[Congressional Bills 112th Congress]
[From the U.S. Government Printing Office]
[H.R. 3239 Introduced in House (IH)]
112th CONGRESS
1st Session
H. R. 3239
To provide certain legal safe harbors to Medicare and Medicaid
providers who participate in the EHR meaningful use program or
otherwise demonstrate use of certified health information technology.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
October 21, 2011
Mr. Marino introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To provide certain legal safe harbors to Medicare and Medicaid
providers who participate in the EHR meaningful use program or
otherwise demonstrate use of certified health information technology.
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 ``Safeguarding Access For Every
Medicare Patient Act''.
SEC. 2. COVERED ENTITIES.
(a) 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) and a year, any of the
following:
(1) Meaningful ehr users.--Any of the following, with
respect to such year:
(A) An eligible professional (as defined in
paragraph (5)(C) of section 1848(o) of the Social
Security Act) 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.
(B) In the case of a qualifying MA organization (as
defined in paragraph (5) of section 1853(l) of such
Act), an eligible professional described in paragraph
(2) 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.
(C) In the case of a qualifying MA organization (as
defined in paragraph (5) of section 1853(l) of such
Act), an eligible hospital described in section
1853(m)(2) of such Act of the organization which
attests under section 1853(l)(6) of such Act to be a
meaningful EHR user for the applicable period with
respect to such year.
(D) An eligible hospital (as defined in paragraph
(6)(B) of section 1886(n) of such Act) 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.
(E) A critical access hospital determined pursuant
to section 1814(l)(3) of such Act to be a meaningful
EHR user (as would be determined under paragraph (3) of
section 1886(n) of such Act) for an EHR reporting
period (as defined in paragraph (6)(A) of such section)
for a cost reporting period beginning during such year.
(F) A Medicaid provider (as defined in paragraph
(2) of section 1903(t) of such Act) eligible for
payments described in paragraph (1) of such section for
such year.
(2) 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 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 section 3(a) of this
Act.
(3) Certain other ehr users.--A health care professional
who, during such year--
(A) is a user of such certified EHR technology;
(B) 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);
(ii) an eligible professional described in
paragraph (2) of section 1853(l) of such Act,
with respect to a qualifying MA organization
(as defined in paragraph (5) of such section);
(iii) an eligible hospital described in
section 1853(m)(2) of such Act, 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);
(v) a critical access hospital; or
(vi) a Medicaid provider (as defined in
paragraph (2) of section 1903(t) of such Act);
and
(C) attests, to the satisfaction of the Secretary,
that but for the reason described in subparagraph (B),
the professional would otherwise satisfy criteria to be
eligible for such incentive payments during such year.
SEC. 3. IMPROVING PATIENT SAFETY THROUGH ERROR REPORTING AND
REMEDIATION, AND CLARIFICATION OF AUTHORITY.
(a) In General.--A covered entity may submit to a Patient Safety
Organization as defined in section 921. Title IX of the Public Health
Service Act (42 U.S.C. 299 et seq.) information on EHR-related adverse
events with respect to certified EHR technology as defined in section
3001 of the Public Health Service Act (42 U.S.C. 300jj-11) used or
provided by such entity, as applicable. The utilization of patient
safety work product shall be for the purpose of providing direct
feedback and assistance to covered entities to effectively minimize
patient risk. Patient Safety Organizations may furnish the Office of
the National Coordinator de-identified reports of their findings for
the purposes of tracking the number and nature of such adverse events.
(b) Application of Safety Organization Privilege and
Confidentiality Protections.--In the case of a covered entity that
submits to such a body information on such an adverse event and in the
case of the collection and maintenance of such information by such a
body, the provisions of section 922 of the Public Health Service Act
shall apply to such information and to the body 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.
(c) Clarification of Authority.--Certified EHR's shall not be
considered a device for purposes of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.).
SEC. 4. 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.
SEC. 5. LEGAL PROTECTIONS FOR COVERED ENTITIES.
(a) General.--For a covered entity described in section 2, the
following protections apply:
(1) Encouraging speedy resolution of claims.--
(A) 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.
(B) 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 not later than 3 years after the
date of the alleged manifestation of injury except that
actions by a claimant under the full age of 6 years
shall be commenced not later than 3 years after the
date of manifestation of injury or prior to the
claimant's 8th birthday, whichever provides a longer
period. In addition to subsection (1)(A)(i)-(iii), 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.
(2) Equitable assignment of responsibility.--In any health
care lawsuit against a covered entity--
(A) 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);
(B) 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
(C) for purposes of this paragraph, the trier of
fact shall determine the proportion of responsibility
of each such party for the claimant's harm.
(3) 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.
(4) 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.
(5) 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.
SEC. 6. DEFINITIONS.
(a) 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.
(b) 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 non
pecuniary losses of any kind or nature. Such term includes economic
damages and noneconomic damages, as such terms as defined in this
section.
(c) 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.
(d) Certified EHR Technology.--The term ``certified EHR
technology'' has the meaning given such term in section 1848(o)(4) of
the Social Security Act.
(e) 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.
(f) 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.
(g) 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.
(h) 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.
(i) 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.
(j) 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.
(k) 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.
(l) 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.
(m) 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.
(n) 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.
(o) 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.
(p) State.--The term ``State'' means each of the several States,
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.
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