[Congressional Bills 112th Congress]
[From the U.S. Government Publishing 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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