case
that a qualifying MA organization attests that not all additional eligible
hospitals of the organization are meaningful EHR users with respect to an
applicable period, the Secretary shall apply the payment adjustment under this
paragraph based on the methodology specified by the Secretary, taking into
account the proportion of such additional eligible hospitals, or discharges
from such hospitals, that are not meaningful EHR users for such
period.;
(G) in paragraph (5)(A), by inserting
and, as applicable, each additional eligible hospital described in
paragraph (7) after paragraph (2);
(H) in paragraph (5)(B), by inserting
and additional eligible hospitals, as applicable, after
eligible hospitals;
(I) in paragraph (6)(B), by inserting
and additional eligible hospitals described in paragraph (7)
after paragraph (2); and
(J) by adding at the
end the following new paragraph:
(7)
Additional
eligible hospital described
With respect to a qualifying MA
organization, an additional eligible hospital described in this paragraph is an
additional eligible hospital (as defined in section 1886(n)(6)(C)) that is
under common corporate governance with such organization and serves individuals
enrolled under an MA plan offered by such
organization.
.
4.
Providing
protections for certain providers, vendors, and users of certified EHR
technology
(a)
Covered
entities
(1)
Covered
entities
For purposes of this
section, a covered entity means, with respect to certified EHR technology (as
defined in section 1848(o)(4) of the Social Security Act (42 U.S.C.
1395w–4(o)(4))) and a year, any of the following:
(A)
Meaningful EHR
users
(i) An eligible professional (as defined in
paragraph (5)(C) of section 1848(o) of the Social Security Act (42 U.S.C.
1395w–4(o))) determined to be a meaningful EHR user under paragraph (2) of such
section for the EHR reporting period (as defined in paragraph (5)(B) of such
section) during such year, or an additional eligible professional (as defined
in paragraph (5)(D) of such section) determined to be a meaningful EHR user
pursuant to paragraph (6) of such section for the EHR reporting period (as
defined in paragraph (5)(B) of such section) during such year.
(ii) In the case of a qualifying MA organization
(as defined in paragraph (5) of section 1853(l) of such Act (42 U.S.C.
1395w–23(l))), an eligible professional described in paragraph (2) of such
section or, as applicable, an additional eligible professional described in
paragraph (9) of such section of the organization who the organization attests
under paragraph (6) of such section to be a meaningful EHR user for such
year.
(iii) In the case of a qualifying MA organization
(as so defined), an eligible hospital described in section 1853(m)(2) of such
Act (42 U.S.C. 1395w–23(m)(2)) or, as applicable, an additional eligible
hospital described in section 1853(m)(7) of such Act (42 U.S.C. 1395w–23(m)(7))
of the organization which attests under section 1853(l)(6) of such Act (42
U.S.C. 1395w–23(l)(6)) to be a meaningful EHR user for the applicable period
with respect to such year.
(iv) An eligible hospital (as defined in
paragraph (6)(B) of section 1886(n) of such Act (42 U.S.C. 1395ww(n))
determined to be a meaningful EHR user under paragraph (3) of such section for
the EHR reporting period (as defined in paragraph (6)(A) of such section) with
respect to such year, or an additional eligible hospital (as defined in
paragraph (6)(C) of such section) determined to be a meaningful EHR user under
paragraph (7) of such section for the EHR reporting period (as defined in
paragraph (6)(A) of such section) with respect to such year.
(v) A critical access hospital determined
pursuant to section 1814(l)(3) of such Act (42 U.S.C. 1395f(l)(3)) to be a
meaningful EHR user (as would be determined under paragraph (3) of section
1886(n) of such Act (42 U.S.C. 1395ww(n))) for an EHR reporting period (as
defined in paragraph (6)(A) of such section) for a cost reporting period
beginning during such year.
(vi) A Medicaid provider (as defined in
paragraph (2) of section 1903(t) of such Act (42 U.S.C. 1396b(t))) eligible for
payments described in paragraph (1) of such section for such year.
(B)
Health
information exchange entities
Individuals and entities (other than States
or State designated entities) which during such year are health information
exchange contractors (consisting of technology providers), health information
exchange participants (consisting of organizations providing supportive
technology to a health information exchange), and other users of health
information exchanges (consisting of other entities that may be exchanging
clinical or administrative data). Manufacturers of electronic health record
(EHR) software and other health information technologies who participate in the
reporting of adverse events or who otherwise contribute relevant patient safety
work product under subsection (b)(1).
(C)
Certain other
EHR users
A health care
professional who, during such year—
(i) is a user of such
certified EHR technology;
(ii) is not eligible
for incentive payments based on meaningful use of such technology under title
XVIII or XIX of the Social Security Act solely because the professional is
not—
(I) an eligible professional (as defined in
paragraph (5)(C) of section 1848(o) of such Act (42 U.S.C. 1395w–4(o)));
(II) an eligible professional described in
paragraph (2) of section 1853(l) of such Act (42 U.S.C. 1395w–23(l)) or, as
applicable, an additional eligible professional described in paragraph (9) of
such section, with respect to a qualifying MA organization (as defined in
paragraph (5) of such section);
(III) an eligible hospital described in paragraph
(2) of section 1853(m) of such Act (42 U.S.C. 1395w–23(m)) or, as applicable,
an additional eligible hospital described in paragraph (7) of such section,
with respect to such a qualifying MA organization;
(IV) an eligible hospital (as defined in
paragraph (6)(B) of section 1886(n) of such Act (42 U.S.C. 1395ww(n)));
(V) a critical access
hospital;
(VI) a Medicaid provider (as defined in
paragraph (2) of section 1903(t) of such Act (42 U.S.C. 1396b(t)));
(VII) an additional eligible professional (as
defined in paragraph (5)(D) of section 1848(o) of such Act (42 U.S.C.
1395w–4(o))); or
(VIII) an additional eligible hospital (as defined
in paragraph (6)(C) of section 1886(n) of such Act (42 U.S.C. 1395ww(n)));
and
(iii) attests, to the
satisfaction of the Secretary of Health and Human Services, that but for the
reason described in clause (ii), the professional would otherwise satisfy
criteria to be eligible for such incentive payments during such year.
(b)
Improving
patient safety through error reporting and remediation, and clarification of
authority
(1)
Quarterly
reporting by patient safety organizations
Paragraph (1) of
section 924(b) of the Public Health Service Act (42 U.S.C. 299b–24) is amended
by adding at the end the following:
(H) Not less than quarterly each year, the
entity shall submit to the Office of the National Coordinator findings
that—
(i) exclude any
individually identifiable information;
(ii) are based on
information submitted to the entity by covered entities (as defined in section
4(a)(1) of the Behavioral Health Information
Technology Act of 2013);
(iii) describe the
number and nature of EHR-related adverse events with respect to certified EHR
technology (as such terms are defined in section 4(e) of such Act) so reported;
and
(iv) for each such
EHR-related adverse event, identify the type event and the type electronic
health record
involved.
.
(2)
Application of
safety organization privilege and confidentiality protections
In the case of a covered entity that
submits to a patient safety organization information on an EHR-related adverse
event with respect to certified EHR technology, and in the case of the
collection and maintenance of such information by a patient safety
organization, the provisions of section 922 of the Public Health Service Act
(42 U.S.C. 299b–22) shall apply to such information and to the organization and
the entity in the same manner such provisions apply to patient safety work
product and a patient safety organization and provider under part C of title IX
of such Act (42 U.S.C. 299b–2 et seq.).
(3)
Clarification of
authority
Certified EHR technology shall not be considered to be
a device for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.).
(c)
Rules relating
to E-Discovery
In any health care lawsuit against a covered
entity that is related to an EHR-related adverse event, with respect to
certified EHR technology used or provided by the covered entity, electronic
discovery shall be limited to—
(1) information that
is related to such EHR-related adverse event; and
(2) information from
the period in which such EHR-related adverse event occurred.
(d)
Legal
protections for covered entities
(1)
General
For
a covered entity described in subsection (a), the following protections
apply:
(A)
Encouraging
speedy resolution of claims
(i)
General
A
claimant may not commence a health care lawsuit against a covered entity on any
date that is 3 years after the date of manifestation of injury or 1 year after
the claimant discovers, or through the use of reasonable diligence should have
discovered, the injury, whichever occurs first. This limitation shall be tolled
to the extent that the claimant is able to prove—
(I) fraud;
(II) intentional
concealment; or
(III) the presence of
a foreign body, which has no therapeutic or diagnostic purpose or effect, in
the person of the injured person.
(ii)
Treatment of a
minor
A health care lawsuit by or on behalf of a claimant under
the age of 17 years at the time the injury was suffered may not be commenced
after the date that is 3 years after the date of the alleged manifestation of
injury except that actions by a claimant under the age of 6 years may not be
commenced after the date that is 3 years after the date of manifestation of
injury or prior to the claimant’s 8th birthday, whichever provides a longer
period. This limitation shall be tolled for claimants under the age of 17 years
for any period during which a parent or guardian and a health care provider or
health care organization have committed fraud or collusion in the failure to
bring an action on behalf of the claimant.
(B)
Equitable
assignment of responsibility
In any health care lawsuit against a
covered entity—
(i) each
party to the lawsuit other than the claimant that is such a covered entity
shall be liable for that party’s several share of any damages only and not for
the share of any other person and such several share shall be in direct
proportion to that party’s proportion of responsibility for the injury, as
determined under clause (iii);
(ii) whenever a
judgment of liability is rendered as to any such party, a separate judgment
shall be rendered against each such party for the amount allocated to such
party; and
(iii) for purposes of
this subparagraph, the trier of fact shall determine the proportion of
responsibility of each such party for the claimant’s harm.
(C)
Subsequent
remedial measures
Evidence of subsequent remedial measures to an
EHR-related adverse event with respect to certified EHR technology used or
provided by the covered entity (including changes to the certified EHR system,
additional training requirements, or changes to standard operating procedures)
by a covered entity shall not be admissible in health care lawsuits.
(D)
Increased burden
of proof protection for covered entities
Punitive damages may, if
otherwise permitted by applicable State or Federal law, be awarded against any
covered entity in a health care lawsuit only if it is proven by clear and
convincing evidence that such entity acted with reckless disregard for the
health or safety of the claimant. In any such health care lawsuit where no
judgment for compensatory damages is rendered against such entity, no punitive
damages may be awarded with respect to the claim in such lawsuit.
(E)
Protection from
libel or slander
Covered entities and employees, agents and
representatives of covered entities are immune from civil action for libel or
slander arising from information or entries made in certified EHR technology
and for the transfer of such information to another eligible provider, hospital
or health information exchange, if the information, transfer of information, or
entries were made in good faith and without malice.
(e)
Definitions
In this section:
(1)
Claimant
The
term claimant means any person who brings a health care lawsuit,
including a person who asserts or claims a right to legal or equitable
contribution, indemnity, or subrogation, arising out of a health care liability
claim or action, and any person on whose behalf such a claim is asserted or
such an action is brought, whether deceased, incompetent, or a minor.
(2)
Compensatory
damages
The term compensatory damages means
objectively verifiable monetary losses incurred as a result of the provisions
of, use of, or payment for (or failure to provide, use, or pay for) health care
services or medical products, such as past and future medical expenses, loss of
past and future earnings, cost of obtaining domestic services, loss of
employment, and loss of business or employment opportunities, damages for
physical and emotional pain, suffering, inconvenience, physical impairment,
mental anguish, disfigurement, loss of enjoyment in life, loss of society and
companionship, loss of consortium (other than loss of domestic service),
hedonic damages, injury to reputation, and all other nonpecuniary losses of any
kind or nature. Such term includes economic damages and noneconomic damages, as
such terms are defined in this subsection.
(3)
Economic
damages
The term economic damages means objectively
verifiable monetary losses incurred as a result of the provisions of, use of,
or payment for (or failure to provide, use, or pay for) health care services or
medical products, such as past and future medical expenses, loss of past and
future earnings, cost of obtaining domestic services, loss of employment, and
loss of business or employment opportunities.
(4)
Certified EHR
technology
The term certified EHR technology has the
meaning given such term in section 1848(o)(4) of the Social Security Act (42
U.S.C. 1395w–4(o)(4)).
(5)
EHR-related
adverse event
The term EHR-related adverse event
means, with respect to a provider, a defect, malfunction, or error in the
certified health information technology or electronic health record used by the
provider, or in the input or output of data maintained through such technology
or record, that results or could reasonably result in harm to a patient.
(6)
Health care
lawsuit
The term health care lawsuit means any
health care liability claim concerning the provision of health care items or
services or any medical product affecting interstate commerce, or any health
care liability action concerning the provision of health care items or services
or any medical product affecting interstate commerce, brought in a State or
Federal court or pursuant to an alternative dispute resolution system, against
a health care provider, a health care organization, or the manufacturer,
distributor, supplier, marketer, promoter, or seller of a medical product,
regardless of the theory of liability on which the claim is based, or the
number of claimants, plaintiffs, defendants, or other parties, or the number of
claims or causes of action, in which the claimant alleges a health care
liability claim. Such term does not include a claim or action which is based on
criminal liability; which seeks civil fines or penalties paid to Federal,
State, or local government; or which is grounded in antitrust.
(7)
Health care
liability action
The term health care liability
action means a civil action brought in a State or Federal court or
pursuant to an alternative dispute resolution system, against a health care
provider, a health care organization, or the manufacturer, distributor,
supplier, marketer, promoter, or seller of a medical product, 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 demand by any person, whether or not pursuant to alternative dispute
resolution, against a health care provider, health care organization, or the
manufacturer, distributor, supplier, marketer, promoter, or seller of a medical
product, including third-party claims, cross-claims, counter-claims, or
contribution claims, which are based upon the provision of, use of, or payment
for (or the failure to provide, use or pay for) health care services or medical
products, 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.
(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)
Health care
items or services
The term health care items or
services means any items 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.
(12)
Malicious
intent To injure
The term malicious intent to injure
means intentionally causing or attempting to cause physical injury other than
providing health care items or services.
(13)
Medical
product
The term medical product means a drug,
device, or biological product intended for humans, and the terms
drug, device, and biological product
have the meanings given such terms in sections 201(g)(1) and 201(h) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1) and (h)) and section
351(a) of the Public Health Service Act (42 U.S.C. 262(a)), respectively,
including any component or raw material used therein, but excluding health care
services.
(14)
Noneconomic
damages
The term noneconomic damages means damages
for physical impairment, mental anguish, disfigurement, loss of enjoyment of
life, loss of society and companionship, loss of consortium (other than loss of
domestic service), hedonic damages, injury to reputation, and all other
nonpecuniary losses of any kind of nature.
(15)
Patient safety
organization
The term patient safety organization
has the meaning given to such term in section 921 of the Public Health Service
Act (42 U.S.C. 299b–21).
(16)
Punitive
damages
The term punitive damages means damages
awarded, for the purpose of punishment or deterrence, and not solely for
compensatory purposes, against a health care provider, health care
organization, or a manufacturer, distributor, or supplier of a medical product.
Punitive damages are neither economic nor economic damages.
(17)
State
The
term State means each of the several States, the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American
Samoa, the Northern Mariana Islands, the Trust Territory of the Pacific
Islands, and any other territory or possession of the United States, or any
political subdivision thereof.